Saluda Medical Pty. Ltd., of Artarmon, Australia, made waves in 2019, winning the CE mark for its Evoke closed-loop spinal cord stimulation (SCS) system. The good news kept coming following the publication of results from a pivotal study in The Lancet Neurology.
With many on Wall Street transfixed by the three injectable calcitonin gene-related peptide (CGRP) therapies cleared in the prophylactic migraine market, Satsuma Pharmaceuticals Inc.’s prospects with STS-101 may have gone overlooked, at least until lately.
A single injection of SOD1-targeting RNA into the subpial space, which is below the innermost meningeal layer, was able to spread throughout the spinal cord and, via retrograde delivery, into brain centers that project to the spinal cord in several animal models, including primates.
Seven years after an advisory hearing on the subject, the FDA has determined that cranial electrotherapy stimulation (CES) devices will be slotted as class III devices when used for depression. The decision comes despite a number of irregularities that took place at the February 2012 advisory hearing.
Digital therapeutics have made great strides in recent years, with Pear Therapeutics Inc. playing a key role. Now, the company has reported the dosing of the first patient in part two of a study assessing Pear-006 – which Pear Therapeutics is developing in collaboration with Basel, Switzerland-based Novartis AG – to address depressive symptoms in multiple sclerosis (MS).
Aspen Neuroscience Inc. hopes to get into the clinic to test autologous neuron replacement in Parkinson’s disease with a $6.5 million seed round. The financing featured several established life sciences venture investors; it was led by Domain Associates and Axon Ventures and included Alexandria Venture Investments, Arch Venture Partners, Orbimed, and Section 32.
There is no FDA-approved medication for Alzheimer’s disease. But there is some hope that if the blood-brain barrier could be more easily penetrated by drug candidates they would prove more effective. That is the line of research being pursued by Israeli company Insightec Ltd. via its Exablate Neuro that provides low-intensity focused ultrasound treatment.