Conavi sees publication of Novasight system case report

Mr. Thomas Looby reports NOVASIGHT HYBRID IMAGING SYSTEM FEATURED IN PUBLISHED JSCAI CASE REPORT DEMONSTRATING SUPERIOR DIAGNOSIS AND PRECISION-GUIDED THERAPY IN COMPLEX CORONARY CASE A compelling case report in the Journal of the Society for Cardiovascular Angiography & Interventions highlighting the clinical impact of Conavi Medical Inc.'s Novasight hybrid IVUS-OCT system in guiding accurate diagnosis and optimal stent placement in a complex coronary artery case has been published. The case was performed, and the images were collected using the first-generation Novasight hybrid IVUS-OCT system. "This publication validates our belief that hybrid imaging is the future of precision-guided interventional cardiology," said Thomas Looby, chief executive officer of Conavi Medical. "Our goal is to help physicians make faster, more accurate decisions and ultimately improve patient outcomes. Also, this article is based on the first-generation system. We are especially excited about our next-generation Novasight hybrid system, which is designed to deliver enhanced image quality and functionality for even greater physician and patient benefit, and the U.S. FDA 510(k) submission is on track for Q3 2025." The report, titled "The Role of Comprehensive Hybrid Imaging in Identification of Plaque Rupture and Ostial Stent Placement: Case Report" (DOI: 10.1016/j.jscai.2025.103814), details the treatment of a 52-year-old male patient with multiple cardiovascular risk factors, including diabetes, hypertension, hyperlipidemia and end-stage renal disease. Initial angiography suggested a calcified lesion at the ostium of the right coronary artery. However, hybrid imaging using the Novasight system, integrating both intravascular ultrasound and optical coherence tomography, revealed the true culprit: a plaque rupture, not significant calcification. "Hybrid imaging has the power to transform how we diagnose and treat complex coronary disease," said Dr. Megha Prasad, co-author of the study and interventional cardiologist. "In this patient, angiography alone could have potentially led us down the wrong path. The ability to combine the high-resolution structural detail of OCT with the anatomical reference points of IVUS in real time allowed us to correctly identify the plaque rupture and precisely treat the lesion, something neither modality could have done alone." The case demonstrates how the simultaneous use of intravascular ultrasound and optical coherence tomography through the Novasight hybrid catheter enabled physicians to: Correctly identify a plaque rupture previously mischaracterized as calcification by angiography alone; Leverage OCT's high-resolution imaging to visualize intraplaque hemorrhage and rupture cavity; Use IVUS to mark and visualize the coronary ostium with precision, allowing for accurate stent placement and optimal expansion. The publication reinforces the Novasight system's role in aligning with new U.S. imaging Class 1A guidelines for intracoronary imaging and acute coronary syndrome that advocate for broader use of intracoronary imaging in PCI. Conavi's hybrid solution uniquely addresses long-standing barriers to adoption, including the need for separate imaging systems and interpretation challenges, particularly among less experienced operators. About Conavi Medical Corp. Conavi Medical is focused on designing, manufacturing and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight hybrid system is the first system to combine both intravascular ultrasound and optical coherence tomography to enable simultaneous and co-registered imaging of coronary arteries. The Novasight hybrid system has 510(k) clearance from the U.S. Food and Drug Administration and regulatory approval for clinical use from Health Canada, China's National Medical Products Administration, and Japan's Ministry of Health, Labour and Welfare. We seek Safe Harbor.