Adagio Medical (Nasdaq:ADGM) announced today that it received FDA breakthrough device designation for its vCLAS cryoablation system. The Laguna Hills, California–based company based its vCLAS cryoablation catheter on its proprietary ultra-low cryoablation technology (ULCT). It aims to address the challenges of ventricular tachycardia (VT) ablations, comprising part of the Adagio VT cryoablation system. The system’s […]
adagiomedical
Adagio Medical to restructure, reduce workforce
Adagio Medical (Nasdaq:ADGM) announced today that it plans a corporate restructuring and realignment of resources. The Laguna Hills, California–based company, which develops catheter ablation technologies for treating cardiac arrhythmias, wants to prioritize its FULCRUM-VT pivotal FDA investigational device exemption (IDE) clinical trial activities and its new product design optimization program. “After a comprehensive strategic review, […]
Adagio Medical picks medtech veteran Todd Usen as new CEO
Adagio Medical (Nasdaq:ADGM) announced today that it appointed Todd Usen as its new CEO and board director. Usen’s appointment follows the departure of Olav Bergheim, the company’s founder, CEO and board chair, effective Dec. 13. The company concurrently made Usen CEO and Orly Mishan chair of the board of directors. Bergheim intends to continue serving […]
Adagio has first case in IDE study for cryoablation tech
Adagio Medical (Nasdaq:ADGM) today announced the first completed procedure in an FDA IDE study of its VT cryoablation system. The company picked up FDA investigational device exemption (IDE) for the study of its VT cryoablation system in May. Laguna Hills, California-based Adagio also reported the first commercial procedures in Europe following CE mark approval at […]
Adagio Medical goes public in SPAC merger
Adagio Medical announced that it completed its previously announced business combination with Arya Sciences Acquisition Corp IV. Arya, a special purpose acquisition company (SPAC), agreed to acquire Adagio in February. The acquisition takes Adagio public, trading under the “ADGM” ticker on the Nasdaq market as of yesterday, Aug. 1. Adagio continues operations under its current […]
Adagio Medical wins FDA IDE for cryoablation study, completes first commercial cases in Europe
Adagio Medical announced today that it picked up FDA investigational device exemption (IDE) for a study of its VT cryoablation system. The Laguna Hills, California-based company also completed the first commercial procedures in Europe following CE mark approval. Adagio Medical designed its VT system with the vCLAS cryoablation catheter based on its proprietary ultra-low cryoablation […]
Ablation tech developer Adagio Medical to go public in SPAC deal
Arya Sciences Acquisition Corp IV agreed to a business combination with Adagio Medical, taking the cardiac ablation company public. Upon the closing of the transaction, Adagio is set to become a subsidiary of Aja Holdco, still operating under its existing management team and under the name “Adagio Medical.” Arya expects to list the combined company’s […]
Adagio Medical starts iCLAS AFib trial
Adagio Medical announced that it enrolled the first patient in its iCLAS investigational device exemption clinical trial for assessing the treatment for persistent atrial fibrillation. The iCLAS is a low-temperature intelligent continuous legion ablation system. The FDA-approved study has the goal of evaluating the safety and efficacy of the system in PsAF to support pre-market approval […]
FDA OKs Adagio Medical’s cryoablation afib trial
Adagio Medical yesterday said it received an investigational device exemption from the FDA for a clinical trial of its cryoablation device for treating atrial fibrillation. The 80-patient study, a non-randomized, single-arm trial of subjects with persistent afib, will use the Laguna Hills, Calif.-based company’s intelligent continuous lesion ablation system to treat patients with afib of […]
Adagio Medical raises $7m
Cardiovascular cryoablation tech developer Adagio Medical has raised approximately $7 million in a new round of equity and options financing, according to a recently posted SEC filing. The company is looking to raise an additional $13 million, which would bring the total raised up to $20 million, according to the filing. Adagio Medical is developing and producing […]
Adagio Medical launches OneShot+ cardio cryoablation cath
Cardiovascular cryoablation tech developer Adagio Medical said it launched its One Shot+ cryoablation catheter, and that the first patient has been treated with the device. The Laguna Hills, Calif.-based company said the newly cleared One Shot+ catheter is intended for pulmonary vein isolation and other continuous ablation lesions of non-pulmonary-vein targets for treating atrial fibrillation. […]
