DewDiligence
16 years ago
338 Patient Pivotal Trial Demonstrates Safety and Effectiveness of Polidocanol Sclerotherapy Product for Varicose Vein Treatment
http://biz.yahoo.com/prnews/080904/aqth531.html
›Thursday September 4, 4:00 pm ET
SAN MATEO, Calif., Sept. 4 /PRNewswire-FirstCall/ -- BioForm Medical, Inc. (Nasdaq: BFRM ) today announced that the pivotal clinical study of Polidocanol, conducted in Germany by BioForm Medical's partner, Chemische Fabrik KREUSSLER & Co. GmbH (Kreussler), successfully met the study primary endpoint and has been submitted to FDA as part of a New Drug Application (NDA) process.
In the pivotal clinical study, named the EASI (Efficacy and safety of Aethoxysklerol compared to Sodium Tetradecyl Sulfate and Isotonic Saline) study, 338 patients with C1 varicose veins (either spider veins of <1mm diameter or reticular veins of 1-3mm diameter), were randomized to receive either Polidocanol (also called Lauromacrogol 400, European tradename, Aethoxysklerol®), Sodium-tetradecyl-sulfate (STS or Sotradecol®, an effective control), or Isotonic saline (a placebo control). Patients were followed for 26 weeks (6 months) with standardized photography of a defined 10x10 cm area of the leg at baseline, 12 weeks and 26 weeks. These photographs were rated by the treating physicians and two blinded evaluators, which served as the basis for efficacy assessment.
The EASI study successfully met its primary efficacy endpoint with demonstrated statistically significant superiority (p<0.0001) of Polidocanol versus placebo. The treatment success rates for Polidocanol were 96% and 95% at 12 and 26 weeks, compared to STS (92%, 91%) and placebo (8%, 6%). A secondary endpoint analysis demonstrated that significantly more patients were satisfied or very satisfied with Polidocanol at 12 or 26 weeks (88%, 84%), compared to STS (63%, 64%; p<0.0001) or placebo (13%, 11%; p<0.0001). Polidocanol was found to be safe and well tolerated in the study. The incidence of side effects, most commonly local tissue reactions near the injection site, was generally lower for patients treated with Polidocanol than for patients treated with STS.
"We are very pleased that the EASI study successfully demonstrated the safety and the efficacy of Polidocanol for the treatment of spider and reticular veins," said Professor Eberhard Rabe, President of the International Union of Phlebology (UIP) and the German Society of Phlebology (DGP) and Professor at the Department of Dermatology, University of Bonn, and the principal investigator in the study. "Polidocanol has been used successfully to treat spider and reticular veins in Europe for over 40 years, and we are pleased to participate in this clinical evaluation to evaluate Polidocanol. These results scientifically confirm our every day experience in clinical practice, and the high patient satisfaction seen with Polidocanol, as compared to STS."
The EASI Study results will be presented at several scientific congresses in the coming weeks by Professor Eberhard Rabe, the principal investigator in the study. Planned presentations include September 8, 2008, at the Australasian College of Phlebology meeting in Australia, November 7, 2008, at the American College of Phlebology, and November 9, 2008, at the American Society of Dermatologic Surgery late-breaking results session.
"We are delighted with the results of this clinical study," said Steve Basta, Chief Executive Officer of BioForm Medical, Inc. "We believe that bringing Polidocanol into the U.S. market will allow physicians in the United States to use what has been regarded internationally as the gold standard product for sclerotherapy, and that the lower rate of local tissue reactions evidenced in this trial versus the leading competing product, combined with the high success rate of this treatment may be the basis of significant future growth in sclerotherapy procedure volume in the United States upon FDA approval and the subsequent commercial introduction of Polidocanol."
"For years, Polidocanol has been the worldwide standard for sclerotherapy of spider veins outside of the United States, and I am very excited about the prospect of being able to offer this treatment option to my patients in the future," said Robert Weiss, MD, President-Elect of the American Society for Dermatologic Surgery (ASDS) and Associate Professor, Dermatology at Johns Hopkins University School of Medicine, Baltimore, Maryland. "If Polidocanol becomes available in the United States, the physician community will have an important additional tool in their aesthetic treatment portfolio."
Kreussler, the company that developed Polidocanol as a sclerotherapy agent and has commercialized this product throughout the world over the past 40 years, conducted the pivotal clinical study pursuant to a special protocol assessment agreed to with FDA in 2006. The EASI study was specifically designed to provide the pivotal clinical data for the FDA related to the open New Drug Application (NDA) for Polidocanol. The final clinical study report on the EASI study has been submitted to FDA as an amendment to the existing NDA. In addition to this clinical report, Kreussler is completing manufacturing documentation for a newly expanded manufacturing facility. Consistent with the previously reported expected timeline for completion of the NDA submission, the manufacturing documentation is expected to be completed and submitted to FDA before the end of calendar year 2008.
BioForm Medical and Kreussler entered into an agreement in 2007 wherein BioForm will have exclusive U.S. rights to sell Polidocanol supplied by Kreussler upon FDA approval, and BioForm will pay Kreussler a royalty and transfer price for the supplied material, and development and commercialization milestone payments.
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® 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.‹
gfp927z
16 years ago
>>> BioForm Medical Announces Extension of Lock-Up Period
Monday May 5, 11:35 pm ET
SAN MATEO, Calif., May 5 /PRNewswire-FirstCall/ -- BioForm Medical, Inc. (Nasdaq: BFRM - News) announced today that lock-up agreements entered into with its underwriters in conjunction with its initial public offering will be extended 18 days beyond the Company's May 1, 2008 earnings release. The lock-up period was due to expire on May 3, but the Company's underwriting agreement provided for an extension, depending on the timing of BioForm Medical's quarterly earnings press release. The first sales of shares restricted by the underwriter's lock-up may take place on Tuesday, May 20, 2008. Approximately 33 million shares will become eligible for sale in the public market upon expiration of the underwriters' lock-up, of which approximately 10 million shares will be freely tradable under Rule 144(b) and the remainder will be held by affiliates and other stockholders subject to the volume and other restrictions of Rule 144.
An additional number of shares equal to less than 5.0% of the shares outstanding prior to the November 2007 initial public offering were either not subject to a lock-up agreement or were subject to a lock-up agreement with the Company, the terms of which were less restrictive than the lock-up agreement with the underwriters, and, as such, became freely tradeable on May 5, 2008.
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's lead product is Radiesse®, a long-lasting dermal filler for use in facial aesthetics. BioForm is developing several future aesthetics products including a nerve ablation device for frown lines, a sclerotherapy treatment for spider veins, and a surgical adhesive for brow lifts. <<<
gfp927z
17 years ago
Thanks to Dew for these comments on BioForm's quarterly earnings -
>>> BFRM Reports FY3Q08 Results
[BFRM has lowered the fiscal-year revenue guidance for the second time in the past two quarters, which is not a good sign for a “growth” company. On the FY1Q08 CC, the FY revenue guidance was $76-81M; on the FY2Q08 CC three months ago, this was lowered to $71-76M; now, it’s been lowered again to $66-68M, which implies that expected revenue during the fiscal fourth quarter ending 6/30/08 is only $15-17M. This compares to revenue of $15.2M, $18.6M, and $17.0M during the first three fiscal quarters, respectively. BFRM blames all this on weak consumer confidence, but the tepid sales may be a sign that Radiesse will never get the kind of market penetration needed to become a big seller.]
http://biz.yahoo.com/prnews/080501/aqth115.html
>>
Thursday May 1, 4:00 pm ET
SAN MATEO, Calif., May 1 /PRNewswire-FirstCall/ -- BioForm Medical, Inc. (Nasdaq: BFRM ) today announced its financial results for the quarter ended March 31, 2008, which is the Company's third quarter of fiscal year 2008. Net sales were $17.0 million for the quarter ended March 31, 2008 as compared to $12.4 million for the quarter ended March 31, 2007, an increase of $4.6 million or 36.3%. The net loss was $4.5 million for the quarter ended March 31, 2008 as compared to $3.6 million for the quarter ended March 31, 2007. Net sales for the nine months ended March 31, 2008 were $50.8 million, as compared to $32.1 million for the nine months ended March 31, 2007. The net loss was $9.5 million for the nine months ended March 31, 2008 as compared to $8.7 million for the nine months ended March 31, 2007.
Operating Results:
Domestic sales were $14.0 million for the quarter ended March 31, 2008 compared to $10.3 million for the quarter ended March 31, 2007, an increase of $3.7 million or 36.6%. International sales were $2.9 million for the quarter ended March 31, 2008, compared to $2.2 million for the quarter ended March 31, 2007, an increase of $0.7 million or 34.9%. The Company attributes the growth in revenue primarily to increased physician adoption since the aesthetics approval of Radiesse® dermal filler, the Company's extensive clinical education programs, and the increase in direct sales personnel.
Gross profit was $13.7 million for the quarter ended March 31, 2008 as compared to $10.4 million for the quarter ended March 31, 2007, an increase of $3.3 million, or 32.3%. As a percentage of sales, gross profit for the quarter ended March 31, 2008 was 80.9% as compared to 83.4% for the quarter ended March 31, 2007. The decline in the gross profit margin was due primarily to a lower average selling price for Radiesse in the United States (primarily associated with customers increasing their average purchase quantities and qualifying for lower prices under our volume pricing programs), and increased costs associated with certain promotional programs offered during the quarter, offset partially by lower overhead and royalty expense per unit.
Operating expenses were $19.2 million in the quarter ended March 31, 2008 compared to $14.1 million in the quarter ended March 31, 2007. The increase in operating expenses was primarily attributable to an increase in sales and marketing costs as a result of the expansion of the Company's sales forces in the United States and Europe in early FY 2008, expansion of the company's clinical education programs, and higher employee related expenses in research and development and general and administration.
Net loss per share applicable to common stockholders decreased to $0.10 for the quarter ended March 31, 2008 as compared to $0.88 for the quarter ended March 31, 2007, due primarily to the increase in the shares outstanding which resulted from the sale of 11.5 million common stock shares in our November 2007 initial public offering and the conversion of 30.4 million shares of preferred stock into common stock shares concurrent with this public offering.
"The March quarter, which is typically down from the December quarter, was lower for us this year than we had expected. We've seen early indications in April of weakness in the June quarter. We believe that rapidly declining consumer confidence is having a significant impact on discretionary spending and, consequently, our business. We have reduced our revenue guidance as a result," stated Steve Basta, CEO of BioForm Medical. "We are taking steps both in the near-term and long-term to enable the Company to accelerate our revenue growth. In our core Radiesse business, one of the key near-term activities for the Company is the expansion of our clinical education team. We have found that clinical comfort using Radiesse, and the experience of seeing and understanding the benefits offered by Radiesse helps grow physician utilization. In addition to our efforts to stimulate growth in Radiesse revenue, we are broadening our product portfolio through business development activities. In the coming years, we expect contributions to our top-line growth from new product introductions, such as the recently announced ACI device, Aethoxysklerol, and BioGlue, each of which will be subject to certain regulatory review and approval requirements."
Fiscal Year 2008 Revenue Guidance:
BioForm Medical is updating its revenue guidance for the full fiscal year 2008 ending June 30, 2008 to approximately $66 to 68 million in net sales.
ACI Transaction:
As previously announced on April 30th, 2008, BioForm Medical has acquired a facial aesthetic nerve ablation technology from Advanced Cosmetic Intervention, Inc for approximately $12 million cash, plus assumption of approximately $0.2 million of payables, future royalties and a potential sales-related milestone. The ACI device uses minimally-invasive bi-polar radiofrequency energy selectively to weaken nerve signal transduction. 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 distribute 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.
Aethoxysklerol® Update:
The Phase III clinical trial of Aethoxysklerol, a sclerotherapy product for the treatment of spider and reticular veins, has completed patient treatment and follow-up, and BioForm's partner, KREUSSLER, has initiated data analysis of the trial results. We expect that the New Drug Application (NDA) filing for this sclerotherapy product will be submitted in CY 2008. Data and results from this clinical trial are expected to be presented at scientific meetings in late CY 2008 or early CY 2009.
Conference Call:
BioForm Medical will hold a conference call today at 2:00 pm Pacific Time (5:00 p.m. Eastern Time) to discuss the financial results and guidance. The conference call will be webcast live on the Investor Relations section of BioForm Medical's website at http://www.bioform.com. The conference call may be accessed by dialing 877-591-4956 for callers in the U.S. and 719-325-4880 for international callers. Please notify the operator that you would like to join "BioForm Medical's Third Quarter Earnings Call" and provide the participant code "7284989", if prompted.
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's lead product is Radiesse®, a long-lasting dermal filler for use in facial aesthetics. BioForm is developing several future aesthetics products including a nerve ablation device for frown lines, a sclerotherapy treatment for spider veins, and a surgical adhesive for brow lifts. <<<
gfp927z
17 years ago
From the company website -
>>> Radiesse® Aesthetic
Radiesse® dermal filler incorporates our patented formulation of CaHA microspheres suspended in a gel carrier and is designed to provide satisfying, long-lasting, cost-effective and safe aesthetic benefits for patients. The product’s unique calcium-based microsphere technology, along with the proprietary gel technology, helps to restore volume and promotes the growth of the body’s own collagen, providing lasting, but not permanent, augmentation. Radiesse® dermal filler is the only dermal-filler in the United States with two FDA-approved facial indications.
Radiesse® dermal filler is indicated for the correction of moderate to severe folds and wrinkles, such as nasolabial folds, as well as for facial lipoatrophy, or facial fat loss, in patients with human immunodeficiency virus, or HIV.
Radiesse® Voice and Radiesse® Voice Gel
Radiesse® Voice and Radiesse® Voice Gel are both indicated for treatment of vocal fold insufficiency. Vocal fold insufficiency is a condition in which the vocal folds are impaired in their motion, typically as a result of a stroke or neurological disorder. The impaired vocal fold motion inhibits speech or reduces voice quality. RADIESSE Voice or RADIESSE Voice Gel can be injected into the space behind the vocal fold that is impaired to adjust the position of that fold and improve speech. RADIESSE Voice may be more appropriate for patients desiring long-lasting augmentation while RADIESSE Voice Gel may be appropriate for patients whose condition is temporary. <<<
gfp927z
17 years ago
Interesting company in the aesthetic medicine area. IPO was Nov 2007, and the 180 day lockup period ends in early May '08 -
>>> Core Technology
The core technology behind Radiesse® dermal filler and Coaptite® injectable has been through significant safety and effectiveness testing, including biocompatibility testing, preclinical studies and several multi-center human trials in more than 1,000 patients, which, along with five years of use by physicians and over 500,000 syringes shipped, has demonstrated its benefits and safety profile. RADIESSE dermal filler and COAPTITE injectable implant require no pre-injection skin testing to determine risk of allergic reaction because it contains no animal or human-derived materials.
RADIESSE dermal filler is a synthetic injectable material that is used by physicians as a dermal filler. RADIESSE dermal filler consists of 30% by volume smooth calcium hydroxylapatite, or CaHA, microspheres ranging in diameter from 25 to 45 microns suspended in an aqueous gel carrier which comprises 70% of the product. The size of the particles allows for delivery through a 27 gauge needle. The gel carrier allows for controlled placement and permits the practitioner to manipulate RADIESSE dermal filler after injection without unwanted migration of the particles. The product's unique calcium-based microsphere technology, along with the proprietary gel technology, helps to restore volume and promotes the growth of the body's own collagen, providing lasting, but not permanent, augmentation. Immediately following injection, the RADIESSE dermal filler adds volume to the space into which it is injected. This volume enhancement is predictable and controllable by the physician, resulting in immediate improvement in patient aesthetics after one treatment. In the first several months after injection, the gel carrier is absorbed by the body and new collagen is formed around the CaHA microspheres, which can reinforce the augmentation effect. Over time the CaHA microspheres, identical to a mineral component of bone and teeth, are also metabolized by the body.
In addition, BioForm Medical has created a strong intellectual property portfolio around its core CaHA technology with 5 issued U.S. patents with broad worldwide counterparts. Additional applications are currently on file and under review in the US. BioForm Medical is committed to creating a strong intellectual property portfolio that protects its current and future products. <<<
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Tina
16 years ago
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