Funds to Support FDA Review of Company’s Next-Gen Cryoablation Technologies
Adagio Medical Holdings, (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, announced the closing of its previously announced private placement , led by existing investors and new healthcare-dedicated institutional investors.
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Adagio intends to deploy the net proceeds to:
- Support submission activities for its FULCRUM-VT pivotal clinical study for Premarket (PMA) approval of the vCLAS ULTC System by the U.S. Food and Drug Administration (“FDA”)
- Advance clinical experience and FDA submission activities for the Company’s faster, smaller, more flexible next generation ULTC catheter
- Build awareness of ULTC and its many advantages as a purpose-built solution for VT patients and the ventricular anatomy
- Expand manufacturing and scale commercial-readiness
- Strengthen overall corporate operations
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The Company anticipates that this infusion of capital will de-risk execution and extend the Company’s cash runway into key inflection points.
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“Closing this financing on the heels of sharing the acute results from our FULCRUM-VT clinical study at the recent VT Symposium is further validation of the positive feedback we received both from the podium and the electrophysiologists in attendance. We have treated over 350 patients, including those from our two regulatory studies, combined with commercial and compassionate use cases, which supports the potential of our Ultra Low ablation technology for VT to improve clinical outcomes and safety. I want to thank our investors for their support and partnership,” said Todd Usen, CEO of Adagio Medical. “We believe we now have the financial flexibility to unlock the full potential of our portfolio of ULTC therapies to transform treatment for the large, underserved population of patients with ventricular tachycardia.”
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Source : businesswire