Case Study

Neuromodulation with MySalvia Migraine Therapy 

Pioneering personalized neuromodulation therapy for migraine 

 

Salvia BioElectronics is a medical device company pioneering neuromodulation therapies for migraine. Salvia's unique, paper-thin implant is designed to reduce the frequency, duration, and intensity of migraine attacks by delivering gentle electrical pulses to the nerves associated with the condition. They are currently in the clinical stage of development.

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Why migraines? 

Migraine affects more than one billion people worldwide each year and is the leading cause of disability in people under 50. Although migraine feels different for each person, episodes typically last 4 to 72 hours and are characterized by a severe throbbing headache on one side of the head that worsens with physical activity. Accompanying symptoms include nausea, vomiting, increased sensitivity to light, sound or odors and cognitive and emotional disturbances, often requiring bed rest. Migraine mainly affects women between the ages of 20 and 50. Chronic migraine is defined as having headaches at least 15 days a month, with a minimum of eight days meeting migraine criteria.  

Cluster headache is a severe one-sided headache that causes excruciating pain behind the eye, often accompanied by tearing, sweating, drooping eyelids and nasal congestion. It is a severe neurological disorder that affects 1 in 1000 people. Cluster attacks are extremely disruptive to daily life, sometimes causing persistent headaches between attacks.  

The project

We collaborated with Salvia to evolve a first-product prototype into a first-generation product and an initial solution for trials and regulatory submission. Our primary focus was developing the device connectivity and mobile application to ensure the implant could safely and effectively transfer sensitive information and allow healthcare clinicians to adjust the parameter limits of the therapy delivered.

 

"Working with S3 Connected Health was an excellent decision. Their expertise helped us accelerate our device development while meeting regulatory requirements."

Daniel Schobben, COO Salvia Bioelectronics

Daniel Schobben

Collaboration

S3 Connected Health collaborated with Salvia on the following scope of work: 

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Developed the first-generation device for clinical studies, focusing on creating a feasible and effective design.

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Engineered firmware for seamless device connectivity, which is essential for the functioning of the implanted device.

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Built a mobile application that is connected to the device through Bluetooth to allow for effective data collection and a user-friendly interface in which clinicians can manage parameter limits.

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Established parameter limits to ensure accuracy, reliability, and safety in therapy customization.

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Implemented secure data management protocols, including encryption, to safeguard data transfer and ensure compliance with HIPAA and GDPR.

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Guided the process of creating documentation for regulatory submission to meet all necessary standards.

 

 

“S3 Connected Health worked with Salvia to transform Salvia's initial product prototype into a first-generation solution, empowering them to confidently advance to clinical studies, validation, and prepare for market launch in the EU and USA." 

Szymon Zysko, Vice President of Research & Development S3 Connected Health

Szymon Zysko

Results

Through this collaboration, Salvia has successfully developed a first-generation device that has advanced to the clinical stage of development. Two ongoing clinical studies were initiated in 2023: the RELIEF migraine study in Belgium and the RESPONSE cluster headache study in Australia. In recognition of their innovation, Salvia has been selected as a 2024 Medtech Innovator Accelerator company, further positioning them for breakthroughs in medical technology.

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