BrainsGate is a medical device company committed to developing innovative therapies for patients suffering from Central Nervous System (lat. Systematis nervosi centralis, CNS) diseases. BrainsGate's platform technology involves electrical stimulation of the Spheno-Palatine Ganglion (SPG), a nervous center known to increase cerebral blood flow. The Spheno-Palatine Ganglion, also known as the Pterygopalatine ganglion, is a parasympathetic nerve center located behind the maxillary sinus next to the nasal cavity. There are two SPG centers, one at each side of the face. The SPG is a triangularly shaped ganglion, 6 mm long that contains synapses for sensory, motor and autonomous nerve fibers. It is known that the SPG supplies the lacrimal and nasal glands. More recently, it was discovered that the SPG also innervates the anterior cerebral circulation in mammals (including humans), which formed the basis for BrainsGate breakthrough technology.
Electrical stimulation of the SPG induces cerebral vasodilatation (increases the diameter of blood vessels supplying the brain). Moderately dilating these blood vessels has been shown to increase blood flow to the brain, and release neurotransmitters such as NO (Nitric Oxide), ACH (Acetyl Choline) and VIP (Vasoactive Intestinal Polypeptide). This phenomenon has a broad range of potential applications and can be used for both acute or chronic indications, and at different intensities. An example for acute, mild stimulation is the case of acute ischemic stroke, where blood circulation has been compromised. SPG stimulation can increase perfusion to the areas suffering from reduced or lack of blood supply, and help save brain tissue. A different (more intense) stimulation regimen, either chronic or acute, can be used to induce a temporary, controlled increase in the permeability of the vessels' walls, thus enabling delivery of drugs, that otherwise would not permeate the Blood-Brain-Barrier.
BrainsGate is also exploring several applications for its technology and is currently focusing on the treatment of acute ischemic stroke. Building on its technology, the company has developed the ISS, based on a miniature electrode implanted at the roof of the mouth in a bedside, minimally invasive, local anesthesia procedure comparable to dental treatment.
The Ischemic Stroke System (ISS) is based on an implantable electrode and designed to deliver electrical stimulation to the Spheno-Palatine Ganglion (SPG). Upon activation (using an external system temporarily attached to the patient's cheek), the system augments cerebral blood flow (CBF). Treatment can be either acute (over a short period of time, hours or days) or chronic (over an extended period, months to years). In addition, the stimulation regimen selected determines the biological effect: a mild stimulation profile leads to gentle augmentation of cerebral perfusion aiding in the management of ischemic stroke or dementia, while a different, more intense regimen enhances the bioavailability of drugs in the CNS by increasing the permeability of the Blood Brain Barrier (BBB).
The ISS is an investigational device currently undergoing clinical studies to determine its safety and effectiveness in patients with acute ischemic stroke. The ISS is comprised of the following components:
- A miniature implantable neurostimulator (INS) - an electrode-equipped implant that is placed adjacent to the SPG in the palatine canal. The INS is inserted into the palatine canal through the greater palatine foramen near the third molar, making the implantation a simple procedure. The INS is MRI compatible thus permits any scan modality to be used as needed.
- A transmitter placed on the patient's cheek, attached by a sticker, to transmit electrical energy from the driver to the implant.
- A controller that allows the caregiver to set treatment parameters and view the system logs.
In 2008, the Company has completed ImPACT-1, a pilot clinical trial for acute ischemic stroke with promising results. In 2011 the Company completed a 300 patients RCT pivotal trial that further substantiated the safety and efficacy of its treatment for acute ischemic stroke patients. BrainsGate is currently running the ImpACT-24b, a multi-national, randomized, double-blind, sham-controlled pivotal study to assess the safety and efficacy of its treatment for stroke patients in a 24-hour window. BrainsGate's investors include Johnson & Johnson, Boston Scientific, Elron Electronics Industries, Pitango Venture Capital, Alice Ventures, Agate Medical Investments, Infinity Ventures and Cipio Partners.