May 17, 2016

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

Results Show Cartiva SCI offers safe and effective alternative to joint-destroying fusion procedure

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 http://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.”

[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.

Contact

Cartiva, Inc.
Peter Pizzo, 770-754-3855
Chief Financial Officer

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