The BrainWave - Episode 3

Episode 3 of #TheBrainWave is now live!

Thanks for the all the support with The BrainWave, we now have over 1200+ subscribers??following the biweekly "go-to Neurology Device newsletter" so if you want to feature in the next issue then get in touch!??

A lot has happened over the past two weeks.... so lets get right into the news.

Funding News:

Adam Molnar and the Neurable team have received investment from Epson. If you didn't know about Neurable they are Boston-based spinout from University of Michigan. They develop brain computer interface (BCI) technology that uses brain wave EEG activity.

Neurable wants to create a world without physical or mental limitations using advanced algorithms and hardware to measure brain activity and provide actionable insights that everyone, everywhere can use in everyday life.

Congratulations Adam, Ramses Alcaide and the wider Neurable team on this investment.

Product Launches:

NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) announces the US Commercial Launch of Evo sEEG's complementary to Zimmer Biomet's robotic neurosurgery platform.

Dave Rosa , CEO of NeuroOne, said “The commercial launch of the Evo sEEG platform represents one of the most impactful milestones in our Company’s history. Paired with Zimmer Biomet’s ROSA One Brain robotic platform and broad distribution network, we believe the Company is well positioned in the market given the synergies that exist between our novel thin film electrode platform and Zimmer Biomet’s robotic platform. Importantly, this new technology potentially provides NeuroOne with a steady and predictable new revenue stream. We expect to complete our initial case within the next 30 days.”

CERENOVUS has announced that its Cerepal detachable coils - the latest innovation in the company's haemorrhagic #stroke portfolio are now commercially available in the USA!

Cerepak provides physicians with a state-of-the-art delivery system designed for ease of use and reliable detachment; next-generation microcatheter stability; effortless tracking through tortuous anatomy; and reduction of radiation (fluoroscopy) exposure with fluoro-saver markers.

Mark Dickinson said "At Cerenovus, we push the boundaries of what is possible in stroke care through continuous innovation. Our main goal is to address unmet clinical needs and improve patient outcomes, and we are proud to announce this latest addition to our haemorrhagic portfolio that furthers our commitment to changing the trajectory of stroke.”

Cala Health has introduced the next generation system and accelerates leadership in Bioelectronic Medicine . Cala are debuting the next generation of Transcutaneous Afferent Patterned Stimulation (TAPS) therapy provides patients the control to do what matters in their daily lives without the side effects of traditional medications. With the new product set to be commercially available in the second half of 2023 it sure is an exciting time to be part of the Cala Health team.

Cala TAPS is the First & Only FDA Cleared Non-invasive Therapy for Hand Tremor.

I'm excited to see the Cala TAPS - Congratulations Renee Ryan , Kate Rosenbluth and the wider Cala Health team.

Clinical News:

SynerFuse announces presentation of IDE proof-of-concept study data. Michael Park - principal investigator for the company's investigational device exemption (IDE) proof-of-concept study—presented data from the study’s first eight patients at the 10th?annual?Minnesota Neuromodulation Symposium (20–21 April, Minneapolis, USA).

"This presentation showcased the promising surgical procedure results to date of the world’s first SynerFuse?implants integrating spinal fusion with neuromodulation of the dorsal root ganglia (DRG) in patients with chronic neuropathic pain of the low back or leg,” said Justin Zenanko

Nervonik, Inc. announced the successful completion of a preclinical study for its nPain product. Designed as a peripheral implantable pulse generator technology. nPain has been developed to manage peripheral nerve pain through neurostimulation.

In a 30-day chronic large animal model study, Nervonik Inc. evaluated the safety of nPain when used to stimulate the common peroneal nerve in an ovine model. The non-GLP study was conducted to ensure that the technology is safe for use in human patients.

The results of the study have been promising, demonstrating the safety of nPain in managing peripheral nerve pain.?Great news for the team and Barry Keenan CEO of Nervonik.

FDA News:

Hot Off The Press!

Cognixion Receives FDA breakthrough device designation for its Brain-Computer Interface with augmented reality for assistive communication.

The Cognixion ONE device has been specifically designed to help individuals with neurodegenerative conditions such as Amyotrophic Lateral Sclerosis, also known as ALS or Lou Gehrig’s disease and MND (Motor Neuron Disease) as well as acquired conditions such as traumatic injuries and cerebral palsy that result in severe motor impairments. At present, no such cleared device exists which can allow fully paralyzed or locked-in patients to communicate once the current standard of care, eye-tracking, is no longer usable for their disease state due to ocular motor decline.??

"This FDA Breakthrough Device designation is a significant milestone, and we are thrilled to receive it for our Cognixion ONE device," said Andreas Forsland , CEO and Founder of Cognixion. "It validates the potential of our technology to make a real difference in the lives of individuals with severe motor impairments and underscores the importance of how AI can be used to assist people in everyday situations. We are excited to continue our work to bring this life-changing technology to those who need it most."?

BIOTRONIK announced FDA approval for the new spinal cord stimulation (SCS) system, Prospera, marks BIOTRONIK's entry into the neuromodulation space. With the Prospera they are offering automatic, daily, remote monitoring with global remote programming capabilities.

This #chronicpain solution is designed to identify potential issues early, deliver an optimal SCS experience and brin a better quality of life to patients across the globe for the pain community.

It will be interesting to see how Prospera performs with competition from the likes of Medtronic, Boston Scientific, Nevro, Abbott, Saluda Medical, Curonix, ONWARD and more.

Full article link here: https://news.biotronik.com/fda-approval-for-biotroniks-prospera-spinal-cord-stimulation-system/?utm_source=linkedin&utm_medium=social

Congratulations the the BIOTRONIK Neuromodulation leadership team: Matt Grobstich Adrian Kimber Todd Langevin Kaitlyn King Warren Dabney Travis Hecker Ryan Brown Jason Oefinger John Collier Ryan Walters Andy Cantrell Jacob Farrel I'm excited to hear more about #Prospera in the near future.

Route 92 Medical have received the first FDA clearance for a complete stroke treatment system they call FreeClimb 70 Reperfusion System. Designed to offer a superior deliverability and high procedural efficiency for a more refine bi-axial approach.

Powered by the Tenzing 7 delivery catheter, enables, neuro-interventionalists to address critical unmet needs in ischemic stroke treatment. Removing clots rapidly and safely.

Tony Chou CEO of Route 92 Medical said: "Route 92 Medical aims to provide neurovascular interventionists with innovative endovascular thrombectomy solutions, helping them maximize their opportunity to restore blood flow to the brain on their first attempt.” "The 510k clearance for the FreeClimb 70 Reperfusion System is a key addition to our portfolio of products that are designed to simplify removal of the embolus and seek to improve outcomes.”

Nevro The FDA have granted Breakthrough Device Designation for the PDN Sensory Study and this potential device indication.

“This PDN Sensory Study affords a path forward to building clinical evidence for slowing the progression of or improving sensory loss of the lower limbs in patients with chronic intractable pain and builds on the significant outcomes seen in the landmark SENZA-PDN RCT," said Mitch Engle

The first 2 patients were enrolled at the Institute of Precision Pain Medicine in Corpus Christi, Texas. The study will enrol up to 236 patients at multiple sites across the U.S.

Acquisitions:

Stryker announced the acquisition of Cerus Endovascular - a move that will see the company expand its current portfolio of brain aneurysm treatment solutions.

Cerus’ CE-marked products, including the Contour neurovascular system and the Neqstent coil-assisted flow diverter, will expand Stryker’s current portfolio of aneurysm treatment solutions, as per a company press release.

Recent Hires:

Neurotrack hires their first Chief Growth Officer Shawn Lemerise .

Shawn brings 20+ years of healthcare experience to this role to help transform the diagnosis and management of #alzheimers and #dementia. This newly created role will accelerate partnerships in the health system and provider markets.

Elli Kaplan said "The expansion of our C-suite and first ever Chief Growth Officer is a reflection of the growing demand in our three-minute cognitive assessment to screen at scale for neurodegenerative conditions such as dementia and Alzheimer’s disease” - Congratulations Shawn and the the Neurotrack team on this growth

Beacon Biosignals have welcomed Christine Vietz, PhD the team as the new Chief R&D Officer. Christine will oversee the development of the teams biomarker validation program, regulatory strategy, real-world evidence and computational neurodiagnostics. Alongside this Christine' work will accelerate delivery of quantitative endpoints that link directly to the development of precision therapies. Congratulations Jacob Donoghue, MD PhD on another great addition to the team.

Gary Flake and Scott Rickard have joined the EMOTIV team. The two "machine learning heavyweights" join the bioinformatics pioneer advancing understanding of the human brain using electroencephalography (EEG).

Dr. Flake joining as CTO after helming R&D teams for large technology companies across two decades, and Dr. Rickard from a multinational hedge fund with more than $62 billion in assets under management. At EMOTIV he will be focussing on building large/advanced brain models and directing the AI/ML team.

Tan Le CEO of EMOTIV said “Gary and Scott have already worked on some of the world’s most enormous and dynamic datasets – but even for data scientists of their stature, the human brain represents the final frontier”

Global Neurology Device Vacancies:

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

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

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

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

Are you looking to add headcount to your team in 2023/2024??

Reach out now to set up an introductory call.

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