SUNEVA MEDICAL CLOSES $25 MILLION FINANCING TO SUPPORT CONTINUED GROWTH OPPORTUNITIES

  • Financing includes $25 million equity investment from Essex Woodlands
  • Growth equity firm’s healthcare expertise key to further elevate Suneva Medical as an innovative aesthetics leader

San Diego, CA (June 14, 2016)—Suneva Medical, Inc., a privately-held and innovative aesthetics leader, today announced the closing of a $25 million investment by Essex Woodlands. This financing strengthens Suneva Medical’s rapid revenue growth and further supports the ongoing commercialization of the company’s flagship products, Bellafill® and Regenica®.

Bellafill® is the only FDA approved dermal filler for the treatment of nasolabial folds, or smile lines, with five-year data for safety, effectiveness and patient satisfaction. It is also the only FDA approved dermal filler for the treatment of facial acne scars, representing a significant clinical advancement for a skin condition that previously had limited treatment choices. The Regenica® skin care line is formulated with the most advanced growth factor technology to enhance skin’s natural repair and renewal mechanisms.

“The expansion of the aesthetics market continues to grow across the United States. With two differentiated indications for Bellafill® and a next generation growth factor product in Regenica®, Suneva Medical is uniquely positioned to be a standout in the aesthetics industry,” said Nicholas L. Teti, Jr., Chairman and Chief Executive Officer at Suneva Medical. “The additional funding from Essex Woodlands fortifies our position and allows us to further accelerate the strong momentum of the business which remains committed to product innovation backed by rigorous scientific data.”

Martin Sutter, Managing Director and Co-Founder of Essex Woodlands, also commented on the investment: “We are pleased to be supporting Nick Teti and the management team as they continue the successful growth trajectories of Bellafill® and Regenica®.  Suneva’s differentiated products are uniquely situated to take advantage of the tailwinds in the aesthetics market. We are excited to be a part of the growth of the company.”

In conjunction with the investment, Essex Woodlands will receive one seat on Suneva Medical’s board of directors and an independent seat will also be appointed. In addition to Essex Woodlands, other major equity shareholders include HealthCare Royalty Partners, Almirall, S.A. and Polaris Partners.

Leerink Partners LLC acted as the exclusive placement agent to the company for the offering.

For more information on Suneva Medical, visit www.sunevamedical.com/old.

About Essex Woodlands

With $2.5 billion under management, Essex Woodlands is one of the largest and oldest growth equity firms pursuing investments in pharmaceuticals, medical devices, healthcare services and healthcare information technology. Since its founding in 1985, Essex Woodlands has maintained its singular commitment to the healthcare industry and has been involved in the founding, investing and/or management of over 150 healthcare companies, ranging across sectors, stages and geographies. The team is comprised of over 20 senior investment professionals with offices in Palo Alto, Houston, New York and London. For more information, please see www.ewhv.com.

About Suneva Medical, Inc.

Suneva Medical is a privately-held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the general dermatology and aesthetic markets. The innovative aesthetics leader markets Bellafill®, the only dermal filler on the market that is approved by the U.S. Food and Drug Administration 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. The company markets Bellafill® in the U.S., Canada and Hong Kong; ArteFill® in South Korea; Regenica® skin care in the U.S., Canada and Hong Kong; and ReFissa® tretinoin cream in the U.S. ArteFill® was rebranded to Bellafill® in the U.S. to reflect the transformational outcomes this unique product can provide to patients seeking correction of their acne scars and nasolabial folds. For more information, visit www.sunevamedical.com/old.

Important Safety Information

Bellafill®
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.

PUREGRAFT
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.

IMPORTANT SAFETY CONSIDERATIONS
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 www.bellafill.com.
Toll-free call (U.S. & Canada): 844-Bellafill (844-235-5234).
Local calls: 858-550-9999. International calls: ++ 858-550-9999.