#USA #Richmond #OrthoPreserve #Defender Implant #FDA Breakthrough

Major Advancement in Knee Pain Management for U.S. Patients

OrthoPreserve, an innovative company based in Richmond, Virginia, has announced a groundbreaking achievement: the receipt of both the FDA Breakthrough Device Designation and enrollment in the Total Product Life Cycle Advisory Program (TAP) for its revolutionary meniscus implant named Defender. This significant milestone promises to transform the treatment of patients suffering from debilitating knee pain resulting from meniscus injuries.

Addressing a Critical Need

Every year, about 250,000 Americans endure persistent knee pain or functional impairment following meniscus surgery. Historically, the conventional treatment for meniscus tears typically involves a partial meniscectomy, which unfortunately has poor long-term outcomes. Consequently, many patients find themselves in a cycle of pain, requiring further surgical interventions or ultimately facing degenerative arthritis and the need for knee replacement surgery.

The Defender meniscus implant by OrthoPreserve offers hope for these patients. According to Dr. Kenneth Zaslav, Director of the Center for Regenerative Orthopedic Medicine at Northwell Lenox Hill Hospital, the device presents a minimally invasive alternative that not only alleviates pain but also enhances the overall quality of life for those affected by meniscus injuries.

Breakthrough Device Designation

The FDA's Breakthrough Device Designation serves to highlight the unmet medical need that OrthoPreserve's meniscus implant aims to fulfill. This designation enables the company to benefit from expedited development and review processes, allowing for quicker access to more effective treatments for critical conditions.

OrthoPreserve is recognized as a pioneer as its device is believed to be the first orthopedic implant to enter the TAP program, which traditionally excluded orthopedic devices. This program facilitates enhanced communication with the FDA and other stakeholders, aiming to streamline the pace at which the Defender implant can be brought to market.

Future Clinical Trials

Looking ahead, OrthoPreserve aims to initiate pilot clinical trials of the Defender implant in 2026, with aspirations for eventual FDA approval by 2029. The company is poised to leverage the insights and support from the TAP program to guide its development journey. Brendan Baggot, Vice President of Regulatory Affairs at OrthoPreserve, emphasizes that the TAP program will expedite the process of market adoption and insurance coverage, which are typically complex challenges that startups face.

The Mission of OrthoPreserve

Founded in 2021 and spinning out technology from Georgia Tech, OrthoPreserve is committed to restoring mobility and enhancing the quality of life for patients through innovative orthopedic solutions. With substantial funding from the National Institutes of Health alongside private investments, the company has already demonstrated the feasibility of the Defender implant through extensive studies involving animals and cadavers. Human trials are slated for the near future, promising a new era in the management of knee injuries.

Jonathan Schwartz, CEO and co-founder of OrthoPreserve, expresses the significance of this achievement: "The anatomical design of our implant is crucial in restoring the meniscus's natural functions, offering a potential solution that could alter the current treatment landscape for knee pain."

Through this groundbreaking journey, OrthoPreserve is not just striving to change treatments but also to provide patients with the hope of a pain-free life and improved mobility, free from the restrictions of traditional surgical approaches.

For more information on OrthoPreserve and their innovative products, visit www.orthopreserve.com and follow them on LinkedIn for updates on their exciting developments.