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BIOSTIMULATOR

THE ONLY FDA APPROVED 5-YEAR FILLER THAT STIMULATES PATIENT’S OWN NATURAL COLLAGEN.

ABSORBABLE
SUTURE

THE FIRST ABSORBABLE SUTURE THAT’S FDA CLEARED FOR COSMETIC FACIAL PROCEDURES.

PLASMA IQ™

THE FIRST FDA CLASS II HANDHELD PLASMA DEVICE

PLASMA ENERGY
DEVICE

COMPREHENSIVE SKIN REJUVENATION

SKIN REJUVENATION
DEVICE

COMPREHENSIVE SKIN REJUVENATION

PLATELET
RICH PLASMA

A PLATFORM TO PROCESS AND CAPTURE OPTIMAL PLATELET CONCENTRATES.

FAT GRAFTING

THE MOST PREDICTABLE FAT GRAFT ON THE MARKET.

WHAT’S HAPPENING AT SUNEVA MEDICAL

Recent News

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Feb 16

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So great to spend time with these teams sharing our knowledge and enhancing patient outcomes: @define_maximumwellnessmd and @strellaaesthetics! #sunevamedical #bellafill #plasmaiq #instalift

So great to spend time with these teams sharing our knowledge and enhancing patient outcomes: @define_maximumwellnessmd and @strellaaesthetics!

#sunevamedical #bellafill #plasmaiq #instalift ...

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Feb 14

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Fresh off of our National Sales Meeting Week and celebrating our 1 millionth Bellafill syringe shipped! Starting the week off like… #sunevamedical #nextgenreg #positivevibes

Fresh off of our National Sales Meeting Week and celebrating our 1 millionth Bellafill syringe shipped! Starting the week off like…

#sunevamedical #nextgenreg #positivevibes ...

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Feb 9

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We’re celebrating a major milestone here at Suneva—as of the close of 2021, we’ve shipped more than a million syringes of Bellafill! Our CEO, Pat Altavilla, put this milestone in perspective of the volume of patients that Bellafill has helped: “The distribution of Bellafill's millionth syringe is an extraordinary milestone for believers like myself at Suneva, but what's more important to us is the improvement in self-image for the countless patients who have benefited from this product. Bellafill's popularity has grown in recent years, as there are a growing number of patients who are looking for longer-term replacements to shorter-acting fillers, which typically last roughly one to two years.” With Bellafill being the only FDA-approved 5 year filler, this exciting and energizing milestone has us even more focused on the next million syringes ahead as demand for biostimulators and regenerative aesthetics continues to climb. Read the full release @ https://bit.ly/1Msyringes #1millionsyringes #bellafill #sunevamedical

We’re celebrating a major milestone here at Suneva—as of the close of 2021, we’ve shipped more than a million syringes of Bellafill! Our CEO, Pat Altavilla, put this milestone in perspective of the volume of patients that Bellafill has helped:

“The distribution of Bellafill's millionth syringe is an extraordinary milestone for believers like myself at Suneva, but what's more important to us is the improvement in self-image for the countless patients who have benefited from this product. Bellafill's popularity has grown in recent years, as there are a growing number of patients who are looking for longer-term replacements to shorter-acting fillers, which typically last roughly one to two years.”

With Bellafill being the only FDA-approved 5 year filler, this exciting and energizing milestone has us even more focused on the next million syringes ahead as demand for biostimulators and regenerative aesthetics continues to climb.

Read the full release @ https://bit.ly/1Msyringes

#1millionsyringes #bellafill #sunevamedical ...

sunevamedical

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Jan 31

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We are excited to announce that the U.S. Food and Drug Administration (FDA) accepted updates to the Plasma IQ™ label, including the removal of the product's eye contraindication. This label update allows Suneva to address treatment around the eye with patients in the United States. "On the heels of our announcement of the planned merger with Viveon Health Acquisition Corp. to build on our leadership in the regenerative aesthetics sector, we are pleased with the FDA's decision to update the Plasma IQ label," said Pat Altavilla, Chief Executive Officer of Suneva. "We believe Suneva's innovations have always been led by science and I look forward to working with our partner Neauvia to provide access of our Plasma IQ device to a larger patient population looking to improve their aesthetics through a focused energy treatment." Read the full announcement at https://www.sunevamedical.com/fda-accepts-label-update-for-plasma-iq-the-first-fda-cleared-handheld-plasma-energy-device/ #plasmaiq #fdaclassIIcleared #nextgenregen #sunevamedical #plasmaiqrejuvenation #plasmaiqtightening #plasmaiqtreatment #plasmafibroblast

We are excited to announce that the U.S. Food and Drug Administration (FDA) accepted updates to the Plasma IQ™ label, including the removal of the product's eye contraindication. This label update allows Suneva to address treatment around the eye with patients in the United States.

"On the heels of our announcement of the planned merger with Viveon Health Acquisition Corp. to build on our leadership in the regenerative aesthetics sector, we are pleased with the FDA's decision to update the Plasma IQ label," said Pat Altavilla, Chief Executive Officer of Suneva. "We believe Suneva's innovations have always been led by science and I look forward to working with our partner Neauvia to provide access of our Plasma IQ device to a larger patient population looking to improve their aesthetics through a focused energy treatment."

Read the full announcement at https://www.sunevamedical.com/fda-accepts-label-update-for-plasma-iq-the-first-fda-cleared-handheld-plasma-energy-device/

#plasmaiq #fdaclassIIcleared #nextgenregen #sunevamedical #plasmaiqrejuvenation #plasmaiqtightening #plasmaiqtreatment #plasmafibroblast ...

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Upcoming Events

Thu 25

AES – Aesthetic Extender Symposium

August 25 - August 28
Oct 06

ASDS

October 6 - October 9
Oct 28

ISPAN

October 28 - October 31
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New Frontiers in Cosmetic Medicine Symposium

November 19 - November 20

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FOR FURTHER INFORMATION

Please use this form to contact Suneva Medical for:

MEDIA INQUIRIES

For press inquiries, please contact at Cammy.Duong@westwicke.com

MEDICAL AFFAIRS INFORMATION


To request medical information, please complete this electronic form: Medical Information Request

Note: Requests are not valid without practitioner’s e-signature.

PRODUCTS

We strive to ensure a positive experience for patients and practice partners and are continuously committed to providing ongoing support programs and special promotions. Call us at (858) 550-9999.

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.