BrainWave - August Wrap Up

So you didn’t score those Oasis tickets... but don’t worry, you’ve got the latest edition of the BrainWave newsletter—no breakups here.

Despite the peak vacation season, the Neurotech industry kept up the pace. So, without further ado, let’s dive into what you might have missed in August.

Funding:

• NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) announces $2.65M Equity financing and $3M credit facility to support the launch of its OneRF Ablation System. Dave Rosa
• Spike Neuro has won $491,579 award from the department of Health and Human Services. The award is for their project, 'Dual-Function Carbon Modified-Silicon Microelectrodes for Biomolecule Detection with Fast Scan Cyclic Voltammetry and Electrophysiology Recording and Stimulation', which aims to develop a dual-function microelectrode for simultaneous recording of neurochemical and electrophysiological biomarkers. Lawrence S. 1
• NAVIGANTIS have closed their Series A of $12M led by Puma Venture Capital, with participation from Cormorant Asset Management, LP and Mirae Asset Capital . The funding will be used to advance the development of its VASCO Robotic Platform. Hyosig Kang Mor Dayan
• NeuroTherapia, Inc. have received $12.3M in Series B round funding. The team have developed an orally avaliable cannabinoid receptor agonist for the treatment of Alzheimer's disease. The team have partnered with Cleveland Clinic Innovations and more to continue research into the disease. The Series B round, led by Cleveland Clinic , includes all previous investors, Brain Trust Accelerator Fund II, Dolby Family Ventures , and the Alzheimer's Drug Discovery Foundation (ADDF), as well as new investors, Foundation For A Better World (FFABW) , and CRUINT. Joseph Foss
• XII Medical raises $45M in Series B financing to advance Best-In-Class neuromodulation therapy for (OSA) Obstructive Sleep Apnea. Omega Funds and Intuitive Ventures join the investors. Garrett Schwab

Product Launches and Regulatory Approvals:

• Gravity Medical Technology launches the Supernova stent retriever and Neutron aspiration catheter for global stroke treatment. Early adoption has demonstrated the successful treatment of more than 60 patients worldwide, according to a company press release. Kunakorn Atchaneeyasakul, MD MPH
• Compumedics Limited - Official Compumedics USA have announced that the Somfit and Somfit Pro have officially received regulatory approval from Health Canada! ?? These ground-breaking sleep technologies are now available across Canada. Craig P. Gallivan David Burton
• 美敦力 says its the first and only company to win FDA approval to offer DBS surgery for patients suffering with Parkinson's and essential tremor. while a patient is asleep (under general anaesthesia), versus awake. “This is a significant advancement in our surgical offering, providing another safe and effective option for patients considering DBS,” said Amaza Reitmeier , VP and GM, Brain Modulation within the Neuromodulation business at Medtronic. “This approval underscores our dedication to continuous innovation to address the needs of patients and healthcare providers.”
• Neuros Medical, Inc. has received FDA Approval for the Altius Direct Electrical Nerve Stimulation System. Physicians and patients now have a clinically proven treatment that addresses the underlying cause of post-amputation pain using an innovative on demand, patient-controlled device without the risk of addiction associated with opioids. David Veino
• RebrAIn announced its second FDA 510(k) clearance for the OptimMRI software, representing a significant milestone in the company’s mission to revolutionize neurosurgical targeting with advanced AI technology. Emmanuel Cuny David C. Nejib Zemzemi Diego Polzoni

Clinical News:

• The Clinical team at Neurovalens have successfully completed their Type 2 Diabetes clinical trial. The goal of this trial is to improve glucose and insulin regulation and therefore positively influence HbA1c. Optimization of the central melanocortin system and regulation of the vagal nerve afferents are the primary target areas to allow better glycaemic control and potentially reduce the need for pharmaceuticals. Poor regulation of metabolic homeostasis drives the development of obesity. Neurovalens targets key hypothalamic and brainstem nuclei involved in the neuro-regulation of body composition, with the aim of improving this dysregulation at source. Sinead Watson Jason McKeown
• Neuralink has been valued at a whopping $8 Billion! This will have changed since the report went live as their 2nd participant received the Neuralink implant "Link" on the 21st August at Barrow Neurological Institute, Alex was discharged the following day of the procedure and his recovery has been smooth. With the Link, he has been improving his ability to play video games and began learning how to use computer-aided design (CAD) software to design 3D objects.
• Byung J. and the team at Arissa Medical has announced the third enrolment of patients into its Syntra study - an early feasibility pilot study evaluating the safety and efficacy of the company’s Syntra device for the treatment of irregular, wide-necked sidewall and wide-necked bifurcation cerebral aneurysms.

News You Need to Know:

• CVRx | Barostim have announced that the Barostim implant procedure is now associated with a higher payment in the?2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule. Kevin Hykes
• EndoStream Medical announced they have been granted another US Patent further strengthening their intellectual property position. This patent protects their core technology as manifested in the Nautilus implant. Danel Mayer Alon May
• NeuroBionics have been awarded the NSF Phase I SBIR grant to support our neurotech development efforts! This grant allows us to tackle one of the most challenging—and often overlooked—aspects of advancing novel neural probe technology: creating robust and streamlined connectors. MJ Antonini Nicolette Driscoll
• Neuronetics, Inc. announced earlier this month that they have agreed to acquire all outstanding shares of Greenbrook in an all-stock transaction. The acquisition creates a vertically integrated organization comprised of two companies that develop transcranial magnetic stimulation (TMS) technology. Keith Sullivan
• Noctrix Health, Inc. announces new CMS Reimbursement Codes and Payment for Nidra Tonic Motor Activation (TOMAC) Therapy for Restless Legs Syndrome (RLS) Shriram Raghunathan, Ph.D
• GrayMatters Health are expanding in the United States bringing the FDA cleared treatment, Prism for PTSD, to Home Base and Fermata clinics. Oded Kraft Kirk Thelander
• Firefly Neuroscience forms strategic partnership with Neurology Consultants of Dallas (NCD) to enhance early detection efforts and disease management for patients with cognitive disorders. NCD Will Integrate Firefly’s BNA Technology into its Patient Management Protocols for Enhanced Brain Function Insights and Improved Patient Outcomes. Jon Olsen
• Stryker announces definitive agreement to acquire Vertos Medical expanding interventional pain management solutions. Kris Krustangel Eric Wichems Andy Pierce
• Stratus Medical announces exclusive distribution agreement with Edge Medical for the United Kingdom. Edge Medical will distribute the innovative NIMBUS? RF Multitined Expandable Electrode and other Stratus Medical RF products that are rapidly gaining market share across the world. Mark Vujovich Will Pankey Bret Boudousquie
• NeuraWorx have announced there partnership with Corundum Neuroscience to initiate a clinical feasibility study and develop innovative neurological disease treatments. NeuraWorx is developing the Cerebrovascular Pacing System, a first-in-class wearable neurostimulator, which leverages established bioelectronic principles to enhance the brain's glymphatic and cerebrovascular systems, aiming to enhance waste clearance for improved brain health. Liron Nunez Weissman
• Spark Biomedical Inc have been issued new CMS Codes for Transcutaneous Auricular Neurostimulation (tAN) Therapy via Sparrow Ascent. Sparrow Ascent is now the first FDA-cleared, non-invasive neurostimulation device to receive these codes, paving the way for broader insurance coverage and making this life-saving therapy available to more Americans with opioid use disorder than ever before. Daniel Powell
• Nevro recently announced that its board is exploring strategic options as it faces increased competition in the spinal cord stimulation space.

Senior Leadership Appointments:

• Jonathan Casey has been promoted to VP of Operations and Quality at MintNeuro .
• Sarah Montana joins ONWARD Medical as Director, Sales and Customer Advocacy.
• Blake Pokress also joins the ONWARD Medical team as Area VP US Sales.
• Lauren Lichtenauer has moved into a new AVP Midwest position for Curonix
• Jason DuBraski started his new position at Firefly Neuroscience as VP of Sales
• Cognito Therapeutics, Inc. announces the appointment of Christian Howell as the new Chief Executive Officer succeeding Bren Vaughan.
• Holger Dr. Witkowski has been appointed as the new Managing Director of Europe for Mainstay Medical
• Danielle Chu starts a new position at Penumbra, Inc. as Vice President LATAM.

Anything Missing?

Did you see anything that I missed?

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