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
Hear from Patients and Physicians
MobiusHD® Patient
Atlanta, Georgia
Chandan Devireddy, MD
Emory University
Interventional Cardiologist
Gregg Stone, MD
Columbia University
Co-Principal Investigator, CALM-2
Professor Bryan Williams, MD
University College London Hospital
Co-Principal Investigator, CALM-2
EVBA: EndoVascular Baroreflex Amplification
MobiusHD® 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.
Martin Rothman
Chief Medical Officer
Professor Martin T. Rothman joined Vascular Dynamics in January 2019. Prof. Rothman is a highly regarded pioneer in interventional cardiology as evidenced by his clinical practice, his extensive pre-clinical and clinical research, and his success within the biotech industry having founded several start-ups and recently had leadership roles of increasing responsibilities at Medtronic.
Over thirty one years as a clinician at Bart’s Health in London, Prof. Rothman played a leading role in establishing interventional cardiology, particularly coronary angioplasty and stent implants. He helped found and became President of the professional society responsible for coronary intervention in the UK, The British Cardiovascular Intervention Society (BCIS). Prof. Rothman has been integral to clinical practice changes establishing new patient pathways for heart attack victims, rapid access for patients with unstable angina, and day-case coronary intervention, all of which have gained national acceptance. He is also widely published with over 200 publications and is the author of several books on interventional cardiology.
Prof. Rothman has been a pre-clinical and clinical evaluator of many new interventional devices and has invented and patented a number of novel devices and is named on more than 120 patents. Prof. Rothman has founded and run a number of successful start-up companies and raised more than $1B in investment funding for early stage ventures.
Prior to joining VDI, Prof. Rothman was Chief Medical Officer and Vice President of Medical Affairs for the Coronary, RDN & Structural Heart Division at Medtronic where he was part of the day-to-day management of a $3.5B revenue business. He also was involved in evidence development strategies and guided new product development teams addressing a wide product spectrum including those for coronary and vascular disease, resistant hypertension, and minimally invasive and percutaneous mitral valve replacement and repair.
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.
Barbara Niksch
Vice President, Clinical Affairs
Barbara joined Vascular Dynamics in July 2018, bringing her 30 years of medical device industry experience in the areas of Clinical and Regulatory Affairs. Most recently she served as Executive Director, Clinical Development Ophthalmology at Allergan. Prior to Allergan, Barbara served as VP of Clinical & Regulatory Affairs for AqueSys, Inc., which was acquired by Allergan. Prior to AqueSys, Barbara served as VP of Regulatory, Quality and Clinical Affairs at Visiogen, Inc. (acquired by Abbott) and Glaukos Corporation. Barbara obtained her BS in Biology from the University of Nevada Reno and she has an MBA from National University. Barbara is a past president of the Orange County Regulatory Affairs (OCRA) discussion group and also served as the Ophthalmic Industry Representative on the FDA’s Ophthalmic Devices Advisory Panel.
Mike Lazinski
Vice President, Finance
Mike joined the Vascular Dynamics team in August of 2018. Mike has more than 15 years of finance and operations experience in the medical device industry with both large publicly-traded companies as well as emerging technology organizations. He most recently served as Senior Director of Finance for NuVasive, where he partnered with leadership to drive the market development, product portfolio, and corporate development strategies for the organization. Previously Mike served as the finance leader for NuVasive Specialized Orthopedics, having joined the organization through the acquisition of Ellipse Technologies. Prior to joining Ellipse in 2015, Mike held finance and operational roles within several GE Healthcare businesses upon successful completion of the GE Financial Management Program. Mike holds a BBA in Finance and Business Economics from the University of Notre Dame.
Joe Bishop
Vice President, Operations/ R&D
Joe joined Vascular Dynamics in September of 2018 as Vice President of Operations and R&D. Joe has over thirty years of diverse experience in the medical device industry. He is an innovative thinker with broad-based expertise in operations, business development, strategic planning, and research & development. Prior to VDI, Joe served as Vice President of Operations and R&D for Suneva Medical Corporation as a member of the Executive Leadership team providing strategic direction for all operational and research and development activities. Joe served as President and CEO of Onset Medical Corporation for eight years developing the company from concept to commercialization and subsequent acquisition by Terumo Medical Corporation. Joe remained another four years with Onset/Terumo as Chief Operations Officer. Previously Joe served as Vice President of Research and Development for Endologix, Inc. and held management and engineering positions at Radiance Medical Systems, CardioVascular Dynamics Inc. and Guidant (Advanced Cardiovascular Systems). Joe is an inventor of multiple product patents and product designs and holds a Bachelor of Science in Business Administration, University of Phoenix, Diamond Bar, CA with multiple certifications in management and engineering.
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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.
Ilan Neugarten
Mr. Neugarten has over 35 years of senior managerial experience, and over 15 years of experience in the medical industry. He brings to Rainbow Medical significant experience in medical devices venture capital investments, commercialization, and asset realization. Mr. Neugarten joined the Viola Partners Group in 2000 as a partner of DOR Ventures, a VC fund focusing on imaging technologies. During his period at DOR Ventures he led various investments including medical imaging ventures. Since 2006, he led the healthcare investments of Viola Partners. Prior to joining the Viola Partners Group, he worked for Scitex (NASDAQ:SCIX) in various management positions in Europe, Japan, and Israel. He received his BSc in Electronics from the Technion, Haifa Israel, and an MBA from Boston University.
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 Names Prof. Martin Rothman Chief Medical Officer
Jan 23, 2019
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:
30 Fairbanks, Suite 100
Irvine, CA 92618 USA
P: +1.949.942.1640
E: info@vasculardynamics.com
©2020 Vascular Dynamics, Inc. All rights reserved. | Reshaping Hypertension is a trademark of Vascular Dynamics, Inc. MobiusHD is a registered trademark of Vascular Dynamics, Inc.