Archive: Company News

New Clinical Data on BellaSeno’s Novel, Resorbable Breast Implants Presented at The Aesthetic MEET 2025

— Presentation by Prof. Anand Deva highlights 87% breast volume retention and low complication rate in one-year patient follow-up

— Successful vascularization and vessel formation in two-year follow-up

— 3D-printed resorbable scaffold to preserve both volume and shape of autologous fat in the medium to long term

BellaSeno GmbH, an ISO 13485-certified medtech company developing resorbable scaffolds using additive manufacturing technologies, today announced that Prof. Anand Deva presented new clinical data on BellaSeno’s novel, 3D-printed, resorbable breast scaffolds at The Aesthetic MEET 2025 conference in Austin, TX, USA.

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AMYRA Publishes Landmark Review Supporting New Gluten Digestion Approach for Celiac Disease

— Findings highlight underexplored role of intestinal brush border in protein digestion, and its vulnerability to inflammatory damage in celiac disease

— Review discusses potential benefits of supplementing brush border exopeptidase activity in celiac disease patients

AMYRA Biotech AG, a leader in pioneering approaches to digestive health, today announced it published a peer-reviewed literature review in Alimentary Pharmacology & Therapeutics [https://onlinelibrary.wiley.com/doi/10.1111/apt.70014]. The review summarizes current knowledge on gluten-digesting enzyme therapies for celiac disease and underlines the benefits of exploring exopeptidase supplementation as a novel therapeutic paradigm. Read more…

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.

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