AIMDs for the stimulation of the nervous system
Image credit: MicroTransponder
FDA approved today the MicroTransponder Vivistim Paired VNS System, a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation (VNS).
Image Credit: Nalu
Nalu Medical, Inc. is a privately held, early-stage start-up based in Carlsbad, California. They developed the Nalu micro-Implantable Pulse Generator (mIPG), which was was named the Implant and Tissue-Replacement device Gold Winner at the 2021 Medical Design Excellence Awards (MDEA).
The Nalu system consists of a fully-featured, battery-free, miniaturized IPG, which is powered by an externally worn Therapy Disc and controlled through a smartphone based remote control app. The Nalu Neurostimulation System is currently FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications.
Nalu’s website is at: nalumed.com
Image Credit: Neuspera Medical
Neuspera Medical is a startup company located in San Jose, CA. They are developing miniaturized neuromodulation implants that are externally powered from a wearable device.
In December 2019, Neuspera announced that it had received FDA’s approval to implant their systems under IDE. Neuspera now announced that they closed a $65M series C equity financing round to fund their trial on the use of their device in patients with Urinary Urgency Incontinence (UUI), a symptom of overactive bladder. The Series C round was co-led by Vertex Ventures HC and Treo Ventures.
Neuspera’s website: http://neuspera.com
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Image Source: Nevro’s Website
FDA has approved an additional indication of Nevro’s Senza® System for the treatment of chronic pain associated with Painful Diabetic Neuropathy (PDN). According to the announcement, “this approval is specific to Nevro’s unique 10 kHz stimulation, and Nevro now has the only spinal cord stimulation system approved by the FDA with a specific indication to treat PDN. The company will immediately initiate commercial launch activities in the U.S. under its recently launched HFX™ branding, as HFX™ for PDN.”
Nevro also announced its Q1 2021 revenue to be around $102.3 million, an increase of 81% compared to $56.4 million in the prior year period and an increase of 9% compared to $93.6 million in the second quarter of 2019. Nevro expects Q2 2021 revenue to be $85.0 million, an increase of 67% compared to $51.0 million in the prior year period and an increase of 9% compared to $78.1 in the second quarter of 2019.
INBRAIN Neuroelectronics S.L. was funded in Barcelona, Spain in 2019 as a spin-off from Graphene Flagship partners, the Catalan Institute of Nanoscience and Nanotechnology (ICN2) and ICREA. Its subsidiary INNERVIA Bioelectronics is working towards the development and commercialization of graphene-based systems to modulate vagus nerve signals.
INBRAIN announced that it will be collaborating with Merck to co-develop the next generation of graphene bioelectronic vagus nerve therapies targeting severe chronic diseases in Merck’s therapeutic areas.
INBRAIN’s website is at: www.inbrain-neuroelectronics.com
Image Credit: CVRx
Back in August of 2019, Minneapolis-based CVRx received a no-panel FDA approval for its BAROSTIM NEO™ device to treat Heart Failure. CVRx has now filed documents with the SEC with plans to offer 6.25 million shares of common stock priced between $15 and $17 per share, expecting to yield approximately $91.5 million in the offering.
The BAROSTIM NEO™ implantable pulse generator is implanted below the collar bone and is connected to a lead that attaches to the carotid artery in the neck, targeting its baroreceptors. The proposed mechanism of action is that the activation of baroreceptors cause the brain to relax the blood vessels and inhibit the production of stress-related hormones to reduce heart failure symptoms.
CVRx’s system is indicated for the improvement of symptoms in patients with advanced heart failure (EF≤35%) who are not suited for treatment with other heart failure devices.
CVRx website: www.cvrx.com
UPDATE: June 30, 2021, 2:49 pm
Yesterday CVRx upsized its IPO of 7M shares of its common stock at a public offering price of $18 per share. Trading started today and share price was $27 mid-afternoon.
UPDATE: July 9, 2021, 2:09 pm
A week after IPO CVRx’s stock has lost all of its initial gains. It is now trading around the original offering price of $18.
Update December 13, 2021
And CVRx stock keeps on tanking…
Image Credit: NeuroPace
NeuroPace of Mountain View, CA announced last month that it filed with the SEC to raise up to $75 million in an initial public offering. However, the IPO was upsized from the initial expectations, with the company offering 6 million shares of common stock at $17 per share, totaling gross proceeds of $102 million. It shares began trading on April 21, 2021 on the Nasdaq under the NPCE ticker.
On April 26 NeuroPace announced the closing of its initial public offering of 6,900,000 shares of its common stock, including the exercise in full of the underwriters’ option to purchase 900,000 additional shares of common stock, at the initial public offering price of $17.00 per share. The gross proceeds to NeuroPace, before deducting underwriting discounts and commissions and offering expenses, were approximately $117.3 million.
Shares rose above $24 after the first day of trading, and have remained steady, closing at $25.78 today.
Unlike Cyberonics’ VNS IPGs, the RNS® neurostimulator is designed to detect abnormal electrical activity in the brain and respond by delivering electrical stimulation to normalize brain activity before the patient experiences seizure symptoms. The neurostimulator is implanted in the cranium and connected to one or two leads that are implanted near the patient’s seizure focus.
Image Credit: Respicardia
Zoll Medical announced on April 12, 2021 that it had acquired Respicardia and its neurostimulation technology for treating sleep apnea. The financial terms of the deal were not disclosed.
Respicardia makes implantable neurostimulators to treat moderate to severe central sleep apnea (CSA). The system is FDA approved to treat severe CSA in adult patients with reduced cardiac function.
Zoll Medical Corporation, an Asahi Kasei company, develops and markets medical devices and software solutions for emergency care, and has been a significant Respicardia investor.
Image Credit: LivaNova
LivaNova and Verily announced that they have enrolled their first patient in a study to evaluate treatment effectiveness for patients living with depression. From the press release:
“The first patient has been enrolled in their collaborative UNCOVER study or “The RECOVER Sub-Study, Which Leverages Quantitative and Credible Research Tools from Verily, Will Provide Assessment Measures for Depressive Episodes.”
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The UNCOVER sub-study deploys technology-enabled research tools from Verily to evaluate the real-world effectiveness of VNS Therapy as an adjunctive treatment for difficult-to-treat depression (DTD).
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Participants in the UNCOVER sub-study will use two Verily-developed digital tools – a wearable, multi-sensor device (Verily Study Watch) along with an Android smartphone application (Verily Mood App). The Verily tools measure passive and active data, such as the participant’s pulse rate, activity levels and sleep quality. The Mood App also allows participants to record voice diaries to more accurately assess depressive episodes and their effect on daily living.
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Quantitative data obtained from these Verily tools will supplement the clinical outcomes collected in the RECOVER study, providing clinicians a more comprehensive view of whether each patient’s depression is improving, staying the same, or worsening.”
Image credit: Onward
Onward is a company dedicated to the development of spinal cord stimulation therapies to improve function after spinal cord injury. Onward was formed in 2014 by researchers at the Swiss Federal Institute of Technology (EPFL). They are now headquartered at the High Tech Campus in Eindhoven, the Netherlands and the EPFL Innovation Park in Lausanne, Switzerland. Onward also has a growing team based in Boston, MA.
Medgadget carried today an interesting interview with Onward’s CEO regarding their technology (the ARC devices).
Onward’s website: onwd.com
Back in March of 2020, Second Sight Medical announced that it was winding down its operations. Second Sight developed implantable devices intended to create an artificial form of useful vision for blind individuals. However, because of the impact of COVID-19 on its ability to secure financing, it laid off the majority of its employees as a first step to an orderly wind-down of its operations.
The company had developed the Orion implant, which is placed directly onto the visual cortex of the patient’s brain. Signals received from a miniature camera integrated within a pair of glasses are fed to the implant and interpreted as “vision” by the brain. At the time of the closure announcement, the company was conducting a feasibility study with the Orion device implanted in six blind patients. Second Sight had been working towards a larger “pivotal” trial of the Orion implant, while all of the patients taking part in the small-scale study had reached the 12-month mark.
On January 6, 2021, Second Sight and France’s Pixium Vision announced that they have entered into a definitive business combination agreement pursuant to which Pixium Vision will, following the contribution to Second Sight of all of its assets and liabilities in relation to its neuromodulation technology used in the treatment of blindness, become the controlling shareholder of the new combined company, owning 60% of the total equity before the capital raise. The combined company will focus on retinal stimulation through Pixium’s Prima System. As part of the transaction, a new subsidiary will be created to focus on cortical stimulation through Orion. The new combined company will own 40% of the new subsidiary and will also have a first option to exclusive global marketing rights for Orion.
Pixium Vision’s Prima System. Image Credit: Images by Pixium Vision
Image Credit: Boston Scientific
Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval of its fourth-generation Vercise Genus™ Deep Brain Stimulation (DBS) System. According to the announcement, The portfolio consists of a family of Bluetooth-enabled, rechargeable and non-rechargeable, MR-conditional, implantable pulse generators (IPGs) that power Cartesia™ Directional Leads.
Image Credit: iota Biosciences
iota Biosciences was established in 2017, building up on the concept of “neural dust” technology invented at the University of California, Berkeley by iota co-founders and co-CEOs Jose Carmena, Ph.D. and Michel Maharbiz, Ph.D.
iota’s “neural dust” consists of a small implantable device (a few mm long) that is powered from an external ultrasound generator. According to iota, their devices can record electrical information, stimulate nerves and communicate with other machines through ultrasound. Iota claims that “neural dust” devices can modulate the information transmitted through nerves, enabling doctors to better treat conditions from arthritis to cardiovascular disease
In 2018 iota completed a $15 million series A funding round aimed at developing a sensing platform. In September 2019, iota entered into a joint R&D agreement with Japanese Astellas Pharma to “design detailed specifications of implantable medical devices and conduct preclinical studies for several diseases with high unmet medical needs.”
Astellas today announced that it would acquire Iota in a deal that includes an initial payment of about $127.5M, covering the equity that Astellas did not acquire in 2018. An additional $176.5M are development-related milestone payments. Iota will be an independent subsidiary under Astellas’ U.S. umbrella.
Eventually, iota hopes to shrink the device to the size of grain of sand that can simultaneously sense neural activity and stimulate nerves to enable highly-targeted closed-loop therapies.
iota Biosciences’ website is at: https://iota.bio/
Image Credit: CVRx
CVRx’s BeAT-HF phase III randomized clinical trial results were published in the Journal of the American College of Cardiology (“JACC”). Results from the trial were used to obtain FDA PMA for the BAROSTIM NEO device for improvement of symptoms in patients with heart failure.
The main results for the study were: