David P. Hochman
Chairman of the Board of Directors, Chief Executive Officer and Founder
Mr. Hochman has served as Chairman and Chief Executive Officer of Orchestra BioMed since May 2018. Since 2006, he has been Managing Partner of Orchestra Medical Ventures, LLC (“Orchestra Medical Ventures”), an investment firm that employs a strategy to create, build and invest in medical technology companies intended to generate substantial clinical value.
Mr. Hochman has also served President of Accelerated Technologies, Inc., a medical device accelerator company managed by Orchestra Medical Ventures. Funds managed by Orchestra Medical Ventures are shareholders in the Company. See “Principal Stockholders.” Mr. Hochman has over 21 years of healthcare entrepreneurial, venture capital and investment banking experience. He was a co-founder of Caliber and was on the Board of Caliber since 2009. He was a co-founder of BackBeat and served as its President and a member of its Board since inception in 2010. He was a co-founder of FreeHold and served as a member of its Board since 2011. He is also Chairman of the board for Motus GI. Mr. Hochman was a co-founder and currently serves as a board member of Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, life-threating inflammatory-fibrotic diseases with clear unmet medical needs. He also serves as a director of Adgero Biopharmaceuticals Holdings, Inc. Prior to joining Orchestra Medical Ventures, Mr. Hochman was Chief Executive Officer of Spencer Trask Edison Partners, LLC, an investment partnership focused on early stage healthcare companies. He was also Managing Director of Spencer Trask Ventures, Inc. during which time he led financing transactions for over twenty early-stage companies raising over $420 million. From 1999 to 2006, Mr. Hochman was a board advisor of Health Dialog Services Corporation, a leader in collaborative healthcare management that was acquired in 2008 by the British United Provident Association for $750 million. From 2005 to 2007, he was a co-founder and board member of PROLOR Biotech, Inc., a biopharmaceutical company developing longer lasting versions of approved therapeutic proteins, which was purchased by Opko Health (NYSE: OPK) in 2013 for over $600 million. He currently serves on the board of two non-profit organizations: The Citizens Committee for New York City and the Mollie Parnis Livingston Foundation (a family foundation for which he is also President). He has a B.A. degree with honors from the University of Michigan.
Darren R. Sherman
President, Chief Operating Officer, Director and Founder
Mr. Sherman has served as President, Chief Operating Officer and a member of the Board of Orchestra BioMed since May 2018. Since 2009, Mr. Sherman has been Managing Partner of Orchestra Medical Ventures, an investment firm that employs a strategy to create, build and invest in medical technology companies intended to generate substantial clinical value.
Since 2008, Mr. Sherman has also served as Chief Technical Officer of Accelerated Technologies, Inc. (ATI), a medical device accelerator company managed by Orchestra Medical Ventures. Funds managed by Orchestra Medical Ventures are shareholders in the Company. See “Principal Stockholders.” Mr. Sherman has over 25 years of management and entrepreneurial experience in the medical technology industry spanning interventional cardiology, cardiac electrophysiology, sudden cardiac death, stroke, surgery, GI, and neurovascular therapies. Mr. Sherman served as Chief Executive Officer and a Director of Caliber since 2009. He was a co-founder and served on the Board of BackBeat since 2010. He was a co-founder and served as Chief Executive Officer and a director of FreeHold since 2011. From 2009 until 2016, he served on the board of directors of Vivasure. He is a member of the board of directors of Motus GI. Prior to joining Orchestra Medical Ventures, from February 2002 until March 2008, Mr. Sherman held various positions in executive management for Cordis Neurovascular (CNV), a Johnson & Johnson company, including Executive Director R&D and Director of Strategic Marketing for stroke products. He had worldwide responsibility for all neurovascular R&D and global strategic marketing responsibilities for the stroke franchise, including budgets, portfolio of products and strategic planning. Mr. Sherman made significant contributions to the design and commercialization of a series of key products including the Enterprise Vascular Reconstruction Device and the Orbit Embolic Coil. From January 1997 until February 2002, Mr. Sherman played an integral role in the formation and development of Revivant Corp (acquired by Zoll) while working with Thomas J. Fogarty, M.D. at Fogarty Engineering. He was Revivant’s first employee and managed the design, development, and testing of the AutoPulse device from concept through market introduction. In addition to the R&D related activities, Mr. Sherman supported the clinical research, marketing, and intellectual property efforts. The AutoPulse is a lightweight, portable tool replacing the need for manual chest compressions during cardio-pulmonary resuscitation (CPR) for patients suffering from sudden cardiac arrest. From January 1995 until January 1997, Mr. Sherman held positions in research and development for Cardiac Pathways Corp., prior to its acquisition by Boston Scientific. Prior to Cardiac Pathways, he worked at Baxter Healthcare. In each of these companies, he participated in the creation, development and launch of products. Mr. Sherman has authored more than 75 U.S. patents with an additional 90+ published applications. He earned a BS degree in Bioengineering from the University of California, San Diego.
C. Evan Ballantyne
Chief Financial Officer and Secretary
Mr. Ballantyne became Chief Financial Officer of Orchestra BioMed in October 2018. He is an experienced financial and strategic leader in the biotech, medical device and information services industries with a proven track record of building and strengthening a company’s financial position during his career of more than 25 years.
Prior to joining Orchestra BioMed, he most recently served as the CFO at Accera, Inc., an Alzheimer’s disease focused company backed by Nestlé Health Sciences. Mr. Ballantyne previously served as Executive Vice President and CFO of Clinical Data, Inc. (NASDAQ: CLDA), a biopharmaceutical company that was acquired by Forest Labs for $1.6 billion. He was also CFO of Synthetic Biologics, Inc. (NYSE: SYN), a microbiome-focused company where he led the company’s re-structuring effort, and CFO at Agenus, Inc. (NASDAQ: AGEN), an immuno-oncology company where he helped complete several acquisitions and partnerships as well as monetize a GlaxoSmithKline royalty-stream for gross proceeds of $115 million. He also served as CFO of the private medical technology companies Avedro, Inc. and ZymeQuest, Inc. Before entering the healthcare industry, Mr. Ballantyne served as CFO of Knowledge Impact, Inc., a software company whose technology was ultimately acquired by Oracle, Inc., and as COO and CFO at the ACNielsen Corporation. He also held positions in finance at IMS Health (d.b.a. IQVIA NYSE: IQV) and Dun & Bradstreet Corp. Mr. Ballantyne holds a BA from the University of Western Ontario and a post-graduate degree in business administration from the University of Windsor.
Yuval Mika, Ph. D.
General Manager and Chief Technology Officer, Bioelectronic Therapies
Dr. Mika has served as General Manager and Chief Technology Officer of Orchestra BioMed’s Bioelectronic Therapies development group since May 2018. Since 2011, Dr. Mika served as the CEO of BackBeat Medical, Inc. He was one of the founders of BackBeat and the leader in the development of BackBeat Cardiac Neuromodulation Therapy from concept and design of the device through preclinical and clinical work demonstrating the effect of the therapy in lowering blood pressure.
Dr. Mika has over 25 years of experience in the medical device industry, bringing technologies from concept to commercialization. He managed the development of active implantable devices for the treatment of major diseases, including heart failure, obesity and diabetes. Dr. Mika started his career in 1992 as a leading researcher at Carmel Biotechnologies in Israel (later called Carmel Biosensors), developing an implantable biosensor for continued measurement of glucose. Medtronic Public Limited Company later acquired some of the company’s assets. In 1996, Dr. Mika became the Chief Scientist and one of the founders of Impulse Dynamics, a medical device company developing an implantable cardiac stimulator for the treatment of heart failure. In 1998, Dr. Mika became Impulse Dynamics’ Vice President of Research and Development, responsible for the development of the company’s implantable system and preclinical and clinical evaluation of the device. Dr. Mika was part of the team that secured an option agreement, receiving $250M in cash from Johnson & Johnson and Guidant Corporation for the option to acquire Impulse’s technology. In 2001, Dr. Mika was appointed the General Manager of Impulse Dynamics and managed the initial clinical studies of the company and the CE approval of its device and CCM therapy in Europe. In 2005, Dr. Mika was appointed as the Chief Operating Officer and acting Chief Executive Officer of Impulse Dynamics, leading the company’s large-scale randomized studies in Europe and its IDE study in the United States, obtaining high value DRG reimbursement to the system in Europe, reimbursement codes for the system in the US and initiating the commercialization of the system in Europe. In 2003, Dr. Mika led the development of a bioelectrical therapy for the treatment of obesity and diabetes based on the concept of impulse dynamics therapy. This led to the formation of MetaCure, a developer of implantable devices for the treatment of obesity and diabetes. Dr. Mika served as MetaCure’s Chief Operating Officer in 2005 and was the Chief Scientist of MetaCure until 2007. Dr. Mika received his BSc in Electrical Engineering and his PhD in Biophysics from the Technion – Israel Institute of Technology.
Inessa R. Wheeler
Vice President, Strategy & Marketing
Prior to joining Orchestra BioMed in September 2018, Ms. Wheeler served since 2010 as President of D&E Strategy, LLC, a business strategy and marketing consulting firm which provides services to established as well as start-up medical device and pharmaceutical companies.
Since 2013, she has provided strategy and marketing services to FreeHold Surgical, Caliber Therapeutics, BackBeat Medical, and Motus GI, making her ideally equipped to provide strategic and marketing leadership to Orchestra BioMed. Prior to D&E Strategy, Ms. Wheeler was Group Marketing Manager for LifeCell Corporation, a regenerative medicine company that was acquired in 2017 by Allergan plc for $2.9 billion. Prior to LifeCell, Ms. Wheeler was a Product Director for Cordis, (a Johnson & Johnson company, subsequently sold to Cardinal Health for $1.9 billion), where she worked on marketing strategy and commercial programs for cardiovascular, neurovascular and endovascular interventional products. She has an M.B.A. from Columbia University and a B.S. in Chemistry from the College of New Jersey.
Dennis Donohoe, M.D.
Chief Medical Officer
Dennis Donohoe, M.D. has served as Chief Medical Officer of Orchestra BioMed since October 2018. Previously, he served as Chief Medical Officer for Orchestra BioMed’s Focal Therapies development group and its predecessor, Caliber Therapeutics.
For the past eight years, Dr. Donohoe has served as clinical and regulatory consultant for a variety of device companies. Dr. Donohoe previously worked in various Johnson & Johnson capacities for a total of twenty years: as Director of Clinical Research at the Pharmaceutical Research Institute; Director of Medical Affairs for Ethicon Inc., working on the clinical testing of a variety of surgical devices used in laparoscopic surgery as well as other surgical devices such as sutures, meshes, bone anchors, and several drugs used to inhibit abdominal adhesions; and World-Wide Vice President of Clinical, Regulatory and Medical Affairs for Cordis Corporation, where he was responsible for the clinical development of cardiology, neurovascular and endovascular devices. He also served as a board member of the Cordis franchise. While at Johnson & Johnson, Dr. Donohoe received the Johnson Medal, the highest scientific recognition awarded by Johnson & Johnson in recognition for the clinical development of a topical growth factor for the treatment of chronic wounds. Dr. Donohoe also served as Director of Clinical Research in the gastrointestinal therapeutic group at Glaxo Pharmaceutical where he worked on clinical trials, including an antidepressant, a non-sedating antihistamine, a recombinant Hepatitis B vaccine, an oral hypoglycemic, and an antiemetic. Before joining industry, he practiced family medicine in the Philadelphia area. Dr. Donohoe holds a medical degree from the Penn State Hershey Medical Center.
Vice President, Research & Development, Bioelectronic Therapies
Prior to joining Orchestra BioMed in August 2018, Mr. Belsky was Chief Technology Officer for NewPace Ltd., a cardiac rhythm management company based in Israel that is developing an implantable subcutaneous string defibrillator device for patients with atrial fibrillation.
Prior to NewPace, Mr. Belsky was a serial entrepreneur helping to found, and serving as CEO for, a number of start-up medical innovation companies in Israel, including: Novogate Medical Ltd. (2010-2013), a company focused on development of a novel means of enabling thoraco-apical access for beating heart procedures; Juvenis (2009-2010), a biomaterials company focused on aesthetic and reconstructive surgical procedures; SphinxTech Ltd. (2008-2009), a research and development company focused on medical devices for the treatment of fecal incontinence; and E-Pill Pharma Ltd. (COO, 2003-2007; CEO, 2007-2008), a company developing an oral drug delivery platform to administer peptides and large molecules (such as insulin and growth hormones), small molecules, as well as low bioavailability drugs. Previously, Mr. Belsky was Director, Business Development from 2000 to 2003 for Wavion Ltd., an Israeli company that manufactures and develops carrier-grade WiFi solutions. From 1998 to 2000, Mr. Belsky was Product Manager for Impulse Dynamics Ltd., a medical device company developing an implantable cardiac stimulator for the treatment of heart failure that was co-founded by Yuval Mika, Ph.D., our General Manager and CTO, Cardiac Neuromodulation. Mr. Belsky received his MBA from Heriot-Watt University, his MSc in electrical engineering from Tel Aviv University, and his BSc in physics and mathematics from Hebrew University in Jerusalem.
Daniel Burkhoff, M.D., PhD.
Senior Director, Scientific & Medical Affairs, Bioelectronic Therapies
Dr. Burkhoff has served as Senior Director, Scientific & Medical Affairs, Bioelectronic Therapies for Orchestra BioMed since May 2018. Previously, he served Chairman of the Scientific Advisory Board as well as Scientific Director of BackBeat Medical under a consulting agreement since 2010.
Dr. Burkhoff is currently Director of Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation, serves as a consultant to several heart-failure device companies and is also Adjunct Associate Professor of Medicine at Columbia University Medical School. He is also the Founder of PVLoops, a cardiovascular educational software company. He is also creator of Harvi, an interactive simulation-based mobile application available for the iPad for teaching and researching the aspects of ventricular mechanics and hemodynamics. After earning a B.S. degree from Cornell University in Applied and Engineering Physics, Dr. Burkhoff obtained Ph.D. and medical degrees from The Johns Hopkins School of Medicine and completed a fellowship in Cardiology at The Johns Hopkins Hospital. In 1992, Dr. Burkhoff became an Associate Professor at the Columbia University School of Medicine and worked at Columbia University Medical Center where he ran the Cardiovascular Research Laboratory through 2003. Dr. Burkhoff then became the Director of the Jack Skirball Center for Cardiovascular Research of the Cardiovascular Research Foundation through 2005. In conjunction with and following this role, Dr. Burkhoff served as the Medical Director of several startup companies, including Impulse Dynamics, Inc. (2003-2014), a company focused on an implantable cardiac stimulator for the treatment of heart failure, Cheetah Medical, Inc. (2006-2012), an advanced hemodynamic monitoring technology company, as well as CircuLite (2009-2013), which he co-founded and which was acquired by HeartWare in 2013. He served as Vice President, Medical Science for Heartware until it was purchased in 2016 by Medtronic for $1.9 billion. Dr. Burkhoff’s expertise includes cardiovascular modeling and research in basic and clinical aspects of ventricular mechanics, cardiovascular monitoring, heart failure, device and pharmacologic treatments for heart failure, including left ventricular assist devices.
Vice President of Quality and Regulatory Affairs
Ms. Eileen Bailey has served as the Vice President of Quality and Regulatory Affairs for Orchestra BioMed since May 2018. Previously, she served in various quality, regulatory and clinical roles for Orchestra BioMed’s Focal Therapies development group and its predecessor, Caliber Therapeutics, beginning in March 2012.
Throughout her career, she has had the opportunity to be involved in all aspects of medical device and combination device product development through commercialization. Because of her diverse technical background and expertise in regulatory quality system documentation, industry standards and cGMP she was invited to serve on the management review board for medical products at W.L. Gore and Associates, Inc. As a project manager, she has guided cross-functional teams through new product/process development and commercialization of medical devices in the fields of general surgery, bariatrics, and coronary catheters. As a functional manager, she has provided training and leadership in the areas of quality engineering and analytical/lab services. Ms. Bailey holds a MS in Polymer Engineering from University of Massachusetts and a BS in Materials Engineering from Drexel University and is a certified auditor and quality engineer with strong statistical background.
Steven Evans, M.D.
Medical Director, Bioelectronic Therapies
Dr. Evans has served as Medical Director, Bioelectronic Therapies for Orchestra BioMed since May 2018. Previously, he served Chief Medical Officer of BackBeat Medical under a consulting agreement since 2011.
Dr. Steven Evans, M.D. obtained his medical degree from New York University School of Medicine and completed his fellowship in Cardiovascular Disease and Electrophysiology at Cedars-Sinai Hospital. He was Director of the Electrophysiology Service at Long Island Jewish Hospital from 1990-1999 and subsequently served as Chief of Electrophysiology at Beth Israel Medical Center in New York. At both institutions, he initiated and ran successful EP Fellowship programs, participated in clinical trials, and published extensively in the field of arrhythmia detection and prediction. He is a strategic advisor in the life sciences area with 25 years of experience working in the medical device sector for companies including Biosense, Johnson & Johnson, Medtronic, Guidant, Impulse Dynamics, St. Jude, and Atricure, and is a consultant for venture funds focused on new medical technologies. His expertise spans scientific assessment, clinical research, market analysis, and regulatory and reimbursement evaluation. He is the co-inventor and co-founder of ImaCor Medical Technologies. He served as CEO of ImaCor, he secured financing and led the company through R&D, clinical trials, product manufacturing, and FDA clearance. He has also served as CEO of two oncology therapeutic companies, Althera, Inc., and Oncolyze, Inc., for which he currently serves as acting CEO and Chairman.
Director, Clinical & Technical Operations, Bioelectronic Therapies
Mr. Norbert Rosenthal has served as the Clinical Director and Technical Manager of Orchestra BioMed’s Bioelectronic Therapies development group since May 2018. He served in the same capacity for BackBeat Medical, Inc. since 2013, supporting BackBeat's clinical trials in Europe.
Mr. Rosenthal started his career in 2005 while still a student in his last semester working on his bachelor’s thesis at MetaCure, a medical device company developing an implantable gastric stimulation device for the treatment of obesity and diabetes, and continued as Field Clinical Engineer following the completion of his studies. He was later promoted to Product Specialist and became the Clinical Project Manager for clinical trials in Europe. In late 2011, Mr. Rosenthal joined EndoStim as the Clinical Trial Manager of the company’s implantable medical device focused on treating Gastro-Esophageal Reflux Disease (GERD) through electrical stimulation of the lower esophageal sphincter. Mr. Rosenthal oversaw the company’s clinical trials program worldwide. The company received its CE mark in 2012 and started with commercialization activities in parallel to clinical and post marketing studies. Mr. Rosenthal holds an electrical engineering degree from The Bosmat Technical College in Israel and a bachelor’s degree of physical engineering with specialization in biomedical engineering from the University of Applied Sciences, Aachen, Germany.
Jürgen Bernhard, Ph.D.
Director, Clinical Operations, Bioelectronic Therapies
Dr. Jürgen Bernhard has served as Director, Clinical Operations of Orchestra BioMed’s Bioelectronic Therapies development group since May 2018. He served in the same capacity for BackBeat Medical, Inc. since 2014, supporting BackBeat's clinical trials in Europe.
Dr. Bernhard has over 24 years of medical device experience in the areas of clinical research, marketing and sales leadership. Dr. Bernhard started his career in clinical research with Biotronik. He spent 16 years at St. Jude Medical focusing on market development, marketing and sales as Vice President for Central Europe of St. Jude Medical, Inc. Dr. Bernhard earned his undergraduate degree in chemistry and Ph.D. in Applied Physics from the University of Regensburg.
William Baumbach, Ph.D.
Vice President, Scientific Affairs, Focal Therapies
Dr. Baumbach, Ph.D. has served as Vice President, Scientific Affairs for Orchestra BioMed’s Focal Therapies development group since May 2018. He over 30 years of experience in pharmaceutical, biotechnology, and medical device R&D.
He co-founded Caliber Therapeutics and served as its Chief Scientific Officer since 2008. Prior to Caliber, he was the Vice President of Research & Development at X-Cell Medical, a Drug-Eluting Stent startup that was based on a novel therapeutic agent, beta estradiol, that offered an enhanced safety profile. Dr. Baumbach oversaw development through a randomized first-in-human clinical trial. Prior to X-Cell, he was Director of Biology at Morphochem, a trans-Atlantic chemical genomics biotech company with pre-clinical product candidates in oncology, diabetes and anti-thrombosis from June 2000 until August 2002. From 1984 to 2000, Dr. Baumbach held a number of positions with the Molecular/Genetic Screen Design group at Wyeth Pharmaceuticals (AHP), including as Principal Research Scientist. Dr. Baumbach has over 13 years of experience in pharmaceutical research, mainly in the areas of peptide hormone receptors, GPCRs, and neurotransmitter transporters. Dr. Baumbach has published over 30 peer-reviewed articles, is an inventor on 8 issued patents, and served on the editorial board of Endocrinology, and as an adjunct professor at Rutgers. He received his Bachelor, Masters and Ph.D. degrees in Biochemistry and Molecular Biology from Princeton University.
Vice President, Pharmaceutical Development & Operations, Focal Therapies
Prior to joining Orchestra BioMed in August 2018, Mr. Dadino was Vice President, Pharmaceutical Development and Manufacturing for Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in dermatology, both aesthetic and medical, and immunology.
Prior to Aclaris, Mr. Dadino was President of Dadino Consulting, LLC, where he provided product development, technical operations, manufacturing and commercialization consulting services to pharmaceutical, biotechnology and medical device companies. Previously, Mr. Dadino spent 13 years with Johnson & Johnson, where he served as Vice President, Development and Technical Operations (2011-2013), providing pharmaceutical development services across all sectors of J&J, and as Vice President, Pharmaceutical Development, Technical Operations and CMC (2001-2011), where he was responsible for development of pharmaceutical attributes for drug/device combination products including the CYPHER® sirolimus-eluting stent. From 1997 to 2000, he was Senior Director, Technical Operations, for Rhone-Poulenc Rorer Pharmaceuticals. Mr. Dadino holds and M.S. in Pharmaceutical Quality Assurance and Regulatory Affairs from Temple University and a B.S. in Pharmacy from University of the Sciences in Philadelphia.