Soft Tissue Injuries

Grant awards to fund novel clinical projects and scientific tools aimed at improving quality of life for individuals impacted by spinal cord injury SHORT HILLS, N.J., March 6, 2024 /PRNewswire/ -- The Christopher & Dana Reeve Foundation, a leading nonprofit organization dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis, announced today three new spinal cord injury (SCI) research grants totaling $3.1 million. The grants support clinical trials and research tools aimed at accelerating the therapeutic development of SCI treatments. Two grants have been awarded to .NeuroRestore, a research, innovation and treatment center that develops and applies bioengineering strategies involving neurosurgical interventions to restore neurological functions. PsychoGenics, a CNS-focused contract research organization that designs and executes preclinical drug discovery and early development programs, received the third grant. Together, the grants will fund projects designed to help catalyze and energize the field of SCI science by channeling resources for a robust clinical pipeline to rapidly increase the number of potential treatments, as well as drive progress and investment in spinal cord injury research by addressing the barriers that limit ambitious engagement. The projects include clinical trials focused on: bladder dysfunction – a major quality-of-life issue for the SCI community; and a trial to advance novel brain-spine interface (BSI) technology, which has been shown to enable thought to control movement. Finally, a preclinical study will focus on innovative techniques and technologies to provide standardized lab research resources that do not currently exist. Specifically: Brain-Spine Interface to Reverse Upper Limb Paralysis: .NeuroRestore will also receive $1.1 million over two years to support its Brain-Spinal Interface (BSI) technology to determine if thoughts, via cortical brain implants, can control not just lower extremity movement (which has been demonstrated in prior research), but also arm and hand function for those with cervical injuries. This technology is being developed by ONWARD® Medical, a medical technology company creating therapies to restore movement, function, and independence in people with SCI and movement disabilities. It is the only company currently advancing both brain-computer interface (BCI) and spinal cord stimulation technology together – a "digital bridge" connecting brain signals with movement. In late February, ONWARD Medical was awarded its 10th Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) for its ARC-BCI™ System, which uses brain-BCI technology in conjunction with the company's ARC-IM® Therapy to restore thought-driven lower limb mobility after spinal cord injury (SCI). Neuroprosthetic System to Manager Lower Urinary Tract Dysfunction After Spinal Cord Injury: With a $1.5 million grant, .NeuroRestore will apply epidural stimulation implants to participants with chronic incomplete spinal cord injuries to examine if the technology can be used to assist in the functionality and control of the bladder. This proof-of-concept, safety, and feasibility study over two years will determine if epidural stimulation, which has seen success in movement and blood pressure, can be used for voiding and storage of the bladder. This early-stage study will utilize ONWARD Medical's targeted ARC Therapy stimulation, which the company is actively developing with .NeuroRestore. Standardized Testing Research InVivo Endeavor (STRIVE): A preclinical grant for $522,000 is awarded to PsychoGenics to develop an in-house standardized model for testing potential therapeutics. This project will help accelerate therapeutic development by providing a validated tool to the SCI research community. The Reeve Foundation is dedicated to developing real-world treatments for people living with spinal cord injury (SCI) and paralysis. Decade by decade, the Reeve Foundation has worked to change what was deemed possible, collaborating with equally determined scientists and labs to map a path toward progress and build a vibrant research field that delivers real improvements for people living with paralysis. Today, as 21st-century technology and cumulative scientific gains converge, we are on the cusp of a new era in spinal cord injury research. "These grants represent a fresh approach to spurring the SCI scientific arena forward through our support of high-risk-high-reward endeavors that address unmet needs of individuals living with spinal cord injury," said Marco Baptista, Ph.D., Chief Scientific Officer of the Reeve Foundation. "It is our goal to facilitate rapid scientific advancement, and these grants are an important step in ensuring that the most promising science of the day is primed for accelerated success." About the Reeve Foundation The Christopher & Dana Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis. Additionally, through a cooperative agreement with the Administration for Community Living, the Reeve Foundation's National Paralysis Resource Center (NPRC) promotes the health, well-being, and independence of people living with paralysis, providing comprehensive information, resources, and referral services assisting over 125,000 individuals and families since its launch in 2002. The Reeve Foundation is committed to elevating our community's voices and needs to achieve greater representation and independence. We meet all 20 of the Better Business Bureau's standards for charity accountability and hold the BBB's Charity Seal. For more information, please visit ChristopherReeve.org or call 800-225-0292. SOURCE Christopher & Dana Reeve Foundation

The study assessed the sensitivity, specificity, and usability of PressureSafe against the standard of care in the detection of early-stage pressure injuries Stage 1 / suspected deep tissue injuries before skin breakage IR-MED reports positive efficacy data for its PressureSafe device. (Credit: Nappy on Unsplash) IR-MED, a developer of a spectrographic analysis technology platform, said that its PressureSafe device has shown 92% efficacy in early, non-invasive, skin colour agnostic detection of pressure injuries. PressureSafe is a non-invasive handheld optical monitoring device. It leverages infrared optical spectroscopy and an artificial intelligence (AI)-based algorithm to detect early-stage pressure injuries for all skin tones. The single arm, bi-centre study of the device was conducted at two medical centres owned by Clalit, a health maintenance organisation. The 14-day efficacy portion of the study was intended to assess the sensitivity, specificity, and usability of PressureSafe. It was compared against the standard of care in the detection of early-stage pressure injuries Stage 1 / suspected deep tissue injuries (sDTI) before skin breakage. IR-MED assessed 38 patients at high risk of pressure injury development. On 154 body sites, 924 scans were performed in total. The highly favourable proof of efficacy data showed that PressureSafe was able to identify Stage 1 / sDTI pressure injuries with 92% sensitivity and 88% specificity. The study also assessed device calibration and validation in addition to safety. A total of 1,493 scans yielded no safety signals, out of the 66 patients whose data was acquired for safety study. Additionally, the rate of incidence of pressure injuries diminished by 50% during the study period. The medical device firm concluded that PressureSafe is a useful, effective, and safe decision support device for the early diagnosis of pressure injuries based on these results. IR-MED CEO Tzur Di-Cori said: “This robust and impressive data from our collaborative study with Clalit comes at an ideal time as we prepare to enter the US market with PressureSafe. “We believe the 92% efficacy findings in real-world data settings at two world-class hospitals will be a big factor in driving adoption in the US.” The handheld optical monitoring device is currently in usability trials at various medical centres.

Each of the participants in Neuralink's PRIME trail will have the N1 device implanted on their brain by the company’s R1 robot. Once in place, the implant’s 1,024 electrodes will record neurological activity and transmit the data to a connected app, where an algorithm will translate the brain activity into computer controls. Less than a month after Neuralink founder Elon Musk announced that the company’s brain-computer interface technology had been implanted in a human for the first time, that study participant is already taking the first steps toward controlling a computer using only their mind, according to Musk. His latest update on the Neuralink clinical trial came, once again, via X, the social media platform he owns. During a livestreamed Spaces event with journalist Katherine Brodsky on Monday night, according to Reuters, Musk reported that Neuralink’s technology has enabled the first implantee to control a computer cursor hands-free. “Progress is good, and the patient seems to have made a full recovery, with no ill effects that we are aware of,” he said. “Patient is able to move a mouse around the screen by just thinking.” Next up, the participant is being tasked with pushing the mouse’s buttons as many times as possible using only their thoughts, Musk said. The progress report arrived exactly three weeks after Musk’s last update on the long-awaited Neuralink trial. In a series of posts on X late last month, he announced that the company’s first human implant had been performed on Jan. 28 and that the patient was “recovering well.” The PRIME study—named after Neuralink’s precise robotically implanted brain-computer interface—was greenlit by the FDA last spring and began recruiting in the fall. At the time, the company said it was looking for volunteers aged 22 and older with quadriplegia caused by a cervical spinal cord injury or amyotrophic lateral sclerosis. Each of the participants will have Neuralink’s N1 device implanted on their brain by the company’s R1 robot. Once in place, the implant’s 1,024 electrodes will record neurological activity and transmit the data to a connected app, where an algorithm will translate the brain activity into computer controls. According to Neuralink, the primary study period will span 18 months, complete with periodic at-home and in-person clinical check-ins and regular brain-computer interface research sessions, followed by a five-year follow-up that will comprise another 20 clinic visits. The initial application for Neuralink’s technology—translating the neurological activity of individuals with paralysis into cursor movements and mouse clicks—has been dubbed Telepathy, Musk said in his late January update. In the future, in addition to linking anyone’s brain to their smartphone, Musk has claimed that Neuralink’s brain-computer interface could potentially be used to restore sight to the blind and mobility to the paralyzed. Despite the technology’s reported potential—or, perhaps, because of it—some scientists have expressed wariness over the company’s current trial. Researchers interviewed in the journal Nature this month took issue with the fact that the trial has not been registered at ClinicalTrials.gov, with no information available about its sites or protocol and most substantial updates on the study coming from either a single recruitment brochure or social media posts by Musk. “My assumption would be that the FDA and Neuralink are following the playbook to a certain extent,” Tim Denison, Ph.D., a neuroengineer at the University of Oxford, told Nature. “But we don’t have the protocol. So we don’t know that.”