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EBR SYSTEMS INC. — Board/Management Information 2021
Nov 28, 2021
64814_rns_2021-11-28_9ad4f879-5c48-4236-9cdd-d1bf9db392bc.pdf
Board/Management Information
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29 November 2021
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ASX ANNOUNCEMENT
EBR Systems announces Senior Management updates
Key Highlights:
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Steve Sandweg appointed as Chief Commercial Officer, bringing 30 years of sales and commercialisation experience in Fortune 500 medical technology companies
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Michael Hendrickson appointed as Chief Operating Officer, with over 25 years of experience in product development and manufacturing of medical devices
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Madhuri Bhat, recently Senior Vice President of Regulatory & Compliance, Quality, and Clinical, promoted to Chief Regulatory Officer
Sunnyvale, California; 29 November 2021 : EBR Systems, Inc. (ASX: “EBR” , “EBR Systems” , or the “Company” ), developer of the world’s only wireless cardiac pacing system for heart failure, today announced the appointment of Michael Hendrickson as Chief Operating Officer (COO) and Steve Sandweg as Chief Commercial Officer (CCO), and the promotion of Madhuri Bhat to Chief Regulatory Officer (CRO).
Michael has joined EBR’s senior management team as COO and has over 25 years of medical device product development and manufacturing experience. Michael was COO at Ceterix Orthopaedics (Ceterix) where he led the development of the NOVOSTITCH Pro Meniscal Repair System. Ceterix was acquired in 2019 by Smith & Nephew where he assumed the role of Site Leader, leading the manufacturing integration activities for Ceterix and Tusker Medical, another Smith & Nephew acquisition. Prior to Ceterix, Michael was Vice President of R&D at Foundry NewCo XI and has also served in engineering roles at multiple medical technology companies. Michael has over 80 issued patents to his name, and graduated with a Master's in Mechanical Engineering from Stanford University and a B.S. in Mechanical Engineering from Northwestern University.
Steve has joined EBR’s senior management team as CCO and will be responsible for all commercialization activities, including global field operations, SOLVE-CRT clinical trial enrollment, marketing, and preparation activities for commercial launch. Steve has 30 years of sales experience in Fortune 500 medical technology companies, primarily within the cardiovascular and structural heart space. Most recently, Steve served as General Manager for Keystone Heart, a Venus Medtech Company, where he was responsible for all clinical, commercial, quality, regulatory and compliance activities within the US and Europe. He also previously led several strategic product launches at Medtronic, including Medtronic’s first drug-eluting stents, Endeavour and Resolute, and Medtronic’s first transcatheter aortic valve devices, CoreValve and EVOLUT. Steve holds a B.S. in Business Administration from the University of Missouri – St. Louis.
In addition, Madhuri has been promoted to CRO and will be responsible for EBR’s global regulatory, compliance, clinical, and quality functions. She joined EBR in February 2019, and most recently served as Senior Vice President of Regulatory & Compliance, Quality, and Clinical. Madhuri has over 20 years of experience in public affairs, public policy, clinical, quality assurance and regulatory roles in medical device companies. Notably, she led several successful pivotal clinical trials and secured regulatory approvals in the US and internationally for Class II and III cardiovascular systems. She holds a Master of Public Policy from Duke University and a B.S. from the University of Bombay.
EBR Systems’ President & CEO, John McCutcheon said:
“I am delighted to welcome Michael and Steve to EBR, and Madhuri to her new role as CRO. These appointments represent a significant milestone in our company’s evolution, as we continue to progress on enrolment for the pivotal SOLVE-CRT trial currently underway.”
“Michael, Steve and Madhuri bring a wealth of expertise and experience to drive our clinical development activities and commercialization strategy to build shareholder value. The EBR team is focused on developing the unique and proprietary WiSE® technology to deliver better and safer treatments for patients.”
ENDS
This announcement has been authorised for release by EBR Systems Board.
EBR SYSTEMS, INC. (ARBN 654 147 127) 480 Oakmead Parkway, Sunnyvale CA 94085 USA T: +1 408 720 1906 W: https://ebrsystemsinc.com/
For more information, please contact:
Company Investors John McCutcheon Joel Seah President & CEO Vesparum Capital P: +1 408 720 1906 P: +61 3 8582 4800 E: [email protected] E: [email protected]
About EBR Systems (ASX: EBR)
Silicon Valley-based EBR Systems (ASX: EBR) is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management. The initial product is designed to eliminate the need for coronary sinus leads to stimulate the left ventricle in heart failure patients requiring Cardiac Resynchronisation Therapy (CRT). Future products potentially address wireless endocardial stimulation for bradycardia and other non-cardiac indications.
EBR Systems’ WiSE® Technology
EBR Systems’ WiSE technology is the world’s only wireless, endocardial (inside the heart) pacing system in clinical use for stimulating the heart’s left ventricle. This has long been a goal of cardiac pacing companies since internal stimulation of the left ventricle is thought to be a potentially superior, more anatomically correct pacing location. WiSE technology enables cardiac pacing of the left ventricle with a novel cardiac implant that is roughly the size of a large grain of rice. The need for a pacing wire on the outside of the heart’s left ventricle – and the attendant problems – are potentially eliminated. WiSE is an investigational device and is not currently available for sale in the US.
Forward-Looking Statements
This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions, and expectations and on information currently available to management. Forwardlooking statements involve known and unknown risks, uncertainties, contingencies and other factors, many of which are beyond the Company’s control (including but not limited to the COVID-19 pandemic), subject to change without notice and may involve significant elements of subjective judgment and assumptions as to future events which may or may not be correct.
All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to commercialize our products including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products including our ability to obtain reimbursement for our products; our expectations with respect to our clinical trials, including enrolment in or completion of our clinical trials and our associated regulatory submissions and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position.
Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. Given the current uncertainties regarding the impact of the COVID-19 on the trading conditions impacting the Company, the financial markets and the health services world-wide, investors are cautioned not to place undue reliance on the current trading outlook.
EBR does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. EBR may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements.
Foreign Ownership Restriction
EBR’s CHESS Depositary Interests (CDIs) are issued in reliance on the exemption from registration contained in Regulation S of the US Securities Act of 1933 (Securities Act) for offers or sales which are made outside the US. Accordingly, the CDIs have not been, and will not be, registered under the Securities
EBR SYSTEMS, INC. (ARBN 654 147 127)
480 Oakmead Parkway, Sunnyvale CA 94085 USA T: +1 408 720 1906 W: https://ebrsystemsinc.com/
Act or the laws of any state or other jurisdiction in the US. The holders of EBR’s CDIs are unable to sell the CDIs into the US or to a US person unless the re-sale of the CDIs is registered under the Securities Act or an exemption is available. Hedging transactions with regard to the CDIs may only be conducted in accordance with the Securities Act.
EBR SYSTEMS, INC. (ARBN 654 147 127) 480 Oakmead Parkway, Sunnyvale CA 94085 USA T: +1 408 720 1906 W: https://ebrsystemsinc.com/