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STUDY OF NFL ALUMNI COHORT FINDS MAJORITY SUFFER FROM HEART DISEASE WITHOUT KNOWING IT

April 11, 2024

Edwards Lifesciences (NYSE: EW) announced the release of data from the HUDDLE study that examined the prevalence of heart disease and associated risk factors among members of the National Football League (NFL) Alumni Association and their families. The findings of this study, which identified a significant discrepancy between participant self-awareness and actual prevalence of heart disease and associated risk factors, were presented today during a late-breaking clinical trials session at the American College of Cardiology (ACC.24/WCC) and published simultaneously in The Journal of the American College of Cardiology.

Results of the HUDDLE study indicated that the prevalence of hypertension in the 498 screened participants was 83.8%, though only about half (46.5%) self-reported a history of hypertension. Of all participants screened and found to have an elevated systolic blood pressure, a staggering 73.8% were also found to have structural heart changes present on transthoracic echo sonography (TTE).

“These alarming results are a call to action,” said Michael Amponsah, MD, ChB, FACC, Interventional Cardiologist, Banner Boswell Medical Center, Peoria, Ariz. “The disparities highlighted in the cohort involved in the HUDDLE study point to a significant opportunity to examine a greater role for routine age-based screening, and especially for the expanded use of echocardiogram to better identify undetected or undiagnosed heart disease and heart failure.”

Initiated by Edwards in 2021, the HUDDLE study’s objective was to examine the unrecognized prevalence of heart disease and associated risk factors, particularly among groups historically known to experience disparities in access to care. For instance, with more than a million patients treated globally with TAVR, the treatment rate of African Americans in the US has remained constant over the past decade at around 4%, despite comprising approximately 14% of the US population.

Conducted across eight U.S. cities in cooperation with NFL Alumni Health, a subsidiary of the NFL Alumni Association, HUDDLE was a cross sectional study of NFL alumni and their family members aged 50 years and above. The participants were mostly male (66.5%) and African American or Black (63%). Study participants self-reported their medical histories and participated in heart health education and screenings that included blood pressure, electrocardiogram (EKG) and echocardiogram.

“Edwards is committed to helping identify and dismantle barriers to access for communities that are underserved due to race, gender and socioeconomic status,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “We realized that by working with the NFL Alumni Association and through this unique network of former players, we might be able to gain a greater understanding of how heart disease is impacting underserved populations, and how education, awareness and simple screening tools can save lives in these communities and in the entire nation as a whole.”

About Edwards Lifesciences

Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend the forward-looking statements contained in this Proxy Statement to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as “may,” “might,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,” “aspire,” “confident” and other forms of these words and include, but are not limited to, statements made by Mr. Wood and statements regarding expected product benefits, patient outcomes, post-treatment reduction of invasive procedures, objectives and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company’s filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.

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Media Contact: Howard Wright, 949-250-2790

Investor Contact: Mark Wilterding, 949-250-6826

Source: Edwards Lifesciences Corporation