Bioactiv® Matrix, Bioactivx's fully synthetic skin substitute, has received HSA approval, enabling its commercial availability in Singapore for its approved indications.
The approval marks an important step inbringing Bioactivx’s fully synthetic regenerative wound-care technology fromthe laboratory into clinical practice.
Bioactivx is pleased to announce that Bioactiv® Matrix has received regulatory approval from Singapore’s HealthSciences Authority (HSA).
This milestone enables Bioactivx to make Bioactiv® Matrix commercially available in Singapore for its approved indications. It also represents an important step in the company’s mission to improve the treatment of burns and other complex wounds through accessible, science-led regenerative solutions.
Bioactiv® Matrix is a fully synthetic, acellular skin substitute designed to support the body’s natural healing processes. Its three-dimensional architecture provides a temporary environment that supports cellular activity and tissue regeneration as the material gradually degrades.
The technology originated from research conducted at A*STAR and Singapore General Hospital. Its development has progressed through laboratory research, preclinical evaluation and a first-in-human clinical study involving patients with partial-thickness burns.
Early clinical observations supported the potential of Bioactiv® Matrix to promote re-epithelialisation while managing inflammation and supporting favourable wound recovery. The HSA approval was supported by the company’s technical, quality, preclinical and clinical evidence.
“Receiving HSA approval is a major milestone for Bioactivx and for the team that has worked to translate this technology from research into a product for patients,” said Dr Teo Peili, CEO and Co-Founder of Bioactivx. “It brings us closer to helping clinicians manage challenging wounds with a fully synthetic and practical regenerative solution.”
Bioactivx operates an ISO 13485-certified quality management system and is preparing for the controlled commercial introduction of Bioactiv® Matrix in Singapore. The company will work closely with healthcare professionals to support appropriate product use, clinical education and the continued collection of real-world evidence.
With its Singapore approval secured, Bioactivx is also advancing its regulatory and commercialisation plans for selected international markets.
