Regenity Biosciences is tackling a long-overlooked challenge in orthopedic medicine. In this R&D 100 Award-winning interview, Natsuyo Shishido Lee (Director of R&D) and Chris Harris (Senior Integration Engineer) discuss RejuvaKnee—a purified, intact bovine meniscus implant made entirely of collagen, designed for segmental defects after partial meniscectomy. With no durable standard of care for years, the team developed a bioresorbable scaffold intended to support tissue ingrowth, earning FDA 510(k) clearance in late 2024 and reaching its first patient implant in early 2025.
Developing RejuvaKnee required collaboration across 20-30 specialists spanning R&D, production, regulatory, marketing and materials management. Lee and Harris share how the team navigated the challenges of scaling the process, building clinical confidence in a space that has seen little innovation, and the personal motivation that drove their work, including Harris’s own connection to the project through his wife’s meniscus surgeries. Early patient feedback has been promising, with one athletic patient reporting strong recovery at her nine-month follow-up.
For more on the FDA clearance behind RejuvaKnee, see our sister publication MassDevice’s coverage.
Tell Us What You Think!
You must be logged in to post a comment.