Ceterix Orthopaedics Announces FDA Clearance of the NovoStitch Pro Meniscal Repair System, Offering Enhanced Features to Improve the Surgical Experience

Meniscus surgery is one of the most common surgical procedures in the
United States, with one million performed annually

FREMONT, Calif.–(BUSINESS WIRE)–#kneesurgery–Ceterix® Orthopaedics, Inc., a leader in the
development of cutting-edge surgical tools for orthopaedic surgeons,
today announced U.S. Food and Drug Administration (FDA) clearance of the
company’s NovoStitch® Pro Meniscal Repair System. This
next-generation meniscal repair system is a significant product
evolution, offering enhanced technical features to improve the ease of
use and workflow for the surgeon.

Ceterix’s NovoStitch systems enable surgeons to place stitches
arthroscopically in tight joint compartments, allowing them to address
complex meniscal tears that have not been amenable to repair in the
past. Enhancements in the newly FDA-cleared NovoStitch Pro system
include an ergonomic and intuitive handle design, the addition of
well-defined visual cues for precise stitch placement, and improved
control and stability from upper jaw texturing.

“The new NovoStitch Pro meniscal repair system represents a significant
improvement to one of the most innovative technologies developed for
arthroscopic knee repair,” said Dr. Peter Kurzweil, president of
Memorial Orthopaedic Surgical Group in Long Beach, Calif. “The
technological enhancements incorporated into the new system offer the
potential to repair tear types that were previously considered difficult
or impossible to sew, with improved control and access for the surgeon.
I look forward to incorporating it into my practice.”

The meniscus is a crescent of soft cartilage resting between the femur
and tibia that cushions the knee and provides stability to the joint.
Meniscal tears are one of the most frequently occurring knee injuries
and are most often treated by a procedure called a meniscectomy, in
which a surgeon removes the torn tissue. Meniscectomy has been shown to
increase a patient’s risk of developing osteoarthritis, which may lead
to total knee replacement later in life. A 2015 health economics study
determined that effective meniscal repair can result in long-term cost
savings vs. meniscectomy due to the reduced risk of requiring costly
future interventions1.

“This FDA clearance is another important milestone in our mission to
reduce the number of meniscectomies and to save the meniscus,” said John
McCutcheon, Ceterix’s president and CEO. “Ceterix continues to be the
leader in meniscal repair by providing innovations that preserve tissue
and sustain the natural biomechanics of the knee joint.”

Arthroscopic surgery is a minimally-invasive procedure in which an
orthopaedic surgeon treats a damaged joint through small incisions using
specialized tools guided by a tiny camera called an arthroscope.
Meniscus surgery is the most common arthroscopic procedure in the United
States, with roughly one million performed annually2,3.

About Ceterix® Orthopaedics

Ceterix® Orthopaedics develops surgical tools that fill unmet
clinical needs for physicians who treat soft tissue joint injuries such
as meniscus tears. Founded in 2010 with the vision of improving outcomes
of arthroscopic procedures, Ceterix’s novel meniscal repair system
enables surgeons to place suture patterns that were previously only
possible in open procedures, or not at all. The NovoStitch®
Pro Meniscal Repair System has received 510k clearance in the United
States and is indicated for approximation of soft tissue in meniscal
repair procedures. The company is based in Fremont, Calif., and is
backed by investors Versant Ventures, 5AM Ventures, and CRG. For more
information, please visit www.ceterix.com
and follow us at @ceterix
on Twitter.

1 Feeley, B. et. al. The Cost-Effectiveness of Meniscal
Repair versus Partial Meniscectomy: A Model-based Projection of Clinical
Outcomes and Costs in the United States Healthcare System. ISPOR
Annual Meeting 2015.
2 Brinker MR, O’Connor DP, Pierce
P, Woods GW, Elliott MN. Utilization of orthopaedic services in a
capitated population. J Bone Joint Surg Am. 2002 Nov; 84-A
(11):1926-32.

3 New Hampshire Outpatient Surgery:
Knee arthroscopy data. Vol. 2008. New Hampshire Comprehensive Health
Care System; 2006.

Contacts

for Ceterix Orthopaedics, Inc.
Krysta Pellegrino
Krysta@healthandcommerce.com