JenaValve Submits IPO Prospectus Highlighting Trilogy THV System: The World’s Only TAVR Approved for Severe Aortic Regurgitation

Trilogy is the world's first and currently the only approved transcatheter aortic valve replacement (TAVR) system for the treatment of severe symptomatic aortic regurgitation or aortic stenosis.

The primary safety endpoint and primary efficacy endpoint of the trial met the pre-specified non-inferiority criteria. Dr. Vinod Thourani from the Piedmont Heart Institute presented the findings at the opening session of the late-breaking clinical trials at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium.

ALIGN-AR researchers concluded that the Trilogy THV demonstrates excellent performance with a large EOA and low transvalvular gradient, as well as low paravalvular regurgitation (0% ≥ moderate regurgitation rate within 1 year). Additionally, echocardiography showed significant improvement in left ventricular remodeling, with patients reporting continuous enhancements in quality of life (QoL) and heart failure functional status over one year.

▲Figure: Trilogy System

Torsten P. Vahl, M.D., principal investigator of the ALIGN-AR trial, stated that the key results of the ALIGN-AR trial showed a significant reduction of over 20% in the weight of the left ventricular muscle (dysfunction of the heart valve may lead to left ventricular hypertrophy), and patients' quality of life was also significantly improved.

JenaValve Chief Medical Officer Dr. Duane Pinto said he is very pleased to share the results of the ALIGN-AR study with everyone.This result demonstrates the safety and efficacy of the Trilogy THV System, as well as its superior technical performance and ability to reverse left ventricular hypertrophy.Special thanks to the researchers and on-site participants of ALIGN-AR for their significant contributions to patients with aortic regurgitation.

JenaValve adopts a slow and steady approach to developing transcatheter aortic valve replacement (TAVR) devices, akin to the tortoise in the Tortoise and the Hare, winning the race slowly and steadily.

Dr. Vinod Thourani compared the company's R&D approach to a fine wine that gets better with time at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

The origin of JenaValve can be traced back to the design concept proposed in 1995 by Dr. Hans Figulla and Dr. Markus Ferrari at Friedrich Schiller University. The company's founders obtained the first patent for a percutaneous self-expanding aortic stent in 1999. JenaValve was officially established in 2006. In 2018, the company launched the pivotal ALIGN-AR trial in the United States, using its transfemoral porcine pericardial valve to treat aortic regurgitation.In 2021, the company raised $100 million in a Series C financing round aimed at supporting FDA approval of its Trilogy Heart Valve System, designed for high-surgical-risk patients with severe symptomatic aortic regurgitation (AR).

Dr. Thourani noted at the latest clinical trial meeting of TCT that 180 high-risk patients with symptomatic, moderate to severe aortic regurgitation in the study were treated with the Trilogy Transcatheter Heart Valve (THV). The study met its primary safety endpoint, which was to evaluate the safety of the Trilogy THV system at 30 days post-implantation.Regarding efficacy, the researchers noted significant improvements in the patients' left ventricular systolic diameter, systolic volume, and mass.After the elimination of arterial valve insufficiency, the ventricle underwent truly significant changes.Over a one-year period, both the patient's quality of life (QOL) and heart failure functional status showed continuous improvement.

# About JenaValve

JenaValve, founded in 2006, is a pioneer in the global TAVR treatment field. The company focuses on the design, development, and commercialization of innovative THV solutions to provide treatment options for patients with heart valve diseases. Its patented locator technology allows the artificial valve to align with the natural anatomy and form a natural seal by clipping the valve leaflets. The company's Trilogy THV System is a TAVR system designed to treat patients with high surgical risk, severe symptomatic aortic regurgitation, and severe aortic stenosis. The Trilogy THV System has received CE Mark approval, offering European physicians the first TAVR device with genuine therapeutic capabilities. Additionally, the Trilogy received the FDA Breakthrough Device Designation in January 2020.