ABK Biomedical

ABK Biomedical today announced its Eye90 microspheres device has received FDA breakthrough device designation.

The designation is indicated for the treatment of patients living with unresectable hepatocellular carcinoma (HCC).

“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,” CEO and President Mike Mangano said in a news release. “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.”

ABK Biomedical recently began enrollment in the Route90 pivotal, prospective multi-…

ABK Biomedical this week announced it received FDA investigational device exemption approval for its Eye90 microspheres yttrium 90 radioembolization therapy.

The FDA IDE approval allows the company to commence a multi-center pivotal clinical study in the U.S.

“FDA approval of this pivotal study is a significant milestone for ABK. The ABK team has worked tirelessly to develop this unique technology. We have created extensive manufacturing and supply-chain efficiencies, established robust quality assurance in all our processes, and collaboratively engaged regulatory bodies for proper guidance,” CEO Mike Mangano said in a news release. “We believe this will become a seminal study for treating patients with unresectable HCC. We designed our Y90 radioembolization technology to align with the most recent, advanced Y90 treatment methods, techniques, and appropriate patient populations. This has the promise to significantly improve outcomes for target…