Hancock Jaffe Laboratories, Inc., founded in 1999, is headquartered in Irvine, California.

Our History

The founders and senior management have pioneered and developed groundbreaking bioprosthetic devices for cardiothoracic and vascular surgery.  Several of these devices have subsequently been acquired by world-leading medical device companies and continue to provide clinical outcomes consistent with established standards of care.

Since 2007 the Company has been developing a number of innovative bioprosthetic medical devices intended to provide both state-of-the-art and new groundbreaking treatments for the most commonly performed cardiothoracic procedures — heart valve replacement and coronary artery bypass grafting — and the universally acknowledged most debilitating vascular disease of the lower limb — deep vein insufficiency.

Our Co-Founder

Norman Jaffe, Ph.D.

Norman Jaffe, Ph.D. co-founded Hancock Jaffe Laboratories, Inc. He was a leading specialist in the design, development and manufacturing of bioprosthetic devices and spent his career in the development and manufacturing of biological heart valves, vascular bioprosthetic devices and orthopedic biologic devices to augment tendon and ligament surgical procedures. He was a pioneering contributor to the development of biological heart valves and considered one of the leading experts in the world in the treatment of biological tissues and tissue engineering. Dr. Jaffe passed away in June 2016.

Major accomplishments of Dr. Jaffe included:

…collaborating with Warren Hancock to provide the first commercial biologic heart valve replacement;

…developing and manufacturing the Intact® bioprosthetic heart valve incorporating processing and design innovations to greatly improve valve function and extend valve durability decades beyond previous generations;

…developing the XCellTM heart valve bioprosthesis combining technologies that greatly reduced the “bulk” of the valve support and established the utilization of gamma radiation to both improve hemodynamic performance and achieve sterilization in normal saline, allowing for a larger valve implant with the elimination of potentially toxic packaging solutions and associated rinsing procedures;

…developing and manufacturing the ProCol® Vascular Bioprosthesis for hemodialysis access;

…developing a completely innovative patented design and technology to manufacture bioprosthetic heart valves; preclinical testing demonstrates that – for the first time – bioprosthetic valve function and performance is mimetic of a native heart valve;

…developing a small diameter vascular graft derived from a uniquely suited tissue source that in first in human studies demonstrated effectiveness as a potential substitute for artery and vein harvest;

…developing a surgically implantable bioprosthetic venous valve for venous hypertension and deep venous insufficiency.

Senior Management

Robert Berman

Chief Executive Officer

Robert Berman has served as our Chief Executive Officer since April of 2018. Mr. Berman has over 25 years of experience in a broad variety of areas including healthcare, finance, acquisitions, marketing, compliance, turnarounds, and the development and licensing of emerging technologies. From September 2012 until July 2017, he served as the President, Chief Executive Officer, and a member of the Board of Directors of ITUS Corporation, a Nasdaq listed company that is developing a liquid biopsy technology for early cancer detection. Prior to ITUS, Mr. Berman was the CEO of VIZ Technologies, a start-up company which developed a beverage dispensing cap, and he was the founder of IP Dispute Resolution Corporation, a company focused on intellectual property licensing. From 2000 to March 2007 Mr. Berman was the Chief Operating Officer and General Counsel of Acacia Research Corporation, which became the preeminent, publicly traded company for licensing and enforcing patented technologies. He started his career at the law firm of Blank Rome. Mr. Berman has a B.S. in Entrepreneurial Management from the Wharton School of the University of Pennsylvania and holds a J.D. from the Northwestern University School of Law, where he is an adjunct faculty member.

Robert Rankin

Chief Financial Officer

Mr. Rankin has more than twenty years of relevant experience helping to shape the operations and financial health of companies across multiple industries. Prior to joining the Company, from November 2015 to December 2017, Mr. Rankin was the Chief Financial Officer of Horsburgh & Scott, a privately held company focused on the design, engineering, manufacturing and repair of heavy duty quality gears and gearboxes. From November 2009 to December 2014, Mr. Rankin was Chief Financial Officer, Chief Operating Officer and Secretary of Process Fab, Inc., a privately held engineering, design and manufacturing firm that provides flight hardware, ground support equipment and tooling to the spaceflight, aerospace and defense markets. Mr. Rankin also served as Vice President of Finance of TBGA LLC, the post-acquisition parent company of Process Fab, Inc., from December 2014 to August 2015. Mr. Rankin holds a Masters of Science degree in Industrial Administration from the Tepper School of Business at Carnegie Mellon University and a Bachelors of Science degree in Mechanical Engineering from Carnegie Mellon University.

Marc Glickman, M.D.

Senior Vice President and Chief Medical Officer

Marc H. Glickman, M.D. has served as our Senior Vice President and Chief Medical Officer since May 2016 and served as member of our board of directors from July 2016 to August 2017. In 1981, Dr. Glickman started a vascular practice in Norfolk, Virginia. He established the first Vein Center in Virginia and also created a dialysis access center. He was employed by Sentara Health Care as director of Vascular Services until he retired in 2014. Dr. Glickman is a board certified vascular surgeon. Dr. Glickman received his Doctor of Medicine from Case Western Reserve, in Cleveland, Ohio and completed his residency at the University of Washington, Seattle. He is board certified in Vascular Surgery and was the past president of the Vascular Society of the Americas. He has served on the advisory boards of Possis Medical, Cohesion Technologies, Thoratec, GraftCath, Inc., TVA medical, Austin, Texas.

Susan Montoya

Senior Vice President of Operations, Regulatory Affairs and Quality Assurance

Susan Montoya has served as our Vice President Operations, Quality Assurance/Regulatory Affairs since 1999. In this role, she is responsible for manufacturing operations, quality procedures and regulatory affairs. Ms. Montoya has overseen clinical trials and regulatory submissions. Ms. Montoya has over 30 years of leadership experience in medical device industry, and has been with our company since our inception. Ms. Montoya was employed by Xenotech Laboratories from 1980 to 1986, where she developed one of the first Quality System and Good Manufacturing Practices for Cardiovascular and Orthopedic bioprosthetic devices and at a precursor company of our company beginning in 1988. She has also held various management positions at several medical device companies, including Medtronic Inc., St. Jude Medical and Leman Cardiovascular S.A. Ms. Montoya holds both a Bachelor and a Masters degree in Biology from the California State University, Fullerton.

Board of Directors

Yury Zhivilo – Chairman of the Board of Directors

Yury Zhivilo has served as Chairman of our board of directors since September 2007. In 2004, he co-founded Leman Cardiovascular S.A., a private company that develops, manufactures and markets bioprosthetic products used in cardiovascular surgery, as well as nephrology indications. Since 2010, he has been serving as President of Leman Cardiovascular S.A, Chief Executive Officer and President of Dante-Lido Financial Limited, and as Managing Director of Biodyne, all of which are based in Morge, Switzerland. Biodyne’s principal line of business is to invest in medical device technology companies. Mr. Zhivilo is also currently serving as a director of Dante-Lido Financial Limited and Biodyne. From 2004 to present, Mr. Zhiyilo served as Chairman of the board of director of Leman Cardiovascular S.A. Prior to that, he served as Chairman and Chief Executive Officer of Base Metal Trading Limited from 1992 to 2004. Mr. Zhivilo received a Senior Specialist degree in economics in 1985 from Moscow State Institute of International Affairs. We believe Mr. Zhivilo is qualified to serve as a member of our board of directors because of his extensive experience in the medical device industry as both an operating executive and as a board member.

Robert Berman – Chief Executive Officer, Director

Robert Berman has served as our director and Chief Executive Officer since April of 2018. Mr. Berman has over 25 years of experience in a broad variety of areas including healthcare, finance, acquisitions, marketing, compliance, turnarounds, and the development and licensing of emerging technologies. From September 2012 until July 2017, he served as the President, Chief Executive Officer, and a member of the Board of Directors of ITUS Corporation, a Nasdaq listed company that is developing a liquid biopsy technology for early cancer detection. Prior to ITUS, Mr. Berman was the CEO of VIZ Technologies, a start-up company which developed a beverage dispensing cap, and he was the founder of IP Dispute Resolution Corporation, a company focused on intellectual property licensing. From 2000 to March 2007 Mr. Berman was the Chief Operating Officer and General Counsel of Acacia Research Corporation, which became the preeminent, publicly traded company for licensing and enforcing patented technologies. He started his career at the law firm of Blank Rome. Mr. Berman has a B.S. in Entrepreneurial Management from the Wharton School of the University of Pennsylvania and holds a J.D. from the Northwestern University School of Law, where he is an adjunct faculty member.

Dr. Francis Duhay – Director

Dr. Francis Duhay, a trained cardiac and thoracic surgeon, is the former Chief Medical Officer at Edwards Life Sciences, the world’s leader in heart valves, where he led medical and clinical affairs for transcatheter and surgical heart valves. While at Edwards, Dr. Duhay led the preparation and submission, and ultimate regulatory approval of two FDA Premarket Approval (PMA) applications for transcatheter and surgical heart valve therapies and was responsible for the design and execution of the applicable clinical trials. Dr. Duhay was also the Vice President and General Manager of the Ascendra™ transcatheter heart valve business unit at Edwards, where he grew the unit from sixteen to eighty employees and contributed to annual growth in sales from $3 million to $250 million. Dr. Duhay was also an industry representative and clinical expert, and member of the working group for ISO 5840, the international quality standard for the design, development, and testing of heart valves.

Marc W. Robins, CFA – Director

Marc W. Robins, CFA is an experienced fund manager, publisher and equity analyst. He is currently the fund manager at Crown Capital Management LP, a new micro-cap and small-cap fund he started in July 2018. Since 2003, Mr. Robins founded and has been a registered investment advisor at Catalyst Financial Resources LLC, a provider of institutional level research for micro-cap companies. Catalyst Financial is the follow-on to The Red Chip Review, which Mr. Robins launched in 1993. At its peak, Red Chip provided research coverage on over 500 companies and had a subscriber base of over 7,000 investors, 100 brokerage offices and 25 money managers. Red Chip was sold in 2002. In addition to Red Chip, Mr. Robins has been published in numerous national publications including The Wall Street Journal, Bloomberg, Investor’s Business Daily, Kiplinger’s, and Forbes, where he had his own column for 8 years.

Dr. Sanjay Shrivastava – Director

Dr. Sanjay Shrivastava has been involved in developing, commercializing, evaluating, and acquiring medical devices for more than 18 years, including serving in Chief Executive Officer and board of director positions at several medical device start-ups, and leadership positions in research and development, business development, and marketing at BTG, Medtronic, Abbott Vascular, and Edwards Life Sciences. While working as a vice president, upstream marketing and strategy at BTG, a medical device and specialty pharmaceutical company with annual revenue of about $800 million, Dr. Shrivastava worked on several acquisition and investment deals. At Medtronic, Dr. Shrivastava was the Director of Global Marketing for the Cardiac and Vascular Group where he helped build the embolization business, from its initiation to a substantial revenue with a very high CAGR over a period of six years. Dr. Shrivastava was a Manager of Research and Development for the peripheral vascular business at Abbott Vascular and a Principal Research and Development Engineer for Trans-Catheter heart valves at Edwards Life Sciences.

Medical Advisory Board Members

Steve Elias, M.D., FACS, FACPH

Steve Elias, M.D., FACS, FACPH, is Director at the Center for Vein Disease at Englewood Hospital and Medical Center. Dr. Elias has extensive expertise in vascular medicine, conducting important research and writing extensively about the treatment of vein disease, and serving as the principal investigator on several major clinical trials. His work has been recognized at national medical and scientific meetings and published in top peer reviewed journals, and he is frequently invited to lecture to both national and international audiences about minimally invasive vein care and surgical procedures. Dr. Elias has been named as one of the 25 most influential professionals in vein care worldwide by VEIN Magazine and has been recognized as Top Doctor in the New York Metropolitan Area for the past nine years by Castle Connolly. He is a member of several medical societies, including The Society for Clinical Vascular Surgery, American College of Surgeons, and the International Society of Cardiovascular Surgery.

Antonio Gasparis, M.D.

Antonios Gasparis, M.D., is Professor of Surgery, Director of the Center for Vein Care, Director of the Wound Center, Medical Director of the Non-Invasive Vascular Laboratory, and Director of Phlebology Fellowship at Stony Brook University Medical Center. His areas of clinical interest and expertise include minimally invasive endovascular surgery for the management of aortic aneurysms; surgery for stroke prevention, aortic aneurysms, lower extremity vascular reconstruction, and dialysis access; pelvic congestion syndrome and pelvic venous insufficiency; minimally invasive percutaneous closure for varicose veins; and treatment of spider veins. Dr. Gasparis is an internationally renowned expert on venous disease and is currently a director of the 2016 New York Venous Symposium, one of the premier international conferences on issues and treatment related to venous disease. Previously, he was Committee Chair of the 2014 American Venous Forum. Dr. Gasaparis is a Fellow of the American College of Surgeons and has authored more than 35 peer-reviewed publications. He was selected for inclusion in Guide to America’s Top Surgeons by the Consumers’ Research Council of America.

Wade Dimitri, M.D.

Wade Dimitri, M.D., is a highly regarded cardiac surgeon in Europe and pioneer in off-pump coronary artery bypass grafting, a Council Member of the Fellowship of Postgraduate Medicine and a member of the Royal Society of Medicine. He is a reviewer for The European Journal of Cardiovascular and Thoracic Surgery. Since retiring from active clinical work, he has increased his involvement with overseas training, teaching cardiac surgeons as well as operating. At Warwick Medical School he is a member of the Panel of Examiners. He is a member of several Cardiac Surgical Societies including The Society for Cardiothoracic Surgery in Great Britain and Ireland, The Society of Thoracic Surgeons (USA), Scottish Cardiac Society, The Egyptian Society Of Cardiovascular and Thoracic Surgery and an Honorary fellow of The Indian Society Of Cardiovascular and Thoracic Surgeon. Dr Dimitri performed several dozens of surgeries with the CoreoGraft CABG graft in Europe with excellent results. He will be instrumental in helping the company bring this product to the market in Europe.

Afksendyios Kalangos, M.D., Ph.D.,

Afksendyios Kalangos, M.D., Ph.D., is a world-renowned pediatric cardiac surgeon. Dr. Kalangos was the 2015 President of the World Society of Cardiothoracic Surgeons, and he has written 300 articles in journals with editorial policy and 10 book chapters, delivered 450 lectures as guest speaker, and presented 700 abstracts in national and international congresses. He was Chairman of the Department of Cardiovascular Surgery at University of Geneva from 2011-2016 and presently Chairman of Cardiovascular Surgery at the Mitera Hospital in Athens, Greece. He has many distinguish honors and has been involved in many of the Cardiovascular Societies in Europe and the Mideast. His interests included development of third general tissue heart valve and in Congenital Heart Surgery.