Imricor Medical Systems (ASX: IMR) has submitted its NorthStar Mapping System to the US Food & Drug Administration (FDA) for pediatric label expansion.
This follows recent adult clearance and aimed at significantly broadening its US market reach, with clearance anticipated this quarter.
The submission was made via the Special 510(k) pathway, following the system's FDA clearance for adult use in January 2026.
The company expects FDA clearance for pediatric use within the current quarter, anticipating that the NorthStar system can help reduce radiation exposure in pediatric cases.
Expanding US Market Access
The pediatric label expansion is a crucial element of Imricor's US commercialisation strategy.
This move is designed to broaden the company's addressable market, targeting approximately 250 children's hospitals across the US.
Imricor plans to proactively market to this segment and establish an installed base in pediatric centres during 2026, assuming the anticipated FDA clearance is received.
There has already been reported inbound interest from children's hospitals following the adult clearance.
FY25 Financials and Liquidity
Imricor's financial results for fiscal year 2025 saw total revenue of US$292,309.
This figure was reportedly impacted temporarily by customer sites enrolling clinical trial patients.
The company reported a GAAP net loss of US$25,318,562, which was an improvement on the prior year.
Despite the revenue figures, Imricor strengthened its balance sheet, reporting total liquidity of US$40,779,957 at 31 December 2025.
This was largely bolstered by proceeds from a March 2025 placement. The operating cash outflow for FY25 was approximately US$19 million.
Regulatory and Commercial Progress
Beyond the US pediatric efforts, Imricor has made substantial regulatory and commercial progress.
The company secured CE Mark approvals under the European Union’s MDR for its second-generation ablation catheter and the NorthStar MRI-native 3D mapping and guidance system.
Clinical advancements include the first-in-human ischemic ventricular tachycardia (VT) ablation performed under real-time MRI guidance at Amsterdam UMC.
The European customer pipeline expanded significantly, growing from 7 sites in the fourth quarter of 2024 to 40 sites by the fourth quarter of 2025.
Regulatory submissions in the US are progressing, with multiple 510(k) reviews underway, and PMA modules 1 and 2 already submitted, with module 3 nearing submission.
The NorthStar and Vision-MR Diagnostic Catheter both received FDA clearance in January 2026, while the company also completed a human factors usability study involving close to 20 US hospitals.
US Reporting Transition
Imricor is also undergoing a significant transition in its corporate governance.
The company filed a US SEC Form 10 because its shareholder base exceeded the Section 12(g) holder-of-record thresholds.
This move is not an initial public offering or US listing, but rather a regulatory requirement.
Upon its expected effectiveness in mid-May 2026, Imricor will become a US public reporting company.
This will subject it to periodic SEC reporting, proxy and tender offer rules, and beneficial ownership reporting, which will increase administrative and compliance burdens.
