Neovasc Inc. has hit pause on its Tiara transfemoral mitral valve replacement (TF) program and is cutting its workforce by more than 40%, citing the additional time and substantial investment required to develop the program and the associated costs. The changes are expected to extend its cash runway from about 18 months to more than three years. The changes were implemented with about 18 months to remain solvent as part of a series of actions to focus on enhancing current shareholder value and focusing investments on near-term value drivers, namely the Reducer stent and the Tiara transapical mitral valve replacement (TA) system.
PARIS – Affluent Medical SAS aims to raise $40 million on the Euronext Paris regulated market to finalize the development of three minimally invasive prostheses in urology and interventional cardiology. The Aix-en-Provence, France-based med-tech will issue 3,387,210 new shares. Affluent has already received subscription pledges exceeding $24 million, including $12 million from funds managed by Paris-based Truffle Capital.
The FDA granted Neurescue a "two-fer" on its intelligent balloon catheter for aortic occlusion with 510(k) clearance for emergency control of hemorrhage and investigational device exemption for use in cardiac arrest. By inflating a soft balloon at diaphragm level, the device dramatically increases perfusion to the heart, brain and lungs within a minute of deployment via the femoral artery.