BioForm Medical, Inc. Acquires Facial Aesthetic Nerve Ablation Technology for $12M
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® 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®, a long-lasting filler for use in facial aesthetics and vocal fold insufficiency, and Coaptite® 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®, 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® 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.
Source: BioForm Medical, Inc.