UPDATED: NEA-backed Cartiva raises $6M after a recent FDA nod, as it heads into a PMA review

Cartiva has raised $6 million to back its musculoskeletal foot surgical products from a single investor just ahead of its first PMA review. The financing could be expanded to up to $8.5 million, according to an SEC filing. The startup has previously identified New Enterprise Associates, which has NEA Partner Justin Klein on its board, as its primary investor.

The financing comes at a key time for the company, which in January garnered an FDA clearance for its ProxiFuse Hammertoe Correction System. And in November, Cartiva said it had completed the two-year, 236-patient, randomized, prospective MOTION study of its synthetic cartilage implant to treat osteoarthritis of the first metatarsophalangeal joint on the great toe, Cartiva SCI.

"We're very enthusiastic about Cartiva's progress," NEA's Klein told FierceMedicalDevices. "Consistent with my philosophy in medical device investing today, the team has invested heavily in generating robust clinical evidence of safety and efficacy of the Cartiva SCI as a treatment option for osteoarthritis."

He added, "Two-year data from the MOTION study will be presented this summer at the American Orthopedic Foot and Ankle Society Annual Meeting."

The MOTION study was conducted at 12 sites in Canada and the U.S. The FDA has agreed to a modular review process of the PMA application for Cartiva SCI. The startup is slated to submit the final PMA module, including MOTION study data, during this quarter.

The primary endpoint for the MOTION study is a composite of three study outcomes: pain as measured by a Visual Analog Scale, function as measured by the Foot and Ankle Ability Measure Sports (FAAM) subscale score, and absence of key safety events. Secondary endpoints include great toe range of motion, VAS pain and return to function as measured by the FAAM Activities of Daily Living Score.

"Cartiva SCI has the potential to be a game-changer for those suffering from the debilitating pain of this condition but who wish to maintain motion in their joint," Dr. Judith Baumhauer, associate chair of academic affairs and a professor in the Division of Foot and Ankle Surgery at the Department of Orthopaedics at the University of Rochester and principal investigator of the MOTION study, said in a statement.

Cartiva SCI is made from polyvinyl alcohol and is intended to replace the damaged cartilage surface and mimic its properties. The current standard of care for moderate to severe osteoarthritis of the first MTP joint is arthrodesis, a procedure involving removal of cartilage, bone resection and fusion of the joint using plates and screws. But this can result in the restriction of movement in the big toe, which can limit some subsequent patient activities.

Osteoarthritis of the first MTP joint is the most common site of the disorder in the foot, affecting roughly two million people in the U.S. That's about one in 45 Americans over age 50, according to the company.

As for the ProxiFuse system, it uses tiny nitinol anchors on each side of the joint that are secured into the bone via a self-locking suture fiber. It's intended to offer continuous compression across the joint to be fused in order surgically stabilize hammertoe, claw toe and mallet toe.

These conditions are typically treated by fusing the joint and using pins or screws to keep the toes straight. The most common approach, a Kirschner wire, can have problems including broken hardware, loosening, bending, migration and pin tract infection, according to Cartiva.

"We believe our system resolves many of the shortcomings of existing products, such as fixation and stability, and could provide an attractive option for patients suffering from this painful condition," Timothy Patrick, president and CEO of Cartiva, said in a statement at the time of the FDA clearance.

- here is the SEC filing