Radiesse(R) Dermal Filler Featured Prominently in Journal of Dermatologic Surgery Special Issue on Fillers
June 26 2008 - 8:32AM
PR Newswire (US)
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 patient
discomfort." 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 induced fibroplasias." 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.
Contact: Adam Gridley 650.286.4025 Vice President, Corporate
Development BioForm Medical, Inc. DATASOURCE: BioForm Medical, Inc.
CONTACT: Adam Gridley, Vice President, Corporate Development of
BioForm Medical, Inc., +1-650-286-4025 Web site:
http://www.bioformmedical.com/
Copyright
Bioform Medical (MM) (NASDAQ:BFRM)
Historical Stock Chart
From Jun 2024 to Jul 2024
Bioform Medical (MM) (NASDAQ:BFRM)
Historical Stock Chart
From Jul 2023 to Jul 2024