IMBiotechnologies has secured approval from Heath Canada for its Ekobi cmbolization microspheres to treat hypervascularized tumors (HVT) and benign prostatic hypertrophy/hyperplasia (BPH).
Image: its Ekobi cmbolization microspheres will be used to treat hypervascularized tumors and benign prostatic hypertrophy/hyperplasia. Photo:
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.
IMB CEO Michael Stewar said: “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.
“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.
Alberta Innovates investments vice president Rollie Dykstra said: “Innovations like this take considerable time and investment.
“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.
Source: Company Press Release