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Brainsgate

brainsgate.com

Founded Year

2000

Stage

Series F | Alive

Total Raised

$93.5M

Valuation

$0000 

Last Raised

$14M | 2 yrs ago

About Brainsgate

BrainsGate develops a technology for modulation of cerebro-vascular properties through neuro-stimulation of the spheno-palatine ganglion. Affected properties are central to many CNS disorders - blood vessel permeability and blood flow. Currently targeted applications include treatment of ischemic stroke and drug delivery to the CNS through modifying the permeability of the blood brain barrier. The Company has initiated clinical trials, delivering a chemotherapeutic agent to primary brain tumor patients.)

Headquarters Location

4 Rotem Hamidbar st. Southern Industrial Park, P.O.B 3548

Caesarea, 38900,

Israel

+972-4-637-7774

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Expert Collections containing Brainsgate

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

Brainsgate is included in 4 Expert Collections, including Medical Devices.

M

Medical Devices

8,802 items

Companies developing medical devices (per the IMDRF's definition of "medical device"). Includes software, lab-developed tests (LDTs), and combination products. *Columns updated as regularly as possible.

B

Biopharma Tech

5,241 items

Companies involved in the research, development, and commercialization of chemically- or biologically-derived therapeutic & theranostic drugs. Excludes vitamins/supplements, CROs/clinical trial services.

C

Cancer

3,605 items

Companies researching, developing, or offering products & services that aid in the screening, prevention, diagnosis, management, and treatment of cancer.

H

Health IT

7,901 items

Brainsgate Patents

Brainsgate has filed 1 patent.

The 3 most popular patent topics include:

  • Implants (medicine)
  • Bones of the head and neck
  • Cardiac surgery
patents chart

Application Date

Grant Date

Title

Related Topics

Status

5/25/2017

12/24/2019

Implants (medicine), Dosage forms, Prosthetics, Drug delivery devices, Bones of the head and neck

Grant

Application Date

5/25/2017

Grant Date

12/24/2019

Title

Related Topics

Implants (medicine), Dosage forms, Prosthetics, Drug delivery devices, Bones of the head and neck

Status

Grant

Latest Brainsgate News

FDA panel rejects BrainsGate neurostimulation implant for ischemic stroke

Dec 14, 2021

Dec 14, 2021 10:10am The Ischemic Stroke System’s implanted electrodes deliver electrical stimulation to nerves behind the nose several times a day with the aim of augmenting cerebral blood flow after acute ischemic stroke. (FDA) Nearly two years after BrainsGate submitted its implantable neurostimulation device for FDA premarket approval, an advisory panel for the agency struck a major blow to the Israeli company’s plans. The Ischemic Stroke System’s electrodes are implanted inside the mouth, where they deliver electrical stimulation several times a day to the sphenopalatine ganglion, a group of nerve cells located behind the nose and linked to pain and other sensory experiences. The device aims to boost blood flow to the brain after acute ischemic stroke. In a meeting that stretched across several hours Dec. 10, the FDA’s panel of experts in neurological devices discussed a handful of concerns with the performance of the Ischemic Stroke System, or ISS, in a BrainsGate-sponsored clinical study—and with the parameters of the study itself. Ultimately, though the panel unanimously agreed on the safety of the system, the majority were unable to affirm that it’s an effective treatment for stroke and that its benefits outweigh the risks. While advisory committee votes act only as a nonbinding recommendation in the FDA’s decision whether to grant clearance to a device or drug, the agency sides with the panel in the vast majority of cases, slimming down BrainsGate’s chances of securing approval for the ISS. Ahead of the meeting, the FDA compiled a list of concerns (PDF) with the clinical trial results. The trial aimed to prove that when the system was implanted within 24 hours of stroke onset, with stimulation applied in four-hour sessions for five days, post-stroke disability would be reduced by the three-month mark. Many of the agency’s concerns stemmed from the study itself. For one, 12% of patients enrolled in the study had to be excluded from the treatment group because the stimulator couldn’t be implanted or didn’t correctly administer stimulation. Meanwhile, none of the participants in the sham group had to be excluded, an imbalance the FDA said “raises serious doubts about the results of the study.” Other issues raised by the FDA questioned the study’s overall measure of effectiveness. Success in the trial was measured by comparing patients’ disability ratings to a predictive model derived from previous trial data, which the agency said contained an “unexpected degree of inaccuracy.” Additionally, the trial’s protocol, statistical analysis plan, primary outcome and even the device used were changed after the study had already begun, all of which can increase uncertainty in a study’s results. In another of its listed discussion points, the FDA said it was “concerned about the risk associated with direct and indirect consequences of implantation of the device,” which it feared may have been underrepresented in the study results. Potential side effects include airway endangerment, laryngospasm, microaspiration and chronic neuropathic pain caused by the process of puncturing the roof of the mouth to implant the device as well as risks of hemorrhagic transformation, brain swelling, hematoma formation, a spike in blood pressure, infection at the implantation site and more—none of which were reported in the clinical trials.

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Brainsgate Frequently Asked Questions (FAQ)

  • When was Brainsgate founded?

    Brainsgate was founded in 2000.

  • Where is Brainsgate's headquarters?

    Brainsgate's headquarters is located at 4 Rotem Hamidbar st., Caesarea.

  • What is Brainsgate's latest funding round?

    Brainsgate's latest funding round is Series F.

  • How much did Brainsgate raise?

    Brainsgate raised a total of $93.5M.

  • Who are the investors of Brainsgate?

    Investors of Brainsgate include Pitango Venture Capital, Elron Ventures, Agate Medical Investments, Medtronic, Spero Ventures and 12 more.

  • Who are Brainsgate's competitors?

    Competitors of Brainsgate include Verily Life Sciences, Theranica, Orchestra BioMed, Stimdia Medical, Cala Health, Lungpacer Medical, Saluda Medical, Cardionomic, Rune Labs, BrainQ and 49 more.

Compare Brainsgate to Competitors

C
Cala Health

Cala Health develops wearable neuromodulation therapies to deliver individualized peripheral nerve stimulation. It was founded in 2014 and is based in San Mateo, California.

e
eNeura Therapeutics

eNeura Therapeutics develops the use of portable, non-invasive Transcranial Magnetic Stimulation (TMS) devices for the treatment of migraines.

N
Noctrix Health

Noctrix Health is developing therapeutic wearables that empower patients to take control of their chronic medical conditions.

S
Stimdia Medical

Stimdia Medical develops a non-invasive lung pacing device that reduces the time required to get a patient off a ventilator, resulting in significant cost savings. Stimdia Medical was formerly known as Andarta Medical. The company was founded in 2015 and is based in Minneapolis, Minnesota.

L
LivaNova

LivaNova is a medical device company in the treatment of cardiovascular diseases. It develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. The company was founded in 2004 and is based in London, U.K.

Saluda Medical Logo
Saluda Medical

Saluda Medical is a global medical device company developing a platform of closed-loop neuromodulation technologies, based on the neural response to stimulation, to aid people suffering from chronic back pain and other debilitating conditions. The company's first device is the Evoke Spinal Cord Stimulation (SCS) System, a closed-loop SCS that is currently being evaluated in a randomized, double-blinded clinical trial.

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