Anteris Technologies (AVR: $3.81) has assembled an experienced advisory board to support the company’s development of its novel 3-D transcatheter aortic valve replacement (TAVR) device.
The company is currently undertaking a study in Belgium of ADAPT-treated leaflets in a valve repair trial, so far with very promising results. Anteris' tissue treatment technology addresses the calcification limitation that affects the valve leaflets made from bovine or porcine pericardium tissue. Calcification has limited the use of implantable valves in younger patients requiring heart valves, usually to address the problem of stenosis. In stenosis, valves which don't close properly cause regurgitation and degrade heart function.
The company's goal is to develop a single piece aortic valve that can be implanted using the transcatheter route, in contrast to the more invasive open surgery. The company has to date evaluated its TAVR approach in three pigs (porcine model) with data expected by year's end from a total of nine animals.
TAVR is becoming more accepted as an implantation method following the publication of several studies in recent years which have shown it to be non-inferior to surgery, and in one study (PARTNER 3) delivering lower rates of all-cause deaths, stroke, rehospitalisation and bleeding.
Medical Advisory Board
The value of medical or scientific advisory boards to small R&D companies can vary. Their value relates to not only credentials and experience of their members but more importantly how they can shape and guide a company’s clinical development and commercialisation plans. Clinically active advisors may also be key opinion leaders in their own right.
Membership may or may not be compensated. If compensation is not much more than a basic honorarium, then the presence of distinguished figures may indicate a company has attracted the interest of leading researchers or physicians with a keen and genuine interest in a potentially worthwhile technology.
Members of the Anteris Medical Advisory Board are listed in the table below. Leading members include: Dr Michael Reardon, from Houston Methodist, with 55 publications relating to randomised clinical trials to his credit; Dr Samir Kapadia from the Cleveland Clinic (57 publications); and Dr Susheel Kodali from Colombia University Medical Clinic (63 publications).
Most of these advisory board members have been involved in the clinical trials of TAVR devices.
It is rare for an ASX-listed medical device company to have assembled an advisory board with this depth of experience, and is an indicator of a high degree of clinical interest in Anteris' technology.
Several members of the Anteris advisory board have discussed Anteris’ ADAPT technology at recent meetings.
At the 2019 Cardiovascular Innovations Foundation meeting, Anteris Advisory Board member Dr Alan Zajarias said that “the next big advancement where valve replacement will come from is not necessarily in modifying the frames but from modifying the leaflet tissue." He said there were two advances to note including Edwards Life Sciences' Resilia and (Anteris') ADAPT. "So with these advances hopefully we will get better, longer durable valves.”
At the same meeting, a six minute presentation prepared by Dr Paul Sorajja, "Tissue Processing for Durability – A Novel TAVR", was presented by Dr Gilbert Tang in the first public presentation of the Anteris ADAPT technology used to make a single piece TAVR.
He discussed other rival alternatives in development which include Xeltis (a bio-resorbable polymer frame), Strait (a biopolymer) and the Inspirus TAVR which is made using Edwards Life Sciences' Resilia process.
Tang said that what the ADAPT processing achieved was to have residual DNA and no calcium binding sites, so preventing calcification. Other tissue methods cited which did lead to calcification included Xenosure, XenoLogiX, Photofix, Fresh BP and CoreMatrix.
He further discussed how an approach called Samurai tissue thinning could be used to thin pericardium and give the tissue a smooth, uniform thickness of 20 to 40 microns, allowing the tissue to be packed into small spaces. Samurai tissue thinning "increases pericardium yield – you don't need to buy as much pericardium – and it maintains its mechanical properties and enables 3-D molding."
Tang also said that 15 stitches were needed to attach the valve compared to 150 stitches for a current TAVR valve. The valve could also be implanted in an inverted position on a frame, which means that a much smaller dimension catheter can be used.
We have upgraded our recommendation for Anteris Technologies to Speculative Buy Class B in recognition of the interest the company has received and is likely to receive from interventional cardiologists, and also the prospects for commercial advances to take place in coming months.
Anteris Technologies is capitalised at $23 million.
Bioshares recommendation: Speculative Buy Class B
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