Funding Will Support Investigational Device Exemption for Concept Medical's Sirolimus-Coated Balloon
October 9, 2018—Concept Medical Inc. (CMI) announced that it is seeking an FDA investigational device exemption (IDE) to conduct a clinical study of the safety and effectiveness of the company's MagicTouch-DEB, a sirolimus-coated balloon with application in coronary and peripheral artery disease.
The company has raised $60 million to fund the support the process. The funds were provided by cardiologist and entrepreneur Kiran Patel, MD, of Tampa, Florida. Dr. Patel is the Founder and Chairman of the Drs. Kiran and Pallavi Patel Family Foundation.
The funds will also be used to augment clinical data and clinical registries to qualify for reimbursement in the European markets, where CMI has commercially launched the sirolimus-coated balloon. A portion of the funds will also be used to bolster the company's manufacturing operations.
The company has globally commercialized its first product, the coronary Abluminus-DES drug-eluting stent. The MagicTouch-DEB is commercially sold in Europe and other international markets.
CMI is headquartered in Florida with a subsidiary in India, Envision Scientific Pvt. Ltd., where all their products are manufactured. Global distribution and marketing network are operated from offices in India, Singapore, Netherlands, and Brazil.