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Theralase(R) Therapy Improves Motor and Non-Motor Function in Parkinson's Patients

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Theralase Technologies (TLTFF) has announced promising interim clinical data showing improvements in both motor and non-motor function for Parkinson's Disease (PD) patients treated with their TLC-2400 Cool Laser Therapy (CLT) system.

In a triple-blind, randomized controlled study at the University of Windsor, patients received 7 treatments over 3 weeks using either active or placebo CLT systems. Key findings include:

  • 11% increase in cognitive assessment scores with active treatment vs 4% with placebo
  • 14% improvement in brain blood flow with active treatment vs 1% with placebo
  • 19% improvement in fine motor control with active treatment vs 6% with placebo
  • 9% improvement in orthostatic tolerance with active treatment vs no change with placebo

The study demonstrates that Theralase's CLT technology can non-invasively penetrate the human skull, promoting anti-inflammatory responses and stimulating dopamine production. This research is particularly significant as PD affects 1 million Americans, with treatment costs reaching $52 billion annually.

Theralase Technologies (TLTFF) ha annunciato dati clinici intermedi promettenti che mostrano miglioramenti sia nella funzione motoria che non motoria per i pazienti affetti da Malattia di Parkinson (PD) trattati con il loro sistema di Terapia Laser Cool TLC-2400 (CLT).

In uno studio controllato randomizzato in triplo cieco presso l'Università di Windsor, i pazienti hanno ricevuto 7 trattamenti nell'arco di 3 settimane utilizzando sistemi CLT attivi o placebo. I risultati chiave includono:

  • Aumento dell'11% nei punteggi di valutazione cognitiva con il trattamento attivo rispetto al 4% con il placebo
  • Miglioramento del 14% nel flusso sanguigno cerebrale con il trattamento attivo rispetto all'1% con il placebo
  • Miglioramento del 19% nel controllo motorio fine con il trattamento attivo rispetto al 6% con il placebo
  • Miglioramento del 9% nella tolleranza ortostatica con il trattamento attivo rispetto a nessun cambiamento con il placebo

Lo studio dimostra che la tecnologia CLT di Theralase può penetrare non invasivamente il cranio umano, promuovendo risposte anti-infiammatorie e stimolando la produzione di dopamina. Questa ricerca è particolarmente significativa poiché la PD colpisce 1 milione di americani, con costi di trattamento che raggiungono i 52 miliardi di dollari all'anno.

Theralase Technologies (TLTFF) ha anunciado datos clínicos interinos prometedores que muestran mejoras tanto en la función motora como en la no motora para pacientes con Enfermedad de Parkinson (PD) tratados con su sistema de Terapia Láser Cool TLC-2400 (CLT).

En un estudio controlado aleatorio a ciegas triple en la Universidad de Windsor, los pacientes recibieron 7 tratamientos durante 3 semanas utilizando sistemas CLT activos o placebo. Los hallazgos clave incluyen:

  • Aumento del 11% en las puntuaciones de evaluación cognitiva con el tratamiento activo frente al 4% con el placebo
  • Mejora del 14% en el flujo sanguíneo cerebral con el tratamiento activo frente al 1% con el placebo
  • Mejora del 19% en el control motor fino con el tratamiento activo frente al 6% con el placebo
  • Mejora del 9% en la tolerancia ortostática con el tratamiento activo frente a ningún cambio con el placebo

El estudio demuestra que la tecnología CLT de Theralase puede penetrar de manera no invasiva el cráneo humano, promoviendo respuestas antiinflamatorias y estimulando la producción de dopamina. Esta investigación es particularmente significativa ya que la PD afecta a 1 millón de estadounidenses, con costos de tratamiento que alcanzan los 52 mil millones de dólares anuales.

Theralase Technologies (TLTFF)는 TLC-2400 쿨 레이저 치료(CL T) 시스템으로 치료받은 파킨슨병(PD) 환자에서 운동 및 비운동 기능 모두에서 개선을 보여주는 유망한 중간 임상 데이터를 발표했습니다.

윈저 대학교에서 실시된 삼중 맹검 무작위 대조 연구에서 환자들은 활성 또는 위약 CLT 시스템을 사용하여 3주 동안 7회의 치료를 받았습니다. 주요 발견 사항은 다음과 같습니다:

  • 활성 치료에서 인지 평가 점수가 11% 증가한 반면 위약에서는 4% 증가
  • 활성 치료에서 뇌 혈류가 14% 개선된 반면 위약에서는 1% 개선
  • 활성 치료에서 미세 운동 조정이 19% 개선된 반면 위약에서는 6% 개선
  • 활성 치료에서 기립성 내성이 9% 개선된 반면 위약에서는 변화 없음

이 연구는 Theralase의 CLT 기술이 비침습적으로 인간 두개골을 관통할 수 있으며, 항염증 반응을 촉진하고 도파민 생성을 자극할 수 있음을 보여줍니다. 이 연구는 PD가 100만 명의 미국인에게 영향을 미치며 치료 비용이 연간 520억 달러에 달하는 만큼 특히 중요합니다.

Theralase Technologies (TLTFF) a annoncé des données cliniques intermédiaires prometteuses montrant des améliorations tant dans la fonction motrice que non motrice pour les patients atteints de la maladie de Parkinson (PD) traités avec leur système de thérapie laser cool TLC-2400 (CLT).

Dans une étude contrôlée randomisée en triple aveugle à l'Université de Windsor, les patients ont reçu 7 traitements sur 3 semaines en utilisant des systèmes CLT actifs ou placebo. Les résultats clés incluent:

  • Une augmentation de 11% des scores d'évaluation cognitive avec le traitement actif contre 4% avec le placebo
  • Une amélioration de 14% du flux sanguin cérébral avec le traitement actif contre 1% avec le placebo
  • Une amélioration de 19% du contrôle moteur fin avec le traitement actif contre 6% avec le placebo
  • Une amélioration de 9% de la tolérance orthostatique avec le traitement actif contre aucun changement avec le placebo

L'étude démontre que la technologie CLT de Theralase peut pénétrer de manière non invasive le crâne humain, favorisant les réponses anti-inflammatoires et stimulant la production de dopamine. Cette recherche est particulièrement significative car la PD touche 1 million d'Américains, avec des coûts de traitement atteignant 52 milliards de dollars par an.

Theralase Technologies (TLTFF) hat vielversprechende vorläufige klinische Daten veröffentlicht, die Verbesserungen sowohl in der motorischen als auch in der nicht-motorischen Funktion bei Parkinson-Patienten (PD) zeigen, die mit ihrem TLC-2400 Cool Laser Therapy (CLT) System behandelt wurden.

In einer dreifach verblindeten, randomisierten kontrollierten Studie an der Universität Windsor erhielten die Patienten über 3 Wochen hinweg 7 Behandlungen mit entweder aktiven oder Placebo-CLT-Systemen. Zu den wichtigsten Ergebnissen gehören:

  • 11% Anstieg der kognitiven Bewertungsergebnisse mit aktiver Behandlung im Vergleich zu 4% mit Placebo
  • 14% Verbesserung des Blutflusses im Gehirn mit aktiver Behandlung im Vergleich zu 1% mit Placebo
  • 19% Verbesserung der Feinmotorik mit aktiver Behandlung im Vergleich zu 6% mit Placebo
  • 9% Verbesserung der orthostatischen Toleranz mit aktiver Behandlung im Vergleich zu keiner Veränderung mit Placebo

Die Studie zeigt, dass die CLT-Technologie von Theralase nicht-invasiv in den menschlichen Schädel eindringen kann, entzündungshemmende Reaktionen fördert und die Dopaminproduktion stimuliert. Diese Forschung ist besonders bedeutend, da PD 1 Million Amerikaner betrifft und die Behandlungskosten jährlich 52 Milliarden Dollar erreichen.

Positive
  • Clinical data shows significant improvements in both motor and non-motor functions
  • Technology demonstrates ability to penetrate skull non-invasively
  • Multiple objective measurements show superior results vs placebo
  • Addresses large market with 1 million American PD patients and $52B annual treatment costs
  • No reported side effects in treatment
Negative
  • Small sample size in current study
  • Results are interim/preliminary
  • Technology still requires further clinical validation
  • Not yet approved or recognized by major industrialized nations

Parkinson's Patients Have Improved Motor and Non-Motor Function After Treatment with Theralase(R) Cool Laser Therapy

Toronto, Ontario--(Newsfile Corp. - March 10, 2025) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses, is pleased to announce that interim clinical data for patients diagnosed with Parkinson's Disease ("PD") and treated with the Theralase® TLC-2400 Cool Laser Therapy ("CLT") system have improved both their motor and non-motor function.

PD is a neurological condition, which affects the brain's ability to produce dopamine – the chemical which helps control movement. It is a progressive condition; whereby, symptoms appear gradually and slowly manifest, as the brain becomes increasingly damaged over time. There is no cure for PD, but the quality of life can be improved with various medications, surgery and lifestyle choices.1

PD is the second-most common neurodegenerative disorder in the United States, with 90,000 people a year diagnosed and as many as 1 million Americans living with the disease. The cost of treatment is estimated to be $14 billion annually, while the combined direct and indirect cost; including: treatment, social security payments and lost income, is estimated to be nearly $52 billion per year. As the U.S. population ages, the number of people diagnosed with PD is expected to double by 2040. Worldwide there are more than 10 million people diagnosed with PD.2,3

In January 2024, Theralase® donated two TLC-2400 Cool Laser Therapy ("CLT") systems to the University of Windsor to conduct a clinical study to aid in the research and development of a novel treatment for patients suffering from Parkinson's, an "active" device with full power and a "placebo" device with virtually no power.

Donation of lasers aids research into Parkinson's disease | DailyNews

Theralase® Donates Cool Laser Therapy Technology to Aid in Research and Development of a Treatment for Parkinson's Disease - Theralase Technologies

Theralase®'s CLT system, with super-pulsed laser technology, is one of the few technologies in the world that is able to non-invasively penetrate the human skull, promoting anti-inflammatory responses and stimulating neurons through the production of dopamine to increase neuromotor function.4, 5

In the latest triple-blind, randomized, controlled, crossover clinical study, titled, "Effects of Cool Laser Therapy Treatment on Cognitive, Physical and Cerebral Neurovascular Function in Parkinson's Disease: A Pilot Study", patients were randomized to either an active or placebo Theralase® CLT system and provided 7 treatments, 3 times per week. After a 4 week "wash-out" period to remove any residual effects, the patients were then "crossed-over" to be treated with the device they had not received treatment from previously.

At the end of each treatment cycle, patients were evaluated for both motor and non-motor assessments:

  • Cognitive Ability (memory – non-motor)
  • Neurovascular Coupling (brain blood flow – non-motor)
  • Fine and Gross Neuromuscular Movement (physical movement – motor)

For all figures, "A" represents the Theralase® CLT system A and "B" represents the Theralase® CLT system B; where, one system is active treatment and the other is placebo treatment.

Each participant completed testing prior to ("Pre") and following ("Post") seven laser treatment sessions with each system.

For all figures, the legend is as follows:

Participant 1 = triangle; Participant 2 = square; Participant 3 = circle

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Figure 1. Montreal Cognitive Assessment

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The Montreal Cognitive Assessment ("MoCA") is a widely implemented non-motor screening tool used to assess cognitive dysfunction. MoCA scores range from 0 to 30; scores, with ≥ 26 indicating normal cognition and scores ≤ 25 indicating cognitive impairment.

The average MoCA score increased by 11% from Pre A to Post A. The average MoCA score increased by 4% from Pre B to Post B.

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Figure 2. NeuroVascular Coupling

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NeuroVascular Coupling ("NVC") is a widely used non-motor assessment tool that evaluates the vascular component of neuronal health by measuring changes in cerebral blood velocity while stimulating specific brain regions corresponding to the imaged vessel. Enhanced blood flow in the brain regions that are stimulated signifies improved neuronal and vascular health.

The average change in cerebral blood velocity during NVC was 14% greater from Pre A to Post A. The average change in cerebral blood velocity during NVC was 1% greater from Pre B to Post B.

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Figure 3. Orthostatic Tolerance Test

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The Orthostatic Tolerance Test ("OTT") is a motor assessment that assesses the ability to transition from laying down to standing up and remain standing in the upright position for five consecutive minutes. This figure illustrates the change in cerebral blood velocity from baseline to the first 30 seconds of standing.

The average change in cerebral blood velocity during the OTT was 9% greater from Pre A to Post A. The average change in cerebral blood velocity during the OTT was unchanged from Pre B to Post B.

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Figure 4. Grooved Pegboard Test

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Grooved Pegboard Test ("GPT") is a commonly used motor assessment tool to assess fine motor control, hand-eye coordination and finger dexterity of participants. A lower time indicates improved motor control.

The average time to complete the GPT using the dominant hand was reduced by 19% from Pre A to Post A. The average time to complete the GPT using the dominant hand was reduced by 6% from Pre B to Post B.

Anecdotal Review:

Participant 1:

Participant 1 appeared to be thinking about his responses to the MoCA questions more intently during the Post A than Pre A session. They also appeared to have reduced hand tremors and improved memory during the Post A compared to the Pre A session. The participant and daughter, who attended each session, noted these improvements as well and inquired about continuing the laser treatments.

Participant 2:

During the Post A session, participant 2 noted that their sense of smell briefly returned and they noticed improvements in their gait (reduced shuffling) compared to the Pre A session.

Participant 3:

Participant 3 and significant other attended the Pre A and Post A sessions. The participant's significant other noticed several changes in the participant from Pre A to Post A; including, improved balance, mood and upper limb fine and gross motor control.

Anthony Bain, Ph.D., principal investigator, University of Windsor is leading the clinical study together with Sean Horton, Ph.D.; Paula van Wyk, Ph.D.; Chad Sutherland, Ph.D.; Brooke Shepley, Ph.D. candidate and Luigi Albano, DC.

Dr. Bain stated, “We are extremely pleased that we have been able to demonstrate subjective and objective indications of neuromotor (motor and non-motor) functional improvement in the treatment of Parkinson’s patients with the Theralase® CLT system. Preliminary results suggest an improvement in motor and non-motor function, with a reduction in symptoms according to both subjective and objective clinical evaluations. This has allowed these patients the opportunity to improve memory and perform tasks that they have struggled with for years. We are especially grateful to the collaboration with Theralase® on the project and for their generous donation of the CLT technology.

Brooke Shepley, Ph.D. candidate, who specializes in cerebrovascular physiology and vascular biology at the University of Windsor, stated, "I am extremely encouraged by the response of the patients to the Theralase® CLT technology. The majority of patients who received the active arm of the study have responded well in most categories, after only a few treatments. It is evident, although the sample size of patients treated is small, that the Theralase® CLT seems to be quite effective in both motor and non-motor function in this patient population. I look forward to completing this pilot study and advancing to a larger clinical study to increase our sample size."

Luigi Albano, D.C., President of Walkerville Chiropractic stated, "In the patients that I have treated in the clinical study to date, I and the patients themselves have seen significant improvements in their Parkinson's symptoms after only a short number of treatments. I look forward to expanding our clinical research to help more patients, whose mental retention and physical movements are at the mercy of this disease. CLT is non-invasive, highly effective and has no side effects."

Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer at Theralase® stated, "Based on this pilot clinical study, Drs. Bain and Albano have clinically demonstrated that Theralase® CLT technology is well indicated in the safe and effective treatment of patients inflicted with neurodegenerative disorders, both motor and non-motor function; specifically, patients diagnosed with PD. The initial results of this clinical study indicate that the CLT treatment protocol is of benefit for patients in various stages of PD and as result will have a significant impact on their quality of life. CLT technology offers painless, non-invasive and effective drug-free solutions for these patients and I look forward to the day when Theralase® CLT technology will be recognized by every major industrialized nation in the world and available for healthcare practitioners to treat neurodegenerative diseases; including, Parkinson's Disease, particularly when so many conventional therapies and drugs have failed to produce sustainable effects or have led to unacceptable side effects."

Roger DuMoulin-White, B.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer of Theralase® stated, "Theralase® was pleased to donate our CLT technology to such a worthy cause as the research and development of a treatment for patients suffering from the symptoms of Parkinson's. Based on the recent success, Theralase® is planning to donate additional equipment to a new clinical study site to increase enrollment into the clinical study. Theralase® is excited by the recent results obtained by Drs. Albano and Bain, demonstrating remarkable improvements in Parkinson's symptoms, both motor and non-motor, with a significant reduction in tremors and dramatic increase in the ability of patients to ambulate and perform tasks that most of us take for granted, after only a few treatments. Our hope is that this clinical research leads to the widespread adoption of Theralase® CLT technology across the world for the benefit of all Parkinson's patients, suffering from this debilitating disease."

References:

1 What is Parkinson's? - Parkinson's Europe
2 Parkinson's Disease: Challenges, Progress, and Promise | National Institute of Neurological Disorders and Stroke
3 Statistics | Parkinson's Foundation
4 Deep brain light stimulation effects on glutamate and dopamine concentration - PMC
5 The potential of light therapy in Parkinson's disease | CPT

About Theralase® Technologies Inc.:

Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecule compounds, their associated drug formulations and the light systems that activate them, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.

Additional information is available at www.theralase.com and www.sedarplus.ca.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements:

This news release contains "Forward-Looking Statements" ("FLS") within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company's proposed development plans with respect to small molecules and their drug formulations and medical devices. FLS may be identified by the use of the words "may, "should", "will", "anticipates", "believes", "plans", "expects", "estimate", "potential for" and similar expressions; including, statements related to the current expectations of Company's management for future research, development and commercialization of the Company's small molecules, their drug formulations and medical devices, through: preclinical research, clinical studies and regulatory approvals.

These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to fund and secure the regulatory approvals required to successfully commercialize various clinical studies in a timely fashion and implement its development plans. Other risks include the ability of the Company to: successfully commercialize its small molecule, their drug formulations and medical devices; access sufficient capital to fund the Company's operations on terms that are commercially favorable to the Company or at all; demonstrate that the Company's small molecule, their drug formulations and medical devices are effective against the diseases and conditions tested in its clinical studies; comply with the terms of license agreements with third parties in order not to lose the right to use key intellectual property in its business; protect its intellectual property; successfully submit, gain acceptance and approval of regulatory filings in a timely fashion. Many of these factors that will determine actual results are beyond the Company's ability to control or predict.

Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS.

Although the FLS contained in this press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these FLS.

All FLS are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such statements.

For investor information on the Company, please feel to reach out Investor Inquiries - Theralase Technologies.

For More Information:
1.866.THE.LASE (843-5273)
416.699.LASE (5273)
www.theralase.com

Kristina Hachey, CPA, X 224
Chief Financial Officer
khachey@theralase.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/243737

FAQ

What improvements did Parkinson's patients show with Theralase (TLTFF) laser therapy in March 2025?

Patients showed 11% improvement in cognitive function, 14% better brain blood flow, 19% better fine motor control, and 9% improvement in orthostatic tolerance with active treatment compared to minimal or no improvement with placebo.

How many treatments did patients receive in the Theralase (TLTFF) Parkinson's study?

Patients received 7 treatments administered 3 times per week, followed by a 4-week washout period before crossover to the other treatment arm.

What is unique about Theralase's (TLTFF) Cool Laser Therapy for Parkinson's treatment?

The technology can non-invasively penetrate the human skull, promoting anti-inflammatory responses and stimulating dopamine production to increase neuromotor function.

What were the subjective improvements reported in TLTFF's Parkinson's treatment study?

Patients reported reduced hand tremors, improved memory, restored sense of smell, better gait, improved balance, enhanced mood, and better upper limb motor control.
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