Hydreight Provides Business Update on its Peptide Healthcare Platform Following Recent FDA Advisory Committee Recommendations
Rhea-AI Summary
Hydreight Technologies (OTCQB: HYDTF) provided a business update on its peptide healthcare platform following the July 23–24, 2026 meeting of the FDA’s Pharmacy Compounding Advisory Committee (PCAC). The committee recommended six peptide-related bulk drug substances (BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon) for potential inclusion on the Section 503A Bulks List, a step that is advisory only and does not constitute FDA approval.
According to Hydreight, peptide-based therapies are already a significant part of its physician-supervised, nationwide platform, which supports GLP-1 therapies, Sermorelin, Ipamorelin and other personalized treatments. The company reports more than 12,000 VSDHOne licenses sold (vs. approximately 3,000 at the end of 2025), a network of 300+ licensed physicians, over 3,000 licensed nurses, a pharmacy network covering all 50 U.S. states and more than 45 physician-supervised treatment offerings. Hydreight also highlights prior investments in clinical protocols, pharmacy relationships, proprietary technology and a strategic investment in Insu Therapeutics, stating these were driven by its long-term personalized medicine strategy rather than the recent PCAC recommendations.
Positive
- VSDHOne licenses exceed 12,000 versus approximately 3,000 at end of 2025
- Nationwide clinician network with 300+ licensed physicians and 3,000+ licensed nurses
- More than 45 treatment offerings including GLP-1, peptide, hormone, NAD+ and IV wellness
- Pharmacy network across all 50 U.S. states supports physician-supervised programs
- Strategic investment in Insu Therapeutics for buccal delivery of peptide and biologic medicines
- PCAC recommends six peptide-related substances for potential Section 503A Bulks List inclusion
Negative
- PCAC recommendations are advisory only and do not constitute FDA approval
- Any future products using recommended peptides remain subject to FDA rulemaking and multiple regulatory reviews
- PCAC did not recommend Emideltide (DSIP) for the Section 503A Bulks List
AI-generated analysis. How Rhea-AI works. Not financial advice.
During its July 23–24, 2026 meeting, the PCAC recommended that six peptide-related bulk drug substances—BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon—be considered for inclusion on the FDA's Section 503A Bulks List. These recommendations are advisory only, do not constitute FDA approval of any substance or finished drug product, and remain subject to the FDA's rulemaking process.
Management considers these recommendations material because peptide-based therapies already represent a significant component of Hydreight's existing business. Through its physician-supervised healthcare platform, the Company currently supports multiple peptide-based treatment categories and has made substantial investments in physician infrastructure, pharmacy relationships, clinical protocols and technology supporting peptide-based care.
"The recent PCAC recommendations are meaningful because they relate to a therapeutic category where Hydreight already operates today," said Shane Madden, Chief Executive Officer of Hydreight. "We've spent years building the physician, pharmacy and technology infrastructure supporting peptide-based healthcare. The recommendations don't change our strategy—they reinforce why we've been investing in this category for years while continuing to focus on compliant, physician-supervised care."
Peptide-Based Medicine is Already an Established Part of Hydreight's Business
The Company currently supports multiple physician-supervised peptide-based treatment categories through its nationwide physician, pharmacy and technology platform, including GLP-1 therapies, Sermorelin and Ipamorelin. These peptide-based therapies form part of Hydreight's broader personalized healthcare platform, which also includes hormone optimization, NAD+ therapies, IV wellness, sexual health, hair restoration and other physician-supervised healthcare programs.
Platform Expansion Driven by Existing Peptide Business
Hydreight's peptide healthcare platform has been under development since 2019 and reflects the Company's long-term strategy of building a nationwide physician-enabled healthcare infrastructure supporting compliant personalized healthcare.
Since 2019, Hydreight has continued investing in its physician, pharmacy and technology infrastructure with the objective of building a scalable platform capable of supporting physician-supervised personalized healthcare across
Today, the Company's healthcare ecosystem includes:
- More than 12,000 VSDHOne licenses sold, compared to approximately 3,000 at the end of 2025;
- A nationwide network of 300+ licensed physicians;
- More than 3,000 licensed nurses operating through the Hydreight platform;
- A nationwide pharmacy network supporting physician-supervised healthcare programs across all 50 U.S. states;
- More than 45 physician-supervised treatment offerings spanning GLP-1 therapies, peptide-based treatments, hormone optimization, NAD+ therapies, IV wellness, sexual health, hair restoration and other personalized healthcare programs offered through the VSDHOne platform; and
- Proprietary technology supporting patient onboarding, telehealth consultations, electronic prescribing, pharmacy coordination, payment processing and ongoing patient management.
The investments described above were undertaken as part of Hydreight's long-term platform strategy and were not initiated in response to the recent PCAC recommendations.
This infrastructure was developed well before the recent PCAC recommendations and supports peptide-based therapies currently available through the Company's platform. It also provides the operational foundation to evaluate additional physician-supervised treatment categories should future regulatory pathways permit their introduction, subject to applicable legal, clinical and regulatory requirements.
As part of these investments, Hydreight has completed medical policies, provider protocols and VSDHOne technology workflows supporting currently available physician-supervised peptide-based treatment categories, while also expanding pharmacy relationships and fulfillment capacity supporting compliant nationwide healthcare delivery.
Clinical, Pharmacy and Technology Infrastructure
As peptide-based healthcare has become a larger component of Hydreight's business, the Company has continued investing in infrastructure supporting physician-supervised treatment categories.
Completed initiatives include:
- Development and implementation of medical policies;
- Completion of provider protocols;
- Expansion of VSDHOne technology workflows;
- Expansion of pharmacy relationships and fulfillment capacity; and
- Clinical coordination supporting physician-supervised peptide healthcare.
These initiatives support treatment categories currently available through the platform while also providing operational readiness should additional physician-supervised therapies become legally available in the future.
Existing Peptide Strategy
Hydreight's peptide healthcare platform includes physician-supervised GLP-1 therapies, Sermorelin, Ipamorelin and other peptide-based treatment categories delivered through the Company's nationwide physician, pharmacy and technology infrastructure.
The Company has continued expanding this platform through investments in clinical protocols, provider workflows, pharmacy relationships and VSDHOne technology, providing the operational foundation to support compliant physician-supervised peptide-based healthcare.
Hydreight's strategy extends beyond its currently available treatment categories. Earlier this year, the Company announced its strategic investment in Insu Therapeutics Inc., a biotechnology company developing proprietary buccal drug delivery technology for peptide and biologic medicines.
Together, Hydreight's existing peptide-based treatment categories, nationwide physician and pharmacy infrastructure, VSDHOne platform and investment in Insu Therapeutics reflect the Company's long-term strategy of building an integrated healthcare platform supporting physician-supervised personalized medicine.
FDA Advisory Committee Recommendations
During its July 23–24 meeting, the PCAC recommended six peptide-related bulk substances for potential inclusion on the Section 503A Bulks List:
- BPC-157
- KPV
- TB-500
- MOTS-c
- Semax
- Epitalon
The committee did not recommend Emideltide (DSIP).
The recommendations relate solely to potential inclusion on the Section 503A Bulks List and do not constitute FDA approval.
Hydreight notes that any future implementation of products involving these substances would remain subject to applicable FDA rulemaking, federal and state regulations, physician oversight, pharmacy participation and product-specific legal and clinical review.
Looking Ahead
Hydreight will continue executing its long-term strategy of expanding its physician, pharmacy and technology infrastructure supporting currently available treatment categories while evaluating additional physician-supervised therapies in accordance with applicable legal, clinical and regulatory requirements.
On behalf of the Board of Directors
Shane Madden
Director and Chief Executive Officer
Hydreight Technologies Inc.
About Hydreight Technologies Inc.
Hydreight Technologies Inc is building one of the largest mobile clinic networks in
About VSDHOne - Direct to Consumer Platform
Developed in partnership with Victory Square Technologies (CSE: VST) (OTC: VSQTF) (FWB: 6F6), Hydreight Technologies launched the VSDHOne platform. VSDHOne aims to simplify the entry challenges for companies and medi-spa businesses to enter the online healthcare space compliantly. This platform is expected to help businesses launch direct-to-consumer healthcare brand in a matter of days in all 50 states. Compliant offerings include: GLP-1s, peptides, personalized healthcare treatments, sermorelin, testosterone replacement therapy ("TRT"), hair loss, skincare, sexual health and more. Hydreight invested in technology, legal and infrastructure to launch this platform. The VSDHOne platform offers a complete, and modular end-to-end solution for businesses looking to launch direct-to-consumer healthcare brands. From compliance and telemedicine technology to nationwide doctor and pharmacy networks, VSDHOne provides all the tools needed for a seamless entry into the online healthcare space. The platform is designed to significantly reduce the time and costs associated with launching such services, making it possible for businesses to go live in days instead of months.
Neither TSXV nor its Regulation Services Provider (as that term is defined in policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.
Cautionary Note Regarding Forward-Looking Information
This press release contains statements which constitute "forward-looking information" within the meaning of applicable securities laws, including statements regarding the plans, intentions, beliefs and current expectations of the Company with respect to future business activities and operating performance. Forward-looking information is often identified by the words "may", "would", "could", "should", "will", "intend", "plan", "anticipate", "believe", "estimate", "expect" or similar expressions and includes information regarding expectations for the Company's 2026 strategic outlook, growth, platform scaling initiatives, and anticipated expansion of VSDHOne and other platform offerings.
Forward‑looking information is based on management's expectations, estimates and assumptions as of the date hereof, including assumptions regarding: continued partner adoption, stable regulatory regimes applicable to telehealth and pharmacy operations in the United States, availability of capital, and general economic conditions.
Investors are cautioned that forward-looking information is not based on historical facts but instead reflects the Company's management's expectations, estimates or projections concerning future results or events based on the opinions, assumptions and estimates of management considered reasonable at the date the statements are made. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company.
Among the key factors that could cause actual results to differ materially from those projected in the forward-looking information are the following: the ability to obtain requisite regulatory and other approvals with respect to the business operated by the Company and/or the potential impact of the listing of the Company's shares on the TSXV on relationships, including with regulatory bodies, employees, suppliers, customers and competitors; changes in general economic, business and political conditions, including changes in the financial markets; changes in applicable laws; compliance with extensive government regulation; and the diversion of management time as a result of being a publicly listed entity. This forward-looking information may be affected by risks and uncertainties in the business of the Company and market conditions.
Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated or expected. Although the Company has attempted to identify important risks, uncertainties and factors which could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. The Company does not intend, and does not assume any obligation, to update this forward-looking information except as otherwise required by applicable law.
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SOURCE Hydreight Technologies Inc.