What is Heart Failure?

Heart Failure is a serious condition in which the heart is unable to pump enough blood to meet the body’s demands. Heart Failure affects nearly 6 million people in the United States and more than 25 million globally. Some heart failure occurs due to conditions that cause the heart chambers to pump in a desynchronized manner, reducing the amount of blood pumped with each heartbeat. Cardiac Resynchronization Therapy (CRT) may be beneficial in these patients to synchronize the contraction of the right and left sides of the heart.

Overcome
limitations.

EBR Systems understands one
solution can’t possibly
work for all patients.

Cardiac Resynchronization Therapy

Patients undergoing CRT receive an implantable pacemaker to synchronize the pumping of the heart chambers,  to improve the pumping action and in turn, reduce heart failure symptoms. CRT is an effective treatment for many patients, but limitations prevent some patients from benefiting.

You have
a choice.

The WiSE CRT System may
improve results and
reduce complications.

The WiSE choice

The WiSE CRT System was developed to address the persistent limitations of current CRT systems and to provide a more customized, patient-specific solution.

The WiSE CRT System uses a proprietary wireless technology to deliver pacing stimulation directly to the inside of the left ventricle of the heart. This approach is designed to overcome limitations of existing CRT systems that deliver pacing stimulation to the outside of the left ventricle. Pacing from the inside of the left ventricle is believed to be more physiologic.9, 10 The WiSE CRT System is designed for more flexibility in pacing site selection to customize therapy for the individual.

What makes the WiSE CRT System
so unique?

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WIRELESS

Does not require a wire (lead) to stimulate the left ventricle. Designed to eliminate lead complications such as placement difficulty, unintended nerve stimulation, dislodgement, extraction and repositioning.

ENDOCARDIAL

Delivers pacing stimulation directly to the inside of the left ventricle. Endocardial pacing is seen as more physiologic.9, 10, 11

CUSTOMIZED

Allows for tailored therapy to meet individual patient needs.  Endocardial pacing provides a broader selection of sites for stimulation, which may lead to better patient outcomes.12

Results are Clear

The SELECT-LV Study is a prospective, multi-center, non-randomized study of 35 patients who previously failed conventional CRT.* Patients were treated with the WiSE CRT System at 6 leading clinical centers in Europe and evaluated at 30-days and 6-months post-procedure.12

*Includes patients considered to be at high risk for CRT upgrades.

 

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97%

successful placements

(N=35)

97%

achieved

cardiac resynchronization at 1-month

(N=34)

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85%

experienced

persistent clinical benefits at 6-months

(N=33)

Our mission.

EBR Systems is driven to deliver superior treatment for millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective and reliable therapies using wireless cardiac stimulation.

Innovation starts at EBR Systems.

EBR Systems, Inc. was founded in 2003 to develop an implantable system for wireless tissue stimulation, with an initial focus on addressing well-recognized shortcomings in treating heart failure with Cardiac Resynchronization Therapy (CRT). Based on a unique concept, the proprietary WiSE Technology is designed to eliminate the need for a lead to the left ventricle in CRT and the associated complications of that lead.

In the future, the company will extend this platform technology into other applications in the $11B cardiac rhythm management (CRM) market.

Meet
the team.

EBR Systems is proud to have an
exceptional team with a track record of success in developing and delivering innovative products to physicians and their patients.

Allan Will, Chairman of the Board, President  & CEO – Allan is an operating executive with extensive experience founding, funding, operating, and selling medical device companies.  Prior to EBR, he led negotiation of Ardian’s acquisition by Medtronic for over $800M.  Will was also founding Managing Director, Split Rock Partners and a Partner at St. Paul Venture Capital.  Previously, he was Founder, Chairman & CEO of The Foundry, co-founding 11 companies there including Ardian, Evalve (acquired by Abbott Laboratories for $450M) & Concentric Medical (acquired by Stryker for $135M).  Previously, Will was CEO of AneuRx, acquired by Medtronic, growing to >$150MM the year of launch.  In 1996 Will co-founded Adjacent Surgical, sold to GSII.  Previously, he was President & CEO of Devices for Vascular Intervention, growing the business to 550 employees, $100MM revenue run rate, and acquisition by Eli Lilly.  Will is an inventor on more than 30 issued patents, and has his M.S. in Management from MIT and his B.S. in Zoology from University of Maryland.  Will has also served on MIT’s Entrepreneurship Center Shareholders Board, on the University of Maryland President’s Committee on Innovation and Entrepreneurship and is a University of Maryland “Distinguished Alumnus”.  Will was the recipient of the Astia/Deloitte Leadership in Mentoring Award for mentoring women executives.

Allan Will

Allan Will 
Executive Chairman of the Board

John McCutcheon, President & CEO – John has over 30 years of sales, marketing, and general management experience in medical devices. John started his career at American Hospital Supply (acquired by Baxter International) and has spent the past 20 years at start-ups, including DVI (acquired by Eli Lily), Perclose (acquired by Abbott Laboratories), Emphasys Medical (acquired by Pulmonx), Ventus Medical and Ceterix Orthopaedics (acquired by Smith & Nephew). He has served on numerous Boards including Emphasys Medical, Ventus Medical, Disc Dynamics, Zeltiq (ZLTQ), Advanced Stent Technologies (acquired by Boston Scientific) and LuMend (acquired by Johnson & Johnson). John holds B.A. degrees in Economics and Psychology from the University of California, Los Angeles and an M.B.A. from the UCLA Anderson Graduate School of Management.

John McCutcheon
President and CEO

Frank Hettmann, Chief Financial Officer – has more than 30 years of leadership experience in medical device and technology industries holding senior and executive positions in finance and operations. Prior to EBR, Frank was CFO for Avenu Medical (acquired by Medtronic). Prior to joining Avenu, Mr. Hettmann served as CFO/VP for privately-held technology companies such as Neology, Inc., Siimpel (acquired by Tessera) and Symwave (acquired by SMSC). Mr. Hettmann also held executive positions at publicly-traded multi-national companies such as Microsemi and Conexant. Mr. Hettmann was also a Co-founder/VP of u-Nav Microelectronics, a GPS chipset technology company (acquired by Atheros, then Qualcomm). Mr. Hettmann holds a BA degree in Business Economics from UC Santa Barbara and an MBA degree from Santa Clara University.

Frank Hettmann

Frank Hettmann
Chief Financial Officer

Spencer H. Kubo, M.D., Chief Medical Officer – Spencer joined EBR in January 2019 as Chief Medical Officer. He is also Chief Medical Officer for Heart Leaflet Technologies where he leads the clinical trials for a next generation Transcatheter Aortic Valve Replacement (TAVR). Dr. Kubo has extensive experience developing innovative cardiovascular devices including neuromodulation, mitral regurgitation and cardiac support.
 
Dr. Kubo has also served as Executive Director of Merck, leading the Academic and Professional Affairs department. Prior to that, Dr. Kubo was Professor of Medicine, Co-Director of Clinical Cardiology and Medical Director of the Heart Failure-Heart Transplantation Program at the University of Minnesota.
 
Dr. Kubo is widely regarded as a leading researcher in heart failure and has published more than 250 papers and abstracts.

Dr. Kubo graduated from Dartmouth College and received his MD from Cornell University Medical College. He is a Fellow of the American College of Cardiology and the American Heart Association.
 
Dr. Kubo maintains a part-time outpatient practice at United Heart and Vascular Clinic in St. Paul, Minnesota.

Spencer H. Kubo, M.D.
Chief Medical Officer

N. Parker Willis, Ph.D., Chief Technical Officer – Parker is an electrical engineer with extensive experience in signal processing applications and has worked in medical devices for over 20 years, all in technical leadership capacities for development of novel technologies for cardiac electrophysiology.  He previously held senior positions at Boston Scientific and Cardiac Pathways.  Willis is an inventor on more than 28 issued patents, and has his B.Sc. in Electrical Engineering from the University of California, San Diego and his M.Sc. and Ph.D. from the University of Illinois Urbana Champaign.

N. Parker Willis, Ph.D.
Chief Technical Officer

Madhuri Bhat, Chief Regulatory Officer – Madhuri has over 20 years of experience in public affairs, public policy, clinical, quality, and regulatory roles in medical devices. She led several successful pivotal clinical trials and multiple registries, and secured regulatory approvals and clearances in the US and internationally for Class II and III cardiovascular systems. Most recently, Madhuri served as Consulting Vice-President RA/Clinical for companies in the reproductive, GI, neurological, urological, and cardiovascular domains such as Kyma Medical (acquired by Zoll) as the Founder / Principal of her own consulting company. Prior to that, Madhuri was the VP of RA/QC at Barrx Medical (acquired by Covidien, then Medtronic), VP of RA/Clinical at Corventis (acquired by Medtronic), and held management positions at Guidant and Abbott Vascular. Madhuri is a book author on child advocacy, and serves as visiting faculty at San Jose State University. She has a B.S. in Biology from University of Mumbai, a diploma in Mass Communications from Sophia Polytech, and a Master’s in Public Policy from Duke University.

Madhuri Bhat
Chief Regulatory Officer

John Sam, Vice President of Engineering and Operations – John has over 15 years of medical device experience and has managed, supported and transferred many different technologies and products from concept to commercialization. He started his career at Abbot Vascular Devices where he contributed to the successful integration of Perclose’s product lines to a larger organization. He later applied these concepts to the expansion of manufacturing at FoxHollow Technologies, which was acquired by Ev3 and is still being manufactured by Medtronic. Subsequently, he led the operational launch of electrosurgery devices at Ardian and tissue-based mitral valve replacements at Twelve (both technologies were acquired and transferred to Medtronic). John holds a B.S. in Mechanical Engineering from California Polytechnic San Luis Obispo and M.S. in Engineering Management from Santa Clara University.

John Sam

John Sam
Vice President of Engineering and Operations

Andrew Shute, Senior Vice President of Field Operations – Andrew has over 20 years of medical device experience and has led the successful commercialization of new technologies and products working in the corporate, start-up and distributor settings.   He brings strong business, clinical training and sales management background to the team, including positions at St. Jude Medical, Endocardial Solutions and Getz Brothers. Shute received his B.S. from the University of Wollongong, Australia. Shute currently holds the position of Chairman of the Cardiac Rhythm Management section of the Association of British Healthcare Industries Ltd (ABHI).

Andrew Shute

Andrew Shute
Senior Vice President of Field Operations

Steve Sandweg, Chief Commercial Officer – 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.

Steve Sandweg
Chief Commercial Officer

Michael Hendricksen, Chief Operating Officer – Michael has over 25 years of medical device product development and manufacturing experience. Prior to joining EBR Systems, Michael served as Chief Operating Officer at Ceterix Orthopaedics where he led the development of the NOVOSTITCH Pro Meniscal Repair System. Ceterix was acquired in 2019 by Smith+Nephew at which time Michael assumed the role of Site Leader, scaling and integrating operations not only for Ceterix but also for Tusker Medical, another Smith+Nephew acquisition. Before Ceterix, Michael was Vice President of R&D at Foundry NewcoXI and served in engineering roles of increasing responsibility at Emphasys Medical, Cardica, and IDEO Product Development. Michael is an inventor on over 80 issued patents, and he holds an MS in Mechanical Engineering from Stanford University and a BS in Mechanical Engineering from Northwestern University.

Michael Hendricksen
Chief Operating Officer

Ms. Drexler is a serial entrepreneur with expertise in the fields of digital health, medical devices, and diagnostics.

Ms. Drexler serves on the boards of two other public companies, Resmed, Inc., where she serves on the compensation and nominating and governance committees, and Outset Medical Inc., where she chairs the compensation committee and serves on the nominating and governance committee.

Ms. Drexler is also on the board of three private companies: Bone Health Technologies Inc., a medtech company focused on treating osteoporosis and its precursor, osteopenia, VIDA Diagnostics Inc., an artificial intelligence powered lung imaging solutions company, and Tivic Health Systems, Inc., a bioelectric medicine company focused on relief of congestion and sinus pain. Ms. Drexler also acts as a senior strategic advisor for other early-stage companies, and spent 11 years on the board of the Keller Center for Innovation in Engineering Education at Princeton University. Ms. Drexler is an active mentor and advisor with Astia, a global nonprofit that supports high-potential female founders. She is a founding member of Astia Angels, a network of individual investors who fund such founders, and a lead mentor with StartX, the Stanford University incubator. She is also on the Life Science and Women’s Health Councils for Springboard, an accelerator for women-led technology-oriented companies.

Ms. Drexler graduated magna cum laude with a B.S.E. in Chemical Engineering from Princeton University, and earned an MBA with honors from the Stanford University Graduate School of Business.

Karen Drexler

Non-executive Director

Dr. Evans AM is an experienced leader and CEO with a broad technical background across multiple industry sectors including medical technology, manufacturing, power generation and distribution, and technical regulation and standards.

Dr. Evans is currently the CEO of Engineers Australia, the Chair of Building 4.0 CRC, and the Director at GME Pty Ltd. Prior to her role with Engineers Australia, Dr. Evans was the CEO of Standards Australia. Dr. Evans has previously held positions in innovation initiatives, including as Chair of MTPConnect (the Industry Growth Center for Medical Technologies and Pharmaceuticals) and was a member of the Industry 4.0 Advanced Manufacturing Forum Leadership group. She has also held various senior engineering roles, including at Cochlear and GE Healthcare.

Dr. Evans has been recognized as one of Australia’s 100 most influential engineers and recognized as a 100 Women of Influence.

Dr. Evans holds a BE (Honors I) and a Ph.D. in Electrical Engineering from the University of Wollongong . She also has an Honorary Doctorate from Swinburne University and is an Honorary Fellow of the University of Wollongong and Engineers Australia and a Fellow of the Australian Academy of Technological Sciences and Engineering.

Bronwyn Evans, Ph.D. AM

Non-executive Director

Mr. McCutcheon has served as President and CEO of EBR since June 2019 and is responsible for the overall management and strategic direction of EBR.

Mr. McCutcheon has over 35 years of experience in sales, marketing, and management of medical device companies. Prior to joining EBR, Mr. McCutcheon was the President and CEO of Ceterix Orthopaedics, Inc. for nine years from 2010 to 2019. He also held CEO roles at Ventus Medical, Inc. (2009-2010) and Emphasys Medical, Inc. (2000-2009).

Mr. McCutcheon holds a B.A. in Economics and Psychology from the University of California, Los Angeles and an MBA from the UCLA Anderson Graduate School of Management.

John McCutcheon

President, Chief Executive Officer, and Executive Director

Mr. Moody has served as a Director of EBR since 2017.

Mr. Moody currently serves as Medical Device Partner at M.H. Carnegie & Co. (since October 2013), where he makes investments in medical device companies. He has also served since January 2010 as President of TM Strategic Advisors LLC, a management consultancy. Mr. Moody was previously a General Partner at Frazier Healthcare Ventures, a large U.S. based private equity and venture capital firm.

Mr. Moody is currently a Director of electroCore, Inc., Australian Medtech Services Pty Ltd., Cardiac Dimensions Pty Ltd., Renew Medical Pty Ltd., Serene Medical Pty Limited, The Brain Protection Company Pty Ltd., and CurvaFix, Inc. Mr. Moody also serves on the board of Angel Flight West, a not-for-profit that provides free air transport for patients requiring long distance travel for medical treatment. Mr. Moody was a Director of Simplify Medical Pty Ltd. at the time of its sale to NuVasive, Inc..

Mr. Moody holds a B.Eng. from the University of Southern Queensland, and a M.S. in Management from the Massachusetts Institute of Technology (Sloan School).

Trevor Moody
Non-executive Director

Dr. Nave has served as a Director of EBR since 2017.

Dr. Nave is a Founder and Managing Director of Brandon Capital Partners and the CEO of the Medical Research Commercialisation Fund. Dr. Nave previously served as the Director of Commercialisation at the Baker Heart Research Institute.

Dr. Nave is currently a Director of The Australian Investment Council, Azura Ophthalmics, Inc., Certa Therapeutics Pty Ltd., Global Kinetics Corporation Ltd., OccuRx Pty Ltd., Osprey Medical Inc., PolyActiva Pty Ltd. and Que Oncology, Inc. Dr. Nave was Chairperson of Fibrotech Therapeutics Pty Ltd. at the time of its successful sale to Shire Plc and a Director of Spinifex Pharmaceuticals, Inc. at the time of its sale to Novartis International AG.

Dr. Nave holds a B.Sc. (Honours) and a Ph.D. in Endocrinology and Physiology from the University of Melbourne. Dr. Nave is also a member of the Australian Investment Council.

Christopher Nave, Ph.D
Non-executive Director

Dr. Steinhaus retired in 2019 as Vice President and General Manager of the Heart Failure Business for the Cardiac Rhythm and Heart Failure Division at Medtronic plc.

Dr. Steinhaus joined Medtronic in 2005, after 20 years of cardiology (electrophysiology) practice. Dr. Steinhaus’ responsibilities at Medtronic included bringing the physician voice to CRHF, identifying future opportunities in new product development, and serving as a liaison to government agencies, professional societies and medical groups.

Dr. Steinhaus has been closely associated with research and academia, performing extensive clinical studies in implantable cardiac devices and leads. He served as Chair of the Department of Cardiology, and Director of the Electrophysiology Department at the Mid America Heart Institute and St. Luke’s Hospital and Director of the Electrophysiology Fellowship Program at the University of Missouri at Kansas City School of Medicine, and has instructed students in medicine since 1982. Since leaving Medtronic, he has served as a consultant and board member to multiple established and early stage medical device companies. He is currently the Executive Chairman of the board of Enopace Biomedical Ltd., a company which produces therapeutic neuromodulation devices for the treatment of heart failure.

A 1973 magna cum laude graduate of Harvard College, Dr. Steinhaus received his medical doctorate from Harvard Medical School as part of the Harvard‑M.I.T. program in Health Sciences and Technology, with AOA honors.

David Steinhaus, MD

Non-executive Director

Mr. Will served as the CEO of the Company from 2011 until 2019, and has served in the role of Executive Chair since 2019.

Mr. Will is a seasoned executive with extensive experience founding, funding, operating, and selling medical device companies. In addition to his role with the company, Mr. Will currently serves as Chair of the boards of Fractyl Health, Inc. and SetPoint Medical Corporation, and a Director of Fogarty Innovation, a not-for-profit institute promoting innovation in medical technology founded by Dr. Thomas J. Fogarty.

Previously, as Chair of Ardian, Inc., Mr. Will led negotiations of the company’s acquisition by Medtronic Inc. for over $800 million. Mr. Will was also founding Managing Director of Split Rock Partners’ Silicon Valley office, focusing on therapeutic medical devices, having joined Split Rock Partners’ predecessor entity St. Paul Venture Capital (SPVC) in 2002. Mr. Will was Founder, Chair and CEO of The Foundry, co-founding 11 companies there, including Ardian, Evalve, Inc. (acquired by Abbott Laboratories for $450 million) and Concentric Medical Inc. (acquired by Stryker Corp. for $135 million).

Mr. Will is an inventor on more than 30 issued patents, is a University of Maryland Distinguished Alumnus and a recipient of the ASTIA/Deloitte Excellence in Mentoring Women Executives Award. He served on the MIT Entrepreneurship Center Shareholders’ Board and the University of Maryland President’s Committee on Innovation and Entrepreneurship.

Mr. Will earned a B.S. in Zoology from the University of Maryland and his M.S. in Management from the Massachusetts Institute of Technology.

Allan Will
Executive Chair

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