News
BellaSeno Successfully Completes Two Clinical Trials with Novel, Resorbable Breast Implants
— One-year follow-up data confirm favorable safety profile of BellaSeno´s scaffolds compared to silicone implants
— Company plans expansion to primary breast augmentation and lumpectomy
BellaSeno GmbH, an ISO 13485-certified medtech company developing resorbable scaffolds using additive manufacturing technologies, today announced that all 19 breast scaffold patients enrolled in 2022 in an Australian breast augmentation revision trial have successfully completed a one-year follow-up without any major scaffold-related complications or scaffold removals. In addition, in a parallel Australian clinical trial, 7 pectus excavatum patients have successfully passed one-year follow-up. Read more…
tiakis Biotech AG Receives Positive Scientific Advice from the U.S. FDA for Planned Phase II Trial of Tiprelestat
– tiakis and Stanford University are preparing for a Phase II in Pulmonary Arterial Hypertension (PAH)
tiakis Biotech AG, a clinical-stage biopharmaceutical company developing novel therapeutics for life-threatening pulmonary and cardiovascular diseases, today announced that the Company has received positive scientific advice from the U.S. FDA on a planned Phase II trial for the treatment of Pulmonary Arterial Hypertension (PAH). The FDA supports the study design of the so-called ATHENA trial and its primary and secondary endpoints. Tiprelestat has already been granted orphan designation in PAH in the U.S. and in Europe.
Next-generation RNA company Inverna Therapeutics launched by Argobio and University of Southern Denmark
— Novel paradigm for therapeutics based on RNA splicing modulation
— Lead program in Huntington’s disease
Inverna Therapeutics, a novel Danish biotech company at the forefront of innovative RNA therapeutics, today announced its launch as a leading-edge RNA therapeutics company. The Company was co-founded by the University of Southern Denmark and Argobio and is dedicated to transforming patient outcomes in severe genetic diseases, starting with a lead program addressing Huntington’s disease.
tiakis Biotech AG Reports Clinical Phase Ib/II Trial Results of Tiprelestat for the Treatment of Hospitalized COVID-19 Patients
–– Tiprelestat was safe and well tolerated, with initial signs of clinical efficacy
tiakis Biotech AG, a clinical-stage biopharmaceutical company developing novel therapeutics for life-threatening pulmonary and cardiovascular diseases, today announced the results of its randomized, double-blind, placebo-controlled clinical Phase Ib/II COMCOVID trial evaluating Tiprelestat for the treatment of patients hospitalized due to COVID-19. In 2021, tiakis Biotech received support from the German Federal Ministry of Education and Research (“BMBF”) to initiate the COMCOVID trial.