Mentioned:
Conexeu Sciences is coming after the opportunity in regenerative tissue. Which is exactly why they are accelerating their manufacturing scale up as they prepare for their 510(k) submission to the United States Food and Drug Administration.
What’s happening:
- Conexeu Sciences (NASDAQ: CNXU) has publicly stated they have begun scaling up their manufacturing and standardized formulation methods with their contract development and manufacturing organization for their lead wound care device candidate Ten Minute Tissue
Why it matters:
- Conexeu Sciences is advancing their manufacturing, testing, packaging and sterilization in order to support their planned 510(k) submission to the United States Food and Drug Administration
Going deeper:
- Conexeu Sciences’ lead wound care device candidate Ten Minute Tissue was developed after more than a decade of preclinical university research and has been granted patent protection in the United States, Japan, Australia and the European Union
- The United States Food and Drug Administration has also given pre-submission feedback to Conexeu Sciences for their initial wound care indication
The intrigue:
- The Wake Forest Institute for Regenerative Medicine and Conexeu Sciences just recently made waves when they launched a preclinical development program for Conexeu Sciences’ 3D printed bioregenerative breast matrix which is aiming to enable the human body to rebuild its own breast tissue to support post-mastectomy reconstruction from breast cancer
