Shockwave Medical Enrolls First Patient in FORWARD CAD Pivotal Study of Novel Forward Intravascular Lithotripsy Platform

Investigational Device Exemption (IDE) study will assess the safety and effectiveness of the Shockwave Javelin Coronary IVL Catheter in difficult-to-cross, calcified coronary lesions

SANTA CLARA, Calif. - April 7, 2025 - Today, Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced it has initiated its pivotal FORWARD CAD investigational device exemption (IDE) study. Investigators in the study will assess the safety and effectiveness of the Shockwave Javelin Coronary IVL Catheter for the treatment of calcified, difficult-to-cross stenotic de novo coronary artery lesions prior to stenting. The first patient was treated recently by operators Evan Shlofmitz, D.O., FACC, Director of Intravascular Imaging and Ziad Ali, M.D., D.Phil., Director of the DeMatteis Cardiovascular Institute and Investigational Interventional Cardiology at St. Francis Hospital & The Heart Center in Roslyn, New York.^†

Coronary artery disease (CAD) is the most common type of heart disease and affects approximately 1 in 20 adults over the age of 20 in the U.S.^1,2 In CAD, progressive buildup of cholesterol-rich deposits gradually narrows the coronary arteries, reducing blood flow to the heart muscle and leading to chest pain (angina) and heart attacks. Over time, these narrowed vessels may harden and block due to accumulation of calcium, making them more difficult to treat by conventional techniques.

"There is an opportunity to improve the treatment of cardiovascular patients with tight, calcific lesions in narrowed coronary vessels that are challenging to cross with balloon-based approaches as currently we have to rely on atherectomy technologies," said Dr. Shlofmitz. "We are delighted to enroll the first patient in the FORWARD CAD clinical trial to determine whether Shockwave's novel forward IVL platform can help reduce the recognized risks of atherectomy in this patient population," followed Dr. Ali.

A prospective, multicenter, single-arm study across approximately 35 sites in the U.S. and U.K., the FORWARD CAD study aims to enroll up to 158 patients with moderate-to-severely calcified, stenotic de novo coronary artery lesions presenting with stable angina or following stabilization after acute coronary syndrome (ACS) and suitable for non-emergent percutaneous coronary intervention (PCI). The co-global principal investigators of the study are Robert Yeh, M.D., MBA, Beth Israel Deaconess Medical Center and James Spratt, M.D., FRCP, St. George's University NHS Trust and the U.S. principal investigator is Robert Riley, M.D., FACC, Overlake Medical Center & Clinics.

The forward IVL platform is designed with a single distal emitter that creates ultrasonic shock waves, with a spherical energy field that extends beyond the tip of the catheter. This novel design delivers lithotripsy closer to highly stenosed calcium lesions than balloon-based platforms.

Nick West, M.D., Chief Medical Officer, Shockwave Medical emphasized the potential of the Javelin Coronary IVL Catheter, stating, "Our commitment to realizing the full potential of IVL to optimize cardiovascular care is unwavering, and we believe Javelin has the promise to transform how interventional cardiologists treat patients with tight, challenging-to-cross, calcified coronary lesions. We look forward to learning more about how our enhanced IVL capabilities could lay the foundation for a new era of treatment that improves outcomes for these complex patients."

About Shockwave Medical
Shockwave Medical Inc., 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 part of Johnson & Johnson MedTech.

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 most recent Annual Report on Form 10-K, 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. Neither Shockwave Medical, Inc. nor 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.

Media Contact
Rachael Jarnagin
rjarnagi@its.jnj.com

† Drs. Shlofmitz and Ali are paid consultants for Shockwave Medical. They have not been compensated in connection with this press release.

1: Centers for Disease Control and Prevention. About Coronary Artery Disease (CAD). https://www.cdc.gov/heart-disease/about/coronary-artery-disease.html. Last Accessed: March 24, 2025.
2: Centers for Disease Control and Prevention. Heart Disease Facts. https://www.cdc.gov/heart-disease/data-research/facts-stats/index.html. Last Accessed: March 24, 2025.