BOSTON & TORONTO--BTL Industries, a leading developer and manufacturer of medical equipment for aesthetic medicine, physical therapy and cardiology, today announced Health Canada approval to market and distribute its EXILIS RadioFrequency(RF) device in the country. EXILIS Focused RF™ technology hit the “superfecta” with Canadian clearance for use in non-invasive body contouring, fat removal, wrinkle reduction and skin tightening. Health Canada approval is similar to U.S. Food and Drug Administration clearance.
Unlike traditional radiofrequency devices, EXILIS is intelligently engineered so that a trained professional can deliver the maximum thermal energy to the desired depth of penetration while monitoring skin temperature in real time. This clinical ability to beneficially affect only targeted tissue in the shortest amount of time makes EXILIS a highly effective aesthetic solution. Treatments are precise, quick and well-tolerated, providing impressive results with utmost patient safety and comfort.
Marcel Besse, President of BTL Aesthetics, said, “We are very pleased about the Health Canada clearance of EXILIS and are proud to be the first focused radiofrequency technology in North America to receive approval for four aesthetic indications. Securing these regulatory clearances indicates the integrity of our compelling data regarding EXILIS’ safety and efficacy.”
The launch of EXILIS RF in Canada will be spearheaded by BASIS Medical Technologies, well-established specialists in the development and distribution of groundbreaking medical aesthetic technologies. The company’s direct sales force will support EXILIS in the Canadian market where it holds exclusive market representation rights.
“We are excited to join forces with BASIS to introduce EXILIS to a new segment of professionals who seek a predictable aesthetic solution to wrinkles, lax skin and stubborn pockets of fat. We are confident that our partnership with BASIS will provide clinicians a global distribution and development platform that can help them expand their consumer base and achieve high patient satisfaction,” Mr. Besse added.
John McCahill, BASIS’ CEO, said, “We look forward to working in cooperation with our new partner to foster the continued success of its technology in Canada.” According to Mr. McCahill, EXILIS has the potential to be a win-win for physicians and patients. It delivers the convenience and fast results patients want with Focused RF technology that is safer and more targeted than conventional rival treatments. At the same time, it is economical for physician practices because EXILIS is affordable, there are no costly disposables, and no topical anesthesia is required. “It nicely fills a void in the physician’s menu of services by providing one RF platform with multiple applications and high utilization.”
About BTL Industries Limited
BTL Industries Limited designs, manufactures and sells medical equipment for physical therapy, cardiology, and medical aesthetics. Headquartered in Prague, the Czech Republic, the Company is among the world’s five largest physical therapy manufacturers. For the past 18 years, BTL Industries supplies its products through distributors designated for each country, or through its sales subsidiaries. Its major markets include the European Union, East Asian markets, and the United States.
Since 2009, BTL Aesthetics division takes the company into aesthetic medicine with non-surgical devices that represent the best in skin tightening, anti-cellulite care, anti-wrinkle treatment, body shaping and fat reduction. For more information, please visit www.exilis.com.
In 2010 the global aesthetic lasers and energy devices market was valued at US$1.1 billion. This is forecast to reach $2.4 billion in 2017 which is more than double. Companies such as Ultrashape, Pollogen, Invasix, and Medicis are awaiting further FDA approvals to launch their non-invasive aesthetic lasers and energy devices in the US
Currently the market is fragmented with no clear dominant player. This has provided an even playing field for newcomers and has also resulted in a reducing price trend in the market. Prices of invasive and minimally invasive devices have declined by about 30% to 40% in the past two years. The reducing price trend is expected to continue, with an increasing number of companies trying to enter the market.
The increasing preference for non-invasive devices. is expected to continue bringing down the prices of both invasive and minimally invasive aesthetic lasers and energy devices. The global non-invasive aesthetic lasers and energy devices market was valued at $519.9m in 2010, and is forecast to reach $1,487.5m in 2017.
In 2009, body contouring was ranked among the top five aesthetic procedures performed worldwide, as per the American Society for Aesthetic Plastic Surgery (ASAPS). Globally, more than 50% of the body contouring procedures performed is non-invasive. About 80% of the skin resurfacing procedures performed globally is non-invasive.
Non-invasive devices are found to provide superior results when used in combination with minimally invasive devices such as laser assisted lipolysis. Fusion with minimally invasive devices enables a significant amount of fat reduction, intended for obesity intervention.
This video shows the Liposonix procedure. It's one of those procedures hoping to be approved soon by the US FDA. Its currently approved in Europe in Canada
Source: Based on a report by Companies and Markets -> www.companiesandmarkets.com/Market-Report/aesthetic-lasers-and-energy-devices.....
View all our laser lipoplasty devices to date in the biotech directory
The makers of 3DEEP have received US FDA clearance for their Fractional Skin Resurfacing Applicator. Its an additional module for the EndyMed PRO multi-application treatment platform. The Fractional Skin Resurfacing Applicator utilizes multi-source RF to provide safe and effective resurfacing of the skin.
According to Klaus Fritz, MD, a board certified dermatologist and president of the European Society of Laser Dermatology (ESLD), 3DEEP fractional skin resurfacing is effective also in treating scars.
View press release-> prweb.com/releases/FDA_Clearance/3DEEP_RF_Fractional....
Until now, treatment for excessive underarm sweating (Hyperhidrosis) has been limited. Drugs and surgical options both involve interupting the nerves that feed the sweat glands. Botox has been indicated for excessive sweating but has a temporay effect.
A new permanent procedure called MiraDry has been approved for excessive underarm sweat by the FDA. The miraDry procedure takes around an hour per visit and works by delivering electromagnetic energy to the sweat glands under the arms. This results in thermolysis of the sweat glands. Typically two sessions are required using only a local anesthetic. There is little to no downtime, and the result is a lasting solution which can be seen almost immediately. The miraDry procedure will be available later in 2011 through miraDry-certified dermatologists.
French company Osyris Medical has received FDA approval for its LipoControl System. The LipoControl is the newest generation of 980nm diode for laser assisted lipolysis. It has "real time" Energy Mapping technology with motion sensing and Energy Memory features included.
The laser power automatically increases as the speed of cannula increases and decreases as it slows down. The power is cut completely when it stops moving. This technology is patented and only available from Osyris Medical themselves.
The CO2RE fractional CO2 resurfacing system has received US FDA and Health Canada approvals meaning it can now be used across North America. The new CO2RE system is lighter, faster and a more versatile solution for skin resurfacing, wrinkle reduction and scar reduction. Multi-depth pulse technology means it offers the ability to treat both superficial and deep skin layers at the same time with precision. Overall, less treatments mean less discomfort and downtime.
The CO2RE product was developed by Inlight Inc., San-Diego, California. which was acquired by Syneron of Israel at the end of 2008. It is optimal for fairer skinned patients of Fitzpatrick skin types I-III. There are seven different treatment modes - four fractional ablative treatments, a traditional resurfacing mode, and two excision modes.
Yet another way to loose fat by laser has been approved by the US FDA. The i-Lipo Ultra created by Chromogenex adds to our directory of laser lipo procedures. Our known total of laser lipo procedures is now four. View all here
According to the press release the i-Lipo Ultra is non-invasive and painless. It reduces the appearance of cellulite and helps slim fatty body areas over a short period of time without needles and down time. The treatment is a stimulus to jumpstart the body's ability to dissolve fat in a safe and effective way. The treatments are zone specific, meaning that common areas of the body like love handles, abs, thighs, stomach, buttocks and even the chin can be focused on.
The CoolSculpting system, a cryolipolysis device made by ZELTIQ has just received approval from the FDA. The device works by zapping fat cells which are located under the skin simply by freezing them, resulting in no damage at all to your skin. All dead cells are naturally flushed from the body, resulting in as much as a 20% fat reduction in the treated areas, apparent within four months after treatment and sometimes in as little as three weeks. CoolSculpting with Zeltiq, was previously approved for skin cooling during dermatological treatments.
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Regular users of Botox can potentially spread apart their treatments and save some money. After two years of treatment at recommended intervals, the frequency of Botox treatments can be cut by half. That's the finding from a study done at the Oregon Health & Science University.
"After two years of treatment at recommended intervals, patients can potentially cut the frequency, and thus the cost, of their Botox® treatments by half," said Roger A. Dailey, M.D., F.A.C.S., professor and Lester Jones Endowed Chair of oculofacial plastic surgery in the OHSU School of Medicine. The results of Dailey's work were presented at a meeting of American Society of Aesthetic Plastic Surgeon on April 24 in Washington, D.C.
The Zerona laser is the first non-invasive body contouring procedure to effectively remove excess fat. The low-level laser works by causing stored fat to be released from fat cells. Treatment involves an average of six sessions over a two week period. Patients lie on a table for 40 minutes (20 minutes front and 20 minutes back), while the laser does its job. The average result has been 3 to 9 inches lost from waists, hips and thighs with the six sessions.
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