Concept Medical has approached the FDA for an investigational device exemption (IDE) for its sirolimus-coated balloon (DCB). To support this process, the company has raised Rs 440 crore (for an undisclosed valuation) from cardiologist and serial entrepreneur Kiran Patel.
An IDE allows the investigational device to be used in a clinical study to collect safety and effectiveness data, a release said.
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.
CMI, headquartered in Florida, has a manufacturing subsidiary in India, Envision Scientific (ESPL), where all its products are made. A portion of the funds will also be utilised to bolster manufacturing operations to meet the increasing demand for its products globally. ESPL also has an India-focused marketing and distribution business. The companies which were established about 10 years ago, have developed innovative and disruptive platform technologies in drug delivery systems to address unmet medical needs in interventional cardiology. They have 96 patents granted.