The BrainWave - Episode 2

Episode 2 of #TheBrainWave is here!

Its been a busy two weeks with plenty to talk about in the Neurology Device industry.

For those who have recently subscribed to this biweekly newsletter, The BrainWave has been designed to keep you, the reader up, to date with all of the news, insights and innovation across the Neurology Device industry.

Here is what has been happening over the past 2 weeks in the industry.

Funding News:

Saluda Medical have announced an additional $150 million equity financing, led by some of the most respected financial institutions in the industry to continue propelling the US commercialization and technology pipeline. The financing was led by Wellington Management , 富达 and TPG . Congratulations Jim Schuermann and the wider Saluda Medical team. Following this news and the recent 36-month data shared at NANS earlier this year what else is to come from Saluda in 2023?

Click here for the full press release:?https://lnkd.in/gRT54Anu

Learn more about the Evoke System:?https://lnkd.in/dnTfsYVH

Risks and Important Safety Info:?https://lnkd.in/dRxynex

Neuromod Devices is in the news again this week after closing €30 million. The funds will be used to further commercialise the tinnitus treatment device, Lenire. As part of the overall Series B funding round Panakes Partners led the funding alongside exisiting investors at Fountain Healthcare Partners . €15 million in venture debt was provided by the European Investment Bank (EIB) . The Lenire has been used in large scale clinical trials with over 700 patients with the first US patients expected to start the treatment for tinnitus this month. With expansion across other areas including Europe such as Italy, Netherlands, Sweden and Portugal, 2023 is set to be an exciting year for Ross O'Neill and the wider Neuromod Devices team.

Neuvotion, Inc. has secured an additional $1.25 million to commercialize the NeuStim Technology for treating stroke and debilitating injuries. If you haven't heard about Neuvotion then you should really keep an eye on them. They're developing neurostimulation product for the rehabilitation, BCI and physical therapy market to restore movement to millions of patients experiencing impairments from stroke, traumatic injury and other conditions. With a multi-site clinical study set to begin this year I'm sure we will be hearing about Neuvotion in a latter episode of The BrainWave. Congrats Chad Bouton and the team at Neuvotion!

Panaxium announced that they have received an investment from Ontario Brain Institute to fund preclinical work that is required for its neuromodulation stroke therapy human clinical trials. "The human brain has an intrinsic, extraordinary ability to rewire itself after an injury," says Brad Schmidt , PhD, CEO and co-founder at Panaxium. "This miraculous natural ability of the brain is what inspired the development of our neuromodulation therapy. Modern advancements have unlocked how the brain can be remapped to restore function – but the tools required to safely and precisely stimulate the cortex do not exist yet. Our solution addresses this massive need." Panaxium is working to solve some of the most difficult and important problems in medicine to change the way neurological disease is treated using the advantages of AI-enabled iontronic devices.

Clinical News:

The EMOTIV device has recently been used to link the brain to the internet similar to IoT! A team of researchers at Wit University in Johannesburg have made a major breakthrough. The "Brainternet" project aims to simplify a person's understanding of their own brain and the brains of others through machine learning and interactivity. This works by taking brainwave EEG signals gathered by an?EMOTIV EEG device connected to the user's head. The signals are then transmitted to a low cost?Raspberry Pi computer, which live streams the data to an application programming interface and displays the data on an open website where anyone can view the activity.

Neuronic announced the publication of a ground-breaking study entitled “Use of Either Transcranial and Whole-Body PBM Treatments Improves COVID-19 Brain Fog” which examined the efficacy of the Neuradiant 1070 and the NovoTHOR Whole Body Light for improving Long COVID cognitive symptoms.

Learn more about the study here:?https://lnkd.in/dXva-dFi

Neuronic's next generation technology in transcranial photobiomodulation increases blood flow, reduce inflammation and increases cellular energy. This non-invasive way to get the benefits of the sun without negative side effects.

Check the Neuradiant 1070:?https://neuronic.online/

I had the pleasure of speaking with Neuronic's Co-Founder- Liam Pingree earlier this week. It's great to hear why the team has grown by 83% in the past 6 months. With an in demand product portfolio that offers a real change to patients lives across many areas including Alzheimer's, long COVID, Parkinson's, autism and brain health it's clear to see why people want to work for this collaborative and driven team.

Tivic Health announced a research collaboration with FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH, THE to conduct a pilot clinical study that will test a novel non-invasive bioelectronic device approach for vagus nerve stimulation.

The new neurostimulation approach will be used in a pilot study involving 20 individuals. The study will also involve data analysis and algorithm development, utilizing the resources and expertise of the Neural and Data Science Autonomic Nervous System monitoring lab.

Parkinson's Disease Biomarker Found!

An international coalition of scientists, led by MJFF and its clinical study PPMI, has achieved a biomarker breakthrough. This accomplishment has been recognized as a significant milestone in the pursuit of finding a cure and improved treatments for Parkinson's disease. According to an article on STAT, a leading health and science news website, this achievement is due to the research funded by the Michael J. Fox Foundation for Parkinson's Research.

This research has resulted in the clearest evidence yet that the presence of a particular misfolded protein, alpha-synuclein, can be used to determine if people have Parkinson's disease. This advancement could be used to develop better diagnostics and accelerate the search for treatments. Previously, it was only possible to confirm the presence of alpha-synuclein clumps through post-mortem analysis.

FDA News:

Hot off the press - Neuspera Medical Inc. announces today the FDA clearance of its system for PNS (Peripheral Nerve Stimulation) - The next generation of ultra miniaturized system. The system is comprised of micro-implant that delivers neurostimulation therapy through a wireless platform including a wearable transmitter and iPad-based clinician programmer.

"We look forward to bringing this innovative technology to physicians and patients in the U.S.," commented? Steffen Hovard , CEO of Neuspera Medical. "The Neuspera ultra-miniaturized system has the potential to revolutionize the way physicians treat patients battling chronic pain while restoring patients' health and quality of life." Great news for Neuspera Medical and their patients. Congratulations Steffen, Alexander Yeh and the wider Neuspera team.

Reach Neuro, Inc. have received an FDA breakthrough device designation for device to restore arm and hand movement to chronic stroke patients!

The Avantis device uses small electrical impulses delivered to the spinal cord to help restore shoulder, arm and hand movement to individuals. The Reach Neuro team was founded in 2021 as a spinout company of the University of Pittsburgh and Carnegie Mellon University, the technology is currently being tested in a NIH funding clinical trial in collaboration with the UPMC. Marc Powell

Recent Hires:

Cognito Therapeutics are in the news again this week with Ralph Kern joining Cognito Therapeutics, Inc. as the Chief Medical Officer and? Kim Kwan ?has been promoted to Chief Technology Officer! ??????

“I am thrilled to welcome Ralph to the Cognito team, and the promotion of Kim to the role of Chief Technology Officer. Their collective expertise and leadership across our medical, technology and engineering divisions will be invaluable as we advance our non-invasive pivotal HOPE study evaluating our proprietary neuromodulation device in Alzheimer’s Disease,” said? Brent Vaughan , CEO, Cognito Therapeutics. “With their dedication to improving patient outcomes, our shared commitment to improve patient outcomes will help us advance our proprietary technology platform and transform the treatment of neurodegenerative diseases."

Read the full release:

https://lnkd.in/eMEViYNs

Global Neurology Device Vacancies:

I’m currently recruiting across the following areas and more:

??Chief Executive Officer -?https://lnkd.in/eUJKga24

??Director of Regulatory Affairs EMEA -?https://lnkd.in/egb7NzWS

??Product Manager - Neurology Software -?https://lnkd.in/embu6TNd

??Quality Technician -?https://lnkd.in/eEE-7ZfT

??Quality Supplier Engineer -?https://lnkd.in/eEE-7ZfT

Upcoming Events:

Minnesota Neuromodulation Week - April 20 and 21

NER - IEEE - April 25 – April 27

WLNC - Rio de Janeiro - April 11-14

ASPN - Miami Beach July 13-16

Cleveland NeuroDesign Workshop - September

Neurotech Leaders Forum (October/November) SF

SfN - Nov 11 - 15, Washington

Are you looking to add headcount to your team in 2023??Reach out now to set up an introductory call.

To stay up to date with news, announcements, and startups from the Neurology Device markets, subscribe to The BrainWave and follow?#TheBrainWave