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Instructions for Use:

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Tel. 833.342.2073

Tepha, Inc 99 Hayden Avenue, Suite 360 - Lexington, MA 02421

INDICATIONS FOR USE: GalaFLEX™, GalaFLEX 3D™ and GalaFLEX 3DR™ Scaffolds are indicated for use as bioresorbable scaffolds for soft tissue support and to repair, elevate, and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. These products, referred to as the GalaFLEX™ Scaffold collection, are also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

GalaFLEX LITE™ Scaffold is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

IMPORTANT SAFETY INFORMATION: Possible complications following implantation of the GalaFLEX™ Scaffold collection include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. In pre-clinical testing, the GalaFLEX™ Scaffold collection elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the scaffold was resorbed. For complete prescribing information, including indications for use, warnings and precautions, consult the specific GalaFLEX™ Scaffold product Instructions for Use.

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