Boosted by Hard2beat, Neuromedical’s VGuard Takes Aim at Alzheimer’s

• Neuromedical raises PLN 3M / USD 800K+ to develop its non-invasive Alzheimer’s therapy
• VGuard by Neuromedical showed up to 5-point cognitive improvement with minimal side effects in trials
• The device is safe, wearable during sleep, and avoids surgery or pharmacological risks
• Future plans include large-scale trials and FDA approval; expansion to other neurological conditions is possible

This May, the Israeli-Polish medtech Neuromedical became one of the first portfolio companies of the newly formed VC firm Hard2beat. Neuromedical’s Seed round amounted PLN 3M (USD 800K+).

A Pioneering Approach to Alzheimer’s

Neuromedical is a Polish-Israeli medtech company developing VGuard—the first fully at-home transcutaneous vagus nerve stimulation (tVNS) system designed for patients with mild cognitive impairment (MCI) and early-stage Alzheimer’s disease. The technology was invented by Dr Tamir Ben David, a serial entrepreneur with over 100 medical device patent applications. Clinical development is led by Dr Adam Broncel, a neurologist and neuromodulation expert who introduced the project in Poland. The company is now headed by Ehud Raivitz, former CEO of Elcam Medical, who scaled that firm into a global OEM supplier with annual revenues between USD 150–300M.

The inspiration behind Neuromedical was a scientific breakthrough: the discovery that vagus nerve stimulation (VNS) could enhance cognitive function in Alzheimer’s patients.

Where Other Treatments Fall Short

To date, Alzheimer’s treatments like cholinergic drugs and memantine could only slow cognitive decline, offering little real improvement in quality of life.

There are also newer anti-amyloid antibodies, such as lecanemab (Leqembi) and donanemab (Kisunla) that showed modest gains on the ADAS-Cog scale but are associated with serious side effects—such as brain swelling and hemorrhage (ARIA)—leading the European Medicines Agency to withhold approval, despite FDA authorization.

Other neuromodulation approaches, like invasive vagus nerve stimulation (iVNS), require surgical implantation, posing risks of infection, nerve injury, and additional operations for battery replacement, making them unsuitable for widespread, long-term use in dementia patients.

Safe, Subtle, and Sleep-Compatible

VGuard, in turn, is a low-invasive technology: with its transcutaneous ear-clip electrodes, it delivers effective vagus nerve stimulation without cutting the skin or any pharmacological side effects. This combines the clinical effectiveness of neuromodulation with the safety and convenience of a wearable device.

‘Aging is the primary risk factor for Alzheimer’s disease—and aging is also associated with a decline in vagus nerve activity and parasympathetic tone. That was a crucial insight. Noninvasive Vagal Nerve Stimulation, a well-established neuromodulation modality, offers a promising therapeutic avenue. Moreover, the vagus nerve connects anatomically to brain structures involved in memory consolidation. These factors together made VNS a compelling therapeutic candidate for targeting the cognitive decline seen in Alzheimer’s,’ Neuromedical’s Chief Medical Officer and EU Manager Dr Broncel comments.

As one may expect, Neuromedical’s journey is marked by rigorous scientific development and regulatory progress. Dr Broncel lists the key milestones achieved so far:

• Filing the initial patent application;
• Completing a four-year animal preclinical research program, during which we discovered that VNS could induce theta rhythms in the hippocampus—an important marker of memory processing;
• Conducting first-in-human trials, which confirmed our proof of concept.

VGuard therapy specifically targets memory—the core cognitive domain most affected in Alzheimer’s disease. Preliminary trials suggest that VGuard may positively influence memory performance, offering patients and families hope for improved daily functioning.

Dr Broncel shares that early human trials demonstrated that Vguard, which operates below the sensation threshold, is safe, well-tolerated, and can be used during sleep without discomfort. Patients were able to wear the device overnight successfully, which is key for long-term adherence in real-world settings.

A Global Health Crisis—and a Market Opportunity

‘Neuromedical is solving a growing global problem. There are 47-50 million people living with dementia in the world today, and according to Alzheimer’s Disease International, this number will triple by 2050; in the US alone, the patient population will grow from 7 million to 12-13 million. An aging population and a lack of competitive solutions create a huge, growing therapeutic gap that VGuard can fill,’ Hard2beat’s founding and managing partner Konrad Trzyna states.

‘The company conducted a medical experiment involving 51 patients with MCI or early Alzheimer. VGuard improved the ADAS-Cog scale score by up to 5 points, and mild side effects, such as short-term headache or skin irritation, occurred in only 17% of participants. This is a result unattainable for current non-invasive therapies and comparable (with better safety) to the latest, expensive biologic drugs, which have not been approved in Europe due to the risk of intra-brain bleeding,’ he adds.

Next Steps: Scaling, Trials, and Approvals

The funding that Neuromedical secured from Hard2beat will support Vguard’s CE certification, FDA preparation, and the final clinical trials. More specifically, with CE certification secured, the next phase will include:

• Launching large-scale, multi-center clinical trials across Europe.
• Preparing regulatory submissions for FDA approval in the United States.

‘Clinical trials are the most resource-intensive phase of medical innovation. They require significant capital—often in the tens of millions—but they are essential for demonstrating safety and efficacy at scale. Regulatory pathways are clearly defined, but navigating them—particularly across different markets—remains a complex process. Once additional approvals are secured, we will focus on expanding access to Vguard through strategic scaling efforts. We are currently executing this roadmap and will share timelines in due course,’ Dr Broncel tells ITKeyMedia.

What’s Next: Commercial Strategy, Exit Potential, and Possible Scaling Beyond Alzheimer’s

‘Our go-to-market strategy centers on direct sales in select European countries, and by strategic partnerships with leading distributors in the United States. We remain acutely aware that millions of patients and their families are awaiting innovative solutions like Vguard. While we are not disclosing specific commercial plans at this stage, our unwavering commitment is to ensure broad, equitable access to Vguard following successful clinical validation,’ Neuromedical’s CEO Ehud Raivitz continues.

The neuromodulation market is characterized by fast and high-profile M&A transactions: for example, the acquisition of ImThera Medical by LivaNova for USD 225M occurred even before the product was fully commercialized. Mr Trzyna is firmly convinced that with solid patent protection, proven clinical efficacy, and a first-in-class treatment for Alzheimer’s, Neuromedical has all the parameters to become the next attractive target for large players or market IPOs, giving Hard2beat a chance for a significant return on investment.

As for other possible plans, it’s worth mentioning that Vguard is designed as a clinical platform with broad potential. In the future, it could be adapted for various neurological and psychiatric conditions—including cognitive aging, depression, or sleep-related disorders. However, the current focus remains squarely on Alzheimer’s-related cognitive decline, where the unmet need is greatest and the team’s data is strongest.