Summary: Conavi Medical is a commercial-stage medical device company that develops image guidance technologies for use in minimally invasive cardiovascular procedures. The company’s first product is Novasight Hybrid system, which uses ultrasound (IVUS) and optics (OCT) to image the arteries that supply the heart with blood. Intravascular coronary imaging is currently limited to ultrasound (IVUS) or optics (OCT). The Novasight Hybrid system received FDA 510(k) clearance in April 2018 and commercial launch is expected later this year. The company’s second product is the Foresight Intracardiac Echocardiography (ICE) system, which uses ultrasound to image the chambers and structures of the heart in 2D and 3D. The system is applicable to a number of minimally invasive structural and electrophysiology procedures. The Foresight ICE system has received FDA 510(k) clearance and Health Canada approval and has been used in over 50 clinical procedures to date. Conavi Medical also has distribution agreements with large, publicly-traded partners in Japan and China.
Need: Minimally invasive procedures are an established and emerging treatment option in medicine, and have been enabled by advances in various medical technologies. Many of these advances have been in the development of therapeutic catheters or devices. By comparison, there have been fewer advances in the development of imaging technologies to guide these procedures, particularly within the past five to ten years. Conavi believes that this represents a major unmet clinical and market need.
Value: Intravascular coronary imaging is currently limited to ultrasound (IVUS) or optics (OCT). Ultrasound visualizes farther in lower resolution, and is useful for determining the size of both the artery and blockage. Optics images nearer in better resolution, and is useful for characterizing the nature of the blockage. Separately, each of ultrasound and optics provide incomplete information to the physician. The Novasight Hybrid system combines ultrasound and optical imaging into a single catheter at a comparable cost, catheter size and image quality, thereby overcoming the limitations of either standalone. Competing ICE systems use 64 ultrasound elements to generate an image, and as a result, are expensive to manufacture. Conavi’s Foresight ICE system uses a single ultrasound imaging element, and therefore, can be manufactured for considerably less. Also, competing ICE systems provide a 2D image with a 90-degree field of view. The Foresight ICE system is both side and forward-viewing, and provides a 360-degree field. The system can also image in both 2D and 3D, and is equipped with colour Doppler (to visualize blood flow) and measurements (to size cardiac anatomy). The system is applicable to a number of minimally invasive structural and electrophysiology procedures.