Galatea Scaffold Material and Product Specifications
What is the Galatea scaffold material?
Galatea scaffold is a bioresorbable, monofilament scaffold, constructed of poly-4-hydroxybutyrate (P4HB™) – an advanced, biologically produced polymer P4HB is derived from a naturally occurring monomer, 4HB, that is present in the body. This polymer belongs to a class of biopolymers called PHAs (polyhydroxyalkanoate) that are biosynthesized by microorganisms. Much like we store energy in the form of fat and carbohydrates, some microorganisms store energy in the form of PHA. In contrast to other polymers used today for soft tissue support, P4HB is produced through a proprietary biologic fermentation process, rather than chemical synthesis. After P4HB is isolated and purified, it can be extruded into monofilament fibers and either used directly as suture or knitted into an open scaffold construction designed for rapid tissue in-growth and low bacterial adherence.  P4HB has been tested extensively in pre-clinical studies to evaluate its safety profile. In addition, P4HB products have been used in surgical applications such as hernia repair, tendon and ligament reinforcement, as well as for suture since 2007. More than 1 million patients worldwide have been implanted with P4HB medical devices with a strong safety profile.
Is Galatea scaffold a tissue?
Galatea scaffold is made from neither human nor animal tissue. It is P4HB, which is derived from a naturally occurring monomer, that is present in the body. Much like we store energy in the form of fat and carbohydrates, some microorganisms store energy in the form of polyhydroxyalkanoate, which is extracted and processed into the natural material of P4HB, and then extruded into individual strands and woven into a scaffold that creates Galatea scaffold.
How does a Galatea scaffold work?
Galatea scaffolds are used to support soft tissue and to reinforce areas that may benefit from additional strength and support. In the same manner that a trellis or a lattice works to support the growth of a rose bush in a garden, Galatea scaffold provides a strong and flexible foundation that encourages the regeneration of the patient’s own tissue. Galatea scaffold initially provides much of the soft tissue reinforcement and strength; however, over time, new tissue grows into Galatea scaffold and this new tissue provides the long-term soft tissue reinforcement while Galatea scaffold bioresorbs.
Multiple pre-clinical in vivo studies show that a normal wound healing response occurs when Galatea scaffold is placed; cells migrate into the pores of Galatea scaffold, collagen deposition occurs, then vascularization, and finally tissue remodeling into tissue that is 3 to 5 times stronger than native tissue. [15,33] This tissue remains after Galatea scaffold is fully resorbed.  Preclinical studies as well as data from tissue explants show strong evidence of fibro-vascular tissue ingrowth throughout the entirety of Galatea scaffold within six weeks of implantation. 
How long does it take for a Galatea scaffold to bioresorb?
Galatea scaffold degrades in the human body primarily through exposure to water (i.e., hydrolysis). The scaffold loses all of its strength by about 12 months, and its mass is fully bioresorbed in approximately 18-24 months. The resulting byproducts of bioresorption are carbon dioxide and water, which the body processes naturally through the Krebs Cycle.
Is Galatea scaffold a mesh? I have heard about vaginal meshes that have led to patient reported adverse events.
Galatea scaffolds could be called a mesh or a biological scaffold. Because Galatea scaffold degrades over time, bioresorbs and is eliminated naturally from the body, Galatea scaffold is fundamentally different than many of the vaginal mesh products that are made from permanent materials and have been linked to adverse events. Currently, Galatea scaffold is not intended for transvaginal placement.
Does Galatea scaffold interfere with future diagnostic tests such as mammograms?
Post market studies have demonstrated that there is no visibility of the Galatea scaffold at one year of follow up with ultrasound and mammogram. At that point, the scaffold has integrated well into the tissues and is typically not detectable by those diagnostic tests. 
The Need for Soft Tissue Reinforcement with Galatea Scaffolds
Why would a patient need additional reinforcement for a procedure?
There are many reasons soft tissue support may be needed to achieve the desired outcome in a surgical repair. Aging is the most common reason. As we grow older, our skin becomes thinner, and less durable due to a significant loss in collagen and elastin. In addition to aging, other factors that affect our tissue quality include cancer, diabetes, nursing children, large fluctuations in weight, menopause (due to lack of estrogen) and smoking. Because of these various factors, skin may begin to show signs of sagging (i.e., ptosis) or skin may feel very loose (i.e., lax) and therefore not provide the sufficient mechanical support.
What is ptosis? What is soft tissue reinforcement?
Ptosis is the drooping or sagging of the skin or skin envelope usually due to excessive weight, gravity, or loss of skin elasticity. Ptosis by definition involves a stretching out of the skin or skin envelope where the skin is weakened and cannot withstand the external or internal forces imposed upon it. Herniation is the protrusion of an organ or fascia through the abdominal wall. By definition, herniation involves weak tissue, often in the abdominal wall. Ptosis and hernias have similar skin weakness etiology. Soft tissue reinforcement, when used in hernia repair, is a way to provide additional support to the abdominal wall to reinforce the weakened area. When used in other parts of the body during a surgery to correct ptosis, soft tissue reinforcement may provide extra support to the skin envelope and/or tissue. Galatea scaffold can be used to provide soft tissue reinforcement. Because it is bioresorbable, Galatea scaffold initially provides much of the soft tissue reinforcement; however, over time, new tissue grows into Galatea scaffold and this new tissue provides the long-term soft tissue reinforcement. In preclinical studies, P4HB scaffolds have been shown to bioresorb and induce the growth of tissue that is stronger than the native tissue. 
Have there been any adverse events associated with the use of Galatea scaffolds?
Possible complications with the use of Galatea scaffold includes infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. In pre-clinical testing, Galatea scaffold elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the scaffold was resorbed. For up-to-date information, please consult the MAUDE database for events that have been reported for Galatea scaffold and other surgical scaffolds.
Galatea Scaffold Cost Justification & Reimbursement
Is Galatea scaffold a reimbursable product?
When used in an aesthetic procedure, Galatea scaffold is not typically reimbursable. Please contact your Galatea Surgical representative for more information.
How can I cost justify the incremental expense of Galatea scaffold in a plastic surgery procedure?
Physicians have integrated the use of Galatea scaffold in procedures where patients have weakened tissue and require soft tissue support to achieve the desired surgical outcome. Galatea scaffold aids in the support, repair, and elevation of weakened tissue and promotes strong tissue ingrowth, providing mechanical support to the surgical site. Galatea is currently investigating the changes in breast profile over time following implantation of Galatea scaffold for soft tissue support, post-mastopexy or reduction, through a post-market study.
Who are Galatea Surgical and Tepha, Inc.? How are they related?
Galatea Surgical, Inc. is a wholly owned subsidiary of Tepha, Inc. Tepha manufactures all P4HB-based products including fiber and mesh-based products. Tepha also supplies raw materials, components and products to other commercial entities such as B.Braun®/Aesculap®, Tornier®, and C.R. Bard®. Galatea Surgical is the commercial entity of Tepha focused on plastic and reconstructive surgery and the only entity through which Tepha sells direct.
What products does Tepha sell? What kinds of customers does it serve?
Tepha, Inc. is a biomaterials company that manufactures and distributes P4HB products such as fiber and meshes to medical device companies. Tepha has several partners that sell commercial product manufactured using P4HB. Current partnerships include B.Braun® (high strength Monomax™ suture), Tornier® (Biofiber™ patch for rotator cuff repair and high strength Phantom™ Fiber Suture for orthopedic applications), and C.R. Bard® (Phasix™ and Phasix ST mesh for hernia repair and reinforcement).
Is Galatea scaffold cleared for use as a medical device outside of the United States?
The P4HB devices have been available and distributed worldwide through Tepha, Inc. via commercial partners since 2007.
Galatea scaffold is FDA cleared and available in the United States. Galatea scaffold has received CE Marking and is available in the European Union. We are in the process of expanding globally, please contact us at firstname.lastname@example.org for the latest product availability information.
Where is Galatea Surgical located? How can I get in touch with a sales representative?
Both Galatea Surgical and Tepha, Inc. are located just outside of Boston, in Lexington, Massachusetts. Should you wish to contact us, please call us at 781-357-1750 or email us at email@example.com.