FDA clears ABK Biomedical’s embolic microspheres for treating tumors

USA – Halifax medical device maker ABK Biomedical has received approval from the United States Food and Drug Administration for its Easi-Vue embolic microspheres, which are used to treat deformed blood vessels and cancer tumors with abnormally large numbers of blood vessels.

Easi-Vue is a radiopaque embolization device allowing direct visualization of the microspheres implant during the embolization procedure.

Founded in 2012 by Dalhousie University researchers Bob Abraham, Daniel Boyd, and Sharon Kehoe, ABK is developing a slate of products that involve injecting tiny, mildly radioactive glass beads into a patient’s bloodstream for the purpose of blocking a blood vessel in order to starve a tumor of oxygen.

Arteriovenous malformations (AVMs) occur when capillaries, veins, and arteries don’t develop properly and may lead to cutaneous discoloration, sensitivity, pain, and vascular bleeding.

Vascular embolization, performed by interventional radiologists, is an effective therapy for addressing the symptoms of patients suffering from this condition.

Hypervascular tumors occur in both benign and malignant states and are characterized by blood supply from an abnormally large number of blood vessels.

Vascular embolization is an effective therapy for addressing symptoms of these conditions. ABK said in a news release that microsphere embolization reduces or eliminates the blood flow to the tumors.

Chief medical officer Dr. Aravind Arepally said that Easi-Vue microspheres offer a highly calibrated technology.

They offer capabilities for visually targeted placement using conventional x-ray and fluoroscopy systems. He added that the technology, with a proprietary controlled-concentration delivery system, could potentially improve patient outcomes.

Eye90 microspheres

Furthermore, the Easi-Vue approval comes as ABK is simultaneously in the process of conducting human trials for the Eye90 microspheres for treating unresectable hepatic cellular carcinoma.

Eye90 microspheres can also be tracked in real-time via medical imaging technology like MRI machines in a process called radioembolization.

The global embolotherapy market size reached US$3.50 Billion in 2020 and is expected to register a revenue CAGR of 9.3 percent, during the forecast period ending in 2028, according to the latest analysis by Emergen Research.

Increasing prevalence of chronic diseases such as cancer, peripheral artery disease, and neurological disorders among others is a key factor driving global embolotherapy market revenue growth.

Steady transition toward minimally invasive procedures from invasive open surgical procedures is expected to continue to drive revenue growth in the global embolotherapy market.

The prominent players participating in this industry include Abbott Laboratories, Boston Scientific Corporation, Medtronic PLC, Terumo Medical Corporation, Penumbra Inc., Johnson & Johnson, Merit Medical Systems Inc., Cook Medical Inc., Kaneka Corporation, and Stryker Corporation.

ABK received US$3 million from the Atlantic Canada Opportunities Agency in 2018 to develop the spheres.

In 2019, the company raised a US$30 million venture capital round despite not yet having a product on the market.

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