The heartbeats of the heart valve devices market are projected to beat faster with a CAGR of 11.9% for the forecasted future of 2022 to 2031. Substantial R&D enthusiasm for introducing new heart valve devices for minimally invasive procedures is fueling the growth of the heart valve devices market.
Next-gen heart valve devices’ growth prospects offer fresh features including a simplified implant with more controlled placement, reduced paravalvular regurgitation, improved valve function, increased durability, and lower cost.
Nonetheless, interventional treatments for structural defects are still at a nascent stage with immense scope for advancement. Smart design, new technologies, and novel biomaterial applications continue to push the boundaries of new product development and thus ensure that these devices are at the forefront of interventional product innovation for cardiovascular conditions.
Anteris Technologies is a proudly Australian structural heart company striving to provide functional cures to some of the biggest challenges facing cardiac patients and doctors worldwide. Anteris Technologies is a highly innovative company revolutionizing the heart valve replacement market.
Anteris Technologies is laser-focused on solving critical issues with surgical and transcatheter heart valves that treat aortic stenosis. But that’s only the beginning. Under the leadership of its CEO, Wayne Paterson, Anteris Technologies is positioned to deliver a range of clinically superior cardiovascular therapies that enable doctors to provide life-changing outcomes for patients well into the future.
The Profound Legacy
Anteris’ regenerative tissue technology, ADAPT™, has already delivered significant clinical benefits to thousands of young cardiac patients. The combination of ADAPT™ and the unique design of DurAVR™, its next-generation 3-D moulded single-piece transcatheter aortic valve, has the potential to restore normal pre-disease blood flow and deliver a functional cure to aortic stenosis patients. The momentous growth and potential of the global TAVR market present Anteris Technologies with a significant global market opportunity.
An Adept Leadership
Wayne is passionate about building high-performance, driven, culturally agile businesses that deliver real value to patients, physicians and shareholders. He has over 25 years of experience as a global business leader, working for Global Healthcare companies worldwide. Wayne had the privilege to lead teams with thousands of employees across Europe, Emerging Markets, China, Japan, the USA, and Australia.
Wayne’s career has led him to work across multiple therapeutic areas, including oncology, metabolic, cardiovascular, infectious diseases, and diabetes, having successfully launched over 30 products, including seven blockbuster drugs. He joined Anteris Technologies at the board level and later became the Chairman of the company.
One of the core platform technologies at the Company was ADAPT, an incredible, novel tissue engineering process invented in Australia by cardiothoracic surgeon Professor Leon Neethling. ADAPT surgical tissue is produced via a patented process that removes known inflammation triggers, making the tissue highly resistant to calcification whilst preserving its collagen structure to make it ideally suited to dynamic cardiac applications. ADAPT-treated tissue is the only tissue on the market proven not to calcify over ten years.
Wayne and his team started the valve program because current technologies are failing within a patient’s lifetime. He saw an enormous unmet need and opportunity to deliver patients and physicians with better solutions than currently available.
Currently, Anteris Technologies delivers a highly durable solution for proper lifetime management of cardiac conditions to younger patients. ADAPT-treated tissue is becoming available to aortic stenosis patients worldwide in the form of DurAVR™ THV, transcatheter aortic heart valve. With the prominent developments empowered by Anteris Technologies, the company aims to change the structural heart landscape as it stands today.
Embracing the Vision and Mission
Anteris Technologies envisions to be the market leader in structural heart innovation by developing clinically superior products through better science and design to create better patient outcomes.
Its corporate mission naturally aligns with this vision. “We drive awareness and adoption of our ADAPT technology through our key partnerships, attracting the best talent and fostering a culture of agility, creativity, quality, and excellence. We apply scientific curiosity and innovative thinking to deliver transformative solutions to patients,” expressed Wayne Paterson.
Innovation and the pursuit of excellence drive everything the company does, so its core values are best encapsulated by the acronym AORTIC – Accountability, Objectivity, Respect, Teamwork, Integrity and Courage. These robust descriptors set the tone for its high-performing organizational culture.
Anteris Technologies’ team is deeply invested in its mission. It comprehends that their contributions are highly valued, impactful and part of a much greater cause that will extend patients’ lives worldwide. That’s how the company lives its mission.
A Bequest of Novelties
“Firstly, we are Australian! With a few obvious exceptions, very few local biotech and MedTech companies have taken their technologies from ideation to full global commercialization,” said Wayne. Anteris combines the best of biotech innovation and MedTech ingenuity to deliver cutting-edge tissue science. All its studies, from bench to first-in-human data, demonstrate superior clinical benefits over existing technologies in patients’ diagnostic cardiac performance measures.
Secondly, many of its competitors are global businesses with a footprint in the TAVR market due to the acquisition of smaller companies that filled a gap in their business portfolio. Anteris’ core technologies are proprietary innovations that have taken place in Australian labs and are informed by real-world physician experiences.
Anteris has innovated, pivoted, consulted, tested, and clinically validated its tissue science over two decades. Its tissue science has been widely used to reconstruct the heart of thousands of congenital heart patients worldwide, proving that the performance characteristics are consistent with durability and longevity in the most challenging patients.
Thirdly, its competitors make small, incremental advancements to try and improve their function or longevity, but the causes of early structural valve deterioration remain. The DurAVR™ THV comprises three proprietary technologies – ADAPT® treated tissue, the DurAVR THV Valve and the ComASUR Transfemoral Delivery System. These unique technologies deliver marked clinical benefits to clinicians and patients.
Furthermore, some of the largest physician-led healthcare funds have strong shareholdings in Anteris Technologies.
Empowering Clinically Superior Solutions
DurAVR™ heart valves address both the acute needs of patients in terms of superior hemodynamic profile and chronic needs in their ability to sustain that profile longer over the patient’s lifetime.
DurAVR™ has been developed with direct input of the world’s pre-eminant interventional cardiologists and TAVR pioneers, guiding Anteris’ R+D Team. No ston was left unturned in addressing the known mechanisms of structural valve deterioration. The DurAVR THV System has been designed with three distinctly innovative technologies. ADAPT® Tissue – DurAVR™ THV – ComASUR™ TF Alignment
ADAPT® tissue is pericardium that is decellularized of all cellular components and remnants, phospholipids and any antigens, leaving pure collagen and elastic material in a triple helix structure. ADAPT tissue has already delivered significant clinical benefits to over 20,000 thousand congenital heart patients worldwide, including in Australia.
ADAPT™ is Anteris’ proprietary tissue engineering process that eliminates bovine pericardium’s antigenicity. Through the eyes of a microscope, ADAPT™ is verified as a paradigm shift in bioprosthetic tissue engineering. A significant body of peer-reviewed, published evidence over two decades provides strong evidence in support of ADAPT™ technology.
ADAPT™ completely re-engineers xenograft tissue into a pure collagen scaffold with remarkable strength and pliability. This is achieved by removing all nucleic acids and alpha-Gal epitope, cells, cell remnants and phospholipids. Any potential triggers of immunologic reactions and inflammatory processes–all precursors to tissue calcification – are eliminated, thereby extending the durability of the bovine pericardium used for making its heart valve.
DurAVR™ is a proprietary 3D single-piece leaflet design that mimics a native aortic valve. Its unique multi-dimensional leaflet design provides hemodynamic performance and truly remarkable valve function. DurAVR is constructed entirely from ADAPT tissue.
ComASUR™ – Anteris Technologies’ unique transfemoral delivery system with commissural alignment. There is growing evidence that commissural alignment is critical to maintaining coronary access, facilitating adjunctive techniques to enable redo TAVR (due to current technologies failing) and optimizing haemodynamics and durability.
This foundation is essential for delivering true lifetime management for younger, more active patients with aortic stenosis; no competitor on the market has this capability. Technologies have used the ground-breaking calcium resistive properties of ADAPT™ to create DurAVR™ THV–3D-shaped- a single piece of bovine pericardial tissue designed to mimic a healthy native human aortic valve’s form and function.
DurAVR™ THV replaces the patients’ diseased aortic valve and is delivered to the patient through a balloon-expandable transcatheter approach. DurAVR™ THV has been designed in diastole, with exceptionally long leaflet coaptation.
Extensive research shows that better coaptation reduces leaflet stress, resulting in less turbulent, laminar blood flow that restores haemodynamic function and reduces negative sequelae that impact durability over the patient’s lifetime. Anteris’ entire tissue science program is designed to meet the #1 unmet need – durability. DurAVR™ THV is designed to offer better outcomes from day one.
Fulfilling the Ever-Evolving Needs of the Industry
The delivery of medicine is rapidly evolving worldwide. Patients are digital-connected, well-informed and proactive in their health journey. They demand more from their healthcare providers and technologies.
In addition, increasing incidence of chronic diseases, lifestyle factors such as obesity and addictions, increasing administrative expenses, medical device and pharmaceutical costs, insurance, ageing populations and end-of-life care, preventative medicine and health disparities amongst social classes all significantly impact rising overall health care costs. Costs are escalating, and payers and payees demand greater value.
For example, TAVI (transcatheter aortic valve implantation) emerged as an alternative for to avoid open-heart surgery (SAVR) in patients suffering severe aortic stenosis with an unacceptably high intra-operative risk.
Advances in technology have broadened the eligibility of TAVR to include younger, intermediate to low-risk patients with moderate symptoms. This demographic shift places new demands for greater durability and longevity on new heart valve technologies.
However, current technologies are failing within the patient’s lifetime. New technologies are not keeping pace with the dynamic needs of the healthcare space. This is exactly the gap that DurAVR™ is fulfilling.
Indulging in the Words of the Wise
Advising the budding aspirants willing to venture into the healthcare space, Wayne shared:
- “Ensure your science and the problems it aims to solve are viable from a clinical and commercial perspective.”
- “Know your story: Simply and easily convey what your science is, what it does and how it solves a real problem. Quantify the size of that problem (an opportunity). A good rule of thumb is to tell your story in 30-60-90 seconds.”
- “Outline why investors should support you and how you will be using their money to advance your technology.”
- “Create a roadmap of your key milestones to aid easy communication to ensure you have an adequate pipeline of capital to fund each stage of development.”
- “Be willing to pivot as you learn more about the applications of your unique science or new problems your science can be used to solve.”
- “Get buy-in from experts in the field to not only inform your design program and development work but also advocate your work to peers and commercial backers.”
- “Protect and retain your intellectual property!”
- “Surround yourself with trusted experts in clinical and business fields to act as sounding boards and keep your ideas grounded in your vision.”
Embracing the Future Roadmap
2023 are poised to be exciting years for Anteris as it continues to progress the development of DurAVR™. The management also continues to invest in R&D activities. In addition, the team is heavily involved in manufacturing TAVR Heart valves for clinical trials, testing, new product development and clinical evaluation. Anteris continues to build up an inventory of valves for its EFS and IDE trials and prepare for commercialization.
Anteris has been delivering on its strategy and continues to do this is the best way to instil market confidence in its technology. Anteris’ team has undertaken detailed modelling of the pathway to commercialization, including regulatory and clinical steps and has explored the US and European paths and looked at the second wave for places, including Australia.
The management of Anteris has completed the process of its second cohort of patients as part of its First-in-man study, with the view of lodging its EFS trial submission. A pivotal trial will follow this. Each of these hurdles represents a significant milestone for Anteris Technologies and increases its value.
By Anteris Technologies delivering on its milestones, its management can experience the share price more than double over the last year and has had several key strategic investors also join the register. They will eventually communicate this progress and findings through media interviews and commentary.
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