Conformal Medical develops the CLAAS AcuFORM LAAO system, a foam-based device designed to conform to a broad range of left atrial appendage anatomies using only two sizes. The company aims to make LAAO a same-day, single-operator procedure and to enable ICE-guided closure that could eliminate the need for transesophageal echocardiography and general anesthesia. Conformal has treated over 100 patients with the AcuFORM System and reports impressive deliverability and safety performance to date. Its CONFORM Pivotal Trial is a prospective, randomized, multicenter study planning to randomize approximately 1,600 patients and is now more than 30% enrolled. The company is completing the CONFORM and GLACE clinical trials to support FDA pre-market approval and to validate its one-size strategy. Proceeds from the recent financing will fund enrollment of the CONFORM trial and key pre-commercialization initiatives for the CLAAS AcuFORM system. Conformal Medical develops the CLAAS System, a proprietary left atrial appendage occlusion (LAAO) implant designed to seal the LAA in patients with non‑valvular atrial fibrillation to reduce stroke risk without anticoagulants. The CLAAS device aims to make LAAO a same‑day, single‑operator procedure by enabling off‑axis positioning and providing a more uniform seal. The implant may eliminate the need for procedural transesophageal echocardiogram and general anesthesia, simplifying the procedure for physicians. The company is advancing the CLAAS System through the CONFORM pivotal clinical trial to evaluate safety and efficacy versus other commercially available LAAO devices and to support U.S. FDA pre‑market approval. Conformal intends to use the new capital to complete the clinical trial and demonstrate the device’s safety profile and clinical utility. Founded in 2016 and led by CEO James Reinstein, the company is based in Nashua, New Hampshire. Conformal Medical is an early-stage medical device company developing the Conformal Left Atrial Appendage Seal for LAA occlusion to prevent stroke in patients with non-valvular atrial fibrillation. The device is designed to adapt to the unique shape of each patient's left atrial appendage, be simpler to place, require less imaging, and eliminate the need for general anesthesia. Conformal's proprietary sealing technology aims to remove the need for long-term anticoagulants by sealing the LAA where clots form. The company says pre-clinical studies have borne out improved delivery and sealing versus first-generation devices. Conformal plans to use its recent financing to validate the technology in human trials. The company was founded in 2016 and is based in Nashua, NH.

Total raised

$76M

Funding rounds

3

Latest round

Series D

Latest activity

Aug 2025