Conavi sees publication of Novasight system case report

Executive Summary

• Conavi Medical’s Novasight hybrid IVUS-OCT system was featured in a published case report in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), demonstrating its ability to improve diagnostic accuracy and precision-guided therapy in complex coronary cases.
• The case report highlights how the system successfully identified a plaque rupture in a 52-year-old patient, correcting a misdiagnosis of calcification that angiography alone had suggested, thereby enabling optimal stent placement.
• CEO Thomas Looby stated that the publication validates the company's focus on hybrid imaging and confirmed that the U.S. FDA 510(k) submission for the next-generation Novasight system is on track for Q3 2025.

Key Details

• Publication Details: Case report titled "The Role of Comprehensive Hybrid Imaging in Identification of Plaque Rupture and Ostial Stent Placement: Case Report" published in JSCAI (DOI: 10.1016/j.jscai.2025.103814).
• Clinical Case: Treatment of a 52-year-old male with multiple cardiovascular risk factors (diabetes, hypertension, hyperlipidemia, end-stage renal disease).
• Diagnostic Outcome: Initial angiography suggested a calcified lesion at the ostium of the right coronary artery; Novasight hybrid imaging (simultaneous IVUS and OCT) revealed the true culprit was a plaque rupture.
• Technical Capabilities Demonstrated:
  • Correct identification of plaque rupture previously mischaracterized as calcification.
  • Visualization of intraplaque hemorrhage and rupture cavity using OCT’s high-resolution imaging.
  • Precise marking and visualization of the coronary ostium using IVUS for accurate stent placement and optimal expansion.
• Regulatory Status:
  • Current Novasight system holds 510(k) clearance from the U.S. FDA and regulatory approval from Health Canada, China’s NMPA, and Japan’s MHLW.
  • Next-generation Novasight system (enhanced image quality and functionality) has an FDA 510(k) submission scheduled for Q3 2025.
• Market Alignment: The publication supports new U.S. imaging Class 1A guidelines advocating for broader use of intracoronary imaging in PCI.

Notable Quotes

• Thomas Looby, CEO: "This publication validates our belief that hybrid imaging is the future of precision-guided interventional cardiology... Also, this article is based on the first-generation system. We are especially excited about our next-generation Novasight hybrid system... and the U.S. FDA 510(k) submission is on track for Q3 2025."
• Dr. Megha Prasad, Co-author/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."