Los Angeles Plastic Surgeon Or Cosmetic Surgeon - The Difference
They enter in to some guilt complex and also believe it absolutely was deserved, in addition any reprisal for their particular vanity of likely for the surgery.
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SANUWAVE Announces Positive Top-Line Data from Its Pivotal Trial Investigating the Use of dermaPACE for the Treatment of Diabetic Foot Ulcers
ALPHARETTA, Ga.--(BUSINESS WIRE)--SANUWAVE Health, Inc. (OTCBB: SNWV) (www.sanuwave.com), an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in regenerative medicine, today announced positive top-line results from the Companys pivotal Phase III, Investigational Device Exemption (IDE) clinical trial comparing dermaPACE to sham control (non-active treatment), when both are combined with the current standard of care for the treatment of diabetic foot ulcers. Diabetic foot ulcers are an area of significant unmet medical need and represent a $2 billion market in the U.S. alone.
The design of this 206-patient, randomized, double-blind, parallel-group, sham-controlled, multi-center, 26-week clinical trial was intended to quantify the effectiveness of four 20-minute, non-invasive procedures with dermaPACE, delivered over a 2-week period.
Comparing wound area closure at 12 weeks, 45% of patients treated with dermaPACE and 26% of sham patients experienced a 90% closure (p=0.0182), and 66% of patients treated with dermaPACE and 47% of sham patients experienced a 70% closure (p=0.0227). Within 4 weeks following the final treatment with dermaPACE (6-week point), and consistently throughout the 12-week evaluation period, there was a highly significant reduction in the size of the target ulcer compared to patients randomized to receive sham (p=0.0038 at week 6, p=0.0018 at week 8, p=0.0007 at week 10, and p=0.0041 at week 12). By 12 weeks, the average percent reduction in the size of the target ulcer in patients treated with dermaPACE was 56%, compared to only 7% in the patients randomized to receive sham. A consistently greater proportion of patients randomized to receive sham experienced continued worsening as evidenced by an increase in the size of the ulcer from baseline, compared to patients randomized to receive dermaPACE treatment.
Patients treated with dermaPACE showed a strong positive trend in the primary endpoint of 100% wound closure. Treatment with dermaPACE increased the proportion of diabetic foot ulcers that closed within 12 weeks by 36%, although this result was not statistically significant. Based on the pure, controlled design of the study, which restricted investigators from closing the wound surgically, and because a 90% wound closure is clinically meaningful, the Company ran a composite analysis of 90% wound closure that demonstrated statistical significance (p=0.0161) in favor of dermaPACE (51/107, 48%) compared to patients randomized to receive sham (31/99, 31%). The median wound closure exceeded 99% for the dermaPACE treated patients in the composite analysis. Notably, the patients treated with dermaPACE started, at baseline, with a 58% larger wound area than patients randomized to receive sham. Patients treated with dermaPACE were twice as likely to achieve 90% to 100% wound closure within 12 weeks of their initial dermaPACE treatment compared to patients randomized to receive sham.
Dr. Robert Galiano, a principal investigator in the dermaPACE study and Assistant Professor, Division of Plastic Surgery, Department of Surgery at the Northwestern University Feinberg School of Medicine said, The overwhelming clinical utility demonstrated in this study means I can expect that at least half of my patients over a 12-week period will be either fully healed or 90% healed. I consider this to be clinically relevant wound closure since most will continue to full closure with a basic dressing and minimal intervention.
Dr. Galiano continued, The scientific mechanism activated by dermaPACE technology has a direct and lasting impact on wounds by immediately increasing blood perfusion and stimulating the bodys own angiogenic and positive inflammatory wound healing responses. These study results have provided the necessary clinical evidence to validate the benefits of such a mechanism when combined with proper wound care.
Importantly, there were no serious and related adverse events associated with dermaPACE treatment reported during the course of the study, and no issues regarding the tolerability of the treatment. Of the patients who achieved complete wound closure at 12 weeks, the recurrence rate was only 4.5% in the dermaPACE group compared to 20% in the patients treated with sham.
The pure study design we implemented was double-blind, randomized and sham-controlled to provide highly credible, unbiased evidence that dermaPACE alone significantly and positively impacts the wound healing process, said Christopher M. Cashman, President and CEO of SANUWAVE.
Mr. Cashman continued, We are confident that the positive data generated by this rigorous Phase III study demonstrates clinical relevance with statistical significance in the composite analysis of 90% or better wound closure and confirms the clinical utility of dermaPACE to treat diabetic foot ulcers. Analysis of the complete data set will continue for some time. A substantial amount of data, in addition to the top-line data announced today, will be included in our PMA submission, the final module of which is expected to be filed in early 2011. SANUWAVE would like to thank our principal investigators and their teams for their disciplined approach to this study and for their consistent and enthusiastic support of our technology to treat their patients who suffer from diabetic foot ulcers.
Study Design Relevance
Unlike many other chronic wound trials conducted in this diabetic patient population, there were two important elements incorporated in the dermaPACE study design: double-blind (patient and principal investigator) randomization, and elimination of the option to close the target ulcer surgically or by other primary means. Maintaining the double-blind in this device trial restricted the knowledge of the treatment assignment so not to influence how a patient was treated or maintained on study and evaluated. This eliminated unintended human bias and qualifies this research as level 1 evidence, allowing the results to be accepted at face value. By not allowing the clinical investigators to surgically close the target ulcer in this study, the results provide a clear and unbiased view of the granulation and epithelialization process attributable to dermaPACE alone.
Diabetes is common, disabling and deadly. In the U.S., diabetes has reached epidemic proportions. According to the American Diabetes Association, about 24 million people (8% of the total U.S. population) have diabetes, and nearly two million new cases are diagnosed in people aged 20 years or older each year. If current trends continue, 1 in 3 Americans will develop diabetes at some point in their lifetime, and those with diabetes will lose, on average, 10-15 years of life expectancy. Importantly, up to 25% of people with diabetes will develop a diabetic foot ulcer, resulting in 3 million diabetic foot ulcers annually in the U.S. alone. More than half of all foot ulcers will become infected, thus requiring hospitalization, and 1 in 5 will require an amputation that carries a high risk of mortality.
Without question, diabetes puts tremendous economic pressure on the U.S. healthcare system. Total costs (direct and indirect) of diabetes reach $174 billion annually, and people with diagnosed diabetes have medical expenditures that are over two times higher than medical expenditures for people without diabetes. Hospitalization costs alone are $16,000 to $20,000 for a patient with a diabetic foot ulcer, and direct and indirect costs of an amputation range from $20,000 to $60,000 per patient. Advanced, cost-effective treatment modalities for diabetes and its comorbidities, including diabetic foot ulcers, are in great need, yet in short supply, globally. According to the American Diabetes Association, by the year 2025 the prevalence of diabetes is expected to rise by 72% to 324 million people worldwide.
Phase III Study Design
The dermaPACE pivotal Phase III trial was a prospective, randomized, double-blinded, sham-controlled, multi-center, 26-week, parallel-group study. The goal of the study was to establish superiority in diabetic foot ulcer healing rates using the dermaPACE treatment compared with sham control, when both are combined with the current standard of care. The standard of care includes wet-to-dry dressings and, for some patients, offloading with a walking boot. Secondary trial endpoints include time to closure, reduction in total wound surface area and volume, rate of improvement, long-term safety, and skin appearance and pain assessments. The studys primary endpoint of wound closure is defined as full skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive visits. A total of 206 patients were enrolled in the trial, which was conducted at 22 sites in the U.S. and two sites in Europe including Boston Medical Center, Phoenix VA, Northwestern University in Chicago, VA Long Beach, California, The Ohio State University Medical Center in Columbus, Kings College Hospital in London, Emory Orthopedics and Spine Center in Atlanta, Calvary Hospital in New York, and the North American Center for Limb Preservation in New Haven, Connecticut. The principal investigators in the study represent the multidisciplinary nature of treating chronic wounds, including specialties such as vascular surgery, plastic surgery, podiatry and general surgery.
PACE, defined as Pulsed Acoustic Cellular Expression, delivers high-energy acoustic pressure waves to produce compressive and tensile stresses on cells and tissue structures to promote angiogenic and positive inflammatory responses and quickly initiate the healing cascade. Benefits of plastic surgery or cosmetic treatments are many yet to get them as well as to avoid any sort of unfavorable results or issues, you have to find a doctor who has enough experience, qualification and also ability to do such jobsThis results in revascularization and microcirculatory improvement, including the production of angiogenic growth factors, enhanced new blood vessel formation (angiogenesis), and the subsequent regeneration of tissue, such as skin, musculoskeletal and vascular structures. PACE treatment triggers the initiation of an accelerated inflammatory response, speeding wounds into proliferation phases of healing and subsequently returns a chronic condition to an acute condition to help the bodys own healing response to re-initiate.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is an emerging regenerative medicine company focused on the development and commercialization of non-invasive, biological response activating devices for the repair and regeneration of tissue, musculoskeletal and vascular structures. SANUWAVEs portfolio of products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the bodys normal healing processes and regeneration. SANUWAVE intends to apply its Pulsed Acoustic Cellular Expression (PACE) technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE, is CE marked for treatment of the skin and subcutaneous soft tissue and recently completed its pivotal Phase III, Investigational Device Exemption (IDE) trial in the U.S. for the treatment of diabetic foot ulcers (DFU). SANUWAVE researches, designs, manufactures, markets and services its products worldwide and believes it has already demonstrated that this technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved Ossatron device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its Ossatron, Evotron, and recently introduced orthoPACE, devices in Europe.
Safe Harbor Statement
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Companys ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the marketing of the Companys product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Companys ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Companys periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
The Normalization of Cosmetic Surgery | Vivian Diller, Ph.D.
The widespread shock and condemnation of Renee Zellweger's "new face" would have you believe that no man or woman would ever fall victim to her fate. Meanwhile, over 11 million surgical and non-surgical cosmetic procedures were performed last year in the US alone. And, according to the American Society for Aesthetic Plastic Surgery (ASAPS), the trend will continue to rise as it has since the 2008 recession, when people began "investing in themselves once again."
What's really going on out there and how do we reconcile this apparent contradiction? The truth is, cosmetic surgery is becoming normalized and its rising popularization both entices and scares us. The answer as to why can be found somewhere between the change in consumer psychology and a shift in how providers market their services.
We have been living in a youth- and beauty-obsessed culture for a long time now, so long that we barely blink at the constant barrage of air brushed and photo-shopped images that reinforce it. The yearning for an ideal image is presented as an imperative. The pressure is incessant. While men feel some of it -- accounting for about a million cosmetic procedures this year -- it compares to 10.3 million performed on women, who feel it more. In short, there is no escaping its influence.
Today, this pressure impacts the psychology of average, everyday people in ways that once largely did only those in the spotlight -- the rich and famous, models, actors and celebrities. Girls as early as age 6 report being preoccupied by the way they look, basing their standards of beauty on body perfection. Both boys and girls grow up surrounded by digitally altered imagery, expecting to look like what they see as they emerge into adults. Websites and reality shows tout life-altering effects from plastic surgery, making going under the knife a reasonable means to achieve beauty. Before and after photos present smoothed skin, newly shaped noses, uplifted round breasts, and flattened tummies, created as if by magic, convincing consumers of all ages that they too can have these transformations if they just find the money and doctor to do the job.
As cosmetic procedures have become fine-tuned, surgeons, dermatologists and cosmeticians are more comfortable offering them as a routine part of their patients' health care and beauty regimen. With less down time and fewer negative consequences, patients can look better and younger with minimal risk and without making radical changes to their appearance. While many providers are enthusiastic about being able to offer improved products and services, they also benefit from a culture driven by ideal imagery. These days, it's not uncommon to hear providers say, "make subtle changes, start early and you can avoid years of work later on." Those words to someone with body image issues are highly persuasive.
Cosmetic surgery is a booming and growing business, totaling more than $12 billion at last count, so marketing to all ages and both genders doesn't surprise me. Younger people now consider it in ways few did in the past. Teens who would have been candidates for surgery only to repair facial and body disfigurements, are now turning to it as a way of avoiding bullying. Twenty-somethings are enticed by alterations to enhance self-esteem or to get a leg up on the competition personally and professionally. It's not hard to imagine youngsters begging their parents for surgery much the way they now ask for a new wardrobe or a cool car to feel more socially desirable. While surgeons hesitate to work on patients under 18 (it requires parental consent), this trend will continue to rise as surgery is viewed as a potential solution to adolescent and millennial angst.
For the "more mature" person, by whom I mean the 30-plus crowd, cosmetic surgery is currently being marketed less to change the way they look, and more to help them look the best they can. This shift was in large part due to baby boomers who reacted negatively, or at least with great ambivalence, to the puffed up faces and dramatic facelifts that beleaguered their generation. Surgeons and dermatologists responded by encouraging them to achieve the "rested, refreshed" look, a way to match the outside with the inside. These less drastic procedures that promise shorter recovery times and fewer risks, have now filtered down to the boomers' babies.
With the popularization and accessibility of cosmetic procedures, we're potentially moving toward the homogenization of beauty, both in terms of physical features and ethnic differences. It's a slippery slope. How long will people with large ears, a crooked nose, a rounded body or small eyes (or for that matter, Asian looking ones) maintain these features and believe they can be attractive? Sounds like a bad science fiction movie -- "I'll take the Angelina lips please, and the Jennifer cheekbones" -- but if more people alter their appearance toward a narrow standard of beauty, will we create a culture of people who look increasingly similar? We already see this trend in the media, where actors and actresses look indistinguishable from one another, and may be the very thing that unnerved so many about Renee Zellweger. If we support the narrowing of acceptable physical features as adults, are we not fostering little tolerance for differences in future generations?
No doubt there are times when cosmetic surgery provides life-changing experiences. No one would argue against correcting congenital defects or repairing disfigurements resulting from accidents. And, there are times when altering physical features clearly improve one's lifestyle -- breast reduction and deviated septum correction are two common ones. There are even cases when the psychological discomfort brought on by premature signs of aging warrant minor work. Plastic surgical treatment is typically done to improve one's appearance, which is additionally perceived as the primary advantage to the procedure. Nevertheless, boosting look is just among numerous possible benefits cosmetic surgery could give.But while I support all of these efforts, I'm opposed to surgery that promotes homogenized beauty.
Needless to say, I have mixed feelings about it, and take a stand in the middle. I am not copping out, but truly feel there are a variety of ways to enhance appearance, stay true to oneself, and mature with grace. To start with, we need a heightened awareness of available preventive measures that avoid premature aging -- like staying out of the sun, less alcohol and drug use. And, I completely support some new and improved dermatological techniques that enhance the health and beauty of women's skin -- daily moisturizers, sun block, Retina A creams and specialized laser treatments. But, I encourage women to become more accepting of the changes that come with age while doing what they can to look after themselves in healthy ways.
Attractiveness comes in lots of different shapes and sizes -- as does beauty at different ages -- but trying to turn back the clock is a never-ending and ultimately unwinnable battle. Finally, the notion that cosmetic surgery is a "simple beauty treatment" is a contradiction in terms, a paradox of sorts. Surgery is almost never simple, physically or psychologically, and the more we believe it's a solution to our beauty needs, the less beautiful we tend to feel.
Vivian Diller, Ph.D. is a psychologist in private practice in New York City. She serves as a media expert on various psychological topics and as a consultant to companies promoting health, beauty and cosmetic products. Her book, "Face It: What Women Really Feel As Their Looks Change" (2010), edited by Michele Willens, is a psychological guide to help women deal with the emotions brought on by their changing appearances.
For more information, please visit my website at www.VivianDiller.com; and continue the conversation on Twitter @ DrVDiller.
For more by Vivian Diller, Ph.D., click here.
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