Volta Medical is announcing a €36 million series B fundraise to lift its total investment to above €70 million.
Leading the round on this occasion is the US investor Vensana Capital, with participation from Lightstone Ventures and the healthcare-focused fund manager Gilde Healthcare, which has backed Volta before.
Volta Medical has developed an AI to help surgeons carry out cardiac ablation procedures. Ablation is used in the theatre room to open up small scars in cardiac tissue, using hot and cold radiofrequencies, which then block abnormal electrical pathways responsible for arrhythmia. While the risks are rare, it is a serious and invasive procedure.
There's been a lot of momentum for assistive AI tools in medicine, as more advanced image detection models trained on deep learning have been sanctioned by regulators in the US and EU to give surgeons an actionable analytical and decision support dashboard.
On the other side of the coin, AI in surgery startups have to convince European healthcare providers to absorb the cost of AI software integration. It's a particularly demanding environment in healthcare at the moment, with many health boards alarmed by intensifying pressure on hospital wards in the wake of the COVID pandemic.
Volta Medical is headquartered in Marseille, France making it a star of southern France's tech innovation scene.
Led by CEO and co-founder Theophile Mohr Durdez, the company is preparing to launch additional clinical trials for its lead product, VOLTA VX1, an AI decision support tool that helps physicians identify and annotate heart abnormalities. The new clinical trials will offer further validation of the AI software building on work undertaken during the regulatory process. For example, Volta has a 342-patient trial underway at three US hospitals expected to report back in 2024.
The additional clinical studies will also support what Volta describes as a "full-scale US commercialisation" while helping to secure regulatory approval in new markets. Volta Medical also proposes to use some of the series B funds to deliver on follow-up products from its roadmap.
Using real-time identification of known abnormal electrograms, seen by clinicians during ablation procedures before, the startup's AI is able to produce live and annotated 3D maps of the patient's cardiac anatomy and electrical impulse system.
The first US patients suffering from persistent cardiac arrythmias were treated using Volta's AI in late-2021. Follow up studies from its earlier clinical trials suggest patients recovered from surgery successfully, with a 73% improvement rate for atrial arrhythmia a year after surgery. Volta Medical says there's a possibility the AI could help surgeons treat more complex arrhythmias, such as persistent atrial fibrillation (AF). Persistent AF can cause serious blood clots and is usually treated with an assortment of first and second-line medications.
"There is a critical need to improve precision and consistency in cardiac ablation procedures for patients with persistent atrial fibrillation," Durdez said. "With half of these patients requiring repeat treatments, clinicians need tools that enable them to better understand the disease and drastically improve patient outcomes.”
The cardiac ablation software assistant is trained to identify heart tissue based on "curated databases of intra-cardiac electrograms." Regulators in the US and EU have sanctioned the product as safe to use, and in the US it was the first to receive FDA clearance for interventional cardiology, Volta Medical claims.
In conjunction with the series B round, Volta Medical is also announcing a fresh hire to its executive team. John Slump, previously of medical device companies Farapulse, Attune Medical and Surgical Innovation Associates, is coming on board as chief financial officer.
Slump said: "I’m excited to join the Volta Medical team and am pleased with our ability to attract significant equity investment from both new and existing investors in an increasingly challenging fundraising climate.
"VOLTA VX1 has the potential to make a major difference in the lives of millions of people with AF, and this Series B Financing will help to accelerate its development and adoption nationally and across the globe.”