Soft Tissue Injuries

CHARLOTTESVILLE, Va., Oct. 10, 2024 /PRNewswire/ -- RIVANNA®, developers of imaging-based medical solutions, has announced the launch of the first multi-site study employing the Accuro® XV musculoskeletal imaging system. This milestone follows a $30.5 million funding option executed in 2023 by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Over 20 million patients present to emergency departments (ED) annually with suspected distal extremity trauma, and an estimated 90% to 99% receive X-ray imaging, according to The Journal of Emergency Medicine. However, it is reported that in the lower leg, the incidence of fractures ranges between 8% to 19%, and in the distal arm, the incidence is between 25% to 57%, according to The Journal of Trauma and Acute Care Surgery and The American Journal of Emergency Medicine. A bedside triage device like Accuro XV may significantly reduce the utilization of radiological resources for low-acuity injury triage. This feasibility study, enrolling 200 participants, aims to acquire fracture images with Accuro XV to evaluate device safety, ability to integrate within ED workflow and the system's ability to render automated diagnostic ultrasound images. Accuro XV integrates ultrasound-based bone and 3D soft-tissue imaging technology with AI-enabled software and is designed to enable rapid automated detection and volumetric assessment of skeletal fractures and soft tissue injuries without harmful radiation exposure. Additionally, Accuro XV aims to address limitations in EDs such as identifying soft tissue injuries during the acute phase, ensuring accurate treatment decisions and prompt discharge of those not needing further intervention. "Since October 2021, we have quickly progressed from design to proof of concept in clinical sites, thanks to our collaboration with BARDA," said Delphine Le Roux, PhD, PMP, Director of Program Management. "Study data will expedite the development of Accuro XV for comprehensive point-of-care musculoskeletal diagnostics and validate product design with ED physician end-users." UVA Health worked with RIVANNA at the study's inception, providing study start-up and optimization before expanding to The University of Texas Southwestern Medical Center, where faculty treat patients at Parkland Memorial Hospital, one of the nation's busiest EDs with 240,000 visits annually. "We are working to transform technological opportunities into applications that may improve treatment for low-acuity patients and reduce wait times," said Chris Thom, MD, RDMS, Associate Professor of Emergency Medicine at the University of Virginia School of Medicine. This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50121C00035. About BARDA. About RIVANNA RIVANNA® is a commercial-stage medical device innovator and manufacturer in Charlottesville, VA. RIVANNA's mission is to develop and commercialize world-first imaging-based medical technologies that elevate global standards of care. RIVANNA is privately held and operates an FDA-registered and ISO 13485:2016-certified manufacturing facility. Learn more: RIVANNA. SOURCE RIVANNA WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HADDONFIELD, N.J., Sept. 16, 2024 /PRNewswire/ -- Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small-molecule oncology therapeutics, today announced the presentation of clinical data at the 2024 ESMO Annual Meeting from its dose-expansion cohort of LNS8801 as a monotherapy in patients with metastatic cutaneous melanoma who could not tolerate immunotherapy due to prior immune-related adverse events. The poster is entitled "Efficacy of LNS8801 in melanoma patients with prior immune-related adverse events from immune-checkpoint inhibitors" (Abstract 1137P). LNS8801 given alone was tolerable without unanticipated toxicities and demonstrated encouraging antitumor activity in patients with metastatic cutaneous melanoma who had prior severe immune-related adverse events on immune checkpoint inhibitor therapies. LNS8801 monotherapy treatment resulted in a disease control rate of 100% in biomarker-positive patients, with a preliminary progression-free survival of over 6 months. This includes a patient that has been on treatment for over 4.5 years with resolution of all soft-tissue lesions and no evidence of active disease in the residual bone-associated target lesion or elsewhere. "We are extremely pleased to showcase these data at ESMO," commented Patrick Mooney, MD, CEO of Linnaeus. "The data from this study demonstrate that LNS8801 is extremely safe and well tolerated and shows very promising signs of efficacy. Given that patients with prior irAEs are often prevented from receiving further immunotherapy, these patients represent a large unmet need. We look forward to generating more data in this patient population and in unresectable treatment refractory melanoma." Linnaeus anticipates initiating a randomized controlled clinical trial in unresectable, treatment-refractory cutaneous melanoma in Q4 of this year. This study will randomize 135 biomarker-positive patients to receive LNS8801 monotherapy; LNS8801 and pembrolizumab; or physician's choice therapy. The study will assess median progression-free survival and overall survival among the groups. About LNS8801 LNS8801 is an orally bioavailable and highly specific and potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc protein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. In the ongoing clinical study in humans, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc protein depletion, and clinical benefit in patients with advanced cancers, and a predictive biomarker has been identified. About Metastatic Cutaneous Melanoma Although there has been progress in the treatment of metastatic cutaneous melanoma, most patients will progress on standard of care therapies and need further treatment. According to the American Cancer Society, almost 8,000 patients die each year in the United States, highlighting the need for safe and effective therapies in the treatment-refractory setting. About Linnaeus Linnaeus Therapeutics, Inc. is a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics that target G protein-coupled receptors. The company was formed and launched in partnership with the UPstart incubator at the University of Pennsylvania's Penn Center for Innovation (PCI). SOURCE Linnaeus Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Friday, Elon Musk told podcaster Lex Fridman the second participant in the Neuralink clinical trial also had a spinal cord injury similar to the first patient. Neuralink has implanted its device in a second patient, according to the startup's owner Elon Musk.The company's brain-computer interface technology is designed to give paralyzed patients the ability to control digital devices using only their minds.Friday, Musk told podcaster Lex Fridman the second participant also had a spinal cord injury similar to the first patient, Reuters reported. Musk said 400 of the implant's electrodes on the second patient's brain are showing signals.The N1 implant includes 1,024 electrodes distributed among 64 threads, according to the company's website."I don't want to jinx it, but it seems to have gone extremely well with the second implant," Musk told Fridman on the podcast interview. "There's a lot of signal, a lot of electrodes. It's working very well."Musk did not specify when the company performed the second patient's surgery. The second implant surgery had to be postponed in June due to the patient's medical condition, Bloomberg reported.The company plans to operate on a total of 10 patients this year, Musk said. The first patient, 29-year-old quadriplegic patient Noland Arbaugh, had Neuralink's device implanted earlier this year. A diving accident had dislocated the vertebrae in his neck, leaving him paralyzed from the shoulders down for years. After receiving the Neuralink implant in January, he has since used the device to play video games, online chess and other activities.In a nine-minute livestream on X, formerly Twitter, Arbaugh said he could now easily move the chess pieces around his laptop screen while also using the digital connection to control its music player.Arbaugh initially faced issues after his surgery when some of the hair-thin connecting wires laced into the tissue stopped reporting back data. In the weeks following the surgery, a number of threads retracted from the brain, resulting in a net decrease in the number of effective electrodes, the company reported.The clinical trial began recruiting last fall, when the company published a blog post looking for adult volunteers with paralysis of the arms and legs caused by a cervical spinal cord injury or amyotrophic lateral sclerosis, also known as ALS.The PRIME study—named for Neuralink’s precise robotically implanted brain-computer interface—will see the company’s specially designed R1 robot implant the N1 devices onto the brains of a handful of participants. The device contains several dozen threads that hold more than 1,000 electrodes; it is placed on a specific region of the brain to record neurological activity, which is then transferred to a connected app.After rejecting a previous request, the FDA gave Neuralink the green light to begin human clinical trials last year, in the midst of a federal probe into animal testing issues, and reports that about 1,500 animals had died in Neuralink’s care during the early stages of the implant’s development. Previously described by Musk as a potential “Fitbit in your skull,” the device includes a chip that replaces a small piece of bone and is connected to the brain via a series of thin, threaded electrodes.In the months following the regulatory go-ahead to begin recruiting human study participants, Neuralink announced it raised $280 million in venture capital funding. That series D round was led by Founders Fund, the firm co-founded by Peter Thiel, who worked alongside Musk at PayPal. Founders Fund previously joined Neuralink’s $205 million series C in 2021 and has also backed Musk’s rocket-building company SpaceX.