Imricor Medical Systems has received firm commitments for a two-tranche placement to raise $35m
Placement support by new and existing security holders – including a number of new institutional investors
Proceeds to fund the growth strategy, which focus on three areas including completing the pivotal US FDA trial for VISABL-AFL
Special Report: Imricor Medical Systems’ growth strategy has received strong support from new and existing investors, who have made firm commitments for a $35m capital raising.
The company’s growth strategy is focused on three areas.
It is completing the US FDA pivotal trial called VISABL-AFL for atrial flutter, expanding treatments with the pivotal European ventricular tachycardia (VT) trial called VISABL-VT and commercialisation – including the activation of sites in Europe and the Middle East to grow the installed base, and expanding into Australia and New Zealand.
Imricor Medical Systems (ASX:IMR) recently started the VISABL-AFL clinical trial at the Cardiovascular Institute of South Paris for a potential US FDA approval in 2025.
This trial aims to evaluate the safety and effectiveness of atrial flutter ablation using the company’s Vision-MR Ablation Catheter System and is expected to enrol 91 patients across the US and Europe by the end of this year with plans for interim analysis after 76 patients.
Securing approval from the FDA is a big deal for biotechs as it not only validates the safety and efficacy of a medical treatment, but also opens the door to substantial commercial opportunities, as it allows medical device companies like Imricor to market and sell the device in the highly lucrative American market.
The FDA trial is a repeat of a trial in Europe to receive CE Mark certification which showed 100% success in all patients.
That has left Imricor confident of a positive outcome in the FDA process, with the US study requiring a success rate of 80%.
Two tranche placement
The prospects of achieving this milestone, which typically leads to increased investor confidence and potential revenue growth, were enough to convince new and existing securityholders – including a number of new institutional investors – to back the two-tranche placement to raise $35m.
Investors made firm commitments to subscribe for about 67.3 million CHESS depositary interests and shares priced at 52c each, a 10% discount to the 10-day volume weighted average price of 57.8c.
The first tranche will raise $25.7m through the issue of ~49.5 million new securities using the company’s available capacity under ASX Listing Rule 7.1 and 7.1A.
The remaining $9.3m will be raised through the issue of ~17.8 million new securities subject to shareholder approval to be sought at an upcoming special meeting.
“The work that took place at Imricor in 2023 allowed us to start 2024 with great momentum, and we have entered the current quarter on the cusp of several major milestones for the company,” chair and chief executive officer Steve Wedan said.
“With the support of our existing and new investors, we can now realise these catalysts with a strong balance sheet.”
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