March 8, 2017 | Blake Mossy
Shoulder Options is preparing to divest its proximal humerus plate portfolio, designed for the treatment of proximal humerus fractures, and for rotator cuff repair.
Shoulder Options, founded in 2007 and based in Waxhaw, NC, develops surgical shoulder implants for rotator cuff repair, humerus fractures, humeral head replacement, and joint surface repair. The company intends to divest three products: its AFT Proximal Humerus Fracture Plate, AFT Greater Tuberosity Fracture Plate, and CRP Cuff Repair.
The AFT Proximal Humerus Fracture Plate, is an anatomically shaped implant that utilizes multiple suture tying points, and is indicated for the treatment of fractures and fracture dislocations of the proximal humerus. The device incorporates 20 degrees of retroversion between its head and shaft in order to help facilitate the restoration of normal anatomy. It received 510(k) clearance from the FDA in 2012 and has been under a limited release in the U.S. market.
The AFT Greater Tuberosity Fracture Plate is a minimally invasive system for the treatment of fractures of the greater tuberosity and cuff avulsions.
The CRP Cuff Repair Plate is a fixable suture anchor plate intended for the augmentation of transosseous rotator cuff repair, specifically in massive tears and re-ruptures in proximity to osteopenic bone. According to the company, it is the first fixable suture plate on the U.S. market and is designed with multiple suture tying points that aim to improve anchorage-to-bone strength during rotator cuff repair. The system received 510(k) clearance from the FDA in 2011 and has been fully launched in the U.S. marketplace.
In addition to FDA approval, the aforementioned assets have utility and design patents from the U.S. Patent and Trademark Office (USPTO).
With this divestiture, Shoulder Options wants to achieve large scale distribution of these products in order to make them more accessible to a greater number of patients and healthcare providers, and to help fund the commercialization of the company's non-FDA approved, Proteus Shoulder Arthroplasty platform.