Pulse Biosciences, Inc. (Nasdaq: PLSE) today announced treatment of the first patients in its multicenter study to evaluate the safety and efficacy of its Nano-Pulse Stimulation (NPS) technology for eliminating Sebaceous Hyperplasia (SH), an unsightly benign skin lesion that typically appears on facial skin and is considered a difficult-to-treat condition with current modalities. NPS is a non-thermal technology that utilizes ultra-short, nanosecond pulsed electrical fields to directly affect cell membranes and intracellular structures while sparing non-cellular tissues.
A previously published study of NPS in the treatment of seborrheic keratosis skin lesions in 58 patients provided the first human evidence that NPS’ mechanism of action is well suited to target a broad range of difficult-to-treat benign and non-benign skin lesions by targeting the cellular structures of lesions, while sparing the surrounding non-cellular tissue of the dermal layer of skin. The sparing of surrounding non-cellular skin tissues enables the treatment of deeper cellular structures in the skin such as the sebaceous glands that cause SH lesions.
According to one of the study’s principal investigators, Dr. Gilly Munavalli, “The unique potential of NPS to target the overactive sebaceous glands that cause these unsightly lesions without damaging the surrounding dermal tissue shows great promise in treating a common problem that my patients ask about every day.” A renowned dermatologic and Mohs skin cancer surgeon, Dr. Munavalli is the medical director and founder of Dermatology, Laser & Vein Specialists of the Carolinas in Charlotte, NC.
Sebaceous Hyperplasia is a common benign skin condition caused by cellular sebaceous glands in the deeper dermal layer of the skin that become enlarged with an oily liquid called sebum, which creates unsightly bulges, or lesions on the surface of the skin. They present as single or multiple bulges that are yellowish, shiny, small papules or bumps with a depressed center and a yellow or white outer rim. If the oily facial bumps are unsightly or embarrassing, patients often choose to have them treated for the benefit of improved skin appearance. Sebaceous hyperplasia is estimated to affect 1% of the healthy U.S. population.
Sebaceous Hyperplasia Study Design
The prospective multicenter study of the Pulse Biosciences NPS device in the treatment of SH is expected to enroll up to a total of sixty (60) patients at five leading medical centers across the United States that specialize in the treatment of skin diseases. Patients with a minimum of two SH lesions and up to five lesions will be enrolled and followed for a 60-day period. The study’s primary success measurement is the degree of clearing of benign SH lesions as rated by the investigator at the final study visit. Since these lesions frequently appear on the face, another important outcome assessment is the return of normal appearance of the skin after the lesion is cleared. Details can be found on ClinicalTrials.gov.
Pulse Biosciences expects to complete the study by the end of 2018. In addition to Dr. Gilly Munavalli, other principal investigators include facial plastic surgeon Dr. James Newman in San Mateo, CA; and dermatologists, Dr. Thomas Rohrer in Boston, MA; Dr. Suzanne Kilmer in Sacramento, CA; and Dr. Brian Zelickson in Minneapolis, MN.
“We are pleased to begin the next clinical study of our Nano-Pulse Stimulation technology for the treatment of Sebaceous Hyperplasia,” said Darrin Uecker, President and CEO of Pulse Biosciences. “We believe this study is an important next step in developing our portfolio of dermatology applications and the opportunity to further demonstrate the excellent safety profile and favorable patient experience of NPS treatments as we look to progress our NPS platform into non-benign applications.”
Ed Ebbers, Vice President and General Manager of Dermatology at Pulse Biosciences added: “Today’s announcement marks the second dermatology clinical program we’ve initiated to evaluate the efficacy of our novel NPS treatment technology. In collaboration with leading skin experts, we hope to prove the broad ability of NPS to target cellular lesions while sparing the surrounding dermal tissue as a unique and valuable mechanism for treating benign and non-benign lesions, particularly the deeper lesions that are hard to treat with available medical options.”
About Sebaceous Hyperplasia
Sebaceous Hyperplasia (SH) occurs when the sebaceous glands, which are attached to hair follicles all over the body, become enlarged with trapped sebum. This creates small, shiny, yellowish lesions or bumps, usually between 2 and 4 millimeters wide, on the skin. Sebaceous Hyperplasia typically appears on the face, especially the forehead and nose, the back, groin, armpits and shoulders. The bumps are harmless and painless, but some people elect to treat them for cosmetic reasons. Sebaceous hyperplasia is most common in middle-aged or older people, particularly those with fair skin who have had a lot sun exposure. There is currently no cure for sebaceous hyperplasia. Some medications, such as retinol or oral isotretinoin, and home remedies may reduce the appearance of bumps. Various professional methods such as chemical peels, cryotherapy, laser therapy and electocautery are available, but a few sessions or applications are often required for full removal and prevention of rapid recurrence. These modalities are also associated with a risk of skin discoloration in the treated area.
About Pulse Biosciences and Nano-Pulse Stimulation
Pulse Biosciences is a publicly listed clinical stage electroceutical company pursuing multiple clinical applications of its proprietary Nano-Pulse Stimulation technology. Nano-Pulse Stimulation (NPS) is a non-thermal, precise, focal tissue treatment technology comprised of nanosecond (billionth of a second) range pulsed electric fields that directly affect the cell membrane and intracellular structures and initiates cell death in treated cells. The initiation of cell death by NPS results in a minimal inflammatory response, which improves healing outcomes and supports the replacement of treated tissue cells with healthy tissue cells. NPS’ unique mechanism of action to initiate cell death has the potential to significantly benefit patients for multiple medical applications in dermatology, immune-oncology, and in other unique tissue targets. In cancerous lesions, NPS has been shown in preclinical models to induce immunogenic cell death (ICD), which exposes the unique antigens of the treated cells to the immune system and enrolls immune system cells, such as cytotoxic T-cells to mount an adaptive immune response. More information is available at www.pulsebiosciences.com.
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences’ expectations regarding the mechanism of action of NPS treatments, current and planned future clinical studies, other matters related to its pipeline of product candidates, future financial performance, regulatory clearance and the timing of FDA filings or approvals, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.
Pulse Biosciences’ Nano-Pulse Stimulation (NPS) is an investigational use therapy.
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