Cartiva Announces Publication of Results of Cartiva Synthetic Cartilage Implant Pivotal Study

ALPHARETTA, Ga.–(BUSINESS WIRE)–Cartiva, Inc., (Company) a developer of innovative solutions for the
treatment of cartilage damage, osteoarthritis and other musculoskeletal
conditions, today announced that the results of the Company’s pivotal
study for its Cartiva Synthetic Cartilage Implant (SCI) were published
in the May print edition of Foot and Ankle International (FAI). FAI is
the official peer-reviewed medical journal of the American Orthopaedic
Foot and Ankle Society. The paper, entitled “Prospective, Randomized,
Multi-centered Clinical Trial Assessing Safety and Efficacy of a
Synthetic Cartilage Implant Versus First Metatarsophalangeal [MTP]
Arthrodesis in Advanced Hallux Rigidus,” presented the results from the
MOTION Study, a 236-patient prospective, randomized multi-center study
comparing the efficacy and safety of Cartiva SCI to the current gold
standard of care, arthrodesis (fusion), for treatment of advanced-stage
hallux rigidus, or osteoarthritis at the base of the great toe. The
paper was awarded the prestigious Roger A. Mann Award at the 2015 Annual
Meeting of the American Orthopaedic Foot and Ankle Society, given in
recognition of the outstanding clinical paper presented at the meeting.
The paper concluded that Cartiva SCI was “an excellent alternative to
arthrodesis in patients who wished to maintain first MTP motion.”
A podcast interview discussing the paper and the study with its
principal investigator, Judith Baumhauer M.D., M.P.H., Professor and
Associate Chair of Academic Affairs, University of Rochester Medical
Center is available on the FAI website at https://footandankle.sage-publications.libsynpro.com/.
Data from the MOTION Study supported the Company’s Premarket Approval
application (PMA) with the Food and Drug Administration (FDA). On April
20, 2016, the Orthopaedic and Rehabilitation Devices Panel convened by
FDA overwhelmingly voted in favor of Cartiva SCI with respect to safety,
efficacy and risk/benefit ratio.
“Previous analyses¹ have shown that there is limited high
quality clinical evidence supporting many of the common surgical
treatment options for hallux rigidus,” said Timothy J. Patrick,
president and CEO of the Company. “We are pleased to see the publication
of this Level 1 evidence supporting the use of Cartiva SCI.”
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.
¹ McNeil DS, Baumhauer JF, Glazebrook MA. Evidence-based
analysis of the efficacy for operative treatment of hallux rigidus. Foot
Ankle Int. 2013;34:15-32.