Conexeu Launches Preclinical B.R.E.A.S.T.™ CXU™ Study at Wake Forest
CNXU•Conexeu Sciences has initiated a preclinical program with Wake Forest Institute for Regenerative Medicine to evaluate its CXU™ 3D-printed B.R.E.A.S.T.™ breast matrix’s durability, integration, and resorbability. Findings will guide future study designs and support the company’s predicate-based US 510(k) regulatory strategy targeting a 2027 submission.
1. Program Launch
On May 27, Conexeu Sciences began a preclinical development program at Wake Forest Institute for Regenerative Medicine to evaluate its B.R.E.A.S.T.™ bioregenerative breast matrix. The study leverages WFIRM’s Integrated Tissue-Organ Printer system to support scalable bioprinting of Conexeu’s proprietary CXU™ platform.
2. Study Focus
The program will assess durability under physiological conditions, host tissue integration, and resorbability of the 3D-printed extracellular matrix device. These performance metrics will inform design parameters, de-risk innovation, and support progression toward clinical validation.
3. Technology and Next Steps
B.R.E.A.S.T.™ is engineered for resorbable, cell-guiding soft tissue restoration and is positioned as an alternative to permanent implants and reconstructive approaches. Findings will guide future study designs and underpin a predicate-based US 510(k) regulatory strategy targeting submission in early 2027.
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Conexeu Sciences Initiates Preclinical Development Program for B.R.E.A.S.T.™ Bioregenerative Matrix Platform with Wake Forest Institute for Regenerative Medicine
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UPDATE - Conexeu Sciences Initiates Preclinical Development Program for B.R.E.A.S.T. Bioregenerative Matrix Platform with Wake Forest Institute for Regenerative Medicine
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