LONDON – Three patients with complete spinal cord injury are able to walk independently after having specialized electrodes implanted below their lesions. The details were published in Nature Medicine on Feb. 7. This is a significant new milestone for the researchers at École polytechnique fédérale de Lausanne (EPFL), Switzerland, who in 2018 delivered proof that electrical stimulation can reactivate spinal neurons, in that case in three patients with partial spinal cord injury. “Here for the first time, we have developed purpose-made technology in order to precisely stimulate the spinal cord to restore movement after paralysis,” said Gregoire Courtine, professor of spinal cord repair at EPFL.
The pivotal, multicenter trial commissioned by Envveno Medical Corp. is intended to show its first-in-class Venovalve implant is safe and effective for treating deep venous chronic venous insufficiency (CVI), which occurs when damaged valves inside the veins of the leg prevent blood from flowing up the leg and into the heart and lungs.
San Francisco-based startup Mirvie Inc. has released data demonstrating how its RNA platform technology can predict preterm birth. The research, presented at the Society for Maternal-Fetal Medicine 42nd Annual Pregnancy Meeting (SMFM 2022), showed the company’s test predicted the condition months before symptoms occurred and identified biological pathways that drive changes in pregnancy.
University of Edinburgh spinoff Biocaptiva Ltd. is taking its cell free DNA (cfDNA) capture device to clinical trials in 2022 following promising preclinical results. The company’s platform technology is designed to increase the quantity of cfDNA available for liquid biopsy testing. Current liquid biopsy practices obtain cfDNA via a venous blood draw but the concentration of tumor-derived ctDNA can be too low for comprehensive testing. Biocaptiva’ device emerged from research at the University of Edinburgh investigating liquid biopsy technologies.
LONDON – The first human challenge study of SARS-CoV-2 infection has reported initial results, showing it is safe to infect healthy volunteers with the virus in controlled conditions, and paving the way for the model to be used to accelerate clinical trials of COVID-19 vaccines, antivirals and diagnostics.
Applaud Medical Inc. has secured breakthrough device designation from the FDA for its acoustic enhancer technology to be used in conjunction with ureteroscopy with laser lithotripsy (URS-LL) for the fragmentation of calcium-based urinary stones. The San Francisco-based company is currently enrolling subjects in an FDA-approved pivotal trial evaluating the technology’s safety and efficacy.
Galvani Bioelectronics Ltd. reported the first patient implanted with its experimental direct splenic nerve stimulation therapy for rheumatoid arthritis (RA). The first-in-human implant is part of a small trial at the NHS Greater Glasgow & Clyde Health Board in Scotland.
A wearable biosensor developed by Scottish startup Pneumowave Ltd. has been tapped for a clinical trial investigating respiratory depression at King’s College London (KCL). Pneumowave’s respiratory monitoring platform will be used to collect breathing data from patients at risk of experiencing slow and shallow breathing as a side effect of opioid medication.
Molecular diagnostics could dramatically improve care for one of the most common infections women face, vaginitis. A study by Becton, Dickinson and Co. (BD) found that clinicians miss more than 45% of positive cases and misidentify an additional 12% of negative cases as positives when compared to diagnostic findings.
Patients who received Intersect ENT Inc.’s Propel sinus implant had fewer doctor visits, emergency department and urgent care visits and subsequent endoscopies following surgery for chronic rhinosinusitis, a real-world evidence study found.
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