Exosome Sciences Inc., a San Diego-based diagnostic subsidiary of Aethlon Medical Inc., reported the initiation of an Institutional Review Board approved protocol for a research study involving retired NFL players and a data-supported biomarker candidate to potentially detect and monitor chronic traumatic encephalopathy (CTE) in living individuals. The sample collection will be conducted in collaboration with Kendall Van Keuren-Jensen, co-director of the Translational Genomics Research Institute's Center for Noninvasive Diagnostics, for biomarker discovery projects. With the approval of the protocol, investigators plan to initiate screening of candidate participants in the coming weeks. The study will enroll former NFL players, who are at high-risk of suffering from CTE, and control subjects who didn't participate in activities that involved repetitive head trauma. The goal of the study for Exosome Sciences will be to further validate a CTE biomarker candidate known as plasma exosomal tau, or a Tausome.
Salt Lake City-based Discgenics Inc., a clinical stage regenerative medicine company focused on developing cell therapies for patients with degenerative diseases of the spine, said it presented results from two preclinical studies on Idct at the Orthopedic Research Society 2018 Annual Meeting, which was held last week in New Orleans. The studies highlight the safety and regenerative capacity of Discogenic Cells, the active ingredient in the company's lead product candidate, Idct, an allogeneic, noninvasive cell therapy for the treatment of degenerative disc disease.
Genentech Inc., of South San Francisco, received U.S. FDA approval for the Lucentis (ranibizumab injection) 0.3 mg prefilled syringe (PFS) as a new method of administering the medicine to treat all forms of diabetic retinopathy. In April 2017, Lucentis 0.3 mg became, and remains, the first and only FDA-approved medicine to treat all forms of diabetic retinopathy in people with or without diabetic macular edema (DME). The Lucentis 0.3 mg PFS is now the first syringe prefilled with an anti-vascular endothelial growth factor agent FDA-approved to treat both diabetic retinopathy and DME. It is expected to be available in the second quarter of 2018.
Medtronic plc, of Dublin, reported that results from two real-world analyses featuring its AdaptivCRT algorithm included a reduction in atrial fibrillation (AF) episodes and an increase in patient activity levels. The results, involving 408 patients with heart failure and a Medtronic cardiac resynchronization therapy (CRT) device at 26 centers in Italy, were unveiled at the European Heart Rhythm Association Scientific Sessions 2018 in Barcelona. The first analysis revealed a significant reduction in the incidence of AF episodes of all measured durations (greater than: one hour, six hours, 12 hours, one day and seven days; p=0.017 for episodes lasting longer than six hours) in 210 patients with AdaptivCRT On compared to 198 patients with conventional CRT. The second analysis showed AdaptivCRT was significantly and independently associated with a higher daily activity level for patients with the feature On compared to those with conventional CRT (AdaptivCRT On at 3.1 hours vs. AdaptivCRT Off at 2.6 hours; p=0.010).
Center Valley, Penn.-based Olympus Medical Systems Group, reported the launch of Easysuite 4K. The next-generation operating room integration system enables surgical and interventional clinicians to connect with the native and uncompressed visual insights derived from legacy, HD and ultra-high definition (UHD) medical sources to streamline pre-, intra- and post-operative clinician workflows. The company said Easysuite 4K is currently available in the U.S. and will be available in selected worldwide markets in 2018. It will be introduced at the AORN Conference March 24-28 in New Orleans.
Respiratory Motion Inc., of Waltham, Mass., said FDA clearance was received for the newest version of its Exspiron Minute Ventilation (MV) monitoring system in pediatric patients. It plans to launch the new Exspiron at the Society for Pediatric Anesthesia and the American Academy of Pediatrics Section on Anesthesiology and Pain Medicine meeting in Phoenix, March 23-25. Exspiron provides continuous, noninvasive measurements for individuals not on a ventilator.