FINWIRES · TerminalLIVE
FINWIRES

ASX:IMR

8 stories mentioning ASX:IMRUpdated 3d ago

Every FINWIRES story that references ASX:IMR, newest first.

Asia

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.

ASX:IMR
Asia

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.

ASX:IMR
Asia

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.

ASX:IMR
Asia

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.

ASX:IMR
Asia

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.

ASX:IMR
Asia

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.

ASX:IMR
Asia

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.

ASX:IMR
Asia

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.

ASX:IMR

Track with the FINWIRES app suite

FolioX
FolioX
Track ASX:IMR in your portfolio
WheelAI
WheelAI
Analyze ASX:IMR options with the wheel strategy
StockInsider
StockInsider
See market sentiment on ASX:IMR