Orthonika, a MedTech spin-out from Imperial College London, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its novel Total Meniscus Replacement (TMR) implant. The company has also been invited to participate in the FDA’s Total Product Life Cycle Advisory Program (TAP), designed to accelerate the development and commercialization of transformative medical technologies.
The designation provides prioritized regulatory engagement, helping to streamline the pathway toward clinical adoption and reduce development risk at a critical stage. Participation in the TAP program also supports alignment with clinicians, payers, and strategic partners throughout the product lifecycle.
Maria Kristina Bartolo, PhD, CEO and Founding Engineer of Orthonika, said, “This designation is a testament to both the unmet clinical need and the strength of our technology. With no approved synthetic solution currently available, total meniscus replacement has the potential to redefine the standard of care for patients with irreparable meniscus injuries. We look forward to utilising the FDA’s strategic guidance to streamline our development and bring a new joint-preserving solution to patients.”
Meniscal injuries are among the most common orthopaedic procedures worldwide, with approximately two million meniscectomies performed annually across the US and Europe. In more than 80% of irreparable cases, the standard of care remains partial or total removal of the meniscus, a procedure that can lead to persistent pain, reduced mobility, and progressive osteoarthritis.
Orthonika’s implant is designed to replicate native meniscus biomechanics and restore joint function through a minimally invasive arthroscopic procedure. By addressing the treatment gap between meniscectomy and total knee replacement, the technology aims to preserve joint health, reduce pain, and potentially delay or prevent the need for knee replacement surgery.
With proof of concept achieved in a highly translational animal model, Orthonika is in the final stages of preclinical development. Combined with regulatory recognition and proprietary technology, the company is positioned to address a multi-billion dollar market in the US and Europe.
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For more information, contact:
Maria Kristina Bartolo, CEO at mk.bartolo@orthonika.com.
About Orthonika
Orthonika is a spin-out company from Imperial College London aiming to develop and commercialise a novel total meniscus replacement device. It uniquely combines an innovative design with world class material science and fibre engineering to develop a fully synthetic anatomical meniscus replacement for the knee joint, fulfilling a gap of high unmet clinical need. For the latest news follow us on LinkedIn https://www.linkedin.com/company/orthonika/ or by visiting our website www.orthonika.com.
