Reshaping Hypertension™
with the MobiusHD® System
Now enrolling in the CALM-2 clinical study
for patients with poorly controlled hypertension
CAUTION: investigational device. Limited by United States law to investigational use.
Hypertension impacts 1 billion people worldwide and the clinical consequences are devastating1,2,3
When your blood pressure is high:
Have high blood pressure
of people with high blood pressure have their condition under control
EVBA: EndoVascular Baroreflex Amplification
Mobius HD® System
The MobiusHD® System is the only hypertension treatment amplifying the natural baroreceptor response in the carotid sinus with a minimally invasive procedure.
CAUTION: investigational device. Limited by United States law to investigational use.
AMPLIFY
Reshaping of carotid sinus amplifies baroreceptor signaling to the brain
REDUCE
Significant blood pressure reduction demonstrated in multiple clinical studies4
LONG LASTING
Durable safety and efficacy at two-years4
NON-SURGICAL
Minimally invasive access using endovascular techniques
Clinical Trials
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CALM-FIM
CALM-FIM was a prospective, first-in-human, open-label study done at six sites in Europe. The MobiusHD system was studied in patients with an office systolic blood pressure ≥160 mmHg despite taking at least three antihypertensive agents, including a diuretic.
Results showed a significant decrease in mean ambulatory blood pressure in 73% of patients at 24 hours and blood pressure reduction of 21/12 mmHg at six months, as compared to baseline4.
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CALM-2
The MobiusHD System is being studied in the CALM-2 clinical trial in patients with resistant hypertension who remain uncontrolled despite pharmacologic treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy.
The CALM-2 clinical trial is currently enrolling at select medical centers in the United States and Europe. For more information visit www.calm2study.com
See if you qualify
About Vascular Dynamics
Vascular Dynamics Inc. is pioneering endovascular baroreflex amplification (EVBA) to advance the treatment of hypertension to bring a better quality of life to patients who are resistant to conventional treatments.
The MobiusHD System targets the natural baroreceptor response in the carotid sinus with a minimally invasive procedure and is designed to stimulate vasodilation, reduce heart rate and modulate kidney response, thereby decreasing blood pressure.
The MobiusHD system has received a CE mark and has been accepted to participate in the FDA’s Expedited Access Pathway (EAP) program. The MobiusHD System is investigational in the United States.
CAUTION: investigational device. Limited by United States law to investigational use.
Leadership
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Management
Ed Roschak
President & CEO
Ed joined Vascular Dynamics in November of 2017 as President and CEO. Ed has a track record of success with more than 20 years in the medical device industry. Prior to VDI, Ed served as the CEO of NuVasive Specialized Orthopedics after he orchestrated the successful acquisition of his former company, Ellipse Technologies, Inc., where he was president and CEO. Prior to his seven years at Ellipse, Ed held senior leadership positions at Broncus Technologies which spun-out Ashmatx, which was acquired by Boston Scientific. Previously, Ed held engineering and management roles at Hewlett-Packard, Origin Medsystems and Krebs Engineers. Ed is a named inventor on 30 granted patents and numerous patent applications. He has also been published in the Journal of Thoracic Surgery. Ed holds a MBA from the University of Oregon Executive Program and a BS in mechanical engineering from the University of California, Santa Barbara.
Brent Seybold
Vice President, Technical Operations
Brent joined Vascular Dynamics when it was founded in 2011. During his tenure at VDI, Brent has led the team in activities in product development, manufacturing, quality, clinical support and physician training. Brent has 20 years of medical device development experience and helped several companies transform concepts to commercially viable products, most recently Genesis Medical Interventional where Brent was Vice President of Product Development. Brent has served in senior technical roles at LuMend (acquired by Johnson and Johnson), Parallax Medical (acquired by Arthrocare), ImetRx, and Micrus Endovascular (acquired by Johnson and Johnson). Brent holds a BS in Mechanical Engineering from the University of California, Davis.
Sujith Shetty
Vice President, Clinical
Suji joined Vascular Dynamics in March of 2012. Suji has more than 12 years of clinical and medical affairs experience including the management and oversight of several device trials. Prior to VDI, Suji was a Senior Clinical Project Manager at Micrus Endovascular, which was acquired by Johnson and Johnson in 2010. Prior to Micrus, Suji was a member of the clinical team at Pulmonx and Asthmatx. Suji started his clinical research career as a research fellow at the University of Southern California, where he contributed to studies in Pulmonary, Critical Care and Cardiology. Suji holds a MBBS from Kempe Gowda Institute of Medical Science (Bangalore, India).
John McIntyre
Vice President, Regulatory and Quality Assurance
John joined the Vascular Dynamics team in February of 2018, bringing his experience in quality system design and maturation as well as his in-depth knowledge of the global regulatory landscape. John has more than 25 years of medical device industry experience, with nearly 15 years in leadership roles. John most recently served as Global Vice President of Regulatory, Quality and Clinical Affairs for NuVasive, following the acquisition of Ellipse Technologies where he served in that same role. Prior to joining Ellipse in 2010, John held leadership positions at Magellan Spine Technologies and Cardiogenesis Corp. John started his career at Edwards Lifesciences (formerly Baxter Healthcare) where he held positions in Research and Development and Regulatory Affairs. John holds a MS in Biomedical Engineering from the University of California, Davis and a BS in Bioengineering from the University of California, San Diego.
Scott Grant
Vice President, Market Development
Scott joined Vascular Dynamics in February of 2018. Scott is a proven business development and commercial operations executive with more than 30 years of experience in the medical device industry. His experience has encompassed both large and emerging technology companies in the areas of sales, market development, product development, clinical research and training. Prior to VDI, Scott held Vice President positions at Nuvaira, Broncus Technologies and Emphasys (acquired by Pulmonx) where he oversaw clinical trials, product launches, reimbursement strategy and global sales distribution. Earlier in his career, Scott worked at Perclose (acquired by Abbott Vascular) and ACS (acquired by Guidant). Scott holds a BS in Health Management Services from Indiana University School of Medicine.
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Board of Directors
Michael Henson
Chairman
Mr. Henson has founded or served as CEO and chairman/board member for 18 emerging healthcare (medical device or biotechnology) firms. Seven of these were privately held firms acquired by multinational companies, while six have advanced through the initial public offering (IPO) stage. Ten of the firms founded by Mr. Henson have been acquired by major healthcare firms. Several of these companies remain closely held private firms. In total, these firms have received financial investments of approximately $1 billion and have employed in excess of 1,000 people. Mr. Henson also serves as a principal manager for four private investment funds and as an advisor to two additional private investment funds, all focused on early and mid – stage medical device startup ventures.
Ed Roschak
Ed joined Vascular Dynamics in November of 2017 as President and CEO. Ed has a track record of success with more than 20 years in the medical device industry. Prior to VDI, Ed served as the CEO of NuVasive Specialized Orthopedics after he orchestrated the successful acquisition of his former company, Ellipse Technologies, Inc., where he was president and CEO. Prior to his seven years at Ellipse, Ed held senior leadership positions at Broncus Technologies which spun-out Asthatx, which was acquired by Boston Scientific. Previously, Ed held engineering and management roles at Hewlett-Packard, Origin Medsystems and Krebs Engineers. Ed is a named inventor on 30 granted patents and numerous patent applications. He has also been published in the Journal of Thoracic Surgery. Ed holds a MBA from the University of Oregon Executive Program and a BS in mechanical engineering from the University of California, Santa Barbara.
Efi Cohen-Arazi
Mr. Cohen-Arazi has more than 25 years of experience in the medical and biotech industries involving executive management responsibility for both development manufacturing and business. Prior to co-founding Rainbow Medical, Mr. Cohen-Arazi served as CEO of IntecPharma, Israel, a company specializing in drug development and delivery. Previously, Mr. Cohen-Arazi was vice president of Corporate Manufacturing, Head of Contract Manufacturing and Site Head at U.S.-based Amgen Corporation. Mr. Cohen-Arazi held senior positions at Immunex in the U.S. and at the Merck-Serono Group in Switzerland. Mr. Cohen-Arazi holds advanced life sciences degrees from the Hebrew University of Jerusalem.
Ben Tsai
Mr. Tsai is a Partner at Invus Opportunities, a NY-based investment firm with over $1 billion under management, where he has led numerous growth investments in healthcare and technology companies since 2008 and served as a Director or Board Observer of over a dozen companies over that period. Representative life sciences investments include Valtech Cardio and CardiAQ (both sold to Edwards Lifesciences), Kythera and Aquesys (both sold to Allergan). Previously, Mr. Tsai was a management consultant at the Monitor Group, where he advised senior executives of companies globally on their most critical strategic issues. He holds an MBA degree from Harvard Business School and a BS degree from the University of Southern California, where he was a Trustee Scholar.
Dr. Thomas Thaler
Dr. Thaler has more than 15 years of experience in investment management and financial research. He is a former senior equity analyst at Bank Julius Baer covering medical technology and healthcare service companies. He also has 15 years of experience in the biotech and medical technology industry holding senior management positions with Sulzer Medica, Schneider (Europe) and Boston Scientific. Dr. Thaler holds a MSc from the Swiss Federal Institute of Technology, (ETH) Zurich in Biochemistry, a PhD in life sciences and a Masters degree in Business Administration (ETH/BWI). Dr. Thaler is a board member of Vascular Dynamics, Ellipse Technologies, Interventional Spine, MiCardia, Tensys Medical and ValCare Medical.
Gary Burbach
Mr. Burbach has extensive experience in the medical technology industry. Prior to joining VDI, he served as CEO of Thoratec Corporation, a publicly-traded company that develops, manufactures and markets proprietary medical devices used for circulatory support. He has also served in executive roles at Digirad Corporation, where he also served on the board, Bacchus Vascular, Inc., a developer of catheter-based medical devices and Philips Nuclear Medicine, a division of Philips Electronics, which had also acquired ADAC Laboratories, where he served as president. He also serves on several boards of directors, including Fluidigm, Inc., Procyrion and Autonomic Technologies.Prior to his in-house management roles, Mr. Burbach spent six years with the management consulting firm of McKinsey & Company, Inc., where he was a senior engagement manager in the firm's healthcare practice.Mr. Burbach has a B.S. in Industrial Engineering from Stanford University and an M.B.A. from Harvard Business School.
Press Releases
Vascular Dynamics Announces Initial Enrollment in Rigorously Designed Hypertension Trial
Sept 4, 2018
Vascular Dynamics Appoints Ed Roschak CEO
Dec 4, 2017
Vascular Dynamics Interim Data on MobiusHD Presented at TCT Conference Shows Significant Reductions in Ambulatory Systolic Blood Pressure At Six Months
Oct 30, 2017
Vascular Dynamics Announces FDA Approval to Initiate CALM 2 Trial for MobiusHD® System for the Treatment of Resistant Hypertension
Sep 15, 2017
Data Published in The Lancet Shows Positive Results at Primary Endpoint in the Treatment of Resistant Hypertension with MobiusHD Device
Sep 1, 2017
Contact
Address:
2134 Old Middlefield Way, Suite J
Mountain View, California 94043 USA
P: +1.650.963.9370
E: info@vasculardynamics.com
©2018 Vascular Dynamics, Inc. All rights reserved. | Reshaping Hypertension is a trademark of Vascular Dynamics, Inc. MobiusHD is a registered trademark of Vascular Dynamics, Inc.