ABK Biomedical Announces Enrollment Initiation of First-in-Human Clinical Study with Eye90 microspheres™ for treatment of liver tumors
HALIFAX, Nova Scotia, Nov 1st, 2021 – ABK Biomedical, Inc., an innovative, clinical stage medical device company dedicated to the research, development and commercialization of advanced embolic therapies, announced the approval and initiation of a First-in-Human study with Eye90 microspheres™, a Y90 radioembolization device, in collaboration with Auckland Hospital Research Unit, New Zealand.
The prospective, single-center, open-label study will evaluate the safety and effectiveness of Eye90 microspheres™ in patients with unresectable hepatocellular carcinoma (HCC) or metastatic colorectal cancer (mCRC). Patients will receive a single Eye90 microspheres™ radioembolization treatment with follow-up visits for one year to assess safety, effectiveness, and quality of life measures.
Eye90 microspheres™ are radiopaque glass microspheres that are visible on x-ray and CT imaging and contain the Yttrium 90 (Y90) radiotherapeutic element. Y90 radioembolization, a local brachytherapy, is currently used to treat malignant liver tumors. HCC is the most common primary liver cancer with over 40,000 cases annually in the US1 with >70% of patients diagnosed with unresectable disease2. Colorectal cancer is the third most diagnosed cancer with metastatic disease (mCRC) present in up to 60% of patients at initial diagnosis3.
“The ABK team has worked tirelessly over the past three years to bring our technology to patients suffering from HCC and mCRC liver tumors,” said Mike Mangano, President and CEO of ABK Biomedical. We are pleased to partner with Dr. Andrew Holden and the team at Auckland Hospital to be the first to treat patients in New Zealand with Eye90 microspheres™. Our Eye90 microspheres™ device is designed with key advancements over the currently marketed Y90 radioembolization therapies with the goal of improving the physician experience and patient outcomes. Eye90 microspheres™ combine in-procedure, tumor-targeting visualization of radiopaque microspheres, and an advanced delivery system allowing physician control of administration, with the proven clinical benefits of Y90 radioembolization therapy.”
Andrew Holden, MD, MBChB, FRANZCR, EBIR, ONZM, study principal investigator, “We are enthusiastic to partner with ABK Biomedical to conduct this important First-in-Human clinical study. We are eager to evaluate the advancements of the Eye90 device and report on the initial safety and efficacy for the treatment of HCC and mCRC liver tumors.”
About ABK Biomedical, Inc.
ABK Biomedical is focused on researching, developing, and commercializing breakthrough medical device therapies to improve treatment outcomes and the lives of patients with benign and malignant hypervascular tumors. ABK Biomedical holds intellectual property in the areas of inorganic polymer microspheres, and unique administration systems. The company possesses advanced intellectual capital and its own R&D and manufacturing facilities for developing and commercializing unique embolotherapy products.
ABK Biomedical, Gary Donofrio, 617-513-9575, firstname.lastname@example.org
1: American Cancer Society. Cancer Facts and Figures, 2021. 2: Van Thai et al, BMC Gastroenterology, 2021. Efficacy and safety of selective internal radiation therapy with Y90 for the treatment of unresectable HCC. 3: Van Cutsem E, et al, Ann Oncology, 2014. ESMO working group metastatic colorectal cancer: ESMO Clinical Practice guidelines for diagnosis, treatment and follow-up.
Historical Press Releases
ABK Biomedical partners with the CNIC to enhance patient care
Toronto, Ontario, Mar 3, 2020
ABK Biomedical, which is developing a transformative Eye90 microspheres® technology, with the potential to provide in-procedure prognostic dosimetry for cutting-edge treatment of liver tumours – has partnered with the Canadian Nuclear Isotope Council.
The CNIC is an independent body made up of representatives from the Canadian health sector, nuclear industry and leading research groups to help deliver innovative cancer treatments to patients. ABK Biomedical is the latest company to get on board as a partner.
“Considering our role in the Canadian isotope sector, adding our voice for a Pan-Canadian strategy on isotopes strengthens the ability of our sector to improve patients’ treatment options and ultimately outcomes,” said Marc Gregoire, Vice President of Research and Development and Nuclear Operations at ABK Biomedical. “Y-90 radioembolization, also known as Selective Internal Radiation Therapy (SIRT) and Trans-arterial Radiation Therapy (TARE) is a minimally invasive therapy for treating non-resectable liver tumours. ABK’s Eye90 microspheres® proprietary technology incorporates the radiation therapy of Y-90 with a novel radiopaque glass composition for procedure visualization via fluoroscopy, X-ray, CT and Cone Beam CT imaging modalities.”
James Scongack, Chair of the CNIC, welcomed ABK Biomedical as the latest Council advocate for the production of medical isotopes and finding new ways to treat cancer.
“From coast to coast, people all across Canada depend on Canadian innovation and the medical isotope research, irradiation and production of the Canadian isotope sector,” Scongack said. “Our members on the West Coast like Triumf, to those in Ontario like Bruce Power and now ABK Biomedical on the east coast, all have an important role to play in ensuring that all Canadians have access to the best standard of care and that people around the world don’t have to face isotope shortages when they are needed the most.
“The CNIC was formed last year to ensure that there is awareness of the importance of isotopes for Canada, from both an economic and social perspective, and to advocate that we solidify this position by establishing a pan-Canadian strategy on isotopes. “
In September, the CNIC released a report highlighting the need for a Pan-Canadian strategy on isotopes led by the federal government to ensure a domestic and international supply of medical isotopes. The report makes it clear that Canada must invest in its isotope infrastructure as these investments would show a commitment to our role as a leader in nuclear medicine, and dramatically bolster the country’s capacity to innovate while delivering substantial economic and societal benefits to both Canadians and patients around the globe.
“Canada has a unique position that is recognized internationally; it is the world’s largest supplier of Cobalt-60 and Iodine-125, it hosts mostly all supply chain partners within its borders, it has a long tradition in supply chain collaboration, and it is renowned around the world for developing new applications,” said Scongack. “We need all of our partners across the industry to support Canadian isotope leadership, and I am delighted to have the support of ABK Biomedical.”
This year, the CNIC is focused on bridging these public and private coalitions into demonstrable results for Canadians, searching for new life-saving cancer treatments. The CNIC will continue to promote public awareness about the use and benefits of medical/industrial isotopes and radiation technologies, and work with government stakeholders to ensure that the public policy landscape promotes innovation and supports the increased proliferation of medical and industrial isotope uses.
ABK Biomedical Inc. Raises $30M USD in Series B Financing
Halifax, NS, April 8th 2019.
ABK Biomedical, Inc., a medical device company dedicated to the research, development and commercialization of innovative embolic therapies, announced a $30 million USD Series B financing. The round is co-led by F-Prime Capital and Varian Medical Systems.
ABK Biomedical will use the funding for continued focused product development of its Eye90 microspheres™, which are designed for transarterial radiation therapy for liver tumors, and its Easi-Vue™ microspheres for bland embolic treatment of hypervascular tumors. This Series B raise is intended to support the research and development, manufacturing, and clinical development program designed for regulatory submission of both Eye90™ and Easi-Vue™.
“Our thought-leading physician partners and advisors see tremendous opportunities to improve procedural and oncologic outcomes for patients suffering from non-resectable liver tumors,” said Mike Mangano, president and CEO of ABK Biomedical. “The ABK platform aims to deliver key technical benefits over existing yttrium-90 (Y-90) microspheres technologies for improved procedural and clinical outcomes. ABK combines the benefits of advanced imaging and dosimetry analysis with the empirically proven clinical benefits of Y-90 transarterial radiation therapy.”
Ketan Patel, MD, partner with F-Prime Capital, comments, “We are impressed with the ABK Biomedical team and believe the company has an outstanding product platform with the potential to make a significant impact on the lives of patients with malignant liver tumors.”
Gregory Sorensen*, vice president of strategy and business development with Varian, comments, “ABK has a unique approach to address a large unmet need for patients with non-resectable liver tumors. This technology is aligned with our goal of delivering innovative solutions in cancer care.”
*As of September 2020, Mr Sorensen is no longer with Varian and thus no longer their representative ABK Biomedical Board Member.
New Strategic Partnership with the University of Missouri Research Reactor Center (MURR®)
Halifax, NS. 13th February 2019
ABK Biomedical Inc. (ABK) is pleased to announce a new multi-year strategic partnership with the University of Missouri Research Reactor Center (MURR®). MURR is the pre-eminent global leader in research reactors, with extensive experience supplying medical isotopes and irradiation services for medical devices. MURR is a key partner for ABK to establish seamless manufacturing, supply, and distribution to critical cancer centers globally. MURR will be the primary irradiation partner for ABK’s radio-embolization products currently under development. MURR’s unparalleled reputation for quality control and reliable irradiation services will complement ABK in the research and development of Eye90 microspheres™ for the treatment of liver tumors.
ABK Biomedical Inc. Appoints Michael J. Mangano as President and CEO
Halifax, NS. July 31st 2018
ABK Biomedical announced today the appointment of Michael J. Mangano as president and chief executive officer. Mangano will be responsible for leading global business activities, including the rapid development, regulatory approval and commercialization of ABK’s unique medical device technologies.
Mangano most recently served as president and CEO of ReShape Medical, a U.S. venture-backed company focused on obesity where he increased organizational value and played a lead role in orchestrating the sale of the company to EnteroMedics in October 2017. Prior to ReShape, Mangano was president of the Americas for Sirtex Medical, a leading publicly traded Australian biomedical company, where he grew the business nearly five-fold from $30M to more than $140 million while building a team of 17 to more than 130 employees in a period of six years. His leadership resulted in a dramatic increase in the company’s valuation, leading to the recently announced acquisition in progress of Sirtex Medical by CDH Investments for $1.4B USD. Prior to Sirtex, Mangano spent 15 years with Boston Scientific in numerous senior management roles, including overseas assignments in Japan and Australia. Mangano was recently appointed to Board of Directors of Ellex Medical Lasers Limited (ASX:ELX), a global leader in medical devices for the diagnosis and treatment of eye diseases.
Mike is an accomplished leader with a history of global success in building dynamic teams, leading organizational change, creating and shaping strategies and executing programs – all directly increasing shareholder value. His vast experience in sales and marketing management, product development, strategic planning, international business, M&A, project management and business model development will be invaluable as he takes the reins at ABK and leads the company into the next phase of our evolution. ABK Biomedical Chairman of the Board Dr. Aaron Berez
I am excited to join the team at ABK, which has outstanding experience in the medical device industry. The talent at ABK, coupled with an innovative technology platform and pipeline, provide a strong foundation and solid prospects for our future growth and success. I especially look forward to working with the interventional radiology and oncology communities to develop and market novel technologies that will help patients and physicians, and want to thank the founders and the board of ABK for their support. ABK Biomedical President and CEO, Mike Mangano
Dr. Bob Abraham, co-founder and former CEO, is a practicing interventional radiologist and will remain with the company as Chief Medical Officer. He will continue to play a key role in product development and the clinical evolution of ABK’s key technology platforms.
Mangano will continue to serve on the ABK board of directors.
ACOA Anounces $3M in Support to ABK for Easi-Vue Embolization Microspheres
Halifax, NS. 22nd February 2018
ABK Biomedical received support from the Atlantic Canada Opportunities Agency (ACOA) to commercialize its Easi-Vue embolization microspheres in-house. The successful commercialization of this innovation will lead to new business opportunities and more well-paying jobs as the microspheres are set to compete in global markets. The funding was announced in February 2018 at ABK’s new facility in Bayers Lake by Darrell Samson, MP for Sackville-Preston-Chezzetcook, on behalf of the Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for the Atlantic Canada Opportunities Agency.
The contribution, being made through ACOA’s Atlantic Innovation Fund (AIF), is going towards the design and development of custom equipment as well as getting the regulatory approval needed for ABK Biomedical to scale-up its manufacturing process. It will support the manufacturing of devices in a clinical study, enabling regulatory approvals for sale of the device in the United States and globally. This AIF project will create six good quality jobs with the potential for more as demand for the product grows.
Innovation isn’t just about finding solutions that make our lives better; it’s about improving everyone’s quality of life. That is why the Government of Canada is committed to supporting projects such as this one, which will have an international impact while enhancing Atlantic Canada’s ability to compete in the global marketplace.
– The Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for ACOA
ABK Biomedical is one of the firms keeping Atlantic Canada’s life sciences community on the leading-edge. By keeping the manufacturing local, ABK will create new jobs and economic opportunities in the area, while setting itself up for international export. Today’s announcement will secure the commercialization of the microspheres to help cancer patients worldwide.
– Darrell Samson, Member of Parliament for Sackville-Preston-Chezzetcook
This investment enhances our competitive presence by allowing us to accelerate plans to manufacture and export medical devices internationally directly from Halifax. ABK is now positioned to develop and sustain high quality jobs in the medical device sector in Atlantic Canada and our company and products will soon help improve the lives of patients with hyper vascular tumours globally.
– Dr. Bob Abraham, CEO, ABK Biomedical Inc.
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ABK Biomedical is proud to partner with cutting-edge organizations and individuals with exceptional skills, scientific expertise, and the highest business ethics.
The ABK Biomedical Team
We are dedicated to encouraging a stimulating work environment offering an opportunity to significantly expand experience and skills by researching, developing, and commercializing cutting-edge medical device technologies with a mandate to effectively treat cancer.
ABK Biomedical is an equal opportunity employer offering competitive compensation packages.
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