Now in 3D! The only formed scaffold withsupporting rim designed to uplift the body’s natural shape,provide easier placement and reduce procedure time.

Naturally Uplifting. Ahead of the Curve.

3-Dimensional

Biologically Derived

Monofilament

Strong

Bioresorbable

Galatea Surgical, Inc. 99 Hayden Avenue, Suite 360 Lexington, MA 02421

Phone: (781) 357-1750Fax: (877) 357-0484 Email: Contact@GalateaSurgical.comwww.galateasurgical.com

1. Data on file at Tepha. Similar studies in humans have not been performed.

2. Martin, David P., et al. “Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications.” Journal of Surgical Research 184.2 (2013): 766-773.

3. Wolloscheck, T., et al. “Inguinal hernia: measurement of the biomechanics of the lower abdominal wall and the inguinal canal.” Hernia 8.3 (2004): 233-241.

Galatea Surgical, Inc. is a wholly owned Subsidiary of Tepha, Inc. Galatea Surgical © 2017. All Rights Reserved. 500030 Rev B

GalaFORM 3D scaffold is the only 3-dimensional scaffold with reinforcing rim for plastic and reconstructive surgery that supports, elevates, repairs and reinforces soft tissue. This unique 3D monofilament scaffold is made from the biologically derived poly-4-hydroxybutyrate (P4HB), which naturally bioresorbs through hydrolysis.

• Formed with a P4HB reinforcing rim to ease scaffold placement, allowing for reduced procedure time and less headaches by fitting to the patient’s natural shape.

• After implantation, the scaffold slowly bioresorbs while tissue grows into the lattice, resulting in tissue that is 3-5 times stronger than native tissue after 18-24 months when the scaffold is entirely bioresorbed.1,2,3

• Choose from a full portfolio of 3D shapes and sizes to complement the body’s natural shape.

Indications for UseGalaFORM 3D scaffold is indicated for use as a bioresorbable scaffold 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. GalaFORM 3D scaffold is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Important Safety ConsiderationsPossible complications include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. The safety and use of GalaFORM 3D for patients with hypersensitivities to the antibiotics kanamy-cin sulfate and tetracycline hydrochloride is unknown. Galatea scaffolds have not been studied for use in breast reconstructive surgeries. The safety and effectiveness of GalaFORM 3D scaffold in neural tissue and in cardiovascular tissue has not been established. The safety and effectiveness of GalaFORM 3D scaffold in pediatric use has not been established.

Consult the GalaFORM 3D Instructions for Use for complete prescribing information, including its indications for use, warnings and precautions.

The Galatea Collection of Scaffolds offers you a full portfolio of sizes and shapes for each patient’s surgical needs.

Shape Product Code# per

PackageSize (cm) Size (in)

FR3D01 15.3 x 15.5 2.1 x 6.1

FR3D02 2

FR3D03 16.4 x 18.5 2.5 x 7.3

FR3D04 2

FR3D05 17.5 x 21.0 3.0 x 8.3

FR3D06 2

FR3D07 1 7.6 x 20.3 3 x 8

FR3D09 12.5 x 7.6 1 x 3

FR3D10 2

FR3D11 12.5 x 10.2 1 x 4

FR3D12 2

FR3D13 17.6 3

FR3D14 2

GalaFLEX GalaSHAPE GalaFORMGalaFLEX GalaSHAPE GalaFORM

GalaFLEX GalaSHAPE GalaFORM

GalaFLEX GalaSHAPE GalaFORM

GalaFLEX GalaSHAPE GalaFORM

GalaFORM 3D: Available Sizes & Shapes

Oval

Rectangular

Rectangular

Triangular

Circular

Shapes that fit right in.