1. FOR IMMEDIATE RELEASE
Company Contact:
Peter Pizzo
Chief Financial Officer
Cartiva, Inc.
770-754-3855
Cartiva, Inc. Announces Positive FDA Advisory Committee Review of Cartiva SCI
Panel Votes Positively on Safety, Efficacy and Risk/Benefit Ratio
Alpharetta, GA, April 21, 2016 – Cartiva, Inc., (Company) a developer of innovative products for the
treatment of cartilage injuries, osteoarthritis and other musculoskeletal conditions, announced today that
the Orthopaedic and Rehabilitation Devices Panel convened by the U.S. Food and Drug Administration
(FDA) voted 10 to two in favor of the safety of the Company’s Cartiva Synthetic Cartilage Implant (SCI)
for the treatment of osteoarthritis at the base of the great toe, nine to three in favor of the efficacy of
Cartiva SCI and eight to two, with two abstentions, that the benefits outweighed the risks. The panel
made their recommendations based on the results from a 236-patient prospective and randomized clinical
trial, the largest ever conducted for this condition.
The FDA is not bound by the panel’s recommendation, but will take it into consideration, among other
things, when reviewing the Company’s Premarket Approval application (PMA). The Company expects a
final decision on approval of the PMA later this year. If approved, Cartiva SCI will be the first synthetic
cartilage device ever approved by the FDA and the first PMA for any product in the forefoot.
“We are extremely pleased with the positive results of the panel vote, which is one of the final milestones
towards the commercialization of Cartiva in the United States,” said Timothy J. Patrick, president and
CEO of the Company. “We thank the panel members for their insights and will continue to work with the
FDA to make Cartiva SCI available to patients in the United States.”
About Cartiva, Inc.
Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with
osteoarthritis, cartilage damage and other musculoskeletal conditions. Cartiva’s venture investors include
New Enterprise Associates, Windham Venture Partners and Domain Associates. Additional information
is available on the company’s website at www.cartiva.net.
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