Digital medicine startup Appliedvr Inc. has gained breakthrough device designation status from the U.S. FDA for its virtual reality (VR) platform for treating treatment-resistant fibromyalgia and chronic intractable lower back pain. The designation follows the completion of a clinical trial assessing VR-based therapy for self-management of chronic pain at home.
Medtronic plc reported 12-month data from a large, multicenter, randomized controlled clinical trial affirming the superiority of differential target multiplexed spinal cord stimulation (DTM SCS) in relieving chronic back pain, vs. traditional SCS therapy, using its Intellis platform.
Medtronic plc reported promising results from a feasibility study of its In.Pact 0.014 drug-coated balloon (DCB) in critical limb ischemia (ICL) patients with chronic total occlusion (CTO) in the infrapopliteal arteries.
Endologix LLC has begun a controlled launch of its Alto abdominal stent graft in Europe, following the receipt of CE mark approval in August. The next-generation Ovation system for polymer endovascular aneurysm repair (EVAR) is designed to provide the broadest indications in infrarenal EVAR grafts, including a 7 mm aortic neck length indication.
Astellas Pharma Inc. has agreed to acquire Iota Biosciences Inc., a company developing ultra-small implantable bioelectronic medical devices, in a deal valued at up to $429 million. According to a merger agreement, Tokyo-based Astellas will make an initial payment of roughly $127.5 million for all outstanding equity not already held by Astellas. Iota shareholders will receive further payments of up to $176.5 million as Iota completes predetermined milestones. In addition, Astellas has agreed to spend a total of $125 million over the next five years to drive Iota’s growth. The deal is expected to close in the third quarter of Astellas’ fiscal year, which ends March 31, 2021.
Keeping you up to date on recent developments in diagnostics, including: Remote speech analysis detects early bulbar changes in ALS; Novel NGS approach captures both mtDNA mutation and copy number; Neutrophils are literal obstacle to stroke recovery.
Medtronic plc has kicked off two clinical trials of its Evolut transcatheter aortic valve replacement (TAVR) system. One study will pit the self-expanding Evolut Pro and Pro+TAVR systems against Edwards Lifesciences Corp.’s balloon-expandable Sapien 3 and Sapien 3 Ultra transcatheter heart valves in small annulus patients.
Intervenn Biosciences said it has identified stark differences in the glycoproteomic profile of COVID-19 patients who became very sick and people infected with the SARS-CoV-2 virus who were either asymptomatic or experienced only minimal effects. The contrast could help clinicians better understand the biological mechanisms of the disease and triage patients at risk of responding detrimentally to early treatments and more intensive care.
Time is of the essence when treating patients with advanced or metastatic cancer, and diagnostic insights can inform treatment plans. To that end, Exact Sciences Corp. has launched its Oncotype MAP Pan-Cancer Tissue test for patients with advanced, metastatic, refractory or recurrent cancer. From a small tissue sample, the test detects genomic alterations in hundreds of cancer-related genes, helping doctors better depict a patient’s tumor and recommend effective therapies or clinical trials.
Neocis Inc., which developed the first U.S. FDA-cleared robotic-assisted dental surgery system, has completed a $72 million series D financing led by Dfj Growth. The funds will be used for broader commercialization and future advancements to the Yomi platform. Also participating in the series D round were Vivo Capital and existing investors Mithril Capital Management, Norwest Venture Partners, Section 32 and Fred Moll. With this latest capital infusion, Miami-based Neocis has raised a total of $120 million in financing to date.
