Synergia Medical has raised $10 million to develop a neurostimulation device for the treatment of epilepsy. The device uses optical fibers, photovoltaic cells and a rechargeable battery to address the shortcomings of existing neurostimulation products.
Devices designed to stimulate the vagus nerve to reduce the frequency of seizures in patients with drug-resistant epilepsy have been on the market for more than 20 years. These devices are a big business—LivaNova’s neuromodulation unit generated net sales of $351 million in 2016—but their size, battery life and other shortcomings leave scope for improvement.
Synergia has spent the past four years working to make these improvements, culminating in it having a clinical-phase candidate it thinks is a better option for patients and doctors.
“The device is smaller than the competition. It's thinner. It's lighter. It's programmable and tunable for therapeutic improvements. It's fully MRI compatible. And finally it's equipped with a fast-charging system, which obviously avoids extra surgery,” Synergia CEO Attila Borbath said.
Borbath and 10 colleagues met their design brief for a small, rechargeable, MRI-compatible device by deploying technologies that are yet to fully establish themselves in medtech. The device features optical fibers, not electrical wires, to make it compatible with full-body MRI scans. Light that passes along the fibers is converted to electrical, nerve-stimulating impulses by photovoltaic cells.
Synergia also focused on battery life. The batteries of existing devices last for years. When they reach the end of their life, the patient must undergo a surgery. This procedure takes less than one hour and can be performed under local or mild general anesthetic, but it is an inconvenience. Synergia’s fix is a battery that is recharged in situ via induction.
The team housed these technologies in a relatively small package with a view to ensuring the device is suitable for use in children. Pediatric use of LivaNova’s device was prohibited for years. That changed last year when the FDA signed off on use of the product in children aged four years and up. But Synergia still thinks the size and weight of its device will be a draw for patients.
Having designed the device, Synergia is now ready to see how it works in patients. This first trial will show how often the battery needs charging—Borbath hopes once a month—and generate the data to support a CE mark filing next year. Synergia has also opened talks with the FDA to start the process of bringing the device to the U.S. market.
Mont-Saint-Guibert, Belgium-based Synergia raised $10 million to support this work. Newton Biocapital led the series A with the support of fellow new investors Financière Spin-off Luxembourgeoise, SRIW and SFPI-FPIM. The round will support Synergia’s near-term objectives.
In the longer term, Synergia wants to apply its neurostimulation platform to indications other than epilepsy, notably sleep apnea. These efforts will draw on technologies used in the current version of the epilepsy device, and other, more experimental approaches that are yet to make it out of the lab. Synergia’s pipeline of technologies includes a supercapacitor capable of near-instantaneous charging, a feature Borbath thinks is particularly well suited to the high energy demands of sleep apnea devices.