News

Like most areas of technology, the neurotech industry has had its share of legal battles. Most of these have involved intellectual property disputes and the resolution of those cases is often long and arduous with complicated settlements and licensing agreements. One of the most significant neurotech patent lawsuits was between the Alfred Mann Foundation and Cochlear Ltd., which was filed in 2007.

Several startup firms and research institutions in the field of bioelectronic medicine have begun to offer therapies for treating COVID-19 and related disorders. In 2020, an influential group of investigators and executives from emerging bioelectronic medicine firms formed a consortium called the International Consortium on Neuromodulation for COVID-19. Earlier this month, 14 members of the consort…

The neuromodulation market for treating psychiatric disorders received a significant boost earlier this month with the news that Abbott is re-entering the market for treating major depression using deep brain stimulation. St. Jude Medical, which Abbott acquired in 2017, departed the psychiatric disorders market after the FDA halted the firm’s BROADEN trial of DBS of Cg25 in 2012 because of a failed futility analysis.

For neuromodulation researchers, clinicians, and entrepreneurs pursuing the market for psychiatric disorders, the road to commercialization of new therapies has been long and bumpy. But as we indicate in our article on page 1 of this issue, the perseverance of those who did not give up the fight after some early setbacks seems like it has paid off. This publication was the first to report on the fa…

The market for treating bowel and bladder disorders using bioelectronic medicine therapies is currently dominated implanted sacral nerve stimulation systems, Medtronic and Axonics. But recently, two startup firms have reported progress at novel approaches to treating these disorders. Neuspera Medical, the San Jose, CA developer of neuromodulation systems, recently announced it will begin enrollment in its pivotal clinical trial, SANS-UUI, a single-arm study that will enroll 145 patients at 25 sites globally.

Several neurotech vendors and research teams pursuing advances in neuroprosthetics have reported significant developments in recent weeks. The steady progress offers hope to individuals with severe paralysis and other disabilities. Synchron, makers of a novel endovascular BCI, announced in May that they received an IDE from the FDA for the first-ever permanently implanted BCI in a human clinical trial.

Neurotech Reports, the publisher of this newsletter, announced that the third annual Neurotech Commercialization Workshop will take place on July 28, 2022. The one-day event, which was held on-line only in 2020 and 2021, will take place in New York City in 2022, in conjunction with the Neuroergonomics/NYC Neuromodulation conference, although there will be an option for on-line participation. The wo…

About 1500 neuromodulation professionals from all over the world assembled in Barcelona, Spain earlier this month for the 15th World Congress of the International Neuromodulation Society. The scientific program was preceded by an “Innovations in Neuromodulation” session dealing with commercialization issues. The full-day session, chaired from UI Chicago and Marc Russo from the Hunter Pain Clinic in…

Since the early days of the neurotechnology industry, a major challenge confronting vendors and researchers has been overcoming obstacles presented . Though much progress has been made, there is still a bias among many clinicians, regulators, payers, and patient advocacy groups who see drugs as the only viable therapy, and regard neurotech devices as a last resort, if at all. As NBR senior consulti…

The market for treating psychiatric disorders with neuromodulation therapy continues to progress as vendors report progress and investigators share new research findings. We reported last month on the formation of Inner Cosmos, which is developing a subcutaneous stimulation system for treating depression [NBR Apr22 p1]. Earlier this month, Neuronetics, the first neuromodulation firm to gain FDA cle…