Progenerative Medical's Regenn™ Therapy System, based on clinically-proven reduced pressure therapy, activates natural bone healing processes that lead to rapid boney integration of spinal fusion devices, resulting in consistent, predictable spinal fusion rates. Regenn™ Therapy is adjunctive and surgical procedure agnostic, integrates seamlessly with surgical practice, and is administered by the surgeon in the hospital.
Spinal fusion surgery has a significant failure rate that often requires one or more surgical interventions. Implants used in spinal fusion frequently fail because of poor integration with the patient’s bone, and surgical outcomes can be compromised by patient age and/or underlying co-morbidities such as obesity, smoking, and diabetes → 20 – 30% of patients undergoing spinal fusion procedures report dissatisfaction with the outcomes of surgery.
Pre-revenue
Regulatory - Product requires FDA approval prior to commercialization, about to go to FDA for Phase 2 of submission, developed de Novo 510(k) strategy for expanded product claims, est regulatory and reimbursement relationships, preparing initial 510(k) submission
Product - Completed therapy system, quality system & product documentation, est manufacturing relationships
Clinical - Selected lead key opinion leaders, seated medical advisory board, est clinical trial relationships, surgeons recognize the value of our RPT-based product in spine & orthopedic indications and are eager to use it in their surgical practices. We
Plan to initiate first in-human clinical evaluation in early 2021.
TMCx Accelerator
