Ocular Systems' corneal graft delivery system reaches the US
This article was originally published in Clinica
EndoSerter, a human corneal endothelium delivery instrument developed by Ocular Systems, has gained 510(k) clearance from the US FDA. The device delivers a corneal endothelial allograft measuring around 8.5mm in diameter and 175microns in central thickness through a single 4mm incision during endothelial keratoplasty procedures. Endothelial keratoplasty is a type of corneal transplantation that does not require a full-thickness graft. Endoserter is the first device to be cleared by the FDA for insertion of endothelial cells that restore corneal transparency, Winston-Salem, North Carolina-based Ocular Systems says. Each year approximately 18,000 patients in the US have endothelial cell replacement surgery.
You may also be interested in...
Dr Noam Emanuel is the founder and chief technology officer of Ness Ziona, Israel-based drug delivery firm PolyPid. The 15-strong firm, established in 2008, has developed an encapsulation technology which allows the precise targeting of drug release.
Mesoblast has received the all-clear from the US FDA to start a Phase III clinical trial for bone marrow regeneration in patients with blood cancers. The study will be conducted together with Mesoblast's strategic alliance partner, Cephalon, which will fund the trial.
Mesoblast has received the green light from the US FDA to begin a Phase II trial of its proprietary adult mesenchymal precursor cell (MPC) product for the treatment of degenerative disc disease, a major cause of chronic low back pain.