MR is stated to be a widespread valvular heart condition. Credit: Jo Panuwat D / Shutterstock.
4C Medical Technologies has closed its Series D financing round, raising gross proceeds of up to $175m.
Led by Boston Scientific, the funding will expedite the clinical development and commercialisation of 4C Medical’s transcatheter mitral valve replacement (TMVR) technology, AltaValve System.
Piper Sandler served as 4C Medical’s strategic adviser and exclusive agent for this transaction.
The proceeds will mainly support the global, pivotal ATLAS trial, currently underway in Europe and the US.
The trial, which was initiated in the US last October, aims to evaluate the system’s effectiveness and safety in individuals with moderate-to-severe or severe mitral regurgitation (MR) who are not suitable for surgical or transcatheter edge-to-edge repair treatments.
4C Medical Technologies CEO and president Saravana Kumar said: “We are excited to welcome Boston Scientific and thank our shareholders for their support with our financing.
“The enthusiasm for participation in our ATLAS pivotal trial is palpable, and with this strong capital raise and the backing of Boston Scientific, we look forward to clinically demonstrating the safety and effectiveness of the AltaValve System in treating patients with MR.”
The ATLAS trial is structured with two distinct cohorts that are not randomised – one is for subjects with moderate/severe mitral annular calcification (MAC), and the other is a primary cohort that will include patients with no or mild MAC.
Collaborating as principal investigators, Allina Health Minneapolis Heart Institute’s cardiologist Dr Paul Sorajja and Barnes-Jewish Hospital’s cardiothoracic surgeon Dr Yoshi Kaneko are responsible for overseeing the US arm of the trial.
Their European counterparts, Interbalkan Medical Center cardiologist Dr Vlasis Ninios and University Hospital Cologne cardiothoracic surgeon Dr Lenard Conradi, are managing the European segment.
A widespread valvular heart condition, MR is caused when mitral valve leaflets fail to close correctly. It affects around one in ten American individuals over 75 years of age and can lead to serious complications if untreated.
In May 2024, the company’s AltaValve system [received dual breakthrough device designations](https://www.medicaldevice-network.com/news/4c-medical-altavalve-dual-breakthrough-designations-fda/) from the US Food and Drug Administration (FDA).