Conformal Medical has secured $85m in a Series C financing round to fund the US pivotal trial of CLAAS technology designed for sealing the left atrial appendage in patients with atrial fibrillation (AFib).
The financing syndicate included Catalyst Health Ventures (CHV) and many returning Series A and B investors.
The round was also joined by new investors Fidelity Management & Research Company and an undisclosed strategic investor.
Conformal Medical president and CEO Andy Levine said: “We are extremely pleased with the strong support of our investment partners, validating the potential of our next-generation technology in the growing left atrial appendage closure (LAAC) market.
“With this significant raise, we look forward to initiating our pivotal trial and taking the next step to establish the CLAAS implant as a cornerstone stroke reduction strategy for patients with AFib.”
Conformal’s CLAAS system uses a proprietary foam-based architecture to accommodate most anatomies with only two sizes.
It also allows physicians to perform LAAC without general anaesthesia by enabling simplified delivery and eliminating the need for procedural transesophageal echo (TEE).
The company expects to begin the randomised pivotal trial for the system next year, enrolling over 1,300 patients at multiple sites worldwide.
The study will investigate the safety and effectiveness of CLAAS technology compared to Boston Scientific’s Watchman products.
LAAC is considered to be an important alternative to blood thinners for preventing strokes in patients with AFib.
It is estimated that the first-generation LAAC devices have a market of $600m globally, which is expected to grow to approximately $1bn in the next five years.
In a separate development, life sciences company Fractyl Laboratories has raised $55m in a Series E financing round led by new investor Taiwania Capital Management Corporation.
Returning investors Bessemer Venture Partners, General Catalyst, Domain Associates, Mithril Capital Management, Emergent Medical Partners, True Ventures and GV also participated in the round, along with new investors Catalio Capital Management, CDIB Venture Capital and YJ Capital.
Fractyl plans to use the proceeds to support the Revita T2Di pivotal clinical trial of Revita duodenal mucosal resurfacing (DMR) for the treatment of patients with type 2 diabetes (T2D).
The trial will enrol 300 patients at 20 centres across three continents and is expected to begin later this year.