EDMONTON, Alberta--(BUSINESS WIRE)--IMBiotechnologies Ltd. ("IMB"), a privately held medical device company focused on developing medical device products for use in the area of embolotherapy, today announced the treatment of the first patient with OCL 500 in a clinical study involving patients with uterine fibroids. Dr. Gary Siskin, an interventional radiologist and recognized thought leader in the area of embolotherapy, and Dr. Peter Cole, an obstetrician & gynecologist specializing in minimally invasive surgical techniques, are conducting the study at the Albany Medical Center in Albany, NY. The study will evaluate the short-term safety and efficacy of OCL 500 in 10 women with uterine fibroids who are scheduled for hysterectomy. Specifics of the study can be found on clinicaltrials.gov, NCT02410018.
OCL 500 is a patented, first in class embolization agent that represents a novel approach to embolotherapy compared to currently marketed embolic agents. OCL 500 microspheres rapidly form a tight, efficient, site-specific and platelet-rich clot that cuts off the blood supply to target tissues. Unlike embolic microspheres currently on the market that remain in the patient’s body for life, OCL 500 microspheres are designed to completely biodegrade over time.
IMB is developing OCL 500 under a licensing agreement with specialist healthcare company BTG plc through its wholly owned subsidiary, Biocompatibles UK Ltd. Under the agreement, first established in February of 2014, BTG has exclusive worldwide rights to develop and market IMB’s lead product, OCL 500, and is supporting the product’s clinical and regulatory development. Financial terms of the agreement were not disclosed.
Mike Stewart, CEO of IMB, stated, “We are pleased to announce the treatment of the first 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.”
IMB has received regulatory clearance from the United States Food and Drug Administration (FDA) for OCL 500 for the treatment of unresectable/inoperable hypervascularized tumors. OCL 500 is in development for the treatment of vascularized tumors, including uterine fibroids, and enlarged prostates (benign prostatic hypertrophy, BPH). IMB acknowledges the Alberta Innovates Technology Futures (AITF) Product Demonstration Program for its support of the OCL 500 project.
About Embolotherapy
Embolotherapy works by cutting off blood
flow to target tissue. 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 targeted
tissue is either destroyed or devitalized, resulting in therapeutic
benefit. Embolotherapy is one option for the more than 2 million women
in the U.S. who seek medical treatment for the debilitating effects of
uterine fibroids.
About IMB
IMB is a privately held Canadian medical device
company focused on developing medical device products for use in the
area of embolotherapy. Lead product, OCL 500 embolization microspheres
is the first biodegradable embolic agent cleared by the US FDA.
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.
www.imbiotechnologies.com