Imricor lands two US hospital customers as NorthStar launch gathers pace

Two US hospitals mark Imricor’s commercial transition

Imricor’s US launch has produced two hospital customers in a matter of weeks, giving the medical-device company its clearest evidence yet that NorthStar is moving beyond regulatory preparation and into commercial use. Rady Children’s Hospital-San Diego became the first customer, followed two weeks later by Children’s Medical Center Dallas, the flagship hospital of Children’s Health.

Rady is establishing what Imricor describes as the first commercial interventional MR cardiac catheterisation program in the United States. Dallas already operates a Philips interventional MR lab, allowing NorthStar to be installed without construction and making the sale the first commercial outcome of Philips’ compatibility declaration. The launch sits alongside the earlier US hospital launch, which reported the two hospitals’ initial commitment to NorthStar.

Revenue is rising, but remains at an early-commercialisation level

Quarterly revenue climbed 437% to US$188,000 from US$35,000 a year earlier, with the first US NorthStar sale providing the main lift. Children’s Medical Center Dallas was installed after the quarter ended, so that sale is expected to be recognised in the December quarter rather than Q3.

The headline growth rate is therefore starting from a very small base. For the nine months, revenue was US$212,000, down from US$232,000 a year earlier, while the net loss widened to US$28.0 million from US$16.6 million. Q3 itself was less severe, with a US$2.9 million loss compared with US$3.5 million in the prior corresponding period, helped in part by non-cash fair-value movements.

Philips partnership widens the addressable sales route

Imricor’s commercial proposition now has a second route into hospitals. Philips has declared compatibility for Imricor’s capital equipment and consumables across five initial MR systems and four upgrades, while the companies have launched a turnkey cardiac iMR lab solution built around Philips’ 1.5T platform. The collaboration builds on the Philips compatibility declaration, which enabled NorthStar to operate at Philips-equipped clinical sites.

Imricor has also launched Imricor Finance with medical-equipment financier DLL. Hospitals can acquire iMR labs and equipment over one to seven years, while Imricor receives payment upfront and DLL carries the credit exposure. Management says additional US hospitals, including adult and children’s facilities, remain in the final stages of purchasing processes, although the filing does not disclose their names, contract values or expected installation dates.

FDA progress supports a broader product platform

NorthStar and the Vision-MR Diagnostic Catheter now have FDA 510(k) clearance for patients of all ages. Imricor has also submitted its NavTrac and NavTrac-MR Steerable Introducers, leaving 14 of the 15 submissions for its full US platform complete or under review.

The FDA has accepted and closed the manufacturing module of the Vision-MR Ablation Catheter’s modular PMA application. That module covers design, manufacturing, validation and quality systems for seven products, but a pre-approval inspection remains due and the final PMA module depends on completion of the VISABL-AFL clinical trial. The FDA manufacturing module closure was previously reported as a step toward US market entry; it is not final approval of the ablation catheter.

Cash provides room to commercialise, with controls still under repair

Imricor held US$62.1 million in cash and cash equivalents at 30 September, after raising about US$41.6 million net through its May placement and receiving proceeds from option exercises. That balance gives management what it says is sufficient liquidity for at least the next 12 months, although operating cash outflow increased to US$21.4 million in the first nine months from US$13.9 million a year earlier.

The 10-Q also says Imricor continued to have a material weakness in internal control over financial reporting. The weakness relates to documentation of internal reviews and the absence of a formal secondary review process for manual journal entries. Management is implementing remediation measures, but the controls will not be considered fixed until they operate effectively for a sufficient period.

The immediate test is commercial conversion: whether the Dallas installation is followed by further NorthStar orders, whether Philips broadens access beyond the first systems and whether procedure volumes eventually create recurring consumables revenue. Until then, the US launch is an important proof point, but not yet a substitute for scale.