Anteris Technologies Ltd (ASX:AVR) is focused on progressing its DurAVR™ aortic valve to market, as a clinically superior solution to help healthcare professionals create life-changing outcomes for patients.
The valve was developed from the ADAPT® tissue technology invented under the previous company name of Admedus Limited, by Perth professor Leon Neethling, and has proven to be the only tissue to last beyond 10 years in the human body.
ADAPT® has unique properties that are critical to longer-lasting aortic valves and has been used in more than 20,000 patients globally.
Unique tissue technology
In heart surgery, one of the biggest issues facing patients – and surgeons – is finding a replacement valve that will last the life of the patient.
The current commercial devices start failing as early as five years after the procedure.
DurAVR™ is a 3D single-piece aortic valve for the treatment of aortic stenosis and addresses the key issues impacting valve durability, including:
- Superior anti-calcification properties compared to other valves constructed from tissue that has residual DNA which promotes inflammation, an immune response that leads to calcification;
- The valve has no residual glutaraldehyde which is toxic and requires manual rinsing pre-implantation;
- DurAVR™ is made from one piece of tissue resulting in 35% less stress on the leaflets, compared to other valves which are constructed of three separate pieces of tissue resulting in greater stress and sub-optimal coaptation;
- The valve shows no wear at 400 million cycles as opposed to competitor valves which demonstrate wear and may breakdown at 250 million cycles; and
- The valve has 20-30 sutures which means lower manufacturing costs compared to other valves with 100s of sutures.
Addressing even one of these could be a competitive advantage, and the DurAVR™ 3D single-piece heart valve addresses all of these issues.
DurAVR™ addresses the key areas that lead to valve deterioration.
First in-human trial
DurAVR™ was successfully implanted into the first patient at the University Hospitals Leuven in Belgium in March.
Professor Bart Meuris MD, PhD, Chief of Cardiovascular Surgery at the University Hospitals, Leuven, Belgium conducted the cardiac heart valve surgery.
Fifteen patients will be enrolled in the first-in-human study and followed up for six months after receiving implantation of the ADAPT® single-piece 3D aortic valve.
A preclinical study is underway to compare anti-calcification properties of its proprietary ADAPT® treated tissue with other bovine and porcine tissues used in commercially available SAVR and TAVR valves.
The study will be conducted in Minneapolis, USA, at a world-renowned preclinical facility with the aim being to evaluate anti-calcification properties in the established subcutaneous rat model.
Around 48 rats will be implanted and harvested implants will be processed for histological and calcium/phosphorus analysis initially at the end of four months.
Animal study underway
Anteris has also implanted its proprietary DurAVR™ Transcatheter Heart Valve into the first three animals (pigs) as part of a transcatheter aortic valve replacement (TAVR) study.
The first feasibility study in pigs aims to confirm DurAVR™ valve deployment and fixation (anchoring) as well as providing insight into the valve’s haemodynamic function.
This study of nine animals is being conducted in Minneapolis, USA and is scheduled to be completed by December 31 2020.
Lessons learned in this study will allow Anteris to make refinements to the frame and delivery system for the DurAVR™ aortic valve, which ultimately will be applied to the device used in the planned US FDA submission for a human clinical trial in 2021.
The 2019 FDA approval for low-risk (younger patients) is driving market expansion
Around 62 million people globally suffer from aortic stenosis – a condition that narrows the valve and in severe cases requires a repair or replacement procedure – and the Transcatheter Aortic Valve Replacement (TAVR) market is growing rapidly.
By 2025, Global Aortic Valve Replacement to expected to reach US$8 billion, and TAVR is anticipated to be 62% of procedure volume and 87% of market revenue.
Additionally, the Food and Drug Administration (US) approved the use of TAVR in ‘low-risk’ younger patients in 2019, with valves required to be extremely durable to last 15 years or more in the younger patient population.
This represents a significant opportunity for the DurAVR™ valve to enter the market as the most durable option to meet demand.