Anteris Technologies completes crucial final animal study ahead of heart valve replacement clinical trial
Formal results from a three-month study of Anteris’ DurAVR™ heart valve replacement in six sheep will be available in the next month.
Company
ASX:AVR
Anteris Technologies Pty Ltd is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.
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Formal results from a three-month study of Anteris’ DurAVR™ heart valve replacement in six sheep will be available in the next month.
The appointment of Dr Meduri, a recognised leader in the field of valvular heart disease, is expected to give further credibility to Anteris’ DurAVR™ aortic replacement valve.
Anteris Technologies is a structural heart company delivering clinically superior and durable solutions through better science and better design.
CEO Paterson said: “With this new capital round we will continue to deliver on our plan of achieving EFS approval in 2021 as well as advancing our Coronary Artery Bypass Graft and surgical valve projects.”
Securities will remain halted until Monday, August 2, 2021, or when an announcement is released to the market.
Having a specialised, proprietary sterilization system enhances the intellectual property barrier around Anteris’ key technologies.
CEO Wayne Paterson said: “Having DurAVR™ recognized at this very important meeting is a clear demonstration of support for our potential within the Structural Heart Faculty.”
The proven benefits of its ADAPT® tissue technology, paired with DurAVR™’s unique 3D single piece aortic valve design, have potential to deliver a functional cure to aortic stenosis patients and provide a much-needed solution to the challen
“As we continue to advance our program and gain prestigious recognition such as being accepted for this presentation, we are increasingly confident that DurAVR™ will be a major market entrant into the global TAVR market,” says CEO.
Results from the study validate ADAPT® ’s anti-calcification properties in highly problematic areas of surgery and move the company closer to a viable alternative for patients of coronary by-pass surgery.
The company is focused on investing in, researching and developing its ADAPT® technology and product development pipeline including DurAVR™, its 3D single-piece aortic valve.
It will repay the short-term facility entered into with Mitchell Asset Management for the advance of $1.22 million for its forecasted R&D tax incentive.
The capital raising validates the structural heart company’s next-generation technologies including The Anteris DurAVR™ aortic replacement valve and ADAPT® tissue technology.
A series of animal studies have been completed to demonstrate the feasibility of the DurAVR™ THV (prosthetic aortic valve) and its bespoke ComASUR™ delivery system.
Anteris’ DurAVR™ prosthetic valve has the potential to solve the problems associated with current aortic valve replacement options, offering a functional valve for life in an estimated US$10 billion market by 2025.
The funding provides additional working capital as Anteris advances the development of DurAVR™, its 3D single-piece aortic valve for the treatment of aortic stenosis.
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.
The ‘structural heart’ biotech has gained 182% since the start of the year, following a big investment in the development of its flagship product, DurAVR™.
The Anteris DurAVR™ aortic replacement valve addresses the acute need in terms of superior hemodynamic profile as well as chronic needs in its ability to sustain that profile longer over the lifetime of the patient.
New York-based investment fund, Mercer Street Global Opportunity Fund LLC will provide a $16.5 million discretionary drawdown facility
The R&D refund confirms the company’s ongoing commitment to invest in, research and develop its technology and product development pipeline.
Anteris’ 3D single-piece aortic valve, DurAVR™, was selected as a “Best Innovation” at the PCR London Valves 2020 virtual conference, with data from the company’s first-in-human trial presented.
The company’s three-dimensional single-piece aortic valve DurAVR™ was selected as a 'Best Innovation' at last month’s PCR London Valves 2020 virtual conference.
Proven benefits of the ADAPT® tissue technology, paired with the unique 3D single piece aortic valve design of DurAVR™, has the potential to deliver a functional cure to aortic stenosis patients and provide a much-needed solution to challen
Data from its first-in-human trial will be presented at the conference to be held on November 22-24, 2020, virtually, given the COVID-19 restrictions.
The company is focused on developing next-generation technologies that help healthcare professionals create life-changing outcomes for patients.
Proven benefits of the ADAPT® tissue technology, paired with the unique 3D single piece aortic valve design of DurAVR™, has the potential to deliver a functional cure to aortic stenosis patients and provide a much-needed solution to challen
Early results show that the DurAVR™ valve was easy to manipulate and able to be optimally positioned by the implanting surgeon in the aortic valve replacement procedures.
Business restrictions caused by COVID-19 precludes face-face meetings but this has not dampened interest in Anteris’ unique technology.
If these results continue, DurAVR™ will be the first TAVR valve to deliver a truly functional cure for severe aortic stenosis patients.
The company presented the data at the TAVR Key Opinion Leader Symposium held on July 20.
The structural heart company will update on its TAVR R&D program and the ongoing first-in-human trial of its ADAPT® 3D single-piece aortic valve for Surgical Aortic Valve Replacement procedures.
The company is focused on reaching its operational goals for 2020 including completing a study of its proprietary DurAVR™ Transcatheter Heart Valve by year-end.
The company’s DurAVR™ product is a highly durable 3D single-piece aortic valve for the treatment of aortic stenosis.
The company has received a tax incentive for R&D costs incurred in developing its ADAPT® technology and products including the DurAVR™ 3D single-piece Aortic Valve.
The study will allow the company to make refinements to the DurAVR™ aortic valve, which will be applied to the device used in the planned US FDA submission for a human clinical trial in 2021.
Anteris is a structural heart company with technology, ADAPT® and DurAVR™, that solves critical issues with marketed heart valves.