Suneva Medical Acquires Product Portfolio from Spear Pharmaceuticals

Suneva Medical Acquires Product Portfolio from Spear Pharmaceuticals

Refissa Leads Suneva into the Topical Aesthetic Market

SAN DIEGO, CA – May 21, 2012 – Suneva Medical, a privately-held aesthetics company, today announced that it has acquired an aesthetic product portfolio from Spear Pharmaceuticals (“Spear”). Under the terms of the agreement, Suneva will acquire worldwide rights to Refissa® and its marketed generic equivalent. The portfolio contains the only tretinoin creams with a .05% strength, emollient base and broad indication for fine facial lines, hyperpigmentation and tactile roughness. Financial terms were not disclosed.

Nick Teti, Chairman and Chief Executive Officer of Suneva Medical commented, “This acquisition is very significant for Suneva on several levels. We are entering the prescription topical aesthetic market, a potential $100 million market opportunity, with a unique basket of products including Refissa®, which has the strength, formulation and a broad indication unlike any other tretinoin cream on the market today. This deal also allows us to offer aesthetic physicians a comprehensive anti-aging solution, which includes our ReGenicaTM skincare line, Refissa®, the gold standard topical treatment for fine lines and hyperpigmentation and our novel injectable filler, Artefill®. We have consistently looked to provide highly differentiated products that deliver high patient satisfaction and represent excellent business opportunities for our physician partners and believe we have accomplished that with our expanded portfolio of products. This acquisition promises to be a transformational event for the Company.”

Spear developed and received approval for a generic tretinoin cream as an ANDA to Renova .05% in 2005. Refissa® is a new formulation of tretinoin, a derivative of vitamin A that contains the same active and inactive ingredients as Renova .05%. The product has been proven in a clinical trial to be effective in the treatment of fine facial wrinkles, tactile roughness of the skin, as well as irregular pigmentation from the sun. It was approved by the FDA in 2008 and is the only .05% prescription-strength, fragrance-free, emollient-based tretinoin cream available on the market today. Refissa® is formulated in a moisturizing base and is an ideal option for mature patients with drier, more sensitive photo damaged skin.

Important Safety Information: Refissa 0.05% is a prescription medicine that may reduce fine facial wrinkles and mottled hyperpigmentation in patients who also protect their skin from the sun and wear sunscreen daily. Refissa does not eliminate wrinkles, repair sun damaged skin or reverse photo-aging. Avoid medicines that may increase your sensitivity to sunlight, ask your pharmacist. Do not use if you are pregnant, attempting pregnancy, or nursing. Refissa, early in treatment, may cause redness, itching, burning, stinging and peeling. Please see Full Prescribing Information at

About Suneva Medical

Suneva Medical, Inc. is a privately-held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the dermatology, plastic and cosmetic surgery markets. The Company currently markets Artefill® and ReGenica™ Skincare in the U.S. and Bellafill™ in Canada. For more information visit

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Media Contacts:

Kate Gilbert
Vice President, Marketing
Phone: (858) 550-9999 x7844
Kellie Walsh
Phone: (914) 315-6072




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.

This product is certified as a medical device in the European Union under the Medical Device Directive 93/42/EEC by SGS CE0120, exclusively for the indication of autologous fat transfer. Other non-medical uses ascribed to this device such as aesthetic body contouring are not within the scope of CE certification, and users should be aware product performance and/or safety has not been evaluated by SGS for those purposes.

Suneva Medical HD PRP
REGULATORY STATUS: FDA-cleared 510(k) Class II medical device. Healeon HD PRP is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of peripheral blood at the patient point of care. The PRP is mixed with autograft and/orallograft bone prior to application to a bony defect for improving handling characteristics. 510(k) number: BK170136

Silhouette Instalift
Silhouette lnstaLift® is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub-dermis in an elevated position.

The Silhouette InstaLift device should not be used in patients with any known allergy or foreign body sensitivities to plastic/ biomaterial or in situations where internal fixation is otherwise contraindicated, (e.g. infection.) The device should also not be used in patients appearing to have very thin soft tissue of the face in which the implant may be visible or palpable.

Like all procedures of this type there is a possibility of adverse events, although not everybody experiences them. These adverse events include but are not limited to infection, minimal acute inflammatory tissue reaction, pain (which may be temporary or persistent in nature), swelling and edema, transient hematoma or bruising and transient rippling or dimple formation. For further safety or product information, please consult your physician.

For more safety information, please consult with your physician and the patient labeling that can be found by visiting our website
Toll-free call (U.S. & Canada): 844-Bellafill (844-235-5234).
Local calls: 858-550-9999. International calls: ++ 858-550-9999.