Restore Medical Ltd. is implanting the first patients with its Contraband technology for congestive heart failure (CHF). The minimally invasive, catheter-delivered implant is being assessed in patients with chronic left ventricular failure. The Or Yehuda, Israel-based startup is carrying out the trial at the ZNA medical center in Antwerp, Belgium, followed by the Kaplan medical center in Israel. The goal of the implant is to enable the right ventricle to strengthen the left ventricle and improve ejection fraction, reduce mitral regurgitation and restore a favorable ventricular geometry.
LONDON – Aviadobio Ltd. has raised $80 million in a series A round to take a precision microdosed gene therapy for treating familial frontotemporal dementia into a phase I/II clinical trial.
While discussing positive data on its lead candidate lenzilumab for treating hospitalized COVID-19 patients, Humanigen Inc.’s CEO sparred a bit with the FDA and its refusal to grant the treatment emergency use authorization. The monoclonal antibody, Cameron Durrant told investors on a Dec. 2 call, could possibly have saved 60,000 to 70,000 patients while the company waits for another meeting with the FDA.
Memed Diagnostics Ltd. has published new data from an EU Commission funded clinical trial evaluating its blood test for differentiating bacterial and viral infections. The prospective, multicenter cohort study, titled “AutoPilot-Dx,” was carried out in emergency wards in Italy and Germany. The goals of the study were to validate the performance of Memed’s BV test in a broad pediatric population with respiratory tract infections or fever without source and estimate its potential to impact antibiotic use.
Ursula Matulonis, a co-principal investigator in the latest study with Immunogen Inc.’s antibody-drug conjugate mirvetuximab soravtansine in stubborn ovarian cancer, said the top-line data are “truly spectacular” and bring “the potential to be transformative for patients.”
LONDON – Quell Therapeutics Ltd. has raised $156 million in an oversubscribed series B, enabling it to start a phase I/II trial of its engineered T regulatory (Treg) cell therapy for promoting long-term immune tolerance in liver transplant patients, averting the need for chronic immunosuppression.
Shares of Krystal Biotech Inc. (NASDAQ:KRYS) rocketed 121.7% higher, to $88.44 on Nov. 29, after top-line data showed its investigational gene therapy for dystrophic epidermolysis bullosa (DEB) achieved the primary endpoint of a pivotal phase III trial, healing 67% of skin wounds associated with the disease vs. placebo at six months.
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