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FluidForm Bio™ Presents Six-Month Efficacy Data of FRESH 3D Bioprinted Human Islet Subcutaneous Scaffolds at the American Diabetes Association (ADA) 85th Scientific Sessions

Presentation also given at the 20th World Congress of the International Pancreas & Islet Transplant Association (IPITA)

WALTHAM, Mass., July 09, 2025 (GLOBE NEWSWIRE) -- FluidForm Bio™, a leader in cell therapies for chronic diseases such as type 1 diabetes, today announced two presentations at recent medical meetings: the 20th World Congress of the International Pancreas & Islet Transplant Association (IPITA) in Pisa, Italy, and the ADA 85th Scientific Sessions in Chicago, Il.

Among the highlights, new data were presented demonstrating six-month efficacy of FluidForm’s FRESH 3D bioprinted human islet subcutaneous scaffolds to restore normoglycemia in SCID Beige mice. Moreover, scaffold retrieval caused a return to a diabetic state.

“The data presented at this year’s IPITA and ADA meetings further validate the potential of our FRESH platform as a next-generation transplantation methodology that can overcome shortcomings of current techniques,” said Adam Feinberg, PhD, Co-Founder and Chief Technology Officer of FluidForm, and Professor, Biomedical Engineering and Materials Science & Engineering, Carnegie Mellon University. “By combining the benefits of engineered design, advanced biofabrication, and collagen-based biomaterial approaches into a single platform, FRESH promotes the rapid revascularization and engraftment of islet scaffolds - and has now demonstrated efficacy out to six months - without the fibrotic host response that often compromises long-term cell viability. We look forward to rapidly completing our pre-clinical work and advancing into human studies with the goal of bringing this potentially curative T1D treatment to market.”

Highlights from the presentations follow:

American Diabetes Association (ADA) 85th Scientific Sessions

Restoration of Normoglycemia via Subcutaneous Transplantation of Islets in FRESH 3D Printed ECM-Based Scaffolds

This presentation highlighted the efficacy of FluidForm’s FRESH 3D bioprinted human islet scaffolds to restore glycemic control for six months post-implantation.

FRESH 3D bioprinted scaffolds are entirely biologic, consisting of a central fibrin compartment containing 2000 islet equivalency (IEQ) human donor islets surrounded by an exterior shell of type I collagen.

Thirteen diabetic SCID Beige mice received subcutaneous FRESH scaffold implants, while three received subcutaneous islet injections. All then underwent active blood glucose monitoring. By day 14, the FRESH scaffolds demonstrated revascularization of human islets and robust engraftment without the fibrotic response typically seen when engineering scaffolds from foreign synthetic materials. Scaffold histology at day 97 displayed host vessel infiltration in the collagen-rich neotissue matrix around and within the transplanted human islet. Notably, following scaffold retrieval, host mice returned to hyperglycemic state. These results demonstrate that FluidForm’s FRESH-printed subcutaneous islet scaffolds restore euglycemia in diabetic SCID mice for up to 180 days.

20th World Congress of the International Pancreas & Islet Transplant Association (IPITA)

Fresh 3D Printed ECM-Based Scaffolds Support Engraftment of Subcutaneously Transplanted Islets

This presentation compared glycemic outcomes for diabetic SCID Beige mice that were implanted with FluidForm’s FRESH 3D bioprinted human islet scaffolds (2000 IEQ per scaffold) versus those that received an equal number of islet cells via subcutaneous injection.

The study found that diabetic SCID Beige mice that received FRESH printed human islet scaffolds via subcutaneous implantation achieved normoglycemia in approximately three weeks, whereas all controls that received islet cell injections remained diabetic.

About FluidForm Bio™

FluidForm Bio™ is a biotechnology company developing next-generation cell therapies for chronic diseases leveraging its proprietary FRESH™ 3D bioprinting technology platform. Using FRESH, FluidForm creates functional tissue with the same materials found in the human body, eliminating chemistries and materials known to trigger negative immune response. FRESH is a powerful vascularization platform, allowing the building of densely cellular vascularized tissue that maintains viability upon implant.

The company’s lead program is an islet cell therapy for type 1 diabetes in which insulin-producing beta cells are arranged in a tissue scaffold ready for subcutaneous implantation. This method is less invasive and less toxic when compared to other delivery sites, offering retrievability and reducing surgical risks and recovery time for patients.

This novel approach to islet cell replacement therapy presents a transformative advancement in diabetes treatment. With superior fabrication techniques, enhanced vascularization, a robust immune modulation platform, and a convenient subcutaneous implant, this method addresses many limitations of current technologies. These improvements offer the potential for a more effective, durable, and patient-friendly therapy, offering new hope for individuals with diabetes.

Founded in 2018, FluidForm is headquartered in Waltham, MA. To learn more, please visit: fluidformbio.com or connect on Twitter and LinkedIn.

Contact:
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com


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