Anteris has developed an aortic heart valve, called DurAVR 3D, that can be implanted through a catheter in a process called transcatheter aortic valve replacement (TAVR). The alternative is through surgical opening of the chest to access the aorta. Around 42% of stents are implanted by a catheter, with 58% through the more invasive surgical procedure. However, over the next six years 76% of all procedures are expected to be via catheter, with Medtronic and Edwards LifeSciences dominating the market (with 88% share).
Last year just over 530,000 TAVR procedures were conducted globally generating device revenue of US$8 billion. This is expected to increase by around 75% to US$14 billion by 2028.
In December last year the first five patients were implanted with the Anteris device with excellent results. The outcome was an 86% reduction in what was previously a largely blocked valve due to calcification. According to the company this was up to 50% lower than what is achieved with other TAVR devices when looking at similar sized valves, as well as up to a 45% larger effective orifice area at 30 days following implant than other devices.
In the last week of May this year, the second cohort of eight patients were implanted with the Anteris TAVR device. Last month the company announced that after 30 days, the pressure across the valve was reduced by 81% with an average 300% increase in effective orifice area. All 13 patients treated to date have shown a strong improvement in health from pre-implant.
Anteris will continue to enrol patients into this study ahead of a planned pivotal study. The company anticipates it will be able to charge US$25,000 per device used in the US clinical program with the first revenues expected next year.
The Anteris valve is made from decellularized bovine pericardium tissue using the ADAPT process developed in Perth. After 10 years of implant (in other tissue repair procedures) the tissue has shown to remain resistant to calcification (hardening). Competing heart valves have shown to begin deteriorating after 12 months in cases and may need replacement after five years according to the company. The appeal of the Anteris technology is for broadening the use into younger patients who can be expected to live with the device for longer, requiring a longer-term solution. Over the last decade the average age of patients receiving an aortic valve replacement through a catheter has fallen by 12 years to an average 73 years of age.
Anteris Technologies finished June with $33 million in cash, following a $28 million placement to Perpetual Life Sciences Master Fund in March (at $15 per share). The company is capitalised at $342 million.
Bioshares recommendation: Speculative Buy Class A
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