FDA grants Dr. Kiran Patel’s company’s invention ‘Breakthrough Device Designation’

Dr. Kiran Patel with his physician wife Pallavi Patel.

In a major shot in the arm for Indian ingenuity in the development of a revolutionary medical device, billionaire cardiologist turned “purposeful philanthropist” Dr. Kiran Patel’s company, Concept Medical Inc., headquartered in Tampa, Florida, has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for ‘Magic Touch,’ its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR), wholly developed at the company’s R & D (research and development) and manufacturing facility in Surat, Gujarat.

ISR is the gradual re-narrowing of a stented coronary artery lesion, due to subsequent tissue proliferation at the stented site. ISR is observed in about 10 percent of patients who undergo a drug eluting stent (DES) implantation and in more than 30 percent of patients who undergo bare-metal stent (BMS) implantation. Such patients, who come back with re-clogging of the coronary arteries following an earlier procedure of a bare metal or a drug-eluting stent implant, are candidates for treatment with the MagicTouch.

Patel said, “The FDA’s designation of MagicTouch for the Breakthrough Device Program will allow CMI to meet its ambition to provide this promising technology and innovative treatment for ISR patients in the U.S.” and added.

“Our confidence in MagicTouch emanates from the positive feedback that we are receiving from the users of our product from current and ongoing commercial sales of MagicTouch in many European countries.”

He said that “CMI is encouraged that the selection of MagicTouch, with its unique drug delivery technology, for the FDA’s Breakthrough Device Program may allow timely access of this promising new technology to the U.S. patients with coronary ISR, with a potential to provide safe and effective treatment.

“It took years of research to master the Limus drug delivery platform technology to devise an innovative product like MagicTouch,” said IMC founder, president and CEO Dr. Manish Doshi.

He said that “MagicTouch has been commercially used in more than 25,000 patients worldwide, with the highest usage in patients in the European region. Besides commercial sales, MagicTouch has been evaluated extensively in clinical studies conducted in countries like the U.K., Italy and Brazil.”

Doshi said, “We are now excited to begin our work with the FDA in bringing our technology to serve the patients in the USA.”

In an interview with India Abroad, Patel declared, “This is really a big deal, because as you know, India historically has been known only for being an outsourcer — where you manufacture things for others.

“But this is where the entire R&D and the manufacturing has been from India, and in my opinion, this will be the first medical device product that has been researched and developed in India that the whole world will be copying.”

Patel, who is the main investor and largest shareholder of the company, besides being the chairman of the board, said, “FDA approval of such products usually costs pharma companies hundreds of millions of dollars and are an extremely protracted and stringent process.”

He predicted that “our product has an estimated $25 billion a year in the worldwide market and so this will be a very big deal and over the next 12 months, there will be multiple announcements as we bring more and more products to market in the U.S.”

Patel argued that “for somebody to bring such a product to market, they wouldn’t even dare without massive amounts of money — they couldn’t do it unless they have a major capital partner and that’s where I came into play with my investment,” in the company, that was established in 2008.

Asked why the product was called Magic Touch, he said that “we call it Magic Touch because it’s a balloon that you inflate for 60 seconds in a coronary artery and that results in the blockage being gone and the recess stenosis is less than two seconds.”

He predicted that the commercialization of their product in the U.S. was envisaged in the next two years and said “the initial approval by the FDA is given to us to be able to do human trials and so that phase would be another 12-24 months. There is a strict criteria and you have to go through all of the investigational protocol.”

“First the FDA approves the study, then every hospital and others will be working on it to see how it can be operational,” he said.

Patel acknowledged that this particular endeavor of his—investing in this company and supporting the R & D in India to come out with this pioneering effort—was also a manifestation of his avowed concept of ‘purposeful philanthropy.’”

In December last year, Patel pledged $20 million for a charter high-school in Temple Terrace, Florida, to bring high quality options to an area that otherwise has none.The school, called the Dr. Kiran C. Patel High School for Innovation and Leadership, is expected to open in August this year in time for the next academic year.

The Kabwe, Zambia-born Patel, along with his physician wife Pallavi Patel, in Sept. 2017 donated $200 million to the Nova Southeastern University—the largest philanthropic gift in its history –to be used to significantly expand NSU’s programs in osteopathic medicine and health care sciences and to develop a new 27-acre campus in Clearwater, Florida. The Patels’ gift was also the single largest donation made by an Indian-American individual or family in the history of Indian-Americans.

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