OrthoPreserve's Meniscus Implant, Defender, Receives FDA Breakthrough Device Designation and TAP Enrollment

Key Insights

• OrthoPreserve's Defender implant received FDA Breakthrough Device Designation and TAP enrollment for treating post-meniscectomy knee pain and impairment.
• The implant addresses a significant treatment gap for patients who experience poor outcomes after standard meniscus surgeries, potentially delaying or preventing knee replacements.
• The FDA programs will expedite Defender's development, assessment, and commercialization, offering enhanced communication and priority review.

OrthoPreserve, a company focused on orthopedic implant solutions, has received Breakthrough Device Designation and Total Product Life Cycle Advisory Program (TAP) enrollment from the FDA for its Defender meniscus replacement implant. This designation is for treating patients experiencing persistent knee pain or impairment following meniscus surgery, a condition affecting approximately 250,000 Americans annually.

The Defender implant aims to address the limitations of partial meniscectomy, the current standard of care for meniscus tears, which often leads to unsatisfactory long-term outcomes. OrthoPreserve's technology has the potential to replace more invasive treatments.

"While current meniscus surgeries and non-operative care can relieve pain temporarily, some patients do poorly in the intermediate to long term, progress to further surgeries, and develop degenerative arthritis that eventually requires a knee replacement. OrthoPreserve's implant has the potential to offer a minimally invasive, durable solution and higher quality of life for patients suffering from pain and mobility issues after a meniscus tear," said Kenneth Zaslav, M.D., Director of the Center for Regenerative Orthopedic Medicine at Northwell Lenox Hill Hospital and Professor of Orthopedic Surgery.

Benefits of FDA Programs

Through the Breakthrough Devices program and TAP enrollment, OrthoPreserve will benefit from early and frequent communication with the FDA and non-FDA stakeholders, along with priority review for future regulatory submissions. These programs are reserved for novel medical devices that offer more effective treatment options for irreversibly debilitating conditions, facilitating accelerated development, assessment, and commercialization of Defender.

Brendan Baggot, Vice President of Regulatory Affairs for OrthoPreserve, noted that "TAP enrollment affords enhanced guidance by agency-selected advisors on a broad range of subjects that device startups struggle with, including market adoption and insurance coverage."

Implant Design and Function

"This Breakthrough Device designation from the FDA is a major milestone for OrthoPreserve and validates the longstanding unmet medical need that our meniscus implant is designed to address," said Jonathan Schwartz, inventor, co-founder and CEO. "The anatomical design of the implant restores the normal stabilization and cushioning functions of the meniscus to relieve symptoms and preserve knee joint health."