ABK Biomedical, Inc., a Halifax-based medical device company developing advanced imageable embolic technologies, has secured an oversubscribed $35 million Series D financing round to advance its flagship Eye90 microspheres toward commercialization. The funding was led by new investor J.P. Morgan Life Sciences Private Capital, with participation from existing investors F-Prime, Santé Ventures, Eight Roads Ventures, and an undisclosed medical device company.
The proceeds will support ongoing clinical operations for the company's Route90 FDA Investigational Device Exemption (IDE) pivotal trial, prepare for Eye90 microspheres commercialization, and drive further product innovation and development. Additional funds will expand the company's manufacturing and supply chain operations to support future commercial demand.
FDA Breakthrough Device Recognition
Eye90 microspheres has received FDA Breakthrough Device Designation, recognizing its potential to more effectively treat life-threatening or irreversibly debilitating diseases or conditions. The designation applies to the company's approach to treating patients with benign and malignant hypervascular tumors, particularly liver cancer.
"ABK's development of Eye90 microspheres has been recognized by the FDA as a Breakthrough Device Designation, having the potential to more effectively treat life-threatening or irreversibly debilitating diseases or conditions," said Joe Siletto, Managing Partner at J.P. Morgan Life Sciences Private Capital. "They are executing well in their Route90 FDA IDE pivotal trial, and we are excited to help support the next steps in their company's evolution."
Pivotal Trial Progress
The company is currently conducting the Route90 FDA IDE pivotal trial to evaluate the safety and efficacy of Eye90 microspheres. According to company leadership, the study is being conducted with exceptional rigor and is expected to generate one of the most robust data sets ever completed within the interventional oncology subspecialty.
"Our Route90 PIs, investigators, and research support staff are conducting the study with exceptional rigor, in what we feel will be one of the most robust data sets ever completed within the Interventional Oncology subspecialty," said Mike Mangano, President and CEO of ABK Biomedical. "We're looking forward to our Route90 study demonstrating the breakthrough promise of Eye90 microspheres, offering better care for patients with liver cancer."
Market Positioning in Y90 Radioembolization
Eye90 microspheres are designed to enhance precision and visibility in Yttrium-90 (Y90) radioembolization procedures, targeting a double-digit growth segment within the interventional oncology device market. The technology combines innovative design with improved procedural visibility and safety for treating hypervascular tumors.
"The advanced design of Eye90 microspheres, its novel delivery system, forward thinking supply chain, and robust data set are poised to do very well in the marketplace," said Ketan Patel, M.D., Managing Partner at F-Prime. "It is primed to take market share, and drive market development in this Y90 radioembolization double-digit growth segment within the Interventional Oncology device market."
Company Infrastructure and Capabilities
ABK Biomedical maintains its own research and development and manufacturing facilities, providing end-to-end control over the development and production of its embolotherapy products. The company holds intellectual property in inorganic polymer microspheres and unique administration systems, supporting its advanced embolic medical device platforms.
The Series D funding represents continued investor confidence in ABK Biomedical's progress since its Series B funding round in 2019. The addition of J.P. Morgan Life Sciences Private Capital to the company's board of directors brings strategic expertise and resources to support the transition from late-stage clinical development to commercialization.
Eye90 microspheres remains an investigational product and is not approved for use in any regulatory jurisdiction outside of approved clinical trials.
