4C Medical Technologies has secured $175m financing in a Series D financing round, led by Boston Scientific, with participation from new and existing shareholders.
The US-based medical device company intends to use the funds to advance the clinical development and commercialisation of its AltaValve System.
AltaValve is a next-generation transcatheter mitral valve replacement (TMVR) technology.
4C Medical will use the proceeds from the financing to primarily support its ongoing ATLAS clinical trial in the US and Europe.
The study aims to evaluate the safety and effectiveness of the AltaValve System in patients with moderate-to-severe or severe mitral regurgitation (MR) who are not eligible for surgery or transcatheter repair.
The trial, which began enrolment in the US in October 2024, consists of two non-randomised cohorts: one for patients with moderate/severe mitral annular calcification (MAC) and a primary cohort for those with no or mild MAC.
4C Medical president and CEO 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.”
MR is a common valvular heart disease that occurs when the mitral valve leaflets fail to close properly, causing blood leakage from the left ventricle back into the left atrium.
If left untreated, MR can lead to severe health issues such as atrial fibrillation, pulmonary hypertension, heart failure, and even death.
AltaValve System presents a significant advancement in MR treatment, using atrial fixation compared to sub-valvular TMVR devices that rely on rigid anchoring mechanisms.
It aims to minimise design limitations associated with the complexity and variability of the mitral annulus and left ventricle, widening its applicability to a larger number of MR patients.
Piper Sandler served as the exclusive agent and strategic advisor to 4C Medical for the Series D financing transaction.
4C Medical board chairman Jeff Chambers said: “This financing and participation of Boston Scientific is timely as we continue enrollment in our global ATLAS pivotal trial.
“With a strong management team and the trial leadership, this financing strategically positions us to accelerate our progress towards device commercialisation.”
