Scimitar Equity Blog

CYTX has received European (CE Mark) approval for the PureGraft™ 250/PURE System for autologous fat grafting procedures, allowing Cytori to immediately commercialize the PureGraft™ product line to physicians in Europe. PureGraft™ will be sold as both a standalone product and as a complement to Cytori’s Celution® 800/CRS System in Europe.

The PureGraft™ System is an optimized tissue processing technology that is positioned at the forefront of the emerging fat grafting trend in the cosmetic and reconstructive surgery market.

• PureGraft™ replaces current non‐standardized methods of graft preparation,
• Used independently, PureGraft™ rapidly and reliably produces optimal graft tissue for use in autologous fat grafting procedures. In combination with the Celution® 800/CRS, PureGraft™ lowers processing times and increases processing volumes, improving the utility and efficiency of Cytori’s core product for soft tissue applications.

The Bottom Line: CYTX will immediately begin commercializing PureGraft™ in Europe, through a combination of direct sales and distributors. In addition to the 27 countries of the EU, the CE Mark is followed by eight other countries and facilitates additional registrations around the world. The PureGraft™ System sets a new standard for fat graft processing with its membrane‐based tissue filtration combined with speed, simplicity, safety and precision. 

• The PureGraft™ technology takes only 15 minutes to purify a fat graft ranging from 50 to 250 mL, removing excess and unwanted fluid, lipid, blood cells and debris in a controllable manner,
• The consumable‐based system, used within the sterile field, “dialyzes” off everything but the purified fat tissue without centrifugation or other methods,
• The ease of use and simplicity of this innovative system sets it apart from other traditional fat grafting methods.

 The PureGraft™ 250/PURE System received 510(k) marketing clearance for aesthetic body contouring from the U.S. FDA in January of this year.

• The product was formally launched at the meeting of the American Society of Aesthetic Plastic Surgeons in April 2010,
• In addition, Cytori received a Canadian medical device license for PureGraft™ in March 2010.