Anteris - Share Price Down as Company Plans for Pivotal Global study in 2025

By Mark Pachacz Posted on April 29th, 2025

Anteris Technologies Global Corporation (AVR: $4.58, last raise US$6 (approx. A$ 9)) has seen its share price fall by 30% this month and by 49% since the start of the year as the US biotech sector continues to be affected by changes being introduced by the new US Government, particularly around staff reductions at the FDA.

Anteris is now capitalized at just $164 million with $110 million (US$70.5 million) in cash at the end of last year. Its last reported staff numbers were 139.

In just three and a half years over 100 patients have been implanted with the company's aortic heart valve, including 65 in its First-in-Human study and its Early Feasibility Study. The company is in preparation for the pivotal study of its device, called the DurAVR transcatheter heart valve.

Comparison with Sapien 3

One-year implant data on the device shows excellent hemodynamic profiles achieved, with no device related adverse events.

A comparison with data from one of the the leading products on the market, the Sapien 3 device, can be made, selecting patients with a similar size aorta. In one study reported from 201 patients implanted (post procedural data) with the Sapien 3 device (https:/ /pmc.ncbi.nlm.nih.gov/articles/PMC9272262/), 67 had a very similar annula size to the Anteris trial which makes it a useful comparison.

The Effective Orifice Area (EOA) with the Anteris device at one year was 2.1 cm², which compares to 1.9 cm² for the Sapien 3 (higher is better). The baseline mean EOD in the Sapien 3 population was 0.71 cm²and 0.75 cm² in Anteris' treated population.

On the measure of Mean Pressure Gradient (MPG), Anteris achieved a reduction to 8.6mmHg from a baseline of 46mmHg. The Sapien 3 achieved a mean reduction to 12.2mmHg from a mean baseline of 43mmHg. (A lower end pressure is better.)

Impressively, the Anteris device recorded no 'Prosthesis-Patient Mismatches (PPM)" at one year from the first 37 patients. PPM is when the EOA is not large enough to achieve

sufficient blood flow, causing higher pressure gradients across the valve and resulting in a lower survival expectation. In this Sapien 3 group of patients, the PMM rate was 10.5%, in line with historical averages.

According to a survey of 37,470 Medicare patients in the US (https://pubmed.ncbi.nlm.nih.gov/30257798/), PPM occurred in 12% of patients, with a smaller size aorta generally increasing the chances of PPM occurring.

Another long-term appeal of the Anteris device is that the tissue used has been implanted in over 55,000 patients for heart and other soft tissue repair procedures with no calcification seen at 10 years.

So far, the data from Anteris' DurAVR device looks very good and supports moving into a pivotal study.

Anteris Pivotal Study

The Anteris pivotal study is expected to start in the second half of this year and involve between 1000-1200 patients. It will compare its DurAVR device against balloon and self-expanding devices on the market (the Sapien 3 and Evolut).

The primary endpoint will be non-inferiority to the Sapien 3 and Evolut devices at one year, based on mortality, stroke and hospitalization. The secondary endpoint will be differences in hemodynamic outcomes at one month and at one year.

The study is expected to involve 80 sites. Two of the leaders in the field, Dr Martin Leon and Dr Michael Reardon, will be the principal investigators.

Anteris has stated it expects to receive US$25,000 for each device used in its study. In its feasibility study in 15 patients, the company generated US$300,000 of device income (an average US$20,000 per device). For Anteris' pivotal study, the company should generate at least US$10 million from device revenue.

A point of difference also for the company to consider is in valve-in-valve procedures, where the Anteris device has achieved some excellent results. A valve-in-valve procedure is where the original valve has failed and a second or third aortic valve is implanted.

Case Study

One patient received a different aortic valve through standard surgery, achieving a mean pressure gradient across the valve of 23 mmHg. Seven years later the patient received an Evolut valve with an MPG of 31mmHg post procedure. However the patient was required to receive a third valve, this time the DurAVR, with the resulting MPG of 20mmHg achieved. Each time a valve is implanted, a lower performance can generally be expected.

Bioshares recommendation: Speculative Buy Class A

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Anteris - Share Price Down as Company Plans for Pivotal Global study in 2025

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