ODT’s Most-Read Stories This Week—April 2

Big data, big (legal) trouble, and big blessings from the FDA drove ODT website traffic this past week.

Smade topped news views by unveiling its smart devices and user-friendly analysis hub (aka S-HUB) at the AAOS 2022 Annual meeting last month in Chicago. The proprietary UX-centric and advanced data analytics platform, called S-HUB, processes field data into actionable insights, addressing OEMs’ needs and enabling more accurate data-empowered decision-making capabilities. Smade’s solution tracks an asset’s full lifecycle, and reveal invaluable information such as how many times the instrument/tray has been in surgery, the number of times it has been in autoclave and cleaning, if unexpected events occurred to them such as drops with impact, and more. Smade’s devices are resistant to extreme environments, and self-powered with long lifespans. They can transmit data via RFID even in a metallic environment and they provide the most accurate information of the surgical instruments and kits on the field.

Runner up to Smade’s news—not surprisingly—was Treace Medical’s burgeoning legal battle with Fusion Orthopedics. Treace filed a lawsuit in Arizona against Fusion Orthopedics, accusing the firm of multiple patent infringements related to its Lapiplasty 3D Bunion Correction system as well as copyright infringement, trademark rights infringement, and unfair competition. Treace is seeking injunctive relief and damages.

Also garnering interest among cybervisitors was the FDA’s approval of CartiHeal’s Agili-C, and another OSSIOfiber product family innovation. 

The agency granted CartiHeal premarket approval for its Agili-C implant to treat International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesions with total treatable area of 1-7cm² and without severe osteoarthritis. A two-year, 251-patient IDE clinical study demonstrated Agili-C’s superiority over microfracture and debridement standard of care to treat knee joint surface lesions, chondral and osteochondral defects. After 24 months, patients using Agili-C showed knee injury and arthritis score (KOOS) improvement of about 43 points compared to about 20 points for those who underwent standard of care treatments.

Meanwhile, the FDA awarded OSSIO its third clearance for the OSSIOfiber product family, essentially clearing a path to expand access to additional implants made from OSSIOfiber intelligent bone regeneration technology over the next six months.  

1. AAOS22: Smade Unveils S-Hub Data Analytics Platform

2. Treace Medical Files Patent Suit Against Fusion Orthopedics

3. FDA Approves CartiHeal’s Agili-C to Treat Cartilage, Osteochondral Defects

4. Innovation Lab and MultiCare Health System Co-Develop Gait MyoElectric Stimulator

5. OSSIOfiber Implants Gain 3rd FDA Clearance in 4 Months