Salvia Bioelectronics BV raised $60 million in a series B financing round for its minimally invasive implantable neuromodulation device, Mysalvia therapy, which treats chronic migraine. The funds will be used for clinical trials and obtaining regulatory approvals in the U.S., Europe and Australia.
Edwards Lifesciences Corp. released new economic and clinical data on severe aortic stenosis (AS) demonstrating intervening in a patient with the disease before symptoms develop can reduce costs to the health care system by $36,000. Data also shows earlier intervention can also lead to fewer follow-ups and hospitalizations for heart failure, after treatment.
Data from the first-in-human study of Tricares SAS Topaz transcatheter tricuspid valve replacement (TTVR) system, showed it significantly reduced tricuspid regurgitation (TR) in patients treated with the device. The early clinical data at 30 days demonstrated that all patients implanted with Topaz were at a TR grade ‘none’ (0+) or ‘mild’ (1+) following the procedure.
Medtronic plc revealed data at the EuroPCR conference which showed there was a significant, safe and sustained blood pressure reduction in patients treated with its Spyral renal denervation system who meet European recommended guidelines criteria over a three-year period.
Three-year data from Elixir Medical Corp.’s Bioadaptor randomized controlled trial showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system continued to see lower adverse events rates compared to those treated with Medtronic plc’s Resolute Onyx drug-eluting stent .
Shockwave Medical Inc., a unit of Johnson & Johnson Medtech, reported positive 30-day results from the EMPOWER CAD trial, which used its intravascular lithotripsy system in women with complex, calcified coronary artery disease. The results from the first prospective, real-world percutaneous coronary intervention study in female patients confirmed the benefit of coronary patients as seen in other retrospective analyses.
Rebrain SAS's Optimmri platform received European Medical Device Regulation CE mark certification to enable surgeons to identify areas of interest in the brain during deep brain stimulation procedures for Parkinson's disease and essential tremor.
PhaseV Inc. raised $50 million in a series A funding round to further develop its machine learning (ML) platform which helps companies reduce the cost and duration of clinical trials, and increase their possibility of success.
A low-intensity transcranial ultrasound stimulation device, developed by Sonomind SAS, was proven to be safe and effective in treating patients suffering from drug-resistant depression. The results of a study published in Brain Stimulation showed a 61% reduction in the depressive symptoms of patients treated with the device over a five-day period, with no serious adverse events.
Mentaily Ltd. raised $3 million in seed funding for its AI-powered mental health diagnosis, triage and support tool, Liv. The platform is designed to help patients suffering from psychological distress and mental illness.