Final Patient Treated in Clinical Trials for Active Implants NUsurface Meniscus Implant

Active
Implants LLC, a company that develops orthopedic implant solutions,
today announced that the final patient was treated in the two clinical
trials evaluating the NUsurface® Meniscus Implant for the treatment of
persistent knee pain caused by injured or deteriorated meniscus tissue.
The trials are being conducted to evaluate the safety and effectiveness
of the NUsurface Meniscus Implant in support of U.S. Food and Drug
Administration (FDA) De Novo 510(k) clearance.

“We are now one step closer to filling the gap in treatment options
between minimally invasive meniscus repair and total knee replacement,
which is a large unmet need in the orthopedic market,” said Ted Davis,
president and CEO of Active Implants. “With enrollment complete, we will
continue to work closely with the FDA and now focus our efforts on
collecting the data required for the U.S. regulatory submission. We
thank our investigator surgeons and patients for making this day
possible.”

The two clinical trials enrolled a combined 243 patients, 176 of which
received the NUsurface Meniscus Implant. The VENUS (Verification of the
Effectiveness of the NUsurface System) trial is a randomized,
multi-centered, prospective, controlled study comparing the NUsurface
Meniscus Implant to the non-surgical standard of care and enrolled 128
patients at 10 U.S. study sites. The SUN (Safety Using NUsurface) trial
is a single-arm study assessing the safety and probable benefit of the
NUsurface Meniscus Implant in restoring function similar to that of a
natural, healthy meniscus and enrolled 115 patients at 13 U.S. study
sites. Active Implants conducted the two different types of studies
concurrently in order to bring the NUsurface Meniscus Implant to market
as quickly as possible while the company worked with the FDA to finalize
the regulatory clearance for marketing in the U.S.

“The NUsurface Implant is being studied in patients who still have
persistent knee pain following a meniscus surgery, have exhausted other
treatment options, and are too old for repair and too young for total
knee replacement,” said Elliott Hershman, MD, orthopedic surgeon at
Lenox Hill Hospital in New York City and medical director for the
studies.

If approved by the U.S. Food & Drug Administration, the NUsurface
Implant would be the first “artificial meniscus.” The meniscus is a
tissue pad between the thigh and shin bones, and once damaged, the
meniscus in middle aged patients has a very limited ability to heal
itself. Current treatment for a damaged or torn meniscus includes pain
management, physical therapy, injections, repair techniques or
meniscectomy. It has been estimated that from 700,000 to over 1 million
partial meniscectomies are performed annually in the U.S. in an attempt
to alleviate pain; however, recent studies have shown that many people
who get a meniscectomy continue to experience pain that impacts their
quality of life and can eventually lead to knee replacement surgery.

About the NUsurface® Meniscus Implant

The NUsurface® Meniscus Implant is an investigational treatment for
patients with persistent knee pain following medial meniscus surgery. It
is made from medical grade polymer and, as a result of its unique
materials, composite structure and design, does not require fixation to
bone or soft tissues. The NUsurface Meniscus Implant mimics the function
of the natural meniscus and redistributes loads transmitted across the
knee joint. The NUsurface Meniscus Implant has been used in Europe under
CE Mark since 2008 and in Israel since 2011.

About Active Implants LLC

Active Implants LLC develops orthopedic implant solutions that
complement the natural biomechanics of the musculoskeletal system,
allowing patients to maintain or return to an active lifestyle. Active
Implants is privately held with headquarters in Memphis, Tennessee.
European offices are in Haarlem, The Netherlands, with R&D facilities in
Netanya, Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to
investigational use.

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