Statement of Purpose

The Patriot Institute of Neurological Regeneration℠ has developed 10 distinct protocols for treating  a wide range of neurological degenerative disorders. The PINR, a Non-Profit Organization, was officially formed April 30, 2026 to specifically target patients with physical impact related brain damage.

Our formation is the result of finding success during years of direct experience developing protocols for neurological disorders. J. Matthew, our CEO and post-doctoral candidate, endured a dozen failed bio/pharmaceutical treatments attempting to repair "permanently damaged" brain cells. Dr Matthew found a promising investigational-only, FDA unapproved 351a biologic, that has been studied in humans across 100's of peer reviewed journals over the past 10-12 years.

 Our ultimate goal is to achieve an FDA Indication & earn FDA Fast Track Designation after proving our treatment for CTE & TBI leads achieves the Primary Endpoint: a sustained PARTIAL RESPONSE (12-mo median follow up). We define PR as a 50% or greater improvement on MRI's taken at baseline plus a scored system assessing improvement across 4 hallmark symptoms associated wth of Chronic Traumatic Encephalopathy or 'Suspected CTE' (Sleep Quality, Mood Stability, Cognitive Function, Decision Making).

The Patriot Institute℠ strives to close two major gaps that have limited treatment clinical trials for CTE:

1. The absence of a definitive way to diagnose (CTE) Chronic Traumatic Encephalopathy in living patients. 'Suspected CTE' is a term Chris Nowinski, PhD uses when all boxes associated with CTE are checked in living subjects.
2. The limitations on assessing true symptom relief from patient reported results.

CTE can currently be confirmed only through postmortem autopsy. Traumatic Encephalopathy Syndrome (TES), the field's only clinical framework for identifying "Suspected CTE" in the living, is an imperfect tool — recent validation research places its positive predictive value at approximately 24%. We treat that not as a disqualifying flaw, but recognize that TES Criteria is only one of many factors we consider when making our clinical evaluation.

Utilization of higher intensity 7-T MRI Images show markers of Neuro-Inflammation that traditional 3-T or 1.5T MRI's never could. Adding these to standardized neurobehavioral testing, the patient's history of contact sports, military combat history, or domestic abuse. We also carefully interview their loved ones in deciding whether patients qualify for our Phase 1/2 Clinical Trial for CTE. Many will qualify for a Registry Trial in the future.

For individuals identified as High-Risk (through our multi-modal approach) we enroll in our CTE Clinical Trial.

"The Matthew CTE Protocol" — a regenerative medicine biologic therapy, applauded by Solutions IRB (Institutional Review Board), our Ethics Committee. As of September 15th, 2026; We have all of the paperwork ready to file to the FDA as an Investigators New Drug (IND) Application for our Phase 1/2 Clinical Trial in "Suspected CTE" and Radiologically confirmed TBI's (Traumatic Brain Injuries). Open enrollment for the Matthew CTE/TBI Protocol begins 30-days after submitting our Investigational New Drug (IND) Application with the FDA.

Call or text for more up-to-date information on our filing date & who our Primary & Co-Investigators are.

Our patients are comprised mostly of professional athletes and military veterans. But the landscape of repetitive-trauma-related neurological injury has rapidly evolved. Thanks to Boston University's CTE Center we have been educated to learn that Chronic Traumatic Encephalopathy can develop in many patients who never played professional football. BU's brain bank has autopsied over 3,000 brains; this provides statistically significant evidence to be able to  forecast disease prevalence. Anne Mckey, MD & Chris Nowinski, PhD, et al have been pivotal in the discovery of our patent-pending treatment for CTE and TBI's.

Boston University's CTE Center continues to publish compelling results from their registry & clinical trials. They provide new information on the incidence of CTE regularly. The researchers, drug development experts, Neurologists, & Psychiatrists at The Patriot Institute have learned from BU's CTE Center and  The Concussion & CTE Foundation. They started their journey to find a CTE diagnosis in living humans 19 years ago. Without these pioneers in CTE discovery we would all still believe CTE only presented in a small number of long-term professional football players and some boxers who fought too long. Now we know that former athletes of football, ice hockey, soccer, rugby, mixed martial arts, and wrestlers increase their likelihood of brain trauma resulting in "Suspected CTE".

Suspected CTE takes multiple data points into account (as of 9/24/2026: CTE cannot be diagnosed in living humans).

A. 

I] Patients must have a history of enduring multiple blows to the head from contact sports across:

• American football, ice hockey, soccer, fighting (mixed-martial arts, boxing), rugby, & lacrosse.
• Military Veterans (all nations) who've endured explosion blasts during training &/or combat.
• Victims of domestic abuse (Women & Men).

 II] Patients must suffer from symptoms across four categories that have not responded to treatment. These symptoms  are scored to determine if TBI or 'Suspected CTE.'

III] Patients must take a baseline MRI on a T7 MRI Machine: New MRI's can now show 5 markers consistent with CTE.*

IV] Input from the patients PCP & Neurology team, with documentation over the last 2 years, including MRI imaging.

V] Input from the patients loved ones regarding potential changes in personality, mood, suicidal ideations, & rage score.

Our purpose is to develop a viable treatment for patients with documented TBI's and "Suspected CTE" while they are alive. If a NIH approved diagnostic tool is developed prior to the randomization stage, we will use that criteria to assess CTE.