Formae, Inc. develops CyborGel®, an investigational synthetic hydrogel cartilage implant system for minimally invasive knee resurfacing in progressive and post-traumatic osteoarthritis. Founded by orthopedic surgeon Kevin Mansmann, M.D., the company brings together medical, engineering, additive-manufacturing and entrepreneurial experience built through more than 25 years of research and development. CyborGel has received FDA Breakthrough Device Designation and remains limited to preclinical use while regulatory submissions and medical trials continue.
FDA Breakthrough Device Designation
Compliance program
Caira SurgicalFounded by surgeons dissatisfied with conventional approaches, Caira Surgical is developing joint-replacement navigation software and radar-based tracking technology for more precise surgery. Its first product is a knee-replacement navigation system, supported by proprietary technology protected by three U.S. patents and additional pending patents. The company’s cross-functional team includes experienced surgeons, medical advisers, software engineers, and hardware specialists.New York, NY
Auxano MedicalBorn from 1980s NASA ion-bombardment research at Case Western Reserve University, Brecksville-based Auxano Medical develops orthopedic implants designed to improve bone integration. Founded by biomaterials researcher Dr. George Picha, the company builds its products around a patented pillared surface morphology and applies it to procedures including midfoot fusion and flatfoot correction. Its research record includes 14 issued U.S. and international patents, two peer-reviewed publications, and a team with more than 75 years of combined orthopedic experience.BRECKSVILLE, OH
Lifejoint Orthopedic Solutions, IncFounded by a hand-trauma patient and her surgeon, Lifejoint Orthopedic Solutions is a Maryland medtech venture developing a small-joint replacement device for people with advanced hand arthritis. Co-founder Marcia Hart’s own table-saw injury exposed the limited options available to patients, while co-founder Ryan Katz brings experience as a Johns Hopkins-trained hand surgeon and educator. The company is pursuing research and FDA approval for an implant designed to relieve pain while preserving motion.BALTIMORE, MD
A.M. Surgical, IncFounded in 1995 by Dr. Ather Mirza, A.M. Surgical develops high-precision devices and biologic solutions for minimally invasive skeletal and soft-tissue procedures. The company is particularly known for its STRATOS carpal tunnel release system, while its newer Allio meniscal allograft extends the Mirza-led business into small-joint resurfacing. Romi Mirza has led the company since 2001 as it has grown into a multimillion-dollar surgical-device business.SMITHTOWN, NY