Human-Validated Fibrosis-Resistant Cell Encapsulation Platform
One of the few human-validated encapsulation platforms with five-year follow-up data and no chronic immunosuppression.
Supported by human clinical follow-up, granted patents, and peer-reviewed research.
Human-validated encapsulation platform designed to reduce fibrosis and support cell protection without chronic immunosuppression.
One of the few encapsulation platforms supported by completed human clinical follow-up.
The Strategic Timing for Cell Therapy
Cell therapy is ready.
Immune rejection remains the primary barrier to broad clinical adoption of cell-based therapy.
ALTuCAPS addresses immune protection without immunosuppression.
ALTuCAPS is designed to protect implanted therapeutic cells from immune detection without chronic immunosuppressive therapy.
Human validation, granted patents, and strategic optionality already exist.
28 granted patents. Five years of human follow-up data. An independently assessed IP portfolio. Strategic optionality is established.
ALTuCELL at a Glance
ALTuCAPS Microencapsulation Technology
ALTuCAPS is a patented cell encapsulation platform designed to protect implanted therapeutic cells from immune detection without chronic immunosuppression. Ultra-purified, triple-filtered alginate. Human-validated. Supported by published research.
Designed to reduce fibrosis and foreign body response
ALTuCAPS is designed to reduce fibrosis and the foreign body response.
Human follow-up data demonstrated operation without chronic immunosuppressive therapy
Human follow-up data demonstrated sustained encapsulated islet cell function without chronic immunosuppressive therapy.
Human clinical follow-up data
Four patients. Five years of follow-up demonstrating sustained encapsulated islet cell function.
Ultra-purified, triple-filtered alginate
Meets FDA endotoxin threshold below 20 EU/g. Endotoxin content below 0.5 EU/g.
Fully retrievable
Injectable under local anesthesia. Fully retrievable for safety monitoring.
Disease-agnostic platform
The same platform addresses diabetes, NAFLD, wound care, drug delivery, and neurodegenerative disease.
Micro-encapsulation of Sertoli cells for prevention and treatment of Type 1 Diabetes Mellitus. Induces neo-genesis of beta-cells while addressing the autoimmune process.
Ultra-purification process for alginates resulting in micro-encapsulation suitable for human cell transplants. Endotoxin content below 0.5 EU/g. Already transplanted into humans with no adverse side effects.
Stem cell derived Myofibroblast isolated from Wharton jelly of a human umbilical cord in ultra-purified clinical grade micro-encapsulation.
From Bench to Bedside
Five indications. The most advanced assets carry existing human data and established regulatory pathway clarity.
| Product | Indication | Stage | Progress | |
|---|---|---|---|---|
Sertoli Cells with ALTuCAPS (SPT64) FDA Priority Review Voucher pathway eligibility established. | Laron Syndrome — Orphan Drug + PRV Pathway | Phase I Complete / Phase II Setup | Key Asset | |
ALTuCAPS Encapsulation System Platform delivery system applicable across multiple cell types. | Permeable and Non-Permeable Drug Delivery | Phase II Ready | ||
Islet/Sertoli Cells (ALTSULIN) Five years of post-transplant human follow-up data in hand. | Type I Diabetes — Late Stage | Phase I/II Human Trials | Key Asset | |
Bio-Hybrid Scaffold with ALTuCAPS Wound healing application. | Diabetic Foot Ulcers and Venous Stasis Ulcers | Phase I | ||
Myofibroblasts MSCs with ALTuCAPS ALTUSTEM platform. Stem cell derived therapy. | NAFLD and Type I Diabetes | Early Phase I |
ALTuCELL's Laron Syndrome pathway qualifies for an FDA Priority Review Voucher. PRV pathway eligibility is established. Additional diligence materials available upon NDA execution.
Established
available under NDA
A Defensible Competitive Position
Each of the following properties is supported by published data or granted IP.
Designed to reduce fibrosis and foreign body response
ALTuCAPS is designed to reduce fibrosis and the foreign body response.
Human follow-up data demonstrated operation without chronic immunosuppressive therapy
Human follow-up data demonstrated sustained encapsulated islet cell function without chronic immunosuppressive therapy.
Human clinical follow-up data in hand
Four patients. Five years of follow-up demonstrating sustained encapsulated islet cell function.
Robust geographic IP protection
28 granted patents across the US, Canada, Europe, and Italy. Independently assessed in a 157-page valuation report.
Strategic pharmaceutical interest established
Strategic interest from pharmaceutical counterparties established.
cGMP manufacturing relationships established
Manufacturing relationships established with Stemmatters (early stage) and Catalent Pharmaceuticals (commercial scale).
One of the few human-validated encapsulation platforms with five-year follow-up data and no chronic immunosuppression.
The Unmet Need
Cell therapy adoption is accelerating globally, but fibrosis and chronic immunosuppression remain major barriers to scalable clinical implementation.
Immunosuppression limits cell therapy adoption
Chronic immunosuppressive therapy remains a significant barrier to cell-based transplantation. Long-term toxicity, infection risk, and patient burden constrain physician adoption and commercial scalability.
Fibrosis defeats competing encapsulation approaches
The foreign body response has historically been the primary failure mode of encapsulated cell therapy platforms. No competing approach has demonstrated fibrosis resistance and immunosuppressant-free operation in human subjects.
Cell therapy adoption is accelerating
ALTuCELL's platform addresses the two technical barriers that have most constrained clinical implementation.
Open to Multiple Structures
ALTuCELL is currently evaluating strategic transaction pathways with selected counterparties. Transaction economics are available within the data room following NDA execution.
Acquisition of the full patent portfolio with milestone-based consideration.
Exclusive license across all indications. Full economics in the data room.
Strategic partnership and structured transaction discussions.
Focused transaction on the most advanced assets. Remaining pipeline available subsequently.
Open to acquisition, licensing, strategic partnership, and co-development discussions. All transaction economics are available within the data room.
Built on Decades of Transplantation Research
Director, Endocrine Cell Transplant Laboratory, University of Perugia since 1987. Originator of the core IP. 150+ peer-reviewed publications.
20+ years of research. Coordinator, Islet Xenotransplantation and Sertoli Cells Group, University of Perugia.
20+ years of research. Pioneer of clinical-grade alginate development.
Founder of ALTuCELL. Led commercialization strategy, IP development, and transaction positioning since inception.
Former commercial leadership across GSK, Pfizer, and Johnson and Johnson. Global pharmaceutical commercialization and business development.
Commercial leadership across Gilead Sciences, Astra USA, and Dupont Pharmaceuticals. Pharmaceutical launch and market access strategy.
Peer-Reviewed Science Behind the Platform
Supported by decades of peer-reviewed transplantation research.
Qualified Transaction Inquiry
For strategic acquirers, licensing partners, institutional investors, and life sciences advisors. Qualified counterparties may evaluate.