ULTHERAPY DECOLLETAGE TREATMENT NOW FDA CLEARED
The FDA cleared Ulthera, Inc.'s Ulthera System for the non-invasive treatment of the chest to improve lines and wrinkles of the décolleté.
The Ultherapy Décolletage Treatment uses the system's signature imaging and micro-focued ultrasound therapy capabilities. The treatment, which takes about 30 minutes to administer, stimulates the natural formation of collagen and elastin in the skin's foundation to gradually smooth chest wrinkles. Results are visible after about three months. As with the FDA-cleared Ultherapy procedure for lifting the neck, eyebrow, and under the chin, results are achieved with one treatment and with no downtime or post-treatment care requirements.
The Ultherapy Décolletage Treatment will be available in more than 1,500 physician practices in the US, beginning in the third quarter of this year.
“At my practice, there is a high patient demand for a safe and effective solution to treat the chest, but the only options available involved needles, multiple treatments, recovery time, and/or required restricted sun exposure,” said principal investigator Sabrina Fabi, MD of Cosmetic Laser Dermatology in San Diego. “Now, with the Ulterapy Décolletage Treatment, I can offer women and FDA-cleared solution that consistently works and can be done on their lunch hour, at any time of year, without downtime.”
In other company news, Merz and Ulthera have entered a definitive merger agreement pursuant to which Merz will acquire Ulthera, Inc. Valued at up to $600 million in upfront cash and milestone payments, the acquisition is the largest in Merz's history.
“This acquisition represents an important strategic milestone for Merz,” said Philip Burchard, CEO of Merz Pharma Group, which has affiliates in 18 countries around the world. “We have a vision to be the most innovative company in aesthetics, and expanding into the rapidly growing field of energy devices will position us for long-term success in this area. The addition of Ulthera's energy device technology complements and expands our global presence in the aesthetics space.”
KYTHERA Biopharmaceuticals Announces NDA Acceptance
KYTHERA Biopharmaceuticals, Inc.'s New Drug Application (NDA) for ATX-101 (deoxycholic acid) has been accepted for filing by the FDA. The acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review. The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of May 13, 2015. The PDUFA date is the goal date for the FDA to complete its review of the NDA.
In addition, the FDA has informed the company that the FDA's Division of Dermatology and Dental Products is currently planning to hold an Advisory Committee meeting on the ATX-101 application during the review.
ATX-101 is an injectable treatment currently in late- stage development for the reduction of submental fat. KYTHERA submitted the ATX-101 NDA to the FDA on May 12, 2014.
“We are pleased that KYTHERA's NDA filing has been accepted by the FDA, representing another significant corporate milestone,” said Keith Leonard, president and chief executive officer, KYTHERA. “While the area under the chin is important to patients, there are no proven non- surgical options to effectively contour the area under the chin. If approved, ATX-101 will be the first non-surgical treatment for the reduction of submental fat.”
Galderma Finalizes Expansion in Aesthetic and Corrective Dermatology
Galderma S.A. has gained full rights to distribute Restylane, Perlane, Emervel, Sculptra, and Dysport from Valeant Pharmaceuticals International, Inc.
“We at Galderma are delighted to bring Restylane, Perlane, Emervel, and Dysport home in the US and Canada as is the case in dozens of countries around the world. Adding Sculptra to our global portfolio allows us to bring additional indications to our broad range of medical solutions for people with skin needs,” said Humberto C. Antunes, CEO and President of Galderma worldwide. “Our science-based approach to fillers and muscle relaxants takes our solutions beyond the aesthetic level to an integral part of holistic medicine, where maintaining, preserving, and restoring the health of the skin is as important and as relevant as treating or correcting conditions. With Restylane, Perlane, and Dysport, as well as the innovations to come, we complement our line of prescription and self-medication products to give physicians an arsenal of effective solutions,” added Antunes.
Emervel Classic and Emervel Deep have been submitted for approval by the FDA and Health Canada and are currently under review.
The US and Canada represent more than 50 percent of the fast growing global medical aesthetics markets,” said Stuart Raetzman, Vice President of Galderma for North America. “Demographics, social and cultural drivers, as well as an improving economy, make this an ideal time for Galderma to expand its geographic footprint in aesthetic and corrective medicine to the United States and Canada. At Galderma, people come first. We are thrilled to take on board the experienced teams from Valeant Aesthetics and, more than ever, our intent is to preserve the quality of the long-lasting relationships built with doctors. We look forward to partnering with healthcare providers in the growth and expansion of aesthetic and corrective medicine in North America and advancing the care and treatment of patients.”
Launch of New Aesthetic Marketing Book
Tracy Drumm, Vice President of IF Marketing, launched “Drive,” a new book designed to help tackle today's challenges in aesthetic marketing. Using candid stories of what has succeeded and failed in aesthetic marketing, the book presents the facts that challenge modern day practices and provides the tools to overcome those obstacles, including a complete, outlined marketing plan, more than 100 ideas to generate revenue, execution tips to guarantee results, and proven tools with quantifiable returns. The book is for industry profes- sionals, physicians, CEOs, owners, practice managers, and administrative staff. For more information, visit http://www.ifmark. com/drive-power-execution-0.
The AAFPRS Continues Support For Veterans Through Faces of Honor
The American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) has been volunteering to treat US veterans since 2009 when their FACES OF HONOR program was founded. The FACES OF HONOR program connects injured soldiers who have sustained facial injuries in the line of duty with facial plastic surgeons willing to provide their services pro bono.
For example, Joseph Jones, a 35-year-old Iraq veteran from Florida will soon receive a beard implant after an IED blast robbed him of his ability to grow facial hair.
According to Edward Farrior, MD, President of the AAFPRS, “It's estimated that 20 percent of survivable injuries suffered in the Iraq and Afghanistan conflicts involve the face and neck. The FACES OF HONOR program was designed to complement the existing medical care that military hospitals currently provide. We want veterans to know that this is a resource for them, in the event of long waiting times for VA medical services.”
The AAFPRS also says it applauds the American Medical Association (AMA) for requesting that the federal government provide timely access to medical care, approve measures that would let veterans seek care from private sector doctors, and create a registry of outside doctors that will see veterans. In addition, the AAFPRS has urged President Obama to take action on this important issue for veterans and their families.
Military veterans can apply and find out more about the FACES OF HONOR program at www.facesofhonor.org.
ASPS Partners with PatientNOW
The American Society of Plastic Surgeons (ASPS) announced today a three-year endorsement agreement of PatientNOW, Inc., an electronic medical record, practice management, and patient engagement system to be available to ASPS Member Surgeons. “ASPS has a rich history of innovation in providing our members with practice management solutions that embrace emerging information technology tools,” said Robert X. Murphy, Jr, MD, President of the ASPS. “Through strategic collaborations, we transform the delivery of healthcare throughout the specialty of plastic surgery while also providing our members with competitive pricing on leading edge information technology.”
“PatientNOW is proud to be endorsed by ASPS and the high standards of excellence they represent in the aesthetic and reconstructive plastic surgery industry,” said Jerry Jacobson, President and founder of PatientNOW. “We are also excited to be a partner in bringing enhanced capability to member practices through new innovative software designed specifically for ASPS member surgeons.”
Additionally, ASPS and PatientNOW have also entered into a strategic partnership where ASPS will collaborate with PatientNOW to:
• Deliver more qualified prospective
patients to each member surgeon through the Find-A-Surgeon integration. This will consist of a Patient Consultation Scheduling Feature (PCSF) between ASPS' Find a Surgeon web directory and PatientNOW's EMR/PM/PAR software systems
• Integrate the ASPS Patient Consent Library (PCL) into PatientNOW's EMR, develop, test, deploy, and maintain a PCSF and the integration of the PCL
• Integrate ASPS web content, content from consent forms, ASPS videos, and other ASPS licensed content into PatientNOW systems
• Deliver real time benchmark data to members.
Pre-wedding Cosmetic Tweaks on the Rise
Beyond the usual hair, makeup and nail routines of brides-to-be, a recent study by the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) sheds light on a new pre-wedding trend—cosmetic tweaks. Survey results show that weddings are the number one special event driving women of all ages towards aesthetic treatments. Injectables such as Botox and hyaluronic acid are popular. The AAFPRS details that the most popular injection sites include the forehead, cheeks, and lips. The same report shows that for the past two years nose jobs, eyelifts, and facelifts were the most requested procedures prior to a wedding.
“Our members noted a 58 percent increase in cosmetic surgery and facial injectables in those under the age of 30 last year,” said Edward Farrior, MD, president of the AAFPRS. “Advances in techniques, reduced recovery times and a growing number of non-invasive options make plastic surgery more appealing to brides looking for a quick fix prior to their big day.”
My New Favorite Thing: Artas Hair Studio
“The biggest benefit of the Artas Hair Studio is that it sets realistic expectations of the results patients can expect to see after their hair transplantation. It allows us to plot and show the patient what they may look like after their transplanted hair grows in. It takes away ambiguity. There are no two hair transplants that are alike. I think that's where the brilliance of the Artas Hair Studio lies — it offers a personalized snap shot of what a patient can expect. “
William Yates, MD | Cosmetic Surgeon | Chicago, IL
REMEMBERING RICHARD E. FITZPATRICK, MD
Clinical dermatologist, researcher, and laser and skincare pioneer Richard Fitzpatrick, MD, FAAD, died July 12, 2014. Dr. Fitzpatrick's various accomplishments are detailed online: clderm. com/richard-fitzpatrick-memorium//
“Fitz and I were friends and colleagues for 28 years. We wrote many of our papers, textbooks, and clinical studies together, and we always had a fun time doing it. From being founding members of the Space Dermatology Foundation, founding SkinMedica with our partner,
Kim Butterwick, to doing what others thought was impossible, collaboration made our time together exciting; although our most exciting time together was watching the Chargers beat the Raiders at Qualcomm Stadium.”
—Mitchel P. Goldman, MD
“Dr. Fitzpatrick was a man of quiet accomplishment and was a genuine colleague with whom I collaborated for over 20 years. He was someone whose professional views and personal thoughts I trusted and whose insight was critical to my own professional development. Fitz was multi-dimensional in the best of ways and he worked tirelessly despite dealing with health issues over the past several years. His sense of irony and humor were very much a part of what was so attractive to all of us who knew him. No matter the event or the occasion, the setting always improved when Fitz was in the room. We will miss him very much.”
—Tina S. Alster, MD
“In the 27 years I knew Richard Fitzpatrick, he proved time and time again that he was always ready to listen, to offer support, to question, to help find a solution, and to share ideas. He gave hugs in times of joy and in times of distress, with good humor, respect, and grace, and rarely lost his unique and positive outlook on life...He had an uncompromised passion for his profession and for scientific enquiry, gave of his knowledge and his skills without hesitation, and was a role model for doctors, students, nurses, the industry, professional organizations, and virtually all who knocked on his door.”
—Penny J. Smalley, RN, CMLSO
“Dick was the guy I always looked forward to seeing and after spending time
with him was really glad I did. I was constantly amazed at his creativity and great insights but mostly of his great love of life. He has made a very meaningful impact on my life and I am truly grateful for that.”
—Brian Zelickson, MD