Elixir Medical Announces Outstanding 9 and 12-Month Clinical and Imaging Results for the Transformational DynamX™ Bioadaptor at EuroPCR

Long-term data demonstrate that the DynamX Bioadaptor implant and
vessel growth accommodates neo-intimal hyperplasia to substantially
maintain vessel lumen area in the treatment of coronary artery disease

MILPITAS, Calif. & PARIS–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/DeNovo?src=hash" target="_blank"gt;#DeNovolt;/agt;–Elixir Medical Corporation, a developer of products that combine
state-of-the-art medical devices with advanced pharmaceuticals,
announced at EuroPCR excellent 9 and 12-month clinical and imaging data
for the DynamX™ Novolimus-eluting Bioadaptor System, a next-generation
coronary intervention system designed to treat blocked arteries via a
novel vessel uncaging mechanism. EuroPCR is the annual meeting of the
European Association for Percutaneous Cardiovascular Interventions.

Fifty patients were enrolled at 7 centers in Europe in the DynamX
Mechanistic clinical trial. Nine-month clinical data for all patients,
and 9 and 12-month angiographic and imaging results for 31 followed-up
patients were presented for the DynamX Bioadaptor System, which
represents a dynamic, new frontier in the percutaneous coronary
intervention (PCI) industry for an innovation beyond stenting. Antonio
Colombo, MD, Director of Invasive Cardiology, Columbus
Hospital, Milan, Italy, and Stefan Verheye, M.D., Ph.D., ZNA Middleheim
Hospital, Antwerp, Belgium, were the co-Principal Investigators.

Conventional drug-eluting stents (DES) cage the coronary artery in a
rigid, immobile frame inhibiting the vessel’s natural ability to expand
in order to preserve the blood flow during disease progression. DES also
impede the artery’s physiologic pulsatility and hemodynamics during the
cardiac cycle, potentially contributing to further adverse outcomes and
accelerated disease progression. Current generation DES have a
continually increasing MACE (Major Adverse Cardiac Events) rate that
cumulatively translates into high clinical events affecting up to 1 in 2
patients within 10 years.

At 9 and 12 months, Elixir’s DynamX Bioadaptor demonstrated an excellent
in-device mean Late Lumen Loss (LLL) of 0.08±0.18 mm and a median LLL of
0.02 mm as measured by QCA.

OCT (Optical Coherence Tomography) imaging results demonstrated
impressive 99% strut coverage with a thin and uniform 0.14 mm neointimal
layer. IVUS imaging results demonstrated mean Vessel and Device Area
increase in the DynamX Bioadaptor-treated segment from post-procedure to
long-term follow-up, while maintaining the mean Lumen Area.

“Elixir’s outstanding data demonstrate the engineering ingenuity of the
DynamX Bioadaptor for uncaging and restoring the vessel’s natural state
to expand and accommodate disease progression thereby maintaining the
blood flow lumen and potentially reducing adverse clinical outcomes for
patients,” said Dr. Colombo, co-Principal Investigator of the DynamX
trial. “I’m delighted to treat my patients with a device presenting such
impressive long-term results that far exceed DES capabilities and yet
providing DES-like excellent acute performance.”

“Another key attribute for reducing adverse clinical events in patients
is preserving the natural angulation of the coronary arteries,” said Dr.
Verheye, co-Principal Investigator of the DynamX trial. “Unlike
conventional DES that tend to straighten angulated blood vessels due to
their rigidity, Elixir’s novel DynamX Bioadaptor demonstrated via
multiple case studies its unique ability to restore the pulsatility,
positive adaptive remodeling, and natural curvature of the treated
arteries, allowing the vessels to elegantly return to their de novo
function.”

The positive clinical and angiographic results were presented to a
packed audience of physicians and industry executives during the EuroPCR
Symposium of “The New Frontier Beyond Stenting for PCI” in Paris,
and co-chaired by Dean J. Kereiakes, MD, Medical Director, The Christ
Hospital Heart and Vascular Center, Medical Director of the Carl and
Edyth Lindner Center for Research and Education at The Christ Hospital,
and Professor of Clinical Medicine, Ohio State University, and Martin B.
Leon, MD, Mallah Family Professor of Cardiology at the Columbia
University Medical Center; Director, Center for Interventional Vascular
Therapy; Founder and Chairman Emeritus, Cardiovascular Research
Foundation, New York.

“Elixir’s DynamX Bioadaptor represents a pioneering innovation in
coronary implant design for the PCI industry by combining the excellent
acute performance of DES while categorically surpassing DES with its
ability to return the vessel to its de novo state,” said Motasim
Sirhan, CEO of Elixir Medical. “Elixir is committed to raising the bar
for treatment of cardiovascular disease, and providing physicians with
innovative products of the highest standard of care to improve patients’
clinical outcomes.”

About Elixir Medical

Elixir Medical Corporation, a privately funded company based in
Milpitas, California, has developed the broadest portfolio of coronary
and peripheral stents, scaffolds, and bioadaptors including DESyne,
DESyne BD, DESolve, DESolve CX, DESolve NXT, Prava, and the breakthrough
DynamX Bioadaptor System. The company’s next-generation systems are
designed to return diseased blood vessels to their de novo state.
For more information, visit www.elixirmedical.com.

Contacts

Vinayak Bhat, PhD
(408) 636-2006