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Mesa firm gets FDA approval on ultrasound device

A Mesa startup company has developed a medical device that uses ultrasound technology to treat everything from sagging eyebrows to liver cancer.

Guided Therapy Systems of Mesa said the device allows doctors to see and treat tissue without using traditional surgery.

The device will be used initially for cosmetic purposes, but backers say the technology has the potential to treat tumors without invasive surgery.

Ulthera Inc., a Mesa-based spinoff of Guided Therapy, gained Food and Drug Administration approval in September to market the device for cosmetic facial treatment. The company now is building its sales staff to market the device to cosmetic dermatologists and plastic surgeons.

Yet Guided Therapy, which describes itself as a technology incubator, sees more possibilities for the ultrasound and imaging technology. Read more

               

Solta Medical Announces FDA 510(k) Clearance of New Fraxel re:store Dual Laser System

Solta Medical, Inc., recently announced it has received FDA 510(k) clearance for the new Fraxel re:store Dual laser system. The Fraxel re:store Dual system adds a novel 1927 nm wavelength, the first ever application of a Thulium laser in the aesthetics market, to the company’s existing technology. The new Fraxel re:store Dual system is optimized for both on face and large body areas to address clearance of pigmentation and other superficial skin conditions all in a single treatment, according to Solta Medical. Read more

               

Pharma bracing for tougher FDA guidance on trials

Transparency welcomed, but threat of added costs creates concerns.

Pharmaceutical companies in New Jersey and elsewhere face more stringent requirements from the Food and Drug Administration on disclosures of mishaps in clinical trials.

And while industry groups and advisers have broadly welcomed the increased transparency and the move toward safer drugs, they want these actions to strike a balance with the costs of complying with them.

As of Sept. 27, the FDA requires drug manufacturers to include the general public in disclosures on “adverse” and “serious adverse” events beyond the regulator and patients participating in trials, said Satish Tadikonda, president of Virtify Inc., in Cambridge, Mass., which provides compliance services to life sciences companies.

Adverse events are side effects like rashes or headaches, while serious adverse events are those that result in death, disability or life-threatening situations, among others, Tadikonda said. Read more

               

Palomar to Commercialize FDA Cleared Over-The-Counter Home Use Wrinkle Treatment Laser Device Without Johnson & Johnson

BURLINGTON, Mass., Oct. 16 /PRNewswire-FirstCall/ — Palomar Medical Technologies Inc. (Nasdaq: PMTI), a leading researcher and developer of light-based systems for cosmetic treatments, today announced the termination of its agreement with Johnson & Johnson Consumer Companies Inc (”JJCC”), a Johnson & Johnson company, to develop, clinically test and commercialize home-use, light-based devices for (i) reducing or reshaping body fat including cellulite; (ii) reducing appearance of skin aging; and (iii) reducing or preventing acne. Despite Palomar having met all of its deliverables under the agreement, JJCC terminated the agreement referencing the current unfavorable economic conditions as the reason for its decision. With this decision, JJCC avoids having to make a large commercialization payment to Palomar and avoids having to commit to the significant level of funding required to successfully launch a new product into the mass market. Upon termination of the agreement, JJCC’s license to Palomar technology was terminated and all technology and intellectual property rights related to light-based devices developed under the agreement were assigned to Palomar. JJCC is also precluded from further development or commercialization of the light-based devices developed under the agreement.

Palomar will continue with the commercialization of the light-based devices developed under the agreement. In June 2009, Palomar was the first company to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for a new, patented, home-use, laser device for the treatment of periorbital wrinkles. OTC clearance allows this wrinkle treatment device to be marketed and sold directly to consumers without a prescription. This consumer wrinkle treatment device was developed by Palomar and completed together with JJCC. Designed specifically for use in the home and based on years of research and clinical testing, this consumer device represents a major breakthrough in the aesthetic device industry.

In order to achieve FDA clearance, numerous clinical studies with hundreds of subjects and thousands of treatments were conducted. These studies demonstrated that the laser-based device delivers comfortable, effective, skin and eye safe wrinkle treatment around the eyes.

Commenting on this development, Palomar Chief Executive Officer Joseph P. Caruso said, “We have developed game changing technology in the consumer area. Over the past few years we have developed advanced patented technology that allows us to penetrate the home market. Wrinkle treatments using OTC products are a multi-billion dollar market opportunity and we plan on entering that market with our products during the second half of next year. The current economic climate does not warrant a large scale investment in a mass market launch at this time. Therefore, we have adjusted our launch plans to be more in line with current economic conditions. In the short-term, our goal is to establish our consumer products in the market using certain specialty channels and gather the valuable information needed to fully execute our long-term strategy of a full mass market launch. Our long-term goal remains the same; to tap into the mass market using our patented technology in a number of key areas with multiple product offerings and multiple channels worldwide”.

Mr. Caruso continued, “We believe that light-based anti-aging applications will one day be an ordinary and necessary part of maintaining a healthy appearance done in the privacy and convenience of the home. We were fortunate to have advanced this technology with the help of a partner who invested significant resources along the way in research, development, clinical testing, consumer testing, and patent protection that will make this a reality and ensure that Palomar maintains a leadership position in this innovative technology. We envision a strong market for this OTC device and an increase in consumer awareness that will help drive growth in our professional business.”

About Palomar Medical Technologies Inc:

Palomar is a leading researcher and developer of light-based systems for cosmetic treatments. Palomar pioneered the optical hair removal field, when, in 1997, it introduced the first high-powered laser hair removal system. Since then, many of the major advances in light-based hair removal have been based on Palomar technology. In December 2006, Palomar became the first company to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for a new, patented, home use, light-based hair removal device. In June 2009, Palomar became the first company to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for a new, patented, home use, laser device for the treatment of periorbital wrinkles. OTC clearance allows the product to be marketed and sold directly to consumers without a prescription. There are now millions of light-based cosmetic procedures performed around the world every year in physician offices, clinics, spas and salons. Palomar is testing many new and exciting applications to further advance the hair removal market and other cosmetic applications. Palomar is focused on developing proprietary light-based technology for introduction to the mass markets.

For more information on Palomar and its products, visit Palomar’s website at www.palomarmedical.com. To continue receiving the most up-to-date information and latest news on Palomar as it happens, sign up to receive automatic e-mail alerts by going to the Investor Relations’ section of the website.

    Contacts:  Kerry McAnistan
               Investor Relations Assistant
               Palomar Medical Technologies Inc.
               781-993-2411
               ir@palomarmedical.com

SOURCE: Palomar Medical Technologies Inc.
Kerry McAnistan, Investor Relations Assistant of Palomar Medical Technologies Inc., +1-781-993-2411, ir@palomarmedical.com

               

Drug Maker Sues FDA Over Ban on Offering Doctors Info About Off-Label Uses

The makers of Botox filed a lawsuit last week against the FDA, challenging federal regulations that ban drug companies from marketing drugs for uses that they have not been established as safe and effective through the FDA approval process.

Allergan Inc. filed the complaint Thursday in the U.S. District Court in Washington, D.C., saying that the FDA’s ban on “off-label” drug promotion by pharmaceutical companies violates their first amendment rights to free speech. The ban restricts Allergan from offering information about off-label use of Botox, an antiwrinkle drug that is used by many doctors for unapproved uses, such as treatment of muscle spaticity in children with cerebral palsy.

Although doctors are allowed to prescribe medications for non-approved uses, drug makers are prohibited from marketing those applications. Allergan says that the ban is unconstitutional and prevents them from offering truthful information and other data that could help doctors prescribe the drugs effectively and safely. Read more

               

Ulthera(TM) Receives First-Ever FDA Clearance to Market Ultrasound

MESA, Ariz., Sept. 16 /PRNewswire/ — Ulthera, Inc., a therapeutic ultrasound
medical device company serving the $30 billion global aesthetics market, today
announced that the U.S. Food and Drug Administration (FDA) has granted
clearance for the use of its Ulthera(TM) System to achieve a non-invasive
eyebrow lift.

The Ulthera System is considered a first-of-its-kind technology, unprecedented
in the marketplace, and as such underwent a 510(k) “de novo” review by the
FDA.  It is substantially different than other in-office aesthetic devices
because it combines visualization beneath the skin’s surface with non-invasive
delivery of ultrasound energy at depths that enable significant lifting of the
skin. While drawing on the same reliable ultrasound principles that physicians
and patients have trusted for decades, Ulthera’s patented DeepSEE(TM)
technology allows physicians in aesthetics to both see and treat deep below
the skin without surgery.  Read more

               

Merz Pharmaceuticals’ Belotero(R) Balance PMA Filing Formally Accepted for Review by the FDA

GREENSBORO, N.C. — Merz Pharmaceuticals, LLC, a leading specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Merz’s premarket approval (PMA) application for Belotero(R) Balance.

Belotero(R) Balance is a hyaluronic acid based monophasic gel dermal filler that utilizes a cohesive polydensified matrix (CPM(TM)) technology. This application seeks FDA approval for injection into mid-to-deep dermis for correction of moderate to severe wrinkles and folds.
Read more

               

Written by leslie · Filed Under FDA News | Leave a Comment 

Coapt Systems, Inc. Launches Hydrelle(TM) a New, FDA-Approved Dermal Filler with Lidocaine for Significant Wrinkle Correction and Greater Patient Comfort

August 18, 2009

The first FDA-approved injectable dermal filler to combine hyaluronic acid and lidocaine, a local anesthetic that improves patient comfort, and provides physicians with a new alternative for their aesthetic practice. Designed, developed and manufactured by Anika Therapeutics, hydrelle is formulated for durability based on its proprietary cross-linking technology and the highest concentration of hyaluronic acid. hydrelle is exclusively distributed within the U.S. by Coapt Systems. Read more

               

Written by leslie · Filed Under FDA News | Leave a Comment 

Information for Healthcare Professionals: Botox/Botox Cosmetic, Dysport and Myobloc

August 5, 2009

FDA ALERT [08/2009]: As announced on April 30, 2009, based on a safety evaluation of the botulinum toxin products, FDA has concluded that the prescribing information for OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic) and RimabotulinumtoxinB (marketed as Myobloc) must be updated to ensure their continued safe use.  On July 31, 2009, FDA, under the authorities granted by the Food and Drug Administration Amendments Act (FDAAA) of 2007, approved the following revisions to the prescribing information of Botox/Botox Cosmetic and Myobloc:

• A Boxed Warning highlighting the possibility of experiencing potentially life-threatening distant spread of toxin effect from the injection site after local injection. 

• A Risk Evaluation and Mitigation Strategy (REMS) that includes a Medication Guide to help patients understand the risks and benefits of botulinum toxin products.

• Changes to the established drug names to reinforce individual potencies and prevent medication errors.  The potency units are specific to each botulinum toxin product, and the doses or units of biological activity cannot be compared or converted from one product to any other botulinum toxin product.  The new established names reinforce these differences and the lack of interchangeability among products. Read more

                 

  Written by leslie · Filed Under FDA News | Leave a Comment 

  FDA Approves Sculptra® Aesthetic, a Facial Injectable for Correction of Nasolabial Folds and Other Facial Wrinkles

  July 30, 2009

  BRIDGEWATER, N.J., July 29 /PRNewswire-FirstCall/ — Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) approved Sculptra® Aesthetic (injectable poly-L-lactic acid) for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles which are treated with the appropriate injection technique in healthy patients. Sculptra®  Aesthetic works gradually to offer natural-looking results that can last up to two years.

  “We are excited by the FDA approval of Sculptra®  Aesthetic because it changes the landscape of what physicians can offer patients seeking natural and gradual looking results from an aesthetic injectable that is long-lasting,” said Doris Day, M.D., Clinical Assistant Professor of Dermatology at New York University and in private practice in New York City. “Sculptra®  Aesthetic allows for a natural correction.” Read more

                 

  Written by leslie · Filed Under FDA News | Leave a Comment 

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