Imricor reactivates hospital customer sites in Q1 CY24 with momentum building
\nCompany progresses pivotal VISABL-AFL trial during quarter required for US FDA approval
\nIMR receives Medical Device Marketing Authorisation from the Saudi Food & Drug Authority <\/p>\n
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Special Report:<\/em><\/strong> Focused on improving safety and first time success rates in cardiac catheter ablation, Imricor Medical Systems says reactivation of customer sites is underway, with momentum building after Covid-19 pandemic delays.<\/strong><\/p>\n Imricor Medical Systems (ASX:IMR)<\/strong><\/a> says a major milestone required for FDA approval is the successful execution of a pivotal clinical trial, \u00a0named Vision-MR Ablation of Atrial FlutterVISABL-AFL.<\/p>\n New drugs and complex medical devices must be proven safe and effective by the all-powerful Food and Drug Administration (FDA) before companies can sell them into the lucrative US market. \u00a0It is a huge milestone for any medtech listed on the ASX.<\/p>\n IMR\u2019s trial will provide the clinical evidence required for IMR\u2019s higher-classification products, in particular the Vision-MR Ablation Catheter and HAT 500 Ablation Generator.<\/p>\n During the period, IMR says it achieved many key milestones toward FDA approval, including:<\/p>\n Approval from Johns Hopkins Hospital\u2019s Institutional Review Board, in Baltimore, USA, to commence VISABL-AFL (the final approval required at Johns Hopkins); \u00a0<\/p>\n After the period, IMR further received the second and final approval by the French Competent Authority to commence VISABL-AFL at ICPS.\u00a0 Swiss Competent authority approval for CHUV is expected in the coming weeks.<\/p>\n With the successful completion of these multiple milestones, VISABL-AFL is fully cleared to start\u00a0at Johns Hopkins and ICPS, with CHUV to follow soon.<\/p>\n Amsterdam UMC is also expected to join the VISABL-AFL trial, and the required Ethics Committee submission will take place once the Amsterdam UMC Ethics Committee approves the VISABL-VT trial in the coming weeks.<\/p>\n All 91 patients in the VISABL-AFL trial are expected to be treated by year-end CY24, opening the door for FDA approval of IMR\u2019s platform of capital and consumable devices in CY25.<\/p>\n \u00a0<\/p>\n IMR\u2019s strategy of engaging closely with European customers last year to establish consistent procedure volumes at active sites and increase active sites in 2024 is proving successful.<\/p>\n The company says it saw a consistent schedule of procedures at the Leipzig Heart Center in Germany during Q1 CY24 as well as the reactivation of Amsterdam UMC in April.<\/p>\n Also in April, Dubrava University Hospital in Croatia issued their first purchase order catheters and other disposables.<\/p>\n Dubrava previously ordered the required capital equipment from IMR, and the lab installation has been completed.<\/p>\n The MRI software upgrades required for real-time imaging were installed by Siemens over the last week of April, and procedures at Dubrava are expected to commence in May.<\/p>\n Also, during the quarter, Semmelweis University Heart and Vascular Centre in Hungary published a tender for the acquisition of iCMR lab infrastructure.<\/p>\n IMR is the only company globally able to bid because it produces the MRI compatible equipment requested in the tender.<\/p>\n Procedures are expected to commence at Semmelweis in late Q2 or early Q3 CY24.<\/p>\n IMR\u2019s Vision-MR Diagnostic Catheter received CE mark certification in the period.<\/p>\n The diagnostic catheter is the first IMR device to receive approval under the new, stricter IMR says the vision-MR Diagnostic Catheter is a lower-cost non-ablating catheter which can replace the second ablation catheter in atrial flutter procedures, thereby increasing margins.<\/p>\n \u00a0<\/p>\n During the quarter IMR received Medical Device Marketing Authorisation (MDMA) from the Saudi Food & Drug Authority (SFDA), opening commercialisation efforts in Saudi Arabia through its exclusive distributor, Al Faisaliah Medical Systems (FMS).<\/p>\n IMR says FMS, with a strong track record and expansive distribution network, is positioned to propel its technology in a market where ~50,000 cardiac ablation procedures are conducted annually.<\/p>\n Furthermore, IMR\u2019s cutting edge technology aligns with the growth objectives of Saudi Vision 2030\u2019s Health Sector Transformation Program.<\/p>\n The company says SFDA approval also opens the door for commercialisation efforts in Qatar.<\/p>\n In late 2022, IMR entered into a 5-year distribution agreement with East Agency WWL, a prominent distributor in Qatar.<\/p>\n The deal grants exclusive rights for the distribution of IMR\u2019s innovative iCMR family of ablation products in the country.<\/p>\n \u00a0<\/p>\n IMR says after quarter end, April consumer revenue had already exceeded Q1 with more site activations to come during Q2.<\/p>\n \u201cWe have been laying the foundations for Imricor and our customers to move this new field forward,\u201d IMR chair and CEO Steve Wedan says.<\/p>\n \u201cEach new site we activate provides near term capital and consumable revenue to Imricor\u201d<\/p>\n \u201cMore importantly however, these same sites will then perform more complex procedures like ventricular tachycardia and atrial fibrillation.\u201d<\/p>\n \u00a0<\/p>\n This article was developed in collaboration with Imricor, a Stockhead advertiser at the time of publishing. <\/em>\u00a0<\/em><\/p>\n This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.<\/em><\/p>\n <\/span><\/p>\n The post Medtech Imricor \u2018laying the foundations\u2019 for growth after momentum builds in Q1 CY24<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"
\nApproval from Lausanne University Hospital (CHUV) Ethics Committee, in Switzerland to commence VISABL-AFL (the first of two approvals required at CHUV);
\nApproval from the Cardiovascular Institute of South Paris (ICPS) Ethics Committee, in
\nFrance, to commence VISABL-AFL (the first of two approvals required at ICPS); and
\nApproval of an Investigational Device Exemption (IDE) for Imricor\u2019s NorthStar 3D
\nmapping system to be added to the VISABL-AFL trial.<\/p>\nEuropean growth strategy a success<\/strong><\/h2>\n
\nEuropean Union Medical Device Regulations (EU MDR).<\/p>\nMoving ahead in Middle East <\/strong><\/h2>\n
\u00a0\u2018Laying the foundations\u2019 for growth<\/strong><\/h2>\n