Shockwave Medical Completes Enrollment in All-Female Coronary IVL Study

The first prospective female-only study of coronary interventions in complex calcific disease, EMPOWER CAD aims to confirm benefits of Shockwave intravascular lithotripsy in women.

Co-Principal Investigator Margaret McEntegart, MD, completed enrollment during a live case at this year's Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington D.C.

SANTA CLARA, CA, October 28, 2024 - Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced the completion of enrollment in EMPOWER CAD, the first prospective all-female study of percutaneous coronary intervention (PCI) in complex calcific disease. The study is seeking to confirm the benefits of coronary intravascular lithotripsy (IVL) in female patients with calcified lesions in a post-market, real-world, all-comers population. Primary endpoint results will be presented in 2025, and patients will subsequently be followed out to three years.

"The completion of enrollment in EMPOWER CAD is a major milestone in our desire to improve cardiovascular outcomes for women with challenging calcified lesions," said Margaret McEntegart†, MD, PhD, Director of the Complex PCI and CTO programs and Cardiac Catheterization Labs at Columbia University Medical Center/New York-Presbyterian Hospital, and co-principal investigator of EMPOWER CAD. "Not only will this study yield valuable insights on the performance of coronary IVL in female patients, but as the first prospective all-comers study of coronary IVL, we also hope to gain additional insights about the utility of the technology in more complex patients."

Women have traditionally been underrepresented in cardiovascular clinical trials, comprising only around a quarter of enrolled patients in many studies¹ and only a tenth of trial leadership committees.² Such underrepresentation for female patients in coronary artery disease studies has led to a lack of actionable gender-specific data to drive improved outcomes, even though women undergoing PCI have a higher risk of procedural complications than men.³

"We are eager to analyze the data and share results next year, with a goal of helping to close the gap in treatment outcomes between men and women," said Alexandra Lansky†, MD, Professor of Medicine, section of Cardiovascular Medicine and Director, Heart and Vascular Clinical Research Program at Yale University School of Medicine and co-principal investigator of EMPOWER CAD. "EMPOWER represents a significant step forward in women's heart health. We also look forward to seeing the participating female interventional cardiologists and clinical researchers in the study continue to take on clinical trial leadership roles in the years to come."

The EMPOWER CAD study enrolled 400 participants across 48 sites, spanning five countries, completing enrollment during a live case by Dr. McEntegart at this year's annual TCT Conference in Washington D.C. Notably, 71% of the enrolling sites were led by female principal investigators, underscoring the study's commitment to diversity and leadership in clinical research. The study's European lead is Nieves Gonzalo, MD, PhD, consultant interventional cardiologist at Hospital Clinico San Carlos in Madrid, Spain.

"We are proud of, and grateful to, all of the dedicated investigators who enrolled this study well ahead of all our expectations, showcasing their commitment to the important issue of women's cardiovascular care," said Nick West, MD, Chief Medical Officer at Shockwave Medical. "This study is a critical step toward closing the gender gap in heart disease treatment, and we recognize the urgent need for clinical data that reflect the unique challenges that women with cardiovascular disease face."

About Shockwave Medical
Shockwave Medical, part of Johnson & Johnson MedTech, is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom, is designed to provide relief to the millions of patients worldwide suffering from refractory angina by redistributing blood flow within the heart. Learn more at www.shockwavemedical.com.

Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke.

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn. Shockwave Medical, Inc. is a Johnson & Johnson company.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Shockwave Medical, Inc and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Shockwave Medical, Inc. or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.as a result of new information or future events or developments.

1: X. Jin, et al. Women's participation in cardiovascular clinical trials from 2010 to 2017. Circulation, 141 (7) (2020), pp. 540-548.
2: K. Denby, et al. Representation of women in cardiovascular clinical trial leadership. JAMA Intern Med, 180 (2020), pp. 1382-1383.
3: M. McEntegart, et al. Sex differences in procedural and clinical outcomes following rotational atherectomy. Catheter Cardiovasc Interv. 2020 Feb;95(2):232-241.

† Drs. McEntegart and Lansky are paid consultants of Shockwave Medical. They have not been compensated in connection with this press release.

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