Provectus Biopharmaceuticals Highlights Preclinical Evidence of PV-10-Mediated Immune Modulation in Burn Wound Healing; Porcine Study Demonstrates Shift Toward Pro-Regenerative Tissue Environment
Rhea-AI Summary
Provectus (OTCQB: PVCT) highlighted independent porcine preclinical data showing PV-10 (rose bengal sodium) in a Pluronic hydrogel shifted wound immunity toward a pro-regenerative state. At day 120 post-burn PV-10 increased pan-macrophage and CD206 expression (p=0.0034; p=0.0277) and reduced CD3+ T cells (p=0.0360) versus saline, with no rise in 4-HNE oxidative markers.
The study found measurable activity after repeated topical dosing without controlled green-light activation, and noted formulation/dosing adjustments may further differentiate effects.
Positive
- Pan-macrophage expression increased at day 120 (p=0.0034)
- CD206 (M2-associated) expression increased at day 120 (p=0.0277)
- CD3+ T-cell infiltration reduced at day 120 (p=0.0360)
- Measurable biological activity after repeated topical dosing without green-light activation
Negative
- Effects were less consistent versus hydrogel vehicle alone
- Authors recommend controlled photoactivation, concentration, or dosing adjustments for clearer differentiation
- Findings are preclinical (porcine model) and not clinical proof of human efficacy
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KNOXVILLE, Tenn., April 02, 2026 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) today highlighted newly published independent preclinical research evaluating the effects of PV-10 in a clinically relevant porcine burn wound model. PV-10 is a formulation of the Company’s proprietary, pharmaceutical-grade active pharmaceutical ingredient rose bengal sodium (RBS). The study, titled “The Association of Rose Bengal with Macrophage Polarization and Oxidative Stress Response in Full-Thickness Excisional and Grafted Burn Wounds: A Porcine In Vivo Study,” was conducted by investigators at the University of Texas Medical Branch (UTMB) and Shriners Children’s Texas in Galveston, with Provectus serving as a funding sponsor, and is published in Medicina. The journal article is available at https://doi.org/10.3390/medicina62040629.
Their research demonstrates that PV-10 delivered in a hydrogel formulation is associated with modulation of the local immune environment, including increased macrophage presence, a shift toward reparative (M2-associated) phenotypes, and reduced T-cell infiltration at later stages of healing. These findings suggest that PV-10 may contribute to establishing a pro-regenerative tissue microenvironment that supports tissue remodeling.
PV-10 as a Modulator of Tissue-Level Immune Biology
The UTMB preclinical study utilized a porcine full-thickness burn, excision, and autograft model that is widely considered one of the most clinically relevant preclinical systems for human wound healing research owing to its close approximation of human skin architecture, immune cell composition, and wound repair kinetics. Across repeated applications on days 1, 7, and 14 post-burn, PV-10-treated wounds showed:
- Significantly higher pan-macrophage and CD206 expression at day 120 post-burn (p = 0.0034 and p = 0.0277 versus saline control, respectively), consistent with a reparative M2 macrophage profile,
- Significantly reduced CD3+ T-cell infiltration at day 120 (p = 0.0360 versus saline control), with values approaching uninjured skin baseline, suggesting attenuation of persistent inflammatory signaling, and
- No increase in 4-hydroxynonenal (4-HNE) oxidative stress markers across treatment groups, indicating immune modulation without excess tissue-damaging oxidative burden.
These effects were most clearly observed relative to saline control, with less consistent differentiation versus hydrogel vehicle alone. The authors note that controlled green-light activation, adjusted formulation concentration, or modified dosing frequency may yield more differentiated results in future studies.
Implications for a Broader Platform Mechanism
These findings extend the understanding of PV-10 to support its potential role as a pathology-targeting agent capable of modulating local tissue biology across disease contexts. To our knowledge, this is the first porcine study to characterize the immunohistochemical effects of multi-dose PV-10 in a grafted burn wound model over an extended 120-day period.
Notably, the study demonstrated measurable biological activity following repeated topical administration under ambient light conditions, without the controlled green-light photoactivation used in photodynamic therapy. This suggests potential flexibility in activation paradigms and clinical deployment, with relevance for non-specialized settings where dedicated light sources are unavailable. Fewer than
Dominic Rodrigues, Provectus’s President and Vice Chair of the Board of Directors said, “We believe this work supports the broader view of PV-10 as a regulator of tissue-level biology. Rather than acting solely as a cytotoxic or antimicrobial agent, PV-10 appears capable of shifting the local environment of diseased or injured tissue toward controlled repair. That concept has implications for wound healing of course, but also for oncology, dermatology, and ophthalmology, where immune balance and tissue response are critical.”
Positioning Within Advanced Wound Care and Beyond
The UTMB study’s observed immune modulation highlights a key challenge in burn care: failure to transition from early inflammation to controlled tissue repair.
Burn wound management remains clinically complex, with approximately 30,000 hospital admissions annually in the U.S. Another approximately 600,000 individuals annually suffer a burn injury that merits emergent care. Outcomes are often driven by wound closure and the quality of immune resolution and tissue remodeling, which influence scarring, function, and long-term recovery. These are areas where current standard-of-care approaches remain limited.
UTMB’s findings suggest PV-10 may contribute to this transition by shifting the local immune environment toward a reparative state. In this context, PV-10’s potential differentiation includes:
- Immunomodulatory activity observed without controlled photoactivation, supporting use in most clinical settings where dedicated light sources are unavailable,
- Increased M2-associated macrophage presence during the remodeling phase, addressing one of the central failure modes in burn wound repair: chronic M1 inflammatory activity and impaired immune resolution, and
- Delivery via a Pluronic-based hydrogel system, which is a relatively simple, cost-effective vehicle compatible with broader clinical translation and potential integration into existing wound dressing platforms.
The global advanced wound care market is projected to exceed
More broadly, UTMB’s findings reinforce PV-10’s potential relevance across multiple therapeutic areas where immune dynamics and tissue remodeling drive disease progression and recovery.
About Provectus
Provectus Biopharmaceuticals, Inc. is a clinical-stage biotechnology company developing a pipeline of immunotherapy medicines based on rose bengal sodium, a first-in-class synthetic small molecule from the halogenated xanthene family. The Company’s clinical programs span oncology, dermatology, and ophthalmology, with additional proof-of-concept programs in hematology, wound healing, infectious diseases, and tissue repair.
For more information, visit www.provectusbio.com.
Forward Looking Statements
The information in this press release may include “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, relating to the business of Provectus and its affiliates, which are based on currently available information and current assumptions, expectations, and projections about future events and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “aim,” “likely,” “outlook,” “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “would,” “project,” “projection,” “predict,” “potential,” “targeting,” “intend,” “can,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.
The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.
Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.
Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the Securities and Exchange Commission (SEC), including those described in Item 1A of the Company’s Annual Report on Form 10-K for the period ended December 31, 2025.
Contacts:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
hraines@pvct.com
(866) 594-5999
Investor Relations & Media
Susan Xu
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(778) 323-0959
