Concept Medical has raised $60m for investigational device exemption (IDE) for what it is claimed to be the world's first sirolimus-coated balloon.
The company approached the US Food and Drug Administration for an investigational IDE for sirolimus-coated balloon (DCB) for use in a clinical trial to collect safety and effectiveness data.
The $60m investment from cardiologist and serial entrepreneur Kiran Patel will support the IDE process.
Concept Medical will utilize the funding to increase clinical data and clinical registries to qualify for reimbursement in the European markets, where it has commercially launched the product.
Concept Medical is a Florida-based company, which has a manufacturing subsidiary in India. All the company’s products are manufactured at the Indian subsidiary, Envision Scientific (ESPL).
A portion of the funding will be used the company to strengthen its manufacturing operations to the meet the increasing global demand for its product. The company has distribution and marketing offices in India, Singapore, Netherlands and Brazil.
Established 10 years ago, Concept Medical and ESPL have developed new technologies in drug-delivery systems to address the unmet medical needs in interventional cardiology.
The company has 96 patents granted, with another 40 under process, around the world in major markets such as the US, China, Japan, Europe, India, Australia and others.
Concept Medical has commercialized its first product, ‘Abluminus-DES coronary stent’, which uses a drug delivery and coating systems. Its ‘MagicTouch-DEB’ (sirolimus-coated balloon with application in coronary and peripheral artery disease) is sold across several European countries including the UK and in other countries such as South Africa, Mexico, Malaysia, Indonesia, Singapore, MENA region.
Concept Medical founder and managing director Manish Doshi said: “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.”