Provides Corporate and Clinical Development Update
BRISBANE, Australia and EAGAN, Minn., June 01, 2020 (GLOBE NEWSWIRE) — Admedus Limited (ASX: AHZ), announced today that it has changed the Company’s name to Anteris Technologies Ltd (“Anteris”). As of May 22, 2020 Anteris, is trading on the Australian Securities Exchange under the ticker AVR. This milestone signifies the completion of Admedus’ restructuring program focused on transitioning to a dedicated structural heart company anchored by ADAPT®, a next generation regenerative bioscaffold platform technology being utilized to address multiple cardiovascular procedures and repairs including, a product (DurAVR™) in development for Transfemoral Aortic Valve Replacement (TAVR) procedures.
“The name change marks the beginning of an exciting chapter in the Company’s growth plan as we are now well positioned to facilitate shareholder value creation,” commented Wayne Paterson, Chief Executive Officer of Anteris Technologies Ltd. “It culminates a three-year period devoted to streamlining operations while enhancing our leadership team, ceasing non-core therapeutic programs, and divesting low margin assets to enable absolute focus on advancing the development of our portfolio of game-changing products generated by the ADAPT® platform.”
The key advantage of DurAVR™ based on the ADAPT® technology, is its ability to solve the issues associated with current aortic valve replacement options. DurAVR™ is expected to have improved durability by preventing valve degradation through a combination of tissue science and valve design. ADAPT® treated valves are built on the only known bioscaffold product to demonstrate “zero-calcification” even after 10 years of use in humans (tissue science). Its unique ability to be molded into a 3D single-piece structure (valve design), also demonstrates significantly less wear at the leaflets than conventional three-piece valves. By combining these two positive features, the valves are able to retain shape and preserve functionality over the long-term. Such a durable, long-lasting valve with the potential to not calcify or need to be replaced is ideal for expanding the TAVR market (already >$5B in sales) to a patient population which is becoming increasingly younger.
ADAPT®‘s core technology distinctions:
- Only commercial bioscaffold product line to achieve years without calcification or rejection
- Only bioscaffold with zero DNA
- Only single-piece 3D bioscaffold used in complex cardiac surgery (aortic valve replacement)
Divestiture Highlights: Sold commercial bioscaffold franchise to LeMaitre Vascular Inc (Nasdaq: LMAT) in Q3 2019 for A$22.8M upfront (A$36.2M including earn-outs). CardioCel® and VascuCel® products which originated from the ADAPT® platform were sold to U.S. based LeMaitre Vascular Inc. (NASDAQ: LMAT), a leading provider of implants and devices for the treatment of peripheral vascular diseases. In addition to the cash payment(s), Anteris also retained exclusive manufacturing rights for three years and will continue to manufacture both products at its wholly owned facility in Malaga, Western Australia on LeMaitre’s behalf at a 20% margin over cost arrangement. CardioCel®, which is the only marketed product to have achieved ten years without calcification or degradation in human, is used to repair congenital heart defects, vessel and cardiovascular repairs, and peripheral vascular reconstruction. VascuCel is used as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing. This divestiture will enable both products to reach their respective peak commercial potential by leveraging the large LMAT sales force while providing continued upside to Anteris in the form of “earn-out” payments. All cost-and time-savings stemming from not having to build a sales force can be now directed to focusing the Company on the larger commercial opportunities in the structural heart space and TAVR market.
Clinical and Corporate Development Update: Creating value on the path to launching DurAVR™, Anteris’ game-changing TAVR product.
After extensive bench and preclinical animal testing, the Company initiated its first-in-human trial for ADAPT®’s 3D single-piece aortic valve (DurAVR™) in March 2020. This study is intended to provide data that will help address Surgical Aortic Valve Replacement (SAVR) surgery, a market estimated to reach approximately $3 billion by 2023. The trial is being conducted at the University Hospitals in Leuven, Belgium, and will enroll fifteen patients with a six-month post procedure observation period per implant. Results from the study are expected between Q1 2021 and Q3 2021 (https://clinicaltrials.gov/ct2/show/NCT04178213).
The first patient was implanted on March 27, 2020 and was discharged from the hospital on April 6, 2020, reporting normal valve function and improved blood flow. This result replicates the findings observed in an earlier animal study performed on six juvenile sheep, the preferred model for bioprosthetic valve implantation.
The SAVR trials’ primary endpoints are hemodynamic performance and safety under the Objective Performance Criteria (OPC) guidelines for Flexible Heart Valve Events Assessments at 6 months following implantation. There are multiple secondary endpoints including, onset atrial fibrillation, ICU duration of stay, and haemolysis screen. Since both Anteris’ SAVR and TAVR forays are based on similar ADAPT®-treated bioscaffolds at its core, this SAVR trial serves as a way to gauge the safety and functionality of the said tissue in humans whether it is placed in the aorta surgically (SAVR) or transfemorally (TAVR). Therefore, this trial is tantamount to the first proxy/proof-of concept of the suitability of the ADAPT®-treated aortic valve replacements. Once the SAVR data is analysed, the Company’s corporate growth plan is to leverage ADAPT®’s novel profile to bolster business development activities for large market indications including a potential partnership to facilitate both DurAVR™ and SAVR product offerings.
In the meantime, an inherent part of Anteris’ strategy is to leverage the unique profile of the ADAPT® – bioscaffold processing platform to establish alliances with a wide range of companies functioning in the cardiac space. The Company formally commenced these types of business development activities in February 2020 when it finalized a licencing agreement with 4C Medical Technologies, a Minnesota based medical device company. 4C is developing AltaValve™, a minimally invasive device for mitral valve repair. The Company recently registered the ADAPT®-processing platform itself as a 510(k) approval with the US FDA, over and above individually approved products such as Cardiocel® and Vascucel®, that have been created using this platform. Formal FDA registration of the ADAPT® technology platform is a steppingstone towards future licensing agreements.
To date, the impact of the COVID-19 pandemic on the Company’s operations have been minimal. A contingency plan for manufacturing was put in place alongside other risk mitigation strategies to ensure the pace of manufacturing remains uninterrupted. There has been no impact on purchase orders from LeMaitre, and Anteris continues to supply ADAPT® tissue to 4C Medical on schedule.
About Anteris Technologies Ltd (ASX:AVR)
A structural heart company built around ADAPT®, a next generation regenerative bioscaffold platform technology applicable for multiple cardiovascular procedures and repairs. ADAPT® combines best-in-class tissue-science with an advanced valve design to produce ultra-durable collagen bioscaffolds. The key advantage of ADAPT is its ability to solve the issues associated with current aortic valve replacement options which are durability and preventing valve degradation through a combination of tissue science and valve design. ADAPT treated valves demonstrate a lack of calcification even after 10 years of use (tissue science) and ability to be melded into a single-piece 3D structure (valve design), and retain that shape over the long-term. ADAPT is the only commercial bioscaffold product line to achieve years without calcification or rejection; the only bioscaffold with zero DNA and only single piece 3D bioscaffold used in complex cardiac surgery (aortic valve replacement). The Company is currently running a first-in-human trial for ADAPT’s single-piece 3D aortic valve to address Surgical Aortic Valve Replacement (SAVR) surgery, a market estimated to reach approximately $3 billion by 2023.
For more information:
Ms Kyahn Williamson
E: [email protected]
P: +61 401 018 828