Galatea Surgical Soft Tissue Support Scaffold Products to be Featured At the 2017 American Society of Plastic Surgeons Meeting

Lexington, MA (September 26, 2017) – Galatea Surgical (“Galatea”), a wholly owned subsidiary of Tepha Inc., will be a featured exhibitor at the prestigious American Society of Plastic Surgeons (“ASPS”) Meeting in Orlando, Florida October 6th–10th.   A leader and innovator in the fast-growing field of regenerative scaffolds, Galatea announced that the most recent clinical experience on the Company’s GalaSHAPE™ 3D and GalaFORM™ 3D Bioresorbable Surgical Scaffolds will be presented by Dr. Bruce Van Natta, a leading plastic surgeon based in Indianapolis, Indiana.  GalaFORM 3D and GalaSHAPE 3D are the first scaffold constructs to be introduced for aesthetic surgery that incorporate a three-dimensional contouring into the design of the product. The Galatea product portfolio will on display at Booth #1022.

Dr. Bruce Van Natta, a pioneer in documenting the need and value of resorbable soft tissue support in aesthetic breast surgery, will present his experience with GalaSHAPE 3D and GalaFORM 3D during the Hot Topics in Plastic Surgery Session – Course ID 701, on Friday, October 6th.  Dr. Van Natta’s talk is entitled, “Absorbable Monofilament Mesh for Enhancing Breast Surgical Outcomes.”

Dr. Van Natta commented, “I have incorporated Galatea’s 3D scaffolds as important tools in my clinical practice. The anatomic contouring engineered into the product designs not only offers great strength and support to the repair, the 3D design facilitates insertion and fixation of the scaffold, leading to reduced surgical procedure time.  I believe GalaFORM 3D and GalaSHAPE 3D represent a truly revolutionary means of achieving excellent and sustainable patient outcomes.”

GalaSHAPE 3D and GalaFORM 3D are the only three-dimensional bioresorbable mesh devices that are indicated for use in plastic and reconstructive surgery for the support, reinforcement, and elevation of weakened soft tissue.  Similar to the GalaFLEX Surgical Scaffold, GalaSHAPE 3D and GalaFORM 3D are mesh constructs comprised of monofilament fibers extruded from a proprietary polymer, P4HB™, developed by Tepha.  P4HB, or poly-4-hydroxybutyrate, is a biologically derived polymer that resorbs in the body with very low inflammation due to its low acidity relative to most other resorbable polymers.  Extensive animal testing and histology from human patients indicate that as P4HB mesh resorbs, it remodels to a functional new tissue plane that adds thickness and strength to the native, healthy tissue.  

Lois Lombardi, Vice President of Galatea, also commented, “The ASPS meeting has always been associated with physician education as well as product innovation. GalaSHAPE 3D and GalaFORM 3D are the only three-dimensional bioresorbable mesh constructs that are indicated for use in plastic surgery.  We look forward to introducing this latest innovation from Galatea to the ASPS membership at the meeting in Orlando.”

ABOUT TEPHA INC:

Tepha Inc, founded in 1998 and headquartered in Lexington, MA, is a supplier of medical devices focused on the Biomaterials market.  Tepha’s products are designed and developed to elevate, support and reinforce areas of soft tissue weakness as well as to promote improved healing responses. To date, Tepha and its partners have received twenty three 510(k) clearances for devices marketed in the US as well as five CE Marking approvals for products sold in Europe. Commercial products based on Tepha’s resorbable P4HB polymer technology include:  high tensile strength sutures for orthopedic soft tissue repair; mesh constructs for ventral and inguinal hernia repair; monofilament sutures for abdominal wall closure and plastic surgery; patches for tendon and ligament repairs; and mesh constructs which have been used in face and breast lifts. To date, products made from P4HB have been successfully used in more than 1,000,000 surgical procedures worldwide, and have been the subject of over 30 published clinical and scientific papers.

ABOUT ASPS:

The American Society of Plastic Surgeons (ASPS) is the largest plastic surgery specialty organization in the world. Founded in 1931, the Society represents 94% of all board-certified plastic surgeons in the U.S., and more than 8,000 plastic surgeons worldwide, making ASPS a global institution and leading authority on cosmetic and reconstructive plastic surgery.

The mission of ASPS is to advance quality care to plastic surgery patients by encouraging high standards of training, ethics, physician practice and research in plastic surgery. The Society is a strong advocate for patient safety and requires its members to operate in accredited surgical facilities that have passed rigorous external review of equipment and staffing.

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For more information visit: www.Tepha.com or by contacting:

Michelle Thompson at (508) 643-8000

michelle@cwrpartners.com

Tepha Inc. Subsidiary, Galatea Surgical, Announces the Launch of GalaFORM™ 3D Surgical Scaffold

Galatea Designated as Premier Partner by American Society for Aesthetic Plastic Surgery

Galatea Surgical, a wholly owned subsidiary of Tepha Inc., announced today the FDA 510k clearance of its GalaFORM™ 3D Surgical Scaffold (“GalaFORM 3D”) for use in plastic and reconstructive surgery. Based on Tepha’s proprietary P4HB™ bioresorbable polymer technology, GalaFORM 3D is the only 3-dimensionally contoured, surgical scaffold with a reinforcing rim, designed to uplift the body’s natural shape, provide easier placement and reduce procedure time. Galatea is a Premier Partner of the American Society for Aesthetic Plastic Surgery (ASAPS), and will commercially launch GalaFORM 3D at the upcoming 50th Anniversary meeting of ASAPS in San Diego, California.

Andy Joiner, President and CEO of Tepha commented, “One of the cornerstones of Galatea is our commitment to surgeon and patient education. We are honored to be a Premier Partner of ASAPS, an organization that is focused on providing its members with access to state-of-the-art educational and practice development programs. Innovation is an important driver of what we do at Galatea, and we are pleased to be launching GalaFORM 3D, a first of its kind resorbable scaffold, in conjunction with the 50th anniversary of ASAPS. Galatea is committed to engineering innovative new products that offer significant surgeon and patient benefits and providing access to this new technology to ASAPS and its membership.”

GalaFORM 3D is 510(k) cleared by the FDA and is indicated for soft tissue support and to repair, elevate, and reinforce soft tissue where weakness or voids exist. Galatea has been a technology leader and innovator in the field of surgical scaffolds for plastic and reconstructive surgery since commencing the clinical evaluation of its GalaFLEX flat mesh in 2011. The launch of the rimmed GalaFORM 3D Surgical Scaffold follows the launch earlier this year of GalaSHAPE 3D, the market’s first 3D surgical scaffold for plastic and reconstructive surgery. Galatea Surgical is committed to both innovation and careful clinical evaluation in order to meet the needs of plastic surgeons and their patients.

William P. Adams, a Dallas based board certified plastic surgeon commented, “Scaffolds play an important role in aesthetic surgery, where we deal with rejuvenating weakened tissue. We have studied soft-tissue support products through the years, but they are much different; they don’t add long-term tissue strength and aren’t as biocompatible. Galatea scaffolds are made of an easily absorbable monofilament, rather than a multifilament, which reduces infection. GalaFORM 3D is a novel scaffold with out-of-the-box shape to better fit the patient’s natural curves. I’m looking forward to using this game-changing 3D scaffold in my patients that require soft tissue support.”

ABOUT TEPHA INC:
Tepha Inc., founded in 1998 and headquartered in Lexington, MA, is a supplier of medical devices focused on the BioMaterials market. Tepha’s products are designed and developed to elevate, support and reinforce areas of soft tissue weakness as well as to promote improved healing responses. To date, Tepha and its partners have received 23 510(k) clearances for devices marketed in the US as well as five CE Marks for products sold in Europe. Commercial products based on Tepha’s resorbable P4HB polymer technology include: high tensile strength sutures for orthopedic soft tissue repair; mesh constructs for ventral and inguinal hernia repair; monofilament sutures for abdominal wall closure and plastic surgery; patches for tendon and ligament repairs; and mesh constructs used in face and breast lifts. To date, products made from P4HB have been successfully used in more than 1,000,000 surgical procedures worldwide, and have been the subject of over 30 published clinical and scientific papers.

ABOUT ASAPS:
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; Active Members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and nonsurgical aesthetic procedures. International Active Members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.

For more information visit: www.Tepha.com or by contacting:
Veronica Welch at 1-508-643-8000
ronnie@cwrpartners.com  

SOURCE: Tepha Inc.

 

Tepha Inc. Subsidiary, Galatea Surgical, Announces Launch of GalaSHAPE™ 3D Surgical Scaffold

Galatea Surgical, a wholly owned subsidiary of Tepha Inc., announced today the launch of its GalaSHAPE™ 3D Surgical Scaffold (“GalaSHAPE 3D”) for use in aesthetic plastic surgery.  Based on Tepha’s proprietary P4HB™ bioresorbable polymer technology, GalaSHAPE 3D is an implantable mesh device that is contoured to facilitate surgical placement in the naturally-curved areas of the human body.  The full launch of GalaSHAPE 3D follows its FDA 510(k) clearance in the fall of 2016.

Dr. Bruce Van Natta, a leading plastic surgeon in Indianapolis, Indiana said, “The ability of the GalaSHAPE 3D scaffold to conform to the variable anatomic contours encountered in aesthetic plastic surgery is a major advance compared to currently available synthetic and biologic meshes.  My colleagues and I already have been using Galatea’s GalaFLEX flat mesh for over five years in a range of aesthetic plastic surgery procedures for the breast, face, brow, and neck.  The combination of P4HB’s strength, bioresorption, and ability to enable rapid tissue ingrowth and integration will help plastic surgeons achieve exceptional aesthetic results for their patients.  The introduction of GalaSHAPE 3D further establishes Galatea Surgical as the innovator in soft tissue reinforcement.”

GalaSHAPE 3D is the only three-dimensional bioresorbable mesh device that is indicated for use in plastic and reconstructive surgery for the support, reinforcement, and elevation of weakened soft tissue.  Similar to the GalaFLEX Surgical Scaffold, GalaSHAPE 3D is a mesh comprised of monofilament fibers extruded from a proprietary polymer, P4HB, developed by Tepha.  P4HB, or poly-4-hydroxybutyrate, is a biologically derived polymer that resorbs in the body with very low inflammation due to its low acidity relative to most other resorbable polymers.  Extensive animal testing and histology from human patients indicate that as P4HB mesh resorbs, it remodels to a functional new tissue plane that adds thickness and strength to the native, healthy tissue.  

Andrew Joiner, President and CEO of Tepha Inc. commented, “Galatea is very excited to initiate the full launch of the GalaSHAPE 3D Surgical Scaffold.  Since the founding of Galatea and the first clinical use of GalaFLEX in 2011, we have been committed to working with thought leaders in aesthetic surgery like Dr. Van Natta, who have recognized the benefits of the proprietary Tepha P4HB technology for both surgeons and their patients.  These clinical collaborations have helped to define Galatea’s careful and thoughtful development strategy in the past and we are confident that they will motivate and guide our innovation strategy in the future.”

About Tepha: Tepha Inc, founded in 1998 and headquartered in Lexington, MA, is a supplier of medical devices focused on the BioMaterials market.  Tepha’s products are designed and developed to elevate, support and reinforce areas of soft tissue weakness as well as to promote improved healing responses. To date Tepha and its partners have received twenty-three 510(k) clearances for devices marketed in the US as well as CE Marking for five products sold in Europe. Commercial products based on Tepha’s resorbable P4HB polymer technology include: high tensile strength sutures for orthopedic soft tissue repair, mesh constructs for ventral and inguinal hernia repair, monofilament sutures for abdominal wall closure and plastic surgery, patches for tendon and ligament repairs, and mesh constructs for soft tissue support. To date, products made from P4HB have been successfully used in more than 1,000,000 surgical procedures worldwide, and have been the subject of over 30 published clinical and scientific papers.

More information about the Company and its products can be found at its website www.Tepha.com and

Contact:  

John Hartnett

Executive Vice President and Chief Operating Officer

781-357-1772

Andy Joiner

President and Chief Executive Officer

781-357-1770

 

SOURCE Tepha Inc.

Related Links

http://www.Tepha.com

Indications for Use

Galatea 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. Galatea 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 Considerations

Possible complications following implantation of Galatea scaffold include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. The safety and product use of Galatea scaffold for patients with hypersensitivities to the antibiotics kanamycin sulfate and tetracycline hydrochloride is unknown. Galatea scaffolds have not been studied for use in breast reconstructive surgeries. The safety and effectiveness of Galatea scaffold in neural tissue and in cardiovascular tissue has not been established. The safety and effectiveness of Galatea scaffold in pediatric use has not been established. Consult the Galatea scaffold Instructions for Use for complete prescribing information; including its indications for use, warnings and precautions.

The information contained in this website is intended for U.S. Health Care Professionals. Patients, please refer to your physician for more information.