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

MWN-AI** Summary

Halberd Corporation (OTC: HALB) has announced promising clinical results stemming from its collaboration with Athena Telemedicine Partnership, LLC, particularly regarding its innovative LDX compound aimed at addressing dialysis-related neuropathy and pruritis. A recent case study featuring a 63-year-old female patient suffering from severe symptoms associated with Stage 4 chronic renal failure highlighted the potential efficacy of LDX. After struggling with various medications, the introduction of LDX led to significant symptom relief, showcasing the potential of this compound not only for dialysis patients but also in broader applications such as addiction and chronic inflammatory disorders.

With approximately 850 million people worldwide suffering from kidney diseases—including conditions like chronic kidney disease (CKD)—there is an urgent need for effective treatments. The global dialysis market was valued at about $116.1 billion in 2024, projected to grow to $198.2 billion by 2033, emphasizing the commercial potential of effective kidney therapies.

In addition to their ongoing clinical work, Halberd is launching a 100-patient study to further investigate the safety and efficacy of LDX for dialysis patients. The study employs a monitored protocol that includes usage of the wearable WatchDawg™ technology, in collaboration with Verizon, to collect objective data on patient symptom relief. This initiative is not Halberd's only focus, as they are also preparing for a comprehensive study targeting PTSD and suicidality.

Both Halberd and Athena GTX Inc. underline their commitment to utilizing innovative approaches, combining pharmaceuticals with advanced monitoring technologies to address significant health issues. As the studies progress, key developments will be communicated to the public, reflecting the companies' transparency and focus on improving patient outcomes.

MWN-AI** Analysis

The recent announcement from Halberd Corporation (OTC: HALB) regarding its collaboration with Athena Telemedicine Partners underscores a significant advance in the treatment of dialysis-related ailments such as neuropathy and pruritis. The positive efficacy findings for the patent-pending LDX compound, particularly in a case report where a patient achieved notable symptom relief, position Halberd favorably within a market encompassing roughly 850 million individuals suffering from various forms of kidney disease globally.

As the global dialysis market is projected to expand from approximately $116.1 billion in 2024 to $198.2 billion by 2033, this presents an opportune landscape for Halberd. They aim to capitalize on this growth with innovative, multifaceted approaches combining pharmaceuticals, nutraceuticals, and advanced wearable technologies developed by Athena GTX, Inc. The partnerships leverage cloud-based data monitoring, potentially enhancing treatment adherence and patient outcomes.

Investors should closely monitor the ongoing 100-patient study aimed at garnering FDA approval, as successful outcomes could not only validate LDX’s efficacy but also broaden its market acceptance and applicability across other chronic conditions, akin to its previous applications addressing PTSD. The dual-focus on both nephrology and mental health opens multiple revenue streams, increasing the stock’s appeal to risk-tolerant investors.

Given the promising initial results, coupled with a lucrative addressable market and a dedicated clinical pathway, potential investors may view Halberd Corporation as an attractive buy, especially as it aligns with broader healthcare trends emphasizing personalized and technology-aided treatment protocols. However, it's vital to consider the inherent risks in biotech investment, including regulatory hurdles and market competition. Stakeholders are advised to conduct thorough due diligence, including keeping abreast of forthcoming clinical results and FDA interactions, which will be critical for future stock performance.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

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. Hartman Mark Darrah, PhD
Chairman, CEO, President, Halberd Corp. CEO Athena GTX
w.hartman@halberdcorporation.com GM Athena Telemed. Partners (LLC)
support@halberdcorporation.com mdarrah@athenagtx.com
www.halberdcorporation.com www.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 key metrics will Halberd Corp HALB utilize to evaluate the success of the upcoming 100-patient study on the LDX compound for dialysis-borne neuropathy and pruritis?

Halberd Corp will likely utilize key metrics such as reduction in neuropathic pain scores, improvements in pruritus severity, quality of life assessments, safety and tolerability data, and overall response rates to evaluate the success of the upcoming 100-patient study on the LDX compound.

How does Halberd Corp HALB plan to navigate the FDA approval process for the LDX compound, given its diverse potential applications beyond kidney disease?

Halberd Corp plans to navigate the FDA approval process for the LDX compound by focusing on strategic preclinical studies, robust data collection, and leveraging diverse applications beyond kidney disease to demonstrate safety and efficacy for various indications.

With the increasing prevalence of kidney disease, how does Halberd Corp HALB differentiate its LDX compound from existing treatments in the dialysis market?

Halberd Corp's LDX compound differentiates itself by targeting the underlying causes of kidney disease rather than merely providing symptomatic relief, potentially reducing the need for dialysis compared to existing treatments in the market.

What steps is Halberd Corp HALB taking to ensure robust patient recruitment and retention for their study, especially considering the complexities of managing chronic kidney disease?

Halberd Corp is implementing targeted outreach strategies, leveraging partnerships with healthcare providers, and utilizing patient engagement tools to enhance recruitment and retention for their chronic kidney disease study.

**MWN-AI FAQ is based on asking OpenAI questions about Halberd Corp (OTC: HALB).

Halberd Corp

NASDAQ: HALB

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