Abk Biomedical Inc. has completed an oversubscribed $30 million series C funding round to support IDE approval for Eye90 microspheres designed to improve outcomes for patients with liver cancer. The departure point for the technology’s development is U.S. FDA-cleared Y90 technology such as Boston Scientific’s Therasphere and Sir-Spheres developed by Sydney, Australia-based Sirtex Medical Ltd. “They are the only radioembolization microspheres on the market and that is the clinical space in which we will be submitting our IDE application,” Abk chief business officer Gary Donofrio told BioWorld. “Hopefully we’ll get approvals for the pivotal study and eventually to market in that space. It’s going to be great to be able to innovate and improve on what’s already been done there.”
Boston Scientific Corp.'s Therasphere Y-90 glass microspheres received a PMA for treatment of patients with unresectable hepatocellular carcinoma (HCC). The radioembolization technique has been used in more than 70,000 patients under a humanitarian device exemption over the last 20 years. The U.K.'s NICE also recently recommended Therasphere for treatment of patients with HCC.