EDMONTON, Alberta--(BUSINESS WIRE)--IMBiotechnologies Ltd. (“IMB” or the “Company”) today announced that it has received approval from Heath Canada to expand the indications of its lead product, EkobiTM Embolization Microspheres (“Ekobi”), to include treatment of uterine fibroids.
Uterine fibroids are a significant women’s health issue; by the age of 50, 70% of women will develop uterine fibroids; up to 50% of uterine fibroids are symptomatic requiring treatment. Symptoms include abnormal uterine bleeding, pelvic pressure and pain, infertility, recurrent pregnancy loss, and a significant reduction in a woman’s quality of life. Ekobi is a patented “first-in-class” embolic therapeutic medical device that provides women with an alternative to traditional surgical treatments, such as hysterectomy (removal of the uterus) or myomectomy (removal of part of the uterus).
“Uterine fibroids can have a major impact on a woman’s physical and social activities,” said Michael Stewart, CEO of IMB. “We are pleased to offer physicians a biodegradable and non-surgical treatment option for symptomatic uterine fibroids.”
Clinical studies have established safety and efficacy of Ekobi™ microspheres and with this approval, Ekobi™ microspheres are now indicated for the treatment of hypervascularized tumors, uterine fibroids, and enlarged prostates caused by benign prostatic hyperplasia (“BPH”). Using a minimally invasive technique called embolotherapy, Ekobi™ microspheres selectively block the blood vessels that feed a target tissue, starving it of oxygen and nutrients. An important advantage of Ekobi is that after providing a therapeutic benefit, Ekobi™ microspheres biodegrade and are completely eliminated from the body. In addition, Ekobi can be easily seen in the body using minimally invasive ultrasound. Ekobi is the first, and only, biodegradable embolic agent detectable by ultrasound.
EkobiTM Embolization Microspheres has also received US FDA clearance for the treatment of unresectable/inoperable hypervascularized tumors.
About EkobiTM Embolization Microspheres
Ekobi is a first-in-class biodegradable embolic agent that is detectable by ultrasound. It is a class II medical device cleared in the USA for the treatment of unresectable/inoperable hypervascularized tumors. In Canada, it is a class IV medical device approved for the treatment of hypervascularized tumors, uterine fibroids and enlarged prostates due to BPH.
Embolotherapy works by reducing or eliminating the blood supply to target tissues. The procedure is performed by injecting embolic agents through a catheter into the blood vessels that feed a target tissue. By selectively blocking the tissue’s blood supply, the target tissue is either destroyed or devitalized, resulting in therapeutic benefit.
About IMBiotechnologies Ltd.
IMBiotechnologies Ltd. is a privately held Canadian medical device company located in Edmonton, Alberta, focused on the commercialization of medical products in the area of embolotherapy.
This press release may contain forward-looking statements and predictions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The Company considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions that these assumptions regarding the future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events and except as required by law.