|Synthetic Cartilage Implant--Courtesy of Cartiva|
Cartiva got a go-ahead in the path toward a potential PMA approval for its Synthetic Cartilage Implant (SCI) to treat osteoarthritis at the base of the great toe. The FDA's Orthopaedic and Rehabilitation Devices Panel voted in support of Cartiva SCI efficacy, safety and that its benefits outweigh its risks. The SCI implant could offer an alternative to a joint fusion approach.
The Alpharetta, GA-based startup expects a PMA decision from the FDA later this year, with a launch reportedly slated for early 2016. If approved, it would be the first synthetic cartilage implant approved by the FDA. A financing to support the marketing of Cartiva SCI is likely in the offing as well.
It's been cash efficient thus far. Cartiva's last disclosed round was an $8.5 million Series D last May. But, according to SEC filings, it's only taken in a total of about $12 million since it was founded in December 2011 as spin-off from Carticept Medical. The company has a prominent investor line-up including New Enterprise Associates, Windham Venture Partners and Domain Associates.
"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 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."
|Synthetic Cartilage Implant at the base of the great toe--Courtesy of Cartiva|
The detailed panel vote was 9 to 3 in support of the efficacy of Cartiva SCI; 8 to 2, with two abstentions, that the benefits outweighed the risks; and 10 to 2 in favor of its safety as a treatment of osteoarthritis at the base of the great toe. If Cartiva is successful, this would be the first PMA approval for any device for the forefoot, the company said.
Cartiva's aim is to introduce novel treatments for cartilage injuries and osteoarthritis. The company's Cartiva SCI is an organic polymer-based biomaterial implant made of polyvinyl alcohol and saline. Unlike a current option, joint resurfacing, Cartiva SCI doesn't require significant removal of healthy tissue. Another surgical solution, joint fusion, has a mixed and controversial history as it can solve one problem but introduce others in delicately balanced bone groupings.
The indication currently before the FDA is to treat osteoarthritis at the base of the great toe--but Cartiva is also investigating its use to treat osteoarthritis at the base of the thumb.
The panel made its recommendations based on a 236-patient prospective and randomized clinical trial, which the company said is the largest ever conducted in this indication. Last July, the company reported that the pivotal trial met its primary endpoint, which was a composite of three outcomes--pain as measured by a Visual Analog Scale, function as measured by the Foot and Ankle Ability Measure Sports subscale score and an absence of key safety events.
In the Cartiva arm, 79% of patients met the definition of success, as compared to 62% in the control group which received joint fusion.
- here is the panel release