Grey Matter is exploiting cutting-edge intellectual property to develop neuromodulation systems that are at once highly portable and exquisitely accurate.
Thanks to our highly experienced engineering and scientific team, we expect to roll-out a best-in-class investigational device in the near-future.
Grey Matter’s technology was originally invented by focused ultrasound pioneer, Dr. Kullervo Hynynen.
Our large collection of licensed and assigned patents enables the creation of non-invasive neuromodulation devices that neither require image guidance nor patient immobilization to achieve highly accurate and precise targeting.
Chair, Department of Psychiatry, University of Texas Southwestern
Director, Harquail Centre for Neuromodulation, Sunnybrook Research Institute
Answers to common investor questions about our technology, plan and more. This question set will be updated periodically.
Our current focus is treatment-resistant depression in seniors and adults. We are also interested in other age-related diseases of the brain, including Alzheimer’s disease, Parkinson’s disease and mild cognitive impairment.
At present, Grey Matter and SRI are working together to identify biomarkers of focused-ultrasound-based neuromodulation and optimize the parameters of same. In the future we plan to conduct initial clinical feasibility studies in partnership with SRI.
We anticipate (but have not yet confirmed) that our first product will be a Class 2 medical device and will qualify for associated regulatory clearance shortly following a multi-centre pivotal study.
Grey Matter is sufficiently capitalized to support all activities up to and including an early feasibility study. Proceeds from our forthcoming series A/B round will be used to support the conduct of a multi-centre pivotal trial and subsequent regulatory approval.
There are several published clinical studies that report that transcranial focused ultrasound and pulse stimulation can sustainably improve mood and enhance cognitive function. Other published reports document randomized controlled trials that examine the safety and efficacy of transcranial focused ultrasound in disorders of consciousness, epilepsy, autism and neuropathic pain. There are myriad published observations of the biological impact of transcranial FUS in experimental models.
Our technology can be used to support ultra-precise delivery of brain-penetrant small molecule drugs to selected structures of the brain, sparing all other regions of the central nervous system and body. We intend to pursue drug-device combination products based on this principle once our transcranial FUS platform is well established.
We are licensing multiple patent families from Sunnybrook Research Institute, which incorporate a range of claims, from the manufacture of high-fidelity transducers to the method of delivering transcranial focused ultrasound using a custom-fitted headset. We have also filed several patent applications for new inventions.
We seek to finalize a minimum viable product shortly and test this device in a well-powered clinical feasibility trial in partnership with Sunnybrook Research Institute in Toronto.
We would be delighted to engage directly with parties seriously interested in participating in our journey.
