Indian American Dr. Kiran Patel of Tampa, Florida has invested $60 million for Concept Medical Inc.’s Investigational Device Exemption (IDE) for the world’s first sirolimus-coated balloon.
As a result, the company, which has a manufacturing subsidiary in Surat, Gujarat, India known as Envision Scientific Pvt. Ltd., will move its headquarters from Miami to Tampa.
According to a press release, Concept Medical Inc. has approached the FDA for an Investigational Device Exemption for their Sirolimus-Coated Balloon.
An IDE allows the investigational device to be used in a clinical study to collect safety and effectiveness data.
According to a Tampa Bay Times report, Patel’s investment will pay for clinical studies on cardiac devices coated with a substance that reduces the risk of heart blockages and the length of time a patient needs to take blood thinners.
“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,” Patel, a cardiologist and serial entrepreneur, is quoted saying in a press release. “I am excited to be a part of CMI whose research & 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.”
The investment “will be primarily to ensure we can get the FDA approvals and further studies in Europe to establish the requirements,” Patel added.
A portion of the funds will also be utilized to bolster the manufacturing operations to meet the increasing demand for their products globally.
Both companies were established about 10 years ago and have developed innovative and disruptive platform technologies in drug-delivery systems to address the unmet medical needs in interventional cardiology.
“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,” Manish Doshi, founder and managing director of the company, is quoted saying in a press release.