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Halberd, Athena GTX, Inc. & Athena Telemedicine Partnership, LLC Clinical Study Updates

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Halberd Corporation (OTC: HALB) has announced significant clinical efficacy for its patent-pending LDX compound in treating dialysis-related neuropathy and pruritis. The company is launching a nationwide 100-patient study for kidney disease patients. A case report highlighted a 63-year-old female patient who experienced immediate symptom relief from severe pruritis and neuropathy using LDX after previous treatments were ineffective. The study will involve a 90-day trial using a titrated dose response protocol, with Athena GTX providing WatchDawg™ wearable monitoring. The global dialysis treatment market, valued at $116.1B in 2024, is projected to reach $198.2B by 2033. With approximately 850M people worldwide suffering from kidney disease and 4.2M undergoing dialysis treatments, the company sees significant market potential for their LDX compound.
La Halberd Corporation (OTC: HALB) ha annunciato un'efficacia clinica significativa per il suo composto LDX, ancora in fase di brevetto, nel trattamento della neuropatia e del prurito correlati alla dialisi. L'azienda sta avviando uno studio nazionale su 100 pazienti affetti da malattie renali. Un caso clinico ha evidenziato una paziente di 63 anni che ha sperimentato un immediato sollievo dai sintomi di prurito severo e neuropatia grazie all'LDX, dopo che i trattamenti precedenti si erano rivelati inefficaci. Lo studio prevede una sperimentazione di 90 giorni con un protocollo di dosaggio titolato, mentre Athena GTX fornirà il monitoraggio indossabile WatchDawg™. Il mercato globale dei trattamenti per la dialisi, valutato 116,1 miliardi di dollari nel 2024, è destinato a raggiungere i 198,2 miliardi entro il 2033. Con circa 850 milioni di persone nel mondo affette da malattie renali e 4,2 milioni sottoposte a trattamenti dialitici, l'azienda intravede un notevole potenziale di mercato per il suo composto LDX.
Halberd Corporation (OTC: HALB) ha anunciado una eficacia clínica significativa para su compuesto LDX, pendiente de patente, en el tratamiento de la neuropatía y prurito relacionados con la diálisis. La empresa está lanzando un estudio nacional con 100 pacientes con enfermedad renal. Un informe de caso destacó a una paciente de 63 años que experimentó un alivio inmediato de los síntomas de prurito severo y neuropatía con LDX, después de que los tratamientos anteriores no fueron efectivos. El estudio incluirá un ensayo de 90 días con un protocolo de respuesta de dosis titulada, y Athena GTX proporcionará el monitoreo portátil WatchDawg™. El mercado global de tratamientos para diálisis, valorado en 116.1 mil millones de dólares en 2024, se proyecta que alcance los 198.2 mil millones para 2033. Con aproximadamente 850 millones de personas en todo el mundo que sufren de enfermedad renal y 4.2 millones en tratamientos de diálisis, la empresa ve un gran potencial de mercado para su compuesto LDX.
Halberd Corporation(OTC: HALB)는 특허 출원 중인 LDX 화합물이 투석 관련 신경병증 및 가려움증 치료에 있어 임상적으로 유의미한 효능을 보였다고 발표했습니다. 회사는 신장 질환 환자 100명을 대상으로 전국 단위의 연구를 시작합니다. 한 사례 보고서에서는 63세 여성 환자가 이전 치료가 효과가 없었던 심한 가려움증과 신경병증 증상을 LDX 사용 후 즉각적으로 완화한 사례가 강조되었습니다. 연구는 90일간의 시험으로, 용량 조절 프로토콜을 적용하며 Athena GTX가 WatchDawg™ 착용형 모니터링을 제공합니다. 2024년 기준 1,161억 달러 규모인 전 세계 투석 치료 시장은 2033년까지 1,982억 달러에 이를 것으로 예상됩니다. 전 세계 약 8억 5천만 명이 신장 질환을 앓고 있으며 420만 명이 투석 치료를 받고 있어, 회사는 LDX 화합물에 대한 시장 잠재력이 크다고 보고 있습니다.
Halberd Corporation (OTC : HALB) a annoncé une efficacité clinique significative pour son composé LDX en instance de brevet dans le traitement de la neuropathie et du prurit liés à la dialyse. L'entreprise lance une étude nationale impliquant 100 patients atteints de maladies rénales. Un rapport de cas a mis en lumière une patiente de 63 ans qui a ressenti un soulagement immédiat des symptômes de prurit sévère et de neuropathie grâce à LDX, après l'échec des traitements précédents. L'étude comprendra un essai de 90 jours avec un protocole de titration des doses, Athena GTX fournissant la surveillance portable WatchDawg™. Le marché mondial des traitements de dialyse, évalué à 116,1 milliards de dollars en 2024, devrait atteindre 198,2 milliards d'ici 2033. Avec environ 850 millions de personnes souffrant de maladies rénales dans le monde et 4,2 millions sous traitement de dialyse, l'entreprise entrevoit un potentiel de marché important pour son composé LDX.
Die Halberd Corporation (OTC: HALB) hat eine signifikante klinische Wirksamkeit ihres patentierten LDX-Wirkstoffs bei der Behandlung von dialysebedingter Neuropathie und Pruritus bekannt gegeben. Das Unternehmen startet eine landesweite Studie mit 100 Patienten mit Nierenerkrankungen. Ein Fallbericht hob eine 63-jährige Patientin hervor, die nach erfolglosen vorherigen Behandlungen sofortige Linderung der Symptome von starkem Juckreiz und Neuropathie durch LDX erfuhr. Die Studie umfasst eine 90-tägige Testphase mit einem titrierten Dosierungsprotokoll, während Athena GTX das tragbare Überwachungsgerät WatchDawg™ bereitstellt. Der globale Markt für Dialysebehandlungen, der 2024 auf 116,1 Milliarden USD geschätzt wird, soll bis 2033 auf 198,2 Milliarden USD anwachsen. Mit etwa 850 Millionen Menschen weltweit, die an Nierenerkrankungen leiden, und 4,2 Millionen, die Dialysebehandlungen erhalten, sieht das Unternehmen ein erhebliches Marktpotenzial für seinen LDX-Wirkstoff.
Positive
  • Successful clinical efficacy demonstrated for LDX compound in treating dialysis-related symptoms
  • Large market opportunity with dialysis treatment market projected to reach $198.2B by 2033
  • Partnership with Athena GTX for advanced monitoring technology integration
  • Expanding potential applications of LDX beyond initial PTSD/Suicidal Ideation focus
Negative
  • Early stage of clinical studies with limited patient data
  • FDA approval still pending for LDX compound
  • Competitive market with established treatment options

Issues nationwide nephrologist solicitation for patients for a 100-patient study involving kidney disease

JACKSON CENTER, Pa., May 28, 2025 (GLOBE NEWSWIRE) -- Halberd Corporation (OTC: HALB) in cooperation with Athena Telemedicine Partners, LLC, announces astounding clinical efficacy for our patent-pending LDX compound for dialysis-borne neuropathy and pruritis in yet another case report and issues nationwide nephrologist solicitation for patients for a 100-patient study involving kidney disease.

We previously found that our patent-pending LDX medication is an incredibly ubiquitous compound that has powerful applications in the management of addiction, chronic inflammatory disorders, neurological disorders, pain management and represents a multibillion-dollar market potential. We recognize that it is important to satisfy FDA indications and advance other unforeseen and profitable indications as we continue to expand the potential use of our proprietary LDX formulation. Following is our recent experimentation with LDX beyond our previous successful program on PTSD/Suicidal Ideation.

The Problem: As of recent estimates, approximately 850 million people worldwide suffer from some form of kidney disease, including chronic kidney disease (CKD), acute kidney injury (AKI), and end-stage kidney failure. International Society of Nephrology 

Chronic Kidney Disease (CKD): In 2021, there were approximately 673.7 million cases of CKD globally. CKD is characterized by abnormalities in kidney structure or function lasting for more than three months and is a leading cause of kidney failure. Frontiers.

End-Stage Kidney Failure: Over 2 million people currently receive treatment for kidney failure through dialysis or kidney transplantation. However, this number may represent only about 10% of those who actually need treatment to stay alive. National Kidney Foundation.

Acute Kidney Injury (AKI): Each year, 13.3 million people experience AKI, which can lead to CKD or kidney failure if not properly managed. International Society of Nephrology

As of 2023, approximately 4.2 million people worldwide are undergoing dialysis treatments for end-stage kidney failure, according to Fresenius Medical Care. This figure includes both hemodialysis and peritoneal dialysis patients. Notably, about 12% of these patients receive home dialysis services, a number that has increased by nearly 2% since the COVID-19 pandemic. Giiresearch+1MarketResearch.com The global dialysis treatment market has experienced significant growth and is projected to continue expanding in the coming years. In 2024, the market was valued at approximately $116.1 billion USD, with expectations to reach $198.2 billion by 2033, growing at a compound annual growth rate (CAGR) of 5.4% from 2024 to 2033. Nexbind Insight Market Research Pvt ltd. Approximately 41% of this market is North America.

Case Report: LD is a 63 y/o female with Stage 4 chronic renal failure on home peritoneal dialysis with severe symptoms of pruritis and neuropathy. Unresponsive to large doses of multiple medications, including Gabapentin, she was placed on LDX and a custom CBD nutraceutical. For the first time in five years, she became almost immediately symptom free.

However, LD stopped the LDX based on physician input, and had a recurrence of her symptoms. She was hospitalized for hypertension and stabilized, a significant reduction in medications prescribed ensued, including Gabapentin, and as a result her neuropathy and pruritic symptoms reappeared. She was started on LDX again, but under a titrated dose response protocol that is patent pending, and immediately found relief of both the pain and itching.

We will be offering a 90-day trial for clinicians dealing with dialysis patients on a safety and proof of efficacy FDA study for LDX. Our platform involves a very low dose initiation and progressive introduction of LDN and methocarbamol with natural cinnamon as a filler to a traditional therapeutic dose.

Athena GTX will be supplying wearable WatchDawg™ monitoring and cloud-based acquisition of data through our partners at Verizon, to supply objective data on the relief of symptoms to both the participants and physicians/care teams. We expect a full data presentation for a large and heretofore patient problem that was very difficult to manage. 

This will be one of two studies with which we are engaged, with a subsequent well-funded study on PTSD, alcohol use disorder, and suicidal ideation, with an end goal to reduce suicide to be announced shortly.

To get the latest on the exciting developments by the Halberd/Athena teams, subscribe by submitting this form. (https://halberdcorporation.com/contact-us/).

For more information, please contact:

  
William A. HartmanMark Darrah, PhD
Chairman, CEO, President, Halberd Corp.CEO Athena GTX
w.hartman@halberdcorporation.comGM Athena Telemed. Partners (LLC)
support@halberdcorporation.commdarrah@athenagtx.com
www.halberdcorporation.comwww.athenagtx.com
Twitter:@HalberdC 
  

About Athena Telemedicine Partners, LLC
Athena Telemedicine Partnership, LLC (ATP) is a partnership between Athena GTX, Inc. and three other partners and a group of private investors. The partnership involves the use of pharmaceuticals, nutraceuticals, yoga/meditation, unique, wearable monitoring, and psychological therapists combining to service veteran mental health issues and suicidal ideation.

About Athena GTX, Inc.
Athena GTX is a certified DoD small business with Corporate Headquarters in Johnston, Iowa. Athena focuses development on wearables and highly mobile, wirelessly connected monitoring technologies, and transitioning those to key markets to meet unmet needs of first responders worldwide. Wireless Patient Monitoring – Athena GTX connects patient and provider About - Athena GTX® Inc.

About Halberd Corporation.
Halberd Corporation (OTC: HALB), is a publicly traded company on the OTC Market, and is in full compliance with OTC Market reporting requirements. Since its restructuring in April of 2020, Halberd has obtained exclusive worldwide rights to three issued patents and has filed 22 related provisional, PCT, or utility patent applications to enhance its value to its stockholders and to attract the interests of potential development partners. Halberd’s policy for responding to individual shareholder questions is to be responsive, while refraining from providing information which relates to or could compromise any information pertaining to trade secrets or that may otherwise compromise our competitive advantages. Simultaneously with such disclosure or potential disclosure, Halberd will make the responsive information public through a tweet, press release or some other form of social media/mass media communication.

Safe Harbor Notice
Certain statements contained herein are “forward-looking statements” (as defined in the Private Securities Litigation Reform Act of 1995). The Company’ cautions our readers that statements, and assumptions made in this news release constitute forward-looking statements and makes no guarantee of future performance. Forward-looking statements are based on estimates and opinions of management at the time the statements are made. These statements may address issues that involve significant risks, uncertainties and associated estimates made by management. Actual results could differ materially from current projections or implied results. Halberd Corporation undertakes no obligation to revise these statements following the date of this news release.

(C) 2025, Halberd Corporation


FAQ

What is Halberd's (HALB) LDX compound being tested for in the new clinical study?

Halberd's LDX compound is being tested in a 100-patient study for treating dialysis-borne neuropathy and pruritis in kidney disease patients, following successful case report results.

How large is the market opportunity for Halberd's (HALB) kidney disease treatment?

The global dialysis treatment market is valued at $116.1B in 2024 and projected to reach $198.2B by 2033, with approximately 850M people worldwide suffering from kidney disease.

What technology will be used in Halberd's (HALB) kidney disease clinical trial?

The trial will use Athena GTX's WatchDawg™ wearable monitoring system with cloud-based data acquisition through Verizon to track patient symptoms and treatment efficacy.

What were the results of the case study for Halberd's (HALB) LDX compound?

A 63-year-old female patient with Stage 4 chronic renal failure experienced immediate relief from severe pruritis and neuropathy symptoms using LDX, after being unresponsive to other treatments.

How will Halberd (HALB) conduct the 90-day clinical trial for kidney disease patients?

The trial will use a patent-pending titrated dose response protocol, starting with low doses of LDN and methocarbamol with natural cinnamon as a filler, progressively increasing to therapeutic doses.
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