JULY - 202319Addressing Unmet Patient Care NeedsDurAVRTM THV arrives at a critical juncture, as the prevalence of aortic stenosis continues to escalate. With global aging and extended life expectancy, the incidence of this cardiovascular condition has reached alarming levels affecting approximately nine million people worldwide according to a recent NCBI report. It is present in about 5 percent of the population at age 65, with increasing prevalence with advancing age. This highlights the urgent need for more effective interventions, a need Anteris Technologies is uniquely equipped to fulfill.DurAVRTM THV is designed as an alternative for patients considered too "high-risk" or unsuitable candidates for traditional open-heart valve surgery. By offering a less invasive option, Anteris Technologies empowers patients with a new choice, offering faster recovery to those who would otherwise face limited treatment choices when dealing with aortic stenosis. In response to the evolving patient demographics, Anteris Technologies' proactive approach also reimagines the existing TAVR products to better serve a diverse range of patients today. To date, TAVR technologies have been focused on providing therapy to older, high-risk surgical patients, typically aged 85 and above, with limited life expectancy. While providing modest extensions to their lives, the primary objective was to enhance their end-of-life experience rather than achieve long-term curative outcomes.However, since 2019, relatively younger patients with an average age of 73 have begun undergoing these procedures--a demographic not initially anticipated during the development of existing TAVR products. This shift presents a new set of challenges. Unlike older patients, these individuals have longer life expectancies, and their active lifestyles and higher cardiovascular functions require solutions that can sustain their health and performance in the long term.DurAVRTM THV is well-suited to meet this need as its unique design greatly enhances the functionality of the heart valve, aiming to bring patients out of the disease and restore their cardiovascular well-being. Under the Hood of DurAVRDurAVRTM THV system comprises three distinct components; the DurAVRTM THV valve, the ADAPT® tissue treatment, and the ComASURTM transfemoral delivery system. DurAVRTM THV--made up of a single piece of tissue to mimic the natural performance of a healthy human aortic valve--offers excellent hemodynamic performance and outcomes. Its multi-dimensional leaflet design produces remarkable hemodynamic performance as longer leaflet coaptation produces near-perfect laminar blood flow and results in "pre-disease-like blood flow through the valve". Large open cells in the stent frame improve coronary access. The innovation does not stop at that.ADAPT® tissue has already delivered significant clinical benefits to over 50,000 heart patients worldwide. This is a truly unique technology, as no other competitor has perfected tissue science or achieved such strong results in peer-reviewed publications before. ADAPT(R) tissue effectively eliminates primary inflammatory precursors responsible for calcification, a key concern with bioprosthetic heart valve failures.Existing bioprosthetic valves possess limitations in their opening capacity, so when patients receive these valves, their gradient across the valve usually remains elevated, categorizing them as still having a mild disease. But Anteris Technologies' optimized design and functionality succeeds in achieving mean gradients on an average of only 8.66 mmHg (millimeters of mercury) immediately, bringing patients into a healthy range. In one instance, a patient had a dire prognosis, with severe mean gradient of over 90 mmHg, and following implant, DurAVRTM THV resulted in a mean gradient of only 9 mmHg within 48 hours.Through pioneering efforts, the Anteris team has developed a novel transcatheter aortic valve replacement (TAVR) product, DurAVRTM THV, with a biomimetic design that impeccably replicates the performance of a healthy aortic valve
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