Adia Nutrition Announces Subsidiary Adia Med's Submission of Second Clinical Study for IRB Review Targeting Lower Back Pain with AdiaVita

Rhea-AI Summary

Adia Nutrition (OTCQB: ADIA) said subsidiary Adia Med submitted a second clinical study for IRB review on February 16, 2026, testing AdiaVita delivered intravenously for lower back pain. The single-blind, placebo-controlled trial will randomize about 100 participants and uses a three-month treatment then crossover design.

Participation is patient-pay at $5,000 per patient, with no extra cost for the crossover phase. Enrollment begins after IRB approval and ClinicalTrials.gov acceptance.

Positive

• Randomized ~100-participant placebo-controlled design
• Crossover design enables within-subject comparisons after three months
• IV systemic delivery tests less invasive alternative to localized injections
• Ongoing ASD study is IRB-approved and active (24-month NCT07304440)

Negative

• Patient-pay model $5,000 may limit enrollment diversity and speed
• Study enrollment pending IRB approval and ClinicalTrials.gov acceptance, creating timing uncertainty

Winter Park, Florida--(Newsfile Corp. - February 16, 2026) - Adia Nutrition Inc. (OTCQB: ADIA), a leader in regenerative medicine and innovative therapeutic solutions, today announced that its subsidiary, Adia Med of Winter Park, LLC, has submitted its second clinical study for Institutional Review Board (IRB) review. This pivotal study will evaluate the efficacy of AdiaVita, Adia Med's proprietary umbilical cord blood-derived stem cell and exosome product, in alleviating lower back pain through non-invasive intravenous (IV) administration.

AdiaVita Vial

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The single-blind, placebo-controlled trial will randomize approximately 100 participants into two groups: one receiving AdiaVita via IV and the other receiving a placebo. The primary objective is to assess AdiaVita's ability to reduce inflammation and promote repair of damaged tissue in the lower back. The study features a crossover design, where after an initial three-month treatment period, participants in the placebo group will receive AdiaVita for the subsequent phase, enabling within-subject comparisons and extended evaluation of effects.

Importantly, unlike conventional treatments that often involve ultrasound-guided injections directly into the affected area, this protocol tests systemic delivery via simple IV infusion. A positive outcome could represent a transformative advancement in lower back pain management, offering patients a less invasive, more accessible option that avoids localized procedures while potentially addressing underlying inflammation and tissue damage.

Participation in the study is structured as a patient-pay model at $5,000 per patient, with no additional cost for the crossover phase.

This submission follows Adia Med's ongoing flagship clinical research in Autism Spectrum Disorder (ASD). The IRB-approved 24-month study (ClinicalTrials.gov NCT07304440), titled "Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study," continues to actively recruit children aged 3-12 nationwide and worldwide. The trial, which aims to enroll approximately 100 participants, investigates whether combining AdiaVita with glutathione therapy yields greater improvements in ASD symptoms compared to glutathione alone, with every participant receiving AdiaVita treatments three times during the interventional phase.

"We are thrilled to progress our second major study, building on the momentum of our autism research program," said Larry Powalisz, CEO of Adia Nutrition. "AdiaVita continues to show promise across applications, and this lower back pain trial could demonstrate its regenerative potential through straightforward IV delivery. Combined with our active ASD recruitment, these efforts reflect our dedication to advancing patient-centered regenerative therapies that prioritize safety, accessibility, and meaningful outcomes.

"Enrollment for the lower back pain study is anticipated to commence upon IRB approval and Acceptance onclinicaltrials.gov. For details on the ongoing autism study or to apply, visit adiamed.com or ClinicalTrials.gov (NCT07304440).

For questions, inquiries, or additional information, please contact Larry Powalisz at ceo@adiamed.com or by phone at 321-788-0850.

Clinic owners and healthcare practitioners interested in licensing the Adia Med name or integrating Adia's regenerative therapies into their practice are encouraged to reach out directly. Strategic partnerships are welcomed as part of Adia's continued mission to expand access to advanced stem cell solutions.

About ADIA Nutrition Inc.:
Adia Nutrition Inc. (OTCQB: ADIA), based in Winter Park, Florida, is a publicly traded company advancing healthcare through innovation. The company specializes in sales of stem cell and regenerative products, such as AdiaVita and AdiaLink, through its lab division, Adia Labs LLC, which is expanding to include insurance-billable wound care products. Adia is also growing nationwide with Adia Med clinics, specializing in orthopedic, pain management, and wound repair. Adia Med clinics also offer specialized regenerative treatments like stem cell therapies and platelet-rich plasma (PRP), advanced treatments including therapeutic plasma exchange (TPE) and autologous hematopoietic stem cell transplantation (aHSCT), and wound repair services.

Revenue is generated through service fees, product sales, equity stakes, and billing insurance for healthcare treatments. Additionally, Adia Nutrition Inc. invests in aligned businesses such as Cement Factory LLC, a nutrition and supplement company with shared values and a focus on health and wellness. Through bold partnerships with top-tier medical entities and unwavering dedication to standardized, FDA-approved lab protocols, Adia Nutrition Inc. is revolutionizing healthcare, igniting a nationwide movement to empower communities with groundbreaking regenerative solutions and vibrant, holistic wellness.

Website: www.adianutrition.com
Website: www.adiamed.com
Website: www.adialabs.com
Website: www.cementfactory.co
Twitter (X): @ADIA_Nutrition

Safe Harbor: This Press Release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based on the current plans and expectations of management and are subject to a few uncertainties and risks that could significantly affect the company's current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company's business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission and OTC Markets, Inc. OTC Disclosure and News Service. The company undertakes no obligation to publicly update or revise any forward-looking statements, because of new information, future events or otherwise.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/283832

FAQ

What is Adia Nutrition (ADIA) studying in the February 16, 2026 lower back pain trial?

The trial will evaluate AdiaVita delivered intravenously for lower back pain in ~100 participants. According to the company, it is a single-blind, placebo-controlled trial with a crossover after three months to compare IV AdiaVita versus placebo within subjects.

How much does participation cost in Adia Med's ADIA lower back pain study?

Participation is priced at $5,000 per patient, with no additional cost for the crossover phase. According to the company, this patient-pay model applies to initial treatment and the subsequent crossover period after three months.

When will ADIA begin enrolling patients for the lower back pain study?

Enrollment will start once the trial receives IRB approval and ClinicalTrials.gov acceptance. According to the company, recruitment timing depends on those approvals and will follow official acceptance onclinicaltrials.gov.

What design features make the ADIA lower back pain study rigorous for investors to note?

The study is randomized, single-blind, placebo-controlled with a crossover phase for within-subject comparison. According to the company, these elements aim to assess inflammation reduction and tissue repair with IV systemic delivery.

How does the lower back pain trial relate to Adia Med's autism research (ADIA)?

The lower back study follows Adia Med's ongoing IRB-approved 24-month autism trial (NCT07304440) recruiting ~100 children aged 3-12. According to the company, the autism study evaluates AdiaVita combined with glutathione versus glutathione alone.