A Unique Approach to Repair Heart Muscle After AttackAugust 1, 2011 – In The News
Ikaria Inc., a critical care-focused biotechnology company, is developing a product that will act like a "splint for a broken heart," said CEO Daniel Tasse.
The solution would be injected within 90 minutes of acute myocardial infarction and turn into a gel when mixed with calcium in the heart muscle. When calcium levels decrease, the gel will turn back into a solution.
The solution is not a drug and Ikaria asked that the FDA classify it as a medical device, which Gerard Norton says gives the company a significant advantage.
"Small-molecule (drugs) -- from the moment you file you FDA submission, it could be five years before you get approval and place it into the market," Norton said, "whereas medical devices take anywhere from one to three years. It's a much quicker pathway."
Norton said the FDA has three different classes for medical devices, ranging from dental floss, to diagnostic tests, to permanent implants like pacemakers, which can make timelines vary.
"We've seen similar injectibles take two years, and also seen similar injectible materials take up to three years," he said. "But every year is revenue, and with the market potential that this has, you could be collecting close to $1 billion" annually.