Mr. Thomas Looby reports

CONAVI MEDICAL ANNOUNCES FDA 510(K) CLEARANCE OF ITS NEXT-GENERATION HYBRID IVUS-OCT SYSTEM FOR INTRAVASCULAR IMAGING

Conavi Medical Corp. has received U.S. Food and Drug Administration 510(k) clearance for its next-generation hybrid imaging system, designed to deliver a more complete assessment of coronary anatomy within a single workflow. The milestone positions the company to initiate its U.S. commercial launch expected in calendar second half 2026 and to expand its hybrid intravascular imaging technology.

Conavi's next-generation hybrid imaging system integrates intravascular ultrasound and optical coherence tomography into a single platform. These technologies together enable physicians to visualize both deep vessel structures and high-resolution surface detail in real time. It is designed to support physician decision making and streamline workflows.

"FDA clearance of our next-generation hybrid imaging system marks a pivotal moment for Conavi as we transition into commercial launch in the U.S.," said Thomas Looby, chief executive officer of Conavi Medical. "We believe hybrid IVUS-OCT imaging represents the next evolution in intravascular imaging, bringing together IVUS and OCT into a single system to give a complete picture of the vessel. With this clearance, we are focused on executing our U.S. commercial launch expected in calendar H2 2026, supporting physician decision making during these procedures and driving adoption in leading U.S. centres. This clearance reflects years of focused work by an exceptional team across engineering, clinical, regulatory and operations, and would not have been possible without the trust of our clinical investigators, the commitment of our manufacturing and supply partners, and the continued support of our shareholders."

"Hybrid IVUS-OCT imaging has the potential to meaningfully enhance how we approach complex coronary interventions," said Dr. Megha Prasad, interventional cardiologist at New York Presbyterian Hospital. "The ability to simultaneously evaluate plaque composition, vessel size and stent expansion in a single pullback can support procedural decision making and workflow efficiency. Technologies like Conavi's next-generation hybrid system are helping move the field toward more precise, image-guided care, and I look forward to using it regularly in my practice."

Advancing the standard of care in intravascular imaging

Intravascular imaging is increasingly recognized as a critical tool in percutaneous coronary intervention, with growing clinical evidence demonstrating improved outcomes when imaging is used to guide stent sizing and placement. However, adoption remains underpenetrated globally, in part due to workflow complexity and the need to use multiple imaging systems.

Conavi's next-generation hybrid imaging system addresses these needs by:

• Enabling simultaneous, co-registered IVUS and OCT imaging in a single pullback;
• Providing lesion and stent analysis tools that incorporate insights from both imaging modalities;
• Enabling streamlined catheter connection workflow designed for ease of use;
• Featuring a catheter design focused on enhanced deliverability;
• Eliminating the need for multiple imaging systems.

As health care systems continue to prioritize precision, efficiency and outcomes, intravascular imaging has become one of the fastest-growing segments in interventional cardiology.

Large and growing market opportunity

The intravascular imaging market, including IVUS and OCT technologies, represents a significant and growing segment within interventional cardiology, driven by increasing adoption of image-guided PCI procedures. The global market opportunity for coronary intravascular imaging is estimated to exceed $4-billion annually, with IVUS and OCT penetration currently at 30 to 40 per cent of eligible procedures and continuing to expand.

Growth is being driven by:

• Increasing adoption of image-guided PCI procedures;
• Expanding clinical evidence supporting improved patient outcomes;
• Greater focus on optimizing stent placement and reducing repeat interventions;
• Continued integration of artificial intelligence and advanced imaging technologies into clinical workflows.

Commercial readiness and launch strategy

Following FDA clearance, Conavi is actively preparing for U.S. commercialization. The company expects to initiate a limited market release in select U.S. centres in the second half of calendar 2026.

About Conavi Medical Corp.

Conavi Medical is focused on designing, manufacturing and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented next-generation hybrid imaging system is the first system to co-register and co-align intravascular ultrasound and optical coherence tomography imaging beams to enable simultaneous hybrid imaging of coronary arteries. The next-generation hybrid imaging system has 510(k) clearance from the U.S. Food and Drug Administration.

We seek Safe Harbor.