E. James Hutchens, Chief Executive Officer
Jim Hutchens is a proven entrepreneur with over 30 years of experience in general and marketing management in the medical technology industry. Mr. Hutchens served as a Managing Partner in Origin Partners, a $55 million early stage, venture capital fund and was the founder and CEO of both Microsurge Inc., a venture-backed, minimally invasive surgery company, and Choice Therapeutics, an advanced wound-care company. Both companies we were acquired by larger healthcare enterprises. Mr. Hutchens also served in senior executive positions at Microvasive Endoscopy, a division of Boston Scientific, Smith & Nephew, and Millipore. He is a former member of the Board of Directors of the Brigham and Women’s and Faulkner hospitals and holds a B.S. in Business Administration from Boston University.
Michael G. Vergano, Director of Operations
Mike Vergano has been president of The Harvest Group Inc. since 1998, where he has provided consulting services for start-ups and major corporations in all phases of project management, including product development, packaging, quality systems, operations, manufacturing engineering, and system/process design and validation. During his more than 30 years in the medical device industry, Mr. Vergano also held management positions at Apple Medical, Inc., Ciba Corning Diagnostics, Microsurge, Inc. and Boston Scientific Corporation. He is the holder of 11 medical device patents. Mr. Vergano holds a Bachelor of Science in Mechanical Engineering from Tufts University.
Stephen Ruggles, Director of Quality Assurance
Stephen Ruggles has over 30 years of experience in domestic and international regulatory affairs, operations management, manufacturing quality assurance, R&D, and supply chain management for early stage companies and large multinationals. As Director of QA / RA for Cambridge Endoscopic Devices, Mr. Ruggles led the effort to earn and maintain ISO 13485 registration, CE Mark, and compliance with Japan’s jPAL. Mr. Ruggles also held various quality engineering, compliance and operations management positions at Becton Dickinson and C.R. Bard’s Angiography, Angioplasty, and Cardiovascular divisions. He holds a BBA from the University of Massachusetts at Amherst and a M.S. in Regulatory Affairs from The Massachusetts College of Pharmacy and Health Sciences.
John Vacha, Chief Financial Officer
John Vacha has 20 years’ experience in the healthcare industry, most recently serving as President, CEO and Board Member of Intact Medical Corporation for 7 years before it was acquired by Medtronic in 2017. Previously, John served as Vice President, CFO and Treasurer of the company. John also served as Senior Consultant at Deloitte & Touche, LLP, where his clients included closely held high-tech manufacturing start-up companies, as well as large retail and manufacturing corporations. John is a licensed CPA in Massachusetts, holds a MBA and an MS in Accounting from Northeastern University in Boston, Massachusetts. He also serves as a member of the Board of Directors at the South Boston Health Center and holds two patents in electrosurgical instrumentation.
Pam Papineau, Director of Regulatory Affairs
Pam Papineau has over 30 years’ experience in quality and regulatory affairs with Baxter, Boston Scientific and Cogentix (Vision-Sciences), and has served as a consultant on a wide variety of devices that includes endoscopy, imaging, GI/GU, orthopedic and cardiovascular. Pam has successfully prepared dozens of FDA pre-market submissions and European Union (EU) technical files to support CE marking of a broad spectrum of medical devices, and has overseen numerous clinical studies entailing protocol development, reporting and management of Clinical Research Organization (CRO) services. Pam is an ASQ Certified Quality Engineer (CQE), a Certified Quality Auditor (CQA), a Certified Biomedical Auditor (CBA), an ISO 13485:2016 Lead Auditor, and holds Regulatory Affairs Professional Society (RAPS) certifications for the US, EU, CAN. Pam will work with Hogan & Lovells, the Company’s legal Counsel, to prepare for a pre-submission meeting with the FDA and follow-on activities through the regulatory approval process.
Thom McMahon, Director of Sales
Thom Mahon has been involved in medical device sales and marketing for over 35 years. Mr. McMahon has been the owner and president of Urolaze, an independent urology-focused distribution company and held various sales and marketing positions with Karl Storz, the leading supplier of the endoscopes, over 25 years.
Ralph de Vere White, M.D., Medical Advisor
Dr. deVere White is the Senior Advisor Emeritus, and Emeritus Distinguished Professor of Urology at UC Davis. Prior to retiring, he served as the associate dean for cancer programs at UC Davis School of Medicine, director of the UC Davis Comprehensive Cancer Center, and was a Distinguished Professor of Urology. Dr. deVere White received his medical degree from Dublin University in Ireland, and completed an internship and residencies in surgery and urology at St. Vincent’s Hospital in Dublin and at Duke University Medical Center in Durham, NC. The author of more than 300 peer-reviewed scientific articles and book chapters, Dr. deVere White serves on the editorial boards of six international scientific journals. His research efforts are now focused on the molecular events that govern the response of prostate and bladder cancer to targeted therapies, the biomolecular mechanisms that make some prostate cancers more virulent than others, and new methods of diagnosing and treating prostate cancer.
Dr. deVere White is the past president-elect of the Society of Urologic Oncology, a member of the Clinical Society of Genitourinary Surgeons and an elected member of the prestigious American Association of Genitourinary Surgeons. He has been named multiple times as one of “The Best Doctors in America” and is one of four urologists serving as a volunteer consultant to the American Cancer Society’s on-line “Experts Answers” bulletin board for questions about prostate cancer. He was awarded the Ramon Guiteras Award in 2017 by the American Urological Association for his career achievements.
Liam J. Hurley, M.D., FACS, Medical Advisor
Dr. Hurley obtained his Bachelor of Arts degree from Harvard University and his M.D. from Boston University School of Medicine. After spending three years in the U.S. Navy, he completed a General Surgery Residency at St. Elizabeth’s Medical Center of Boston and his Urology Residency at the Lahey Clinic in Burlington, MA. He is trained as an adult and pediatric urologist with expertise in genitourinary oncology. Dr. Hurley is a private practice community urologist who has clinical affiliations with Tufts New England Medical Center and Lahey Clinic. Other accomplishments include launching The Boston Urologic Society, serving on the Executive Committee for the Massachusetts Association of Practicing Urologists, and presiding as the Eastern Massachusetts representative to the New England Section of the AUA.
Dr. Hurley is Board certified in Urology and is a Fellow of the American College of Surgeons.
Edward M. Messing, M.D., Medical Advisor
Dr. Edward Messing, Chief of Urology at the University of Rochester Medical Center, is a renowned expert in the diagnosis and treatment of cancers of the bladder, prostate, kidney, and other genitourinary organs. He has conducted extensive research in the basic biology of bladder and prostate cancers and has been the principal investigator on numerous clinical studies for the detection, prevention and treatment of genitourinary cancers. Dr. Messing received his M.D. degree from New York University, performed his surgical training at NYU-Bellevue Hospital, and his Urology Residency at Stanford University. He was Director of the Urologic Oncology Program at the University of Wisconsin and assumed his current position at the University of Rochester School of Medicine and Dentistry in September 1995. Dr. Messing received the Ramon Guiteras Award at the American Urological Society’s annual meeting in May, 2018 for his 35 years of accomplishment in improving care for individuals with bladder, kidney, prostate, and testicular cancer.
Dr. Messing has been involved in multiple clinical studies relevant to Imagin’s focus. Having both Dr. Messing and Dr. Stavros Demos, the inventor of the i/Blue, at the same institution, is a major advantage that will help drive Imagin’s development and clinical trial programs.
Roger Buckley, M.D. Member, Medical Advisor
Dr. Roger Buckley is the Division Head of Urology at North York General Hospital in Toronto where he has held various positions since 1985, and is considered one of the top urologists in Canada. He has been vice president and president of the Medical Staff Association at NYGH and a member of the Board of Governors. Dr. Buckley conceptualized and opened the Gale and Graham Wright Prostate Center at NYGH in 2007, the first prostate center in the province to offer timely diagnosis, information, expertise and resources for prostate cancer in a community hospital setting. He also developed and has chaired the International Bladder Cancer Group (IBCG) from 2006-2016, a consortium of American, Canadian and European Union countries whose mission is to improve the diagnosis, prevention, and treatment of bladder cancer through the application of biologic markers. Dr. Buckley is currently vice president of the IBCG, and as a member, has co-authored numerous peer-reviewed articles on bladder cancer. He has an ongoing interest in bladder cancer and prostate research and education. Dr. Buckley received his M.D. from the University of Toronto where he also completed his urological Residency and Fellowship.