ReGelTec, Inc. is a Baltimore-based clinical-stage medical device company developing HYDRAFIL®, a percutaneous hydrogel implant for chronic low back pain caused by degenerative disc disease. Founded by chemical engineers with polymer-science expertise alongside medical-device professionals with multiple successful startup exits, the company is pursuing a minimally invasive alternative to more invasive spinal interventions. HYDRAFIL has received CE Mark under the European Union Medical Device Regulation but remains investigational in the United States.
CE Mark under the European Union Medical Device Regulation (MDR)
MDSAP
ISO 13485
ExogearFounded in 2015 by inventor and entrepreneur Walter Wolanske, Exogear is a national medical device company focused on helping people with acute or chronic back pain remain active. From its West Palm Beach headquarters and Buffalo facility, the company handmakes its Recoil Spinal Support System and manages its own research, assembly, and customization in the United States. Wolanske’s companies have produced more than 7,000 spinal support devices for customers nationwide.KENMORE, NY
KKT InternationalFounded by chiropractor and researcher Dr. Aslam Khan, KKT International develops medical devices, software and clinical protocols for chronic back, neck and joint pain. Its signature Khan Kinetic Treatment uses precisely generated sound waves and patient-specific diagnostics in a non-invasive approach to spinal care. Founded in 2003, the company reports more than 500,000 treatments through 25 centers in 12 countries, with its technology protected by patents and cleared or approved by regulators including the U.S. FDA and European Commission.New York, NY
ReVivo MedicalReVivo Medical develops spinal-surgery implants, with its CEM-Plate and CEM-Cage currently under investigation in an FDA-sanctioned first-in-human clinical trial. Based in Loudonville, the company was founded by spine surgeons and biomedical researchers to improve patient outcomes while simplifying operating-room workflow and reducing implant components. Its work is backed by 18 issued U.S., European, and Canadian patents, as listed by the company.LOUDONVILLE, NY
Formae, IncFormae, 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.DEVON, PA