Sientra Inc SIEN shares are trading after the FDA granted a 510k-clearance to its AlloX2 Pro Tissue Expander.
AlloX and AlloX2 Tissue Expanders are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, mainly to aid in reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in the treatment of soft tissue deformities.
Building upon the proprietary dual port technology of the company’s AlloX2 tissue expander, the AlloX2 Pro expands this platform by removing 95% of the metal traditionally associated with tissue expander ports.
This allows the AlloX2 Pro to be labeled as MRI-conditional, making it the only tissue expander cleared in the U.S. for exposure to magnetic resonance imaging.
AlloX2 Pro offers minimal interference with radiation therapy for post-mastectomy patients, faster port filling and drainage, and a softer drain for enhanced patient comfort.
“This is the third new product cleared or approved by the FDA in the past 12 months, setting Sientra apart from the competition,” commented Ron Menezes, President and CEO of Sientra.
Price Action: SIEN shares are up 65.8% at $2.90 on the last check Friday.