dilluns, 23 de novembre del 2015

IMBiotechnologies treats 1st patient in OCL 500 study

IMBiotechnologies IMBiotechnologies said last week it treated the 1st patient in a clinical trial of its biodegradable OCL500 embolization microspheres to treat uterine fibroids.

The OCL500 microspheres are designed to rapidly form site-specific, platelet-rich clots that cut off the blood supply to target tissues and completely biodegrade over time, Canada-based IMBiotechnologies said.

“We are pleased to announce the treatment of the 1st patient with OCL 500 in the uterine fibroid study. This is an important step toward expanding the labeling for our lead product. Our relationship with BTG, a world leader in innovative embolic products, is pivotal to the successful development and commercialization of OCL 500,” CEO Mike Stewart said in a press release.

The study of the microspheres aims to evaluate the short-term safety and efficacy of the OCL 500 in 10 women with uterine fibroids scheduled for hysterectomies.

IMBiotechnologies is developing the OCL 500 under a licensing agreemenet with specialist healthcare company BTG  through a wholly owned subsidiary. BTG maintains exclusive worldwide rights to develop and market the OCL 600 and its supporting products clinical and regulatory development.

IMBiotechnologies said it has won FDA 510(k) regulatory clearance for the OCL 500 for treating unresectable/inoperable hypervascularized tumors.

The post IMBiotechnologies treats 1st patient in OCL 500 study appeared first on MassDevice.



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