Dedicated to developing solutions that simplify and streamline the generation of "big RNA data, Alithea genomics develops BRB-seq technologies and kits enable researchers to discover novel biomarkers and essential data needed to develop new drugs at a fraction of the traditional cost and time. The startup has expanded its product portfolio with the addition of MERCURIUS™ Full-Length DRUG-seq library preparation technology, which combines, for the first time, massive sample multiplexing, an extraction-free workflow and full transcript coverage in a unique RNA-seq workflow. The technology allows the preparation of Illumina-compatible RNA sequencing libraries for up to 384 samples in a time and cost-efficient manner. The kit enables full-length transcript coverage, as opposed to 3' coverage of the standard DRUG-seq kit, detecting over 40,000 different transcripts at only 4M reads/sample, reaching similar levels to non-multiplexed gold standard techniques. Furthermore, the technology allows the detection of different isoforms, splicing variants, and alternative promoters.
Cutiss enters clinical phase 3
Cutiss has received authorization from the European Medicines Agency (EMA) to commence the Phase 3 clinical trial for its lead product denovoSkin™ in adult & adolescent severe burn patients. denovoSkin is a personalized, bioengineered skin graft composed of an epidermis and dermis designed for the permanent treatment of skin defects and injuries. The phase 3 confirmatory trial will run across eight countries including Belgium, France, Germany, Italy, the Netherlands, Poland, Portugal, and Spain and aims to validate the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with severe burns compared to standard of care.
First implantation accomplished with Vanarix’s allogeneic Cartibead
While autologous chondrocyte implantation (using a patient’s own cartilage cells) has been a standard treatment for over three decades, its widespread use has faced various challenges such as inconsistent long-term regeneration of hyaline-like cartilage, the need for two surgical procedures, and the high costs associated with the treatment. Vanarix is addressing these shortcomings with its allogeneic Cartibead product, a bio-implant created from donor chondrocytes (cartilage cells) that targets the treatment of articular cartilage lesions, including focal lesions and those related to osteoarthritis. The company has now made the first transplantation of allogeneic Cartibeads, derived from donor cells. Three months post-implantation, surgeons have reported outstanding results, with the patient showing complete regeneration of cartilage that closely resembles natural tissue with no sign of immune rejection of the bioengineered allograft implant. The procedure took place at Ente Ospedaliero Cantonale (EOC) and Cell Factory at Lugano as part of a collaborative clinical study alongside HUG - Hopitaux Universitaires de Genève, Hirslanden Genève, and Universitätsklinik Balgrist in Zurich.
Distalmotion treats first patients in outpatient setting
Less than 30 days after receiving FDA De Novo marketing authorization, Distalmotion has treated the first U.S. patients in an outpatient setting at UC San Diego Health. Two adult inguinal hernia repairs were completed with Dexter, a surgical robot is designed to address the growing demand for cost-effective and efficient solutions for high volume procedures in these settings. Its mobile design, small form factor, and open platform design make it particularly well-suited to outpatient environments, enabling hospitals and ASCs to optimize resources while still accessing the latest technologies and best-in-class surgical tools. Dexter seamlessly integrates into existing operating workflows and is fully compatible with current operating room equipment, protecting hospitals' existing investments. Additionally, its single-use instruments remove the complexities of reprocessing, further enhancing workflow efficiency. With more than 1,400 patients successfully treated in Europe, Distalmotion’s extensive experience has paved the way for bringing this innovation to the U.S. market.
(Press release/RAN)