IMBiotechnologies Ltd. Receives Health Canada Approval for a New Biodegradable Embolic Agent
IMBiotechnologies Ltd. (“IMB” or the “Company”) today announced that it has received Heath Canada approval for its lead product, Ekobi™ Embolization Microspheres (“Ekobi”), for the treatment of hypervascularized tumors (“HVT”) and benign prostatic hypertrophy/hyperplasia (“BPH”).
The Ekobi™ product is a patented “first-in-class” embolic therapeutic medical device that provides an alternative to surgery. Ekobi™ is the first and only biodegradable embolic agent detectable by ultrasound.
Ekobi™ microspheres selectively block the blood vessels that feed a target tissue, starving it of oxygen and nutrients. The advantage of Ekobi™ is that after providing a therapeutic benefit, Ekobi™ microspheres biodegrade and are completely eliminated from the body. Additionally, Ekobi™ can be easily seen in the body using minimally invasive ultrasound.
Ekobi™ has already received US FDA clearance for the treatment of unresectable/inoperable hypervascularized tumors. The Health Canada approval further expands IMB’s portfolio of approved indications for its lead product.
“We are pleased that Health Canada has issued a medical device license for our product. Ekobi™ provides physicians with a new option to treat patients with hypervascularized tumors, and men with enlarged prostates caused by benign prostatic hyperplasia,” stated Michael Stewart, CEO of IMB. “This approval underscores IMB’s commitment developing and manufacturing safe and effective products, while providing economic value to healthcare consumers and providers.”
The development and commercialization of Ekobi™ microspheres was made possible, in part, by IMB accessing the Alberta innovation network. A clinical study in patients with BPH was conducted at the University of Alberta and was supported, in part, by funding from Alberta Innovates. The clinical study which evaluated the safety and effectiveness of Ekobi™ was integral in achieving Health Canada approval.
“Innovations like this take considerable time and investment,” says Rollie Dykstra, Vice President, Investments at Alberta Innovates. “We know that with the right support at the right time companies like IMBiotechnologies Ltd. succeed. We congratulate them on achieving this tremendous milestone. It’s not only good for Albertans but also for people around the world.”
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 cleared as a class IV medical device for the treatment of hypervascularized tumors and benign prostatic hypertrophy/hyperplasia.
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 embolotherapy.
About Alberta Innovates
Alberta Innovates invests in research, innovation and entrepreneurship to drive provincial economic growth and diversity. We ignite the power of innovation through our work with researchers, industry and entrepreneurs to move Alberta to a lower-carbon future, enhance the responsible use of land and water, and contribute to the improved health and well-being of Albertans.
Alberta Innovates provides technical expertise, entrepreneurial advice and support, opportunities for partnerships, and funding to advance the best ideas. We support a broad range of research and innovation activity – from discovery to use. Collaboration is at the heart of what we do – bringing together bright minds and great ideas to drive innovation. Find out more at albertainnovates.ca
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 the target tissue. By selectively blocking the tissue’s blood supply, the target tissue is either destroyed or devitalized, resulting in therapeutic benefit.
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.
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