Announcement • May 09
Conavi Medical Corp. has filed a Follow-on Equity Offering. Conavi Medical Corp. has filed a Follow-on Equity Offering.
Security Name: Common Shares
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Announcement • Apr 21
Conavi Medical Announces FDA 510(k) Clearance of its Next-Generation Hybrid IVUS-OCT System for Intravascular Imaging Conavi Medical Corp. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation hybrid imaging system, designed to deliver a more complete assessment of coronary anatomy within a single workflow. Conavi’s next-generation hybrid imaging system integrates intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single platform. These technologies together enable physicians to visualize both deep vessel structures (IVUS) and high-resolution surface detail (OCT) in real time. It is designed to support physician decision making and streamline workflows. Intravascular imaging is increasingly recognized as a critical tool in percutaneous coronary intervention (PCI), with growing clinical evidence demonstrating improved outcomes when imaging is used to guide stent sizing and placement. 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, and eliminating the need for multiple imaging systems. 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 30–40% 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, and continued integration of AI and advanced imaging technologies into clinical workflows. Following FDA clearance, Conavi is actively preparing for U.S. commercialization. The Company expects to initiate a limited market release in select U.S. centers in the second half of calendar 2026. New Risk • Mar 02
New major risk - Revenue and earnings growth Earnings have declined by 8.1% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$21m). Earnings have declined by 8.1% per year over the past 5 years. Shareholders have been substantially diluted in the past year (134% increase in shares outstanding). Revenue is less than US$1m (CA$706k revenue, or US$518k). Minor Risk Market cap is less than US$100m (CA$38.3m market cap, or US$28.1m).