On May 27, 2025, the neuromodulation technology company headquartered in Eindhoven, the NetherlandsSalvia BioElectronicsDeclaration Completed$60 million (approximately RMB 430 million) Series B financing, co-led by New Enterprise Associates (NEA) and Forbion, with participation from Kreos Capital, Panakes Partners, and existing shareholders.

This round of financing will be primarily used to advance the company’s core products.MySalvia Therapyclinical trials, regulatory submission, and commercialization preparation.

Salvia stated that, following the financing, the company will continue to advance its multi-center randomized controlled clinical trials of MySalvia Therapy in Europe and the United States (the RECLAIM study) and prepare for future marketing authorization applications and market deployment.

# Unmet Market Needs in the Treatment of Severe Migraine

Migraine is the second leading cause of disability worldwide, with the global number of patients exceeding1.06 billion people，Among them, chronic migraine (with attacks occurring on 15 or more days per month) accounts for 10%–15%, i.e., approximately100–150 million people. Patients with chronic migraine often face challenges such as poor response to medication, drug resistance, or severely impaired quality of life. According to GBD and WHO reports, migraine isLeading Cause of Disability in Individuals Under 50 Years of Age, causing more than annually$110 billioneconomic losses.

Despite recent advances in oral prophylactic medications and biologic agents such as CGRP monoclonal antibodies, these treatments are ineffective for some patients or associated with adverse effects, leaving a strong demand for non-pharmacological, personalized, and long-lasting therapeutic options. Neuromodulation, asBypassing the Central Nervous System, Adjustable, Non-addictive, has become an important direction in the treatment of chronic migraine.

# Implantable Neural Stimulation Combined with User Active Control

MySalvia TherapyThe system is implanted via a minimally invasive procedureTwo ultra-thin electrodes (frontal and occipital)，Respectively TargetingTrigeminal NerveandOccipital Nerve, delivers electrical pulses to modulate neuronal excitability, aiming to reduce the frequency and intensity of migraine attacks.

Key Technical Points:

• Target Selection：The trigeminal nerve and occipital nerve are key pathways in migraine attacks, and dual-point coverage is expected to enhance the modulatory effect.

• Electrode Design：Electrode thickness is less than1mm, conforming to the subcutaneous contour for discreet implantation and daily wear.

• Control System：Patients can activate stimulation programs on demand via a wearable controller, featuring both personalized settings and real-time feedback.

• Management Platform：Smartphone apps record usage frequency, symptom improvement, and adherence, supporting physician follow-up and remote management.

The system received the U.S. FDA “Breakthrough Device” designation (2020) and is currently conducting the RECLAIM pivotal trial. Early data show that the number of migraine days per patient per month decreased fromReduced from 22 days to 7 days, significantly outperforming the 30%–40% improvement rate of most non-invasive devices, demonstrating preliminary potential for adjustability and durability.

# Non-invasive Devices Are Mature, While Invasive Solutions Begin to Show Advantages

Over the past five years, the field of neuromodulation for migraine has established a framework centered onProduct Portfolio Centered on Non-Invasive Devices. Several products have already received FDA approval, including:

• gammaCore（electroCore）: Modulates brainstem neural activity by delivering low-intensity electrical pulses to the cervical vagus nerve;

  

• SAVI Dual（eNeura）: Based on single-pulse transcranial magnetic stimulation (sTMS) technology, primarily acting on the cerebral cortex to alleviate migraine with aura;

  

• Nerivio（Theranica）: Utilizes Remote Electrical Neuromodulation (REN) to stimulate the peripheral nervous system via a device worn on the upper arm, thereby engaging pain modulation mechanisms;

  

• Cefaly: Based on transcutaneous trigeminal nerve stimulation (e-TNS), inhibiting pain pathways via frontal electrodes.

Common Characteristics of This Type of DeviceConvenient to use, low risk, suitable for mild to moderate patients, particularly demonstrating high compliance and acceptance in home settings. Nerivio, owing to its intelligent operation and low cost, performs well among adolescents and novice users, with a 2-hour pain relief rate of66%。

but inSevere Chronic MigraineAmong the population, the therapeutic depth and durability of efficacy of these devices remain limited. This is particularly true for patients experiencing more than 15 headache days per month who are refractory to medication.Existing Non-Invasive Pathways Fail to Meet Long-Term Management Needs。

In this context,MySalvia TherapyAs the first to enter registrational clinical trialsInvasive, Dual-Target Neuromodulation Device, bringing a differentiated pathway to the field. Its key technical advantages include:

• Deeper Targeted Intervention：The dual electrodes act on the trigeminal nerve and occipital nerve, respectively, forming a“Trigeminal-Brainstem” Neural Network: Coordinated Regulation, theoretically enabling more effective interruption of the central initiation circuitry of migraine.

• More stable stimulation with higher compliance：Adopting a split design with implanted electrodes and a wearable controller avoids the issue of traditional stimulators being easily affected by wearing habits.Enhance long-term usability.

• Highly Discreet Design, Adapting to the Pace of Modern Life：Users can go about their daily lives without exposing the device, preserving aesthetics and social interactions, aligning with the current trend toward “privacy-focused and portable” chronic disease management.

However, as aRequires implantation via minimally invasive surgeryof the device, MySalvia also faces the challenge of relatively high market entry barriers. Currently, it has not been included in mainstream medical insurance systems, and its economic accessibility in practical application remains to be further validated by clinical value, particularly depending onRECLAIM Studyfinal efficacy and safety data.

If it can demonstrate in this study in the futureLong-term efficacy superior to conventional regimens, and has gained recognition from regulatory authorities and health insurance payers,MySalvia Therapy is poised to become a “high-tier solution” in the escalating treatment pathway for migraine, from mild to severe cases., addressing the current unmet treatment gap for patients with severe conditions.

# About Salvia BioElectronics

Salvia BioElectronics, founded in 2017 and headquartered in Eindhoven, the Netherlands, is dedicated to developing minimally invasive neuromodulation technologies based on neuroanatomical atlases. Its core team members hail from companies such as Medtronic, Sapiens, and NeuroPace, bringing extensive engineering and clinical expertise. The company has established independent capabilities in development, manufacturing, and clinical translation. Following its Series B financing round, total funding has reached $105 million. The RECLAIM study is expected to disclose its initial results in 2027.