ASX:IMR

Imricor Says US FDA Accepts Premarket Approval Submission Manufacturing Module, Shares Jump 3%

Imricor Medical Systems (ASX:IMR) received notification from the US Food and Drug Administration (FDA) that the regulator completed its evaluation of the manufacturing module of the firm's premarket approval submission, and that the module has been accepted and is considered closed, according to a Thursday Australian bourse filing.The module covers the design, manufacturing, and quality processes for seven products in total. Six of these are the firm's own products undergoing the premarket approval process, including the Vision-MR ablation catheter and the RF-5000 ablation generator and pump, as well as a third-party product that Imricor will distribute.The FDA will also conduct a pre-approval inspection of the company's manufacturing sites before a final premarket approval.Its shares rose 3% in recent trading on Thursday.

Imricor, Philips Collaborate on Interventional Magnetic Resonance Lab Product for Cardiac Intervention

Imricor Medical Systems (ASX:IMR) collaborated with Royal Philips to offer an interventional magnetic resonance lab product for cardiac interventions, combining Philips' 1.5T magnetic resonance imaging platform with Imricor's portfolio of magnetic resonance-compatible systems and consumables, according to a Friday statement.The first commercially available configuration includes Philips' SmartHeart AI-powered cardiac planning and advanced cardiac imaging applications alongside Imricor's NorthStar interventional magnetic resonance mapping and guidance system, Advantage-MR EP recorder/stimulator, as well as the Vision-MR family of electrophysiology catheters.These technologies allow for the visualization of cardiac anatomy and arrhythmia substrate, tracking of catheters, performance of electroanatomical mapping, assessment of lesion formation, and evaluation of treatment response throughout procedures.

Jarden Research Adjusts Imricor Medical Systems' Price Target to AU$3.35 from AU$3.30, Keeps at Buy

Imricor Medical Systems Nears 'Genuine Commercial Inflection Point' After Two Decades of Platform Development, Jarden Says

Imricor Medical Systems (ASX:IMR) is nearing a "genuine commercial inflection point" as it transforms almost two decades of platform development into a recurring, high-margin revenue stream, Jarden said in a late Monday note.The company delivered a first-half underlying net loss of $15.1 million, a modest miss to Jarden's estimate of a $13.6 million loss, due partly to higher research and development spending as well as an increase in selling, general, and administrative expenses following the launch of commercial operations in the US.However, with Imricor continuing to pursue full regulatory approval for its electrophysiology ablation platform, the primary focus of the results was on the commercialization pathway for the platform and the launch of its Imricor Cardiovascular vertical rather than the financials, the investment firm said.The Children's Medical Centre of Dallas is the second US customer to purchase Imricor's NorthStar cardiac mapping and guidance system, and several more US hospitals are in the final stage of the purchasing process."This growing pipeline, which appears to extend into adult hospitals, further validates Imricor Cardiovascular as a standalone growth driver in its own right, and as a beachhead for the eventual rollout of Imricor's [electrophysiology] ablation platform," the equity research firm said.Jarden maintained a buy rating on Imricor while raising its target price to AU$3.35 from AU$3.30.Imricor's shares gained nearly 2% in recent Tuesday trade.

Imricor Medical Systems Q2 Loss Narrows, Revenue Down

Imricor Medical Systems' (ASX:IMR) second-quarter net loss was $7.4 million, compared with $7.8 million in the prior-year quarter, according to a Monday Australian bourse filing.Revenue for the three months ended June 30 came in at $60,500, compared with $65,200 in the year-ago period, the medical device company said.The company said it is expanding its US commercial team, with additional hires to be added during the September and December quarters to cover new regions of the US.Imricor Medical Systems' shares rose nearly 3% in recent trading on Monday.

Imricor Medical Secures Second US Customer, Shares Up 3%

Imricor Medical Systems (ASX:IMR) secured its second customer in the US, with Children's Medical Center, Dallas, in Texas purchasing its NorthStar interventional magnetic resonance (iMR) mapping and guidance system, according to a Monday Australian bourse filing.The hospital has an existing Philips magnetic resonance lab, which means no lab construction will be required, and procedures guided with the system can begin following installation. Children's Medical Center Dallas will launch a NorthStar-guided interventional magnetic resonance cardiac catheterization program.Its shares rose 3% in recent trading on Monday.

Imricor Says Philips Issues 'Third-Party Product Compatibility Declaration' for Its Interventional Magnetic Resonance Products

Imricor Medical Systems (ASX:IMR) said Philips Medical Systems Nederland issued a "Third-Party Product Compatibility Declaration," covering Imricor's interventional magnetic resonance products when used with Philips' magnetic resonance systems, according to a Friday Australian bourse filing.This will allow Imricor's NorthStar mapping and guidance system to connect and operate in a commercial clinical setting with Philips magnetic resonance scanners.The declaration covers five initial magnetic resonance systems and four magnetic resonance system upgrades running software versions R12.1.1 or greater.

Imricor Launches Cardiovascular Unit to Expand iMR Use in Cardiac Catheterization

Imricor Medical Systems (ASX:IMR) launched Imricor Cardiovascular, a new business vertical designed to broaden the application of interventional magnetic resonance (iMR) in cardiac catheterization alongside its existing electrophysiology and ablation portfolio, according to a late Monday statement by the company.The platform enables US hospitals to perform radiation-free cardiac catheterization by integrating magnetic resonance imaging and catheterization into a single procedure.The approach is expected to shorten procedure time for each patient by around 35%, enhancing hospital efficiency while increasing available capacity in X-ray catheterization laboratories.The company said the technology particularly benefits pediatric and congenital heart patients by enabling repeated catheterizations without ionizing radiation while improving imaging and reducing anesthesia use.

Imricor Medical Systems Begins US Commercial Launch with Sale of iMR Mapping, Guidance System

Imricor Medical Systems (ASX:IMR) began its official US commercial launch, with the Rady Children's Hospital in San Diego, California, purchasing its NorthStar interventional magnetic resonance (iMR) mapping and guidance system, according to a Monday Australian bourse filing.It also launched a new vertical, Imricor Cardiovascular, for the NorthStar system. It expects to continue adding devices and applications within the Cardiovascular business over time.Several US hospitals are in the final stages of the purchasing process, the filing added. Revenue from the NorthStar sales is expected to exceed the European business' aggregate full-year revenue in 2025.

Imricor Medical Systems Submits Steerable Introducers for US FDA Clearance

Imricor Medical Systems (ASX:IMR) submitted its NavTrac and NavTrac-MR steerable introducers for market clearance under the US Food and Drug Administration's 510(k) premarket notification pathway, according to a Monday filing with the Australian bourse.The devices are used to insert and guide a range of cardiovascular catheters into the heart during certain medical procedures, per the filing.Imricor said it has now completed 14 of the 15 FDA submissions required to establish a full product platform in the US.The company's shares gained 1% in recent Monday trade.

Imricor Secures US FDA Clearance for Pediatric Expansion of NorthStar, Vision-MR Systems

Imricor Medical Systems (ASX:IMR) received US Food and Drug Administration (FDA) clearance to expand pediatric use of its NorthStar iMR navigation system and Vision-MR diagnostic catheter, according to a Thursday Australian bourse filing.The approvals permit both devices to be marketed to patients of all ages, including children and young adults, especially those receiving care at more than 250 children's hospitals across the US, per the filing.The company said its interventional magnetic resonance imaging approach may be beneficial in pediatric cardiology for congenital heart defects requiring repeated catheterizations, eliminating exposure to ionizing X-ray radiation.

Imricor Medical Systems Files US Registration Statement for About 39 Million Class A Shares

Imricor Medical Systems (ASX:IMR) filed a registration statement with the US Securities and Exchange Commission for 38.9 million class A common shares, according to a Friday notice on the Australian bourse.The shares are issuable under options the company previously granted as part of an equity incentive plan, per the filing.

Imricor Submits Third US FDA Premarket Approval Module for Vision-MR Ablation System

Imricor Medical Systems (ASX:IMR) has filed the third module of its premarket approval application with the US Food and Drug Administration (FDA), covering non-clinical bench testing for its Vision-MR Ablation Catheter 2.0, RF-5000 Ablation Generator, and irrigation tubing set, according to a Thursday Australian bourse filing.The submission contains testing data covering product performance, sterile shelf life, packaging integrity, software testing, electrical safety, electromagnetic compatibility, magnetic resonance safety, and usability, per the filing.The company is streamlining FDA approval via a modular review process while pursuing additional device clearances, with three products already cleared, including NorthStar, Vision-MR Diagnostic Catheter, and Vision-MR Diagnostic Catheter Cable, the filing added.

Imricor Medical Systems Granted Waiver From Certain ASX Listing Rules After Becoming US Public Reporting Company

Imricor Medical Systems (ASX:IMR) was granted a waiver from certain ASX listing rules, effective Tuesday, in order to align its ASX periodic reporting with the reporting requirements in its home jurisdiction in the US, according to a Wednesday Australian bourse filing.The company said its registration statement on Form 10 became effective on May 17, making it a US public reporting company, subject to the periodic reporting requirements, including requirements to file annual reports on Form 10-K, quarterly reports on Form 10-Q, and periodic reports on Form 8-K with the US Securities and Exchange Commission (SEC).Imricor will not be required to lodge an Appendix 4D, an Appendix 4E, and an Appendix 4C.The waiver will cease to apply if Imricor ceases to be subject to an obligation to file Forms 10-K and Forms 10-Q with the US SEC.

Imricor Medical Systems Secures AU$60 Million in Institutional Placement

Imricor Medical Systems (ASX:IMR) has secured firm commitments from new and existing institutional and sophisticated investors to raise AU$60 million through the issue of 32.4 million Chess depositary interests (CDI) at AU$1.85 per CDI, reflecting a 7.7% discount to its 10-day volume-weighted average price, according to a Monday Australian bourse filing.The new CDIs will be issued in a single tranche under the company's existing placement capacity and will rank equally with existing CDIs, per the filing.Settlement is expected on Thursday, with the new CDIs scheduled for issuance and set to begin trading on the Australian Securities Exchange on Friday, the filing said.The funds will be used to accelerate the company's growth strategy, including launching NorthStar in the US, advancing regulatory approvals for its full electrophysiology platform, completing key clinical programs, progressing pulsed field ablation development, and supporting expansion in the Middle East and other target markets, the filing added.The company's shares fell 1% in recent Monday trade.

Imricor Medical Systems Expects First Sales for Mapping System in Q2

Imricor Medical Systems (ASX:IMR) said the first sales in the US for its NorthStar 3D mapping and guidance system are expected in the second quarter after it received clearance from the US Food and Drug Administration (FDA), according to a Tuesday Australian bourse filing.The firm believes the US opportunity is compelling in the adult electrophysiology and in pediatric settings.It also supported the development of future commercial sites and regional expansion opportunities in the Middle East.