Native Orthopaedics Inc., a sports medicine startup, recently announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market its Native Root System for meniscal root repair. Tom Gamache, co-founder and CEO of Native Orthopaedics, spoke with Providence Business News about the system and the recent FDA clearance.
PBN: Now that Native Orthopaedics has FDA 510(k) clearance, what's next for the company?
GAMACHE: First and foremost, it’s about delivering on the promise that we’ve made. To the four of us – Chris [Dr. Christian Anderson, founding surgeon and chief medical officer], myself, Sam [Samuel Grossman, chief technology officer] and Brian [Brian Morley, chief marketing officer] – then to the sports medicine surgeons and their patients who deserve better than a 60% success rate. Then to our investors and partners who have joined us on this journey. It’s time to deliver the native root system and the Dragonfly technology to address all those deficiencies with the standard of care today and impact that 40% failure rate in a significant way.
PBN: How was the Native Root System created?
GAMACHE: Native Root is a manifestation of converging forces.
First, it represents the emergence of a new surgical procedure. Dr. Anderson, our co-founder, has immersed himself in the research of this procedure and has identified key deficiencies that are impacting the success rate.
Next, is the evolution of our co-founder’s thinking. Chris has spent over six years developing a novel implant technology that addresses multiple limitations of current sports medicine implants. He connected the dots between his experience with meniscal root repair and how this implant technology can address it.
Third, it’s the formation of our team. Chris and I co-founded Native because of my depth and expertise in the medical-device industry space, my ability to take an innovation into the marketplace. We formed our leadership team with Sam and Brian with the understanding to create an invincible business.
PBN: Why is it important that sports medicine surgeons are able to instantly re-tension during procedures?
GAMACHE: Soft tissue repair – whether it be an ACL, meniscus, rotator cuff – all needs to be handled with an incredible amount of care. These are complicated joints and made up of delicate tissue. If the tissue is not tensioned properly during repair, there’s a high likelihood for failure and re-operations. In the worst case, it means a total joint replacement.
Our intent is to remove the variability of tensioning to help the surgeon achieve their goals of repairing that tissue, creating a healthy joint and avoiding the disease cascade that would result in a total joint replacement.
PBN: Who will benefit most from the Dragonfly technology within the Native Root System?
GAMACHE: This is always about doing what’s best for the patient first and foremost. To reiterate, we aim to empower surgeons with a more precise and accurate repair, to delay or avoid the progression of a disease, and provide a healthy joint for that patient.
Secondly, having a surgeon on the inside, we developed the system to address every pain point along the way of this procedure. Our expectations are that the Native Root acts like a high-performing sports car in the operating room.
PBN: Why are meniscal root tears called a “silent endemic”?
GAMACHE: Root repairs have picked up steam over the last five years for a few reasons. One reason is we’re learning much more about how important a properly functioning meniscus is to a healthy knee. Second, a meniscal root tear is not visible like a traditional meniscus tear, so they were often unrecognized and left untreated. Third. we didn’t really understand the function of the root, so we needed to build up research, understanding the function of it, what happens if you don’t repair it, how it heals, etc. Now we have better diagnostic tools and research to understand these dynamics, which informs our innovation and the unmet need we are addressing.
Katie Castellani is a PBN staff writer. You may contact her at Castellani@PBN.com.
