공시 • Dec 27
Anteris Technologies Ltd. Ordinary Shares to Be Deleted from OTC Equity Anteris Technologies Ltd. Ordinary Shares will be deleted from OTC Equity effective December 27, 2024, due to CUSIP Suspended. 공시 • Dec 14
Anteris Technologies Global Corp. has completed an IPO in the amount of $88.8 million. Anteris Technologies Global Corp. has completed an IPO in the amount of $88.8 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 14,800,000
Price\Range: $6
Discount Per Security: $0.42
Transaction Features: Sponsor Backed Offering 공시 • Sep 13
Anteris Technologies SPONSORED ADR to Be Deleted from OTC Equity Anteris Technologies Ltd. SPONSORED ADR (Australia) will be deleted from OTC Equity effective September 12, 2024, due to ADR /GDR Program Terminated. 공시 • Jul 25
Anteris Technologies Ltd has filed a Follow-on Equity Offering in the amount of AUD 30 million. Anteris Technologies Ltd has filed a Follow-on Equity Offering in the amount of AUD 30 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,875,000
Price\Range: AUD 16
Discount Per Security: AUD 0.96
Transaction Features: Subsequent Direct Listing 공시 • Jul 01
Anteris Technologies and v2vmedtech Announce Concept Lock of Next Generation Mitral and Tricuspid Repair System as VClip Passes Animal Study Anteris Technologies Ltd. and v2vmedtech, inc. announced they have reached concept lock on the first phase of the system. TEER is fast becoming the primary intervention for patients with mitral and tricuspid valve disease, however current marketed systems have limitations that often prevent optimal procedural outcomes or limit eligibility for certain patient groups. The VClipTM design intent is to address these unmet needs and provide better outcomes for patients. 공시 • Oct 26
Anteris Technologies Ltd has completed a Follow-on Equity Offering in the amount of AUD 40 million. Anteris Technologies Ltd has completed a Follow-on Equity Offering in the amount of AUD 40 million.
Security Name: Ordinary shares
Security Type: Common Stock
Securities Offered: 1,689,150
Price\Range: AUD 20
Discount Per Security: AUD 1
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 310,850
Price\Range: AUD 20
Discount Per Security: AUD 1
Transaction Features: Subsequent Direct Listing 공시 • Aug 15
Anteris Technologies Ltd Announces DurAVR THV Demonstrates Exceptional Results in Second Valve-in-Valve Case Anteris Technologies Ltd. reported that DurAVR™ THV, a new class of biomimetic heart valve and the only balloon-expandable, single-piece transcatheter aortic valve was implanted in a second successful Valve-in-Valve (ViV) procedure as part of Health Canada’s Special Access Program (SAP). A ViV procedure is required for patients with a life-threatening situation wherein their current bioprosthetic aortic valve is failing due to calcification or structural deterioration, and a new heart valve must be implanted inside the failing valve. These patients are at high risk for another surgery and require a minimally invasive treatment option. Currently available commercial products can leave patients with a high risk of remaining in a diseased state post-procedure, with unsatisfactory high gradients. Canada’s SAP exists so that life-saving technology not currently available for commercial use in Canada can be provided when no other commercially available alternatives are suitable. Dr Janar Sathananthan, an interventional cardiologist at Vancouver General and St Paul’s Hospital and a world expert on bench testing the hemodynamic effects of different valves used in ViV procedures, made the request to Health Canada to make DurAVR™ THV available for this procedure. DurAVR™ THV was implanted in a 79-year-old female who was previously implanted with a Trifecta surgical valve that had severely degenerated, causing debilitating symptoms. The intraoperative results after DurAVR™ THV was implanted were phenomenal, with a mean pressure gradient of 7mmHg, restoring near-normal physiology. The patient was safely discharged less than 24 hours after the procedure. DurAVR™ THV continues to be investigated in a clinical trial setting for severe aortic stenosis patients in two Early Feasibility Studies (EFS) being run in the US and Europe at this time. 공시 • Aug 01
Anteris Technologies Announces First Successful Implantation of Duravr™ Thv in A Valve-In-Valve Procedure Anteris Technologies Ltd. announces that the DurAVR™ THV was used for the first time in a valve-in-valve (ViV) procedure as part of Health Canada’s Special Access Program (SAP). A ViV procedure is required for patients with a life-threatening situation wherein their current bioprosthetic aortic valve is failing due to calcification or structural deterioration, and a new heart valve must be implanted inside the failing valve. These patients are at high risk for another surgery and require a minimally invasive treatment option. Canada’s SAP exists so that life-saving technology not currently available for commercial use in Canada can be provided when no other commercially available alternatives are suitable. Dr. Anita Asgar, Co-Director of the Structural Heart Program at the Institut de Cardiologie de Montreal (Montreal, Canada), made the request to Health Canada to use the DurAVR™ THV in a patient with a failing valve that needed optimal hemodynamic results as well as a short frame height as they were very high risk of poor hemodynamic result with a conventional ViV procedure. Dr. Asgar performed the procedure on an 84-year-old male and implanted a DurAVR™ THV inside the failed surgical aortic valve replacement (SAVR). The procedure was successful. The hemodynamic performance of the valve was outstanding in such a complex patient. The patient had an 88% reduction in mean gradient which brought the patient back to a near-normal physiologic state, with a final gradient of only 6mmHg after deploying the valve. These results mirror what DurAVR™ THV has seen in its extensive ViV bench-top studies. 공시 • Feb 10
Anteris Technologies Ltd has completed a Follow-on Equity Offering in the amount of AUD 35.000016 million. Anteris Technologies Ltd has completed a Follow-on Equity Offering in the amount of AUD 35.000016 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,458,334
Price\Range: AUD 24
Transaction Features: Subsequent Direct Listing 공시 • Feb 07
Anteris Technologies Ltd announced that it expects to receive AUD 50 million in funding from Yorkville Advisors Global LP Anteris Technologies Ltd announced that it will issue convertible note for gross proceeds of AUD 50,000,000 on February 6, 2023. The company has entered into binding agreement with the new investor, Yorkville Advisors Global LP. Under the agreement, the company expects to receive funding within 2 days. The company can require the Investor to subscribe for new shares by issuing a drawdown notice, up to a maximum of AUD 50,000,000 worth of new shares over a 36 month period. Shares issued under the drawdown notice would be issued at a price equal to 93% of the lowest daily VWAP over a five-day period after company gives the drawdown notice to the Investor. Each drawdown may be up to the greater of such amount as is equal to 200% of the average daily traded value during the 5 days immediately prior to the date the company requests each drawdown, or AUD 5,000,000. Each placement will utilize the company’s existing placement capacity under Listing Rule 7.1 or 7.1A as determined at the date of each placement or as otherwise advised to the market. A AUD 500,000 commitment fee would be payable to the Investor, AUD 250,000 of which may be settled in ordinary shares or cash. The non-binding agreement is subject to the Investor’s due diligence and internal approvals process, and entry into a binding agreement. 공시 • Jan 16
Anteris Technologies Ltd Announces 12 Month Results for Anteris DurAVRTM Transcatheter Heart Valve Aortic Stenosis First in Human Study Anteris Technologies Ltd. announced 12-month results from the DurAVRTM First-in- Human Study designed to evaluate the safety and efficacy of the DurAVRTM THV in patients with symptomatic severe aortic stenosis. DurAVRTM THV is a new class of aortic valve replacement device that utilises the patented ADAPT anti-calcification process and innovative tissue-shaping technology in single-piece transcatheter heart valve. DurAVRTM THV's unique, first-in-class biomimetic design replicates the normal blood flow of a healthy human aortic valve. This First-in-Human Study shows DurAVRTM THV restored normal, pre-disease blood flow, producing large effective orifice areas, enabling the valve to open widely with low mean pressure gradients. Fewer sutures preserve tissue integrity and reduce leaflet stresses with longer coaptation - all crucial precursors for valve durability, improved patient outcomes and survival. The first five patients implanted with DurAVRTM THV continue to show stable, improved valve function with excellent safety at 12-month follow-up. Study results demonstrate: Increased average Effective Orifice Area by 294% from baseline, as observed at 30 days and 12 months - an indicator paramount for increased long-term survival and exercise capacity. Reduced mean pressure gradient across the valve by 85% from baseline, which remains consistent to 12 months. Increased blood flow velocity through the valve with stable hemodynamics from baseline, as observed at 30 days and 12 months. No mortality (all causes), disabling stroke, life-threatening bleeding or myocardial infarction was reported at 12 months. No device-related complications. The 6-minute walk test distance (6MWTD) measuring patient exercise capacity after aortic valve replacement improved by 32% from baseline, with a 17% improvement from the 30-day result at 12 months. 공시 • Sep 14
Anteris Technologies Announces Presentation of First-In-Human Data for its Novel TAVR Product, DurAVR™ at the 2022 Annual TCT Congress in Boston Anteris Technologies Ltd. announced the presentation of clinical data from its first-in-human (FIH) trial for DurAVR™at the annual meeting of the Transcatheter Cardiovascular Therapeutics (TCT) medical conference to be held in BostonSeptember 16-19, 2022. The FIH study commenced in November 2021 and thus far, has treated 13 patients with symptomatically severe aortic stenosis (AS). The study will continue to enroll patients through 2022 and details of FIH can be found at ClinicalTrials.gov [1] (Identifier: NCT05182307). The primary and key secondary endpoints of this trial include device feasibility assessments such as success of implantation at the anatomically accurate position, and hemodynamic performance assessments including effective orifice area (EOA), mean gradient, aortic regurgitation, paravalvular leak (PVL) and Doppler Velocity Index (DVI). Patient outcomes such as stroke, myocardial infarction, life-threatening bleeds, and all-cause mortality are to be reported at 30 days and 1-year post implantation. 공시 • Jul 13
Dr. Martin Leon, MD Joins Global Medical Advisory Board of Anteris Technologies Ltd Anteris Technologies Ltd. welcomed Dr. Martin Leon, MD to Anteris' Global Medical Advisory Board. Dr. Leon is a Professor of Medicine at Columbia University Medical Center. Dr. Leon is also Director of the Columbia Interventional Cardiovascular Care Center, Past Director of the Cardiac Catheterization Laboratories, and on the Executive Board of the Columbia New York Presbyterian Heart Valve Center in New York City. Dr. Leon is also the Founder and chairman Emeritus of the Cardiovascular Research Foundation and the Founder of Transcatheter Cardiovascular Therapeutics. He is globally recognized as an early pioneer in the development of minimally invasive approaches to treating coronary and structural heart disease. He has served as a principal investigator for more than 75 clinical trials that have shaped the field of interventional cardiology, co- authored more than 2,000 papers, and performed more than 10,000 procedures. As a leader in the field of interventional cardiology and structural heart disease, Dr. Leon's involvement with Anteris will accelerate progress in both product development and clinical science to bring validation for novel DurAVRTM Transcatheter Heart Valve System for patients with severe aortic stenosis. 공시 • Jul 11
Anteris Technologies Ltd Provides Update on First In Human DurAVR THV Study Anteris Technologies Ltd. reported the 30-day follow-up results on the second cohort of (eight) patients showed clinically significant improvements. Specifically, there was an average 81% decline in Mean Pressure Gradient (range, -89% to -74%) with an average 300% increase in EOA (effective orifice area) (range, 217%-582%), denoting a marked improved in the valve's surface area and, hence, improved blood flow. Furthermore, The company continues to observe best-in-class laminar flow and improved (normalized) pressures under high cardiac output conditions. All thirteen patients in this first-in-human DurAVRTM THV study (performed at the Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia) continue to show marked improvements in their clinical status compared with pretreatment levels. The study will continue to be reported on at the 12- month mark. Highlights: Outstanding haemodynamics despite complex anatomy; The ComASURTM delivery system performed as expected allowing accurate valve placement; Outstanding laminar flow; Excellent improvement in quality-of-life markers (including 6-minute walk test); No thrombus on CT. 공시 • Jun 21
Anteris Announces 6 Month Follow Up of First Cohort of 5 Patients Anteris Technologies Ltd. announced the 6 month follow up of first cohort of 5 patients. The 6 month follow up is informal (formal follow ups according to the study protocol are 30 days and 1 year). All patients are doing very well and in fact have shown marked improvements since the 3 month follow up. Key data continues to show exceptional haemodynamics (peak mean gradient have reduced 86% since baseline and 6% since the 3 month follow up). Importantly 6-minute walk test which is a key marker of patient well-being has improved 46% since baseline and a further 21% improvement between 3 months and 6 months, demonstrating how much more active and fit these patients are able to become. Laminar flow on MRI continues to show significant improvements when compared to existing valves. This aspect of the DurAVRTM's performance is expected to bring significant clinical/patient benefits in the future. 공시 • May 31
Anteris Technologies Ltd Announces Successful Completion of Second First-In-Human Study Anteris Technologies Ltd. announced that eight more patients were successfully treated last week, as part of the ongoing first-in-human DurAVRTM THV study conducted at the Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia. Data from the latest cohort will be reviewed at the 30-day follow-up which is the key inflexion point for indicating ongoing valve performance. All patients enrolled in the study have done exceptionally well. 공시 • May 26
Anteris Technologies Ltd Announces Expansion of First in Human Trial Anteris Technologies Ltd. announce that have commenced treating the second cohort of patients as part of the first-in-human study for the Company's DurAVR transcatheter heart valve system. 공시 • May 25
Anteris Technologies Ltd Appoints Dion Stub to Medical Advisory Board Anteris Technologies Ltd. appointed Associate Professor Dion Stub MBBS, PhD, FRACP of the Alfred Hospital and Monash University to Anteris' Australian Medical Advisory Board. Associate Professor Dion Stub specialises in structural heart procedures, including angioplasty, aortic valve replacement (TAVI), and balloon valvuloplasty. He has further special interests in treating myocardial infarction and cardiac arrest, particularly with interventional methods. Based in Melbourne, Associate Professor Stub is a highly experienced interventional cardiologist, having performed thousands of cardiac procedures, helping patients experience life to the fullest again. His Medical Advisory Board participation is a welcome addition as company continue building clinical validation for novel DurAVRTM 3D single-piece transcatheter aortic heart valve system. 공시 • Mar 05
Anteris Technologies Ltd has completed a Follow-on Equity Offering in the amount of AUD 27.6 million. Anteris Technologies Ltd has completed a Follow-on Equity Offering in the amount of AUD 27.6 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,840,000
Price\Range: AUD 15
Transaction Features: Subsequent Direct Listing 공시 • Feb 25
Anteris Technologies Ltd, Annual General Meeting, May 19, 2022 Anteris Technologies Ltd, Annual General Meeting, May 19, 2022. 공시 • Feb 17
Medicus Sciences Acquisition Corp. (NasdaqCM:MSAC) (MSAC) cancelled the acquisition of Anteris Technologies Ltd (ASX:AVR). Medicus Sciences Acquisition Corp. (NasdaqCM:MSAC) (MSAC) signed a non-binding letter of intent to acquire Anteris Technologies Ltd (ASX:AVR) on February 8, 2022. All existing Anteris shareholders will receive shares in MSAC in exchange for their shares. The proposal contemplates an issuance of new equity by MSAC in exchange for the current shares in Anteris at an equivalent value and stipulates that post-transaction the merged entity.
Medicus Sciences Acquisition Corp. (NasdaqCM:MSAC) (MSAC) cancelled the acquisition of Anteris Technologies Ltd (ASX:AVR) on February 15, 2022. Anteris Technologies Ltd declined the proposal because its Board concluded the timing of the proposal was not in shareholders nor the Company’s best interest at this point. 공시 • Jan 24
Anteris Technologies Ltd Reports Successful Interim Results for the First-In-Human Trial Anteris Technologies Ltd. reported the first-in-human DurAVR THV study met or exceeded its interim study objectives. At the 30-day follow up point, the first five patients of the planned 10-patient study showed: All five subjects continued to do well with no reported adverse events (no death, stroke, myocardial infarction, reintervention), An average 86% improvement in mean gradient (standard measure of stenosis severity) from pre-treatment levels. Mean gradients were up to 50% lower than other TAVR devices when matched to annular size. All patients are in the normal or near normal range when compared to the general population with normal valve function. Average Effective Orifice Area (EOA) was up to 45% larger than those reported with other TAVR devices in matched annular sizes. No conduction (heart rhythm) disturbances due to the procedure. No clinically significant paravalvular regurgitation despite very complex and heavily calcified anatomy. Echocardiographic and CT analysis reported normal leaflet mobility, no leaflet calcification or thrombus generation. Echocardiographic and CT imaging data showed consistent laminar flow throughout the valve and long coaptation length in all five patients. Ostensibly, these features indicate lower leaflet strain leading to long term durability. The system also allowed for excellent commissural alignment; a significant patient benefit if future coronary intervention were required. A 20% increase from baseline in 6 min walk test (a measure of patient exercise tolerance). This is a 170% greater improvement than observed in studies of other TAVR valves. This indicates a marked improvement in patients' functional status and exercise tolerance. The improvement in exercise capacity may be associated with the increased EOA (larger valve opening area due to its unique design) allowing optimal haemodynamics (blood flow) at rest and during exercise. Exercise performance is a critical marker of cardiac health. 공시 • Jan 06
Anteris Technologies Ltd Reports New Patent Application for ADAPT Anteris Technologies Ltd. reported that it has filed a provisional application for a new patent pertaining to ADAPT®. The new patent adds to the current patent family as well as sets new patent protections into the future for the ADAPT® process. Internally dubbed "ADAPT® 2.0" the new patent specifically applies to particular aspects of the sterilization process allowing the safe transfer of product to manufacturer of valves. 공시 • Aug 10
Anteris Technologies Ltd announced that it has received AUD 9 million in funding On August 9, 2021, Anteris Technologies Ltd closed the transaction. 공시 • Jun 15
Anteris Technologies Ltd Announces Successful Completion of Proof of Concept (Poc) Animal Study Anteris Technologies Ltd. announces the successful completion of its Proof of Concept (POC) animal study testing the viability of ADAPT® treated conduits in the carotid artery. The conduits treated with the ADAPT® process showed no evidence of calcification, as indicated by histopathology. Moreover, there were no visible signs of inflammation, specifically in the intimal or medial layers of the conduits. The grafts also showed the presence of a partial neo-intimal layer, likely indicating surface remodeling of the vessels. Previous attempts by investigators to use animal vessels in this setting failed due to heavy calcification deposits occurring whereas none were shown here with the ADAPT® treated conduits. The study used bovine carotid and mesenteric arteries as the conduits to test the viability of Adapt treated conduits in the carotid artery (as a proxy for CABG) in sheep. These conduits ranged from 2.5mm to 3.8mm in diameter and one six to seven cm length was implanted per animal. Based on these results, Anteris plans to start a larger animal study in Australia during 2021 implanting the conduit into the CABG position. 공시 • Jun 01
Anteris Technologies Ltd has completed a Follow-on Equity Offering in the amount of AUD 2.327895 million. Anteris Technologies Ltd has completed a Follow-on Equity Offering in the amount of AUD 2.327895 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 310,386
Price\Range: AUD 7.5
Transaction Features: Subsequent Direct Listing 공시 • May 24
Anteris Technologies Ltd announced that it expects to receive AUD 2.327895 million in funding Anteris Technologies Ltd (ASX:AVR) announced a private placement 310,386 ordinary shares at a price of AUD 7.50 for gross proceeds of AUD 2.327895 million on May 24, 2021. The transaction will include participation from predominantly existing top 10 institutional shareholders. The investors will receive one unlisted 2-year option exercisable at $11.50 for every two new shares issued. If shareholder approval is not granted, investors will instead receive a cash payment equivalent to AUD 1.25 per option. The Shareholder approval sought will be at the company’s annual general meeting to be held in July 2021. 공시 • Mar 15
Anteris Technologies Ltd, Annual General Meeting, May 14, 2021 Anteris Technologies Ltd, Annual General Meeting, May 14, 2021, at 10:01 E. Australia Standard Time. Agenda: To consider be the election of Directors. 공시 • Feb 18
Anteris Technologies Ltd, Annual General Meeting, May 14, 2021 Anteris Technologies Ltd, Annual General Meeting, May 14, 2021. 공시 • Jan 22
Anteris Technologies Ltd has completed a Follow-on Equity Offering in the amount of AUD 1.171499 million. Anteris Technologies Ltd has completed a Follow-on Equity Offering in the amount of AUD 1.171499 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 341,545
Price\Range: AUD 3.43
Transaction Features: Subsequent Direct Listing 공시 • Dec 30
Anteris Technologies Ltd has completed a Follow-on Equity Offering in the amount of AUD 1.068135 million. Anteris Technologies Ltd has completed a Follow-on Equity Offering in the amount of AUD 1.068135 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 316,954
Price\Range: AUD 3.37
Transaction Features: Subsequent Direct Listing 공시 • Dec 17
Anteris Technologies Announces Resignation of Yanheng Wu as A Non-Executive Director on the Board Anteris Technologies Limited advised that Dr Yanheng Wu has resigned from his position as a Non-Executive Director on the Board of the Company, due to other commitments. Dr Wu's resignation is effective as of 15 December 2020. 공시 • Nov 10
Anteris Technologies Ltd Reports Interim Results from Anti-Calcification Study Anteris Technologies Ltd. reported interim results from the Company's anti-calcification study indicating its ADAPT® treated tissue has superior anti-calcification attributes compared with tissues used in competitor valves. Results at the half-way point (four months) showed the ADAPT® treated tissue used in the DurAVRTM 3D single-piece aortic valve had approximately 40% less calcium concentration compared with the Medtronic AOATM arm tissue used in commercially available SAVR (surgical aortic valve replacement) and TAVR (transcatheter aortic valve replacement) valves. In the study, 48 juvenile rats were implanted with four different samples into separate subcutaneous pockets for calcification evaluation of the following tissues: ADAPT®-treated bovine pericardium; AOATM-treated porcine tissue; AOATM-treated bovine tissue; Control (Glutaraldehyde-treated bovine pericardium). The interim results correlated with existing clinical data and those of the prior head-to-head study with a similar protocol which produced significant differentials between ADAPT® tissue and Edwards Life Sciences' Thermafix tissue at the eight to 12-month mark. Calcification (hardening) is a significant contributor to the failure of heart valve replacements made from animal tissue. There is an imperative for better anti-calcification treatments such as ADAPT® to help ensure replacement heart valves last longer and work better. The final results of the eight month study will be used in the US Food and Drug Administration submissions to demonstrate DurAVRTM superiority compared with currently available valves subject to the final results being consistent with these positive interim results. 공시 • Oct 11
Anteris Technologies Limited Announces DurAVR Valve Patient Outcomes Anteris Technologies Limited advised that the early results from the first-in-human study of its proprietary DurAVR aortic valve found that patient outcomes exceeded the results of what is normally expected following a Surgical Aortic Valve Replacement (SAVR). The DurAVR valve was easy to manipulate and was able to be optimally positioned by the implanting surgeon in the aortic valve replacement procedures, promoting better results.
Professor Bart Meuris MD, PhD - Chief of Cardiovascular Surgery at University Hospitals, Leuven (Belgium) and lead surgeon in the study - presented the findings at the European Association for Cardio-Thoracic Surgery (EACTS) Annual Conference, a world premier cardio-thoracic conference held on 8-10 October 2020. The presentation noted: DurAVR can restore normal pre-disease hemodynamics and has the potential to be a functional cure for the treatment of severe aortic stenosis; Patient recovery was swift, and no stay in an intensive care unit was needed; Ongoing development continues, including animal studies for transcatheter heart valve replacement; This technology, with both surgical and transcatheter options, offers a potentially more durable solution for enhancing acute and long-term outcomes for patients with aortic valve disease.