In what represents the first patenting from Cerathrive Ltd., its co-founder and CEO, Sarah Turner, describes their development of the Cera system, which they claim to be the first and only U.S. FDA-cleared red-light device that targets the gut-brain axis to improve focus and energy levels.
According to World Health Organization data, endometriosis affects about 10% of reproductive-age females globally. That already makes endometriosis a wildly underresearched and underfunded disease in relation to its prevalence. Plus, Rama Kommagani thinks even 10% is an underestimation. “Diagnosis is very underreported, particularly in low- and middle-income countries,” Kommagani, who is an associate professor of pathology at Baylor College of Medicine, told BioWorld.
Endostart s.r.l obtained CE marking for the expanded use of its magnetic balloon system for use in endoscopic procedures, Endorail, to enteroscopy. The company believes that Endorail, which helps resolve intestinal looping, will make the procedure more accessible and improve patient care.
Clostridioides difficile is traditionally isolated from healthcare facilities' inpatients, but it is increasingly being identified in people who have not recently been hospitalized and is more and more found in community settings. Investigators from Perelman School of Medicine at University of Pennsylvania developed an mRNA-LNP vaccine with promising results in preventing and controlling C. difficile infection.
A collaborating team of researchers from the U.K.’s University College London and the Incliva Biomedical Research Institute in Valencia, Spain, filed for protection of a machine learning model called AMMON-OHE to predict occurrence of overt hepatic encephalopathy in patients with cirrhosis of the liver.
Microbiotica Ltd. is poised to advance two of its microbiome-derived products into the clinic after securing regulatory approval and fresh finance. The first live bacterial therapeutic, MB-097, will be tested in combination with Keytruda (pembrolizumab) in patients with advanced melanoma who have not responded to treatment with immune checkpoint inhibitors. The second product, MB-310, is a once-daily oral therapy for treating the inflammatory bowel disease, ulcerative colitis.
The U.S. Court of Appeals for the Federal Circuit reinstated patent claims covering Allergan USA Inc.'s bowel treatment drug Viberzi (eluxadoline), reversing a lower court that had invalidated the claims for not meeting obviousness-type double patenting or written description requirements. However, the appellate court said the district court “can, and should, address any other grounds of invalidity raised … at trial that are adequately supported by the record.”
The first patenting to emerge in the name of Copenhagen, Denmark-based 1Health Gut In Balance ApS (dba Gut In Balance) describes development of an apparatus and system that enables hospitals to produce fecal microbiota transplantation capsules on site, and much more efficiently and cheaply.
The U.S. FDA granted Signum Surgical Ltd. de novo marketing clearance for its Biohealx technology as a treatment for anal fistula. Biohealx is a single use, bioabsorbable implant, designed to not only to treat the condition in a minimally invasive procedure but also promote healing, prevent fistula recurrence and protect patient continence.
Merit Medical Systems Inc. acquired the Esophyx Z+ device from Endogastric Solutions Inc. for $105 million in cash, adding a durable, non-pharmacological treatment for gastroesophageal reflux disease to its line-up of gastrointestinal products.
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