BrainWave - May Wrap Up

Here is your wrap up for May - but before we get into the roundup.

BrainWave is just part of my position here at CM Medical Recruitment

I support start-ups, SME's and leading manufacturers across the United States, EMEA and APAC in their sourcing, hiring and talent strategy to attract and headhunt the best talent in the market.

If you are a hiring manager who is not satisfied with your current recruitment partners or wanting to work with a consultant that can provide you quality candidates in all functions and therapy areas of the Neurotech market then get in touch.

Funding

• Neo-Bionica have received a $5 Million investment from Breakthrough Victoria to accelerate further growth across both internationally and domestically. Congratulations Ludovic Labat Uli Gommel Robert Klupacs and the wider team!
• Neurable raised $13M to further develop their non-invasive brain-computer interface BCI technology - the investment saw contributions from Ultratech Capital Partners , TRAC, Pace Ventures and Metaplanet increasing total funding to over $30 million. Ramses Alcaide Adam Molnar
• OCULOGICA raised $7.6M to advance their devices further to test concussion. Uzma Samadani and the team have raised a total of $25.3M in funding and have secured grants from the US Department of Defence the National Institutes of Health and the FDA. Rosina S. Joel Sanderson Justin Johnson
• CereVasc announced a whopping $70M Series B financing to advance their novel eShunt System for the treatment of normal pressure hydocephalus. Daniel Levangie
• neuroClues have closed €5M for eye tracking device to diagnose neurological disorders - the round was led by White Fund SA . The start up have raised a total funding of €12M. Antoine Pouppez Pierre Daye
• MindAffect successfully raised €1.1M in Series A funding to advance their hearing diagnostics technology.
• StrokeDx raises oversubscribed $5M Seed Prime Round to advance next-generation stroke technology. The MedTech Innovator Winner have been going from strength to strength and are now gearing up for their next stage of growth to bringing their technology to stroke patients worldwide! Alex Ballatori Shane Shahrestani, MD, PhD Brian N.
• Sensars has secured €1.1M in funding helping the team advance their neuromodulation technology for treating chronic pain and sensory loss. Guy Siman Francesco Maria Petrini

Product Launches and Regulatory Approvals

• Route 92 Medical received FDA clearance for the FreeClimb 54 reperfusion system!
• Penumbra, Inc. unveiled the debut of its Midway 43 and Midway 62 delivery catheters, alongside receiving the CE-mark certification and launching three reperfusion catheters in Europe: Red 43, Red 72 featuring Sendit technology, and Red 78.
• NICO Corporation announced the launch of the new Myriad SPECTRA technology after 3 years of development. A hand held device that be used for fluorescence-guided surgery and can toggle between blue (405nm) and white light with the click of a button, improving the workflow for medical professionals. Jim Pearson
• Cognixion have launched their ground-breaking Axon-R Integrated Neural Interface System designed to transform neurophysiological research and clinical applications! Combining BCI with Augmented Reality for an unparalleled precision and adaptability. Tailored to accommodate a wide range of neurological conditions. Andreas Forsland Chris Ullrich
• CereVasc receives FDA IDE Approval for the STRIDE Pivotal study of the eShunt System for the treatment of patients with Normal Pressure Hydrocephalus (NPH)
• Scientia Vascular expands their portfolio to help more patients suffering from stroke with their Plato 17 and Socrates 38 Neurovascular Catheters now FDA approved. Paul Fischer John Lippert
• Omnia Medical announced their TiBrid SA plating system that can be used in conjunction with their TiBrid SA interbody system has received FDA 510k clearance.
• CorTec has approved an IDE for an early feasibility study for the rehabilitation of stroke patients with closed-loop brain interchange implant system!
• Axonics, Inc. have received regulatory approval for their recharge-free sacral neuromodulation system in Australia!

Clinical News:

• Precision Neuroscience has set a new world record by implanting 4096 electrodes in a human brain (surpassing the previous record of 2048. Benjamin Rapoport Craig Mermel Michael Mager
• Neuralink aims to enrol three patients to evaluate its device in a study expected to take several years to complete, according to details on the U.S. government's clinical trials database. Prior to this, their first human brain implant malfunctioned with retraction of threads resulting in a decrease in effectiveness for patient Noland Arbaugh to control a computer cursor with his brain.
• Carthera announced recently that they have received Orphan Drug Designation from US and EU authorities for the use of carboplatin in malignant glioma. Michael Canney, Ph.D. Frédéric Sottilini
• Synergia Medical have had the go-ahead for first-in-human trials in Belgium. These FIH will be for their new generation of neural stimulator NAO.VNS following FAMHP authorisation. Attila Borbáth
• Tivic Health announced the successful completion and effectiveness of its patent-pending non-invasive cervical vagus nerve stimulation approach ncVNS. This induces responses in the autonomic, cardiac, and central nervous systems and can be expected to have clinical utility in several major disease areas. Blake Gurfein, PhD Jennifer Ernst
• STALICLA announce first patients have been recruited in STALICLA Drug-Drug interaction Phase 3 enabling study. Lynn A Durham
• PainTEQ receives two new patents for the LinQ Procedure advancing treatments for SI Joint Dysfunction.
• MindRhythm, Inc. has announced that results from the pilot phase of its three-phase clinical study, EPISODE, have been published in Academic Emergency Medicine, and confirm the reliability of the company's Harmony technology in identifying LVO. John Keane
• XCath successfully performs first public telerobotic mechanical thrombectomy demonstration Eduardo F.
• Spryte Medical publishes first-in-human study of novel intravascular brain imaging technology. Matthew Gounis Vitor Mendes Pereira Pedro Lylyk

News You Need to Know:

• WISE SpA and Axontronic have joined together to commercialize WISE Cortical Strip in Germany and Austria! ?? A great collaboration between the two companies to distribute the WISE product portfolio. The WISE Cortical Strip is a single-use medical device designed for Intraoperative Neurophysiological Monitoring (IONM). Luca Ravagnan Thomas Bianchi Valentina Ferpozzi
• MagVenture announces collaboration with Magnus Medical to bring SAINT to the US market! Romain Moreau-Gobard Brandon Bentzley, MD, PhD Dave Vort Christian Wanding Stig Wanding Andersen
• Nexstim and inomed enter into strategic alliance agreement for US Market strengthening collaboration of Commercial and Clinical functions across both companies. Mikko Karvinen
• Panaxium have successfully graduated from the Neuro stream of prestigious Creative Destruction Lab's accelerator program. Brad Schmidt

Senior Leadership Appointments:

• Evan Greif joins CereVasc Board of Directors
• 美敦力 has appointed Linnea Burman as the new SVP and President of its Neurovascular business unit. Linnea succeeds Daniel Volz who will now take on global commercial transformation. Congratulations to both Linnea and Dan!
• Ken Rys joins Precision Neuroscience as VP of Engineering
• Mark Saxton has started as Chief Commercial Officer at Neuroelectrics
• Rahul Sharma steps into his new role of Medical Director at Synchron
• Nanoscope Therapeutics Inc. welcomes Khandan Baradaran, PhD as SVP of Regulatory and Quality.
• Firefly Neuroscience appoints Healthcare Industry Executive David Johnson
• Ken Nelson joins Epitel as a member of their Board of Directors.
• Priya Gaiha MD MBA is appointed as Head of Medical Affairs US for Artiria Medical

BrainWave CEO Spotlight - MindAffect - Jennifer Goodall

What have you learnt in building MindAffect?

"Personally I have learned an enormous amount because I come from, an investment banker background for many years. I did advise and invest in startup previously. But you can imagine coming into a team like MindAffect is a pretty big difference than normal health tech."

What are you most proud of regarding MindAffect?

"I feel so blessed that the people I work with all have a common vision and we all trust each other" "There is real neurodiversity in the team - there is a real combination of people taking the time and respect each other"

What do you enjoy outside of work?

"I have turned into a bit of a fanatic workaholic with MindAffect - everything is all systems go"

"Outside of work, I do a lot of fitness and when I can do Yoga. When I can I travel to do Yoga retreats, and then I come back completely zen and chilled."

What will MindAffect be doing with the recent investment?

"Okay, so we have now two validated proof of concepts and one validated proof of prototype. And it's in vision, it's in a type of cognition, are the concepts that have been validated. And the proof of prototype is in hearing diagnostics. So we are moving forward with the 1.1 to focus on hearing diagnostics for children from ages two and older."

"The 1.1M will help to pay for the final development of the system. The new hardware that we're hoping to get from our fabulous partner, Bitbrain "

"We will hope to be certified by the end of 2025 and then hit the market in 2026."

Where do you see MindAffect in 2 years time?

"Our focus will be getting our FDA Class 2 approval and the medical certification Class 2A in Europe and the UK."

"We're making a very strong plan to focus first on audiology clinics. So really the key market for us are the most experienced and credible parties that really will look at our system and we will hopefully sell it to them by beginning in early 2026."

What do you believe is missing from the Neurotech industry

"More non-invasive neurotech therapies for patients, the more the better for patients and I look forward to growing this therapy area with MindAffect"

Live Vacancies

• Regional Manager North West UK - Neuromodulation
• Regional Manager London - Neuromodulation
• Engineering Director US - Neuromodulation
• Sales Manager Germany - TMS
• Quality Manager France - Neurovascular
• Neurovascular Clinical Specialist - US

Anything Missing?

Did you see anything that I missed?

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Thanks for tuning in and see you at the end of June!