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March 27, 2015 7:02 PM ET

Healthcare Equipment and Supplies

Company Overview of Suneva Medical, Inc.

Company Overview

Suneva Medical, Inc. develops, manufactures, and commercializes aesthetic products for dermatology, plastic, and cosmetic surgery markets in the United States and Canada. It offers Artefill and Bellafill, which are dermal fillers for the correction of wrinkles; and ReGenica Skincare, an anti-aging rejuvenation system. The company’s products are used in various applications, including acne scar correction, malar augmentation, HIV and age related lipoatrophy, rhinoplasty revision, nasal defects, and other reconstructive and cosmetic surgeries. In addition, it produces commercial cGMP grade bovine collagen. Suneva Medical, Inc. was founded in 2008 and is based in San Diego, California.

5870 Pacific Center Boulevard

San Diego, CA 92121

United States

Founded in 2008

Phone:

858-550-9999

Fax:

858-550-9997

Key Executives for Suneva Medical, Inc.

Chairman of the Board and Chief Executive Officer
Age: 61
Chief Financial Officer
Age: 57
Executive Vice President
Age: 52
Chief Medical Officer
General Counsel
Age: 63
Compensation as of Fiscal Year 2014.

Suneva Medical, Inc. Key Developments

Suneva Medical Introduces Regenica® Recovery Gel

Suneva Medical, Inc. announced the introduction and availability of Regenica® Recovery Gel, a new addition to the Regenica® skin care system. Regenica® Recovery Gel is a soothing balm that is specially formulated to help quickly heal damaged skin. It infuses Multipotent Resignaling Complex (MRCx™) next generation growth factor technology with well-recognized and trusted natural anti-inflammatory and calming agents, arnica, vitamin K, aloe vera, beta-glucan and SymCalmin®, to help in the overall appearance of compromised skin. Regenica® Recovery Gel is part of the popular Regenica® product line that includes Regenica® Renew SPF 15, Regenica® Replenishing Crème and Regenica® Repair Complex.

Suneva Medical, Inc. Presents at Leerink's Global Healthcare Conference, Feb-12-2015 10:20 AM

Suneva Medical, Inc. Presents at Leerink's Global Healthcare Conference, Feb-12-2015 10:20 AM. Venue: Waldorf Astoria New York, New York, New York, United States. Speakers: Nicholas L. Teti, Chairman of the Board and Chief Executive Officer.

Suneva Medical, Inc. Receives FDA Approval for Bellafil for the Treatment of Acne Scars

Suneva Medical, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the dermal filler, Bellafill, for the treatment of acne scars. Bellafill represents clinical advancement as the only filler on the market approved for this disfiguring skin condition. Bellafill was studied extensively prior to its FDA approval and proven to be safe and effective for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years. FDA approval of Bellafill was based on the outcomes of a double-blinded, randomized, placebo-controlled pivotal study in which subjects were treated with Bellafill at 10 U.S. clinical centers. Bellafill was found to be a safe and effective treatment when compared to subjects treated with a Control saline injection. The study required a high threshold for success in which the primary effectiveness endpoint was proven superior for subjects treated with Bellafill compared to Control at 6 months. A responder was defined as a subject who had 50% or more of treated acne scars improve by two or more points on a validated 4-point Acne Scar Rating Scale (ASRS). At 6 months, the response rate for Bellafill was 64% vs. 33% for Control (p=0.0005). Bellafill continued to show effectiveness by an unblinded assessment at 12 months (71%). Secondary effectiveness endpoints were evaluated, where both investigators and subjects were asked to evaluate appearance on a Global Aesthetic Improvement Scale that was blinded through 6 months and unblinded at 12 months. Both groups rated appearance as improved, reaching statistical significance at every timepoint after the touch-up period (at week 4) through 6 months. On the Physician Global Aesthetic Improvement Scale (PGAIS) 84% of subjects were rated as improved at 6 months and 98% were improved at 12 months by an unblinded assessment. On the Subject Global Aesthetic Improvement Scale (SGAIS), 77% of subjects rated their appearance as improved at 6 months and 83% rated their appearance as improved at 12 months. In addition, subjects were asked to rate their level of satisfaction with acne scar correction treatment on a Subject Assessment of Scar Correction scale (SASC). At 6 months (blinded), 84% of subjects were satisfied while 90% were satisfied at 12 months (unblinded).

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