David P. Hochman
Chairman of the Board of Directors and Chief Executive Officer
Mr. Hochman has over 20 years of venture capital and investment banking experience. Since 2007, Mr. Hochman has been Managing Partner of Orchestra Medical Ventures, LLC, an investment firm that employs a strategy to create, build and invest in medical technology companies intended to generate substantial clinical value.
Mr. Hochman served as the President of Accelerated Technologies, Inc., a medical device accelerator company managed by Orchestra Medical Ventures. Funds managed by Orchestra Medical Ventures will be shareholders in the Company. Mr. Hochman was a co-founder of Caliber and has been on the Board of Caliber since 2009 and serves as its Chairman of the Board. He was a co-founder of BackBeat and has served as its President and a member of its Board since inception in 2010. He is also Chairman of the board for Motus GI and a director of FreeHold Surgical, Inc., both of which are Orchestra Medical Ventures portfolio companies. 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 and Director
Mr. Sherman has over 24 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.
Since 2009, Mr. Sherman has been Managing Partner of Orchestra Medical Ventures, LLC, an investment firm that employs a strategy to create, build and invest in medical technology companies intended to generate substantial clinical value. Mr. Sherman has also served as Chief Technical Officer of Accelerated Technologies, Inc. (ATI), a medical device accelerator company managed by Orchestra Medical Ventures. Until recently, Mr. Sherman served as Chief Executive Officer and a Director of Caliber Therapeutics, Inc., and Chief Executive Officer and a director of FreeHold Surgical, Inc. From 2009 until 2016, he served on the board of directors of Vivasure. 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. 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. 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. He currently serves as a director of Motus GI. Mr. Sherman has authored more than 70 U.S. patents with an additional 80+ published applications. He earned a BS degree in Bioengineering from the University of California, San Diego.
Dennis Donohoe, M.D.
Chief Medical Officer
Dr. Dennis Donohoe, M.D. currently serves as the Chief Medical Officer for the Vascular Interventions Business Unit. 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.
Yuval Mika, Ph. D.
General Manager and Chief Technology Officer, Cardiac Neuromodulation
Dr. Yuval Mika, Ph.D. 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 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.
Vice President, Strategy & Marketing
Ms. Wheeler is a proven healthcare strategic marketing executive with over 15 years of experience in marketing strategy and commercial program development.
Prior to joining Orchestra BioMed, Ms. Wheeler served since 2010 as President of D&E Strategy, LLC, a business strategy and marketing consulting firm that worked with established as well as start-up medical device and pharmaceutical companies. 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. Ms. Wheeler earned an M.B.A. from Columbia Business School and a B.S. in Chemistry from The College of New Jersey.
Vice President, Quality and Regulatory
Ms. Eileen Bailey will be the Vice President of Quality and Regulatory Affairs for OBIO. 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.
Semih Oktay, Ph.D.
Senior Regulatory Consultant
Dr. Semih Oktay, Ph.D. is the President and Founder of CardioMed Device Consultants. Prior to founding CardioMed, he was Vice President of Regulatory Affairs and Engineering at MicroMed Laboratories, Inc. (Petaluma, CA).
In this capacity, Dr. Oktay provided engineering and regulatory consulting services to the medical device and related industries, and managed MicroMed’s east-coast office. Prior to joining MicroMed, Dr. Oktay worked for six years as an expert mechanical engineer and scientific reviewer for the FDA in the Office of Device Evaluation, Interventional Cardiology Devices Branch, where he served as primary reviewer in the product areas of coronary stents, peripheral stents, and balloon angioplasty catheters. Dr. Oktay holds a considerable, in-depth understanding of the fields of material science, medical devices, medical device regulations, and regulatory submission requirements. He has extensive experience interpreting and evaluating engineering data, developing and presenting reports of scientific review, and devising and modifying guidelines and protocols for the testing of medical devices.
Dr. Oktay earned his masters’ and doctoral degrees in mechanical engineering from the University of Maryland and his bachelor’s degree in mechanical/manufacturing engineering from the Istanbul State Academy of Engineering and Architecture, Turkey.
Steven Evans, M.D.
Chief Medical Officer, Cardiac Neuromodulation
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. As the CEO of ImaCor, he secured financing and led the company through R&D, clinical trials, product manufacturing, and FDA clearance.
Vice President, Research & Development, Cardiac Neuromodulation
Mr. Belsky joins Orchestra BioMed having most recently served as Chief Technology Officer for NewPace Ltd., a cardiac rhythm management company based in Israel.
Over the course of his career, Mr. Belsky has established a strong track record as a serial entrepreneur helping to found, and serving as Chief Executive Officer for, a number of start-up medical innovation companies in Israel including: Novogate Medical Ltd., a company focused on development of novel means of enabling thoraco-apical access for beating heart procedures; Juvenis, a biomaterials company focused on aesthetic and reconstructive surgical procedures; SphinxTech Ltd., a research and development company focused on medical devices for the treatment of fecal incontinence; and E-Pill Pharma Ltd., a company developing an oral drug delivery platform to administer peptides and large molecules, small molecules, as well as low bioavailability drugs. Mr. Belsky has also served as Director, Business Development from for Wavion Ltd., and 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., Orchestra BioMed’s General Manager and CTO of 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.
Director, Clinical & Technical Operations, Cardiac Neuromodulation
Since 2013, Mr. Norbert Rosenthal has served as the Clinical Director and Technical Manager of BackBeat Medical, Inc., supporting BackBeat's clinical trials.
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 of physical engineering degree with specialization in biomedical engineering from the University of Applied Sciences, Aachen, Germany.
Jürgen Bernhard, Ph.D.
Director, Clinical Operations, Cardiac Neuromodulation
Dr. Jürgen Bernhard has over 23 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. Prior to joining BackBeat Medical, Inc. in 2014, Dr. Bernhard served as a 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.
Daniel Burkhoff, M.D., PhD.
Director, Scientific & Medical, Cardiac Neuromodulation
After earning a Bachelors of Sciences degree from Cornell University in Applied and Engineering Physics, Dr. Daniel Burkhoff, M.D., Ph.D. obtained Doctorate of Philosophy and medical degrees from The Johns Hopkins School of Medicine and completed a fellowship in Cardiology at The Johns Hopkins Hospital.
Dr. Burkhoff then moved to Columbia University in the City of New York where he ran the Cardiovascular Research Laboratory through 2003. Dr. Burkhoff was the Director of the Jack Skirball Center for Cardiovascular Research of the Cardiovascular Research Foundation through 2005. Later, as the Medical Director of several startup companies, including CircuLite, which was acquired by HeartWare (purchased in 2016 by Medtronic), he focused on the research and development of medical devices. 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. 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. He is also author of Harvi, an interactive simulation-based mobile application available for the iPad for teaching and researching the aspects of ventricular mechanics and hemodynamics.
Vice President, Research & Development, Cardiovascular Interventions
Mr. Hikmat Hojeibane is an accomplished R&D expert in the medtech industry with in depth knowledge and experience in product development, innovation and regulatory approvals.
He has held numerous leadership positions in both start-ups (Cryocath and more recently Stentys) as well as large companies (C.R. Bard and Johnson & Johnson) resulting in the commercialization of pioneering technologies in the cardiovascular and electrophysiology fields. Some of Mr. Hojeibane’s accomplishments include the development of the first endovascular cryoablation system (Cryocath) and novel cardiovascular implants (Cordis, Johnson & Johnson) for coronary and peripheral vascular diseases. More recently Mr. Hojeibane held the position of Chief Technology Officer of Stentys, a Paris-based company where he led the development and manufacturing of numerous self-expanding drug-eluting stents and delivery systems for coronary and peripheral markets across Europe and the Middle East, as well as receiving FDA IDE approval for Stentys self-expanding stent in the US. Mr. Hojeibane holds a B.A. as well as a M.S. degree in biomedical engineering from Rutgers University.
William Baumbach, Ph.D.
Vice President, Scientific Affairs, Cardiovascular Interventions
Dr. Baumbach, Ph.D. has over 30 years of experience in pharmaceutical, biotechnology, and medical device R&D. Before co-founding Caliber Therapeutics in 2008, 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, Cardiovascular Interventions
Mr. Dadino joins Orchestra BioMed with more than 30 years of pharmaceutical experience and having commercialized over 20 pharmaceutical and combination products.
Mr. Dadino most recently served as Vice President of Pharmaceutical Development and Manufacturing for Aclaris Therapeutics, Inc. (Nasdaq:ACRS), where he assisted in bringing the company’s first product to market. 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. During his career, Mr. Dadino spent 13 years with Johnson & Johnson (NYSE: JNJ), where he served as Vice President, Development and Technical Operations from 2011-2013, and as Vice President, Pharmaceutical Development, Technical Operations and CMC from 2001-2011, where he was responsible for development of pharmaceutical attributes for drug/device combination products including the CYPHER® Sirolimus-eluting stent. Prior to J&J, Mr. Dadino served as Senior Director, Technical Operations, for Rhone-Poulenc Rorer Pharmaceuticals. Mr. Dadino holds an 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.
Greg Kopia, Ph.D., CMPP
Director, Pre-Clinical Development, Cardiovascular Interventions
Dr. Kopia joins the Orchestra BioMed team with more than 20 years’ experience in the preclinical evaluation of local therapies for cardiovascular disease encompassing both drugs and devices.
Dr. Kopia most recently worked in medical communications at PharmaWrite, LLC and served as the Principal of Kopia Consulting LLC, where he provided preclinical development consulting services to companies developing cardiovascular drugs and devices. Since 2009, Dr. Kopia has provided consulting services to Caliber Therapeutics related to the development of Virtue® SEB. Prior to this, he was a Research Fellow for Cordis, a Johnson & Johnson company which was subsequently sold to Cardinal Health for $1.9 billion. As a Research Fellow at the Cordis Corporation, Dr. Kopia was involved in extensive work in the area of safety and efficacy of vascular devices used for post-angioplasty restenosis including stents, balloon delivery catheters, and drug-device combinations. He is one of the recognized inventors of CYPHER®, the first commercially successful drug-eluting stent, and was deeply involved with the early research and development of this milestone therapeutic device. As a result of this work, Dr. Kopia was co-recipient of the prestigious Johnson Medal for the discovery and development of the CYPHER® sirolimus-eluting coronary stent. Prior to Cordis, he served as Director of Pharmacology from 1989 to 1995 for Zynaxis Cell Science, Inc., a localized drug delivery development company, as well as Assistant Director, Pharmacology for GlaxoSmithKline from 1987 to 1989. He completed his postdoctoral fellowship in Pharmacology at the University of Michigan Medical School, received his Ph.D. in Pharmacology from the University of Medicine and Dentistry of New Jersey, and B.A. in Biology from Gettysburg College.