Quotes

1. We are delighted to have received MHLW approval of the Novasight Hybrid system. Clinical data in the past several years has increasingly demonstrated that intravascular imaging with either IVUS or OCT has significant potential to improve outcomes in the large number of patients being treated with angioplasty and stenting for coronary artery disease. However, there are substantial differences between the images generated by these two technologies. Until now, physicians in Japan have had to choose between IVUS or OCT when performing percutaneous coronary interventions (PCI). We are delighted that Conavi and Japan Lifeline can now begin to offer both of these highly complementary imaging techniques on a single catheter to physicians in Japan.

   In Conavi Medical and Japan Lifeline Announce MHLW Approval of Novasight Hybrid Intravascular Imaging System for Japanese Market

2. Conavi is delighted to receive approval for the clinical use of the Novasight Hybrid System in Canada and are thankful to the many researchers, clinicians, patients, employees and other stakeholders that made this milestone possible.

   In Conavi Medical Announces Health Canada Approval of Novasight Hybrid System for Visualization During Coronary Angioplasty Procedures

3. The announcement of Japan Lifeline applying for regulatory approval is an important commercial event for the company. Intravascular imaging is used frequently in the 260,000 angioplasty and stenting procedures performed every year in Japan. The Novasight Hybrid system is uniquely able to simultaneously acquire inherently co-registered IVUS and OCT images. I have been fortunate to work with a number of cardiologists in Japan whose experience and knowledge of intravascular imaging is incredibly profound. The input that we have received from Japanese physicians in the development of our product has been incredibly valuable in ensuring that our technology fits well with their clinical needs.

   In Conavi Medical and Japan Lifeline Advance Japanese Sales Strategy of Novasight Hybrid Intravascular Imaging System

4. The purported advantages of the synergistic information that IVUS and OCT can provide have been highly anticipated in the interventional cardiology community...These cases performed in Hamilton represent the first worldwide clinical use of any system that combines IVUS with OCT on a single catheter. In an era of personalized and precision medicine, we believe that the ability to collect comprehensive imaging data in patients with coronary artery disease (CAD) provides an important opportunity to generate improved clinical decision-making capabilities for these patients in the future.

   In Conavi Medical Announces Clinical Use of the Novasight Hybrid System with Simultaneous Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) Capabilities

5. 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...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.

   In Conavi Medical Announces FDA 510(k) Clearance of the Novasight Hybrid System with Simultaneous Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) Capabilities

6. 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 cardiovascuar procedures to patients in China.

   In Conavi Medical and China Grand Pharmaceutical and Healthcare Enter into Distribution Agreement for Minimally Invasive Imaging Technologies in China