Dr Kiran Patel-backed company gets key FDA designation for product that could reduce leg amputations

A company backed by serial Tampa Bay entrepreneur Dr Kiran Patel has secured a key designation that will help advance a product from the medical device company.

Concept Medical Inc. has been granted “Breakthrough Device Designation” from the US Food and Drug Administration for MagicTouch Percutaneous Transluminal Angioplasty, which is a Sirolimus drug-coated balloon catheter, for the treatment of peripheral artery disease.

Patel, a cardiologist and serial entrepreneur, has backed Concept Medical Inc since 2018 when he invested $60 million.

The device is for a disease that takes place below the knee, also called an infra-popliteal arterial lesion, and can open up a blocked blood vessel.

This is the second such designation received by Concept Medical. The first was for the treatment of coronary artery disease in patients with in-stent restenosis.

The MagicTouch PTA device is for those with peripheral vascular disease and peripheral artery disease, a circulatory problem in which the peripheral blood vessels — usually the arteries of the legs — do not have blood supply due to narrowing, blockage or spasm of the supplying blood vessels, according to the company's press release.

The disease is commonly found in those who have diabetes. Patients can be faced with the difficult choice of needing an amputation.

"It's quite exciting to bring this to the United States," Patel told the Tampa Bay Business Journal. He said the designation hopefully allows the concept to come to fruition sooner rather than later. Asia and Europe have been testing the balloon catheter and the results have been positive.

Peripheral arterial disease affects over 8 million people in the US alone.

The designation offers Concept Medical an opportunity to interact with US Food and Drug Administration experts through several options to address topics as they arise during the premarket review phase. That can help manufacturers receive feedback from the FDA and identify areas of agreement.

Dr Patel is the founder of WellCare Health Plans Inc., which he sold for around $200 million in the early 2000s. In early 2018, he sold America's 1st Choice for more than $1.7 billion. He and his wife, Dr Pallavi Patel, are among the most active philanthropists in the Tampa Bay region, donating millions of dollars to charities every year.

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