The BrainWave - Episode 5

Welcome to Episode 5 edition of #TheBrainWave.?

Your Neurology Device Newsletter brought to you by Ryan Tosh ?and?#CMMedical.

Did we miss something big that happened at your company? Leave us a comment or a message to let us know.

Funding News:

REGEnLIFE , a French MedTech start-up focused on researching and developing medical technologies for the prevention and treatment of neurodegenerative diseases, recently secured a funding of 3 Million from both existing and new private investors. This investment will support two studies concerning concussions and Alzheimer's disease.

Their innovative technology revolves around utilizing three distinct light sources (red, infrared, and laser waves). These light sources are administered through an electronically controlled helmet and abdominal belt, targeting both the head and abdomen regions. Congratulations Guillaume Blivet and the wider REGEnLIFE team.

Full Article - https://euro.dayfr.com/health/241320.html

Earlier this week Vertos Medical annouced they had raised $26 Million in an oversubscribed Series C equity funding round. With this being led by new investor Norwest and additional funding from Pitango - an existing investor.

Eric Wichems President and CEO of Vertos Medical said: “We are thrilled to have Norwest join our investor group, with their support, we are confident in our ability to accelerate our commercial expansion and achieve our goal of making the Mild Procedure accessible to every patient suffering from lumbar spinal stenosis (LSS) in the United States.”

Full Press Release - https://www.vertosmed.com/vertos-medical-secures-26-million-to-expand-commercialization-efforts-and-develop-breakthrough-treatments-for-chronic-low-back-pain/

Clinical News:

Precision Neuroscience have begun the first-in-human study for their Neural Interface Technology. A great leap forward for the #BCI industry. Congratulations Craig Mermel Benjamin Rapoport and Michael Mager

In collaboration with West Virginia University's Rockefeller Neuroscience Institute, this ground-breaking study marks the inaugural application of Precision's electrode technology in mapping human brain activity. This cutting-edge technology is specifically engineered to capture brain activity with unparalleled precision, providing a level of detail never achieved before.

Full Article - https://www.globenewswire.com/news-release/2023/06/06/2682588/0/en/Precision-Neuroscience-Begins-First-in-Human-Study-of-its-Neural-Interface-Technology.html

Nalu Medical, Inc. have announced the first randomised patient enrolment of the COMFORT-2 in the Clinical Study of A Micro-Implantable Pulse Generator For the Treatment of Peripheral Neuropathic Pain

The study will focus on comparing the responder rate of PNS (Peripheral Nerve Stimulation) combined with conventional medical management to that of conventional medical management alone.

The COMFORT-2 randomized controlled trial will enrol up to 200 patients in up to 20 study centers in the U.S. Subjects who have been diagnosed with peripheral neuralgia, mononeuropathy, neuropathic pain, or osteoarthritis pain in the low back, shoulder, knee, or foot (including ankle) will be randomized to PNS combined with conventional treatments or conventional treatments alone

“This milestone marks an important step in clinically validating the efficacy of the Nalu PNS system for the long-term treatment of chronic intractable peripheral neuralgia of post-traumatic or post-surgical origin,” says Thomas A. West , Nalu Medical CEO and President. “We are proud to lead the charge in building scientific evidence for PNS while growing our portfolio of Nalu PNS clinical outcomes. We are committed to being the leader in PNS clinical data development.”

Full Article -https://www.businesswire.com/news/home/20230530005208/en/Nalu-Medical-Inc.-Announces-First-Enrollment-of-COMFORT-2-Peripheral-Nerve-Stimulation-Randomized-Controlled-Trial

Neuralace Medical have announced the clinical milestone including presentation of the safety and efficacy of Axon Therapy (SEAT). While completing enrolment in the Axon Therapy Painful Diabetic Neuropathy Study (AT-PDN) and launching a pilot study, focused on the treatment of chemotherapy induced peripheral neuropathy (CIPN)

Building upon its clinical milestones, Neuralace Medical remains committed to utilizing them as a catalyst for its ongoing seed fundraising endeavours. Notably, the company recently achieved a significant milestone with a first close of $3.1 million, representing a substantial step towards its overall funding goal of $5 to $7 million.

Congratulations to Keith Warner , Shiv Shukla , joe milkovits and the wider team at Neuralace Medical.

Full Article - https://www.prnewswire.com/news-releases/neuralace-medical-announces-clinical-milestones-including-presentation-of-the-safety-and-efficacy-of-axon-therapy-seat-study-at-the-american-society-of-pain-and-neuroscience-conference-aspn-while-completing-enrollment-in-the--301836903.html

Comphya have commenced recruitment for their first pilot study in Prostatectomy Patients. The pilot clinical trial will investigate the CaverSTIM system, the first neurostimulator designed to treat erectile dysfunction. The trial has already received necessary approvals from the HREC and TGA, making Australia part of an international clinical development program, joining the US, France and Brazil. Watch this space for Comphya SA, exciting developments to come in 2023/2024 I'm sure. Congratulations Rodrigo Fraga-Silva , Fiona Joseph and Mikael Sturny .

Full Article - https://www.dhirubhai.net/posts/comphya_comphya-sa-commences-recruitment-for-first-activity-7071336449597411328-QqwU?utm_source=share&utm_medium=member_desktop

FDA Approvals:

Omniscient Neurotechnology (o8t) have received their second FDA clearance for their recent upgrade on the Quicktome. The platform conducts a comprehensive analysis of millions of data points extracted from a patient's MRI, providing invaluable insights to neurosurgeons prior to and throughout the course of brain surgery.

I spoke with Michael Sughrue, MD - Cofounder & CMO, earlier this week where we discussed what this FDA approval means for the Omniscient team and the wider Neurology space.

"The impact of novel products can take a while to become clear, but I truly believe that this is a watershed event in the evolution of clinical neuroscience as for the first time, mysteries about the function of the diseased cerebral cortex are potentially answerable."

In addition to providing maps of brain networks as before, this upgrade makes the following possible:

• Conducting an analysis of the functional connectome between any two brain regions within a relevant time frame for clinical purposes.
• Introducing the first approved resting state fMRI product for use in the United States.
• Enabling the creation and storage of diverse connectivity configurations, opening up possibilities for innovative applications that were previously unimaginable in studying patients.
• Utilizing structural and functional information analysis to inform treatment planning and identify targets for interventions, essentially allowing for comprehensive exploration and actionable insights into connectivity.

Penumbra, Inc. have expanded their computer-aided thrombectomy offering with Lightning Bolt 7 launch.

Lightning Bolt 7 is hailed by Penumbra as the market's most cutting-edge and formidable arterial thrombectomy system. By incorporating modulated aspiration, a novel technique that combines Penumbra's Lightning intelligent aspiration technology with an advanced microprocessor algorithm, Lightning Bolt 7 significantly improves the efficiency of removing sizeable, fibrous blood clots in arteries while minimizing blood loss. This breakthrough addresses critical conditions such as acute limb ischemia (ALI), hibernating thrombus, and visceral occlusions.

Lightning Bolt 7 received US FDA clearance and became available in March 2023. It is part of Penumbra’s Indigo system with Lightning portfolio, which are the only computer-aided mechanical thrombectomy systems currently available in the USA.

Artiria Medical Artiria Medical, a Swiss neurovascular company, has achieved a significant milestone with the FDA granting clearance for its ground-breaking real-time, deflectable guidewire.

This accomplishment paves the way for an enhanced and highly effective approach to treating #stroke, as well as other neurovascular and peripheral conditions.

The guidewire developed by Artiria provides physicians with unparalleled control, taking medical practice to the next level. It offers an improved method for maneuvering through the intricate network of cerebral arteries. Notably, the device's distal tip can be adjusted in real time without the need for removal from the patient, while the wire's support profile can be modified during a procedure as required.

“We are excited about receiving the FDA clearance on a cutting-edge, Swiss-made technology,” said Guillaume Petit-Pierre , co-founder and CEO of Artiria. “We are looking forward to starting our clinical activities in the USA very soon.”

“Our sincere thanks go out to our dedicated team who has helped us to reach this significant milestone,” added Marc Boers , co-founder and COO of Artiria.

Congratulations on this great achievement Guillaume, Marc and the wider Artiria team!

Full Article - https://artiria-medical.com/artiria-receives-fda-510k-clearance-for-innovative-neurovascular-guidewire/

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