REVA MEDICAL ANNOUNCES ENROLLMENT OPEN FOR MOTIV IDE CLINICAL TRIAL

SAN DIEGO, September 28, 2022 /PRNewswire/ — REVA Medical, LLC, a technology leader in bioresorbable polymers for vascular applications, announced today that enrollment has begun in the pivotal MOTIV trial at clinical centers in the United States and Europe. The study will evaluate the use of the MOTIV® sirolimus-emitting bioresorbable vascular scaffold for the treatment of patients suffering from chronic limb-threatening ischemia (CLTI). CLTI is an advanced stage of peripheral arterial disease (PAD), often affecting the arterial bed below the knee (BTK), and is associated with impaired quality of life due to a high risk of major health problems, including amputation, adverse cardiovascular events, and mortality.

The MOTIV study is a worldwide randomized controlled trial (RCT) designed to evaluate the safety and efficacy of the MOTIV scaffold for the treatment of infrapopliteal lesions in patients with LCTI in a randomized comparison with standard balloon angioplasty. The study, led by co-principal investigators Dr. Ehrin Armstrong of Adventist Health in St. Helena, Californiaand MD Andrej Schmidt from the Universitätsklinikum Leipzigwill follow 292 patients at approximately 35 clinical centers in the United States and Europe.

“The lack of an approved device as a specialty treatment option for approximately 20 million patients¹ worldwide with CLTI is a significant unmet need,” said Dr. Jason Ritchie of Bellin Health Cardiology Associates in Green Bay, Wisconsinand the doctor who enrolled the first US patient. “I am delighted to play a role in this important trial and to assess its potential to advance the science and therapies available for this very complex patient population.”

MOTIV is a fully bioresorbable, sirolimus-eluting scaffold that is designed to dissolve over time, leaving the artery without a permanent implant and thereby allowing it to return to its natural motion, or vasomotion. MOTIV is made from REVA’s proprietary polymer, Tyrocore®, which has been developed specifically for scaffolding. New Tyrocore properties provide increased scaffold strength in a slim buttress design; are designed to improve ease of use, including one-step inflation; and allow visibility of the entire device under fluoroscopy, a unique attribute for MOTIV among bioresorbable scaffolds.

“The launch of our MOTIV clinical trial is an exciting and important milestone for REVA as well as the global medical community,” he commented. Jeffrey Anderson, President and CEO of REVA Medical, LLC. “We are focused on addressing the need for longer-lasting treatment options for this debilitating disease and are committed to finding the best possible therapies to improve patient outcomes.”

The MOTIV scaffold has been approved for use in Europe since 2018, when the device became the first bioabsorbable scaffold to be CE marked for use below the knee. Dr. Schmidt, MD, recently recorded a live case using the MOTIV scaffold, which was shown at the 2022 Transcatheter Cardiovascular Therapy (TCT) Conference. During the procedure, Dr. Schmidt, MD, implanted three 60 -millimeter MOTIV scaffolds in a patient with CLTI below the knee and the patient showed positive postoperative results.

“The MOTIV scaffold has a proven track record of positive clinical results and I am honored to perform the first procedures with the device in this trial,” said Henrik Schröder, MD, who enrolled the first European patients in the trial at Ihre Radiologien MVZ in Berlin. “The scaffold was easily delivered and the procedure was aided by visibility of the device under fluoroscopy, which is helpful in confirming correct placement.”

In August, REVA announced the closing of $45 million in Series B equity financing to support its MOTIV scaffold clinical program. This funding was provided by Boston Scientific and existing investors.

Additional information can be found on the REVA website: www.revamedical.com

About REVA Medical

REVA Medical is a medical device company focused on the development and commercialization of bioabsorbable polymer technologies for vascular applications. The company’s products include MOTIV bioresorbable scaffolds for the treatment of peripheral artery disease, Fantom and Fantom Encore bioresorbable vascular scaffolds for the treatment of coronary artery disease, and TyroSphere embolic beads. REVA is headquartered in San Diego, California. More information can be found on the REVA website: www.revamedical.com.

Fantom, Fantom Encore and MOTIV only have the CE mark. Fantom, Fantom Encore and MOTIV are available in selected countries in Europe and Middle East. Fantom, Fantom Encore, MOTIV, and TyroSphere are not available in the United States or other countries that do not accept CE marking. Fantom, Fantom Encore, MOTIV, TyroSphere and Tyrocore are trademarks of REVA Medical, LLC.

Forward-looking statements

This release contains or may contain forward-looking statements that are based on management’s beliefs, assumptions and expectations, as well as information currently available to management. All statements that are not statements of historical fact, including those statements that relate to future operating plans or performance and events or developments that may occur in the future, are forward-looking statements, as are those statements regarding projections and timing around business operations. and sales, clinical trials, ongoing product development and future funding. Undue reliance should not be placed on forward-looking statements. Although management believes that the forward-looking statements are reasonable when made, the forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. Any forward-looking statement in this release speaks only as of the date on which it is made. REVA undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

¹ Duff S, Mafilios MS, Bhounsule P, Hasegawa JT. Burden of critical limb ischemia: a review of recent literature Vasc Health Risk Manag. 2019; 15: 187-208. doi: 10.2147/VHRM.S209241

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