University of Pennsylvania

New data from largest head-to-head randomized control TAVR trial demonstrates non-inferior clinical outcomes and superior valve performance for Evolut TAVR compared to Sapien™ at one year DUBLIN and ATLANTA, April 7, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced new data from the largest head-to-head comparative trial of transfemoral transcatheter aortic valve replacement (TAVR), were presented as a late breaking clinical trial at the American College of Cardiology Annual Scientific Session and simultaneously published in The New England Journal of Medicine. The one-year results of the SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial in individuals with aortic stenosis (AS) with small aortic annuli (SAA) demonstrated noninferior clinical outcomes and superior valve performance as measured by bioprosthetic valve dysfunction performance for the Evolut™ TAVR platform compared to the SAPIEN™ platform. "SMART was launched to better understand how the two most commonly used TAVR systems perform in patients with small aortic annuli, and particularly in women who tend to have smaller heart valves," said Nina Goodheart, senior vice president and president, Structural Heart & Aortic, which is part of the Cardiovascular Portfolio at Medtronic. "We continue to develop evidence to better understand the benefits of our Evolut TAVR technology in all patients, including patient populations that are underrepresented, under-diagnosed and under-treated. The results from the SMART trial demonstrate these benefits in a large patient population and reinforce our commitment to driving health equity and engineering the best technology to solve unmet patient needs." In addition to being the largest comparative trial of TAVR, SMART is also the largest TAVR trial to date to enroll primarily women (87%). Symptomatic severe aortic stenosis can be fatal if left untreated and the average patient survival is two years without treatment.1 Despite women's longer life expectancy, once impacted by severe aortic stenosis they suffer from higher mortality than men, even after matching for age.2 Both TAVR and surgical aortic valve replacement (SAVR) are options for women to treat AS. Due to their smaller aortic annuli, women can often receive a valve replacement that does not properly fit their anatomy — highlighting the need for clinical evidence to inform the best treatment approaches.3 Additionally, despite prevalence of chronic conditions associated with AS in women over 65, a new survey of over 1,000 women announced today found that the majority have never been referred to a cardiologist. "As clinicians, we know that tailored approaches are needed to address the unique presentation of AS in the small annulus patient population, which is primarily women. Little comparative data exists to help us with valve selection," said Howard C. Herrmann, M.D., Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Penn., and lead investigator of the SMART Trial. "While we know women have a greater benefit than men when treated with TAVR vs SAVR, now for the first time there is definitive data demonstrating that women have the best valve performance when treated with the Evolut TAVR system." The SMART Trial is an international, prospective, multi-center, randomized (1:1) post-market trial comparing the safety and performance of self-expanding versus balloon-expandable TAVR in patients with symptomatic severe AS and SAA. The trial randomized and treated 716 patients, 87% of which were women, across more than 80 sites worldwide. Eligible patients had a computed tomography aortic valve annulus area of ≤430 mm2 and suitable anatomy for transfemoral TAVR with both an Evolut PRO/PRO+/FX or a SAPIEN 3™/3 Ultra™ valve. "For patients with heart valve replacements, early bioprosthetic valve dysfunction can lead to increased risk of serious long term outcomes including mortality and rehospitalization," added Dr. Herrmann. "As clinicians, these data further reinforces that not all valves are the same, and we strongly need to consider valve performance when determining device selection." Results demonstrated that the Evolut TAVR platform met both co-primary endpoints of clinical non-inferiority and hemodynamic superiority at one year. Evolut TAVR met non-inferiority for the clinical outcome primary endpoint, a composite of all-cause mortality, disabling stroke, or heart failure rehospitalization at one year (9.4% Evolut vs. 10.6% SAPIEN, p<0.001 for non-inferiority). Evolut TAVR demonstrated superiority for the valve function primary endpoint, bioprosthetic valve dysfunction through one year (9.4% Evolut vs. 41.6% SAPIEN, p<0.001 for superiority). "Medtronic is committed to providing clinicians and patients with aortic stenosis long-term data to help to inform their treatment decisions," said Jeffrey Popma, M.D., vice president and Chief Medical Officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business at Medtronic. "Our prior studies have shown an important link between valve performance, mortality, and re-hospitalization at five years. All SMART patients will be followed for five years to assess the relationship between better valve performance and improved clinical outcomes in patients with small annuli." Analyst and Investor Briefing Medtronic will host an analyst and investor briefing to discuss the results from the SMART Trial on Sunday, April 7, 2024, at 10:45 AM EDT. The briefing will feature remarks from Medtronic management, immediately followed by answering questions from institutional investors and equity analysts. A live, listen-only webcast will be available and can be accessed by clicking on the Events link at investorrelations.medtronic.com on April 7. An archived replay will be available on the same webpage later in the day. This event is not part of the official ACC Scientific Sessions. About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit , and follow Medtronic on LinkedIn. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. 1Carabello BA, Paulus WJ. Aortic stenosis. Lancet. March 14, 2009;373(9667):956-966. 2Am Heart Assoc. 2021;10:e018816. DOI: 10.1161/JAHA.120.018816. 3Lester SJ, Heilbron B, Gin K, Dodek A, Jue J. The natural history and rate of progression of aortic stenosis. Chest. April 1998;113(4):1109-1114 Contact: Ryan Weispfenning Investor Relations +1-763-505-4626 Kimberly Powell Public Relations +1-202-498-2601 SOURCE Medtronic plc

SALT LAKE CITY, April 4, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx™" or the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that last month the Board of Directors appointed Richard Abbott as President of Co-Diagnostics, Inc., concurrent with the Company naming David Nielsen to be its Chief Operations Officer (COO), Christopher Thurston as its Chief Technology Officer (CTO), and Seth Egan as Chief Commercialization Officer (CCO). Prior to his new role at the Company, Richard Abbott (President) served as the President of Advanced Conceptions, Inc., a wholly-owned subsidiary of Co-Diagnostics since December 2021, and has been instrumental in establishing the teams and technology of the Co-Dx PCR platform*. His experience includes over 25 years in senior leadership positions of in-vitro diagnostics companies, including VP of Engineering at BioFire Diagnostics, where he built and led highly effective cross-functional teams that generated billions of dollars in revenue. Mr. Abbott holds a Master of Science degree from Brigham Young University and an M.B.A from the Wharton Business School. In his new role, Mr. Abbott will play a key role in the development and commercialization of the Co-Dx PCR platform and associated tests. David Nielsen (COO) previously held the role of COO for Idaho Molecular, also acquired by Co-Dx in 2021, and has worked in concert with Advanced Conceptions and Co-Dx to help guide the development of the Company's new platform since that time. Including his time at Idaho Molecular, Mr. Nielsen has over 25 years of R&D technical and leadership experience, primarily at BioFire and BioFire Defense, filling various key roles which also included managing and coordinating the FilmArray diagnostic system throughout development and launch as the VP of Product Development. David earned both a Master of Science and M.B.A. from the University of Utah. As COO, David will leverage his experience to help lead Co-Dx's product development and manufacturing processes. Christopher Thurston's (CTO) distinguished career has included decades of experience serving as senior developer and architect of software platforms for companies including Ernst and Young, BioFire Defense, and BioMerieux, demonstrating his expertise in big-data solutions. Following his experience in executive positions at several startups, Christopher co-invented the Co-Dx PCR platform at Idaho Molecular, pursuing his passion for democratizing access to PCR diagnostics though technological innovation. Mr. Thurston's technology expertise will be significant in the advancement of Co-Dx's platform and tests. Seth Egan (CCO) has been with Co-Dx since its inception, leading the Company's sales, marketing and product commercialization efforts from the beginning, including managing the sales team as it sold approximately 35M Logix Smart® tests to centralized laboratories in more than 50 countries since the beginning of the pandemic. Mr. Egan has operated in many key capacities for the Company and continues to play an important role helping to oversee the relationship with CoSara Diagnostics, the Co-Dx joint venture in India. He holds a Bachelor of Science in Business Communications from Utah Valley University. Mr. Egan will play a crucial role as CCO in driving the Co-Dx PCR platform's commercialization efforts. Dwight Egan, Company CEO, remarked "I am enthused to have the honor of leading the team at Co-Dx with support from these accomplished individuals, whose background and experience are expected to be crucial additions to the management team as we proceed through our next stage of growth. We welcome them in their new roles as the world continues its shift towards a more decentralized approach to diagnostics. Co-Dx intends to help fill the equitable diagnostics access gap, which we believe can be made possible thanks to the efforts of people who share our corporate mission and possess the skills to make that vision a reality." *The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA. About Co-Diagnostics, Inc.: Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform and to locate genetic markers for use in applications other than infectious disease. Forward-Looking Statements: This press release contains forward-looking statements. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Forward-looking statements include statements made with respect to our Co-Dx PCR platform. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 14, 2024, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. SOURCE Co-Diagnostics

Nearly 25 years ago, a young man with an inherited liver disease died from a vicious immune reaction to an experimental gene therapy. Now Jim Wilson, the scientist behind that failed treatment, is back with a new attempt to cure the disease, this time by editing the genes of newborns and infants. Philadelphia-based iEcure, one of several biotech companies spun out of Wilson’s expansive gene therapy program at the University of Pennsylvania, is preparing to treat babies up to 9 months of age with the severest form of the metabolic condition, called ornithine transcarbamylase deficiency. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.