BioForm Medical Acquires Facial Aesthetic Nerve Ablation Technology
April 30 2008 - 8:50AM
PR Newswire (US)
Technology designed to selectively weaken specific muscles may
provide an attractive alternative treatment for frown lines SAN
MATEO, Calif., April 30 /PRNewswire-FirstCall/ -- BioForm Medical,
Inc. (NASDAQ:BFRM) announced that it has acquired substantially all
of the assets of privately-held, Denver, CO based, Advanced
Cosmetic Intervention, Inc. (ACI) and associated technology rights
for $12 million cash, plus future royalties and a potential
sales-related milestone. This acquisition provides BioForm Medical,
a leading medical aesthetics company, with a commercially-
available technology for local nerve ablation. ACI's device,
sometimes also referred to as the GFX device in prior media
reports, is currently cleared via a 510(k) by FDA to create RF heat
lesions in nerve tissue. The ACI device uses minimally-invasive
bi-polar radiofrequency energy selectively to weaken nerve signal
transduction with durable effects. The use of this technology on
nerves that control the muscles of the forehead may reduce the
appearance of frown lines, or glabellar furrows. BioForm Medical
expects to conduct clinical studies specifically intended to
support an FDA application seeking clearance to market this product
for the treatment of frown lines. The Company expects to also seek
a CE mark and certain other international registrations of the ACI
device for aesthetics indications. "We are building a leading
medical aesthetics company. We believe this new treatment will
offer patients an attractive alternative therapy for the treatment
of frown lines. Many patients in our consumer research surveys have
indicated that they choose not to receive neurotoxin treatment due
to fear of losing facial expressions, or fear of injections with a
toxin," stated Steven Basta, CEO of BioForm Medical. "We believe
that the synergy of this product with our Radiesse dermal filler
will be terrific. We have a differentiated, long-lasting filler,
and in the coming years we hope to offer physicians a new treatment
option for frown lines. This is part of our commitment to
partnering with physicians to offer them improved aesthetic
treatment options that can grow their practices. This device could
appeal to many of the same physicians who select Radiesse dermal
filler for their patients, and will leverage our existing sales and
marketing organization." In the acquisition of ACI, BioForm Medical
will hire several of ACI's employees, and retain others as
consultants to maintain continuity of this program and to
accelerate future product development and commercialization
activities. In addition to the up-front consideration, BioForm
Medical will pay a single-digit royalty to ACI. The Company
anticipates that significant positive revenue impact of this
acquisition is not likely until it obtains clearance for the
product for aesthetic applications, anticipated to occur in
calendar year 2009. BioForm Medical will discuss this transaction
further on Thursday, May 1, 2008, when it reports its financial
results for the quarter ended March 31, 2008, and holds a
conference call with investors at 2:00 p.m. Pacific Time (5:00 p.m.
Eastern Time). About the ACI Device & the Market for Treatment
of Frown Lines: The ACI device provides a minimally invasive
technique for creating a focal lesion inhibiting the function of
the target nerve. The product is comprised of a RF energy generator
box, approximately the size of a small monitor, a sterile handheld
probe and a foot pedal to activate energy delivery. The probe has
two functions -- stimulating the nerve to identify the proper
location for treatment, and delivering the heat energy in a
measured dose to reduce activity of the targeted nerve. The
minimally invasive procedure is conducted in physician's offices
with local anesthesia, usually taking approximately 30 minutes. The
probe tip is inserted under the skin and the correct nerve is
identified through stimulation, which causes visible muscle
contraction. The same probe delivers localized and controlled
bi-polar RF energy for approximately 30 seconds to reduce nerve
function. Commonly reported adverse effects include some pain or
discomfort during the treatment, and swelling following the
treatment. As with any medical procedure, other adverse outcomes
may also occur. Approximately 300 patients have received nerve
ablation treatment with the ACI device worldwide, many in clinical
studies intended to support development and evaluation of this
device and procedure for aesthetics applications. BioForm Medical
intends to further evaluate the ACI device in additional clinical
studies worldwide and expects to launch the product commercially
upon achieving appropriate regulatory clearances in each market.
Neurotoxin products, such as Botox(R) Cosmetic from Allergan, Inc.,
are the current leading option for treatment of frown lines. This
needle- injection treatment typically provides a short-term (up to
four months) effect. Neurotoxins are injected through the skin into
the muscle. The neurotoxin keeps the muscle from moving, reducing
the appearance of frown lines. Approximately three million
treatments per year with Botox Cosmetic are performed in the U.S.
annually according to the American Society for Aesthetic Plastic
Surgery. About BioForm Medical, Inc.: BioForm Medical, Inc. is a
medical aesthetics company headquartered in San Mateo, California.
BioForm is dedicated to bringing doctors and their patients safe
and effective products for use in the dermatology, plastic surgery
and ENT markets. BioForm's products include Radiesse(R), a
long-lasting filler for use in facial aesthetics and vocal fold
insufficiency, and Coaptite(R) for treating female stress urinary
incontinence which is marketed through a partnership with Boston
Scientific Corporation. BioForm has licensed U.S. marketing rights
to Aethoxysklerol(R), the worldwide leading sclerotherapy agent,
which is currently being evaluated in a Phase III clinical trial.
BioForm has also licensed BioGlue, a new surgical adhesive product
for plastic surgery applications, which is being developed in a
partnership with CryoLife, Inc. Botox(R) is a registered trademark
of Allergan, Inc, Forward-Looking Statements: This press release
contains forward-looking statements within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995. Specifically,
statements concerning BioForm Medical's expectation that the new
treatment will be cleared by the FDA and other international
regulatory bodies for the treatment of frown lines or other
aesthetic indications, and offer patients an attractive alternative
therapy for such use, that the product will have synergies with the
Company's Radiesse dermal filler, that the acquisition will lead to
future product development and commercialization activities, and
that the acquisition will result in significant positive revenue
impact are forward-looking statements within the meaning of the
Safe Harbor. Forward- looking statements are based on management's
current, preliminary expectations and are subject to risks and
uncertainties, which may cause BioForm Medical's actual results to
differ materially from the statements contained herein. Further
information on potential risk factors that could affect BioForm
Medical's business and its financial results are detailed in its
Form 10-Q for the quarter ended December 31, 2008 as filed with the
Securities and Exchange Commission on February 7, 2008. Undue
reliance should not be placed on forward-looking statements,
especially guidance on future financial performance, which speaks
only as of the date they are made. BioForm Medical undertakes no
obligation to update publicly any forward-looking statements to
reflect new information, events or circumstances after the date
they were made, or to reflect the occurrence of unanticipated
events. 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/
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