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Devices Surgery FDA

 News Release - March 23, 2022

TendoNova wins FDA Clearance for Its New Microinvasive Ocelot Surgical Tool

ATLANTA, March 23, 2022 -- (Healthcare Sales & Marketing Network) -- TendoNova, an emerging leader in microinvasive sports medicine procedures, is pleased to announce the FDA 510(k) clearance of its new Ocelot surgical tool, which uses an innovative technology for fragmentation or debridement of soft tissue. The FDA found the Ocelot TDS 1000 substantially equivalent to the Tenex TX1 (recently acquired by Trice Medical) which is routinely used for percutaneous tenotomy in orthopedics, sports medicine, pain management, and podiatry. The Ocelot System's form factor and price point make it an exciting alternative to existing tools.

Using technology licensed from Georgia Institute of Technology and Emory University School of Medicine, the Ocelot facilitates procedures that require fragmentation and debridement of soft tissue under external image guidance in a simple hand-held format. TendoNova was able to achieve this success through grants and investor backing of groups such as the Georgia Research Alliance and the NFL Players' Association.

"According to studies cited by the Centers for Disease Control and Prevention, more than 30 million people in the U.S. suffer from chronic tendon pain, and half of those have little or no relief from physical therapy or medication," said TendoNova CEO, Mark A Samuels. "The Ocelot is the company's first product and was conceived in response to a request by Atlanta Hawks head team physician Dr. Ken Mautner for an improved tool."

Dr. Mautner, who practices at Emory, commented that, "After 15 years of treating elite and recreational athletes for tendinopathy, I have been frustrated by the tools we have had to help heal these injuries. The TendoNova device could be a game changer in getting our athletes back to the healthiest level possible."

The Ocelot System performs mechanical fragmentation or debridement of a targeted area. The use of fragmentation and debridement is part of a common treatment for encouraging the growth of healthy tendon to supplant painful pathologic tendon tissue. Chronic tendon pain disorders, or tendinopathies, include tennis elbow, plantar fasciitis, and jumper's knee. Tendinopathy is prevalent in athletes and anyone else who engages in repetitive tasks. If left untreated, can lead to months or years of pain and even career-ending injuries.

TendoNova plans to manufacture the Ocelot in Georgia and is presently working to validate the Ocelot disposable component production. The Ocelot is expected to be available to physicians in the second half of 2022.

About TendoNova

Founded in 2017, TendoNova is a medical device company that is an emerging leader in microinvasive sports medicine procedures. The company's initial product is the Ocelot™ TSD 1000, a patented, FDA cleared medical device for fragmentation or debridement of soft tissue. TendoNova is also working on a digital health solution projected to provide device operating feedback during a procedure to reduce training times and improve outcomes. Dedicated to helping people live healthier lives with less pain and fewer injuries, the company plans a series of instrumented microinvasive tools designed to help physicians better heal patients suffering from advanced tendon and other pathologies.

For more information about TendoNova Corporation, visit our website at www.tendonova.com.


Source: TendoNova

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