EBR undertakes a $50m capital raise ahead of anticipated US FDA approval for WiSE. Pic: Getty.
Health & Biotech
Special Report: EBR Systems will undertake a fully underwritten Institutional placement and entitlement offer to raise $50m to support the commercialisation of its WiSE CRT system in anticipation of US FDA approval in Q1 CY25.
EBR Systems (ASX:EBR) said ~61 million new CDIs (CHESS depositary interest) will be issued under capital raise which represents ~19.8% of the current CDIs on issue with each representing one share of common stock.
The offer price per new CDI under the capital raise is 82 cents, which represents a:
EBR said the new CDIs issued under the capital raise will rank equally with all existing CDIs.
The entitlement offer comprises both the institutional entitlement offer and retail entitlement offer.
EBR said all holders of CDIs in Australia and New Zealand, as well as institutional holders in Hong Kong, Singapore and the UK (eligible security holders) can apply for one new CDI for every 20 CDIs they hold.
Bell Potter Securities, Morgans Corporate and E&P Capital are acting as joint lead managers and bookrunners for the capital raise.
Wilsons Corporate Finance is also acting as a joint lead manager, with the capital raise fully underwritten by Bell Potter.
The institutional placement is expected to raise $37.4m in gross proceeds. New CDIs under the institutional placement are expected to be issued on September 26, 2024.
The entitlement offer will comprise both an institutional entitlement offer and a retail entitlement offer and is expected to raise up to $12.6m.
EBR said any shortfall from the retail entitlement offer will be subscribed for according to terms of the underwriting agreement.
New CDIs under the retail entitlement offer are expected to be issued on October 16, 2024.
EBR said funds raised from the institutional placement and entitlement offer will be used to support commercialisation, manufacturing scale-up of its WiSE cardiac resynchronisation therapy (CRT) system, R&D, plus general administrative and working capital
EBR Systems recently announced it had submitted the final premarket approval (PMA) application module to the FDA for WiSE, which holds the distinction of being the world’s first leadless pacemaker for the heart’s left ventricle.
The company said the WiSE System offers a solution for patients with no existing treatment options, potentially improving outcomes for millions, with EBR targeting a market valued at US$3.6bn.
EBR’s pivotal study SOLVE-CRT for WisE was recently published in the prestigious journal JAMA Cardiology.
EBR expects approval for WiSE in Q1 CY25, based on the typical PMA review cycle, and remains on track for a US commercial launch next year.
The company said the initial launch will focus on driving adoption of the WiSE system at key high-volume procedure sites across the US.
This article was developed in collaboration with EBR Systems, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
