Privacy Policy

Collection of Information from Website Visitors

We may collect and/or track the following information: (a) the Internet Protocol addresses for system administration and auditing site usage; (b) home server domain names, e-mail addresses, type of client computer, and type of Web browser of visitors to this Website, (c) the e-mail addresses of visitors that communicate with us via e-mail, (d) user-specific information on what pages visitors access; and (e) any other information you provide to us through the Website.

We may also use Internet cookies and other types of clickstream data on visitors’ hard drives. Internet cookies save, among other things, the visitor’s name, password, user-name, screen preferences, the pages of the Website viewed by the visitor, and the advertisements viewed or clicked by the visitor. Internet cookies are stored on the visitor’s hard drive and are not stored, in any form, by us. Visitors may decline the Internet cookies by using the appropriate feature of their Web client software, if available.

Use and Disclosure of Personal Information

Personal data, including, but not limited to, your name, address, email address and telephone number (“Personal Information”), that is collected by us will not be shared with third parties in a personally-identifiable form but may be used by us for purposes including, but not limited to, to protect our rights, property or to enforce the terms and conditions of this Website, to comply with laws, regulations, court orders or other legal processes, to contact you or otherwise respond to your request/inquiries, for editorial and feedback purposes, for marketing and promotional purposes, for a statistical analysis of user behavior, for product development, for content improvement, to inform advertisers as to how many visitors have seen or clicked on their advertisements, and to customize content and layout of our Website. In addition, Personal Information collected may be added to our databases and used for future calls and mailings regarding Website updates, new products and services and other announcements. We may transfer your Personal Information to the subsidiaries, divisions, affiliates or other entities under common ownership with us. We will not sell, exchange or publish your personal information without your permission, except as noted above or in conjunction with a corporate sale, merger, dissolution, acquisition, or other similar event. You also agree that we may share your Personal Information with others who help us with these activities.

Use and Disclosure of Anonymous Information

All information that is not personal to you or someone else, including, but not limited to, questions, comments, ideas and suggestions (“Anonymous Information”) shall be deemed non-confidential information and owned by us. We will not obtain your consent before posting collected data on our Website, or sharing, renting, selling, or otherwise disclosing Anonymous Information to third parties. We shall be free to disclose and use the Anonymous Information for any purpose and through any means without any obligations whatsoever to you. Further, we are free to use any ideas, inventions, concepts, know-how or techniques provided or submitted to us for any purpose whatsoever, including, but not limited to, developing, manufacturing and marketing new products and services.

Opt-Out

Visitors may opt out of having their Personal Information collected, used, or disclosed by us by contacting us. We can be contacted by e-mail at info@sunevamedical.com.

Access to and Ability to Correct Personal Data

Upon request via e-mail we will provide to visitors a summary of any Personal Information retained by us. Visitors may modify, correct, change, or update their personal record or cause their personal record to be removed from our database. We will only send personal records to the e-mail address on file for the visitor name associated with it.

Collection of Personal Data from Children

Our Website is not intended for or marketed to persons under the age of 18. We do not collect or post information from children under the age of 13 (“children”) unless done so with the authorization of a parent or guardian. We do not and will not provide any personally identifying information collected from children, regardless of its source, to any third party for any purpose whatsoever. In the event a child submits information to our Website and we become aware of it, the child’s parent or guardian will receive an e-mail alerting them to the child’s registration and providing instructions on how the parent could delete the child’s registration, if so desired. No information collected from children is used for any marketing or promotional purposes whatsoever.

Our Right to Contact User

We reserve the right to contact Website visitors regarding this privacy policy, or any other terms and conditions, policies or agreements relevant to this Website.

Our Right to Change Privacy Policy

We reserve the right to change this policy at any time with or without notice. It is your responsibility to check back to this Website to review revisions and changes to this privacy policy. Specifically, we encourage you to review this privacy policy each and every time you visit the Website.

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Important Safety Information

Bellafill® is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years. Patients who have had a positive reaction to the Bellafill® Skin Test, have a history of severe allergies, have known bovine collagen allergies, are allergic to lidocaine, have bleeding disorders or are prone to thick scar formation and/or excessive scarring should not receive Bellafill®. The safety of Bellafill® for use during pregnancy, breastfeeding, or in patients under 21 has not been established. You may experience temporary swelling, redness, pain, bruising, lumps/bumps, itching, and discoloration at the treatment site. These side effects are usually transient and typically resolve within 1–7 days. You may experience lumps/bumps/papules that may occur more than one month after injection and that may persist. Less common side effects include rash and itching more than 48 hours after treatment, persistent swelling or redness, lumps/bumps, acne, and increased sensitivity at treatment sites. Infrequently, granulomas may occur and may be treated by your licensed physician provider. Be sure to call your licensed provider immediately if you notice any unusual skin reactions around the treatment area. Based on the 5-year Post-Approval Study on nasolabial folds with 1,008 patients, long-term safety of Bellafill® for up to 5 years has been established.

References

1. Gottfried Lemperle, et. al., ArteFill® Permanent Injectable for Soft Tissue Augmentation: I. Mechanism of Action and Injection Techniques., Aesthetic Plast Surg. 2010 Jun;34(3):264–72. 2. Bellafill® [Instructions for Use]. San Diego, CA: Suneva Medical, Inc.; 2015. 3. Jacob CI, Dover JS, Kaminer MS. Acne scarring: A classification system and review of treatment options. J Am Acad Dermatol; July 2001; 109-117. 4. Data on file. Suneva Medical, Inc. 5. Haneke et al. Polymethyl Methacrylate Microspheres in Collagen. Semin Cutan Med Surg 23:227-232,2004. 6. Cohen et al. Artecoll: A Long-Lasting Injectable Wrinkle Filler Material: Report of a Controlled, Randomized, Multicenter Clinical Trial of 251 Subjects. Plast. Reconstr. Surg. 114: 964,2004. 7. American Academy of Dermatology, http://www.aad.org/media-resources/stats-and-facts/conditions/acne#.Uc2hG_nvt8F. 8. Journal of Plastic, Reconstructive and Aesthetic Surgery, 2008, http://www.sciencedirect.com/science/article/pii/S1748681508003951. 9. Formula PR Independent Study, 2013. 10. Suneva Medical AAD Advisory Board, August 2015, data on file. 11. Keep in mind each patient is unique and your results may vary. 12. Cohen et al. Five-Year Safety and Satisfaction Study of PMMA-Collagen in the Correction of Nasolabial Folds. Dermatol Surg. 2015 Dec;41 Suppl 1:S302-13. 13. Karnik et al. A double-blind, randomized, controlled trial of suspended polymethylmethacrylate microspheres for the correction of atrophic facial acne scars. J Am Acad Dermatol. 2014 Jul;71(1):77-83.

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