Imricor’s Q4 Consumables Revenue Soars 840% Amid Regulatory and Market Advances

Regulatory Milestones Signal Growing Confidence

Imricor Medical Systems, a pioneer in MRI-compatible cardiac ablation devices, closed out 2024 with significant regulatory achievements that underpin its growth ambitions. The company successfully completed the US FDA review of its first modular submission, a critical step in the phased approval process for its innovative NorthStar platform. This early success, returned ahead of schedule, reflects a collaborative relationship with the FDA and bodes well for the anticipated full submission in 2025.

In Europe, Imricor advanced its regulatory positioning by submitting the NorthStar system for CE Mark approval, alongside a separate submission to bring catheter shaft manufacturing in-house. The latter move is expected to enhance gross margins and reduce lead times, signaling operational maturity as the company scales. Additionally, a successful onsite audit by TÜV SÜD prepares Imricor for the commercial launch of its Gen 2.0 catheter and MR Advantage EP Recorder/Stimulator under the stringent new European MDR framework.

Commercial Expansion and Market Penetration

Commercially, Imricor is making tangible strides. The company recorded a remarkable 840% increase in consumables revenue to $255,000 in Q4, contributing to total revenue of $280,000. Notably, this figure excludes a capital sale in Qatar, which will be recognised upon installation, indicating further revenue growth ahead. The first MRI-guided cardiac ablation in Switzerland at Lausanne University Hospital (CHUV) marks a clinical milestone, demonstrating real-world application of Imricor’s technology.

Geographically, Imricor is broadening its footprint with initial sales in Qatar and regulatory approvals in Saudi Arabia, a market with approximately 50,000 cardiac ablations annually. This aligns strategically with Saudi Vision 2030’s Health Sector Transformation Program, offering a promising growth avenue. To support this expansion, Imricor has bolstered its sales teams in Europe and the US, focusing on key markets such as Germany, the Netherlands, and the Nordics, while preparing for a US commercial launch post-FDA approval expected in late 2025.

Operational Efficiency and Financial Health

Operationally, Imricor demonstrated disciplined cash management with operating cash outflows contained at US$3.48 million for the quarter, down from the previous quarter’s US$4.5 million. The company ended the period with a robust cash balance of US$15.7 million, providing a runway of approximately 4.5 quarters at current burn rates. This financial stability supports ongoing clinical trials, including the VISABL-AFL and VISABL-VT studies, which are critical for regulatory submissions and market adoption.

Importantly, Imricor’s strategy to internalise catheter shaft manufacturing is expected to improve product margins and quality control, a key factor as the company scales production to meet anticipated demand. This operational shift, combined with regulatory progress and expanding sales efforts, positions Imricor well to capitalize on the estimated US$8 billion global cardiac ablation market.

Looking Ahead: Pioneering VT Ablations and Market Growth

Imricor’s long-term vision remains focused on enabling complex ventricular tachycardia (VT) and atrial fibrillation (Afib) ablations under real-time MRI guidance. The upcoming first-in-human VT procedure at Amsterdam UMC, facilitated by intensive training on Imricor’s Gen 2.0 catheter, represents a potential breakthrough that could redefine cardiac ablation standards. Success here would not only validate the technology but also accelerate adoption across major cardiac centers globally.

With regulatory approvals, clinical milestones, and commercial expansion converging, Imricor is poised for a transformative 2025. The company’s ability to navigate regulatory landscapes, scale manufacturing, and penetrate new markets will be critical to sustaining momentum and delivering shareholder value.