Pressure BioSciences, Inc. (OTCQB: PBIO) (“PBI” or the “Company”), a leader in the development and sale of broadly enabling, pressure-based instruments, consumables, and platform technology solutions to the worldwide life sciences industry, today announced the Company’s patented pressure cycling technology (“PCT”) platform was featured as an integral part of a new, innovative workflow for the analysis of proteins from cancer biopsy samples. This workflow was presented in a plenary session at the Annual Meeting of the International Gynecologic Cancer Society (“IGCS”) on September 21, 2019 in Rio de Janeiro, Brazil. The mission of the IGCS is to improve the care and outcomes for women with gynecologic cancer worldwide through education, training and public awareness.
According to Dr. Larry Maxwell, MD, gynecologic oncologist and Chair of OB-GYN at Inova Fairfax Hospital, “the conventional use of chemotherapy in ovarian cancer treatment is being rapidly replaced by biologic therapeutics that target the cancer (the “seed”) and also the micro-environment (the “soil”) in which it grows. Being able to collect small tissue specimens and characterize them across multiple genomic and proteomic platforms will enable us to markedly enhance our ability to develop companion diagnostics and prognostics as well as identify targets for future therapeutic strategies. Technology provided by Pressure BioSciences has become an essential requirement for our novel workflow in meeting our goals.”
Gynecologic malignancies include ovarian, uterine, and cervical cancers. Together they are responsible for approximately 35,000 deaths annually in the United States with ovarian cancer ranking fifth in cancer deaths among women (Aurora Healthcare and the Centers for Disease Control and Prevention). According to Acumen Research and Consulting (2018), the global ovarian cancer diagnostics market alone is forecasted to grow at a CAGR around 5.9% over the forecast time frame and reach around US $1.8 billion by 2026. New, improved methods to detect these cancers are vitally needed to support the design and development of better treatments through enhanced precision medicine. The IGCS is committed to addressing this critical issue.
Dr. Thomas Conrads, a nationally acclaimed protein chemist, is the Senior Director of Women's Health Research at the Inova Women's Hospital. Dr. Conrads’ group was invited to present their innovative workflow for analyzing cancer tissue proteins at the IGCS meeting. The presentation titled Interim Analysis of Ovarian Cancer by the US National Cancer MOONSHOT’S Tri-Federal (DOD/NCI/VA) Applied Proteogenomic Organizational Learning and Outcomes (APOLLO) Research Network, was made by Dr. Maxwell. Data demonstrated the feasibility of proteogenomic characterization of known-patient tumors for specimen preparation in support of large-scale analyses in the U.S. Cancer Moonshot’s APOLLO program. This program focuses on genetic sequencing and proteomic analysis of tumors in order to develop clinically actionable molecular panels for precision medicine and personalized health.
The novel workflow developed by Dr. Conrads and his colleagues integrates the Leica Microsystems’ laser microdissection (LMD) platform and PBI’s PCT platform, enabling micro-scale quantitative proteomics and phosphoproteomics on a ThermoFisher Scientific mass spectrometry (MS) instrument. LMD is a state-of-the-art method for precise excision of cells from biopsy tissues at microscopic scale by a laser. Excised cells are delivered directly into PBI’s MicroTubes for critical sample preparation, including rapid and efficient high-quality cellular protein release. Proteins are then analyzed by mass spectrometry (MS), the global method-of-choice for high throughput and comprehensive protein analysis.
Dr. Conrads commented: “We are very pleased to have been invited to present the results of our work in gynecologic cancer research in a plenary session at this important international meeting. The novel workflow developed by our group integrates and operationalizes state-of-the art techniques: laser microdissection (LMD), pressure cycling technology (PCT), and mass spectrometry (MS) to improve our understanding of the complex tissue microenvironment and, in this case, to enable identification of biomarkers associated with women’s cancers. We believe that the insights we gain from applying this novel workflow will result in significant improvements in the clinical management of gynecologic cancer.”
Dr. Nate Lawrence, Senior Consultant to PBI, said, “Precision medicine promises a paradigm shift in the diagnosis and treatment of disease. This shift is highly dependent on the generation and evaluation of high-quality data generated during comprehensive analyses of each patient’s tumor samples. Although critical to precision medicine the generation of such data from biopsy samples has been difficult to date, as it requires the integration of multiple and varied laboratory processes, including tissue extraction, critical sample processing, and analysis. The innovative workflow developed by Dr. Conrads and his colleagues combines the precision of Leica Microsystems’ state-of-the-art LMD system on the frontend with the superior analytical capabilities of Thermo Scientific’s mass spectrometer on the backend. In the middle, integral to connecting these two superb instrument systems, is the speed, robustness, reproducibility, and versatility of PBI’s PCT Barocycler system.”
Mr. Richard T. Schumacher, President and CEO of PBI, concluded: “We were delighted to see PBI’s Barocycler system featured in its pivotal position in this important new tumor processing workflow that Dr. Conrads and his colleagues have presented: the critical enabling step after LMD excision and before MS analysis. Based on results to date, we believe that the number of laboratories worldwide performing laser microdissection followed by mass spectrometric analyses will increase at a steady but significant rate, that our Barocycler system will remain a critical part of this workflow, and that the adoption of this novel new workflow should result in a measurable increase in Barocycler sales over the coming months and years.”
See full news release here: https://www.globenewswire.com/news-release/2019/10/01/1923202/0/en/Pressure-BioSciences-Proprietary-PCT-Platform-Fills-Pivotal-Role-for-Tumor-Analyses-in-Novel-Workflow-Presented-at-Leading-Global-Gynecologic-Cancer-Meeting.html
Pressure BioSciences, Inc. (OTCQB: PBIO) (“PBI” or the “Company”), a leader in the development and sale of broadly enabling, pressure-based instruments, consumables, and platform technology solutions to the worldwide life sciences industry, today announced that the Company’s patented pressure cycling technology (“PCT”) platform was prominently featured in no less than ten separate presentations from scientists affiliated with seventeen leading research institutions worldwide at the International Human Proteome Organization World Congress (“International HUPO”), held this year from September 15-18, 2019 in Adelaide, Australia.
International HUPO plays a pivotal role in defining and promoting proteomics through international cooperation and collaborations by fostering the development of new technologies, techniques, and training to better understand the full complement and roles of proteins in human health and disease. The multiple PCT-related presentations included development of new methods and applications using PBI’s unique PCT platform to advance knowledge and understanding in areas such as cancer research, with particular focus on cancer biomarker discovery.
Ms. Roxana McCloskey, PBI's Global Director of Sales & Marketing, commented: "We are delighted to note that the number of PCT-related presentations at important international meetings is now exploding, in response to our years of investment in building collaborations and supporting research and the publication of now over 150 peer-reviewed scientific articles. Most importantly, several presentations describe new workflows, applications, and techniques for the PCT platform that were developed independently by scientists from many different prestigious institutions. We believe that several of the methods described will eventually lead to the routine use of the PCT platform in clinical diagnostics and precision medicine, a market that is expected to reach $217 billion by 2028 (BIS Research, 2019).”
PCT-related presentations delivered at this meeting were primarily in the key areas of new and approved methods and protocols and in new applications for the discovery and identification of cancer markers. The presentations continue to show the flexibility and increasing potential for the PCT platform in cancer diagnostics and discovery. These include:
New and Improved Methods and Protocols Using PCT
- Dr. Dylan Xavier (a scientist at the ProCan cancer research center near Sydney, Australia – a world-renowned group that focuses on the proteomics of cancer) presented data on a novel method combining bead beating (a common laboratory technique) with a PCT-based Barocycler 2320EXT system from PBI. The data showed that this new method facilitated full sample preparation for proteomic analysis by mass spectrometry in under one hour (very fast compared to competing methods) and resulted in an increase in diversity and abundance in yields of proteins for analysis (increasing the chance for discovery) compared to current methods.
- Dr. Philip Robinson (Co-Director of ProCan) emphasized in his presentation that new methods, such as the one reported by Dr. Xavier, “are essential for greater accuracy and high-throughput capabilities that are required to realize the vision of precision medicine.”
- A team of scientists from South Africa reported on their efforts to develop a seamless, fully automated workflow that included PCT sample preparation as an integral step, from the extraction of proteins to the analysis by mass spectrometry.
Characterization of Specific Cancers Using PCT
Several presentations illustrated the flexibility of PCT to extract proteins and nucleic acids from different types of tissue biopsies used in the characterization of specific cancers.
- Data presented from a study conducted by 12 scientists from four leading academic and research institutions in China demonstrated the effectiveness and practicality of PCT in a study of colorectal cancer.
- Another study showed PCT to be an effective component of the workflow to help highlight details of gastric cancer, including key information that could aid in the discovery of novel prognostic markers and potential therapeutic targets.
- Yet another cancer-related study showed that the combination of PCT and mass spectrometry could result in a superior method for “ruling-in and ruling-out” cancer in thyroid nodules compared to current diagnostic tests.
Dr. Nate Lawrence, Senior Consultant to PBI, said: “We are excited that international teams of scientists from more than seventeen institutions on four continents contributed to presentations showing the power and versatility of PCT for cancer research, biomarker discovery, proteomics, and molecular biology. It has been projected that these combined markets are expected to be in excess of $200 billion by 2025 (Zion Market Research, 2019).”
In summation, Ms. McCloskey commented: “We believe the unique value provided by our PCT platform for cancer research and diagnostics, which was broadly highlighted across ten presentations at this important international human protein conference, will help to accelerate awareness and adoption for our unique PCT sample preparation platform across multiple large and growing markets. Subsequently, we believe this increased awareness and conversion into adoption will result in increased sales of our PCT instruments and consumables in Q4 2019 and beyond."
See full news release here: https://www.globenewswire.com/news-release/2019/09/26/1921341/0/en/Pressure-BioSciences-PCT-Platform-Featured-in-Multiple-Presentations-at-Major-International-Science-Conference.html
Pressure BioSciences, Inc. (OTCQB: PBIO) (“PBI” and the “Company”) is a leader in the development and sale of innovative, broadly enabling, pressure-based instruments and related consumables for the worldwide life sciences and other industries. The Company announced today the publication of two scientific journal articles, led by independent teams of scientists in China and Australia, reporting excellent results with PBI’s Pressure Cycling Technology (“PCT”) platform in processing preserved formalin-fixed paraffin-embedded (“FFPE”) and fresh frozen biopsy tissue samples for discovery and elucidation of cancer biomarkers and potentially for use in clinical diagnostics based upon these markers. The Chinese team from Westlake University (Hangzhou, China) purchased their first two PCT platforms in 2017 and subsequently purchased four additional PCT systems. The Australian Proteome of Human Cancer (“ProCan”) team bought their first PCT system in 2016 and have subsequently added five more PCT platforms.
FFPE preserved tissue samples are an invaluable resource for retrospective studies of disease progression and response to therapy, because the disease outcome associated with the tissue and patient’s treatment history are known. Effective studies on these sample sets can accelerate discoveries of new therapies, drugs, and preventive strategies. FFPE has been long-established as the most common technique worldwide for the preservation of tissues for later study. Archival repositories exist that contain a total of millions to a billion or more FFPE tissue samples. However, the analysis of FFPE samples has historically been problematic. FFPE preservation techniques were designed for permanence and stability – hence it is challenging to reverse this fixation and to liberate and extract the important biomolecules relevant as cancer biomarkers. Significantly, both publications cited here, together with other publications (See PBI Website), now report excellent results using the PCT sample preparation platform for comprehensive and reliable extraction and presentation of important proteins for analysis, from both FFPE and fresh frozen tissue samples.
Mr. Richard T. Schumacher, President and CEO of Pressure BioSciences, commented: "It is estimated (Nature volume 448, pages 959–962, 23 August 2007) that well over one billion archival FFPE tissue samples exist in pathology and other laboratories worldwide. We believe there are millions of new FFPE tissue samples processed and stored each year. These samples offer the promise of unveiling invaluable information that can lead to the development of new treatments, cures, and preventive measures for cancer and many other diseases. However, up to now, it has been very difficult to extract this information from biomolecules in FFPE samples.”
Ms. Roxana McCloskey, Director of Marketing and Sales at PBI, said: “We believe that our PCT platform is establishing itself as the method of choice for the superior extraction of potential biomarkers and their presentation for the effective proteomic analyses that will propel the growth of this huge market. We expect this exciting, now proven application of our PCT Platform for protein biomarker discovery in fresh frozen and FFPE biopsy samples to manifest itself in increased instrument sales starting in the second half of 2019.”
The global cancer biomarkers market alone is expected to exceed more than US $157 Billion by 2022 (MarketWatch - January 8, 2019).
In their publication High-throughput proteomic analysis of FFPE tissue samples facilitates tumor stratification, Professor Tiannan Guo, Laboratory Director at Westlake University, explained: “We developed the PCT-SWATH/DIA method of coupling pressure cycling technology for sample preparation with a high throughput mass spectrometry workflow, to analyze FFPE tissue proteomes. We showed that our workflow is a robust and reproducible proteomic method to analyze FFPE tissues from both bulk tissue and tiny biopsy samples as well as sectioned tissue slices.”
Dr. Guo continued, “We believe that the vast reservoirs of historical FFPE tissue samples accumulated in biobanks worldwide offer enormous potential using our methods for biomarker discovery, by leveraging thepracticality and superiority of PBI’s PCT sample preparation platform for maximizing the diversity and abundance of results from FFPE samples (over even fresh frozen samples), followed by mass spectrometry analysis in the PCT-SWATH/DIA workflow.”
Professor Phil Robinson, Co-Director of ProCan, stated: “The key to clinical application of tissue-based proteomics is to adapt to the practical requirements of clinical workflow. Our results from FFPE tissues following PCT sample preparation are consistent with other reports showing that high quality data can be generated and that the scale and scope of quantifiable proteins is comparable to that obtained from fresh frozen tissues.”
Professor Robinson continued: “After samples are collected, tissue lysis and digestion protocols must be rapid, efficient, reproducible and broadly applicable to tissues of different kinds and from different source laboratories. In addition, the methodology should be adaptable for integration of robotics to facilitate high throughput where possible. ProCan has instituted the use of pressure cycling technology (PBI Barocyclers) to achieve consistent and superior lysis and digestion of tissue samples.”
See full news release here: https://www.globenewswire.com/news-release/2019/09/10/1913564/0/en/Pressure-BioSciences-PCT-Platform-Identified-as-Pivotal-for-Cancer-Biomarker-Discovery-and-for-Potential-Clinical-Diagnostics.html
Pressure BioSciences, Inc. announced financial results for the second quarter ended June 30, 2019, provided a business update, and offered guidance for the remainder of FY2019 and for FY 2020.
Financial Results: Q2 2019 vs. Q2 2018 (rounded to nearest hundred except for EPS)
Total revenue for the second quarter ended June 30, 2019 was $518,700 compared to $638,800 for the same period in 2018, a 19% decrease. Product and services revenue was $518,700 for the second quarter of 2019 compared to $618,400 for the same quarter of 2018, a 16% decrease. Instrument sales decreased to $247,000 in Q2 2019 compared to $397,000 in Q2 2018, a decrease of 38%. Sales of consumables were $91,400 for the second quarter of 2019 (an all-time record) compared to $64,100 for the same period in 2018, a 43% increase. BaroFold contract services for protein disaggregation and controlled refolding applications were $69,700 for the 2019 second quarter compared to $52,600 for the same period in 2018, an increase of 32.5%. UST contract services reached $41,400 in Q2 2019 compared to $14,300 in the second quarter of 2018, an increase of 197.5%. Grant revenue in Q2 2019 was none compared to $20,000 in Q2 2018. Our NIH grant ended in November 2018.
Operating loss for Q2 2019 was $1,400,400 compared to $920,900 for the same period in 2018. This increase included legal fees for fundraising, increased use of investor and public relations services, non-cash stock compensation relating to renewed vesting of stock options, and employee costs relating to the hire of a chief commercial officer with related travel for business development.
Loss per common share - basic and diluted- was $(2.22) for Q2 2019 compared to loss per common share of $(9.20) for the same period in 2018. The decreased loss per share resulted from the Company recording deemed dividends in the prior year relating to the beneficial conversion feature on the Series AA preferred stock and a price protection provision triggered on May 2, 2018 by the sale of Series AA preferred stock, affecting Debentures and Warrants to purchase Common Stock held by existing Debenture holders.
Financial Results: First Half (1H) 2019 vs. First Half (1H) 2018 (rounded to nearest hundred except for EPS)
Total revenue for the 1H 2019 was $1,028,900 compared to $1,249,500 for the prior year same period, a decrease of $220,600 or 18%. This decrease was primarily due to lower revenue from instrument sales, as described below. We believe total revenue will increase over the remaining two quarters of 2019. Product and services revenue decreased to $1,028,900 for the first half of 2019 compared to $1,203,700 for the same period in 2018, a decrease of $174,800 or 15%. Comparing 1H 2019 to 1H 2018, instrument sales decreased to $385,700 from $817,100, consumable sales increased to $153,400 (an all-time record) from $138,800, BaroFold contract services increased to $220,800 from $52,600, and UST contract services reached $128,300 compared to $14,300. We believe product and services revenue will continue to increase (YoY) for the remaining quarters of 2019.
Operating loss was $2,797,000 for the first six months of 2019, compared to a loss of $2,029,000 for the same period in 2018, an increase of $768,000 or 38%. The increase included legal fees for fundraising, increased use of investor and public relations services, non-cash stock compensation relating to renewed vesting of stock options, and employee costs relating to the hire of a chief commercial officer with related travel for business development.
Net loss per common share was $(4.24) -- basic and diluted -- for the six months ended June 30, 2019 compared to a net loss per common share -- basic and diluted -- of $(11.01) for the same period in 2018. The decreased loss per share resulted from the Company recording deemed dividends in the prior year relating to the beneficial conversion feature on the Series AA preferred stock and a price protection provision triggered on May 2, 2018 by the sale of Series AA preferred stock, affecting Debentures and Warrants to purchase Common Stock held by existing Debenture holders.
Recent Operational and Technical Highlights
Launch of our Revolutionary UST-Based System to Make High Quality, Water-Soluble Nanoemulsions of CBD Oil
- We released a short video demonstrating the ability of our proprietary UST platform to create water-soluble CBD Oil that disperses instantly when infused into soft drinks, sports drinks, and beer for enhanced quality and absorption
- We announced our entrance into the CBD market with the launch of a novel processing system (the BaroShear K45) to revolutionize the manufacture of water-soluble, long-term stable, highly absorbable, nanoemulsified CBD Oil
- We announced the initial close and customer for our BaroShear K45 nanoemulsification system
- We made measurable progress on the build-out of our GMP-compliant manufacturing laboratory, where we expect to showcase the BaroShear K45 and the industrial scale, high volume, 2 liter per minute UST-based nanoemulsification systems
Ohio State/PBIO Project to Develop Safer, More Nutritious, Long Shelf-life, Clean Label Food and Beverages
- We achieved the first major milestone in our USDA-funded project to develop a potential breakthrough processing method for higher quality, more nutritious, and safer food and beverages - with a focus on dairy products such as milk. This novel processing method is based on PBIO’s patented Ultra Shear Technology™ (UST™) platform.
Expansion of our Recently Launched BaroFold Contract Services Business
- We entered into a six-figure agreement with a multi-national, multi-billion-dollar biopharma company
- We continued discussions towards an agreement with a second multi-national, multi-billion-dollar company
- We expanded the contract services laboratory with additional specialized equipment and new methods/applications
Expanded Applications for our Core Suite of PCT and Constant Pressure-based Instruments
- At the June conference of the American Society for Mass Spectrometry, Dr. Tom Conrads (a nationally-acclaimed protein chemist) spoke on the critical role played by PBI’s Barocycler EXT platform in helping to make the profiling of their Laser Capture Microdissected tumor tissue samples possible at the throughput required in their APOLLO Cancer Moonshot program
- Scientists at Tennessee State University showed that PBIO’s HUB instrument platform was highly effective in studies to develop improved methods for food safety, addressing the need for new ways to prevent serious food-borne diseases caused by bacteria such as E. coli and Listeria.
Richard T. Schumacher, President and CEO of PBI, said: “Because of the poor water solubility of today’s oil-based CBD products, most ingested CBD is flushed from the body, leaving little of the product to provide its beneficial properties. After much diligence and analysis, we concluded that we have the expertise and experience to successfully address this critical issue. Consequently, we pulled significant hours away from many of our staff over the past few months and had them focus on the development of an instrument system - based on our patented UST platform - that would increase the water-solubility, and thus the absorption, of CBD Oil. We succeeded; the result of that success is the BaroShear K45 processing system.”
Mr. Schumacher continued: “The CBD market is expected to hit $20 Billion by 2024 (BDS Analytics, 2019). There are currently hundreds upon hundreds of companies in this field. To survive, companies will need to differentiate themselves from the competition by delivering the highest quality products possible. Such products would undoubtedly need to have high water-solubility, absorption, and bioavailability, along with long shelf-life and a minimal amount of added chemicals. This is exactly what we intend to deliver.”
Mr. Schumacher concluded: “We have already begun to pre-sell limited quantities of the BaroShear K45. Units sold over the coming weeks will be delivered and installed in early 2020. We believe that such sales will have a significant impact on 2020 total revenue, potentially resulting in more than twice the total revenue of 2019. We further believe that revenue from our BaroFold platform contract services will continue to increase, and that the decline in PCT platform instrument sales observed over the past two quarters (caused in part by our focus on the development of the BaroShear K45) will end, and that we will see an increase in PCT product sales over the second half of 2019, and beyond.”
Pressure BioSciences, Inc. announced the initial sale of its revolutionary BaroShear™ K45 processing system. This novel instrument system is based on the Company’s proprietary Ultra Shear Technology™ (UST™) platform. The BaroShear K45 is a unique and powerful nanoemulsification system designed to resolve one of the most critical problems facing CBD manufacturers today: the extremely poor water solubility of CBD Oil.
CBD is a non-psychoactive compound that has been broadly demonstrated to offer powerful health benefits, addressing a variety of challenging medical conditions. CBD is extracted from the cannabis plant in an oil form. After ingestion of CBD, because oils are not well absorbed by human and other animal water-based bodies, most of the CBD is flushed from the system, leaving little of the product absorbed and circulating to provide its beneficial properties. Because of these solubility issues, many CBD products on the market today contain a costly and inefficient over-abundance of CBD, and/or undesirable chemicals that may be have been used to try and improve its solubility in water.
Processing most oil-based products into nanometer-size droplets in emulsions with water (“nanoemulsions”) often improves their absorption, medicinal benefits, visual appearance, and sensory presentation. Unfortunately, traditional processing methods used to make nanoemulsions struggle with this challenge. PBI’s patented UST platform uses ultra-high pressure to create extreme shearing forces that create highly stable, homogenized nanoemulsions of materials that normally do not mix, such as CBD Oil and water. To view PBI’s UST-processed CBD Oil being added to a soft drink, a sports drink, and a beer, please use the following link: PBI UST CBD Video 040219.
Mr. Christopher Holden, Founder of Nano CBD Cosmetics LLC, commented: “We are thrilled to be the first purchaser of the BaroShear K45 system. This groundbreaking technology will enable companies producing nano-scale CBD emulsion products to meet the ever-increasing demand for CBD nanoemulsion products. In fact, our own nano-CBD products are currently selling faster than we can produce them. However, with PBI’s cutting-edge technology, we expect to increase our nano-emulsified, water-soluble CBD production capacity to many multiples of what it is today…and that is huge.”
Mr. Dan Jorgenson, a Director of Nano CBD Cosmetics LLC, said: “We strongly believe that nano-emulsified CBD products will soon become established as an important new standard in the industry. Consequently, Chris and his team have spent significant time working on the development of our own nanoemulsification strategies, while concurrently evaluating options from multiple sources. In the end, we came to the inescapable conclusion that PBI’s BaroShear K45 CBD processing system offers the most important opportunity that we have identified to truly revolutionize the water-soluble, nano-CBD industry.”
The total cannabinoid market is expected to hit $89 billion by 2024 (https://mordorintelligence.com/industry-reports/cannabis-market), with CBD oil-based products being the cornerstone of the non-psychoactive portion of this exploding market. For CBD products commonly consumed orally - including CBD oils in edibles and beverages - absorption is typically below 10% (ERTH 8/28/2018: Water Soluble CBD - The Science of Nanoemulsions and Bioavailability). PBI believes that processing with the UST-based BaroShear K45 system will deliver greatly improved absorption results (potentially as high as 90%) for CBD and a universe of other oil-based supplements.
Richard T. Schumacher, President and CEO of PBI, said: “From my first meeting with both Dan and Christopher earlier this year, I was impressed with their knowledge of the industry, the quality of their products, and their dedication to their company and customers. I was most impressed with their commitment to make and sell only the highest quality CBD products possible. Although they have spent significant time and money developing their own methods to make water-soluble CBD, they ultimately were compelled to invest in PBI’s UST-based method for achievement of truly superior and stable nanoemulsion results. They are fully committed to switching to the BaroShear K45 system as it becomes available from our initial production run. We applaud their dedication to their customers and feel privileged to welcome them into the PBI Family”.
Mr. Schumacher continued: “We are also pleased to announce that we are in advanced discussions with over a half dozen additional companies about the potential of their purchasing the BaroShear K45 processing system. Since we plan to make only about a dozen processing systems in our initial manufacturing run, we are optimistic that purchase orders will be received for all available BaroShear K45 systems well before our original forecast of September 30, 2019. This is truly an exciting time to be a stakeholder in PBI.”
Pressure BioSciences, Inc. (OTCQB: PBIO) announced it has signed a contract services agreement with a world-renown, multi-billion dollar biotherapeutics company to enhance the process manufacturing of one of their candidate protein drugs.
The manufacturing of therapeutic proteins can be a complex and challenging process. According to a report in F1000 Research (Lagasse, Feb 2017), producing a typical protein drug may include more than 5,000 critical steps. Two of the major challenges associated with manufacturing recombinant proteins are (i) the formation of aggregates, and (ii) protein misfolding. These are significant issues that can prevent a protein drug candidate from ever making it to market. PBIs BaroFold technology platform offers a unique and cost-effective way to address these manufacturing challenges.
PBI purchased the assets of BaroFold, Inc. in late 2017, including their extensive patent portfolio. Since that time, the Company has incorporated its own proprietary technology and developed a cost-effective way to improve the process manufacturing of proteins by utilizing high pressure. To capitalize on these capabilities, PBI launched the BaroFold Biopharma Services Business in January 2019.
Dr. Alexander Lazarev, Chief Science Officer of PBI, said: The BaroFold platform can be applied to the development and production of many different therapeutic proteins, can improve product safety, and is scalable and practical for standard bioprocess environments. Moreover, it offers ways to reduce or eliminate the use of aggressive chemicals in the protein manufacturing process. Thus, we believe this unique technology platform can help biopharmaceutical companies create and manufacture high quality novel protein therapeutics and biosimilars, lower the cost of existing formulations, and help protect our environment.
Protein-based therapeutics are a large and growing part of the global healthcare industry. Based on data in the THPdb database (http://crdd.osdd.net/raghava/thpdb/), there are over 200 therapeutic proteins and peptides currently approved by the FDA for clinical use in the US. These target therapies have shown significantly improved outcomes for many patients suffering from severe medical conditions, such as cancer and immunological diseases. According to a report from Research and Markets (May 2016), the global protein drug market will reach approximately $248 billion by 2020.
Richard T. Schumacher, President and CEO of PBI, commented: Our proprietary BaroFold Biopharma Services Business offers us a unique opportunity to enter the estimated $44 billion (by 2026) global bioprocess technology market (Transparency Market Research, July 2018). In addition to successfully performing contract services for two biopharmaceutical companies since the beginning of 2019, we are also in discussions with three additional biopharmaceutical companies interested in utilizing our proprietary BaroFold services for their protein drug candidates. To take full advantage of this opportunity, we have doubled the capacity of our contract services team, purchased additional sophisticated equipment, and developed new high-pressure concepts that further improve and enhance our BaroFold process scalability and its GMP compliance.
Mr. Schumacher concluded: We believe our recently launched BaroFold Biopharma Services Business could add as much as $500,000 to 2019 total revenue and significantly more to total revenue for 2020 and beyond. It is important to note that these estimates do not include the anticipated growth in Barocycler 2320EXT sales that we believe will result from biotechnology and biopharmaceutical companies developing their own manufacturing, quality control, and protein characterization applications on our leading PCT-based instrument system. These are truly exciting times for all stakeholders in PBI.
Pressure BioSciences' PCT Platform Highlighted at International Conference in China
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" and the "Company"), a leader in the development and sale of innovative, broadly enabling, pressure-based instruments and related consumables for the worldwide life sciences and other industries, today announced that its flagship Barocycler 2320EXTREME instrument was prominently featured at a three-day, internationally-attended scientific conference held at the elite Westlake University ("Westlake") in Hangzhou, China. One of the primary conference organizers was Professor Tiannan Guo, MD., PhD, a well-known protein research scientist. In 2017, Professor Guos Westlake laboratory was named a PBI Center of Excellence.
Professor Guo and internationally recognized proteomics expert Professor Ruedi Aebersold (ETH-Zurich, Switzerland) are the co-developers of PCT-SWATH, a breakthrough method in high throughput proteomic sample analysis. PCT-SWATH is a novel proteomics method that combines the unique capabilities of PBIs patented pressure cycling technology (PCT) for sample preparation (a critical step in the research process) with the cutting-edge analytical capabilities of SCIEXs mass spectrometry SWATH method. Data strongly indicate that PCT-SWATH allows scientists to reproducibly identify, extract, and quantify more proteins from complex samples types in a shorter time period than other current methods, potentially facilitating the path to earlier and superior biological insights and discoveries.
Under Professor Guos leadership and direction, his laboratory at Westlake University has grown to have the largest number of PCT Barocycler systems in the world, with eight instruments to meet the demand of preparing thousands of tissue samples for analysis. Professor Guo said: Many of the studies on cancer biopsy tissues performed at Westlake and in the laboratories of our collaboration partners rely critically on PBIs PCT platform to rapidly and reproducibly extract high quality proteins from tumor tissues for analysis by mass spectrometry. It is hoped that such activities will eventually result in the discovery of new biomarkers of disease and possibly even new drug targets.
Professor Guo continued: PCT is a novel, enabling technology platform. My team and I believe that the PCT platform can help researchers worldwide make new discoveries in multiple fields, including proteomics, genomics, and metabolomics. We were able to use used the Westlake University conference to educate research scientists on the features and benefits of the PCT platform. Many scientists left the conference with an excellent understanding of the advantages of PCT, and how this platform technology can help them in their research, especially in the area of preparing cancer biopsy samples for evaluation. We believe the use of the PCT platform will continue to grow in China and elsewhere.
Roxana McCloskey, Global Director of Sales and Marketing for PBI, said, We are very pleased that the PCT platform was featured in several presentations during the three-day Westlake Conference and was the focus of a scientific session entitled Reproducible preparation of clinical specimens using Pressure Cycling Technology. On the third day of the conference, many attendees participated in a hands-on workshop that demonstrated the use of the PCT platform in preparing high quality tissue biopsy samples for evaluation, a very large market opportunity for PBI (the aspiration and biopsy needle market alone is projected to reach $1.27 billion by 2024. Research and Markets, July 2019).
Ms. McCloskey continued: Our Chinese distributor (PowerTech Technology Co.) attended the conference and had the opportunity to speak with many potential customers about the Barocycler 2320EXTREME. We believe this conference has significantly increased awareness of our PCT platform among protein scientists in China and other countries, and that it will result in a number of instrument sales in the future.
See full news release here: https://ir.pressurebiosciences.com/press-releases/detail/315/pressure-biosciences-pct-platform-highlighted-at
Pressure BioSciences Enters CBD Market with Launch of Novel Instrument System to Revolutionize Manufacturing of High Quality, Water-Soluble CBD
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company"), a leader in the development and sale of broadly enabling, pressure-based instruments, consumables, and platform technology solutions to the worldwide life sciences industry, today announced the launch of its BaroShear K45 system based on the Company's proprietary Ultra Shear Technology (UST) platform. The BaroShear K45 system is a unique and powerful next generation nanoemulsification system designed to fix one of the most critical problems facing CBD manufacturers today: the extremely poor water solubility of CBD oil.
CBD, a non-psychoactive compound believed to offer powerful health benefits, is extracted from the cannabis plant in an oil. After ingestion, because oils are not well absorbed, most of the CBD is flushed from the body, leaving little of the product to provide its beneficial properties. Because of these solubility issues, many CBD products on the market today contain an inefficient over-abundance of CBD and/or undesirable chemicals to try and improve its solubility in water.
For most oil-based products, the ability to prepare them as nanoemulsions can improve the product's absorption, medicinal benefits, visual appearance, and sensory presentation. Unfortunately, traditional processing methods struggle with this challenge. PBI's patented UST platform uses ultra-high pressure to create extreme shearing forces to make highly stable, homogenized nanoemulsions of materials that normally do not mix, such as CBD Oil and water. To view PBI's UST-processed CBD oil being added to a soft drink, a sports drink, and a beer, please use the following link: PBI UST CBD Video 040219.
Dr. Nathan Lawrence, Senior Advisor to PBI, said: "The unique concept of the BaroShear K45 system is based on PBI's proprietary UST platform. It was designed for the efficient and affordable manufacture of limited quantity oil-based material into high quality, water-soluble nanoemulsions. The BaroShear K45 system uses a custom-designed, highly responsive ultra-high pressure generating subsystem, matched to our patented BaroIsolator device and NanoGap valve. This allows for the highest effectiveness possible at working pressures up to 45,000 psi. The BaroShear K45 system is ideally suited for processing small amounts (e.g., 50 mL - 2 L) of high value product, such as CBD oil, into nanoemulsions with high yield."
Dr. Bradford A. Young, Chief Commercial Officer of PBI, commented: "Over the past several months, we have spoken with dozens of CBD companies. A common theme has been their desire to develop new and improved delivery methods for CBD and their concern with how best to make stable nanoemulsion mixtures of CBD oil and water. Our new UST platform, the BaroShear K45 system, can help companies make high quality, CBD-based products using physics (e.g. ultra-high pressure) instead of chemistry (e.g. lots of strong detergents). We look forward to helping our customers address the large and growing market for CBD infused foods, beverages, cosmetics and topicals."
The total cannabinoid market is expected to hit$89 billion by 2024 (https://mordorintelligence.com/industry-reports/cannabis-market), with CBD oil-based products being the cornerstone of the non-psychoactive portion of this exploding market. For CBD products commonly consumed orally - including CBD oils in edibles and beverages - absorption is typically below 10% (ERTH 8/28/2018: Water Soluble CBD - The Science of Nanoemulsions and Bioavailability). PBI believes that processing with the UST-based BaroShear K45 system will deliver greatly improved absorption results (potentially as high as 90%) for CBD and other oil-based supplements.
Dr. Keith Warriner, Professor of Food Science at the University of Guelph (Toronto), and a recognized expert in the cannabis industry, commented: "The data I have reviewed to date on UST-generated nanoemulsions of CBD oil are very impressive. Creating nanoemulsions of CBD oil with full preservation of CBD throughout the process, while not generating impurities, remains a significant challenge in the industry. These data indicate that UST can achieve that goal, thereby offering great promise to the future."
Richard T. Schumacher, President and CEO of PBI, said: "The BaroShear K45 system will list for $195,000; we believe that sales of these Systems will become a major revenue-generating part of our business. We will be accepting purchase deposits on pre-sale orders immediately. Based on feedback from potential customers, we believe purchase deposits on instruments from the initial build could start being received by mid-July. We plan to stop accepting purchase deposits on September 30th; however, we will stop earlier if demand exceeds reasonable manufacturing limits."
Mr. Schumacher continued: "We are looking forward to working with the early adopters of this exciting technology platform. Early adopters will be the first to use the UST platform in the CBD field, thus giving them a significant head-start over companies who choose to wait or useother methods. They will always be the first to get full access to new instruments, technologies, and applications that can positively impact the UST platform (a commitment to early adopters). They will also have "most favored nation" pricing for subsequent UST platform systems. Finally, because there is much to learn about CBD formulations and their benefits for various factors, we will be offering collaboration opportunities to the first three groups who submit purchase deposits. This is a very exciting time for the entire PBI Team, and for all stakeholders in PBIO."
Pressure BioSciences Announces Achievement of First Major Milestone in Development of Potential Breakthrough Processing Method for Higher Quality and Safer Food and Beverages
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company"), a leader in the development and sale of broadly enabling, pressure-based technology and products to the worldwide life sciences industry, today announced the achievement of the first major milestone in its collaboration with the College of Food, Agricultural, and Environmental Sciences ("CFAES") of The Ohio State University ("Ohio State"). The primary program goal is to develop and make available for commercialization a continuous-flow manufacturing process to prepare foods and beverages with superior sensory and nutritional qualities, while delivering long, room temperature shelf stability without requiring refrigeration or chemical additives. The Company believes it can achieve this highly sought-after consumer demand through scale-up of its innovative and patented Ultra Shear Technology ("UST") platform.
A four-year, $891,000 grant awarded to scientists at CFAES by the U.S. Department of Agriculture's National Institute of Food and Agriculture ("NIFA") is supporting this collaborative program. PBI was granted a $318,000 sub-contract to build a working benchtop instrument and a pilot plant floor model, both based on the Company's patented UST platform. The delivery of the working benchtop instrument was the first major milestone identified by the collaborators.
Dr. Edmund Y. Ting, Sr. VP of Engineering at PBI, said: "We are very excited to have met this first major milestone. We believe our proprietary UST platform can be used to make the higher quality, more nutritious, longer-lasting foods that consumers now demand. The UST-based bench-top instrument - together with the larger scale, floor model, higher capacity instrument we are now developing - will be used to generate the fundamental food science quality and safety validation data that we believe will enable future process adoption by industry and acceptance by the regulators."
Dr. V.M. "Bala" Balasubramaniam, a CFAES professor of food engineering who is leading the collaborative project, commented: "Today's consumers demand food that is nutritious, minimally processed, and pathogen safe. They also want food that tastes and looks good, while being free of synthetic ingredients. We believe the UST platform has the potential to offer food manufacturers the ability to process safe wholesomebeverages, nutritional drinks, sauces, condiments and pumpable liquid foods."
The total "clean label" (no artificial ingredients or chemicals) food market is currently estimated at $62 billion in the U.S. and $165 billion worldwide (Nunes, 2016). This market is comprised of several unique food processing methods, including high pressure processing ("HPP"). The global HPP food market is estimated to reach $27.4 billion in 2023 and $51.1 billion by 2027 (https://foodsafetytech.com/feature_article/hpp-keeps-food-safe-while-extending-shelf-life/).
Richard T. Schumacher, President and CEO of PBI, stated: "Food processors have been seeking new minimal heat processing technologies that can provide extended shelf-life, while meeting "clean label" requirements that also satisfy consumer expectations. Many clean label foods are currently processed using costly, batch oriented HPP techniques, including juices, seafood, meats, baby food, guacamole, fruits and vegetables. Unfortunately, these HPP food products all require refrigeration after processing. Commercializing a minimal heat processing technology that can produce shelf-stable (without refrigeration), high quality, ready-to-eat foods such as coffee, tea, broth, condiments, sauces, dairy products (e.g., milk, liquid cheese), and other such liquid foods would be a breakthrough. This is the primary goal of the project, which we believe can be attained through scale-up of our innovative, patented UST platform."
The OSU-PBI UST research team will be advised by an industry advisory board representing food processors and regulatory agencies. Food processors interested in joining this effort should contact Dr. Bala Balasubramaniam or Dr. Edmund Ting.
See full news release here: https://www.accesswire.com/549936/Pressure-BioSciences-Announces-Achievement-of-First-Major-Milestone-in-Development-of-Potential-Breakthrough-Processing-Method-for-Higher-Quality-and-Safer-Food-and-Beverages
Pressure BioSciences' PCT Platform Prominently Featured in Record Number of Presentations at Major International Science Conference
Scientists from Leading Laboratories in Europe, Asia, Oceania, and North America Highlight the Critical Importance of PBI's Patented PCT System in Cancer and Other Priority Research Areas
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company"), a leader in the development and sale of broadly enabling, pressure-base instruments, consumables, and platform technology solutions to the worldwide life sciences industry, today announced that the Company's patented pressure cycling technology ("PCT") platform was prominently featured in 15 independent presentations at the annual conference of the American Society for Mass Spectrometry ("ASMS"), held from June 1-6, 2019 in Atlanta, GA. The presentations spanned wide ranging applications for PBI's unique PCT platform in scientific studies, particularly their essential use in advancing knowledge and understanding in such areas as cancer research, protein function, molecular biology, and biomarker discovery.
Roxana McCloskey, PBI's Global Director of Sales & Marketing, commented: "The number of PCT-related presentations at the 2019 ASMS conference significantly exceeded prior PBI records for a scientific meeting. We are gratified that the use of our PCT platform continues to expand to new investigators and laboratories worldwide, and that its use has shown great promise in critical areas of human health, such as cancer. We believe the presentations at this prestigious annual meeting clearly show the increasing potential for the PCT platform in diagnostics and discovery, which we believe could eventually lead to the routine use of the PCT platform in precision medicine, a rapidly expanding market that is expected to reach $217 billion by 2028 (BIS Research, 2019)."
PCT-related presentations delivered at the 2019 ASMS meeting were primarily in the following key areas.
Nine presentations focused on the importance of PBI's PCT platform in the study of cancers.Of these, three described the development and use of a novel, streamlined, sample preparation protocol and system featuring PBI's Barocycler 2320EXT instrument and proprietary MicroTubes as the link between two widely used techniques: laser microdissection and mass spectrometry. In this new suggested system, precise small sections of cells are cut from suspected tumor tissue slices while being viewed under a microscope. Once cut from the biopsy tissue, the slices of interest fall directly into PBI's MicroTubes, are processed by PCT and are then analyzed by mass spectrometry. Data show that the PCT platform has the potential to accelerate and strengthen protein analysis, improve cancer characterization, and provide clinically relevant information for diagnosis and treatment guidance in a timely manner. Findings also highlighted the necessity for the development of new methods and equipment for better identification of gynecologic cancers specifically, and cancer biomarkers in general.
Researchers from China and Australia reported on advancements in their cancer diagnostic programs. These large studies of thousands of cancer samples rely critically on PBI's PCT platform to rapidly and reproducibly extract proteins from tumor tissues for analysis by mass spectrometry.
The PCT platform was also used in studies to better understand underlying racial disparities in cancer. Such studies may provide improved early detection and thus more effective treatment options to minorities.
Several presentations reported results from studies that used the PCT platform for basic research and discovery of unique cancer biomarkers. Discovery of new biomarkers for early diagnosis, cancer subtyping, progression, and underlying pathway dysfunction is vital to help improve clinical outcomes. In addition to cancer biomarker discovery, a presentation reported the use of the PCT platform to help reveal unique biomarkers due to exposure to chemicals in the environment such as benzene. This is the second report of using PBI technology to monitor the effects of environmental pollutants.
Protein and Molecular Biology Studies
The PCT platform continues to be used for basic but important proteomic research. The proteome consists of all the proteins made or modified by an organism. Studies presented of proteins, using PBI's high pressure PCT system, included the use of pressure to accelerate enzymatic reactions for molecular biology and other applications, and for muscle tissue studies.
Richard T. Schumacher, President and CEO of PBI, said: "We are thrilled with both the number and caliber of presentations made at the annual ASMS conference highlighting the advantages of the PCT platform. Well-known research groups from both academia and industry, including key opinion leaders in proteomics and cancer diagnostics, presented data at the conference strongly supporting the use of the PCT platform in multiple areas of scientific research. These researchers were from highly respected labs and institutions worldwide, including: Johns Hopkins University, Fred Hutchinson Cancer Center, John P. Murtha Cancer Center, the Inova Schar Cancer Institute, Westlake University (China), Children's Medical Research Institute (Sydney, AU), the ETH Zurich, PPD Madison, Pfizer, and SCIEX."
Dr. Bradford Young, Sr. VP and Chief CommercialOfficer of PBI, said: "By 2025, the combined projected market sizes forcancer research, biomarker discovery, proteomics, and molecular biology isexpected to be in excess of $200 billion.The global proteomics market alone is projected to be in excess of $40 billionby 2025 (Zion Market Research, 2019). We believe the unique value provided by our PCT platform for samplepreparation and biomarker discovery as shown in the 15 presentations at this year's ASMSConference will help generate awareness and demand for our platforms in these very largeand growing markets."
Pressure BioSciences, Inc. Reports First Quarter 2019 Financial Results and Provides Business Update
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company"), a leader in the development and sale of broadly enabling, pressure-based instruments, consumables, and platform solutions to the worldwide life sciences industry, today announced financial results for the quarter ended March 31, 2019, provided a business update, and offered limited guidance for FY2019.
Financial Results: Q1 2019 vs. Q1 2018 (Rounded to nearest hundred except earnings per share)
Total revenue for Q1 2019 was $510,000 compared to $611,000 for the same period in 2018, a 16% decrease. Revenue from our new, proprietary Biopharma (BaroFold platform) and Ultra Shear Technology (UST platform) contract services accelerated as expected, with combined revenue of $238,000 in Q1 2019 compared to no services revenue in Q1 2018 and revenue of $202,000 for all of 2018. Sales of both instruments and consumables decreased in Q1 2019 compared to the same quarter of 2018. Overall, products and services revenue was $510,000 for the first quarter of 2019 compared to $585,000 for the same quarter of 2018, a 13% decrease. There was also no grant revenue in Q1 2019 compared to grant revenue of $25,000 in Q1 2018.
Operating loss for Q1 2019 was $1,397,000 compared to $1,108,000 for the same period in 2018, an increase of 26%. This increase was primarily driven by non-cash stock compensation relating to stock option repricing; costs relating to the hire of our first Chief Commercial Officer; and increased utilization of contracted investor and public relations services.
Loss per common share - basic and diluted- was $(2.01) for Q1 2019 compared to loss per common share of $(1.64) for the same period in 2018.
Mr. Richard T. Schumacher, President and CEO of PBI, said: "We believe this disruption in our long trend of increasing quarterly products and total revenue on a year-over-year basis was an anomaly, relating to a combination of several factors: (i) the December 2018 retirement of Dr. Nate Lawrence, our VP of Marketing and Sales for many years; (ii) the loss of several field sales representatives during the second half of 2018; (iii) the beginning of a shift in the focus of our sales strategy from individual academic users and opinion leaders towards more lucrative and efficient long-term growth relationships with biopharmaceutical companies; and (iv) increasing strategic focus and resources on our two new growth areas: contract services related to the BaroFold and UST platforms. The convergence of these factors on decreasing Q1 2019 revenue was unfortunate, but we believe short term in nature."
Mr. Schumacher continued: "As previously announced, we are moving quickly with new business leadership under Dr. Bradford Young and are actively recruiting sales representatives to fill out our team. We believe strongly that the deliberate shift in our sales strategy and new emergent contract services area will both result in increased revenue growth through the current fiscal year."
Dr. Bradford Young, PBI's Chief Commercial Officer, added: "We placed a large amount of effort and focus on our new BioPharma and UST contract services with very encouraging results. We will continue to emphasize these key strategic growth initiatives going forward. We believe the markets for our proprietary technology platforms are very large and that the need for our services and platform technologies will continue to grow as we begin to aggressively promote the benefits of our patented BaroFold and UST platforms for R&D and manufacturing. We anticipate that the growing use of these new services will also support increased sales of our PCT instruments and consumables."
Recent Operational and Technical Highlights
- We released a video demonstrating the ability of our proprietary UST platform to create water-soluble CBD Oil that disperses instantly when infused into soft drinks, sports drinks, and beer for enhanced quality and absorption;
- We announced the establishment of a Center of Excellence at Dr. Christine Vogel's laboratory at New York University's Center for Genomics and Systems Biology;
- We announced a collaboration with The Steinbeis Centre for Biopolymer Analysis & Biomedical Mass Spectrometry, a world-renown German research organization, to develop a revolutionary method for optimizing disease-fighting antibodies;
- We released scientific analyses confirming important benefits from processing CBD Oil with PBI's UST Platform: analyses showed UST-prepared CBD Oil solutions met challenging nanoemulsion specifications and exhibited minimal loss during processing;
- We released a short video demonstrating the use of our prototype UST Platform to make water-soluble CBD Oil, offering a solution to CBD absorption issues in food and beverages.
- We announced a collaboration with nutraceutical manufacturer NutraLife Biosciences for the development of high quality, water-soluble nanoemulsion-based nutraceuticals.
- We announced that a record number of scientific papers citing the significant benefits of PBI's PCT technology platform were published in 2018, with several authored by global Key Opinion Leaders (KOLs).
- We announced the commercial launch of our unique Biopharma contract services business, offering improved manufacturing, quality control, and remediation opportunities for highly valuable protein therapeutic candidates and products, opening key opportunities for us to serve an estimated $250 billion global market.
The Company will hold an Earnings Conference Call at 4:30 PM EDT on Thursday, May 16, 2019. To attend this teleconference via telephone, Dial-in: (844) 602-0380 (North America), (862) 298-0970 (International). Verbal Passcode: PBIO First Quarter 2019 Financial Call and Business Update. Replay Number (877) 481-4010 (North America), (919) 882-2331 (International). Replay ID Number: 49215. Teleconference Replay Available for 30 days.
See full news release here: https://ir.pressurebiosciences.com/press-releases/detail/309/pressure-biosciences-inc-reports-first-quarter-2019
Pressure BioSciences, Inc. to Discuss First Quarter 2019 Financial Results and Provide Business Update
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" and the "Company") today announced that the Company will host a teleconference to discuss its First Quarter 2019 financial results and to provide a business update. Anyone interested may listen to the teleconference either live (by telephone) or through a replay (by telephone or via a link on the Company's website approximately one day after the teleconference).
The teleconference will include a Company presentation followed by a question & answer period.
Date: Thursday, May 16, 2019. Time: 4:30 PM Eastern Time (ET).
To attend this teleconference, live by telephone:
Dial-in: (844) 602-0380 (North America); (862) 298-0970 (International)
Verbal Passcode (for the operator): PBI First Quarter 2019 Financial Call & Business Update
For those unable to participate in the live teleconference, a replay will be available beginning Friday, May 17, 2019. The replay will be accessible via telephone and the Company's website for 30 days.
Replay Number: (877) 481-4010 (North America); (919) 882-2331 (Int'l); Replay Passcode: 49215
Pressure BioSciences Announces CEO Succession Plan
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" and the "Company"), a leader in the development and sale of innovative, broadly enabling, pressure-based instruments and related consumables for the worldwide life sciences industry, today announced that Mr. Richard T. Schumacher, the Founder of the Company, notified the Company's Board of Directors on April 25, 2019 that he plans to step down as President and CEO effective September 9, 2019. Mr. Schumacher has been working with the Company's Board of Directors on leadership succession planning for many months, including the selection of Bradford A. Young, PhD, MBA, as SVP & Chief Commercial Officer ("CCO") for the Company in November 2018. To facilitate an orderly transition in leadership, the PBI Board of Directors has identified Dr. Young as their designee to succeed Mr. Schumacher and will be working closely with Dr. Young to effectuate this transition.
PBI's Chairman of the Board, Jeffrey N. Peterson, explained: "Since founding Pressure BioSciences, Ric Schumacher's vision and leadership have attracted and retained an exceptionally talented senior management team and support group. Together they have positioned the Company's original life sciences sample preparation business to achieve an enviable level of prominence and recognition amongst key opinion leaders and in scientific peer-reviewed literature. With this business now poised for more rapid growth, the Company has added two new and potentially much larger growth opportunities in: (1) supporting protein therapeutics development and manufacturing, through the December 2017 acquisition of BaroFold, Inc.'s controlled protein refolding and disaggregation patented technology, and (2) the innovation of the Company's patented Ultra Shear Technology ("UST"), opening up a vast array of market opportunities from nanoemulsions offering long-term room temperature stability and improved sensory experience for foods and other products. Nanoemulsions also allow for much higher bioavailability of oil-based nutrients and therapeutics - including our lead demonstration product area in CBD-infused nutraceuticals."
Mr. Peterson continued: "The Board believes that the Company is now positioned for a major growth phase, and we will be working closely with our investment bankers to complete our capital plans for funding these exciting growth opportunities, while completing improvements to our Balance Sheet and allowing the Company to pursue its planned up-listing to a major US stock exchange (NYSE or NASDAQ) for access to a much broader investor base. Given the scope of our vision and planned activities, coincident with Mr. Schumacher's announced transition, the Board wished to provide substantial advance notice of PBI's succession plan, designed to (i) notify staff, customers, partners, shareholders, and other PBI stakeholders of this impending change, and (ii) retain the services of Mr. Schumacher in a senior advisory role for a minimum of one year from the date of transition. To that end, Mr. Schumacher has agreed to continue with the Company during the transition period in a senior consulting role. Mr. Schumacher will also continue serving on the Company's Board of Directors."
Mr. Schumacher said: "PBI was founded on the vision that pressure - especially ultra-high pressure - could be safely used in the life sciences area to significantly accelerate the discovery and development of new drugs, vaccines, and diagnostics, which in turn could lead to better, higher quality, less expensive, and more widely available healthcare. My 15 years as CEO has overseen an exciting, successful, and sometimes challenging journey, as is often the case when driving market acceptance of paradigm-shifting technology platforms. I believe we are very close to achieving success around the original vision for PBI, and I am extremely excited over the prospects for our new BaroFold and Ultra Shear Technology businesses. Nonetheless, as I will be seventy years old in August 2020, I have worked closely with the Board to prepare for a strong and orderly transition in leadership as we enter this new growth phase. I am convinced that PBI is now poised for success thanks to the depth and dedication of our senior management and support teams. The addition of Dr. Young to our team has brought highly relevant scientific experience, knowledge, and vision, combined with his business acumen and leadership qualities that I believe will be pivotal in propelling the Company forward for decades to come."
Dr. Young said: "Ric and the senior management team have done an impressive job of taking PBI from a dream to a publicly-traded company with three, innovative platform technologies that harness the power of pressure for biological research, development and manufacturing. I believe that our proprietary, platform technologies have the potential to create new and improved biotechnology products and can position the Company for significant growth and profitability. I am thrilled to have joined such an exciting Company, and I look forward to leading the continued development and commercialization of these innovative platforms."
See full news release here: https://ir.pressurebiosciences.com/press-releases/detail/307/pressure-biosciences-announces-ceo-succession-plan
Pressure BioSciences, Inc. Reports Record Fourth Quarter and Fiscal Year 2018 Financial Results and Provides Business Update
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company"), a leader in the development and sale of innovative, broadly enabling, pressure-based instruments and related consumables for the worldwide life sciences and other industries, today announced financial results for the fourth quarter and fiscal year ended December 31, 2018, provided a business update, and offered limited guidance for FY2019.
Financial Results: Q4 2018 vs. Q4 2017
Total revenue for Q4 2018 was $686,558 compared to $502,708 for the same period in 2017, a 37% increase. This increase was primarily due to our double-digit growth in products and services and in grant revenues.
Products and services revenue was $535,860 for the fourth quarter of 2018 compared to $455,767 for the same quarter of 2017, an 18% increase. Sales of instruments increased to $388,356 in Q4 2018 compared to $317,498 in Q4 2017, an increase of 22%. Sales of consumables were $52,935 for 2018 fourth quarter compared to $60,108 for the same period in 2017, a 12% decrease. Grant revenue in Q4 2018 was $150,698 compared to $46,941 in Q4 2016 an increase of 321%.
Operating loss for Q4 2018 was $1,514,730 compared to $1,318,384 for the same period in 2017. This increase in operating loss was primarily due to increases in general and administrative expense.
Loss per common share - basic and diluted - was $(2.93) for Q4 2018 compared to $(2.37) for the same period in 2017.
Financial Results: FY2018 vs. FY2017
Total revenue for FY2018 was $2,457,871 compared to $2,240,498 for FY2017, a 10% increase. This increase was primarily due to our growth in products and services and in grant revenues.
Products and services revenue was $2,200,539 for the year ended December 31, 2018 compared with $2,065,891 for the year ended December 31, 2017, a 7% increase. Sales of instruments decreased to $1,418,731 for FY2018 compared to $1,459,326 for FY2017, a decrease of 3%. Sales of consumables were $235,132 for the year ended December 31, 2018 compared to $260,331 for the same period in 2017, a decrease of $25,199 or 10%. Grant revenue for fiscal year 2018 was $257,332 compared to $174,607 for the 2017 fiscal year, an increase of $82,725 or 48%.
Operating loss for FY2018 was $4,477,083 compared to $4,647,048 for FY2017. This decrease was primarily due to increases in total revenue.
Loss per common share - basic and diluted - was $(15.33) for FY2018 and $(9.62) for the 2017 fiscal year.
Operational & Technical Highlights: FY2018
- Bradford A. Young, Ph.D., MBA Joins PBI as Senior VP and Chief Commercial Officer in November 2018.
- We Converted $13.6 Million of Debt into Equity, Significantly Reducing Total Liabilities.
- A Major Cancer Research Center Reported that Our Patented Pressure Cycling Technology ("PCT") Platform Could Play Major Role in Improving Cancer Diagnosis and Treatment.
- PBI and ISS, Inc. Announced Two-Year Worldwide Co-Marketing and Distribution Agreement.
- We were Awarded a Key U.S. Patent for Novel High-Pressure Flow-Through Microfluidic Sample Prep Device.
- Our Ultra High-Pressure Instruments, Processing Methods, and Platform Technologies were Prominently Featured at a Leading, Worldwide Food Science Meeting.
- We Announced the First Contract Utilizing our Recently Acquired, Patented Protein Refolding and Disaggregation Platform Technology from our December 2017 Purchase of All Assets of BaroFold, Inc.
- We Accelerated the Development of our Novel Ultra Shear Technology ("UST") Platform to Pursue Commercialization into Major New Markets, Including Food & Beverages, Nutraceuticals, and Cosmetics.
- Our Patented UST Platform was Featured as a Potential Breakthrough Processing Method for Higher Quality, Longer Lasting Liquid Foods and Beverages not requiring Refrigeration or Chemical Additives, such as Shelf Stable Milk and Other Dairy Products.
- We Announced a Strategic Collaboration with Ohio State's College of Food, Agriculture, and Environmental Sciences, and were Awarded $318,000 from a USDA Grant to Build the First Prototype UST Instrument.
- We Achieved Two Major Milestones in the Development of our Proprietary UST Technology Platform, Including the Development of a UST-based Process to Make Nanoemulsions of CBD Plant Oil from Hemp.
Mr. Richard T. Schumacher, President and CEO of PBI, said: "This past year was filled with multiple significant financial, operational and technological accomplishments. Key among these was the hiring of Dr. Brad Young as PBI's Chief Commercial Officer. In this leadership role, Dr. Young will be responsible for assessing multiple major new and divergent market opportunities, and for optimizing the commercialization priorities and strategy for PBI. In addition to this essential role in strategic planning, Dr. Young will also drive the execution of critical partnering and commercialization programs to build customer adoption and accelerate growth."
Dr. Bradford A. Young, Chief Commercial Officer of PBI, commented: "We are pleased with the overall performance of the Company in 2018, especially in Q4 when total revenue reached a record, all-time high for quarterly revenue. In addition to recording significantly increased sales of our core, PCT platform in 2018, we also recorded the first revenue from our newly launched BioPharma Services business. Our BioPharma Services business helps us not only monetize the BaroFold assets we acquired in December 2017 for improved manufacturing of protein therapeutics, but also supports sales of our Barocycler PCT platform. In fact, we use the Barocycler 2320 EXTREME to perform our BioPharma Services and saw increased demand for our Barocycler 2320 EXTREME in 2018 for quality control applications used during the manufacturing of protein therapeutics."
Dr. Young continued: "It's clear that our PCT and BaroFold platform technologies can help companies produce new and improved therapeutic products, a market that is expected to reach $240 billion dollars by 2023 (ResearchAndMarkets.com, 2018). In addition, the new, cutting-edge Ultra Shear Technology (UST) platform we are developing for the production of high-quality nanoemulsion mixtures of oil & water can provide an enhanced way to deliver therapeutics or drugs. Thus, our UST platform has the potential to provide a superior method to develop and deliver drug formulations with improved bio-absorption and faster uptake. We look forward to building on the great progress we've made in 2018 and growing the adoption of our life sciences platform technologies for research, development and manufacturing applications in 2019 and beyond."
The Company will hold an Earnings Conference Call at 4:30 PM EDT on Thursday, April 25, 2019. To attend this teleconference via telephone, Dial-in: (844) 602-0380 (North America), (862) 298-0970 (International). Verbal Passcode: PBIO Fourth Quarter and Fiscal Year 2018 Financial Call. Replay Number (877) 481-4010; (919) 882-2331 (International). Replay Passcode: 47337. Teleconference Replay Available for 30 days.
Pressure BioSciences, Inc. to Discuss Fourth Quarter and Fiscal Year 2018 Financial Results and Provide Business Update
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" and the "Company") today announced that the Company will host a teleconference to discuss its Fourth Quarter and Fiscal Year 2018 financial results and to provide a business update. Anyone interested may listen to the teleconference either live (by telephone) or through a replay (by telephone or via a link on the Company's website approximately one day after the teleconference).
The teleconference will include a Company presentation followed by a question & answer period.
Date: Thursday, April 25, 2019 Time: 4:30 PM Eastern Time (ET)
To attend this teleconference, live by telephone:
Dial-in: (844) 602-0380 (North America); (862) 298-0970 (International)
Verbal Passcode (for the operator): PBI Fourth Quarter and FY 2018 Financial Call & Business Update
For those unable to participate in the live teleconference, a replay will be available beginning Friday, April 26, 2019. The replay will be accessible via telephone and the Company's website for 30 days.
Replay Number: (877) 481-4010 (North America); (919) 882-2331 (Int'l); Replay Passcode: 47337
CBD-Infused Beverages Achieve Quality and Clarity Breakthrough Utilizing Pressure BioSciences' Ultra Shear Technology Platform
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" and the "Company"), a leader in the development and sale of broadly enabling, pressure-based instruments, consumables, and platform technology solutions to the life sciences and other industries, today released a new, short video demonstrating the ability of the Company's proprietary Ultra Shear Technology (UST™) platform to create water-soluble CBD oil that disperses instantly, resulting in improved dosing effectiveness, enhanced absorption, and more aesthetically-pleasing products when added to carbonated soft drinks, vitamin-infused sports drinks, and beer.
Link to video: PBI UST CBD Video 040219
In addition to superior aesthetic quality, the Company believes the resulting low nanometer-scale emulsions ("nanoemulsions") of UST-processed CBD oil should also result in optimized and reproducible bodily absorption, bioavailability, and dosing safety for CBD oil and other UST-processed materials, when compared to many of the processed CBD oils and products that are commercially available today.
Mr. Edgar Ward, President and CEO of NutraLife Biosciences (OTCQB: NLBS), said: "NutraLife manufactures and sells NUTRAHEMPCBD, a line of CBD-infused products that includes creams, sprays, and other products that support daily health and wellness uses. We strive to ensure that our CBD-infused products will always be of the highest quality possible; therefore, we are constantly looking for advanced technologies to continue to improve our manufacturing processes. After reviewing available data and PBI's videos, we believe methods like PBI's UST platform may enable us to offer products with superior quality and effectiveness."
CBD is a non-psychoactive, oil-soluble compound extracted from the cannabis plant, and is typically marketed dissolved in plant oil. It has been widely reported to offer numerous health benefits from stress and anxiety relief, to decreased muscle, joint, cancer and other pain, reduced inflammation, and to nearly miraculous relief of persistent seizures. However, because CBD is an oil-based product, its ingestion typically results in poor absorption in water-based living systems. There has been enormous interest in the development of truly water-soluble CBD, to achieve efficient absorption and bioavailability from foods and beverages. The market for CBD beverages alone could achieve revenue of $260 million in just the U.S. by2022 (Bloomberg, September 27, 2018) and much more world-wide. Unfortunately, because of solubility issues, many CBD products on the market today contain an inefficient over-abundance of CBD and/or undesirable chemicals to improve and stabilize its solubility in water. PBI believes that all of these beverages and other CBD-based products could substantially benefit from PBI's Ultra Shear Technology platform, to achieve water solubility and stability from the physics of high-pressure shearing - rather than from dependency upon chemistry and reliance upon use of undesirable chemicals.
Dr. Brad Young, Chief Commercial Officer of PBI, commented: "We are very pleased to now show (in this follow-up video) the ability of our proprietary UST platform to mix CBD oil in water and infuse carbonated soft drinks, vitamin-infused sport drinks, and beer. This latest video further highlights the power of our UST platform to make nanoemulsions and its potential to help nutraceutical and beverage manufacturers make high-quality, oil-based products. With such compelling results to rely on, and with numerous opportunities ahead of us, we intend to accelerate the development of our UST platform to better address what we believe are several multi-billion-dollar markets in nutraceuticals, cosmetics, and food & beverages."
See full news release here: https://ir.pressurebiosciences.com/press-releases/detail/304/cbd-infused-beverages-achieve-quality-and-clarity
Pressure BioSciences Names the Vogel Laboratory at New York University's Center for Genomics and Systems Biology a Center of Excellence
Pressure BioSciences, Inc. (OTCQB: PBIO) announced the establishment of a Center of Excellence ("CoE") at Dr. Christine Vogel's laboratory at New York University ("NYU")'s Center for Genomics and Systems Biology (the "GSB Center").
As a Center of Excellence, the Vogel Lab will have free use of the Company's primary instrument system, the Barocycler 2320EXTREME (the "2320EXT") until the end of 2020. They will also be offered early access to new, modified, and/or improved versions of the 2320EXT instrument and its associated applications during the collaboration period. Finally, they will have the opportunity to work closely with PBI's senior science and engineering staff on new developments in the Company's pressure-based technology platforms.
Dr. Christine Vogel, an Associate Professor and internationally recognized scientist with multiple publications and awards, is an expert in the field of proteomics (the study of proteins), with special emphasis on protein expression patterns and their relationship to human disease - such as cancer. Dr. Vogel's laboratory uses state-of-the-art equipment and methods to investigate these and other important properties of proteins, and their association with human disease. As part of the CoE, Dr. Vogel and colleagues, along with students and visitors to the GSB Center, will use PBI's patented pressure cycling technology™ ("PCT") platform to help in the development and validation of protocols for tissue-based protein studies that might eventually be used in a clinical setting. In addition, the Vogel laboratory will be open by invitation to local, national, and international scientists for workshops and seminars on the use of the PCT platform in the discovery, identification, and elucidation of proteins that may be involved in human disease.
Ms. Roxana McCloskey, PBI's Global Director of Sales and Marketing, said: "The innovative 2320EXT intrument is based on PBI's patented and enabling PCT platform. The 2320EXT is currently used by research scientists worldwide for the safe, rapid, and reproducible lysis of cells and tissues, to release proteins and other important biomolecules (e.g., DNA, RNA, lipids) for analysis. Such analyses are a critical step in the discovery and development of diagnostic, prognostic, and predictive clinical tests used to identify risk, disease presence, or disease progression, and to guide treatment in many diseases, such as cancer."
Professor Vogel commented: "My laboratory uses the most advanced technologies available to investigate the regulation of proteins in different systems in response to environmental stress. We continually look for powerful, cutting-edge tools to help us reach the highest level of quality possible in our research."
Dr. Bradford A. Young, Chief Commercial Officer of PBI, said: "We are pleased to have the opportunity to collaborate with Professor Christine Vogel, a well-respected thought leader in proteomics. We believe the 2320EXT has the potential to support and advance the exciting work that she and her team already have underway at the GSB Center. We further believe that the added exposure received by the PCT platform during the collaboration period will increase awareness of the benefits of our pressure-based technologies in helping to provide scientists with superior proteomic analyses. We believe this added awareness should result in increased products and services revenue in 2019 and beyond."
About the NYU Center for Genomics and Systems Biology
The NYU Center for Genomics and Systems Biology is considered by many as a "hub of science" in New York City. It has state-of-the-art "loft laboratories" where scientists including professors, researchers, and students interact to leverage the extraordinary potential of genomics and systems biology in research and education. This involves the combined skills of genomic, computational, and evolutionary biologists. Faculty also collaborate with researchers in other departments and schools at NYU, such as Physics, Chemistry, Medicine, Engineering, and Global Public Health, as well as with researchers from other major institutions in New York and around the world. The intellectual synergisms brought about by these internal and external collaborations, enable us to develop unique approaches to genomics and systems biology. Working with organisms from all the major branches of the tree of life, researchers at the Center address how genomes encode regulatory genetic networks, respond to changes in the environment or during development, how genes evolve, and how this generates diversity within and across species. These principles are being applied to global questions in human health, food sustainability, bio-energy, and the environment.
Pressure BioSciences and The Steinbeis Centre Combine Efforts to Develop Revolutionary Method Based on Optimizing Disease-Fighting Antibodies
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" and the "Company"), a leader in the development and sale of pressure-based instruments and platform technologies to the life sciences and other industries worldwide, today announced a collaboration with The Steinbeis Centre for Biopolymer Analysis & Biomedical Mass Spectrometry ("The Steinbeis Centre"), a world-renown German research organization. The collaboration is combining the unique capabilities of PBI's patented pressure cycling technology ("PCT") for sample preparation, protein characterization, and biotherapeutics quality control with the Steinbeis Centre's innovative PROTEX-MS instrument for elucidating structural details of antibody interactions to create an instrument system to accelerate the development of new protein therapeutics and improve existing drug treatments.
The collaborative program will be directed by Dr. Michael Przybylski, Professor of Analytical Chemistry and Biochemistry and Director of The Steinbeis Centre, who explained the selection of PBI's PCT platform: "The high-quality digestion of proteins is an essential initial step in the discovery, analysis, and characterization of potential therapeutic proteins. In the past, we have not been fully satisfied with the results achieved when using traditional protein digestion procedures and instrumentation. However, with PBI's proprietary PCT platform, we now achieve high quality and reproducible digestion of proteins. Consequently, we believe that PCT, in combination with our innovative PROTEX-MS system, could more rapidly lead to the discovery and development of biopharmaceutical treatments for a large number of diseases, resulting in substantial improvements in patient care and outcomes."
The PCT-PROTEX-MS platform will be used to elucidate critical details of how the immune response functions as the body defends against bacteria, viruses, and other harmful molecules, organisms and cells. When an immune response is generated, proteins called antibodies are produced that interact with specific molecules ("antigens") presented by these invaders, by physically fitting and binding (like a key in a lock) with specific regions on these molecules ("epitopes"). Better characterization of these epitopes on specific antigens of the invaders, and how they bind to the antibodies that recognize them, provide valuable insights into how the immune system combats disease, and how to improve the development of targeted protein therapeutics. The past decade has seen a dramatic increase in the use of targeted antibodies as effective protein therapeutics in auto-immune diseases, cancers, and other life-threatening conditions.
Dr. Alexander Lazarev, Chief Science Officer of PBI, said: "We believe the PCT-PROTEX-MS platform being developed will offer the global research community a powerful new laboratory tool for the rapid and sensitive digestion of protein and peptide antigens followed by measurement of binding affinity (strength) and identification of epitopes captured on immobilized antibodies."
Dr. Lazarev continued: "Furthermore, the potential of this new platform in the rapid discovery of new targeted therapeutics and improvement of existing treatments tailored specifically to individual patients and their conditions offers great promise for a wide range of diseases and conditions, including cancer, arthritis, Crohn's disease, and transplant rejection."
Dr. BradfordA. Young, Chief Commercial Officer of PBI concluded: "We are delighted to becollaborating with a research team of such global stature as The Steinbeis Centreto develop a new platform technology for the characterization of binding siteson antibodies and the potential development of new and/or better proteintherapeutics. This work has very important clinical applications, as it may helpto develop more effective protein drugs with reduced side-effects in cancer,auto-immune, neurodegenerative, and other critical diseases and conditions. We are honoredthat Dr. Przybylski and his team have incorporated our proprietary PCT platformas a critical component of this innovative solution. The results of this collaborationwill provide PBI with another valuable and broad application area for our Barocyclerinstruments, and we anticipate this new instrument system will be of greatinterest to both current and future customers in the monoclonal antibody therapeutics market, expected to reach $218.97 billion by the end of 2023 (Zion Market Research, 2018)."
Scientific Analyses Confirm Important Benefits from Processing CBD Oil with Pressure BioSciences' Proprietary Ultra Shear Technology Platform
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" and the "Company") is a leader in the development and sale of broadly enabling, pressure-based instruments, consumables, and platform technology solutions to the life sciences and other industries. The Company today announced that analytical testing on hemp-derived CBD oil processed via PBI's Ultra Shear Technology™ (UST™) platform has confirmed that UST processing uniquely achieves the challenging criteria for creating highly-effective "nanoemulsions" of CBD oil in water, without loss or modification of CBD throughout the entire UST process (> 99% recovery).
The ultimate goal in mixing oil-based nutritional and therapeutic products like CBD oil into water, for effective oral or topical delivery and absorption, is to reduce the size of the oil drops to such a level that they seemingly "vanish" into the water (become "water soluble"). These exceedingly small, nanometer-scale droplets are so tiny that it becomes very easy for the human (or other animal) body to absorb the oil-based nutrients or drugs (like CBD) directly from the inner surface of the oil droplet. Traditional processing methods struggle mightily with this challenge, but PBI's proprietary UST platform uses ultra-high pressure to create extreme shearing forces to make nanometer-scale droplets of fluids that become highly-stable, homogenized "nanoemulsions" of materials that normally do not mix (e.g., CBD oil and water).
Dr. Vera Gross, Director of Applications Development at PBI, explained: "We asked an independent, university-affiliated laboratory to determine the size of oil droplets achieved in UST-processed CBD oil, using a universally-accepted sizing method called DLS. Their analytical results revealed that the UST- processed oil drops were reduced to approximately 65 nm in size, well into the 20-200 nm range targeted for truly effective nanoemulsion delivery and absorption of nutrients and therapeutics, such as CBD (Nano- and Microscale Drug Delivery Systems, 2017)."
Dr. Gross continued: "It was critically important to also demonstrate that CBD from hemp-derived CBD oil was not lost or modified during UST processing. For this we enlisted the help of scientists at NutraFuels, Inc. (OTCQB: NTFU), which has an FDA-inspected, highly-qualified analytical testing laboratory with state-of-the-art equipment and well-trained chemists with years of experience in laboratory testing."
Mr. Cooper Dodd, R&D Scientist at NTFU, said: "Using a powerful laboratory method called HPLC to measure the concentrations of CBD and potential impurities, we determined that no appreciable amount of CBD was lost during the UST process. These results compare well to our standard processing method of ultrasonication, which can carry a risk of measurable loss of CBD, and sometimes creates the appearance of impurities if not performed properly. While there is more work to be done, as a nutraceutical manufacturer with products already on the market, we see these results as a robust leap towards better optimization of our CBD-enhanced products."
Dr. Keith Warriner, Professor of Food Science at the University of Guelph (Toronto), and a recognized expert in the cannabis industry, commented: "The data released today on UST-generated nanoemulsions of CBD oil are very impressive. Creating nanoemulsions of CBD oil with full preservation of CBD throughout the process, while not generating impurities, remains a significant challenge in the industry. These data indicate that UST can achieve that goal, thereby offering great promise to the future."
Professor Warriner continued: "Not only does the UST process appear capable of achieving stability of emulsions, but the controlled heating that also occurs may offer a valid alternative to thermal and non-thermal pasteurization methods to reduce the risk of harmful microbes in products such as edibles and topicals. I believe that CBD-infused topicals and similar products will prove more popular with users than edibles. However, to be successful, it is imperative that topicals be highly stable, safe, bioavailable, and readily absorbent nanoemulsions. After consideration of the data released today, the UST process appears to be a leading candidate to fill that important need."
Dr. Bradford A. Young, Chief Commercial Officer of PBI, summarized: "We were delighted to release a short video last week showing the ability of our new UST platform to make visually clear and stable mixtures of CBD oil and water. The scientific data released today have further validated the achievement of creating high quality, nanoemulsion mixtures of oil and water using our UST platform. In particular, these data specifically show that CBD levels are preserved all the way through UST processing to the finished product. We are very excited by these results and believe our proprietary Ultra Shear Technology can help a diverse variety of customers to develop a vast array of new and beneficial products spanning multiple large markets, including CBD and nutraceuticals, cosmetics and topicals, food and beverages, drug delivery and more."
See full news release here: https://ir.pressurebiosciences.com/press-releases/detail/301/scientific-analyses-confirm-important-benefits-from
Pressure BioSciences Makes CBD Oil Water Soluble, Offering Solution to CBD Absorption Issue in Food & Beverages
Pressure BioSciences, Inc. (OTCQB: PBIO) (''PBI'' and the ''Company''), a leader in the development and sale of broadly enabling, pressure-based instruments, consumables, and platform technology solutions to the life sciences and other industries, today released a short video demonstrating the Company's proprietary Ultra Shear Technology (USTTM) platform and its ability to create extremely small, nanometer-scale oil droplets that effectively dissolve in water (nanoemulsions) to provide optimized bioavailability for absorption.
Dr. Bradford A. Young, Chief Commercial Officer of Pressure BioSciences, explained: ''We have all observed how oil and water do not normally mix or dissolve in each other, and routinely separate after mixing. Even with modern, advanced mixing technologies, oils remain in relatively large drops in water, which are poorly absorbed by the body. PBI's proprietary UST platform employs ultra-high pressure and extreme shearing forces to create very small, nano-scale emulsions (nanoemulsions) of oil droplets in water with vastly improved absorption and stability characteristics."
Bioavailability describes the percentage of and rate at which a substance is absorbed into the bloodstream. Oil-water emulsions of nutraceuticals and supplements present a serious challenge for many oral and transdermal therapies, due to most of the beneficial molecules remaining hidden inside of the oil drops. For CBD products commonly consumed orally - including CBD oils in edibles and beverages - absorption is typically below 10% (ERTH 8/28/2018: Water Soluble CBD - The Science of Nanoemulsion and Bioavailability). PBI believes that processing with the UST platform will deliver greatly improved absorption results (90% or higher) for CBD and other oil-based supplements.
Dr. Young continued: ''For many oil-based products, the ability to create nanoemulsions can improve a product's absorption, medicinal benefits, visual appearance, and sensory presentation. The potential for the UST platform to impact the CBD industry is promising, with the total cannabinoid market expected to hit $22 billion by 2022 (Brightfield Group, 2018), with CBD oil-based supplements being the cornerstone of this market. More importantly, while CBD is an attractive opportunity for our proprietary UST platform, we believe that the nutraceuticals, topicals and cosmetics, and food and beverage markets as mentioned could be 10-50 times larger. We will be addressing these additional market opportunities in parallel with our efforts in CBD.''
The short video released today is the first in a series of product-targeted video presentations designed to offer investors, future clients, and other interested groups additional information on PBI's UST platform and the numerous applications and opportunities for this transformational, proprietary technology.
Pressure BioSciences, Inc and NutraFuels, Inc to Collaborate on the Development of Water-Soluble Nanoemulsion-based Nutraceuticals
Pressure BioSciences, Inc. (OTCQB: PBIO) and NutraFuels, Inc. (OTCQB: NTFU) (together, the ''Companies'') today announced a collaboration to advance the development of a new generation of health and wellness nutraceutical products based on processing by PBI's proprietary Ultra Shear Technology (UST™) platform. The Companies believe that nanoemulsions prepared by the UST Platform will have improved quality and effectiveness compared to current emulsions, which will help to facilitate the development of a new generation of improved nutraceutical and other emulsion-based products, such as cosmetics and pharmaceuticals.
PBI is a leader in the development and sale of enabling high pressure-based instruments, consumables, and related services for the life sciences industry. PBI has more than 300 high-pressure instruments installed in over 200 life sciences laboratories worldwide, including in some of the world's leading academic, government, and biopharmaceutical laboratories.
NTFU manufactures and distributes nutritional and dietary supplements focusing on in-house product development and the highest manufacturing standards. All quality control testing and manufacturing processes are in compliance with FDA and cGMP standards. NTFU has developed multiple products for the wellness and nutraceutical markets, including formulas to support energy and focus, sleep, stress, joints, and weight loss.
Edgar J. Ward, President and CEO of NTFU, said, ''We pride ourselves in ensuring that we incorporate the highest level of quality possible in our manufactured products. When we heard that PBI was developing their new, proprietary UST processing platform, and learned of its potential to significantly increase the quality and effectiveness of nutraceutical products, we spoke with PBI and offered to help accelerate its commercial introduction. We are thrilled to be working with such experienced scientific leaders and innovators, in a program that we believe can change lives worldwide for the better.''
Mr. Ward continued, ''We believe PBI's UST platform has the potential to create long-term room temperature stable, water-soluble nanoemulsions of oil-based solutions. Nanoemulsions are known to offer greater stability and bioavailability than the standard macroemulsions used today in nutraceuticals, cosmetics, and other industries. We are excited to have the opportunity to work with a life science industry leader in the optimization of a process that has the potential to bring higher quality not just to our products, but to nutraceutical products worldwide.''
Dr. Bradford A. Young, Chief Commercial Officer of PBI, commented, ''We are pleased to have the opportunity to work with NTFU's scientists and manufacturing personnel in the development of new and improved nutraceutical products utilizing our UST platform. This proprietary technology employs ultra-high pressure and extreme shearing forces to create nano-scale emulsions of oil and water with long-term stability. For many oil-based products, the ability to create very small, nanometer-sized oil droplets that can effectively dissolve in water (nanoemulsions) can improve a product's appearance, sensory and medicinal benefits. There is a large and growing market opportunity for nutraceutical products with proven health and wellness benefits. We believe PBI's UST platform can help manufacturers accelerate growth and success in this market with higher quality, water-soluble, oil-based products with superior dietary absorption and shelf-life.''
Mr. Richard T. Schumacher, President and CEO of PBI, added, ''We are excited to work with Edgar and his NTFU team in the optimization of our UST platform, which we believe will result in the development of new and beneficial health and wellness products. The staff at NTFU has years of experience in manufacturing nutraceutical products in a quality environment. They also have access to both raw materials and finished goods, both of which are needed for optimization. Finally, they have an existing analytical laboratory with state-of-the-art equipment and well-trained chemists who can perform testing on both pre and post-processed materials, which will be invaluable to the optimization process. This collaboration clearly supports both company's strategic objectives: we look forward to an exciting and mutually beneficial relationship with our colleagues at NutraFuels.''
See full news release here: https://ir.pressurebiosciences.com/press-releases/detail/298/pressure-biosciences-inc-and-nutrafuels-inc-to
Record Number of Scientific Papers Citing the Significant Benefits of Pressure BioSciences' PCT Platform Published in 2018
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company"), a leader in the development and sale of broadly enabling, pressure-based instruments, consumables, and platform technology solutions to the life sciences and other industries, today announced that more than 20 scientific papers citing the advantages of the Company's pressure cycling technology ("PCT") platform were published by independent researchers worldwide in 2018. The publications, authored by scientists from academia, government, and industry, described a wide range of enabling applications for PBI's patented PCT Platform in cancer research, biomarker discovery, and food safety, as well as in proteomic and molecular biology studies.
In 2018, a record number of scientific papers highlighting the advantages of PCT over competitive methods were published, authored by researchers in North America, Europe, and Asia. Importantly, a number of these papers were written by scientists considered by many in the life sciences as Key Opinion Leaders ("KOLs") in their field. High quality papers authored by independent scientists - especially KOLs - and published in well-known, respected journals are an integral part of PBI's marketing strategy.
Roxana McCloskey, PBI's Global Director of Sales & Marketing, commented: "We know that scientists have a strong tendency to rely heavily on data and opinions from colleagues and other experts in their field. We therefore enhanced our marketing efforts during the second half of 2018 with a concerted effort to forward this large number of scientific publications to our base of existing and potential customers.We were pleased to see this effort result in increased interest and sales of our Barocycler instruments in 2018, which we believe will continue into 2019 as well."
The 2018 publications were primarily in the following key areas.
Pressure BioSciences, Inc. Announces Commercial Launch of its Unique Biopharmaceuticals Contract Services Business
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" and the "Company"), a leader in the development and sale of enabling high pressure-based instruments, consumables, and related services for the worldwide life sciences industry, today announced the commercial launch of its Biopharmaceuticals Contract Services Business. The launch of this new business has been eagerly anticipated following the Company's acquisition of the assets of BaroFold, Inc. in December 2017, including patents, equipment, and other intellectual property relating to Barofold's unique, high pressure-based protein disaggregation and refolding platform.
PBI expects that the unique Barofold technology platform will substantially improve the quality and costs of manufacturing protein therapeutics, by helping to resolve protein aggregation, improving solubility, and refolding complex misfolded protein therapeutic molecules into their desired, therapeutically-optimized conformations for improved drug efficacy and lower immunogenicity.
Protein-based therapeutic drugs are a large and rapidly growing part of the global healthcare industry. There are over 200 therapeutic proteins and peptides approved for clinical use in the U.S. (THPdb database: http://crdd.osdd.net/raghava/thpdb/). Protein therapeutics are valued for their more potent and specific therapeutic effectiveness for many diseases, such as cancer and auto-immune disorders. They are also the preferred treatment choices for hormone and growth factor deficiencies. Research and Markets (May 2016) forecasted that the global protein drug market will grow to $248 billion by 2020.
Dr. Alexander Lazarev, Chief Science Officer of PBI, explained: "The development and manufacture of protein-based drugs can be complex and fraught with difficulty. According to a recent publication from a team of researchers from the U.S. Food and Drug Administration (Lagasse, Feb 2017), producing a typical protein drug may include more than 5,000 critical manufacturing process steps. High on the list of significant problems that can occur during manufacturing and storage of protein drugs are the formation of protein aggregates and the misfolding of the complex protein molecules into configurations that are therapeutically ineffective, undesirable, and even harmful. Our Barofold technology platform offers a unique and cost-effective processing strategy that is expected to be effective in addressing and resolving these expensive manufacturing challenges."
Dr. Lazarev continued: "In May 2018, we began applying the Barofold platform to help resolve a major challenge in the manufacturing process for a key protein drug candidate being developed by an Asian biopharmaceutical company. Based on the successful progress of our Barofold platform to date, this client recently expanded their initial request to now include other variations on their protein drug candidate. In addition, we have recently been approached by another multi-national biopharmaceutical company for help on a similar issue."
Dr. Bradford A. Young, Chief Commercial Officer of PBI, said: "We are excited to announce the launch of our Biopharmaceutical Contract Services Business for the disaggregation and controlled refolding of proteins. For companies involved in protein manufacturing, aggregation of proteins and challenges in achieving and maintaining optimal protein folding conformations are well-known issues that can dramatically reduce a drug's efficacy and shelf-life. Our proprietary, pressure-based Barofold technology platform can help resolve and optimize these outcomes and can enable the development of novel protein therapeutics in both mammalian and non-mammalian systems, which we believe to be a very large and growing market opportunity."
Dr. Young concluded: "We are very pleased to be helping our first client, a publicly-traded biopharma company, in improving their protein manufacturing processes using our proprietary Barofold protocols. The early results were so encouraging in helping our client surmount difficult manufacturing challenges in the production of their protein therapeutic drug candidate, that they have now asked us to extend our Barofold work to include two additional protein drug candidates. In addition, improved pressure-based disaggregation and protein refolding protocols have become exciting new product applications for our core Barocycler™ instrument platforms, which were already being sold into biotechnology and pharmaceutical companies for quality control, as well as for biomarker or drug target characterization purposes. We look forward to building on these successes and growing our Biopharmaceutical Contract Services Business in 2019."