Y90 radioembolization, also known as Selective Internal Radiation Therapy (SIRT) and Trans-arterial Radiation Therapy (TARE) is a minimally invasive therapy for treating liver tumors. Current marketed Y90 radioembolization technologies are designed for injection through the hepatic arterial system into tumors, aimed at providing a lethal dose of radiation within tumors while sparing normal liver parenchyma.
ABK’s Eye90 microspheres™ technology is a breakthrough combination of Y90 microspheres for radioembolization made with a proprietary, radiopaque glass composition for procedure visualization via fluoroscopy, x-ray, CT and Cone Beam CT imaging modalities. An advanced technology with the promise to improve the placement precision of the Y90 microspheres, and the potential to provide in-procedure prognostic dosimetry for cutting-edge treatment of liver tumors
Bland embolization is a minimally invasive method for blocking blood vessels that flow to and feed a tumor. The particles injected into the blood vessels are called embolic microspheres. Current embolic microspheres are plastic or polymer. The common bland microspheres are not visible on X-ray, requiring the radiologist to inject contrast media (X-ray “dye”) with the microspheres to determine flow path.
ABK’s Easi-Vue™ technology is a tailored radiopaque permanent embolization microspheres. Easi-Vue embolization microspheres offer a range of microsphere size ranges that are inherently radiopaque for direct visualization of the embolic at the target site during embolotherapy.
President and CEO
Mike Mangano is an accomplished global executive leader with over 25 years’ experience in the medical device industry. Over this time, he served as a member of senior leadership and executive committees and has a long history of success in building dynamic teams, leading organizational change, creating and shaping strategies, and executing programs leading directly to increased shareholder value. These accomplishments include his recent role as CEO of ReShape Medical, and his success in growing Sirtex Medical, an Interventional Oncology medical device manufacturer, from $34 million in revenue to over $130 million, during his six-year term as President of the Americas.
Prior to his role at Sirtex Medical, Mike served 15 years at Boston Scientific, where he functioned in many key roles and most recently as Director of International Distribution Management. Mike brings pragmatic leadership to ABK with his vast experience in sales/marketing management, product development, strategic planning, international business, M&A, project management, and business model development. His experience and guidance will help take ABK Biomedical to the next level in delivering commercial excellence for our customers and the patients that will benefit from our innovative products.
Chief Business Officer
Gary Donofrio brings extensive marketing and commercialization experience to ABK, with over 25 years in the medical device field, including Sirtex Medical and Boston Scientific.
Gary spent over seven years at Sirtex Medical, a global therapeutic oncology/medical device company, most recently as Senior Vice President, overseeing Marketing and Health Economics functions, and General Manager of the Latin America business unit. He started his career at Sirtex as Director of US marketing, where he managed all the marketing functions, including strategic planning, market development, conference management, KOL development, product commercialization, new business development (merger/partner assessment), and the sales force. He moved to Vice President, Marketing and then to Vice President, Americas Marketing and General Manager, Latin America, before becoming Senior Vice President. Gary also spent 17 years with Boston Scientific, Endoscopy, leading sales, marketing and commercialization functions.
Gary has multiple achievement awards & accomplishments in sales, sales training, region sales management, global product management, global marketing management, e-marketing management, and market development management.
Chief Financial Officer
Mike Tyson has extensive history and financial capabilities, including over 35 years’ experience in public accounting and leadership positions with Allergan, Abbott Medical Optics (AMO) and six years with VC-backed AqueSys, Inc.
Mike began his career working at Price Waterhouse Cooper, where he achieved his CPA designation. Mike then joined Allergan, where he spent 12 years, initially in their Corporate Accounting & SEC reporting group. He then moved overseas as Director of Finance in Puerto Rico, and finally lead Allergan’s North American Accounting Operations. Mike joined ophthalmic medic device-maker AMO upon their spin-off from Allergan in 2002 and was appointed VP of Finance. There he set up the finance operation, headed finance for all their divisions, both domestic and international, and integrated key acquisitions. Mike was recruited by AqueSys, Inc. in 2010 to become VP of Finance & Operations. In October 2015 the company was acquired by Allergan in a highly successful, $300/$725 million exit. Most recently Mike has consulted with start-ups in the Orange County area, including ReShape Lifesciences and Fresca Medical.
Mike is responsible for ABK’s Finance, HR, and IT functions.
VP R&D and Nuclear Operations
Marc Gregoire is an accomplished professional mechanical engineer with extensive experience in in the nuclear medical products sector. Throughout his over 25 year career, he has held several leadership positions directing the development, engineering and realization of radioactive medical devices and radiopharmaceuticals and manufacturing facilities in a complex regulated environment.
Marc spent almost 20 years with Nordion Inc., working on radiopharmaceutical products and manufacturing facilities including Yttrium-90 and Indium-111 parenteral solutions, Y-90 implantable microspheres, Cobalt-60 external beam therapy machines and product delivery systems. During his tenure at Nordion, Marc also held prominent roles in package engineering, quality assurance, operations and strategic supply management.
After Nordion, Marc spent four years developing a successful professional consulting practice working with multinational corporations, governments and healthcare institutions as Director of Versant Solutions Inc. before joining ABK.
At ABK, Marc is responsible for R&D, product engineering, and manufacturing operations.
VP of Clinical Development and Regulatory Affairs
David Dobrowski is an accomplished Life Sciences Executive and Enterprise Leader with over 25 years of pharmaceutical and medical device development experience. He has shepherded numerous new products through development and commercialization and has successfully executed more than a dozen FDA new product approvals, with a 100% success approval rate for 510k, NDA, BLA, and PMA submissions.
David most recently worked at Merz where he started as Head of Regulatory Affairs and Product Safety in 2011. He was promoted to VP of R&D, responsible for Clinical Affairs & Operations, Scientific Affairs, Project Mgmt., NBD Integration, Product Safety, Medical Writing, and Regulatory. David was part of the Executive Leadership Team, managed a team of over 50 people, and was the recipient of CEO’s Business Excellence President’s Club award in 2015. Prior to joining Merz David shaped his career with roles of increasing responsibility at Salix Pharmaceuticals, UCB / Schwarz Biosciences, Wyeth, and Novartis.
David will be responsible for the development/management of ABK’s clinical programs and regulatory strategy/execution. He will also oversee the quality function.
Co-Founder and Chief Medical Officer
Dr. Bob Abraham has spent more than 20 years as a practicing clinician and interventional radiologist (IR) at the Nova Scotia Health Authority (NSHA). He earned his medical degree from Dalhousie University in Halifax, interned at St. Paul’s Hospital in Vancouver, returned to complete specialty training in Diagnostic Imaging at Dalhousie University and completed subspecialty training in Interventional Radiology at the Royal Melbourne Hospital in Australia. He returned to Dalhousie as Attending Staff and is now Full Clinical Professor at the Medical School.
Bob has a track record of licensed catheter innovations, granted patents and is actively engaged in funded research projects with funding to date totaling more than $4 million. He established the Uterine Fibroid Embolization (UFE) program at QEII Health Sciences Centre and IWK in 2001. Dr. Abraham’s primary clinical expertise and research interests are in bland embolization, Y-90 Radioembolization, Chemoembolization, Arterial and Venous Angioplasty / Intravascular Stenting and endovascular treatment of complex thoracic and abdominal aortic aneurysms (Fenestrated and Branched Stent Graft Deployment). He is a recognized leader in Canada and has served as Chair of the Royal College of Physicians and Surgeons of Canada Examination in Diagnostic Radiology and as President of the Canadian Association for Interventional Radiology (CIRACAIR). He is a Fellow of the Royal College of Physicians and Surgeons of Canada (FRCPC) and remains active on the CAIR Board.
Bob was honored as a Fellow of the Society of Interventional Radiology (FSIR) in 2016 for his outstanding contributions and achievements in Interventional Radiology.
Dr. Abraham is a co-founder of ABK Biomedical Inc. and served as CEO from 2013-2018 developing the operational infrastracture and building the team to support the current R&D and manufacturing facilities.
Vice President, Manufacturing and Facilities
Anthony Headley is an accomplished medical device executive with 25 years experience leading and building engineering, manufacturing, operations and R&D organizations for multi-national and start-up medical device companies including Symbiosis, Boston Scientific, Enpath Medical, Kimberly-Clark Healthcare, and Hollister Incorporated. He has held positions of increasing responsibility including Director, Sr. Director, Vice-President and General Manager during his career.
He began his medical device career with Symbiosis Corporation (now Boston Scientific) where he quickly advanced into leadership positions in engineering and operations. He later relocated to Boston to lead the R&D stent development organization for Boston Scientific – Endoscopy where his team developed and introduced a number of market leading stent technologies. He most recently led the engineering organization for Hollister Incorporated where he managed a global team located in the US, Europe and Asia. Anthony is a licensed professional engineer and has been issued 26 US patents for medical device technologies during his career.
Board of Directors
Dr. Berez is the founder and CEO of Alembic, LLC, a medical device development company in Mountain View developing new devices for Interventional Neuroradiology. Cathera, Inc, an Alembic company, developed a suite of microcatheters optimized for intracranial navigation. Cathera was acquired by Medtronic in 2018. Palmera, Inc, an Alembic company, is developing new technologies for the minimally invasive treatment of stroke that have the potential to improve outcome for patients that are currently treated, as well as widen the scope of patients that can benefit from therapy.
At his previous company, Chestnut Medical, he led the development of the Pipeline Embolization Device for the treatment of complex intracranial aneurysms. In 2012, Pipeline was recognized as a top ten medical device innovation by the Cleveland Clinic. Today, it is being used to treat aneurysm patients all over the world and represents a $150MM annual franchise for Medtronic. Chestnut Medical was acquired by ev3 in 2009. Prior to that Dr. Berez worked at Smart Therapeutics where he helped develop the Neuroform and Wingspan intracranial stents, and Endovasix.
Dr. Berez is currently an investor, advisor, and director to privately held medical device companies focused on capital-efficient medical device development. He is a graduate of the Georgetown University School of Medicine, where he received his MD degree. His postgraduate training was at UCSF/Mt. Zion in Internal Medicine, and Stanford University in Radiology and Neuroradiology
James McLaren is a Managing Director of TM Capital Corp. and brings his extensive background in corporate finance and the healthcare industry to ABK Biomedical’s Board. James joined TM Capital from Asante Partners, which he founded more than twenty years ago to provide quality strategic advice to middle-market healthcare companies. Previously, James had a twenty-year career advising corporate clients at Goldman, Sachs & Co. where he served as head of European Corporate Finance in London and of International Corporate Finance in New York, leading teams that executed significant global transactions.
James is a an advisory board member of Radius Ventures, a New York-based firm focused on the healthcare industry and was a director of Montreal-based RTP Pharma until its sale to Skye Pharma. James earned a BA with Honors in Economics from Oxford University.
President and Chief Executive Officer
Mike Mangano is an accomplished global executive leader with over 23 years’ experience in the medical device industry. Over this time, he served as a member of senior leadership and executive committees and has a long history of success in building dynamic teams, leading organizational change, creating and shaping strategies, and executing programs leading directly to increased shareholder value. These accomplishments include his recent role as CEO of ReShape Medical, and his success in growing Sirtex Medical, an Interventional Oncology medical device manufacturer, from $34 million in revenue to over $130 million, during his six-year term as President of the Americas.
Prior to his role at Sirtex Medical, Mike served 15 years at Boston Scientific, where he functioned in many key roles and most recently as Director of International Distribution Management. Mike brings pragmatic leadership to ABK with his vast experience in sales/marketing management, product development, strategic planning, international business, M&A, project management, and business model development. His experience and guidance will help take ABK Biomedical to the next level in delivering commercial excellence for our customers and the patients that will benefit from our innovative products
Ketan Patel is a Partner with F-Prime Capital and has worked in the healthcare sector as an investor, consultant, and physician. Prior to joining F-Prime Capital in 2007, Dr. Patel advised biopharmaceutical and medical device companies on brand strategy, clinical development plans, and business development activities in the corporate consulting division of Leerink Swann & Company.
Dr. Patel served as a physician at the VA Boston Healthcare System and at Weill Cornell Medical Center-New York Presbyterian Hospital and Memorial-Sloan Kettering Cancer Center where he completed his internal medicine training. Dr. Patel focuses on investing in therapeutics and medical device companies and has served as a director or board observer of Aclaris Therapeutics, Acorn Cardiovascular, Amphora Medical, Bioconnect Systems, Eywa Pharma, Ivenix, Laurus Labs, Medwell Ventures, Menlo Therapeutics, NextWave Pharmaceuticals, Vicept Therapeutics, and Xcyton Diagnostics.
Dr. Patel is a graduate of Tufts University School of Medicine, where he received both his MD and MBA as part of that institution’s Healthcare Management Program and was elected to the Alpha Omega Alpha Medical Honor Society. He completed his undergraduate studies in biology and economics with highest honors at Rutgers University.
PJ Bullock is a Managing Director for Varian Medical Systems where he has served within the Strategy & Corporate Development function for almost a decade. Varian, headquartered in Palo Alto, California, is focused on combining the ingenuity of people with the power of data and technology to achieve new victories against cancer. PJ’s influence on Varian’s continued growth is driven by his proven leadership in managing company-wide planning processes, executing complex strategic transactions, and facilitating investments in expansion initiatives.
During his time at Varian, PJ completed over two dozen transactions in 10 countries that directly contributed to Varian’s efforts in cancer therapy, clinical workflow solutions, data analytics, imaging, care delivery, and professional services. His broad background in various oncology related fields brings a level of specialized expertise in M&A, project management, market assessment, and deal structuring to the ABK Board. Mr. Bullock has also represented Varian as an observer to the Boards of Augmenix, Inc. (acquired by Boston Scientific in Sept. 2018) and Oncora Medical, Inc.
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ABK Biomedical Inc. provides and continues to provide accurate information on its website. However, ABK Biomedical Inc. assumes no responsibility for accuracy and/or completeness, express or implied, as to the information contained or omitted and/or the products described. Furthermore, ABK Biomedical may change the products mentioned at any time without notice. ABK Biomedical Inc. is a Pre-clinical stage company engaged in the active research and development of new medical devices. ABK Biomedical products are considered investigational only and are not FDA cleared for use..
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