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LightIntegra, the 2009 New Ventures BC first-prize winner, expects to complete Canadian clinical trials of its diagnostic test, Thrombolux, in the new year.
ThromboLUX is a simple diagnostic test for determining blood-platelet quality and function, making it easy to quickly screen blood platelets prior to giving blood transfusions to patients.
Traditional testing methods are unreliable, time-consuming, expensive and not routinely used. Poor-quality platelets result in ineffective blood transfusions, which affect outcomes for cancer and heart surgery patients, as well as others.
The clinical trial began in 2010 and, when completed, will have followed the outcomes of 200 patients who randomly did or did not receive ThromboLUX-tested blood platelets. A U.S. clinical trial began recently.
If successful, the results from these clinical studies, and recently completed laboratory work, will be submitted for FDA approval. Currently, ThromboLUX can only be sold as a lab instrument for research. FDA approval is required for sales to U.S. hospitals.
LightIntegra expects that patients who receive the tested platelets will have a shorter stay in hospital and fewer complications, resulting in cost savings for hospitals.
“Our value proposition says a hospital the size of Vancouver General could recover its cost for ThromboLUX in less than six months,” says Elisabeth Maurer, LightIntegra’s founder and the inventor of ThromboLUX.
She plans to present the final data from the clinical trials in late 2014 at the annual meetings of the American Association of Blood Banks and the American Society of Hematology.
LightIntegra has grown from a single employee in 2009 to 10 full-time employees involved in research and engineering.
The company has raised $5.5 million in three rounds of angel financing, and has also received funding from the Industrial Research Assistance Program and Canadian Blood Services.
Maurer says the company has a current market value of approximately $12.9 million.
LightIntegra’s ISO 13485 certification indicates that the company complies with international quality standards. ThromboLUX has also obtained CE marking that permits sales to research laboratories. Further CE marks will be required for hospital use in Europe.
If the clinical trials are successful, Maurer hopes to begin marketing to hospitals in Canada in 2015. She says there are already international companies waiting in the wings to form a strategic partnership to introduce the device in Canada and the U.S.
Marketing into Europe will require a different strategy, however, since hospitals there are not used to challenging blood-product suppliers and demanding better-quality blood platelets.
”So we’re developing a strategy to approach the children’s cancer hospitals, where they could use the instrument for research,” says Maurer. “If we can drive it from the pediatric use, and demonstrate the value for a patient group, then the other hospitals would take note.”