Pluristyx Partners With Leading Regenerative Medicine and Aerospace Pioneers to Standardize Clinical-Grade Hepatocyte Manufacturing for Space and Earth Applications
SEATTLE and WINSTON-SALEM, N.C., July 27, 2026 (GLOBE NEWSWIRE) -- Pluristyx, Inc., a leading provider of advanced induced pluripotent stem cell (iPSC) technologies and proprietary, genetically engineered solutions, and Wake Forest Advocate Health today announced a landmark collaborative initiative to develop a standardized, clinical-grade hepatocyte (liver cell) manufacturing workflow. Partnering with the Wake Forest Institute for Regenerative Medicine (WFIRM), Innovian Space, and RegenMed Development Organization (ReMDO), the consortium bridges the frontiers of terrestrial cell therapy and low-Earth orbit (LEO) biotechnology. The partnership represents a critical step toward establishing a commercially scalable manufacturing framework for implantable regenerative medicine products, with applications spanning terrestrial health care, distributed manufacturing and the emerging orbital biomanufacturing economy.
Aligned with NASA's In-Space Production Applications (InSPA) program, where the WFIRM team is developing a bridge-to-transplantation approach as a first step toward future whole-organ bioengineering, the joint project establishes a scalable, clinically compliant foundation for advanced tissue engineering. The primary objective is to create a robust supply chain of clinical-grade hepatocytes supporting bridge-to-transplantation therapies, providing temporary, life-saving liver function for patients awaiting a donor organ.
“We are building the foundational architecture for the next generation of regenerative medicine. By combining clinical-grade cell manufacturing with orbital biomanufacturing capabilities, this consortium is turning the goal of scalable, bioengineered organs into a commercial reality for patients on Earth and beyond,” said Dr. Priya Baraniak, chief commercial and development officer, Pluristyx.
“Microgravity unlocks new possibilities for complex tissue maturation and assembly. Partnering with this team allows us to move orbital biomanufacturing from a scientific frontier to an economically sustainable, life-saving industry,” said Jana Stoudemire, chief commercial officer, Innovian Space.
Building functional liver constructs requires a high standard of cell purity, identity and safety. The collaboration integrates Pluristyx's expertise in iPSC technology to construct a staged, clinical-grade cell banking workflow. The initiative draws on a multidisciplinary ecosystem to bring the clinical-grade cells to development:
“Regenerative medicine is at an inflection point where biology, automation and space-enabled innovation converge. ReMDO is proud to help pioneer the commercial, regulatory and infrastructure frameworks required to power this new orbital and terrestrial biomedical supply chain,” said Dr. Joshua Hunsberger, chief technology officer, ReMDO.
“Our mission is to translate breakthroughs into life-saving clinical realities. Standardizing this hepatocyte workflow is a critical step in delivering viable, bridge-to-transplantation alternatives for patients facing acute liver failure,” said Dr. Anthony Atala, director, WFIRM.
To ensure compliance with regulatory requirements and clinical efficacy, the manufactured hepatocyte-like cells will undergo functional validation. Cells will be continuously screened for primary liver-specific outputs, including albumin production, bilirubin metabolic clearance and urea synthesis, alongside expanded metrics evaluating coagulation factor secretion and metabolic profiles.
The workflow is targeted for process optimization and initial validation delivery by December 2026, anchoring the consortium's trajectory toward full InSPA Phase 2 readiness for orbital deployment in April 2027.
About Pluristyx, Inc.
Pluristyx is a provider of advanced induced pluripotent stem cell (iPSC)-based solutions for the cell and gene therapy industry, offering a platform designed to accelerate therapeutic development with speed, safety and scalability. Using proprietary mRNA bulk reprogramming and a polyclonal iPSC approach, Pluristyx produces genetically younger, more stable and highly expandable cells. The company's portfolio spans off-the-shelf, clinical-grade iPSC lines, custom gene editing and engineering, and safety and immune-evasion technologies, including the FailSafe safety switch and iACT immune cloaking system. Beyond cell sourcing, Pluristyx supports the full development continuum, from organoid-based disease modeling and high-throughput drug screening to GMP-scale manufacturing, helping therapeutic developers streamline workflows, reduce risk and accelerate the path to clinic.
About Wake Forest Advocate Health and WFIRM
The Wake Forest Institute for Regenerative Medicine is recognized as an international leader in translating scientific discovery into clinical therapies, with many world firsts, including the development and implantation of the first engineered organ in a patient. Over 550 people at the institute, the largest in the world, work on more than 40 different tissues and organs. A number of the basic principles of tissue engineering and regenerative medicine were first developed at the institute. WFIRM researchers have successfully engineered replacement tissues and organs in all four categories: flat structures, tubular tissues, hollow organs and solid organs and 18 different applications of cell/tissue therapy technologies, such as skin, urethras, cartilage, bladders, muscle, kidney, and vaginal organs, have been successfully used in human patients. The institute, which is part of Wake Forest University School of Medicine, is located in the Innovation Quarter in downtown Winston-Salem, NC, and is driven by the urgent needs of patients. The institute is making a global difference in regenerative medicine through collaborations with over 600 entities and institutions worldwide, through its government, academic and industry partnerships, its start-up entities, and through major initiatives in breakthrough technologies, such as tissue engineering, cell therapies, diagnostics, drug discovery, biomanufacturing, nanotechnology, gene editing and 3D printing.
About Innovian Space
Innovian Space helps established and new-to-space organizations develop and execute strategies to unlock economically sustainable and profitable uses of space. Its focus is on accelerating discovery and making the promise of a diverse, space-based economy real. The Innovian team has spent more than 25 years building a more diverse, space-based economy, conducting space-based research and development and establishing foundational applications that drive the orbital manufacturing economy. Platform-agnostic and client-focused, Innovian helps organizations develop and implement strategies to navigate the expanding “spacescape” and achieve their business objectives.
About RegenMed Development Organization (ReMDO)
ReMDO is a nonprofit organization dedicated to accelerating the commercialization and manufacturing readiness of regenerative medicine technologies. Through strategic partnerships, ecosystem development, regulatory planning, workforce initiatives and industry engagement, ReMDO helps bridge the gap between scientific innovation and market adoption. As a core partner within the NSF Regenerative Medicine Engine in North Carolina, ReMDO supports the development of scalable manufacturing systems, standards frameworks and commercialization pathways that help next-generation regenerative medicine products reach patients faster. Within the Bridge-to-Transplantation program, ReMDO is leading commercialization strategy, regulatory alignment, industry partnerships and market development activities to position the technology for both terrestrial and future in-space applications.
Media Contact:
Priya Baraniak
Chief Commercial and Development Officer
Pluristyx, Inc.
priya@pluristyx.com