Sports Medicine Product Updates: CoNextions Medical and Fuse Medical

In keeping an eye on lesser-known companies, I noticed two up-and-comers to share. These small startups are increasingly appearing in the news, including recent announcements in mid-September.

CoNextions Medical completed enrollment in the clinical trial for the CoNextions TR tendon-to-tendon repair device. The company plans to submit a 510(k) application to FDA in 1Q20.

CoNextions TR is a stainless steel and ultra-high molecular weight polyethylene implant designed as an alternative to sutures for surgical repair in CoNextionsTRdigital flexor and extensor tendons. The system enables rapid, strong, low profile and reproducible repair in any lacerated or ruptured tendon appropriately sized for the device in the hand, wrist, forearm, foot and ankle. The deployment system is pictured at right.

The 80-patient multi-center, blinded randomized clinical trial, which commenced enrollment in 2018, compared CoNextions TR to the standard of care suture repair of Zone 2 flexor tendon lacerations, with a primary goal to demonstrate safety and efficacy. CoNextions Medical will release trial data following completion of 12-week follow-up.

CoNextions was founded in 2011 in Salt Lake City, Utah. Members of its management team have experience at Amedica, Stryker and various medical device companies. Since 2016, the company has raised ~$10 million in funding, most recently a little over $1 million at the end of 2018.

Fuse Medical launched Galen Medial and Galen XT Suture Anchors, the Kopis Knotless Anchor and Vida Interference Screws, expanding their sports medicine portfolio. The devices are pictured above.

Fuse suture anchors are made in the U.S. from PEEK and titanium materials, and are intended for fixation of ligament, tendon, bone or soft tissue to bone in knee, shoulder, foot/ankle, elbow and hand/wrist procedures. They are provided sterile and loaded on individual inserters, and are available with or without integrated sutures and needles. Accompanying disposable instrumentation helps reduce or eliminate facility processing costs.

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