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Seth L. Sherman, MD, recently became one of the first surgeons in the United States to enroll patients in a new clinical research study for the U.S. Food and Drug Administration (FDA) approval of CartiHeal’s innovative implant for knee cartilage repair. Dr. Sherman is a sports medicine orthopedic surgeon at Missouri Orthopedic Institute, and is among 14 other primary investigators in the United States conducting the FDA-IDE study.
This study has begun in the wake of the first Agili-C™ implant case in December of 2018. This pivotal study was intended to demonstrate the superiority of the Agili-C™ implant over current standard of care measures for cartilage defects in both arthritic and non-arthritic knees, which includes microfracture and debridement treatments.
The Agili-C™ is a novel, cell-free approach to cartilage repair that employs the inorganic exoskeleton of sea coral. This study aims to use the implant to treat a variety of cartilage defects and patient demographics, which are further reasons why it appeals to orthopedic surgeons.
Cartilage damage is a common knee issue and can occur due to injury or typical wear and tear over time. Additionally, this ailment can occur in patients of all ages. The damage generally causes knee swelling, stiffness, and pain, reducing overall joint function and decreasing patient quality of life.
According to orthopedic soft tissue market research published by iData Research, microfracture is currently the fastest-growing segment in the cartilage repair market. As the Agili-C™ is projected to offer significant improvements over existing microfracture treatments, it is estimated that the Agili-C™ could cannibalize some of the microfracture segment’s monstrous growth. (Source: iData Research)
“We are thrilled to be on the leading-edge of orthopedic sports medicine and joint preservation,” Dr. Sherman said. “In the US, there are limited options for off-the-shelf cartilage repair technologies that can be used by sports medicine surgeon performed during a single surgical procedure. Benefits of this technology include its relative low cost, ease of use, without burning future bridges, and strong previous basic science and clinical track record.”
For Further Information
More on the orthopedic soft tissue repair market in the U.S. can be found in a series of reports published by iData Research entitled the U.S Market Report Suite for Orthopedic Soft Tissue Repair and Sports Medicine.