Vascular Dynamics, Inc.: Vascular Dynamics Appoints Ed Roschak CEO

MOUNTAIN VIEW, Calif., 2017-12-04 15:45 CET (GLOBE NEWSWIRE) --
Vascular Dynamics, Inc. (VDI), a privately held medical device company which
has developed an innovative treatment system for the treatment of hypertension,
today announced the appointment of Mr. Ed Roschak as its president and chief
executive officer. 

"We are fortunate that Ed has decided to join the VDI Team as CEO.  He has
extensive experience in managing the IDE/PMA process with the FDA, raising
capital to finance complex clinical studies, managing a rapid revenue ramp for
novel, clinically superior devices and successfully guiding companies through
the exit process," commented Michael Henson, VDI Chairman. "These skills make
Ed an excellent fit for Vascular Dynamics as we begin the CALM 2 IDE-approved,
pivotal clinical study in the U.S., maximize the value of the Expedited Access
Pathway for the VDI Mobius system granted to us by the FDA, and prepare for
worldwide commercialization." 

Mr. Roschak joins VDI from NuVasive Specialized Orthopedics, where he served as
CEO upon the successful acquisition of his previous company, Ellipse
Technologies, Inc., where he was president and CEO.  Prior to his seven years
at Ellipse, he held a variety of positions at Broncus Technologies, Inc., an
interventional pulmonology startup company focused on asthma and emphysema. 
Asthmatx, Inc. was spun-out of Broncus and acquired by Boston Scientific.  He
also held engineering roles with increasing responsibility at Hewlett-Packard,
Origin Medsystems and Krebs Engineers.   Mr. Roschak is a named inventor on 30
granted patents, more than 60 patent applications published in the U.S., and
more worldwide.  He has also been published in the Journal of Thoracic Surgery.
 Mr. Roschak earned his MBA from the University of Oregon Executive Program and
earned a BS in mechanical engineering from University of California, Santa
Barbara. 

"The use of VDI's MobiusHD device in the first 68 patients with resistant
hypertension has produced outstanding results, exceeding anything published to
date by alternative devices.  I am excited to join the VDI team as we begin to
execute our FDA-approved pivotal trial.  If we are successful, MobiusHD has the
potential to become a revolutionary treatment option for patients suffering
from this life-threatening disease," said Mr. Roschak. 

About The MobiusHD System
The MobiusHD System, a minimally-invasive system, capitalizes on the ability
of the body's baroreceptor mechanism to regulate blood pressure. Baroreceptors
are receptors located in the carotid artery that sense blood pressure and relay
that information to the brain. The MobiusHD implant is designed to amplify the
signals received by the surrounding arterial baroreceptors, and thereby
increase the body's natural response to lower blood pressure through
vasodilation.  Results of the European arm of the CALM-FIM trial, the
first-in-humans trial of the system were published in the September 1, 2017
issue of The Lancet. 

About Resistant Hypertension
Hypertension, or elevated blood pressure, is a common medical condition that
currently affects one billion people worldwide.2 If left untreated,
hypertension can cause life-threatening problems, including heart attack,
aneurysm, stroke or kidney failure. In cases with advanced hypertension,
medical therapies may be prescribed. Patients experiencing resistant
hypertension are uncontrolled with at least 3 antihypertensive drugs and are at
four times greater risk of cardiovascular events compared with hypertensive
patients achieving blood pressure targets.3 The American Heart Association
(AHA) estimates that high blood pressure costs the U.S. $46 billion each year,
including the cost of healthcare services, medications to treat high blood
pressure, and lost productivity. 

About Vascular Dynamics, Inc.
Vascular Dynamics develops catheter-delivered technologies to bring a better
quality of life to patients who are resistant to conventional treatments for
hypertension. Vascular Dynamics was one of nine companies chosen in 2012 by the
FDA to participate in the Early Feasibility Study IDE Pilot Program, and the
MobiusHD system has also been accepted to participate in the FDA's Expedited
Access Pathway (EAP) program. The device is covered by seven issued and pending
U.S. and international patents. The MobiusHD system has received a CE Mark for
the treatment of hypertension in the European Union. However, the MobiusHD
system is not commercially available in the United States.  More information is
available at www.vasculardynamics.com. 

CAUTION: In the United States, the MobiusHD Device is limited by law to
investigational use only. 
1  Spiering, W, Williams, B, Van der Heyden, J..., and for the CALM-FIM_EUR
investigators. Endovascular baroreflex amplification for resistant
hypertension: a safety and proof-of-principle clinical study. Lancet; 2017
(published online Sept 1. http://dx.doi.org/10.1016/S0140-6736(17)32337-1)
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32337-1/fullte
xt 

2 Kearney PM, et al. Global burden of hypertension: Analysis of worldwide data.
Lancet. 2005;365(9455):217-23 
3 Pierdomenico SD, Lapenna D, Bucci A, et al. Cardiovascular outcome in treated
hypertensive patients with responder, masked, false resistant, and true
resistant hypertension. Am J Hypertens. 2005;18: 1422-8. 

Contact:
Jules Abraham
[phone]
[e-mail]