Desktop 3D printer manufacturer UltiMaker and Singaporean MedTech startup Bioactivx have signed a memorandum of understanding (MoU) to jointly develop a deployable, on-demand 3D printing solution for regenerative wound care.
The announcement coincides with two milestones Bioactivx reached. The more significant of the two is Health Sciences Authority (HSA) approval for Bioactivx’s flagship product, the Bioactiv Matrix, a fully synthetic, animal-free artificial skin substitute designed to treat severe burns, cuts, and abrasions.
Singapore’s HSA sits at World Health Organization (WHO) Maturity Level 4 for medical device regulation, indicating extremely high standards for medical device approvals, and Bioactivx has ongoing regulatory submissions in the United States, the European Union, Australia, and across the rest of ASEAN.
“Bioactivx’s certification and regulatory approval is a powerful proof point for the medical 3D printing industry,” said Mr. Michiel Alting von Geusau, CEO of UltiMaker “It demonstrates that with the right process and quality controls, 3D printing on UltiMaker platforms can meet the exacting standards required for certified, end-use medical devices – not just prototypes.”
Developing On-Demand Medical Manufacturing
The Bioactiv Matrix is manufactured through a digital production process that Bioactivx built entirely around UltiMaker hardware. The company compounds a proprietary active-ingredient filament in-house, then runs the final product through a fleet of UltiMaker 3D printers inside a certified cleanroom facility, which it also opened alongside the MoU announcement.
That end-to-end process is what earned Bioactivx both ISO 13485 certification and HSA approval specifically for end-use medical manufacturing, a more demanding bar than prototyping or component production.
Under the MoU, the two companies will work over the coming months to refine a 3D printing configuration that can be deployed closer to where treatment is needed, instead of depending on centralized manufacturing and cold-chain distribution.
The stated aim is to shorten the time between injury and treatment within what Bioactivx describes as the critical window following a wound, though no specific deployment timeline or unit targets were disclosed.
A validated on-demand 3D printing setup, if it clears regulatory requirements in each target market, could allow a product like the Bioactiv Matrix to be manufactured at or near the point of use.
3D Printing Finds Clinical Wound Care Applications
3D printing’s application to wound care has been producing results at the clinical level. At the University of Toledo Medical Center, physicians used the Aplicor 3D bioprinter, developed by Tides Medical, to 3D print patient-specific grafts derived from a small sample of a patient’s own fat tissue.
The graft is shaped to fit the exact dimensions of the wound, and at least one patient with a persistent chronic lesion reported visible wound closure within two weeks of the procedure.
In a parallel development, Swiss biotech company Cutiss reported positive interim results in 2025 from two phase II clinical trials of denovoSkin, a bilayer skin substitute, tested in children and adults recovering from burns or reconstructive surgery. At the time of reporting, the company announced a European phase III trial in the pipeline, and has already extended access to a limited number of patients in the US and Europe under compassionate-use exemptions.
These developments illustrate 3D printing and engineered skin technologies moving into clinical treatment and clinical development, while production time, scalability, and regulatory requirements remain constraints. The Bioactivx-UltiMaker MoU addresses a different part of this challenge by focusing on how an already regulated wound-care product could eventually be manufactured closer to the point of treatment.
Further validation and regulatory clearance in each target market will determine how viable that model proves beyond Singapore.
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Featured image shows from left to right: UltiMaker CEO, Michiel Alting von Geusau, Member of Parliament and Guest of Honor Ms Tin Pei Ling, and BioactivX CEO, Dr Peili Teo, at the MoU signing. Photo via UltiMaker.
