Five Published Articles Demonstrate Safety, Effectiveness, and Collagen
Stimulating Properties of Radiesse
SAN MATEO, Calif., June 26 /PRNewswire-FirstCall/ -- BioForm Medical, Inc. (Nasdaq: BFRM) today announced the publication of five studies in the June 2008 issue of the Journal of Dermatologic Surgery, a peer-reviewed publication of the American Society of Dermatologic Surgery. The five published clinical and preclinical reports were:
-- A 52-Month Summary of Results Using Calcium Hydroxylapatite for Facial Soft Tissue Augmentation - THOMAS L. TZIKAS, MD
-- An Investigation of Changes in Physical Properties of Injectable Calcium Hydroxylapatite in a Carrier Gel When Mixed with Lidocaine and with Lidocaine/Epinephrine - MARIANO BUSSO, MD, AND ROBERT VOIGTS, MS
-- Radiographic and Computed Tomographic Studies of Calcium Hydroxylapatite for Treatment of HIV-Associated Facial Lipoatrophy and Correction of Nasolabial Folds - ALASTAIR CARRUTHERS, MD, MARC LIEBESKIND, MD, JD, JEAN CARRUTHERS, MD, AND BRUCE B. FORSTER, MD
-- Calcium Hydroxylapatite Filler for Facial Rejuvenation: A Histologic and Immunohistochemical Analysis - ALEXANDER L. BERLIN, MD, MUSSARRATT HUSSAIN, MD, AND DAVID J. GOLDBERG, MD
-- Neocollagenesis after Injection of Calcium Hydroxylapatite Composition in a Canine Model - KYLE M. COLEMAN, MD, ROBERT VOIGTS, MS, DALE P. DEVORE, PHD, PAUL TERMIN, DVM, PHD, AND WILLIAM P. COLEMAN, III, MD
"These recent papers demonstrate safety with Radiesse(R) dermal filler in 1000 patients over 4 years, evidence the rigorous scientific work that our clinical advisors and scientists are doing, and show the significant collagen stimulating effects of Radiesse," commented Steven Basta, Chief Executive Officer of BioForm Medical. "With over 60 peer-reviewed publications in various prestigious journals, Radiesse dermal filler is one of the most rigorously studied materials in facial aesthetics. We thank the authors of these publications for sharing their results with the medical community."
A 52-Month Summary of Results Using Calcium Hydroxylapatite for Facial Soft Tissue Augmentation
This retrospective clinical review conducted by Thomas L. Tzikas, MD, documented the safety and effectiveness of Radiesse dermal filler in treatment of nasolabial folds, marionette lines, and other areas of the face. Over a 52 month period, from October 2002 to January 2007, Radiesse filler was injected in 1,000 patients (886 women and 114 men, ranging in age from 21 to 85 years) for a variety of facial aesthetic applications. The nasolabial folds were the most frequently treated site, followed by the marionette lines/oral commissures.
The clinical review found a high satisfaction rate with Radiesse dermal filler treatment, with most patients experiencing at least 80% persistence of effect at 1-year follow-up without retreatment, independent of the area of the face where treatment was received.
In conclusion, the author stated, "Radiesse was well tolerated over the
4 years of use described here. Adverse events were minor, and most resolved
without treatment. No product-related serious adverse events were reported.
Some patients experienced minor effects, such as redness, swelling,
itching, and bruising, which are commonly seen with any injectable
material, including collagen and hyaluronic acid."
The study abstract is available at http://www.blackwell-synergy.com/doi/abs/10.1111/j.1524-4725.2008.34237.x
An Investigation of Changes in Physical Properties of Injectable Calcium Hydroxylapatite in a Carrier Gel When Mixed with Lidocaine and with Lidocaine/Epinephrine
This study, led by a leading Dermatologist, Mariano Busso, MD, was intended to characterize the physical properties of Radiesse dermal filler when manually combined with lidocaine-HCL solutions via mixing syringes in order to determine if the addition of anesthetic agents to prefilled Radiesse syringes could provide sufficient anesthetic effect to warrant reduction of conventional pretreatment anesthetic procedures.
Through a multitude of laboratory tests the authors determined that the addition of lidocaine to Radiesse filler can be accomplished without adverse changes in physical properties of the original soft tissue filler. The authors noted that further studies are required to explore whether the addition of lidocaine to Radiesse improves patient comfort, or effects durability, and efficacy.
The paper reports that "The combination of lidocaine and [Radiesse]
intuitively suggests, as do anecdotal reports, that patient discomfort
levels will likely be reduced during injection of the product. One example
of the decrease in patient discomfort is the treatment of the hand with a
bolus of [Radiesse]. With the addition of lidocaine (and perhaps
epinephrine) to [Radiesse], physicians have increased flexibility in their
treatment techniques and sites of injection, and the benefits of decreased
The study abstract is available at http://www.blackwell-synergy.com/doi/abs/10.1111/j.1524-4725.2008.34238.x
Radiographic and Computed Tomographic Studies of Calcium Hydroxylapatite for Treatment of HIV-Associated Facial Lipoatrophy and Correction of Nasolabial Folds
In this open-label, single site study patients received Radiesse treatment for the correction of pronounced nasolabial folds or HIV-associated facial lipoatrophy. The treatments and the imaging were conducted by Drs Alastair and Jean Carruthers in Vancouver, British Columbia and the results were evaluated by two blinded evaluators in a private radiology center in New York, New York. Twenty-seven patients were imaged immediately after a 12-month touch up treatment for lipoatrophy. Twenty-three of these patients were also imaged a minimum of 12 months from their initial lipoatrophy treatment. An additional, previously untreated, 15 patients with lipoatrophy and 15 with nasolabial folds were treated with Radiesse and imaged before and immediately after treatment.
Through various radiographic and tomographic evaluations the authors concluded that "This study documents that CaHA does not obscure adjacent structures and would not confound the radiologist with a proper history of its use."
The study investigators added that "The persisting correction [with
Radiesse] is most likely due to the production of the patient's collagen
induced by the injection of [Radiesse], the latter of which has
subsequently disappeared. In other words, the long-term correction provided
by [Radiesse] is not due to the continued presence of the beads but to
The study abstract is available at http://www.blackwell-synergy.com/doi/abs/10.1111/j.1524-4725.2008.34247.x
Calcium Hydroxylapatite Filler for Facial Rejuvenation: A Histologic and Immunohistochemical Analysis
This study was conducted to characterize the expression of collagen, using a variety of staining methods, in patients treated with Radiesse. Five subjects were treated in their nasolabial fold and postauricular areas and six months following injection, the patients received biopsies of the postauricular injection area.
The authors were able to confirm the deposition of new collagen around -- and eventual infiltration into -- the filler microspheres and found that, although slightly irregular, the microspheres appear mostly preserved at six months following implantation, consistent with the previously documented long life of the filler material within biological tissue.
In conclusion, the authors established in a small-scale human histological study that "CaHA filler [Radiesse] stimulates new collagen deposition and infiltration around the injected material at six months, which likely contributes to the clinical improvement in the treated rhytids."
The study abstract is available at http://www.blackwell- synergy.com/doi/abs/10.1111/j.1524-4725.2008.34245.x
Neocollagenesis after Injection of Calcium Hydroxylapatite Composition in a Canine Model
This study of six subjects over a period of 4 to 78 weeks, conducted by BioForm Medical, was intended to quantitatively measure the increase in host collagen content in a canine model. The study utilized independent pathologists who were blinded to the time interval of the sample during interpretations.
This study demonstrated increased density of host collagen over time in
areas treated with Radiesse dermal filler. The authors concluded that
"Although more studies are needed to determine if similar results occur in
vivo in humans, injections of calcium hydroxylapatite led to endogenous
collagen production in a canine model. This is an important observation
because local tissue atrophy and aging facial folds are partially caused by
decreased collagen density and increased collagen fragmentation."
The study abstract is available at http://www.blackwell-synergy.com/doi/abs/10.1111/j.1524-4725.2008.34243.x
About BioForm Medical, Inc.:
BioForm Medical, Inc. is a medical aesthetics company headquartered in
San Mateo, California, developing products that enhance aesthetic
procedures performed in dermatology and plastic surgery practices. BioForm
Medical's lead product is Radiesse(R) dermal filler, a long-lasting filler
for use in facial aesthetics. BioForm Medical is developing several future
aesthetics products, including a radiofrequency treatment to reduce nerve
function in the forehead, a sclerotherapy treatment for spider veins, and a
surgical adhesive for brow lifts. For more information about BioForm,
please visit http://www.bioform.com.
Radiesse(R) is a registered trademark of BioForm Medical, Inc.
Vice President, Corporate Development
BioForm Medical, Inc.
|SOURCE BioForm Medical, Inc.|
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