FibroBiologics Announces Release of CYWC628 Drug Product for Phase 1/2 Diabetic Foot Ulcer Clinical Trial

HOUSTON, May 04, 2026 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced the release of the first batch of its CYWC628 drug product to support its Phase 1/2 clinical trial in patients with diabetic foot ulcers (DFUs).

The CYWC628 drug product was manufactured in accordance with the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) and has successfully passed all required safety and quality testing, enabling its release for clinical use. This milestone follows the Company’s recent completion of manufacturing of the first cGMP batch of CYWC628.

CYWC628 is an investigational fibroblast-based therapy designed to address DFUs, a chronic condition affecting millions of patients worldwide with limited effective long-term treatment options.

The Phase 1/2 clinical trial is evaluating the safety, tolerability, and preliminary efficacy of CYWC628 in patients with DFUs.

“With the first batch of the CYWC628 drug product released, we are now positioned to begin enrolling patients in our Phase 1/2 DFU trial,” said Pete O’Heeron, Founder and CEO of FibroBiologics. “This milestone allows us to begin the process of generating the data needed to evaluate safety, tolerability, and efficacy in DFUs. These initial results will be important in shaping the commercial path forward for CYWC628 and further validating our fibroblast-based platform.”

For more information, please visit FibroBiologics’ website or email FibroBiologics at info@fibrobiologics.com.  

Cautionary Statement Regarding Forward-Looking Statements 

This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning indications of interest, plans for, and the anticipated timing of the initiation and completion of, FibroBiologics’ clinical trials, and the robustness, progress, timing, and momentum of FibroBiologics’ research and development program. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections, and beliefs, as well as a number of assumptions concerning future events. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of FibroBiologics’ R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; (d) the ability of FibroBiologics to successfully prosecute its patent applications; (e) FibroBiologics’ ability to manufacture its product candidates; and (f) FibroBiologics’ ability to conduct clinical trials. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. 

About FibroBiologics

Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 270+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com.

General Inquiries:
info@fibrobiologics.com

Investor Relations:
Nic Johnson
Russo Partners
(212) 845-4242
fibrobiologicsIR@russopr.com

Media Contact:
Liz Phillips
Russo Partners
(347) 956-7697
Elizabeth.phillips@russopartnersllc.com

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