DECEMBER - 202219Eric Goslau, the CEO of Transverse, mentions, "The POINT-GUARDTM is a solution to the proverbial missing piece of the puzzle. Just as Scientists and Physicians base much of their decisions and practices on data information, developers of important medical devices that can save patients' lives apply the same reasoning, when trying to solve an unmet clinical need." The value of information throughout each phase of development cannot be overlooked or underappreciated. "You can do all the bench testing and pre-clinical work that will de-risk and increase overall confidence, but you will never know what you truly have achieved (or may achieve) until you put your technology in human patients," says Goslau.In early 2019, the company's first-generation POINT-GUARDTM was tested in a series of first-in-human (FIH) patients by Dr. Axel Linke, at Dresden Medical Center in Dresden, Germany. The FIH experience verified that the key to enhanced performance of the Point-Guard in the wide variety of TAVR aortic arch anatomies would require a new way of thinking and innovation not yet observed in prior generations or other known competitive CEP devices. One of these key design characteristics is the application of an asymmetrical design. Dr Linke subsequently presented the findings in the Innovation Theater during the globally recognized TCT conference in 2019. Transverse Medical's clinical steering committee--Dr. Mike Reardon, Houston Methodist Texas, Dr. Samir Kapadia, Cleveland Clinic Ohio, and Dr. Axel Linke, Dresden Medical Center Germany--then further defined (and simplified) the required success criteria for a next-generation cerebral embolic protection device: Maximum Protection/Coverage of all Great Arch Vessels, Anatomical Conformity that accommodates nearly all patient anatomies, reliable Stabilization throughout the procedure, and Operator Ease of Use.The next generation POINT-GUARDTM is different from the SentinelTM and other known CEP devices in development as it is scientifically designed and engineered to address the unmet need for full coverage in a variety of ways. "In fact," says Goslau, "The POINT-GUARDTM is a symphony of key vector forces that come together in harmony to deliver a solution for maximum protection." Despite the impact and delays of the Covid-19 Pandemic in 2020, Transverse has moved into design freeze for the next generation POINT-GUARDTM and continued their milestone schedule. The next key steps for Transverse are to complete a Series B round of financing and gain FDA IDE approval for an Early Feasibility Study that will be used to inform and structure a successful Pivotal study leading to 510k market clearance. The company will also continue to address the need to completely protect the brain during all procedures. The POINT-GUARDTM is a symphony of key vector forces that come together in harmony to deliver a solution for maximum protection
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