FibroBiologics Announces Significant Advancements in Bone Marrow Organoid Platform Enabling Development for Cancer and Immune-Related Therapies

Pilot studies have shown encouraging results that are supporting the company’s pre-IND enabling development, marking a critical step toward clinical translation of the Bone Marrow Organoid technology

HOUSTON, Sept. 10, 2025 (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 significant advancements in its Bone Marrow Organoid platform, which may offer promising new treatment options for hematopoietic cancers and age-related immune decline.

The company’s proprietary Bone Marrow Organoids have demonstrated potential in multiple therapeutic applications:

  • Our Pre-IND animal trials show that Transplantation of Bone Marrow Organoids into xenografted melanoma mouse model significantly reduced tumor size.
  • The organoids enable efficient ex vivo gene editing, allowing for swift and targeted therapeutic interventions before transplantation.
  • FibroBiologics’ Bone Marrow Organoids can be cryopreserved, offering a scalable and readily available treatment option for bone marrow transplantation.

“Our organoid platform has the potential to do much more than target cancer,” said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics. “We see potential opportunities to help regenerate one or more desired immune cell type, counter age-related immune system decline, and restore immune function in patients with a compromised immune system. Looking ahead, this approach could also potentially enable the in-vivo generation of advanced cell therapies, such as CAR-T and CAR-NK cells, directly within patients.”

“These breakthroughs are an important milestone in the journey to transform the way we approach cancer and immune-related diseases,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. “Our pilot studies are laying the foundation for IND-enabling preclinical development and positioning our Bone Marrow Organoid technology for clinical advancement. The real power of this platform is its versatility and scalability, designed to deliver meaningful impact across multiple therapeutic areas.”

For more information, please visit FibroBiologics’ website or email FibroBiologics at: [email protected].

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 the potential and capabilities of bone marrow organoids to treat cancer and immune-related therapies. 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) expectations regarding the initiation, progress and expected results of our R&D efforts and preclinical studies; (b) the unpredictable relationship between R&D and preclinical results and clinical study results; (c) risks related to FibroBiologics’ liquidity and its ability to maintain capital resources sufficient to conduct its business, and (d) the ability of FibroBiologics to successfully prosecute its patent applications. 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.

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