Market Overview

JenaValve Technology Initiates U.S. Patient Enrollment in Early Feasibility Study of Next-Generation TAVR System for the Treatment of Severe Aortic Stenosis and Severe Aortic Regurgitation


Successful Implantations Completed with Everdur™ Transcatheter Valve
and Coronatix™ Transfemoral Delivery Catheter at Columbia University
Medical Center and MedStar Washington Hospital

JenaValve Technology, Inc., a developer and manufacturer of
differentiated transcatheter aortic valve replacement (TAVR) systems,
today announced initiation of patient enrollment in the Early
Feasibility Study (EFS) of its next generation JenaValve Pericardial
TAVR System using the Everdur™ transcatheter heart valve (THV) and
CoronatixTM Transfemoral Delivery Catheter at
NewYork-Presbyterian/ Columbia University Medical Center (CUMC), New
York City, and MedStar Washington Hospital Center, Washington, DC. The
EFS is investigating the JenaValve Pericardial TAVR System for the
minimally invasive treatment of patients with symptomatic, severe aortic
stenosis (AS) and symptomatic, severe aortic regurgitation (AR) for whom
open surgery is an extreme or high risk. The JenaValve Pericardial TAVR
System is an investigational device in the United States and

The EFS is a prospective, single-arm study of the JenaValve Pericardial
TAVR System being conducted at several centers of excellence in the
United States under an FDA-approved investigation device exemption
(IDE). It is part of a larger, ongoing CE Mark clinical program
investigating the JenaValve Pericardial TAVR System for the same
indications at centers in Europe and New Zealand.

The JenaValve system is proprietary and differentiated from currently
available TAVR devices due to the Everdur THV locator-based technology,
designed to enable anatomically-correct, predictable implantation using
the new 18-Fr equivalent Coronatix Transfemoral Delivery Catheter.
Enrollment has been completed for the AS CE Mark clinical program and is
ongoing for the AR CE Mark clinical program.

The Executive Chair of the JenaValve Clinical Development Program Dr.
Martin Leon (Director of the Center for Interventional Vascular Therapy
and Professor of Medicine at CUMC) said, "Both myself and my CUMC
colleagues, Dr. Susheel Kodali and Dr. Torsten Vahl, are extremely
pleased to be the first U.S. physicians to treat patients with the new
JenaValve TAVR system. The first procedures for both AS and AR patients
demonstrated the system's ease of use and potential that the Everdur
valve may be an important addition to the transcatheter valve products.
In particular, the JenaValve TAVR technology enables TAVR treatment for
patients with severe AR who are at increased surgical risk that until
now have not had a suitable transcatheter option in the U.S. We look
forward to continuing our work with the JenaValve clinical and product
development teams to expand the study of its TAVR technology in the U.S."

"It has been our goal since the early development of our next generation
TAVR System to bring this novel technology into the United States," said
JenaValve Chief Executive Officer Victoria Carr-Brendel, PhD. "We are
greatly encouraged to initiate enrollment at these prestigious centers
under the direction of these physicians, and thank them for their
efforts. We will continue to work tirelessly with our clinical partners
to expand patient enrollment at new clinical sites in the United States."

The Company is seeking FDA approval for expanded IDE access to patients
at the top clinical centers in the U.S.

About JenaValve Transfemoral TAVR System

The JenaValve Pericardial TAVR System consists of the EverdurTM
Pericardial Aortic Valve (manufactured at the JenaValve England
facility) and the Transfemoral Delivery System. The bioprosthesis
comprises a self-expanding nitinol stent with a porcine pericardial
valve manufactured using state-of-the-art tissue processing techniques.
The CoronatixTM transfemoral delivery catheter is designed to
deliver the bioprosthesis using a simple stepped approach with anatomic
positioning over the native valve. The System is available in three
sizes intended for aortic annulus diameters from 21mm to 27mm. A larger
bioprosthesis size is in development.

About JenaValve

JenaValve Technology, Inc., with locations in Irvine, California, Leeds,
England, and Munich, Germany, develops, manufactures and markets
transcatheter aortic valve replacement (TAVR) systems to treat patients
suffering from aortic valve disease. The Company is in clinical
development of its next generation transfemoral TAVR system, consisting
of the EverdurTM valve and CoronatixTM
transfemoral delivery catheter, in both the U.S. and CE Mark countries
for treating patients with aortic stenosis and/or aortic regurgitation.
The Company's first generation transapical system, consisting of the
JenaValveTM valve with Cathlete PLUSTM delivery
system, was commercialized under CE Mark approval for aortic valve
stenosis and for aortic valve regurgitation. JenaValve is backed by
world-class U.S., European and Asian investors, including Andera
Partners (formerly Edmond de Rothschild Investment Partners), Gimv (a
Euronext-listed investment company - ticker: GIMB), Legend Capital,
NeoMed Management, Omega Funds, RMM, Valiance Life Sciences and VI
Partners. Additional information is available at

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