Merakris Therapeutics and iFyber Collaboration Receives Top SAWC Research Award for MTX-001 Wound Healing Study in Human Skin Model

Phase 2 Clinical Program Underway as Award-Winning Data Strengthen MTX-001’s Position in a Multi-Billion-Dollar Wound Care Market

iFyber Partnership Integrates Advanced Tissue Models and Quantitative Bioanalytics to Enable Mechanistic and Biodistribution Insights

RESEARCH TRIANGLE PARK, N.C., April 14, 2026 (GLOBE NEWSWIRE) -- Merakris Therapeutics, a clinical-stage regenerative medicine company, today announced that, in collaboration with iFyber, it received the Best Laboratory Research Award at the Symposium for Advanced Wound Care (SAWC) Spring 2026, a leading industry forum. The award recognizes preclinical data demonstrating that Merakris’ lead asset, MTX-001, delivers statistically significant wound healing in a human-relevant model—positioning the program as a potential first-in-class entrant in a stagnant, multi-billion-dollar market.

The award-winning study utilized a living human skin (ex vivo) platform, enabling direct measurement of therapeutic activity in human tissue. MTX-001 demonstrated statistically significant acceleration of wound closure versus saline control, along with robust re-epithelialization and tissue regeneration. Quantitative analysis confirmed retention and biodistribution of MTX-001 within human skin, supporting its therapeutic activity.

Key findings include:

• Statistically significant wound closure vs. control
• Enhanced re-epithelialization and tissue regeneration
• Biodistribution of MTX-001 within skin correlates with wound healing activity
• Confirmed retention of MTX-001 active components in human skin

MTX-001 is derived from Merakris’ proprietary cell-free amniotic fluid (cfAF) platform, a multi-modal biologic designed to address the complexity of chronic wound biology—an area where single-target approaches fall short and where no new drug approvals have emerged in nearly 30 years.

“We believe MTX-001 represents a differentiated, multi-modal approach to wound healing with the potential to shift the treatment paradigm,” said Dr. Roger Ilagan, Chief Scientific Officer of Merakris Therapeutics. “This recognition, combined with our ongoing clinical progress, reinforces the strength of our platform and the opportunity ahead.”

Merakris is currently advancing MTX-001 in an ongoing multicenter, double-blind, placebo-controlled, randomized Phase 2 trial in venous leg ulcers (VLUs)—a key value inflection point. In parallel, the company is progressing toward commercial readiness, including plans to manufacture pilot-scale batches and initiate FDA filings later this year, signaling a clear path toward potential commercialization.

The collaboration with iFyber further differentiates the program by leveraging advanced human tissue models and quantitative bioanalytics (LC-MS/MS) to generate high-resolution, human-relevant data. This approach enables earlier assessment of therapeutic performance and supports translational confidence in MTX-001’s development.

“This study underscores the power of combining new approach methodologies, such as our advanced viable human skin model, and advanced bioanalytics with innovative biologics,” said Dr. Aaron Strickland, Vice President of Research & Development at iFyber. “The data generated here provide a strong foundation for this exciting testing platform and continued clinical advancement of MTX-001.”

The poster is available for download at: https://merakris.com/merakris-ifyber-receive-top-sawc-2026-award-mtx-001/.

About iFyber

iFyber is a contract research organization specializing in supporting therapeutic and medical device companies by combining translational test systems, such as new approach methodologies (NAMs) with bioanalytical services. iFyber’s team integrates deep knowledge in chemistry, biology, and biomaterials into development programs.

About MTX-001

MTX-001 is a first-in-class injectable biologic drug candidate purified from cell-free amniotic fluid. It is currently being evaluated in a multicenter Phase 2 trial (NCT04647240) for venous leg ulcers (VLUs) and is also available through an Expanded Access Program (EAP) for cutaneous wounds (NCT06730022). Part 1 of the Phase 2 study, published in the International Wound Journal in March 2025, demonstrated favorable safety and early efficacy signals, including wound closure and symptom improvement.

About Merakris Therapeutics

Merakris Therapeutics is a leading innovator in regenerative medicine focused on developing and commercializing biologically derived products for wound healing and other complex conditions. Leveraging advanced biologic manufacturing capabilities and a robust research pipeline, Merakris is committed to improving patient outcomes and advancing the science of regenerative therapies.

Merakris Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of Merakris’ products, or regarding potential future revenues from any such product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Merakris’ management believes that any forward-looking statements in this press release are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Merakris, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and advisors and on the global economy as a whole.

CONTACT: Contact:
Jonathan Berlent, MBA
Investor Relations
jberlent@merakris.com