Allied Healthcare Group (ASX: AHZ) submitted its 510(k) application for FDA clearance of its CardioCel device, a tissue patch designed to repair heart deformities and malfunctioning valves.
The Australian medical device maker has the green-light in Australia for this product and is waiting to hear back about European CE Mark approval. The company is touting recent study data that shows no tissue calcification 4 years after the device is implanted.
"Our U.S. opinion leaders are very supportive of our application and key centers are ready to use CardioCel when approved by the FDA," Allied managing director Lee Rodne said in prepared remarks. "This is a significant milestone for us. Gaining approval gives us commercial entry into markets, as well as offering patients and surgeons a superior product with key differences and advantages from products currently used."
The company said it raised a total of $4.6 million in funds, a majority of which will be dedicated to market launch of CardioCel
