SMT Research and Development Ltd. Announces Financing to Pursue Development of Novel Embolic Protection Device for Use in TAVI Procedures
By Smt Research And Development Ltd., PRNESaturday, April 2, 2011
Deflection of Embolic Materials Seen as Key Step in Reducing Adverse Events in Groundbreaking Transcatheter Aortic Valve Implantation ("TAVI") Procedures (New Orleans, Louisiana-American College of Cardiology)
HERZLIYA PITUACH, Israel, April 3, 2011 - SMT Research and Development Ltd. (SMT) of Herzliya Pituach, Israel
announced today a significant investment by OrbiMed Advisors LLC. SMT is
finalizing the development of a novel embolic protection device designed for
use during Transcatheter Aortic Valve Implantation (TAVI) procedures.
Improved safety through reduction in the number of strokes and post-procedure
brain lesions is the goal of this collaboration. The $10.5 million USD staged
financing was led by OrbiMed and closed last week.
(Photo: photos.prnewswire.com/prnh/20110403/LA76310)
Post-procedure brain lesion formation has been reported in the literature
to occur in 68% to 91% of TAVI procedures on MRI, and the incidence of
symptomatic stroke following TAVI has been reported to be between 3% and 10%
in most series. Anticipating this problem, SMT has spent five years
developing and refining a deflection device specifically designed to reduce
the chance of stroke and embolic events during TAVI and other structural
heart procedures. "TAVI is truly one of the most exciting areas of medicine
today, allowing patients suffering from life-threatening aortic valve
stenosis to receive new, functional heart valves via minimally invasive
techniques, thereby replacing traumatic open heart surgery," said Dov Shimon,
MD, cardiac surgeon and founder of SMT. "Current TAVI devices are working
well, but despite efforts to refine the technique, we continue to see
post-procedure complications associated with cerebral embolism resulting in
stroke and other ischemic events."
The Company initiated a pilot clinical study in early 2010. Pieter
Stella, MD, of the University Medical Center in Utrecht, The Netherlands, has
performed the first-in-man cases using the SMT device. "TAVI is an exciting
new procedure for patients and cardiologists," said Dr. Stella. "However, as
with any new procedure, new risks arise. It is clear from the published
studies in TAVI that embolic events do occur and need to be minimized. The
SMT device is the first embolic protection device that I have seen that
offers coverage of all three primary vessels feeding the brain. I have been
pleased with our early results, and believe that the SMT deflector will help
to ensure the continued market expansion for safe, effective TAVI
procedures."
"We like the fact that the SMT device was designed from the perspective
of a highly-experienced surgeon who understands the anatomy of the aortic
arch and the variability of arteries that branch off to deliver blood to the
brain and central nervous system," said OrbiMed Principal and new SMT board
member, David Bonita, MD. "To our knowledge, this is the only device in
development designed to protect the entire neurovascular system by covering
all three major arteries feeding the brain - the innominate, the left common
carotid and the left subclavian. SMT is also the only system designed for
placement via one of two femoral artery access ports typically used in TAVI -
unlike other approaches which require a third puncture located in the arm."
In connection with the financing, the Company has appointed
cardiovascular industry veteran Paul Zalesky, PhD as CEO, and has added to
the board of directors two additional OrbiMed professionals, Nissim Darvish,
MD, PhD and Vince Burgess, who will serve as Chairman.
The SMT deflector device is an investigational device and is not
available for commercial use in the USA, EU or other markets of the world.
About SMT Research and Development Ltd.:
SMT is a Herzliya Pituach, Israel-based medical device company founded in
2004. SMT is focused on the development and commercialization of procedural
tools and accessories for use during TAVI and other complex percutaneous
structural heart procedures.
About OrbiMed Advisors LLC:
OrbiMed Advisors is the largest healthcare-dedicated fund manager in the
world. With approximately $5 billion under management and offices in New
York, San Francisco, Tel Aviv, Shanghai, and Mumbai, OrbiMed offers the
global resources to be an exceptional long term partner for its portfolio
companies.
www.smtmed.com
Paul Zalesky, PhD, Chief Executive Officer of SMT Research and Development Ltd., +1-714-585-2423, pzalesky at smtmed.com
Tags: April 3, Herzliya Pituach, Israel, Smt Research And Development Ltd.