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FDA Approves Radiesse® Facial Filler for Two New Aesthetic Indications

FDA Approves Radiesse® Facial Filler for Two New Aesthetic Indications

San Mateo, CA- December 27, 2006. BioForm Medical, Inc., a privately – held medical aesthetics company today announced that the U.S. Food and Drug Administration (FDA) approved Radiesse®, the next- generation cosmetic dermal filler, for the long – lasting  correction of moderate to severe facial wrinkles and fold such as nasolabial fords. Radiesse® also received a second FDA approval for the long- lasting correction of facial fat loss (lipotrophy) in people with human immunodeficiency virus (HIV).

Radiesse® is the first filler with advanced calcium- based mircrosphere technology that not only provides volume replacement to wrinkles, folds and sunken depressions but also stimulates the body to produce new collagen; this unique action restores the fullness and contours of a youthful, health appearance with sustained results that last an average of one year or more.

“Today’s FDA approval of Radiesse® for use in facial aesthetic applications confirms our rigorous clinical findings that Radiesse® is safe and effective for long – term facial aesthetic enhancement,” said Steven L. Basta, President and Chief Executive Officer of BioForm. With it advanced calcium – based microsphere technology, Radiesse® is the first facial cosmetic filler with a proven 12-month benefit in multiple clinical studies. Accordingly, Radiesse® is raising the bar to become the new standard for the treatment of facial wrinkles and folds such as nasolabial folds.”

Radiesse® is composed of calcium hydroxylapatite microspheres in a water – based gel carrier. Radiesse® provides immediate improvement so a patient looks better the moment the product is injected. The calcium microsphere technology also enables the body to generate new collagen, providing a longer lasting effect than other available fillers. Further, because Radiesse® is robust, full – bodied material, it provides physicians a superior level of control, predictability and finesse for facial applications.

“The approval of Radiesse® ushers in a new era in the non-surgical management of facial aging because it both ‘volumizes’ facial folds and rebuilds the skin’s foundation to restores a youthful facial appearance for out patient,” said Lawrence Bass, M.D., Clinical Assistant Professor of Plastic Surgery; Director, Minimally Invasive Plastic Surgery Program, New York University Medical Center, New York, NY, and investigators for Radiesse® pivotal trials. “Our findings form the pivotal clinical trial and those of a separate clinical study comparing the long – term efficacy of Radiesse® with the leading hyaluronic acid product demonstrate clear advantages that make Radiesse® the preferred treatment option for the correction of nasolabial folds.”

FDA approval of Radiesse® for treatment of facial wrinkles and folds was based on the results of the pivotal clinical trial supporting Radiesse®’s safety and effectiveness.

About the Nasolabial Fold Study

In the pivotal study, conducted at four medical centers in the United States, 117 patients with nasolabial folds were treated with Radiesse® on one side of the face and a control agent (Cosmoplast, a human collagen product) on the other. Results based on rating of three blinded evaluators showed that six months after treatment, Radiesse® was more effective than the control on every comparative efficacy outcome (p< 0.0001).

Key clinical findings include:

  • 82 percent of nasolabial folds treated with Radiesse® showed improvement after six months. This was significantly higher than the control which showed improvement in only 27 percent of treated folds (p<0.0001).
  • After six months, the fold treated with Radiesse® was more improved in 79 percent of patients compared to the control treated fold. The folds treated with the control rated more improved only 5 percent of patients.
  • The nasolabial folds treated with Radiesse® required approximately half as much volume (1.22cc) than the folds treated with the control. (2.35cc).
  • Both products were safe and well tolerated, with no serious adverse events reported. In the 117 patients treated, Radiesse® had zero granulomas and the same low rate of nodules as the control.

About Radiesse®:

Radiesse® is longer- lasting injectable dermal filler used in many cosmetics, reconstructive and therapeutic applications to augment soft tissue, such as facial wrinkles, fold and contours. Composed of calcium hydroxylapatie (CaHA) microspheres suspended in an aqueous gel, FDA- approved Radiesse® both fill and stimulates the body to produce new collage for immediate results that last about on year or more. As such, next generation Radiesse® is setting a new standard for the correction of nasolabial folds. Manufactured and distributed by BioForm Medical, Inc., Radiesse® has been proven safe and effective in hundreds of thousands of procedures worldwide. For more information about Radiesse®, please visit

 About BioForm Medical, Inc.:

BioForm Medical, Inc. is a privately- held medical aesthetics company headquarterd in San Mateo, California. BioForm is dedicated to bringing doctors and their patients safe and effective products for sue in the dermatology, ENT, and plastic surgery markets. BioForm’s products include Radiesse, the first 12 month filler for use in facial aesthetic and vocal fold insufficiency; Cutanix for facial associated with conditions such as rosacea; a new surgical adhesive product for plastic surgery applications being developed in the partnership with CryoLife, Inc.: and Coaptite for treating female stress urinary incontinence (“SUI”) which marketed through a partnership with Boston Scientific Corporation. For more information about BioForm, please visit

EDITOR’S NOTE:  B- Roll videotape, including animation of how Radiesse® works, treatment footage, before, and after visuals, is available upon request.

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