Galvani Bioelectronics Reaches Major Milestone in RA Neuromodulation Therapy with First Patient Implantation

Five years ago, we announced that we were joining forces with GlaxoSmithKline (GSK) to form a new research and development-focused company, Galvani Bioelectronics. This new venture would be dedicated to tackling the challenge of treating chronic conditions, including Rheumatoid Arthritis (RA), through targeted neuromodulation therapies.

Today, we are excited to share that our work together has reached an important milestone: successful implantation of the first-ever investigational treatment for RA through stimulation of the splenic nerve in a patient. This not only represents a major accomplishment for Verily, GSK and Galvani Bioelectronics for innovative precision health solutions, but opens a potential new treatment class for auto-immune conditions via a patient enabled platform for data monitoring and more effective outcomes.

Each year, more than 200,000 Americans are affected by RA, an autoimmune disease that causes severe pain, swelling and damage to the joints. Current treatments for RA - like disease-modifying antirheumatic drugs and biologics - are not effective in all patients. And even then, many treatments can cause side effects like headaches, fatigue and nausea that lower quality of life. This has left a large unmet medical need within the RA community.

“There is a significant unmet medical need in RA patients whose disease activity is inadequately controlled with existing therapies,” said Dr. René van der Merwe, Chief Medical Officer of Galvani Bioelectronics.

The Galvani Bioelectronics platform uses the world’s first fully laparoscopically implanted neurostimulator to target the nerve to the spleen - the point at which the body’s nervous system and immune system interact - and a key component in the body’s inflammatory reflex. By sending specific electrical signals to this nerve, the implant is designed to affect and reprogram the body’s circulating immune cells, which contribute to the inflammation in the joints that leads to RA symptoms. More generally, this approach to treatment aims to restore the targeted organ - in this case the spleen - to healthy function, or to adjust it to a different level of necessary function, thereby opening the door to potentially minimizing the symptoms of a number of autoimmune diseases.

The Galvani neurostimulator is designed to be implanted in a minimally invasive outpatient procedure. After implantation the patient and their care provider are then able to control, monitor, and charge the device as needed to ensure continued potential efficacy.

In November 2021, a team of laparoscopic surgeons successfully completed the first implantation of a Galvani device in a patient. Over the last month, therapy was initiated as part of a small clinical study at the NHS Greater Glasgow and Clyde Health Board. At the same time, Galvani has also kicked off a larger U.S.-based study under approval from the FDA. This study will assess the safety and effectiveness of the Galvani platform in the RA patient population. Patients located in Dallas, Texas; Austin, Texas; Anniston, Alabama; and New York City can currently enroll in the study.

Together, Verily and GSK are delivering on their ambitious agenda to transform treatment using innovative hardware and software. Verily’s expertise in miniaturizing low-power electronics, developing medical devices and crafting data analytics and software solutions - along with GSK’s history and heritage in treating chronic disease - have been critical in bringing the Galvani platform to this pivotal moment.

"The innovative design, rapid development, and rigorous testing of the bioelectronics platform are a combined major achievement by the Verily and Galvani team. We look forward to bringing the wide-ranging potential of splenic nerve stimulation to the clinic as a hopeful new treatment option for people suffering with rheumatoid arthritis," said Stephen Gillett, President and COO of Verily and Galvani Board Director.

This digital, 'near organ' investigational therapy is first in a new class of potential precision therapies for autoimmune and other diseases across multiple nerve targets. When combined with traditional drugs that focus on other pathways, the potential for Galvani’s novel platform cannot be understated, and we look forward to continuing this journey together to deliver more effective and more precise health solutions where they are needed most.

People between 22 and 75 years old experiencing moderate to severe active rheumatoid arthritis and currently taking or have taken medications that do not work well enough, can inquire if they qualify for a research study evaluating an implanted device to treat the symptoms of RA - https://www.splenicstimulationforra.com/.