Mr. Thomas Looby reports

CONAVI MEDICAL REPORTS FISCAL 2024 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS

Conavi Medical Corp. today released its financial results for the fiscal year ended Sept. 30, 2024. These results are presented in accordance with international financial reporting standards as issued by the International Accounting Standards Board.

• Completed $7.7-million (U.S.) financing and reverse takeover to take company public;
• Chinese partner achieved regulatory approval, setting stage for royalty stream and triggering $5.9-million (U.S.) payment, enabling company to fully repay debt to that partner;
• United States Food and Drug Administration submission of Novasight 3.0 system on track for calendar 2025.

"With our equity raise and going-public transaction, we capped off a highly productive fiscal year," commented Thomas Looby, Conavi Medical's chief executive officer. "Commercially, we continued to advance, with our Chinese partner achieving regulatory approval earlier this month, setting the stage for a recurring royalty stream. As the safety and efficacy advantages of intravascular imaging are increasingly recognized, we believe our world-leading Novasight Hybrid platform offers a no-compromise solution for interventional cardiologists, payers and hospital administrators seeking to improve patient outcomes and control costs. We're on track to submit our AI-enhanced next generation Novasight Hybrid system to the U.S. Food and Drug Administration in the coming year, a key milestone as we roll out the first dual-modality imaging system for the world's most common cardiovascular procedures."

Business highlights

All amounts are in U.S. dollars unless specified otherwise:

• Subsequent to fiscal 2024 year-end, on Oct. 11, 2024, the company completed a reverse takeover of Titan Medical Inc. in an all-stock transaction and completed a concurrent private placement to certain institutional and accredited investors of 7,729,300 subscription receipts for gross proceeds of $7.7-million (U.S.) ($10.6-million).
• Conavi Medical's common shares (which, at the time, were Titan Medical Inc.) were voluntarily delisted from the Toronto Stock Exchange on Oct. 15, 2024, and commenced trading on the TSX Venture Exchange under the symbol CNVI effective Oct. 16, 2024. The company subsequently engaged ICP Securities Inc. to provide automated market-making services.
• Also in October, 2024, the Journal of the American College of Cardiology: Cardiovascular Interventions published a peer-reviewed paper by Tufaro et al. that provided an overview of recent developments in hybrid intracoronary imaging and discussed its value in a range of clinical practice and research areas, including percutaneous coronary intervention (PCI) guidance, vulnerable plaque detection, and the assessment of focal and systemic therapies for atherosclerosis. The publication came at an opportune time as the company showcased the Novasight Hybrid system at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C.
• On Dec. 9, 2024, the company announced that its exclusive licensing partner in China, East Ocean Medical (Hong Kong) Company Ltd. (EOM), had received approval by the China National Medical Products Administration (NMPA) for its coronary imaging system, which is based on Novasight Hybrid system intellectual property licensed to it by the company via a June, 2021, technology transfer and licensing agreement (TTLA). The NMPA triggered a fourth and final $5.9-million milestone payment from EOM to Conavi Medical, which the company will use to extinguish a $5.9-million promissory note owed by it to EOM. With this milestone achieved, the company expects to begin benefiting from a recurring royalty revenue stream, as detailed in its press release of Dec. 9, 2024.
• Also in December, 2024, Conavi Medical presented an update on its business at the MedInvest MedTech, AI & Digital Health Conference in New York, marking its first investor event presentation as a public company.

Fiscal 2024 financial results

In the fiscal years ended Sept. 30, 2024, and 2023, the company was focused on development of Novasight 3.0, and incorporating clinical user feedback from its current system. For the fiscal year ended Sept. 30, 2024, the company recorded revenue of approximately $2.16-million, comprising approximately $2.03-million primarily from sales to EOM, including systems and catheters to support regulatory approval as well as components to support pilot builds pursuant to the TTLA. Revenue of approximately $130,000 related to licensing and research and development (R&D) services attributable to milestone fees recognized on milestones achieved pursuant to the TTLA with EOM. This compares with approximately $2.36-million in the 12 months ended Sept. 30, 2023.

Operating expenses for the 12 months ended Sept. 30, 2024, were approximately $26.3-million, compared with approximately $23.0-million in the same period in 2023. The operating loss for FY 2024 was approximately $26.2-million, compared with approximately $23.0-million for FY 2023. Research and development expenses for FY 2024 were approximately $17.9-million, compared with approximately $15.2-million for FY 2023.

FY 2024 net loss was approximately $43.6-million, or $7.08 per common share, compared with a net loss of approximately $26.0-million, or $4.24 per common share, in the 12-month period ended Sept. 30, 2023. The increase in net loss was primarily the result of a change in the fair value of the company's 18-per-cent secured convertible debentures and 10-per-cent secured convertible debentures, an increase in net finance costs, costs related to the reverse takeover of Titan Medical and concurrent private placement, and a decrease in gross profit.

As of Sept. 30, 2024, cash and cash equivalents were $436,000. This amount does not include the $7.7-million (U.S.) in gross proceeds from the concurrent private placement received after fiscal year-end.

For detailed financial results, please refer to Conavi Medical's filings on SEDAR+ and the company's website.

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 (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.

We seek Safe Harbor.