- 01Signs first two US hospitals for iMR procedures
- 02Dallas/Philips revenue due in December quarter
- 03US$62.1m cash; 14/15 US filings done or under review
Imricor Medical Systems (ASX: IMR) has signed its first two US hospital customers for interventional magnetic resonance (iMR) cardiac procedures as it begins commercialising its technology in the country.
Rady Children’s Hospital in San Diego became the first customer, followed two weeks later by Children’s Medical Centre Dallas after the platform gained compatibility with Philips magnetic resonance (MR) systems.
The medical technology developer ended September with US$62.1 million in cash, while third-quarter revenue increased to US$188,000 from US$35,000 a year earlier.
Its US regulatory program has reached 14 of 15 submissions completed or under review, although outstanding approvals remain necessary for parts of the wider platform.
First US Customers
The San Diego installation establishes Imricor’s first US commercial iMR cardiac catheterisation program, extending its technology beyond electrophysiology applications.
The Dallas order represents the first commercial customer attributed to compatibility with Philips equipment, with installation completed after the September quarter.
Imricor expects to recognise revenue from Dallas in the December quarter, rather than including it in the September result.
The group has also launched Imricor Cardiovascular and identifies more than 250 children’s hospitals and 2,000 adult hospitals as potential US customers.
Under a financing arrangement with DLL, hospitals can spread payments over one to seven years while Imricor receives payment upfront.
Final Regulatory Filings
The US Food and Drug Administration has cleared paediatric label expansions for the NorthStar Mapping System and Vision-MR Diagnostic Catheter, allowing the products to be used across age groups.
Related diagnostic cable clearance has also been obtained, while submissions for the NavTrac-MR introducer and cable products have been lodged.
Two premarket approval modules covering the Vision-MR Ablation Catheter system have been accepted and closed by the FDA, with another submitted and the final module pending.
The company has separately progressed its Philips relationship into a jointly marketed iMR laboratory solution built around the Philips 1.5-tesla BlueSeal scanner.
Imricor says Philips compatibility allows NorthStar to control the scanner, receive images in real time and track compatible catheters during procedures.
Cash to Support Expansion
Quarterly revenue arose from the first US NorthStar sale, while the reported net loss narrowed 17% to US$2.9m from US$3.5m in the corresponding period.
That improvement reflected a non-cash fair-value movement in convertible notes rather than lower underlying operating expenditure.
Underlying net loss widened to US$7.7m from US$5.4m as research and development spending and other costs increased with staffing and professional services activity.
Operating cash outflow rose to US$7.3m from US$4.8m, despite cash and marketable securities increasing 36% year on year.
The next stage of expansion will be driven by customer installations, adoption of the Philips-compatible offering, and completion of the remaining FDA process.
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