Regulatory achievements, mergers and acquisitions, significant fundraising and more within neurotech have all been topics that garnered the interest of the MassDevice readers so far this year.
We even have lists of some neurotech companies you should know, plus a third annual installment of a list of brain-computer interface (BCI) companies you should know that published in 2024, in case you need a refresher on some of the relevant innovations in the space.
At DeviceTalks West in Santa Clara, California, Oct. 16-17, a wide range of neurotech will be featured. (Learn more about the event and register at West.DeviceTalks.com.)
Ahead of DeviceTalks West, let’s take a look at the neurotech stories that caught your attention in 2024:
Axonics remains the news for a number of reasons
Axonics made waves when it became a key part of one of the biggest medtech M&A plays of the year, as Boston Scientific agreed to pay $3.7 billion to add the Axonics urology technologies to its portfolio.
That deal hangs in the balance, though, as the FTC requested additional information regarding the acquisition.
While we await the outcome of that acquisition, Axonics earned a significant IP victory this month when a jury unanimously ruled in its favor in a patent spat with Medtronic. The jury found that Axonics does not infringe on any of the three patents-in-suit related to its tined lead design and temperature sensor technology.
Medtronic has a new head of its Neurovascular unit
The medtech giant in May said that it appointed Linnea Burman as the new SVP and president of its Neurovascular business unit.
The medtech giant selected Burman to succeed Dan Volz, who will take on the new role of SVP, global commercial transformation. In this new role, Volz leads a company-wide effort to modernize and transform commercial strategies and go-to-market approaches.
Burman’s responsibilities in her new role include portfolio strategy, product development and commercial execution within the unit focused on stroke treatment. She reports to Brett Wall, EVP and president of the Medtronic Neuroscience portfolio.
“Linnea is a strategic and visionary leader who maintains a customer-first mindset while building and developing high-performing teams,” said Wall. “Her strong record of success, deep medtech industry knowledge, and previous experience in stroke demonstrate her business acumen and underscore the commitment to making a meaningful impact on patient outcomes.”
Neuralink faces more questions but continues to advance pipeline
However, the company hit a snag over a potential wiring issue with the BCI in May. Neuralink said previously that several threads retracted from the brain in the weeks following the first human implant.
The company reportedly knew of this issue for years, but felt it was not enough of a risk to require a redesign effort. Still, the FDA in May gave the company the go-ahead to complete this upcoming second human implant.
Meanwhile, Neuralink has another brain implant on the way. In September, the company announced on social media that it received FDA breakthrough device designation for its vision-restoring Blindsight implant. Musk said the Blindsight device “will enable even those who have lost both eyes and their optic nerve to see.”
Cognito Therapeutics touts non-invasive neuromodulation technology
Cognito reported maintained statistically significant separation of activities of daily living over the 12 months of its study of the disease-modifying therapy.
These results suggest that combined Spectris outcomes fall in line with published criteria for disease modification. Cognito said the results support early treatment as well. Additionally, the company saw no serious treatment-related adverse events in OVERTURE II. It reported high device adherence (80%), similar to its OVERTURE I study that rolled into OVERTURE II.
Cognito continued to push ahead in its effort to bring the neuromodulation technology to market with the appointment of a new CEO in August.
Inspire Medical wins FDA nod for next-gen sleep apnea neurostim
Inspire Medical, the neurostimulator developer offering an alternative to traditional CPAP therapy for people with sleep apnea, took another step forward with a major regulatory nod in August.
The Minneapolis-based company received FDA approval for its Inspire V therapy system, which features a next-generation neurostimulator and associated Bluetooth patient remote and physician programmer.
Inspire’s pacemaker-like device delivers mild electrical stimulation to the hypoglossal nerve, which controls tongue muscles.
The company said at the time that its focus remains centered on operational readiness following this approval. That includes product manufacturing and establishing inventory to support a full commercial launch in the U.S. Inspire Medical targets a soft launch for Inspire V in late 2024, followed by a full launch in 2025.
Inspire Medical’s sleep apnea treatment market share continues to grow since a severe recall knocked traditional PAP maker Philips out of the market for a while.
Abbott takes a big leap forward with rechargeable deep brain stimulation
Liberta RC DBS (rechargeable deep brain stimulation) features remote programming for treating people with movement disorders. Abbott says it requires the fewest recharges of any FDA-approved DBS system, needing just 10 recharge sessions a year for most users.
The system is also the first and only rechargeable DBS device compatible with Abbott’s proprietary NeuroSphere virtual clinic. NeuroSphere allows people to communicate with doctors, ensure proper settings and functionality and receive new treatment settings remotely.
Abbott’s DBS device comes in at approximately the height and width of a smartwatch face. Abbott says it’s about 31% smaller than other commonly used, implantable, rechargeable DBS devices available in the U.S.
Meanwhile, the company’s neurotech offerings continue to expand as Abbott also won expanded MRI labeling from the FDA for its Proclaim system in January as well.
LivaNova study of neurotech for depression hits a snag
Symmetry VNS Therapy did not meet its primary endpoint in the unipolar cohort in the RECOVER study. However, LivaNova said it achieved statistical significance in select secondary endpoints with its neurotech.
The primary endpoint measured the difference between active and sham VNS Therapy on the rate of Montgomery–Åsberg Depression Rating Scale (MADRS) response for the unipolar patient cohort. Over 12 months, the active treatment arm demonstrated statistically significant and clinically meaningful improvement from the treatment arm’s baseline.
LivaNova said the study recorded an unforeseen strong response in its sham group. That led to the failure to achieve statistical separation between arms for the primary endpoint, the company said. However, the company says the totality of the data supports a meaningful treatment effect from VNS Therapy.
CorTec wins FDA IDE nod for closed-loop BCI
The neurotech company designed its Brain Interchange system to deliver fully implantable, closed-loop BCI to clinicians to investigate therapies. Chief Technology Officer Dr. Martin Schuettler believes the closed-loop functionality enables new possibilities for individualized treatments.
IDE allows the University of Washington School of Medicine (UW) to evaluate CorTec’s Brain Interchange implant system in a clinical study. It will investigate the novel stroke rehabilitation treatment that uses cortical stimulation to enhance plasticity within the brain.
The studies have NIH funding and aim to obtain initial first-in-human safety data. Additionally, investigators hope to look at the development of novel therapeutic rehabilitation approaches for upper limb impairment in stroke patients through direct cortical electrical stimulation delivered by Brain Interchange. They slated earmarked the third quarter of 2024 for enrollment and the first implant.
Medtronic advances its DBS pipeline
DBS uses a surgically implanted device like a cardiac pacemaker. Medtronic offers the Percept neurostimulators, which transmit electric signals via slender wires to specific brain targets affected by neurological disorders. Percept offers sensing, directionality and advanced programming. The company’s DBS system with BrainSense technology captures and records brain signals. This provides valuable data and insights needed to tailor therapy to patients’ individual needs.
In a presentation at the J.P. Morgan Healthcare Conference, Chair and CEO Geoff Martha called it a “game-changing” device that exemplifies “how Medtronic engineers are really leading the industry in innovation, developing smaller devices and inventing sensing technology to improve therapeutic benefit.”
About eight months later, the company announced another DBS breakthrough, earning FDA approval for asleep DBS surgery for people with Parkinson’s and essential tremor (ET).
Medtronic says it’s the first and only company to win FDA approval to offer DBS surgery while a patient is asleep (under general anesthesia) or awake.
Synchron bolsters BCI with AI features
The company says its BCI is the only one tapping into blood vessels to capture signals from the brain. The implant goes on the surface of the motor cortex of the brain via the jugular vein. Once implanted, it detects and wirelessly transmits motor intent out of the brain, potentially allowing severely paralyzed people to control personal devices with hands-free point-and-click.
As the company moves forward with a clinical trial for its BCI, it continues to add additional features. In July, Synchron announced that it integrated generative AI, powered by OpenAI, into its BCI platform. Adding generative AI to this platform further enhances the capabilities, enabling users with severe paralysis who lost upper limb mobility to interact with the digital world hands-free with thought alone. Months after the AI integration, the company also linked its BCI to Amazon’s Alexa platform.
Early impressions of Stentrode from its clinical trial are strong, too, as Synchron recently said there were no serious adverse events in its 12-month Command study, which also showed reliable performance from the implant.
