Healthcare Industry News: CryoLife
News Release - December 12, 2007
Radiesse Provides Greater Patient Satisfaction Than Either Juvederm or Perlane as Reported in a 205-Patient Clinical Trial Published in the Journal of Dermatologic SurgerySAN MATEO, Calif., Dec. 12 (HSMN NewsFeed) -- BioForm Medical, Inc. (Nasdaq: BFRM ) today announced the publication of a multi-center, randomized, blinded comparative study of nasolabial fold treatments reporting higher patient satisfaction with its Radiesse® dermal filler than reported after treatment with either Juvederm(TM) or Perlane®. The results of this study were published in the December 2007 Filler Issue of the Journal of Dermatologic Surgery, a peer-reviewed publication of the American Society of Dermatologic Surgery. In this first direct comparison study of Radiesse dermal filler against two leading competitors, the study concluded that 1) patients were substantially more satisfied if they received Radiesse dermal filler than other leading fillers tested, 2) patients who received Radiesse were substantially more likely to return for future treatments, and 3) Radiesse dermal filler offers advantages in durability and cost, while exhibiting similar safety characteristics as hyaluronic acid fillers.
Results from two other studies were also published in this special issue of Dermatologic Surgery. The results of the pivotal U.S. clinical study of Radiesse dermal filler versus CosmoPlast® (collagen), demonstrated superiority of Radiesse to CosmoPlast on virtually every effectiveness measure in the study, and Radiesse dermal filler was found to provide a comparable safety profile to collagen. Three leading dermatologists, Dr. Neil Sadick, Dr. Bruce Katz, and Dr. Deborshi Roy, also published in this special issue their long-term clinical experience with Radiesse, also demonstrating safety of Radiesse in clinical use and high patient satisfaction.
"We often hear from our customers that the reason they choose Radiesse for many of their patients is first and foremost that they believe their patients are more satisfied with Radiesse than other dermal filler options. The published report of the comparative study of Radiesse against leading hyaluronic acid fillers demonstrates this difference in a well-controlled clinical study setting," commented Steven Basta, Chief Executive Officer of BioForm Medical. "We are grateful to the many investigators in the U.S. and European clinical studies, and to the leading physicians who routinely take time out of their practice to report on their growing positive experiences with Radiesse."
Radiesse vs. Juvederm and Perlane Clinical Trial
A 205-patient comparative study was conducted at five clinical sites in Europe to assess patient satisfaction and aesthetic improvement in treating nasolabial folds with Radiesse dermal filler as compared to three leading hyaluronic acid fillers, Perlane and two forms of Juvederm. The results of this prospective, multi-center, randomized study, led by Marion Moers-Carpi, MD, Hautok, Munich, Germany, demonstrated higher patient satisfaction, higher likelihood to return for additional treatment, and a greater likelihood to recommend treatment with Radiesse dermal filler, as compared to the three hyaluronic acid products tested: Juvederm 24 (not available in the U.S.), Juvederm 24HV (known as Juvederm Ultra in the U.S.) and Perlane. The study was designed to measure the results achieved by several products on a comparative basis after the completion of two treatments, at baseline and at four months in order to achieve optimal correction. The paper published in the Journal of Dermatologic Surgery reports on results achieved through a 12-month follow-up after the second treatment.
The results from the study demonstrated that at 12 months after the last injection, 90% of Radiesse treated patients rated their satisfaction as "satisfied" or "extremely satisfied" compared to 48% with Perlane (p<0.001) and less than 10% for each Juvederm group (p<0.001). When asked whether they would be likely to return for future treatments, 93% of patients said that they were "likely" or "extremely likely" to return for future treatments with Radiesse versus 38% for Perlane (p<0.001) and less than 10% for each Juvederm group (p<0.001). When asked if they would recommend their treatment to others, at each timepoint evaluated (4, 8 and 12 months), 94% or more of Radiesse-treated patients indicated that they would, a higher percentage than with any of the hyaluronic acid products.
Substantially less Radiesse filler than the hyaluronic acid fillers was injected to achieve optimal correction in this study. Average total volume of Radiesse injected in two treatment sessions was 2.2cc, compared to 2.9cc of Perlane (p<0.0001), 2.9cc of Juvederm 24HV (p<0.005) and 4.8cc of Juvederm 24 (p<0.0001). The authors noted in the study report that "for the patient who may choose to buy only a single syringe, one syringe of Radiesse would likely provide a patient better immediate correction than one syringe of Juvederm or Perlane."
In conclusion, the authors stated, "We believe that CaHA Gel (Radiesse) offers advantages in durability, patient satisfaction, and cost, for safe correction of nasolabial folds."
The study abstract is available at http://www.blackwell-synergy.com/doi/abs/10.1111/j.1524-4725.2007.33354.x
Radiesse vs. CosmoPlast Nasolabial Fold Treatment Clinical Trial
The authors of this prospective, randomized, multi-center, split-face study, led by Stacy Smith, MD, Therapeutics Clinical Research and UCSD Division of Dermatology, San Diego, California, found Radiesse superior on virtually every effectiveness measure. In this 117 patient study conducted at four investigational sites in the U.S., 79% of patients had superior improvement on the Radiesse side through 6 months (p<0.0001) while requiring significantly less volume and fewer treatment visits than CosmoPlast (collagen). The study also noted that greater than 96% of both patients and physicians preferred Radiesse over CosmoPlast. The article notes that adverse event rates between Radiesse and CosmoPlast were comparable with some increase in bruising and swelling for the Radiesse side, and most adverse events generally resolved within 14-21 days.
In conclusion the authors determined that Radiesse provides a significantly longer-lasting correction of nasolabial folds while demonstrating a comparable safety profile to that of human collagen, which is widely regarded as one of the safest dermal filler materials. The data presented in the publication formed the basis of the FDA approval of Radiesse for the treatment of moderate to severe lines and folds, such as nasolabial folds, in December 2006.
The study abstract is available at http://www.blackwell-synergy.com/doi/abs/10.1111/j.1524-4725.2007.33350.x
A Multi-center, 47-Month Study of Radiesse for Nasolabial Folds and Other Areas of the Face
The clinical publication reported observations from two leading physician practices. The authors were Neil S. Sadick, MD, of Sadick Dermatology of New York City, and Weill Medical College, Cornell University, of New York City, Bruce E. Katz, MD, of JUVA Skin and Laser Center in New York City, the Cosmetic Surgery and Laser Clinic at Mount Sinai Hospital in New York City, and Deborshi Roy, MD, of Sadick Dermatology of New York city, and the Division of Facial and Plastic and Reconstructive Surgery, Lenox Hill Hospital, New York City. This publication reported safety and effectiveness results from using Radiesse in the treatment of nasolabial folds and other areas of the face. In this 113 patient clinical report of experience at two sites, the authors found that Radiesse performed well with favorable safety profile and high patient satisfaction, with 90% of patients reporting very good or excellent results. The authors concluded that they were pleased with the low incidence of adverse events coupled with the favorable responses from patients due to longevity of correction.
The study abstract is available at http://www.blackwell-synergy.com/doi/abs/10.1111/j.1524-4725.2007.33351.x
About BioForm Medical, Inc.:
BioForm Medical, Inc. is a medical aesthetics company headquartered in San Mateo, California. BioForm Medical is dedicated to bringing doctors and their patients safe and effective products for use in the dermatology, plastic surgery and ENT markets. BioForm Medical's products include Radiesse® filler for use in facial aesthetics and vocal fold insufficiency, and Coaptite® injectable implant for treating female stress urinary incontinence which is marketed through a partnership with Boston Scientific Corporation. BioForm Medical has licensed U.S. marketing rights to Aethoxysklerol® sclerotherapy agent, which is the leading worldwide sclerotherapy agent and is currently being evaluated in a Phase III clinical trial. BioForm Medical has also licensed BioGlue® surgical adhesive product for plastic surgery applications, which is being developed in a partnership with CryoLife, Inc.
Radiesse® is a registered trademark of BioForm Medical, Inc.
Juvederm(TM) is a mark owned by Corneal Industries SAS.
Perlane® is a registered trademark of HA North American Sales AB.
CosmoPlast® is a registered trademark of Allergan, Inc.
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 ability to continue to grow demand for Radiesse and likelihood and timing of future product introductions 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 prospectus as filed with the Securities and Exchange Commission on November 6, 2007. 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.
Source: BioForm Medical
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