egnite, Inc. and JenaValve Announce Novel Research on Outcomes with Untreated Aortic Regurgitation at the 2024 American College of Cardiology Conference

- Study Led by Philippe Généreux, MD, and Colleagues was Presented Today at the 2024 ACC Annual Meeting -

- Key Findings Demonstrate Untreated Mortality Risk for Some Patients with Moderate Aortic Regurgitation and Cardiac Damage is Similar to Severe Aortic Regurgitation, Suggesting the Need to Re-Evaluate Current Approaches to Care -

egnite, Inc., a leading digital health company for cardiovascular care, and JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, unveil a novel study presented at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.24).

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The study, led by esteemed cardiologist Philippe Généreux, MD, sheds light on key trends determining the management of aortic regurgitation (AR) and utilizes egnite’s industry-leading database of over one million patients from 27 leading teaching and non-teaching institutions across the United States.

Key findings demonstrated:

• Similar high mortality risk for some patients with untreated moderate AR with key markers of cardiac damage and untreated severe AR
• Up to 30% of patients with moderate AR exhibit at least 1 sign of cardiac damage

“This research underscores the poor outcomes for patients with moderate AR who exhibit cardiac damage, stressing the need to monitor distinct characteristics in this population. These insights may also prompt a reassessment of our management strategies and suggest a shift in our approach to intensified follow-up for both moderate and severe AR patients,” says Généreux, Director of the Structural Heart Program at Morristown Medical Center’s Gagnon Cardiovascular Institute.

Recent conservative estimates suggest that over 500,000 patients in the United States are diagnosed with moderate or severe AR, indicating a substantial opportunity for novel therapeutic options to treat patients suffering from AR. The urgency for development of new therapy options is further underscored by an observed 2-year treatment rate of 46% for patients with severe AR historically, despite a 2-year observed mortality rate of 15%-20% in the absence of aortic valve replacement.

About JenaValve

JenaValve Technology, Inc. is a medical device company focused on the design, development, and commercialization of innovative transcatheter heart valve solutions for the treatment of patients suffering from heart valve disease. The Company’s Trilogy® Heart Valve System is a transcatheter aortic valve replacement (TAVR) system designed to treat patients with symptomatic, severe aortic regurgitation (ssAR) and symptomatic, severe aortic stenosis (ssAS) in high surgical risk patients. The Trilogy System received CE Mark approval in May 2021, providing European physicians with the first TAVR device with true dual-disease treatment capabilities.

JenaValve received Breakthrough Device Designation from the FDA to facilitate the review of ALIGN-AR, a pivotal trial in the U.S., as part of its PMA application for the Trilogy Heart Valve System for the treatment of ssAR in high surgical risk patients. If approved, the Trilogy System would become the first and only TAVR system in the U.S. indicated for the treatment of AR.

JenaValve is headquartered in Irvine, California, with additional locations in Leeds, U.K., and Munich, Germany.

JenaValve is backed by Bain Capital Life Sciences, Andera Partners, Valiance Life Sciences, Rosetta Capital, Cormorant Asset Management, Legend Capital, NeoMed Management, RMM, VI Partners, Pictet Alternative Advisors SA, Qatar Investment Authority (QIA), Innovatus Capital Partners, and Peijia Medical Limited.

US: CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.

Additional information is available at www.jenavalve.com

About egnite, Inc.

egnite is a data-centric digital health company committed to advancing the health of our society through innovative cardiovascular solutions. egnite uses AI-driven algorithms and big data to produce business intelligence for healthcare, elevating the role of data in critical decisions. The company partners with leading hospitals and life sciences organizations to transform care delivery for cardiovascular patients. The company is based in Aliso Viejo, Calif., for more information, visit www.egnitehealth.com.

egnite, egnite, Inc., CardioCare and the spark logo are trademarks of egnite, Inc. All other trademarks are the property of their respective owners.

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