Conexeu Sciences Inc., a preclinical-stage medical device and regenerative medicine company, has announced it is now undergoing manufacturing, testing, and preclinical work to support its planned FDA 510(k) submission for its wound care device.
The device, known as Ten Minute Tissue, is based on the company’s CXU investigational tissue-restoration platform. Conexeu says it remains on track to make the submission in the first calendar quarter of 2027.
In a press release, the company said that it expects the establishment of a controlled and reproducible manufacturing process to support not only the generation of representative materials for regulatory testing, but also the development of supply capabilities intended to meet future market demand subject to FDA clearance.
“We have moved from process development to implementing a controlled manufacturing process,” said Miles Harrison, President and CEO of Conexeu. “That progress is important for two reasons. First, it supports the regulatory testing required to advance our planned FDA 510(k) submission. Second, it moves us closer to establishing the scalable manufacturing infrastructure needed to support commercialisation. We believe manufacturing scale-up is one of the critical bridges between regulatory development and our ability to ultimately bring our lead device to market.”
Ten Minute Tissue is built on the Company’s CXU platform, which is based on the extracellular matrix (ECM), the natural framework that holds the body’s tissues together. It can be applied as a liquid, and is designed to turn into a gel at body temperature within about ten minutes, making it a viable solution for difficult of irregularly shaped wounds where sheets, meshes, and powders may not be fully suited.
Amongst its current regulatory and development activities, Conexeu said it is carrying out manufacturing process development and scale-up; demonstrating reproducible performance of CXU material across multiple scaled-up batches; expanding production of representative Ten Minute Tissue test samples to support planned preclinical, biocompatibility, chemical characterisation, stability and other regulatory testing; and progressing toward commercial manufacturing readiness.
