CoNextions Inc. announced today that its has enrolled its first two patients in a multicenter, blinded, randomized clinical trial comparing the CoNextions TR System to standard of care suture repair for repair of Zone 2 tendon lacerations. The first two patients were enrolled at Groote Schuur Hospital in Cape Town, South Africa.
Five fellowship trained hand surgeons will enroll eighty patients at four different centers in South Africa. Groote Schuur is currently actively recruiting patients with the remaining three centers looking to commence active enrollment in the next few weeks. CoNextions TR™ tendon approximation system is a pioneering technology with the potential to dramatically advance the state-of-the-art for numerous tendon repair applications. CoNextions TR™ is a revolutionary alternative to sutures in tendon-to-tendon approximation and repair. CoNextions TR™ allows surgeons to produce a rapid, strong, and reproducible repair in any lacerated or ruptured tendon appropriately sized for the device.
CoNextions Inc. looks forward to a successful trial that will provide the proper support for a 510K submission to the FDA in 2019.