NEW SURVEY REVEALS DEMAND FOR LONGER LASTING DERMAL FILLER OPTION

NEW SURVEY REVEALS DEMAND FOR LONGER LASTING DERMAL FILLER OPTION

Suneva Medical Provides Solution with 5-Year Results from Bellafill®

May 10, 2018 (San Diego, CA) – Suneva® Medical, Inc., parent company for Bellafill announces groundbreaking survey by The Harris Poll. Results reveal of the 9 million patients who have had dermal fillers1, an estimated 8 million are experiencing filler fatigue2. The findings called attention to this pharma phenomenon, with 58% of users noting frustration and hassle in scheduling regular appointments. More than two in three users also claimed that their fillers don’t last as long as they used to. By far, the top reason for not getting fillers as often as they would like is the cost of ongoing maintenance (56%).

91% of survey respondents universally agreed that a 5-year filler would be innovative and is important to them. An impressive 88% of respondents also shared that they thought a 5-year filler is unique. In fact, a filler that is longer lasting is the most commonly mentioned improvement users want.3

 

Overall, 9 in 10 users are interested in a 5-year filler that is FDA approved. Two-thirds of filler users also shared they would change providers if their current doctor did not have a 5 year option, but another did. In contrast, when current providers offered Bellafill, 88% of filler users said they would be likely to continue seeing their provider for other types of procedures they haven’t had done before.4

 

“We are thrilled with the results of our recent Harris Poll survey,” says Suneva Medical CEO Preston Romm. “The data is powerful, supporting our belief that Bellafill is the most unique and innovative filler the aesthetics industry has seen since its start. We are meeting the demand for those who are familiar with the feeling of ‘Needle Fatigue’ once and for all.”

 

Bellafill® is the only dermal filler on the market 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 21+. Bellafill® uses an innovative blend of 2 distinct components to create results that are both immediate and long lasting (80% collagen and 20% PMMA). Once injected, the collagen goes to work instantly, adding natural-looking volume to soften smile lines or acne scars. Over time, the body naturally metabolizes the collagen. The PMMA microspheres work as a scaffolding system, supporting the development of your own collagen and laying the foundation for long-term smoothness that lasts up to five years for cosmetic and one for acne.

 

Because efficacy and safety are number one to Suneva Medical, Bellafill® has five-year data from the largest and longest prospective dermal filler study ever conducted through the FDA.  The incredible results were no surprise – 87% of patients enrolled admitted to being in a committed relationship with Bellafill® and stayed on the study for all five years!5

 

Bellafill® is only available through licensed medical professionals. The list of providing physicians and additional information can be found at www.bellafill.com
About Suneva Medical, Inc.

Suneva Medical is a privately‐held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the 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 old. The company markets Bellafill® in the U.S., Canada, Hong Kong, Korea and Mexico. For more information, visit www.sunevamedical.com/old.

 

 


1) According to the 2017 U.S. Census Bureau Current Population Survey, there are 148.4 million U.S. adults ages 30-65. According to the survey conducted by The Harris Poll, 6.1% of U.S. adults ages 30-65 have used a dermal filler.

2) “Filler fatigue” is defined as those who selected strongly or somewhat agree for any of the following statements: If I could, I would get fillers more often; There are times that I’ve felt that my filler doesn’t last as long as it used to; Having to frequently get fillers gets in the way of me living my life the way I want to; I don’t get fillers as often as I would like; It is a hassle to find time to schedule a filler appointment; I have to frequently make appointments to get fillers.

3,4) The survey was conducted online by The Harris Poll on behalf of Suneva Medical and Vance & Associates within the United States between February 26 and March 14, 2018 among 503 U.S. adults ages 30-65 who have had dermal fillers in the past. Data were weighted where necessary to bring them into line with their actual proportions in the population.

5) Suneva Medical, Inc. Data on file.

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.

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.