US-based Conformal Medical has completed a Series D extension financing round, securing $32m to support its ongoing clinical trial and fund pre-commercialisation activities for the CLAAS AcuFORM left atrial appendage occlusion (LAAO) system.
This funding will primarily facilitate the continuation of the CONFORM pivotal trial, designed to assess the efficacy and safety of the system in comparison with other LAAO devices available on the market.
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The system is intended for sealing the left atrial appendage (LAA) in individuals with non-valvular atrial fibrillation (AFib) to minimise the stroke risk, eliminating the requirement for anticoagulants.
The multi-centre, prospective, randomised controlled study has already enrolled more than 30% of its target of approximately 1,600 subjects across various international sites.
Its objective is to provide pivotal data that will aid in the advancement of stroke prevention treatments for patients with non-valvular AFib who are looking for alternatives to long-term use of oral anticoagulants.
The system’s foam-based structure is tailored to adapt to a wide range of LAA anatomies using two sizes.
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By GlobalDataIt could also catalyse a shift towards intracardiac echocardiography (ICE)-guided LAAO closure, potentially removing the requirement for a transoesophageal echocardiogram and general anaesthesia during the procedure.
This progression could lead to a single-operator procedure that would be less invasive for individuals.
Conformal aims to complete additional clinical trials, including GLACE, to establish a strong safety profile and demonstrate the potential of their technology to revolutionise the treatment of LAAO.
In this transaction, Conformal engaged Piper Sandler as the exclusive financial advisor and Gunderson Dettmer as legal counsel.
Conformal Medical CEO and president James Reinstein said: “We are pleased to have treated over 100 patients with the next-generation AcuFORM System, with impressive deliverability and safety performance to date.
“We look forward to building upon this robust body of evidence to further validate our one-size strategy, and the promising experience from our GLACE trial, demonstrating successful use of ICE guidance as it would eliminate the need for general anaesthesia and intubation for these procedures.”
