- Meditech company Anteris Technologies (AVR) has received world-beating interim data from tests of its novel heart valve tech
- The study is testing the Anteris ADAPT treated tissue used in the company’s DurAVR 3D single-piece aortic valve against a leading competitor’s valves
- Interim results show 40 per cent less build-up of calcium in the ADAPT tissue compared to two kinds of Medtronic tissue
- While the results aren’t final, it’s the second head-to-head study in which AVR has outperformed a rival
- Demonstrating the superiority of the DurAVR valve against its competitors is crucial in the U.S. FDA approval process
- If the final results mirror the interim data, Anteris could have a market leader on its hands
- Anteris Technologies closed Tuesday’s session grey at $3.66
Anteris Technologies (AVR) has received world-beating interim data from tests of its novel heart valve tech.
Animal tests
The study is testing the Anteris ADAPT treated tissue used in the company’s DurAVR 3D single-piece aortic valve against a leading competitor’s valves.
48 juvenile rats have each been implanted with four samples under their skin and are being monitored to check for calcification.
One sample contains the ADAPT treated tissue, while two incorporate the Medtronic AOA tissue used in commercially available SAVR (surgical
aortic valve replacement) and TAVR (transcatheter aortic valve replacement) valves.
The fourth sample is a control made from glutaraldehyde-treated cow heart tissue.
The interim results come halfway through the eight-month study, and show the ADAPT tech is streets ahead of the Medtronic tissues.
While the results are far from final, the ADAPT tissue showed a 40 per cent lower calcium concentration than the Medtronic tissues.
This result is also consistent with an earlier head-to-head trial in which the ADAPT tissue had a similar response compared to Edwards Life Sciences’ Thermafix tissue at the eight to 12-month mark.
Anteris CEO, Wayne Paterson, says the results speak for themselves.
“The results were highly positive for ADAPT, indicating our ADAPT anti-calcification treatment is statistically superior to both of the major competitors,” Wayne said.
Outlook
Calcification is a major problem in heart valve replacements made from animal tissue, with a potentially huge addressable market.
A reduction in calcification would make replacement valves last longer and work better.
Once the eight-month study is complete, Anteris will submit results to the U.S. Food and Drug Administration for assessment.
The Anteris CEO says demonstrating the superiority of the DurAVR valve against its competitors is crucial in the approval process.
“Whilst we have long understood the clinical superiority of ADAPT, it’s critical for the regulatory submission to prove this against market incumbents specifically in the TAVR space,” Wayne said.
If the final results mirror the interim data, Anteris could have a market leader on its hands.
Anteris Technologies closed Tuesday’s session grey at $3.66.