Conavi Medical Highly Encouraged by New U.S. Intracoronary Guidelines

– IVUS and OCT cited as playing essential and complementary roles, validating Novasight’s unique hybrid imaging capability

– Guidelines constitute strong recommendations based on the highest level of evidence

– Clinical data show intracoronary imaging leads to lower risk of target vessel failure (including cardiac death) in coronary procedures

– Company anticipates similar changes to other guidelines covering coronary procedures

TORONTO, March 04, 2025 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI; OTC: CNVIF) (“Conavi Medical” or the “Company”), a commercial stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures, responded today to new intracoronary imaging guidelines by the American College of Cardiology, American Heart Association and other medical organizations. The guidelines apply to patients presenting with acute coronary syndrome (ACS) and undergoing a coronary intervention in the left main artery or complex lesions. Notably, the guidelines are rated Class 1A, indicating the highest level of evidence and strongest level of recommendation.

The new guidelines offer strong validation for Conavi as the only provider of hybrid IVUS (ultrasound) and OCT (optical) imaging technology. As the authors explain, “both IVUS and OCT play essential roles in evaluating the necessity for lesion preparation, choosing the appropriate stent size, reducing the likelihood of geographical errors, confirming proper stent expansion, identifying complications, and determining the underlying reasons for stent failure.”

“The updated guidelines reaffirm the critical role of intracoronary imaging in optimizing stent procedures and improving patient outcomes,” said Dr. Megha Prasad, an interventional cardiologist. “By leveraging the advantages of both IVUS and OCT, we can enhance precision in stent placement, minimize complications, and ultimately optimize care for patients with complex coronary artery disease. Conavi’s Novasight system, as the only hybrid IVUS-OCT device, uniquely equips physicians with both imaging modalities in a single platform, streamlining procedures, limiting contrast usage, and supporting more informed clinical decisions.”

“We’re highly encouraged that both IVUS and OCT imaging are recognized as important and complementary,” commented Thomas Looby, Conavi’s CEO. “The changes reflect the mounting evidence of improved patient outcomes, including a 46% drop in cardiac death¹ compared to angiography alone. Our value proposition of combining IVUS and OCT hits the bullseye for patients, doctors, payers, and hospital administrators. Also, we believe that similar changes in the future to other guidelines in the US covering intracoronary procedures are likely.”

The new guidelines are available at doi.org/10.1016/j.jacc.2024.11.009. Please see section 7.3 for “Use of Intracoronary Imaging”.

About Conavi Medical

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 (IVUS) and optical coherence tomography (OCT) 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, Labor and Welfare. For more information, visit conavi.com.

Cautionary Statement Regarding Forward-Looking Information

This news release contains “forward-looking statements” within the meaning of applicable Canadian and U.S. securities laws, which reflect the current expectations of management of Conavi’s future growth, results of operations, performance and business prospects and opportunities. Forward-looking statements are frequently, but not always, identified by words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions, although these words may not be present in all forward-looking statements. Forward-looking statements that appear in this release may include, without limitation, references to Conavi’s plans for the commercialization of its Novasight Hybrid™ system and potential future changes to clinical guidelines.

These forward-looking statements reflect management’s current beliefs with respect to future events, and are based on information currently available to management that, while considered reasonable by management as of the date on which the statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in actions, events, conditions, results, performance or achievements to be materially different from those projected in the forward-looking statements. Forward-looking statements involve significant risks, uncertainties and assumptions and many factors could cause Conavi’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Such factors and assumptions include, but are not limited to, Conavi’s ability to retain key personnel; its ability to execute on its business plans and strategies; and other factors listed in the “Risk Factors” sections of the joint information circular of Conavi dated August 30, 2024 and of the Preliminary Prospectus of the Company dated January 29, 2025 (each of which may be viewed at sedarplus.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements.

Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions and Conavi has attempted to identify important factors that could cause actual actions, events, conditions, results, performance or achievements to differ materially from those described in forward-looking statements, Conavi cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, Conavi expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Accordingly, investors should not place undue reliance on forward-looking statements. All the forward-looking statements are expressly qualified by the foregoing cautionary statements.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

Contacts

Stefano Picone
Chief Financial Officer
ir@conavi.com
(416) 483-0100

¹ Stone GW, Intravascular imaging-guided coronary drug-eluting stent implantation: an updated network meta-analysis, The Lancet 2024; 403: 824–3.