ABK Biomedical successfully secured Breakthrough Device Designation from the FDA on December 5, 2023, for its Eye90 microspheres device, which is indicated for the treatment of unresectable Hepatocellular Carcinoma (HCC). The FDA’s Breakthrough Device Program is designed to speed up the development, assessment, review for premarket approval, 510(k) clearance, and de novo marketing authorization of medical devices “that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” This program replaces the FDA’s Expedited Access Pathway and Priority Review for medical devices. Clearance of the Eye90 device was supported by ABK Biomedical’s recently initiated Route90 trial, an FDA Investigational Device Exemption-supported multicenter trial. The trial evaluated tumor response rates and the duration of response in patients living with unresectable HCC from treatment with Eye90 microspheres. The Route90 study follows a previous study performed on the Eye90 product conducted in New Zealand, which provided encouraging results. In its announcement, Mike Mangano, President, and CEO of ABK Biomedical said:
We are pleased with the FDA’s decision to grant Breakthrough Device Designation for Eye90 microspheres Y90 radioembolization device. This confirms our belief that Eye90 represents an important evolution of radioembolization technology with the potential to significantly improve patient outcomes. Our discussions with the FDA have been productive, and this designation will allow us to streamline interactions with FDA and bring this product to market in an efficient manner. We look forward to executing our Route90 trial and our continued collaboration with the FDA.
The Halifax-headquartered ABK Biomedical was founded in 2012 at Dalhousie University by Dr. Robert Abraham, Dr. Daniel Boys, and Sharon Kehoe. The company develops and commercializes therapies directed to treatment of benign and malignant hypervascular tumors using a platform built on “x-ray visible” glass microspheres. The company has previously received FDA 510(k) clearance for its EasiVue embolic microspheres medical device product. The EasiVue product is designed for the treatment of patients with arteriovenous malformations and hypervascular tumors. According to Dr. Aravind Arepally, Chief Medical Officer of ABK Biomedical, the approval of Eye90 provides the opportunity for ABK Biomedical to further advance the field of Y90 radioembolization. Receiving Breakthrough Device Designation is expected to allow ABK Biomedical to bring the Eye90 product to market in an efficient manner.
Tags
510(k), breakthrough device, FDA clearance, Medical Devices, medical devices regulatory approval
