Expanding Celution EU Indications, Cytori (NASDAQ: CYTX)
CYTX expanded its Celution® System CE Mark by receiving additional indications-for-use, which build upon the existing device approval.
The current Celution System indications-for-use allow for the digestion of adipose tissue to extract, wash and concentrate a patient’s own stem cells and other associated cells for re-injection back into the same patient. These new indications add specific medical applications for the re-injection of cells, which include:
- Breast reconstruction,
- Repair of soft tissue defects,
- The facilitation of healing certain types of wounds, such as those resulting from Crohn’s disease.
The Bottom Line: The importance of his development is that it improves the ability of our sales force and distributors to offer the Celution® System to hospitals. Until now, sales activities have been focused mostly on private-pay plastic and cosmetic surgery clinics. Additionally, this supports efforts to gain reimbursement for stem and regenerative cell-enriched breast reconstruction and other reconstructive surgery procedures. Clinical data from the RESTORE 2 breast reconstruction trial in Europe and other wound repair clinical studies were used to support the expanded CE Mark. The CE Mark, in addition to the 27 countries of the EU, is followed by 8 additional countries around the world and facilitates other registrations around the world. For more information, please see the attached release.
