Neurotech Entrepreneurs Make Presentations at LSI USA 25

by James Cavuoto, editor

Published in the March 2025 issue, Neurotech Business Report

Executives from several neurotechnology firms joined hundreds of other medtech professionals at the LSI USA 25 conference, held in Dana Point, CA earlier this month. The conference featured several keynotes and panel discussions related to investment, partnering, reimbursement, and other key topics.

Lisa Earnhardt, group president of medical devices at Abbott, gave a keynote on the second day of the meeting. She described her background in the early days with Guidant before it was acquired by Boston Scientific. Commenting on the difference between a small company and a large firm, she cited the variety of functions a CEO of an emerging firm must perform. “I did clinical data, quality control, I was the receptionist, and I did the dishes,” she quipped. But one similarity in both types of firms is the importance of focusing on the customer. Earnhardt stressed the significance of telehealth to Abbott’s medical device portfolio. Citing the company’s DBS offering, she noted that there are only a few hundred centers of excellence locations in the U.S. and Parkinson’s patients can’t easily drive the 150 miles on average to get their therapy adjusted. Abbott had originally planned to launch its telehealth platform in 2027 or 2028 but the advent of the pandemic forced the company to accelerate development. “It’s been a game changer,” she said.

A workshop devoted to reimbursement featured Tonya Dowd from PRIA Healthcare and Charlie Alvarez, CEO of neurosensing firm Stratus. Dowd said that in addition to the traditional pillars of coding, coverage, and payment, medtech firms should pay attention to benefit categories. She described the difference between diagnosis codes and procedure codes. CPT codes, are owned by the AMA. “It is a 90% politically charged process, and 10% politics,” she said of the process.

Numerous neurotech executives made presentations at the conference, including startups pursuing neurosensing, BCI, and therapeutic neurostimulation segments of the market.

On the therapeutic side, Neuronoff CEO Manfred Franke described his firm’s injectable electrode platform. The company’s adaptive, minimally invasive Injectrode technology transforms complex neuromodulation procedures into simple outpatient procedures, he said. The device enables electrical stimulation of hard to reach nerves and tissues using an 18 gauge needle and self-anchor to prevent lead migration.

Paul Le Floch, CEO of European firm Axoft, described his firm’s implantable BCI targeting applications in the diagnosis and treatment of disorders of consciousness. The company is starting its first-in-human clinical study this year and plans to submit an IDE early feasibility study in the U.S. by 2027. Le Floch said that Axoft’s soft Fleuron material reduces tissue scarring and enables higher bandwidth than other thin-film implants, with 4,096 sensors per ASIC.

Reach Neuro CEO Marc Powell described how the company is harnessing spinal cord stimulation technology to repair brain-to-spine connections damaged by stroke. Designed to work seamlessly with the nervous system, this system restores movement to the arm and hand, empowering stroke survivors on their recovery journey.

Sana Health CEO Richard Hanbury gave an update on his firm’s noninvasive headset using audio and visual stimulation to treat pain conditions. The company has submitted a de Novo application to the FDA for neuropathic pain, obtained Department of Defense funding for PTSD, as well as FDA breakthrough device designation.  Sana has raised $24 million to date and is seeking to raise another $5 million in the current round. 

Sensars COO Guy Siman explained how his firm is transforming diabetic neuropathy care through peripheral nerve-penetrating SENSY device, which restores natural sensations in the feet, helping prevent complications like ulcers, amputations, and chronic pain. The company has obtained FDA breakthrough device designation.

Nalu Medical CEO Thomas West described the company’s battery-free, micro-implantable neurostimulation system for both PNS and SCS treatment of chronic pain, though the bulk of the company’s sales are from PNS applications. Nalu revenues reached $47 million in 2024.

Cognito Therapeutics CEO Christian Howell related the story of Justice Sandra Day O’Connor and her husband, both of whom fell victim to Alzheimer’s disease. He went on to explain potential mechanisms of action for the company’s 40-Hz therapy, including the expression of key genes and proteins, and improvements in the glymphatic system.

Nia Therapeutics CEO Dan Rizzuto offered an update on his firm’s brain stimulator for the treatment of memory loss resulting from traumatic brain injury, degenerative disease and aging. The company’s core technology was developed with funding from the DARPA, and it utilizes artificial intelligence to personalize each patient’s therapy based upon their unique patterns of brain activity. Nia’s first clinical target is memory loss due to TBI, a $32 billion market, which will provide a launchpad into the larger mild cognitive impairment and Alzheimer’s markets.

Karl Stoklosa, CEO of Heidelberg, Germany-based company Precisis GmbH, described his firm’s EASEE (Epicranial Application of Stimulation Electrodes for Epilepsy) implant, a, minimally invasive neurostimulation system designed to treat epilepsy. This technology, CE marked in 2022, offers a highly effective and low-invasive solution for epilepsy patients. The system includes implantable components and external control systems for practitioners and patients. Key features of EASEE include its minimally invasive nature, personalized therapy options, and high efficacy, with clinical studies showing a 65% responder rate at two years post-implantation.

Synergia Medical CEO Charles Nolet described his firm’s optoelectronic neural stimulation platform initially targeting VNS for refractory epilepsy. By providing real-time feedback on stimulation effects, the technology allows for personalized treatment adjustments to improve patient outcomes. Additionally, the platform is designed to minimize MRI-related constraints, enabling a broader range of imaging procedures essential for diagnosis and treatment.

Wave Neuroscience CEO Fred Walke described how his firm is transforming mental health care by integrating objective brain-based biomarkers into patient treatment journeys to alleviate the pain and duration of mental health challenges. The company’s advanced neurotechnology platform empowers medical practices to deliver personalized neuromodulation treatments, optimizing brain network functionality for a wide range of behavioral health disorders.

NeuWire Medical has developed a miniature closed-loop implantable vagus nerve stimulator to enhance functional recovery in persons with ischemic strokes. The technology was awarded FDA breakthrough status and is part of the FDA TAPs program. NeuWire Medical is preparing for a Series A round to fund the pivotal trial with the goal of obtaining FDA approval by 2028.

Several neurosensing firms also presented at the meeting. Danish firm BrainCapture has developed a diagnostic system called the BC-1 that enables portable, hospital grade EEG-based diagnoses without a neurologist or EEG technician onsite. It consists of a CE-marked amplifier and electrode cap for capturing EEG recordings; a proprietary smartphone application that can guide a non-expert to perform a medical-grade EEG; and a cloud-based telemedicine solution that allows secure transfer of patient data to be read by a remote expert.

BrainDynamics, based in Houston TX, is developing software to enhance brain sensing and stimulation (neuromodulation) technologies for treating brain conditions. Its first product, EnCompass, addresses critical clinical and workflow challenges in epilepsy treatment for neurologists and neurosurgeons. BrainDynamics aims to optimize care and improve outcomes through advanced neurotechnology.

Epitel is a digital health company modernizing brain health solutions. By leveraging a proprietary cloud-based wearable sensor system and other innovative AI technologies, Epitel is empowering more informed treatment decisions by making EEG readily deployable and accessible with an initial focus on improving seizure monitoring and detection. 

EpiWatch is an innovative company bringing continuous seizure monitoring, seizure detection and alerting to individuals and families living with epilepsy. EpiWatch is a software as a medical device AI/ML based platform running on an Apple Watch, providing real-world, objective seizure data that improves safety, care management, and ultimately risk forecasting and precision medicine for epilepsy. The company recently received FDA clearance for the device.

UNEEG Medical A/S is a commercializing stage company developing cognitive technologies for continuous EEG monitoring to optimize treatment of epilepsy patients. The company specializes in ultra long-term subcutaneous EEG monitoring with its MDR CE-marked 24/7 EEG SubQ solution, designed to detect electrographic seizures in daily life. UNEEG’s technology provides objective insights into seizure burden for epilepsy management. The company is headquartered in Denmark and has recently been awarded FDA breakthrough device designation.

Zeto EEG is designed to meet the need for faster diagnosis in patients with suspected seizures and other neurological conditions. Zeto has developed an innovative EEG solution to make brain monitoring more accessible and efficient. Its rapid, full-montage EEG with video enables bedside brain monitoring in minutes, delivering real-time data, AI-powered seizure detection, and remote interpretation services for urgent and long term neurological assessment.