ASX:IMR

4 stories mentioning ASX:IMR

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

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

Asia19d ago

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

Asia42d ago

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

Asia48d ago

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