VENUS Clinical Trial for Persistent Knee Pain Now Underway in North Carolina

Local Medical Center One of 10 Sites Nationwide Enrolling Patients in
New Study of Investigational Meniscus Replacement

DURHAM, N.C.–(BUSINESS WIRE)–Active Implants, a company that develops orthopedic implant solutions,
today announced that the company’s VENUS (Verification of the
Effectiveness of the NUsurface® System) trial is now underway at Duke
University Medical Center. Duke is the only center in the state – and
just one of 10 sites nationwide – participating in the VENUS clinical
trial to evaluate the company’s investigational meniscus implant for the
treatment of persistent knee pain caused by injured or deteriorating
meniscus cartilage.

The meniscus is a tissue pad between the thigh and shin bones. Once
damaged, the meniscus has a very limited ability to heal. Over 1 million
partial meniscectomies to remove or repair a torn meniscus are performed
in the U.S. every year, about the same as the total number of hip and
knee replacement surgeries combined. However, many patients still
experience persistent knee pain following meniscus surgery.

“There are limited options for patients who experience persistent knee
pain following meniscus surgery,” said William E. Garrett Jr., M.D.,
Ph.D., professor of Orthopaedic Surgery at Duke University School of
Medicine. “Damage to the meniscus with loss of meniscal function can
lead to activity-related pain in the near-term and, in some cases, to
arthritis in the long-term.”

The VENUS study will enroll approximately 130 patients at orthopedic
centers in the U.S., Europe and Israel. Participants who meet study
requirements and agree to enter the trial are randomized to receive
either the NUsurface device or non-surgical treatment, which is the
current standard of care for patients with persistent knee pain
following meniscus surgery. To be eligible for the study, participants
must be between the ages of 30 and 75 and have pain after medial
meniscus surgery that was performed at least six months ago. To learn
more about the study, call (844) 680-8951 or visit www.meniscus-trial.com.

About the NUsurface® Meniscus Implant

In the U.S., the NUsurface® Meniscus Implant, from Active Implants LLC,
is an investigational treatment for patients with persistent knee pain
following medial meniscus surgery. NUsurface is made from medical grade
plastic and, as a result of its unique materials, composite structure
and design, does not require fixation to bone or soft tissue. The
NUsurface device mimics the function of the natural meniscus and
redistributes loads transmitted across the knee joint. It is inserted
into the knee joint through a small incision, and patients typically can
go home soon after the operation. After surgery, patients undergo a
six-week rehabilitation program. NUsurface has been used clinically in
Europe since 2008 and Israel since 2011.

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

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

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