Concept Medical Inc. has approached the FDA for an Investigational Device Exemption (IDE) for their Sirolimus-Coated Balloon (DCB).
To support this process, they have raised Rs. 440 crores (for an undisclosed valuation) from cardiologist and serial entrepreneur Dr. Kiran Patel (Tampa, Florida). An IDE allows the investigational device to be used in a clinical study to collect safety and effectiveness data.
The funds will also be utilized to augment clinical data and clinical registries to qualify for re-imbursement in the European markets, where the company has commercially launched the product.
CMI, headquartered in Florida, has a manufacturing subsidiary in India, by the name, Envision Scientific Pvt. Ltd. (ESPL), where all their products are made. A portion of the funds will also be utilized to bolster the manufacturing operations to meet the increasing demand for their products globally. Their global distribution and marketing network are operated from offices in India, Singapore, Netherlands and Brazil. ESPL also has an India-focused, marketing and distribution business.
The companies (CMI and ESPL), which were established about 10 years ago, have developed innovative and disruptive platform technologies in drug-delivery systems to address the unmet medical needs in interventional cardiology. They have 96 patents granted (another 40 under process) around the world in major markets like USA, China, Japan, Europe, India, Australia and others.
They have, since, successfully commercialized globally, their first product, "Abluminus-DES coronary stent", using their proprietary drug delivery and coating systems. "MagicTouch-DEB" (sirolimus-coated balloon with application in coronary and peripheral artery disease), is commercially sold in many European countries including UK and other countries like South Africa, Mexico, Malaysia, Indonesia, Singapore, MENA region.
Extended applications of "MagicTouch-DEB" in Renal transplant, Erectile dysfunction, AVF/AVG for Renal dialysis patients are under on-going clinical trials. The Company has initiated series of global clinical programs for "Abluminus-DES" like 'En-abl', 'Dedicate', 'Ability' and clinical programs for "MagicTouch-DEB" like 'Nanolute', 'Eastbourne', 'Transform-I', 'Transform-II'. They are also pursuing regulatory pathways in Japan, and in China (with local partners in both Japan and China).
CMI raised the funds from the family office of 'Dr. Kiran and Pallavi Patel'. With the fresh infusion of funds, both CMI and ESPL aim to bolster their operations in the existing and new markets.
"We want to make a world of difference to the way medical devices companies operate globally. We are a young organization and innovation runs in the soul of our entire organization. This investment enables us in advancing our innovation platforms vigorously. Besides the investment, Dr. K brings a serious value add with his vast experience which is synergistic," said founder and MD, Manish Doshi.
Dr. Kiran Patel, a staunch supporter of innovative and disruptive medical technologies, says, "Cardiovascular diseases (CVDs) are the number 1 cause of death globally, representing 31% of all global death and it is increasing due to changes in lifestyle and increase in hypertension amongst the young and old. I am excited to be a part of CMI whose research and innovative technologies will meet a major unmet need in patients with diabetes and cardiovascular diseases. This venture enables me to contribute to the millions of hearts beating around the world.
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