Hypothermic therapy startup Tectraum Inc. has finished enrolling patients in a pivotal trial of its Pro2cool device for the treatment of concussion. The company expects to submit the results to the U.S. FDA to support regulatory clearance by the end of this year and commercially launch Pro2cool in the U.S. in the first quarter of 2023.
Xeltis BV plans to expedite an international pivotal trial investigating its restorative hemodialysis access graft Axess following encouraging preliminary data. The company released results from a clinical trial investigating the graft at CX 2022, the Charing Cross International Symposium on Vascular and Endovascular Challenges, in London. Data showed the graft had 100% functional patency and safety in a patient cohort of 11, with a median follow-up of 6.5 months.
Arecor Therapeutics plc has presented early stage clinical data from a novel concentrated insulin formulation, which it hopes will outperform marketed rivals by allowing lower volume and reduced frequency doses. Cambridge, U.K.-based Arecor presented data at the International Advanced Technologies and Treatments for Diabetes meeting from AT-278, an investigational meal-time concentrated (500 U/mL) novel formulation of insulin.
Samsara Vision Inc. has received FDA approval to begin a U.S.-based PMA supplement trial to assess improvements in visual acuity and safety of its smaller-incision next-generation implantable miniature telescope, called SING IMT, in people with late-stage age-related macular degeneration (AMD). The device has been available in the EU since 2020.
The days when paclitaxel was the subject of controversy in connection with peripheral artery disease (PAD) seem to be drawing to a close, thanks in part to a new drug-coated balloon (DCB) by Trireme Medical Inc., of Pleasanton, Calif. Trireme’s Chocolate Touch device, a second-generation DCB with paclitaxel as an antiproliferative, fared well against a legacy paclitaxel device, thus opening a new front in the competition in the PAD space and seemingly relieving any concerns about the safety of paclitaxel.
Toosonix A/S has launched two trials as it moves to gather data enabling its high-intensity focused ultrasound (HIFU) device to get approval for use in clinical dermatology indications. The company reported on April 19 that the first patients have been treated in a trial of its System One-M device in treating basal cell carcinoma (BCC). Meanwhile, the first patient has been cleared for treatment on April 28 in a study in neurofibromatosis, an inherited condition that causes benign tumors to form on the skin.
China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld.
The FDA has given thumbs up to two clinical studies for a transcatheter aortic valve replacement (TAVR) system developed by HLT Inc. to treat aortic stenosis among high-risk patients. Those studies will include aortic regurgitation which also occurs when an aortic valve doesn't open and close tightly enough but for which there are few suitable, noninvasive treatments.
Impel Neuropharma Inc. presented multiple abstracts affirming the effectiveness of Trudhesa (dihydroergotamine mesylate) nasal spray in treating migraine attacks. The data – all subsets from the phase III, open-label, pivotal STOP-301 trial – show that acute use of Trudhesa delivered via Impel’s Precision Olfactory Delivery (POD) technology may enhance patients’ quality of life by reducing migraine-associated disability, prolonging headache-free periods and limiting the number of migraine attacks over time.
Results from a new peer-reviewed study show people develop emotional bonds with artificial intelligence (AI) therapy chatbots in a similar way to in-person therapists. The study evaluated 1,205 people using a mental health app developed by Wysa Ltd. to assist symptoms of anxiety or depression. The chatbot guides users through therapy exercises including cognitive-behavioral techniques (CBT), dialectical behavior therapy, meditation, breathing and yoga to build mental resilience skills.
RSS
