Imricor’s Cash Burn Rises as FDA Approval Timeline Remains Unclear

• FDA 510(k) submissions for NorthStar and Vision-MR Diagnostic Catheter underway
• NorthStar commercially launched in Europe post-CE Mark approval
• Operating cash outflows rose to US$4.8 million in Q3 CY25
• Cash and short-term investments total US$45.7 million
• Growing clinical trial footprint and hospital interest in MRI-guided cardiac ablations

Regulatory Progress and Clinical Trials

Imricor Medical Systems has marked a pivotal quarter with parallel regulatory submissions to the US Food and Drug Administration (FDA) for its NorthStar and Vision-MR Diagnostic Catheter devices. These 510(k) filings represent crucial steps toward commercialising MRI-guided electrophysiology procedures in the US, a market with an estimated US$10 billion opportunity. The company also completed a human factors study involving approximately 20 hospitals, underscoring its commitment to rigorous clinical validation.

Meanwhile, Imricor is expanding its clinical trial footprint, with several US hospitals equipped with cardiology-owned MRI scanners preparing to join the VISABL-AFL trial. This growing trial participation is expected to bolster evidence supporting the safety and efficacy of MRI-guided cardiac ablations.

Commercial Launch and Market Expansion in Europe

Following CE Mark approval, Imricor launched NorthStar commercially in Europe at the end of the quarter. The company reported strong momentum with an expanding pipeline of 35 European hospitals, up from 26 in the previous quarter. This growth reflects increasing demand for radiation-free cardiac ablation procedures, driven by the superior imaging capabilities of MRI compared to conventional x-ray fluoroscopy.

Additionally, regulatory approval from a European Notified Body allows Imricor to bring catheter shaft manufacturing in-house. This strategic move is expected to improve product quality and increase margin on consumable revenues, enhancing the company’s commercial position.

Financial Overview and Cash Flow Dynamics

Financially, Imricor reported operating cash outflows of US$4.8 million for Q3 CY25, a 9% increase from the prior quarter. Cash receipts from customers were modest at US$124, temporarily impacted by the enrollment of patients in non-revenue generating clinical trials. The company ended the quarter with US$38.3 million in cash and an additional US$7.5 million in short-term investments, providing a solid liquidity buffer as it advances regulatory and commercial milestones.

Operating costs rose slightly due to annual insurance premiums, but adjusted operating expenses excluding these premiums actually decreased by 6% compared to Q2. Imricor continues to invest in research, development, and market expansion while managing its cash runway prudently.

Strategic Outlook

CEO Steve Wedan highlighted the company’s focus on driving adoption of MRI-guided cardiac ablation technology globally, expanding clinical trials, and delivering on its vision to transform cardiac arrhythmia treatment. With growing hospital interest in the US and Europe, and regulatory progress underway, Imricor is positioning itself at the forefront of a potentially transformative medical technology sector.

However, the timing of FDA approvals remains uncertain, and the short-term financial impact of clinical trial enrollments tempers near-term revenue growth. Investors will be watching closely for upcoming regulatory decisions and commercial traction in key markets.

Bottom Line?

Imricor’s regulatory and commercial advances set the stage for growth, but upcoming FDA decisions and trial outcomes will be critical to watch.

Questions in the middle?

• When can investors expect FDA clearance for NorthStar and Vision-MR Diagnostic Catheter?
• How quickly will European commercial momentum translate into sustainable revenue growth?
• What is the company’s plan to manage cash flow amid ongoing clinical trial enrollments?