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Anteris DurAVR® THV Demonstrates Favorable Hemodynamics in Small Annuli Patients with no Valve Related Mortality at One Year
Globenewswire· 2025-10-28 22:08
MINNEAPOLIS and BRISBANE, Australia, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, announced one-year clinical outcomes for the DurAVR® Transcatheter Heart Valve (THV) in symptomatic severe aortic stenosis patients with small aortic annuli (aortic annulus area 396 + 37 mm2). The DurAVR® ...
Anteris Technologies Announces First Patients Treated in DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)
Globenewswire· 2025-10-27 21:43
Core Insights - Anteris Technologies has initiated the global pivotal trial for its DurAVR Transcatheter Heart Valve (THV) aimed at patients with severe calcific aortic stenosis, marking a significant step towards commercialization [1][2] - The PARADIGM Trial will provide comparative evidence on the safety and effectiveness of the DurAVR THV against existing transcatheter aortic valve replacements (TAVRs) [3][4] Company Overview - Anteris Technologies is a global structural heart company focused on developing innovative medical devices to restore heart function, with a strong presence in both Australia and the United States [7] - The DurAVR THV is designed to treat aortic stenosis and is the first biomimetic valve, utilizing Anteris' patented ADAPT tissue technology, which has been clinically used for over 10 years [8][9] Trial Details - The PARADIGM Trial is a prospective randomized controlled trial that will enroll approximately 1,000 patients, comparing the DurAVR THV to commercially available TAVRs [4][6] - The primary endpoint of the trial is to assess non-inferiority in terms of all-cause mortality, stroke, and cardiovascular hospitalization at one year post-procedure [4]
Anteris Technologies Announces One-Year Clinical Outcomes for DurAVR® THV to be Presented at TCT® 2025
Globenewswire· 2025-10-27 12:43
MINNEAPOLIS and BRISBANE, Australia, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR), a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced that one-year clinical outcomes with the DurAVR® Transcatheter Heart Valve (THV) will be presented by Rishi Puri MD PhD, at TCT® 2025 – The 37th Annual Transcatheter Cardiovascular Therap ...
Anteris Receives First European Regulatory Clearance to Commence DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)
Globenewswire· 2025-10-15 13:18
MINNEAPOLIS and BRISBANE, Australia, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, announced today it has received regulatory clearance from the Danish Medicines Agency to initiate the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial in patients with severe calcific aortic s ...
Anteris Technologies Global Corp. Announces Adjournment of Special Meeting of Stockholders
Globenewswire· 2025-09-19 06:30
MINNEAPOLIS and BRISBANE, Australia, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR), a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced that after convening its Special Meeting of Stockholders (the “Special Meeting”) virtually on Thursday, September 18, 2025, at 5:00 p.m. Central time (being 8:00 a.m. AEST on Friday, Sep ...
Top 2 Health Care Stocks That May Keep You Up At Night This Month - Anteris Technologies Glb (NASDAQ:AVR), Equinox Gold (AMEX:EQX)
Benzinga· 2025-09-18 12:07
Group 1 - Two stocks in the health care sector are signaling potential warnings for momentum-focused investors as of September 18, 2025 [1] - The Relative Strength Index (RSI) is a key momentum indicator, with values above 70 indicating that a stock may be overbought [2] - Major overbought stocks in the health care sector include 89bio Inc and Anteris Technologies Global Corp [3] Group 2 - 89bio has agreed to be acquired by Roche for $14.50 per share, representing a 79% premium over its closing stock price on September 17, with an RSI value of 82.2 [6] - 89bio's stock has a 52-week high of $11.84 and gained 1.4% to close at $8.08 on Wednesday [6] - Anteris Technologies reported mixed quarterly results, with a stock gain of approximately 48% over the past month and a 52-week high of $8.79, but its shares fell 1.8% to close at $5.61 [6]
Top 2 Health Care Stocks That May Keep You Up At Night This Month
Benzinga· 2025-09-18 12:07
Group 1 - Two stocks in the health care sector are showing signs of being overbought, which may concern momentum-focused investors [1][2] - The Relative Strength Index (RSI) is a key momentum indicator, with values above 70 indicating overbought conditions [2] - 89bio Inc has agreed to be acquired by Roche for $14.50 per share, representing a 79% premium over its closing stock price on September 17 [6] - Anteris Technologies reported mixed quarterly results, with a stock price increase of approximately 48% over the past month [6] Group 2 - 89bio's stock has a 52-week high of $11.84 and an RSI value of 82.2, indicating strong momentum [6] - Anteris Technologies has a 52-week high of $8.79 and an RSI value of 75.9, suggesting it is also in an overbought condition [6] - The stock price of 89bio closed at $8.08, while Anteris Technologies closed at $5.61, reflecting recent price movements [6]
Anteris Technologies Global Corp. Announces Postponement of Special Meeting of Stockholders
Globenewswire· 2025-09-04 05:42
Core Points - Anteris Technologies Global Corp. has postponed its Special Meeting of Stockholders to September 11, 2025, to allow more time for stockholder participation [1][2] - The Board of Directors recommends voting FOR the proposals in the definitive Proxy Statement filed with the SEC on August 18, 2025 [2] - The company’s lead product, the DurAVR Transcatheter Heart Valve, is designed to treat aortic stenosis and utilizes patented ADAPT tissue technology [8] Voting Details - Stockholders who have already voted do not need to take further action as their votes will remain counted [3] - Proxies must be submitted by 11:59 p.m. Eastern time on September 10, 2025, for Internet or telephone submissions, and by the close of business on the same date for mail submissions [4] - CDI holders must direct CDN to vote by 5:00 p.m. Central time on September 9, 2025 [5] Company Overview - Anteris Technologies is a global structural heart company focused on developing medical devices to restore heart function [7] - The company is based in Australia with a significant presence in Minneapolis, USA, and is committed to delivering solutions for structural heart disease [7]
Anteris Technologies Global Corp(AVR) - 2025 Q2 - Quarterly Results
2025-08-12 00:56
[Financial Performance Summary](index=1&type=section&id=Financial%20Performance%20Summary) For the six months ending June 30, 2025, Anteris Technologies reported a 16% decrease in revenue to $1.17 million compared to the same period in 2024, with the loss from ordinary activities after tax increasing by 23% to $43.0 million and the net loss attributable to members growing by 22% to $42.7 million Financial Performance Overview | | Six months to June 30, | | | | |---|---|---|---|---| | | 2025 (US$'000) | 2024 (US$'000) | Change (US$'000) | Change (%) | | Revenues from ordinary activities | 1,174 | 1,398 | (224) | (16%) | | Loss from ordinary activities after tax | (42,993) | (34,972) | (8,021) | 23% | | Loss for the period attributable to members | (42,698) | (35,057) | (7,641) | 22% | - No dividend has been proposed or declared for the reporting period[3](index=3&type=chunk) [Capital Management and Use of Funds](index=1&type=section&id=Capital%20Management%20and%20Use%20of%20Funds) The company raised net proceeds of $80.0 million from its initial public offering in December 2024, primarily allocating these funds to the development of the DurAVR® THV and its pivotal trial ($37.6 million), with the remainder used for working capital and general corporate purposes, including debt repayment, while payments to related parties totaled $640,000 in Q2 2025 - The company completed an initial public offering on December 12, 2024, issuing 14,878,481 shares at $6.00 per share, raising net proceeds of **$80.0 million** after expenses[5](index=5&type=chunk)[6](index=6&type=chunk) - As of June 30, 2025, the use of IPO proceeds included: - **$37.6 million** for the ongoing development and pivotal trial of DurAVR® THV - **$14.1 million** for net working capital, v2vmedtech expenditure, and other corporate purposes, which included a **$6.4 million** debt repayment[9](index=9&type=chunk) - During Q2 2025, aggregate payments to related parties and their associates, including executive remuneration and director fees, amounted to **$640,000**[6](index=6&type=chunk) [Company and Product Overview](index=2&type=section&id=Company%20and%20Product%20Overview) Anteris is a global structural heart company focused on developing medical devices, with its lead product, the DurAVR® Transcatheter Heart Valve (THV), a biomimetic valve designed to treat aortic stenosis using patented ADAPT® tissue, which has been clinically used in over 55,000 patients worldwide - Anteris is a global structural heart company focused on designing, developing, and commercializing medical devices to restore healthy heart function[10](index=10&type=chunk) - The company's lead product is the DurAVR® Transcatheter Heart Valve (THV), a balloon-expandable, biomimetic valve designed to treat aortic stenosis by mimicking a healthy human aortic valve[11](index=11&type=chunk) - DurAVR® THV utilizes ADAPT® tissue, Anteris's patented, FDA-cleared anti-calcification technology, which has been clinically used for over 10 years in more than **55,000 patients**[11](index=11&type=chunk)
Anteris Announces Results for the Second Quarter of 2025
Globenewswire· 2025-08-11 20:52
Core Insights - Anteris Technologies reported significant progress in the second quarter of 2025, particularly in the clinical development of its DurAVR transcatheter heart valve (THV) [3][4] - The company is preparing for the PARADIGM trial, which aims to further validate the clinical benefits of DurAVR THV [5][8] Financial Performance - For the six months ended June 30, 2025, Anteris recorded net operating cash outflows of $41.0 million, primarily due to increased clinical, regulatory, and manufacturing activities [11] - Research and development (R&D) expenses for the second quarter were $16.3 million, focusing on the PARADIGM trial preparations and patient enrollment [11] - The company held $28.4 million in cash and cash equivalents as of June 30, 2025 [11] Clinical Development - A total of 130 patients have been treated with the DurAVR THV, with 49 patients treated in the first half of 2025 and 21 in the second quarter [4][15] - The company has qualified 79 sites for the PARADIGM trial, with significant preparatory work completed [5][15] - Anteris hosted both European and Global Investigator Meetings to align operational efforts for the PARADIGM trial [6][7] Corporate Governance - On June 10, 2025, Anteris appointed David Roberts and Gregory Moss to its Board of Directors to enhance leadership capabilities [9]