Terms of Use

Welcome to the Galatea Surgical website. As a wholly owned subsidiary of Tepha, Inc., this website, is the property of Tepha, Inc. Your visit and use of this website will be governed by these Terms of Use. We invite you to use the content for your personal use, and your visit and use of this website constitute acceptance of these Terms of Use.

1. Website

This website is offered to provide information about Galatea Surgical’s products and business. Neither Galatea Surgical nor Tepha practice medicine or provide medical services or advice, and you should not construe information on this website as medical advice. Please consult your healthcare professionals for medical advice and other advisors as appropriate for legal, investment or other advice.

2. Intellectual Property Rights in the Galatea Surgical  Website and Content

All content on the Galatea Surgical website is the property of Tepha or its licensors, or is used with the owner’s permission by Tepha, and is protected by United States and international copyrights and other laws. You may download or print limited content for your personal, noncommercial use, so long as you retain all associated copyright, trademark and other proprietary notices. As a wholly owned subsidiary of Tepha, Inc., this website, is the property of Tepha, Inc. Galatea®, Galatea scaffold®, GalaFLEX®, GalaSHAPE®, GalaFORM®, Tepha®, TephaFLEX®, and the Tepha logo are trademarks of Tepha, Inc.

3. Links

Our website may contain links to other websites. Neither Tepha nor Galatea Surgical assume  any responsibility for the content or terms of use of other websites and encourages you to read the terms of use of any linked sites.

4. Disclaimer

To the maximum extent permitted by law, the Galatea Surgical website and content are provided “as is” and “as available,” without warranties of any kind, express or implied. Galatea Surgical does not warrant the accuracy, completeness, currency or reliability of content available through this website, or that access to this website will be uninterrupted or error-free.

5. Privacy Policy

View our Privacy Policy.

6. Digital Millennium Copyright Act Notice

If you believe that your work has been copied and is accessible at this website in a way that constitutes copyright infringement, or that this website contains links or other references to another online location that contains material infringing your copyrights, you may notify us by providing our copyright agent the information required by the U.S. Online Copyright Infringement Liability Limitation Act of the U.S. Digital Millennium Copyright Act, 17 U.S.C. §512.

Our agent for notice of claims of copyright infringement relating to this website can be reached at: contact@galateasurgical.com. These Terms of Use were last revised October 21, 2008. Galatea Surgical may revise these Terms of Use or website content from time to time, and we encourage visitors to review the Terms of Use when visiting this website. The Terms of Use in effect at the time of a visitor’s use of our website will apply.

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 Galatea scaffolds, 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.

Important Safety Information

Possible complications following implantation of Galatea scaffolds 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 scaffolds 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 scaffolds in neural tissue and in cardiovascular tissue has not been established. The safety and effectiveness of Galatea scaffolds in pediatric use has not been established. Consult the specific Galatea scaffold Instructions for Use for complete prescribing information, including its indications for use, warnings and precautions.