Cardiologist invests US$60 m in DEB device firmDecember 13, 2018
An Indian-American cardiologist and entrepreneur, Dr Kiran Patel, has invested $60 million in a medical company that develops sirolimus-coated balloons as an alternative to stents used in coronary angioplasty.
Concept Medical Inc, a Florida-based medical device company, has approached USFDA for an Investigational Device Exemption (IDE) for the world’s first sirolimus-coated balloon.
The company can commence clinical studies to determine the safety and efficacy of the device after obtaining IDE from the US drug regulatory agency.
According to the company, the investment by Dr Kiran Patel will pave way for clinical studies using the device.
The fund will be utilised to augment clinical data and clinical registries to qualify for reimbursement in the European markets, where the company has commercially launched the product, said Concept Medical Inc.
MagicTouch-DEB, the sirolimus-coated balloon with application in coronary and peripheral artery disease, is currently available in many parts of the world.
Extended applications of MagicTouch-DEB in renal transplant, erectile dysfunction and Arteriovenous Fistula/ Arteriovenous Graft (AVG) for renal dialysis patients are under ongoing clinical trials.
The company has initiated a series of global clinical programmes for MagicTouch-DEB including Nanolute, Eastbourne, Transform-I, Transform-II. They are also pursuing regulatory pathways in Japan and China.
Concept Medical has a manufacturing subsidiary in India, Envision Scientific Pvt. Ltd., where all their products are made. A portion of the funds will also be utilized to bolster the manufacturing operations. The company’s global distribution and marketing network is operated from offices in India, Singapore, Netherlands and Brazil. ESPL also has an India-focused, marketing and distribution business.
A Board-certified cardiologist, Dr. Patel completed his residency in Internal Medicine in New Jersey after obtaining a medical degree from Gujarat University in India and an internship in Africa. In 1982, he completed his fellowship in Cardiology from a Columbia University-affiliated programme.
Dr. Patel subsequently entered the managed care industry and was the chairman of WellCare of Florida till 2002.