Name Change for Admedus – Now Anteris Technologies

Admedus has changed its name to Anteris Technologies (AVR: $6.29). The company is now wholly focused on the development of heart valves that rely on the company's proprietary ADAPT tissue treatment technology to make cardiovascular tissue implants. The implants are arguably far less susceptible to calcification than rival tissue treatment methods.

The ADAPT process removes residual DNA from tissue used in implants, with residual DNA suggested as the driver of calcification (tissue hardening).

ADAPT tissue has been shown to have no DNA and has data showing no calcification occurring over 10 years in humans.

The company is developing DurAVR SHV for surgical aortic valve replacement (SAVR) and DurAVR THV for transcatheter aortic valve replacement (TAVR). Transcatheter in- tervention involves the implantation of a device using a catheter, usually via the femoral artery. The method avoids various risks associated with more invasive surgery.

TAVR Superior to SAVR in Low-risk Patients To Drive Need for Valves With Less Chance of Calcification

Edwards Life Sciences’ PARTNER 3 trial showed in a 1,000 low-risk patient trial of its SAPIEN 3 TAVR device, that the device was superior to surgically implanted devices on the primary endpoints of all-cause death, all-cause stroke and re-hospitalisation.

In low-risk patients, the rate of death at one year for all cause death was 1% for SAPIEN 3 TAVR patients compared to 2.5% for surgical intervention (p=0.09), for all-cause stroke 1.3% versus 3.1% (p=0.04), for re-hospitalisation, 7.3% versus 11.0% (p=0.046). Of note was the difference in life threatening major bleeding, 7.7% versus 25.9% (p<0.001).

This is an opportunity for Admedus, either directly with its own TAVR device, or through the outlicensing of ADAPT to market leaders such as Edwards Life Sciences and Medtronic, which markets the Evolut PRO. For example, younger, low risk patients could be implanted with a device that could be functional for l5 years, well in excess of the five years time point when current valves begin to fail.

Anteris Technologies' heart valve products have the potential to deliver functional su- periority to rival products in terms of both durability, tensile strength and mechanical performance, with ADAPT tissue having passed 400,000 cycles of stress testing, equiva- lent to 10 years of human use.

Leaflet Repair Trial

The company announced in mid-May that a second patient had been implanted with an ADAPT treated leaflet, in a 15 patient trial underway in Belgium NCT04178213. The trial is recruiting pa- tients with moderate or severe aortic stenosis and/or aortic insuf- ficiency.

Anteris has stated that it will provide a further update once enrol- ment is completed, with the global SARS-CoV-2 pandemic a factor influencing recruitment.

The open label (unblinded) nature of the study means that pro- gressive updates could be provided to the market regarding the immediate post-operative well-being of trial subjects, which is what the company has done with the first two patients in the trial in Belgium.

However, in our opinion, a 'soft' milestone for the company could be the implant of the eighth patient, or approximately half-way through the trial. Investors could then be informed of the rate of recruitment for the trial, in addition to receiving data concerning the discharge and recovery profile of the implanted patients, in- cluding hemodynamic data. Measures of hemodynamics which enable valves to be compared with others, include effective orifice area (extent of valve openness), and mean gradient and peak gra- dient of blood pressure.

The company also recently announced the initiation of an anti- calcification comparison study in 48 rats, to compare ADAPT treated tissue with tissue used in marketed SAVR and TAVR de- vices for which the tissue is treated using other methods. Tissue will be harvested and evaluated after four months for calcium and phosphorus levels.

The results of this comparison study will enable the company to present data on a head-to-head basis of the relative performance of the ADAPT treatment process compared to the tissue used in commercially available SAVR and TAVR devices.

Single Piece (3D) Design

A point of difference for the heart valve prostheses being developed by Anteris Technologies is that they are formed as a single piece. Marketed devices combine leaflets sourced from bovine or porcine pericardium which are integrated with synthetic materials.

For example, Edwards Life Science’s SAPIEN 3 heart valve is described as a “balloon-expandable, radiopaque, cobalt-chromium frame, trileaflet bovine pericardial tissue valve, and polyethylene terephthalate (PET) fabric skirt.”

Anteris believes that its single piece device is capable of creating a wider valve opening, thus producing improved blood flow, in addition to needing fewer stitches for implanting.

A further milestone for the company this year will be the release of results from pre-clinical studies of the single piece DurAVR THV.

Anteris Technologies is capitalised at $36 million. The company retained cash assets of $11 million at March 31, 2020.

Bioshares recommendation: Speculative Buy Class C

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