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 US$60 million (for an undisclosed valuation) from cardiologist and serial entrepreneur Kiran Patel (Tampa, USA). An IDE will allow the device to be used in a clinical study to collect safety and effectiveness data.
The funds will also 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.
Concept Medical Inc. (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 utilised 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, the 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 (with another 40 currently in process) around the world.
The companies have previously commercialised their first product, Abluminus-DES coronary stent, which uses their proprietary drug delivery and coating systems. MagicTouch-DEB, a sirolimus-coated balloon with application in coronary and peripheral arterial disease, is commercially sold in many European countries as well as South Africa, Mexico, Malaysia, Indonesia, Singapore, and in the MENA region.
Extended applications of MagicTouch-DEB in renal transplant, erectile dysfunction, and arteriovenous fistulae and grafts for renal dialysis patients are currently in on-going clinical trials.
CMI raised the funds from the family office of Kiran Patel and Pallavi Patel. With the fresh infusion of funds, both CMI and ESPL aim to bolster their operations in the existing and new markets.
Kiran Patel, a staunch supporter of innovative and disruptive medical technologies, says, “Cardiovascular diseases (CVDs) are the number one 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.“