Anteris Technologies Global Corp. develops structural heart medical devices for aortic valve disease, with its lead product, the DurAVR® Transcatheter Heart Valve, designed for patients with aortic stenosis. News about AVR commonly centers on the DurAVR THV System, the ADAPT® anti-calcification tissue technology, the ComASUR® Delivery System and the company’s work in transcatheter aortic valve replacement.
Company updates also cover the PARADIGM global pivotal trial, including clinical enrollment, U.S. reimbursement under Medicare coverage for TAVR procedures, regulatory and clinical strategy, manufacturing expansion, capital raises, strategic investment activity, financial results and healthcare investor conference presentations. The company is listed on Nasdaq and ASX under the symbol AVR.
Anteris Technologies (NASDAQ/ASX: AVR) has announced a significant milestone with over 100 patients worldwide now treated using their DurAVR® Transcatheter Heart Valve (THV) for severe aortic stenosis. The treatment includes first-time cases, valve-in-valve patients, and complex bicuspid aortic valve cases.
Key clinical outcomes include:
- 65 patients completed primary endpoint measures showing safety and efficacy at 30 days
- 37 patients reached one-year follow-up, demonstrating sustained large effective orifice areas and low mean pressure gradients
- No valve or cardiovascular-related mortality reported at one-year
The company plans to commence the DurAVR® THV Pivotal Trial in Q3 2025, pending FDA approval. This trial will be an all-risk, head-to-head registration study, marking a significant step in the company's development of what they describe as the first new class of product in this space in many years.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) announced one-year results for its DurAVR® Transcatheter Heart Valve (THV) System at Sydney Valves on March 21, 2025. The data demonstrates sustained favorable hemodynamic performance with an Effective Orifice Area (EOA) of 2.1 + 0.2 cm2, a Mean Pressure Gradient of 8.6 + 2.6 mmHg, and Doppler Velocity Index of 0.58.
Key highlights include:
- No valve or cardiovascular-related mortality at one year
- Zero prosthesis-patient mismatch (PPM) in small annuli patients
- 65 patients completed the primary endpoint measure at 30 days
The results are particularly significant as current commercial devices show PPM rates between 11.2% to 35.3%. The company plans to include this data in their upcoming FDA Investigational Device Exemption submission for the DurAVR® THV randomized, global pivotal study.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) reported its 2024 financial results and corporate updates. Key highlights include a successful U.S. IPO raising $88.8M and preparations for the DurAVR® Transcatheter Heart Valve's global pivotal study. The company completed 86 patient cases and initiated European Early Feasibility Study in Denmark.
Financial results show net sales of $2.7M and a net loss of $76.0M for 2024, ending with a cash position of $70.5M. The planned pivotal trial will be an all-risk, head-to-head TAVR registration trial involving 80 sites and 1,000-1,200 patients with severe calcific aortic stenosis.
The company advanced manufacturing scale-up in Malaga and Minneapolis facilities, presented clinical data at major conferences, and plans to submit an IDE application to FDA in Q1 2025.
Anteris Technologies (NASDAQ/ASX: AVR), a structural heart company developing the DurAVR THV biomimetic heart valve, has announced its participation in two major healthcare investor conferences.
CEO Wayne Paterson will present at both the 45th Annual TD Cowen Healthcare Conference and the Barclays 27th Annual Global Healthcare Conference. Additionally, Chief Medical Officer Dr. Chris Meduri will participate as an expert panelist in the Structural Heart-TAVR panel discussion, which will be moderated by Joshua Jennings.
Investors can access the conference fireside chat webcasts through the Investor Center section on the Anteris website, where recordings will remain available for up to 90 days.
Anteris Technologies Global Corp. (AVR) has completed its U.S. initial public offering, raising $88.8 million through the sale of 14.8 million shares at $6.00 per share. The company began trading on NASDAQ on December 13, 2024, under ticker 'AVR'. An additional $13.3 million could be raised if underwriters exercise their Green Shoe option for 2.22 million shares.
The company plans to list its CHESS Depositary Interests on ASX on December 17, 2024. Proceeds will primarily fund the development of DurAVR® transcatheter heart valve and a global pivotal study for treating severe aortic stenosis, with remaining funds allocated to working capital and debt repayment.
Anteris Technologies Global Corp. (AVR) has announced the pricing of its U.S. Initial Public Offering of 14,800,000 shares at $6.00 per share. Trading is expected to begin on the Nasdaq Global Market on December 13, 2024, under the ticker symbol 'AVR', with the offering closing on December 16, 2024.
The underwriters have a 30-day option to purchase up to an additional 2,220,000 shares. The company plans to use the proceeds for the development of its DurAVR® transcatheter heart valve, preparation for a global pivotal study, working capital, and debt repayment. TD Cowen, Barclays, and Cantor are joint book-running managers, with Lake Street Capital Markets as lead manager.