“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/fulltext
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
+1-917-885-7378
jabraham@vasculardynamics.com
