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“This is the world’s first intravascular imaging system for clinical use with the capability to acquire both IVUS and OCT images using a single catheter. IVUS and OCT are the two most commonly used intravascular imaging technologies in addition to angiography,” says Dr. Brian Courtney, President and CEO of Conavi. “The Novasight Hybrid System provides the resolution and contrast of OCT with the larger field of view of IVUS, and displays the images in a precisely co-registered fashion.”

Dr. Courtney continues, “This regulatory clearance represents an important milestone for the company as we build a portfolio of image guidance products for cardiovascular procedures. We are delighted to now be able to offer physicians in the USA the opportunity to use the Novasight Hybrid System to obtain intravascular images of coronary arteries as part of their care for patients undergoing interventional procedures.”

Dr. Brian Courtney, Conavi’s President and Chief Executive Officer, states that “This agreement represents an important commercial milestone for Conavi. China has the second largest volume of cardiovascular interventional procedures in the world and is growing quickly as a result of extensive investments in healthcare infrastructure. We are delighted to have found a partner that shares our vision of bringing the potential benefits of advanced image guidance to a broad range of existing and emerging minimally invasive cardiovascular procedures to patients in China.”

Conavi’s Foresight ICE System has received 510(k) clearances from the United States Food & Drug Administration (FDA) and a Medical Device License from Health Canada and is currently being marketed in North America. The Novasight Hybrid System combines the two most frequently used intravascular imaging technologies, intravascular ultrasound (IVUS) and optical coherence tomography (OCT), into a single catheter and platform. The Novasight Hybrid System has been submitted to the US FDA for 510(k) clearance.

“This system is the world’s first intracardiac echo system with the capability to acquire 2D and 3D images with a broad field-of-view that includes both side-viewing and forward-looking capabilities. We have now expanded upon this foundation by adding image quality enhancements, features to minimize the effects of cardiac motion and the inclusion of additional imaging modes.” says Dr. Brian Courtney, CEO of Conavi.

The system’s indication for use has been expanded to include the ability to assess physiology with its new Doppler capabilities. Dr. Courtney continues, “The addition of Doppler imaging and flow quantification greatly expands the range of clinical scenarios in which Conavi’s Foresight ICE System can be used. As a result, we are the only provider of rotational ICE that provides Doppler capabilities, and thus benefit from being able to target regions of the cardiac anatomy anywhere around the 360-degree field-of-view of our catheter. The achievement of this 510(k) clearance demonstrates Conavi’s commitment to being a highly responsive source of imaging technologies to physicians performing electrophysiology procedures, structural heart interventions and other cardiovascular procedures that stand to benefit from image guidance.”

The Government of Canada is investing $2.6+ million over five years in the Nova Scotia Health Authority (NSHA) to develop the endoscope prototype. Throughout the development, Conavi will lend our medical and technological expertise to assist the NSHA in taking the solution from concept to creation. Upon creation, Conavi will commercialize the solution for cardiovascular surgical applications, allowing patients worldwide to benefit from improved clinical outcomes.

Fellow Toronto-based company Synaptive Medical will also assist in developing the solution and will likewise commercialize the solution for neurological applications.

The authorization comes from Health Canada—Canada’s federal regulator responsible for monitoring and evaluating the safety, effectiveness, and quality of diagnostic and therapeutic medical devices. After evaluating the Foresight ICE System, Health Canada granted a Canadian Medical Device License (MDL)—giving us the clearance needed to market the solution in our home country of Canada.

“Attaining Health Canada approval for our Foresight ICE System represents a key milestone in our mission to provide Canadian physicians with superior visual guidance to achieve improved clinical outcomes” says Murray Maynard, President and CEO of Conavi Medical. “Not only does this approval allow us to begin marketing our technology in Canada, but a device license in our domestic market is key to obtaining regulatory approval in other jurisdictions.”

The Foresight ICE System is the first catheter- based ultrasound system capable of providing both 2D and 3D ultrasound images of cardiac anatomy around the circumference of the catheter’s tip. The system includes the dual display Conavi Hummingbird imaging console and the Foresight ICE catheter. These products can be used to support a growing number of minimally invasive cardiovascular procedures performed in the US, such as ablations and other procedures that may require access to targeted regions of the heart.

OBIO’s priorities are to build companies that can stay here and grow and a sustainable industry that will: strengthen Ontario’s economy; commercialize research output; employ the best-educated, most innovative workers in the world and provide cost effective, value-driven healthcare solutions. Conavi Medical was selected as a Capital Access Advisory Program (CAAP) Company in which OBIO operates downstream from existing entrepreneurship programs and targets the critical issue of access to capital at the “Series A” and later stages of venture financing. Led by OBIO and a North American Steering Committee of life science venture capitalists and serial entrepreneurs, CAAP Companies work closely with a team of CAAP Advisors to address specific goals and objectives to position them for financing success. In addition to investor materials preparation and guidance, CAAP Goals include intellectual property, clinical and regulatory, market access other key strategic items to position companies for financing success

From Invention through Innovation to International Invoice, HTX provides non-dilutive project financing to emerging and established Ontario-based companies to develop, produce and commercialize innovative market-leading advanced health technologies. Through its Health Technology Commercialization Program (HTCP), its new REACH Innovation Procurement program, and its MedTech ecosystem support activities, HTX is the leading resource and catalyst for accelerating the growth of Ontario’s MedTech industry. The work supported by this partnership has been supported through financing provided by the Health Technology Commercialization Program through htx.ca – The Health Technology Exchange (HTX) and with the support of Sunnybrook Research Institute. This Program has also been made available through the support of the Ontario Ministry of Research and Innovation (MRI).