The new aim for the company was to apply the ADAPT tissue re- engineering technology (sourced from bovine pericardium), used to make the CardioCel and VascuCel products, in aortic stents. The benefit of the ADAPT process is that human use in heart procedures has shown no signs of calcification at more than 10 years following implant. The issue with existing transcatheter aor- tic heart valves is their short lifespan, limiting use to the elderly who are not able to undergo open heart surgery.In February 2019 its first animal study utilised an ADAPT treated, single piece, aortic valve with six sheep implanted. The 'Effective Orifice Area' (the larger the better) was an improvement to existing stents on the market, and the pressure gradient across the valve (the lower the better) was also very good at 4-6 mmHg. There was good, stable valve function at six months with no significant re- gurgitation.A human study with the Anteris one-piece, aortic heart valve was started in March, being implanted first through open heart sur- gery. Seven patients were enrolled in this study last year with results exceeding what can be expected with other valves accord- ing to the company. According to the company's website, the aor- tic valve area restored was effectively normal (at 2.44m2) and the pressure gradient was just slightly higher than normal at 7.4mmHg (<5mmHg being the max pressure gradient across a normal valve).This compares to 9-16 mmHg and 8.3-14.4 mmHg pressure gradi- ent for the two competing products from Edward Lifesciences and Medtronic respectively, which have an effective orifice area of 1.2- 1.7cm2 and 1.1-2.1 cm2.The five patients implanted last month received the device via a catheter (a transcatheter heart valve). The procedures were con- ducted by the company's CMO (Dr Chris Meduri) and two of its Scientific Advisory Board members (Dr Paul Sorajja and Dr Vinayak Bapat). Dr Sorajja said that the device, from the so far early experi- ence, "showed superior hemodynamics with some of the largest effective orifice areas I have seen in any TVR platform." Dr Meduri stated that: "Not only did the valve performance exceed our very high expectation, but the additional aspects of commissural align- ment, flow characteristics and hemodynamics were proven to be clinically significant." CEO Wayne Paterson said there was zero turbulence with perfect laminar flow that has not been seen before (with other devices), with a 65% better result than other valves.Advantages of the Anteris ValveThere are three main advantages of the Anteris DurAVR THV de- vice. The first is the ADAPT treated tissue used that has shown to exhibit an excellent profile over 10 years with respect to little or no calcification. The second is it is the only single piece, 3-dimen- sional aortic valve with 90% less sutures. The third is its improved hemodynamic flow properties with better alignment in the aorta.US$10 Billion Market by 2025The company believes that the aortic valve market is expected to be worth US$10 billion by 2025 with two main players, Medtronic and Edwards Lifesciences. With transcatheter procures becoming more common with younger patients, there is a growing need for longer lasting valves for younger patients, which will drive de-mand for the Anteris treated tissue that generates less calcifica- tion. The aortic valves sell for around US$35,000.Anteris is capitalised at $125 million (including Convertible Notes that will convert next year).Bioshares recommendation:
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