Australian med-tech company Admedus (ASX:AHZ) is looking to become the “gold standard” in cardiac bio-scaffolds and expand their product into other realms to promote rebuilding of tissue over artificial replacements.
Admedus COO Julian Chick spoke to MassDevice.com yesterday about the company’s flagship product CardioCel, how its using bio-scaffolds to grow in the cardiac repair market and where it’s looking to take the bio-scaffolds next.
Admedus’ CardioCel bio-scaffolds are regenerative tissue patches designed for cardiac and vascular repairs and reconstructions and promote autologous growth, Chick said.
“It’s taken about 11 years to get where we are today. The basis of it was – a group of bioengineers and cardiologists had gotten together to discuss existing tissues on the market, and they all had problems. They had calcification issues, rejection problems, scarring and etc. And they thought how can we adapt that manufacturing process to produce a tissue that doesn’t go through that,” Chick told MassDevice.com in an interview.
The net result was the creation of the Adapt process, which Admedus uses to produce the CardioCel bio-scaffolds, Chick explained.
The company’s 1st forays with the scaffolds were in the pediatric realm in patients with congenital heart problems, Chick said.
“We went into pediatrics and did a phase 2 study prior to approval. The product was used in 30 cases in pediatric cases from 2 months old to 6 years of age,” Chick said.
The company kept following 15 of the patients, with the longest having been implanted with the scaffold for 7 years. None of the initial patients have had detectable calcification or the need for retreatments, even in cases where the procedures were more complex, Chick said.
While the company began by focusing on cardiac repairs, the bio-scaffold patches now see use in vascular and other reconstructive repairs, Chick said. The bio-scaffolds have won approval in Canada, the U.S., the European Union, Hong Kong and Singapore, Chick added, with clearances for both vascular and cardiac repair.
“The idea here is to become the gold standard of bio-scaffold products used in the cardiovascular space. In addition, we’re also starting development outside cardiovascular,” Chick said.
That expansion includes exploration of dura mater repairs, hernia repairs, breast augmentation and orthopedic uses, Chick said. The company will be presenting data on a study of the scaffolds used for dura mater repairs in October, Chick added, with hopes of submitting a 510(k) clearance application in the near future.
AdMedus is also exploring the transcatheter aortic valve replacement market, using its bio-scaffolds to repair valves without replacing them with artificial units.
“The idea here is just providing an alternative, and that alternative is repairing the patient’s valves. If repaired properly, it will repair autologously as well,” Chick said.
Valve repairs with the bio-scaffold would operate with native tissue, Chick said, and aid in valve and leaflet function – something he said would make it a considerable alternative to valve replacement.
“If anything, we want to be disruptive to the TAVR market, and support a rebuilt valve, a native valve, so the patient doesn’t need those other products,” Chick said.
Admedus isn’t looking to completely change how the market works, but to promote regrowth and native tissues use for repairs over prosthetic alternatives, Chick said.
“We aren’t changing a paradigm here – but what we are changing is to go back to what surgeons used to do: offer a process to reconstruct and offer patients the ability to get back native valves and tissue, as opposed to an interventional cardiology management program,” Chick said.