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Ceterix Orthopaedics Announces FDA Clearance of New Suture Cartridge, Providing Increased Flexibility and Enhanced Options for Surgeons

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New Size 0 Cartridge Offers Strength and Flexibility to Aid in
Meniscal Repair

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) 510(k) clearance of an added feature to the
NovoStitch® Pro Meniscal Repair System – a size 0 suture cartridge –
offering surgeons more options to repair meniscal tears.

The NovoStitch Pro system enables surgeons to place stitches
arthroscopically in tight joint compartments, allowing them to address
meniscal tears which have not been amenable to repair in the past. With
the addition of the NovoStitch Pro's new 0 suture cartridge, surgeons
have expanded options in suture size and are able to pass a complete
stitch within the knee joint without having to remove the device to
reload a suture, a common shortcoming among other systems.

More than 100,000 patients each year experience a common yet
debilitating type of meniscal injury known as a meniscal root tear1.
The availability of the 0 suture cartridge to the NovoStitch Pro system
offers greater flexibility to physicians performing meniscal root and
other complex repairs.

"The considerable strain placed on the knee's meniscus during common
physical activities makes it particularly prone to injury," said Dr.
David Flanigan, professor of orthopaedics and director of the Cartilage
Restoration Program at The Ohio State University Wexner Medical
Center. "Having access to a larger suture provides additional
possibilities for meniscal repair."

"Ceterix continues to bring advanced technology to orthopaedic surgeons
who are looking for better ways to preserve the meniscus," said John
McCutcheon, Ceterix's president and CEO. "This latest innovation will be
especially beneficial to those surgeons who prefer an ‘all-inside,
all-suture' procedure with a stronger suture for the more-demanding
meniscal root repairs."

The meniscus is a crescent of soft cartilage that sits between the femur
and tibia, providing stability and shock absorption to the knee. The
meniscus attaches to the tibia at its root but is subject to tearing at
this attachment point. Historically, this type of repair would have been
treated with a meniscectomy (complete or partial removal of the
meniscus) which has been shown in studies to increase a patient's risk
of developing osteoarthritis, which may lead to total knee replacement
later in life.2

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 annually.3,4

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 510(k) 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.

1Cinque, M. E., Chahla, J., Moatshe, G., Faucett, S. C.,
Krych, A. J., & LaPrade, R. F. (2018, July 01). Meniscal root tears: A
silent epidemic. http://dx.doi.org/10.1136/bjsports-2017-098942
2Chung
et.al. Arth 2015 Oct; 31(10):1941-50.
3Brinker 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.
4New Hampshire Outpatient Surgery: Knee
arthroscopy data. Vol. 2008. New Hampshire Comprehensive Health Care
System; 2006.

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