Founded by spine surgeon Dr. Stephen Banco and MedTech accelerator Runway Healthcare, Waypoint Orthopedics develops vertebral-fixation tools, led by its FDA-approved Waypoint GPS™ disposable pedicle probe. Its proprietary color-sensing technology gives surgeons real-time feedback as the probe advances through bone, with the aim of helping avoid cortical breaches and reducing radiation during open and minimally invasive spine surgery.
FDA Approval for use in open and MIS Spine surgery
Omnia MedicalFounded by engineers and medical-device professionals, Morgantown, West Virginia-based Omnia Medical develops orthopedic implants for spine and interventional pain care. Its work is especially focused on sacroiliac-joint stabilization, including the PsiFGuard system, which the company describes as FDA-cleared real-time guidance technology for SI-joint detection. Omnia also develops spinal fusion and biologic solutions through surgeon collaboration, with a mission centered on safe, reproducible instrumentation and shorter operative times.MORGANTOWN, WV
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
Altus SpineAltus Spine develops and manufactures medical devices for spinal correction surgery, pairing surgeon collaboration with in-house engineering and manufacturing in its West Chester, Pennsylvania plant. Its systems include the Sochi occiput-to-sacrum platform and the Brickyard ALIF system, with design emphasis on streamlined instrumentation and rapid response to clinical needs. The company operates under ISO 13485 regulatory requirements and has received FDA 510(k) clearances for products including Sochi and Monaco HA.WEST CHESTER, PA
StabilizOrthoFounded in 2009 by an orthopaedic surgeon and partners, StabilizOrtho develops, builds and sells orthopaedic fracture-care devices through an accelerator model that moves ideas from clinical need to market. Its portfolio includes the SimpliFix Hip System and SPL® technology, including a hybrid metal-polymer screw system designed to change stiffness as a fracture heals. The company’s team brings more than 100 years of combined medical-device experience and works closely with surgeon partners to validate new solutions.EXTON, PA