SkinMedica Acquires Leading Professional Mineral Makeup Company Colorescience

Carlsbad, CA – SkinMedica, Inc., the fastest growing professional skin care company in the U.S., today announced it has acquired Colorescience, a leading, science-based mineral makeup company in a merger transaction. Colorescience is widely adopted in physician-based aesthetics practices and highly regarded among dermatologists for color correction, sun protection and comfortable, post-procedure coverage. Colorescience was founded by Diane Ranger, creator of the mineral makeup category.

Josie Juncal will lead the new Colorescience subsidiary as VP, New Commercial Operations. Ms. Juncal has more than 10 years of experience in sales, sales management, marketing and education. During her tenure at SkinMedica, Ms. Juncal has held lead roles in product development, marketing, public relations, and education. She holds a Bachelor’s degree in Psychology from UC Irvine and a Master’s degree in Industrial Organizational Psychology from Elmhurst College.

“Mineral makeup has been a priority expansion target for us for some time. It is especially gratifying to combine with Colorescience, as their product line is based in science and trusted by our physician customers,” said Mary Fisher, CEO of SkinMedica. “Josie has very strong relationships with the clinical leaders in medical aesthetics and a proven track record for driving growth. I am confident the outstanding team at Colorescience will deliver further impressive results under her leadership.”

“We are excited to add these highly complementary product offerings to expand our presence in the physician channel,” said Ted Schwarz, SkinMedica President. “With Colorescience, we can now offer our physician customers three categories of patient care – skin care, non-surgical procedures, and now mineral makeup – which will further deepen our relationships with our customers and their patients by enhancing outcomes with immediate results.”

Colorescience recently launched Colorescience PRO, its high-performance line of cosmetics created to remedy and camouflage specific skin concerns while protecting from the damaging effects of the sun. These dermatologist-recommended formulations can be layered and blended together to achieve an instant, flawless, and beautiful appearance. Diane Ranger, creator of the mineral makeup concept, also founded Bare Escentuals, the first makeup of its kind. Ms. Ranger’s concept revolutionized the cosmetics industry and popularized the notion that “looking good can be good for your skin” and that it is now possible for consumers to have “makeup that does more”.

“Each Colorescience product has been carefully formulated to work together in achieving the best results. It is with that same thoughtful consideration of synergy and results, that we have chosen to merge with SkinMedica,” said Diane Ranger, founder of Colorescience. “Our shared values and commitment to creating advanced products for the Physician channel make this an exciting partnership.”

In 2011, SkinMedica was again named Fastest Growing Professional Skin Care Company in the U.S. and received several prestigious product awards. In addition, the company expanded its sales force, increased its educational programs and licensed several new technologies.

“With their extraordinary collection of innovative products and unparalleled management team, SkinMedica was the ideal choice to take Colorescience to the next level,” shared David Baram of VMG Partners. “Under SkinMedica’s leadership, Colorescience is now positioned to become the leading mineral makeup brand in the doctor and spa channel.”

Financial terms of the transaction were not disclosed.

About SkinMedica
SkinMedica, Inc. is focused on developing, acquiring and commercializing products that improve the appearance of skin. The Company markets and sells to physicians, with a focus on aesthetics, both prescription and non-prescription skin care products. The Company’s full line of aesthetic skin care products includes the revolutionary TNS Essential Serum™ and hallmark TNS Recovery Complex®. The formulations in the Company’s clinical skin care collection enhance skin appearance, reduce signs of aging and provide other skin care benefits.

SkinMedica’s primary prescription product is VANIQA® (eflornithine hydrochloride) Cream, 13.9%, the only FDA-approved prescription product for the reduction of unwanted facial hair in women.

SkinMedica is based in Carlsbad, California. For more information, visit: www.skinmedica.com.

TNS Recovery Complex®, VANIQA®, and SkinMedica®, are registered trademarks of SkinMedica, Inc and affiliates.

About Colorescience Pro
Experience makeup that does more. Colorescience Pro’s high-performance cosmetics were created to remedy and camouflage specific skin concerns and protect skin from the damaging effects of the sun and environment. Its dermatologist recommended formulations blend and layer together to achieve an instant and easy flawless face. Colorescience Pro’s luxury aesthetic makeup line is sold in the medical, spa and aesthetician channel.

About VMG Partners
VMG Partners is a private equity investment firm with an exclusive focus on acquiring highly branded consumer products companies in the lower middle market. The firm’s defined set of attractive target industries include lifestyle, wellness, food/beverage, personal care, pet and leisure. The firm is led by a seasoned group of partners who have worked together over many years and whose complementary operating, marketing, and investing skills help to source proprietary transactions and enhance the value of the brands they acquire. The firm currently has $700 million of committed equity capital. VMG Partners is headquartered in San Francisco and Los Angeles.

Source: SkinMedica

Envy Medical Announces New Lumixyl® Revitaleyes Brightening Eye Cream

WESTLAKE VILLAGE, Calif., Nov. 30, 2011 /PRNewswire/ — Envy Medical Inc., announced the launch of the Lumixyl Revitaleyes Brightening Eye Cream, the latest addition to the Lumixyl Topical Brightening System of products for an even skin tone and a brighter, healthier complexion.

What makes Lumixyl Revitaleyes special? It is the first and only eye cream formulated with decapeptide-12 as part of a truly comprehensive treatment to correct dark circles, eye-area lines and wrinkles, dryness and inflammation. Most other products tackle just one or two of these issues, leaving behind unresolved problems. First introduced in the popular Lumixyl Brightening Creme, decapeptide-12 is the Stanford University developed technology that is clinically shown to reduce the appearance of hyperpigmentation in skin without causing the irritation or redness associated with other brands. Combined with other potent ingredients, Lumixyl Revitaleyes addresses all of the major contributing factors to dark circles under the eyes. The result is brightness, smoothness, and firmness that is truly age defying.

“Physicians and their patients have been telling us that they don’t have good options for treating dark under-eye circles,” says Curtis A. Cluff, Chief Executive Officer of Envy Medical, Inc. “We realized that there was no single product that comprehensively addressed the issues in a safe and effective manner. Envy Medical is in a unique position to do just that using the Lumixyl peptide technology as part of a comprehensive formulation to diminish under-eye circles, no matter what the contributing factors are.”

“Our formula pairs industry proven ingredients that help with dermal iron deposits and inflammation with our proprietary skin brightening decapeptide-12 technology, making Revitaleyes the most comprehensive, professional-strength treatment for dark under-eye circles on the market today,” states Felipe Jimenez, Ph.D., Chief Scientific Officer for Envy Medical.

In fact, Lumixyl Revitaleyes Brightening Eye Cream expertly addresses the six biggest eye-area complaints, including:

SYMPTOM & ACTIVE INGREDIENT

Hyperpigmentation
Decapeptide–12 (Lumixyl peptide) – Reduces overproduction of skin pigment to brighten around the eyes

Iron Deposits
Chrysin, N-Hydroxysuccinimide, EDTA – Removes discoloration caused by iron deposits in skin tissue around the eyes

Inflammation
Dipotassium Glycyrrhizate – Inflammation casts a shadow around the eyes. This botanical anti-inflammatory naturally reduces this type of darkness

Dry Lines
Glycerin, Butyrospermum Parkii (Shea) Butter, Sodium Hyaluronate — Promotes smooth texture and reduces the appearance of fine-line wrinkles

Wrinkles
Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Bambusa Vulgaris Extract, Pisum sativum (Pea) Extract–A powerful anti-aging cocktail that reduces the appearance of crepiness around eyes

These proven potent ingredients are together for the first time, delivering improved eye lift, tone, texture and vitality never before achieved by a standard eye cream. The product will be sold through dermatology, cosmetic surgery and medical spa physicians throughout the United States. Suggested retail price is $65.00 per 0.5 oz tube.

About Envy Medical
Envy Medical develops, markets and sells highly effective non-invasive skin rejuvenation therapies for patients suffering from either dermatologic or aesthetic conditions. The Company’s lead products include SilkPeel®, a breakthrough device combining exfoliation with Dermalinfusion™ for deeper tissue delivery of active ingredients and better patient outcomes.

Envy is also the exclusive licensor of skin brightening peptides including Lumixyl, developed at Stanford University. The Lumixyl peptide is now also available as a topical solution for SilkPeel procedures, addressing hyperpigmentation and photo-damage.

Envy Medical
888.848.3633
www.envymedical.com

Source: Envy Medical Inc.

Pollogen Receives CE Mark for TriFractional™ - An Advanced Anti-Aging Technology

Exclusively on the Maximus complete anti-aging platform, TriFractional enables deep, effective fractional skin resurfacing – an in-demand aesthetic treatment.

Tel-Aviv, Israel (PRWEB) - Pollogen announced that it has received the Medical CE Mark for its TriFractional product, a fractional skin resurfacing technology based on radiofrequency. Treatments with TriFractional technology work on all skin types, penetrate to the mid-dermis for substantial skin renewal, cause minimal damage to the epidermis and enable the patients to easily schedule in this lunch-time procedure. TriFractional is effective for the reduction of wrinkle, scars - including acne scars - and pigmentation, as it also improves the texture and firmness of the skin.

An innovation on other fractional products, the TriFractional applicator uses a special algorithm to introduce radiofrequency energy to the skin which enables deep penetration to the mid-dermis with minimal discomfort, for one of the most effective fractional skin resurfacing treatments. The TriFractional RF energy creates tiny wounds which trigger the body’s natural healing response mechanism, inducing neocollagenesis and creating healthy skin cells. After the treatment, the untreated areas in the skin layers function as healing centers.

TriFractional is an add-on module to Pollogen’s flagship multi-application Maximus platform, adding fractional technology to Pollogen’s leading proprietary technologies – TriLipo Radiofrequency (RF) and TriLipo Dynamic Muscle Activation (DMA). Using these three technologies, the Maximus platform enables physicians to treat four layers of tissue: epidermis, dermis, muscles and fat, which no other single aesthetic device is able to do. The wide range of skin applications for both the face and body possible with Maximus, include wrinkle reduction, improved appearance of acne scars, firmed and rejuvenated skin, facial contouring, skin tightening, cellulite reduction, long-lasting circumferential reduction, stretch mark improvement and lifting, toning and firming of muscles.

Alex Levenberg, M.D., from the Physicians Center, Plastic Surgery Department in Tel Aviv, Israel, commented: “I have been using Pollogen’s Maximus with the new TriFractional applicator and the results I’ve seen on my patients are impressive. I’ve used the TriFractional solution for treating wrinkles, acne scars and improving skin complexion with a high degree of patient satisfaction. The treatment is quick and the results can be seen after one treatment.”

Pollogen’s CEO, Mr. Amichai Bar-Nir, stated, “Pollogen is pleased to receive the CE Mark for TriFractional, it is aligned with our strategy to consistently introduce compelling new products to our customers. The Maximus platform has been very well received in the 60 countries in which Pollogen products are sold and we expect the TriFractional module for this platform to enhance sales, since it answers patients’ demand for a fast and effective anti-aging procedure that does not interrupt their daily routine.”

About Pollogen
Pollogen Ltd. Is a global leader in the medical aesthetic market providing innovative, safe and effective solutions for women and men that enhance the practices’ of medical aesthetic professionals. The company offers products to address a range of skin treatments under the industry’s three premier brands: TriPollar®, TriLipo® and TriFractional™.

Pollogen offers a full line of clinically-proven, non-invasive anti-aging facial and body contouring treatment platforms for wrinkle treatment, skin tightening, acne scarring, circumference reduction and cellulite reduction. Pollogen’s medical aesthetic devices, Maximus, apollo, and regen XL offer customers clinically-proven, safe and effective anti-aging lunchtime beauty treatments that deliver immediate and long-lasting results, With a distribution network in over 60 countries, Pollogen is providing innovative solutions to medical professionals globally.

Pollogen Ltd.
866.640.6397
www.pollogen.com

Source: Pollogen

Pollogen Launches the TriLipo MED Anti-aging Procedure at the EADV

Clinical evidence confirming the benefits of the TriLipo MED procedure for anti-aging facial treatment as well as body contouring and cellulite reduction will be presented by G. Buendía, M.D. and A. Levenberg, M.D. during the upcoming EADV conference. A technological breakthrough, TriLipo MED allows for treatment of 4 layers of skin tissue, using 3 advanced technologies all within a single system.

Tel-Aviv, Israel (PRWEB) - Pollogen Ltd., a global leader in medical aesthetics, launched its latest development - the TriLipo MED procedure in Europe during the prestigious European Academy of Dermatology and Venerology Meeting (EADV) held in Lisbon, Portugal last month, October 20-24, 2012. The procedure is a breakthrough in aesthetic medicine since it allows practitioners for the first time to safely and effectively treat all four layers of the skin- the epidermis, dermis, hypodermis and muscle using a single system. By treating all four layers, practitioners can significantly improve and rejuvenate most facial and body areas. The anti-aging results are impressive- a significant reduction in wrinkles, lax skin, scars, cellulite and body circumference.

The TriLipo MED procedure is available using a single system, the Maximus platform, which can deliver three advanced proprietary technologies- TriLipo RF, TriLipo DMA and TriFractional. TriLipo radiofrequency (RF) is used to for skin tightening, cellulite reduction and fat reduction. The TriLipo dynamic muscle activation (DMA) is used on the body to clear released fat and on the face to “lift” the SMAS (Superficial Muscular Aponeurotic System). The TriFractional technology enables effective fractional skin resurfacing used on delicate areas such as the face, neck and décolleté. Combined, the technologies complement each other to provide enhanced anti-aging results.

During the EADV meeting, Gabriel Buendía, M.D., from the world rewound Médico Teknon Center in Barcelona, Spain will lecture on “Non invasive optical measurements of the skin for efficacy assessment of a radiofrequency system combined with dynamic muscle activation (DMA) for cellulite treatment: A comparative study” (Friday, October 21st at 10:10). The 10 week randomized study included 28 patients and confirmed the safety and efficacy of Pollogen’s TriLipo RF and TriLipo DMA technologies for cellulite reduction and circumference reduction on the thighs. The results showed a reduction of up to 4.5 cm in treated vs. untreated thighs. There were no adverse events. Results were validated using optical measurements which enabled extensive and precise assessments of the treatment outcomes and which confirmed texture and firmness improvement. The 3D optical analysis showed a pattern of improvement of dimples, nodules, firmness and volume for the treated thigh. In addition, high frequency ultrasound measurements used during the study demonstrated dermis thickening as well as a reduction of hypodermis thickness in the treated thigh.

Gabriel Buendía, M.D., stated: “The Medico Teknon Center is an advanced aesthetic clinic. It is important for us to use cutting edge technologies in order to deliver the best anti-aging results for our patients. I am very pleased with the study results and impressed by the TriLipo MED procedure”.

Pollogen will host a Meet the Expert Session on Saturday, October 22nd from 14:30-15:30. During the session Gabriel Buendía, M.D., will lecture on “TriLipo MED Body Treatments” and discuss the safety and efficacy of the TriLipo procedure in treating a wide variety of aesthetic needs- body contouring, cellulite reduction and skin tightening. In addition, A. Levenberg, M.D., an Israeli plastic surgeon who has been using Pollogen’s technology for over 6 years, will lecture on “TriLipo MED Facial Treatments”. Dr. Levenberg has been using the TriLipo MED procedure both post-liposuction and facelifts and as a stand-alone anti-aging solution. In his talk, Dr. Levenberg will present case studies which confirm the effective short and long term results achieved using the Maximus system.

Alexander Levenberg, M.D., said: “I am very excited about the TriLipo MED procedure. I have used it for a wide variety of treatments and I have seen impressive results. With no downtime, I am able to quickly and effectively treat delicate areas such as wrinkles around the lips and eyes, and post-liposuction the procedure enhances the results and accelerates the recuperation period”.

Amichai-Bar Nir, Company CEO stated: “Pollogen is dedicated to delivering innovation. The TriLipo MED procedure is an inclusive solution that provides a great deal of treatment flexibility. Physicians can use 3 technologies on 4 layers of skin tissue with a single system. We are excited about the TriLipo MED procedure and confident that it will quickly become the industry standard. “

About Pollogen
Pollogen Ltd. Is a global leader in the medical aesthetic market providing innovative, safe and effective solutions for women and men that enhance and expand the practice of medical aesthetic professionals. The company offers products to address a range of skin treatments under the industry’s three premier brands: TriPollar®, TriLipo® and TriFractional™.

Pollogen offers a full line of clinically-proven, non-invasive anti-aging facial and body contouring treatment platforms for circumference reduction, cellulite reduction and skin tightening. The company’s medical aesthetic devices, Maximus, apollo, and regen XL offer customers clinically-proven, safe and effective anti-aging lunchtime beauty treatments that deliver immediate and long-lasting results, With a distribution network in over 60 countries, Pollogen is providing innovative solutions to medical professionals globally.

Pollogen Ltd.
866.640.6397
www.pollogen.com

Source: Pollogen

LIMITED HOLIDAY EDITION
Le Grand Sérum
Enhancing elixir

Among all signs of aging, those associated with the skin are naturally the most visible.

While skin quality is partially determined by genetics, cutaneous aging occurs increasingly more prematurely and becomes further exacerbated by the hormonal deficiencies arising with menopause, excess sun exposure and all incidence of oxidative stress due to the harmful effects of free radicals. As a result, a shutdown in estrogen hormone production leads to a reduction in collagen and elastin fibers. The fundamental substance surrounding dermal cells is modified and changes the very cohesion of the cells. Skin becomes slack and loses its suppleness.

Ultraviolet light increases the breakdown rate of skin’s constituent elements by comparison to their production. Consequently, skin becomes thinner and less resistant. Free radicals, the unstable molecules generated by our metabolism, are mostly trapped and transformed into substance by anti-free-radical mechanisms in a young body, but this line of defense loses its effectiveness over time. When free radicals build up excessively within the body, they attack cellular membranes and our precious DNA. They are, therefore, responsible for premature tissue aging, causing collagen breakdown and accentuated wrinkles.

Thinner and less resilient than the skin on the body, facial skin is more exposed to sunlight and all other external aggressors. Accordingly, it requires suitable care.

The Biologique Recherche Solution

Ten years ago, the founder of Biologique-Recherche, Yvan Allouche, created Le Grand Millesime.
Today, the founder’s son, Dr. Philippe Allouche, and his team have revised this concentrate of luminescence and performance to boost its protective benefits and its appeal to the senses. The result, Le Grand Sérum, is a genuine concentrate of skincare benefits and long-lasting radiance, the serum of a timeless Instant.

Although Le Grand Sérum was initially introduced as an exclusive limited series due to the quality and complexities of both its formula and presentation, it will become available once again for the holiday season.

The Biologique Recherche serum with the richest formula in terms of active ingredients
With 27 active ingredients, Le Grand Sérum is a truly ubiquitous serum with global action. It boosts skin’s age-defying performance and effective self-defense against aggressions. Ideal before makeup application, this sublimating elixir works like a true beauty concentrate, enhancing skin’s natural glow and protecting epidermal hydration. Its effects gain in intensity with every use. Recommended for all Skin Instants®.

Actions
• Helps prevent premature skin aging.
• Tones, revitalizes and soothes the skin.
• Helps strengthen the skin’s natural defense system.
• Illuminates the complexion and moisturizes the outer skin layers.

Results
• An exceptional result that leaves the skin plumped up, toned and glowing.
• Procures a genuine booster effect on the skin.

Active Ingredients Against Signs of Premature Skin Aging
Amino acids, Complex based on Elder, Chestnut and Tropical Almond Extract, Watercress Extract

Anti-Free Radical Active Ingredients
Mimosa Extract, Cranberry Extract, Wasabi Extract, Vitamin B1,B6,PP Complex, Cider Vinegar

Soothing Active Ingredients
Rhamnose-rich polysaccharides, Kudzu Extract, Essential oil of Carvone, Essential oil of Jasmine

Moisturizing Active Ingredients:
Reconstituted Natural Moisture Factors, Hyaluronic Acid, Rhizobian Gum, Silk Extract, Gluconolactone, Vitamin B3

Toning Active Ingredients:
Cucumber Extract, Complex made with Witch Hazel and St. John’s Wort Extract, Black Crowberry Juice, Essential oil of Mint

Directions for use:
Home use: This serum for a magical Skin Instant can also be repeatedly applied as a month-long treatment. Apply a few drops of Le Grand Sérum to clean skin all over the face, neck and décolleté with light upward strokes. Use mornings and/or evenings.

Please note: Due to its rich composition featuring a high concentration of active ingredients, Le Grand Sérum may be used alone.
However, it may also be applied after the recommended cream when used on mature skin types.
Version: 1.02 oz. Professional Price: $200
4.24 oz. Professional Price: $320

Availability for sale: October 2011
Limited golden bottles in numbered golden boxes, embossed with the Biologique Recherche flower.

BIOLOGIQUE RECHERCHE
212.989.6077
www.biologique-recherche.us

Source: Biologique

Evelyn Lauder Dies, Co-Founder Of Pink Ribbon Breast Health Awareness

Chances are that at some point you’ve donned a small pink ribbon supporting awareness of breast health and efforts to fight breast cancer. Chances are you might not recognize one of the women who brought it to universal prominence. Evelyn Lauder died on Saturday. She was a vice president of the cosmetics corporation founded by Estee’ Lauder, her powerful mother-in-law. The Estee Lauder Companies says Evelyn Lauder, who was 75, died at home in New York of non-genetic ovarian cancer.

It wasn’t her first bout with cancer. Evelyn Lauder spent more than 20 years raising awareness of a different ailment; she was diagnosed with breast cancer in 1989, and used her experience to increase awareness of the disease among others. In 1992, Lauder, her husband Leonard, and friend Alexandra Penney, started handing out tiny pink lapel ribbons, according to CBS.

These were distributed at Estee Lauder makeup counters, and many people mistakenly thought it was part of an AIDS awareness campaign. She told CBS:
“There had been no publicity about breast cancer, but a confluence of events - the pink ribbon, the color, the press, partnering with (model) Elizabeth Hurley, having Estee Lauder as an advertiser in so magazines and persuading so many of my friends who are health and beauty editors to do stories about breast health - got people talking.”

The fundraising proceeds also helped Lauder found the Breast Cancer Research Foundation in 1993. She led another fundraising effort that created the Evelyn H. Lauder Breast Center at Memorial Sloan-Kettering Cancer Center in New York City.

Her life story is compelling: in addition to the positions she held within the Estee Lauder Companies, she was also an accomplished photographer and recently published a cookbook, according to the Breast Cancer Research Foundation. She worked for several years as a New York City public school teacher before she joined the Lauder family business.
Evelyn Lauder said she learned well before her marriage that her mother-in-law was tough; according to the New York Times (paywall), Estee Lauder “implored” Evelyn to run the birthday party for her son, Leonard, and Evelyn’s eventual husband. It was only their second date, but Evelyn accepted. Evelyn said she later spoke more frankly to Estee as she worked in the family business, and credited her childhood as a refugee from the Nazis with her strength of mind.

The report adds Evelyn Lauder escaped Vienna, Austria with her parents in 1938 after Hitler annexed the country. The family eventually arrived in England where they were separated for a time. In 1940, they sailed to New York.

Lauder is survived by her husband, Leonard, two sons, a daughter-in-law, and five grandchildren. Memorial details haven’t been announced.

Source: NPR

KYTHERA BIOPHARMACEUTICALS Preliminary Long-Term Follow-Up Study Results from Phase 2 Trials with ATX-101

Long-Term Study Results Through 2 Years Demonstrate Sustained Aesthetic Correction by Patient and Physician Evaluation and Long-Term Tolerability of ATX-101

LOS ANGELES, November 7, 2011 (Business Wire) – KYTHERA Biopharmaceuticals, Inc. (“KYTHERA”), a privately-held biotechnology company focused on the development and commercialization of prescription products in aesthetic medicine, today presented results from a long-term follow up study assessing persistence of efficacy and post-treatment safety of ATX-101, a first-in-class, injectable drug that is under investigation for the reduction of submental (‘under the chin’) fat. Kevin C. Smith, MD, FAAD, FRCPC presented study results from the first two years of a 5-year follow up on Phase 2A patients at the 2011 Annual Meeting of the American Society for Dermatologic Surgery (ASDS) in Washington, DC.

As of mid-2011, 45 responders, defined as ATX-101 treated subjects who exhibited a 1-point improvement based on physician assessment (CR-SMFRS) at the completion of Phase 2A studies, have enrolled in the long-term follow-up study. Preliminary results demonstrate that at a 2-year follow up visit, 90% of these subjects sustained or improved their response based on physician evaluation using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS). Additionally, 80% of these subjects demonstrated sustained or improved satisfaction based on patient evaluation using the Subject Satisfaction Rating Scale (SSRS). No new adverse events were reported during the 2-year follow up evaluation period.

“These results from such a rigorously controlled study are encouraging as they address key questions in terms of long-term safety and durability of the aesthetic correction with ATX-101,” said Kevin C. Smith, a board-certified dermatologist in private practice in Niagara Falls, Ontario, Canada and an investigator in the Phase 2A and long-term follow up studies. “Treatment results with ATX-101 appear to be sustained and well-tolerated, which illustrates its potential as a novel, non-surgical approach to reducing submental fat.”

Results from two randomized, double-blind, placebo-controlled, dose-ranging Phase 2A studies were originally presented at the Scientific Session during the 2009 American Society for Dermatologic Surgery (ASDS) and American Society of Cosmetic Dermatology and Aesthetic Surgery (ASCDAS) Joint Annual Meeting. In both studies, clinical response was evaluated by physician assessment using a validated, 5-point Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and by subject assessment using a 7-point Subject Satisfaction Rating Scale (SSRS). Results demonstrated that ATX-101 was well tolerated and the most common adverse events were mild pain, swelling, numbness, bruising and induration. Additionally, ATX-101 yielded statistically significant reductions on both physician and subject assessments versus placebo in all dose groups (baseline to week 16, p<0.05).

Subjects who completed participation in the Phase 2A studies were eligible to enroll in a long-term follow-up study allowing evaluation of safety and efficacy measures for up to 5 years. Efficacy measures include physician and subject assessment using CR-SMFRS and SSRS, respectively.

“While these results are still preliminary, they support our expectation that ATX-101 may result in a long-term aesthetic correction,” said Patricia Walker, MD, PhD, KYTHERA’s Chief Medical Officer. “We look forward to continuing to follow these patients and to further characterizing the long-term safety and efficacy profile of ATX-101.”

A poster highlighting results from a Phase 2B study with ATX-101 using investigator, subject and magnetic resonance imaging assessments was also presented by Jeffrey S. Dover, MD, FRCPC, a board-certified dermatologist in private practice in Chestnut Hill, MA and an investigator in the ATX-101 Phase 2B study.

KYTHERA has completed extensive development work on ATX-101 for the reduction of submental fat, completing seven clinical trials in more than 350 subjects. European Phase 3 studies of ATX-101 were initiated in late 2010 (with completed enrollment of more than 700 subjects) in collaboration with Bayer’s Dermatology unit, which has licensed rights to ATX-101 outside of the U.S. and Canada.

About ATX-101
ATX-101 is a first-in-class injectable drug being studied for the reduction of localized fat. ATX-101 is a proprietary formulation of deoxycholate, a well-studied endogenous compound that is present in the body to promote the natural breakdown of dietary fat. ATX-101 reduces subcutaneous fat through localized fat cell membrane disruption followed by elimination from the treated area. This mechanism may enable a non-surgical alternative for the reduction of subcutaneous fat. Clinical studies to date have demonstrated that ATX-101 is well tolerated and may effectively reduce localized fat in the submental (‘under the chin’) area. Three randomized, double-blind, placebo-controlled, Phase 2 studies with ATX-101 in the reduction of submental fat and four Phase 2 studies (pharmacokinetic, histology, lipid and tolerability) have been successfully completed. Also, two Phase 3 randomized, double-blind, placebo-controlled studies are ongoing in Europe in collaboration with the Dermatology unit of Bayer, who has licensed the development and commercialization rights to ATX-101 outside of the U.S. and Canada. .

About KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc. is a privately held, clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic market. KYTHERA’s lead clinical program, ATX-101, is focused on the reduction of submental (‘under the chin’) fat. The company also has active research programs with focused interest in hair and fat biology, pigmentation modulation and facial contouring. Find more information at www.kytherabiopharma.com.

About Bayer Dermatology
The Dermatology unit of Bayer is an integrated pharmaceutical business with its headquarters in Berlin, Germany, dedicated to offer solutions to treat skin diseases with an annual sales of EUR 300 million (2010). Bayer Dermatology is part of Bayer HealthCare and focuses on the development, manufacturing and marketing of high quality, innovative topical therapies. The current product portfolio comprises treatments of eczematous disorders including atopic dermatitis, acne, rosacea, hemorrhoidal disease and fungal skin infections (mycoses). Find out more at www.dermatology.bayer.com.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of more than EUR 16.9 billion (2010), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 53,700 employees and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.

Portrait Plasma Skin Regeneration Resurfaces at Prestigious Symposium

NYACK, N.Y. and SWANSEA, Wales, Sept. 14, 2011 /PRNewswire/ — At the historic Grove Park Inn in Asheville, North Carolina, Portrait Plasma Skin Regeneration returned as a technology discussed at the advanced symposium, Controversies & Conversations in Laser and Cosmetic Surgery, directed by Drs. Kenneth A. Arndt and Jeffrey S. Dover of SkinCare Physicians of Chestnut Hill, MA. In the session titled, “Does the choice of wavelength energy sources and/or use of fractionation make a difference in the treatment of photo-aging and scarring,” pre-eminent panelists presented and discussed clinical results and attributes of an array of technologies used in their practices.

Portrait Plasma Skin Regeneration has returned to the market under new ownership and worldwide support by the Energist Group (Swansea, UK and Nyack, NY). Portrait is FDA-cleared for the treatment of superficial and deep wrinkles, skin discoloration, precancerous and benign skin lesions, as well as acne scars. Chris Zachary, MD, Chair of Dermatology, University of California, Irvine, had commented, “I am personally delighted to see this technology back in the market, as it provides a well-researched and very effective mechanism for skin rejuvenation.” And as a panelist at Controversies, he further stated, “We’re delighted to use plasma again.” Ken Arndt, MD, director of the symposium, added, “Yes, we’re all glad it’s back.”

Portrait Plasma provides dramatic cosmetic results by delivering a unique thermal profile that stimulates a significant response by the entire skin architecture without creating an open wound like ablative, chromophore-targeted, and fractional technology procedures. Suzanne Kilmer, MD, founder of the Laser & Skin Surgery Center of Northern California, and past president of The American Society of Lasers in Medicine and Surgery (ASLMS), commented, “Where to deliver heat is the key in treatments.” She further said, “Having the skin intact is very important and acts as a natural biological dressing; it is less uncomfortable for the patient….This is the beauty of the [plasma] technology, and Portrait also provides significant tightening.”

Brian Biesman, MD, oculoplastic and laser surgeon, founder of the Nashville Centre for Laser and Facial Surgery and also a past president of ASLMS, who performed an extensive clinical study of Portrait Plasma to treat and tighten the upper and lower eyelids, added that, “Portrait is more versatile compared to full CO2 [treatments].” In the aesthetic, non-surgical skin treatment market for wrinkles and sun damage, full/non-fractionated CO2 has been considered the gold standard of treatment.

Jonathan Prutton, CEO of Energist Group, commented, “We are delighted to hear the comments from such a prestigious panel of experts at the Controversies symposium. Portrait Plasma is a keystone technology for Energist. We’re up and running to provide nozzles and support to the physicians who already own the system and to new customers now acquiring the technology. The unique Portrait system offers a wide range of treatments from lunchtime/MedSpa to full resurfacing procedures, making it one of the most versatile, as well as effective, aesthetic technologies available in the market today.”

The Portrait Plasma technology, clinically proven in over 30 IRB studies and in day-to-day clinical use in some 500 installations worldwide, is in its infancy compared to lasers, light sources, and radio frequency treatments. Prutton further commented that, “Portrait Plasma’s full potential is yet to be realized — and Energist is committed to developing the future of plasma skin regeneration for patients and providers of the treatments.”

About Energist Group
Energist Group is a leading supplier of light-based, laser, and plasma energy devices to the cosmetic and beauty markets worldwide providing solutions for anti-aging of the skin, body shaping, vascular treatments and the removal of unwanted hair. Energist Group is headquartered in Swansea, Wales, (UK), with other operations in Copenhagen (Denmark), Stettfeld (Germany) and Nyack, NY (U.S.), with distribution in over 50 countries and over 9000 systems placed worldwide.

Energist Group - North America
845-348-4900
www.energistna.com

Source: Energist Group

EndyMed Pro Unique Multisource RF 3DEEP® Technology

Long-term controlled study published in the Journal of Clinical Aesthetic Dermatology shows persistent reduction of body circumference up to 12 months after the end of treatment.

Caesarea, Israel – June 27, 2011 – A newly published study conducted by the world renowned Instituto Medico Laser in Madrid, Spain has confirmed that the EndyMed PRO radiofrequency (RF) treatment system is a very safe and effective treatment option for long-term body shaping and circumference reduction. In addition, the study shows that EndyMed PRO’s unique Multi-Source RF 3DEEP® technology continues to provide positive long-term results, up to 12 months after completion of treatment. These long-term results show a significant advantage of EndyMed’s 3DEEP® technology over other radiofrequency technologies that have failed to prove the same level of long-term continuous effects after treatment completion in a controlled peer reviewed study.

The EndyMed PRO study was conducted by Dr. Josefina Royo de la Torre, Dr. Javier Moreno-Moraga, Dr. Estefania Munoz and Dr. Paloma Cornejo Navarro. The study group was comprised of 33 women with an average age of 44.2 years. The women received six treatment sessions, with follow-up visits at 6, 9 and 12 months after the end of the treatment. The study shows that there was significant difference in circumferential reduction in the treated area at each of the follow-up visits, proving that patients who are treated with EndyMed’s 3DEEP® technology will continue to enjoy long-term effects well
after their treatment is finished.

VIEW THE SUMMARY OF THE PUBLISHED STUDY - CLICK HERE

About EndyMed Medical, Ltd.
EndyMed Medical, Ltd., established in 2007, is a medical device company that develops and commercializes energy-based aesthetic treatment systems for the professional markets. EndyMed’s management, clinical, marketing and R&D teams have extensive experience in the medical aesthetic market. With the leading proprietary Multisource 3DEEP® radiofrequency technology and proprietary products like EndyMed PRO, the company is committed to changing the way aesthetic professionals perform fractional skin resurfacing and provide painless wrinkle reduction, skin tightening and body contouring solutions.

EndyMed Medical
800.759.6876
www.endymed.com

Source: EndyMed Medical

Suneva Medical Announces Canadian Approval of Bellafill(TM)

SAN DIEGO, CA – Suneva Medical, a privately-held aesthetic medical device company, announced the expansion of its core aesthetics injectable business with approval from Health Canada to market Bellafill(TM), its long lasting dermal filler for nasolabial folds or smile line correction. In addition to offering patients a unique, long-lasting treatment, Bellafill provides physicians the opportunity to provide a differentiated, premium product and enhance their practice economics.

“Temporary hyaluronic acid based fillers are quickly becoming recognized for what they were designed to be, a short term fix to a lifelong aesthetic issue. Additionally, patient fatigue with temporary fillers and a desire by physicians to differentiate their practices by offering unique and premium products, creates a significant opportunity and benefit for the patient, the physician and the Company ,” commented Nicholas Teti, Chairman and CEO of Suneva Medical, Inc. “Canadian approval of Bellafill allows Suneva to meet this growing demand in the market. The approval of Bellafill is also an important milestone in our overall international expansion strategy. We are currently evaluating our options for a Canadian launch; in addition, we have established international partnership agreements in several countries around the world and expect a number of international product launches later this year.”

Bellafill is composed of bovine collagen and unique, third generation, engineered microspheres and includes lidocaine for improved patient comfort. This distinct formulation offers patients long-lasting wrinkle correction. In addition, the proprietary microsphere production process provides tightly controlled microsphere size and an enhanced safety profile versus products previously sold in Canada. Bellafill meets the rigorous standards of quality and safety of Health Canada. A pre-treatment allergy test is optional. In clinical trials, Bellafill demonstrated a significant duration of correction and a positive safety profile with no significant device-related adverse events.

About Suneva Medical
Suneva Medical, Inc. is a medical technology company focused on developing, manufacturing and commercializing novel, differentiated aesthetic products for the dermatology, plastic and cosmetic surgery markets. The Company’s long-lasting injectable product is marketed as Artefill® in the U.S. and Bellafill(TM) in Canada to correct facial wrinkles.

Suneva Medical
858.550.9999
www.sunevamedical.com

Source: Suneva