Jenny Mollen and her get-to dermatologist, New York Urban center's Patricia Wexler, Md have such a close rapport that they can, and often do, cease each other's sentences.

And it was similar this from the get-get, shares Dr. Wexler. "It's a chemistry that doesn't happen that oftentimes," she admits. "I dearest all of my patients, simply I don't always get to express my personality. You tin't practice that with every patient."

Ms. Mollen, xl, clearly isn't just whatever patient. She is an actress, New York Times-best selling author, and something of an Instagram phenom. She calls Dr. Wexler "Pat" and sees her often for treatments, touch ups, or just to say hi and prove off a new coat. Ms. Mollen and her husband actor Jason Biggs often double appointment with Dr. Wexler and her husband.

"It only works," they both say, nigh in unison.

"She is conspicuously an influencer, merely I don't phone call her that," Dr. Wexler adds. That said, Ms. Mollen is influential. Her Instagram account boasts 408k followers who have her advice on everything and annihilation from making kids lunches (she packs an elaborate Bento box for her sons) and all things parenting and style including Botox Cosmetic and other anti-aging tweakments.

Dr. Wexler and Ms. Mollen sat down with Modern Aesthetics® as part of a media blitz to promote Allergan's beginning annual National Botox Cosmetic Day, which was held on Nov 20.

So how did Ms. Mollen celebrate National Botox Solar day? Scooping up special "Buy one/Get ane" gift cards for everyone on her vacation list. "It'due south the best Christmas souvenir and it can expose my friends who haven't gotten there however. It's a absurd way to say 'Listen, I am hooking you up.'"

Ms. Mollen's volume titles "I Like You Just the Way I Am" and "Live Fast, Diet Hot" speak volumes about how she feels about growing older. She start started getting Botox in her late twenties. "The 1 in my eleven was getting very strong and I wanted to adjourn it," she recalls. At the time she was living in Los Angeles and in that location was no stigma attached to injectables or any cosmetic treatment. "It wasn't a secret. Everyone did it, including my mom."

Ms. Mollen and Dr. Wexler are now in a committed md-patient human relationship, and Ms. Mollen admits that she had her share of "flings" with other artful health care providers. She was very public about the severe bruising she experienced after having her lip fillers dissolved.

"I like filler," she says. "I may have gone to the wrong md at first."

Dr. Wexler had her at "peel cancer check."

"You can go to any storefront med spa to get injections at your ain run a risk, but I wanted to give her a proper exam," Dr. Wexler says. Ms. Mollen's first visit involved a head-to-toe skin cancer screening. "I liked that she was a straight shooter," Ms. Mollen recalls. The rest is history.

Revance's DAXI Now One Step Closer to FDA Nod

Revance Therapeutics, Inc. has submitted a Biologics License Application (BLA) to the FDA for daxibotulinumtoxinA for Injection (DAXI) in the treatment of moderate to severe glabellar lines.

Under the current Prescription Drug User Fee Agreement (PDUFA VI), the FDA has agreed to file acceptable applications within 60 days of receipt and to review the majority of BLAs within 10 months post-obit the Day lx filing engagement. Based on that timeline, Revance anticipates potential product approval in the second half of 2020.

"The submission of our BLA represents a significant milestone in the company's history and initiates our transition from a development visitor to a commercial arrangement. I'grand incredibly excited about the opportunity to innovate the first truly novel advocacy in neuromodulator products in over 30 years. We believe that a long-interim neuromodulator product volition fill up a significant, unmet need in both aesthetics and therapeutics and that the market is hungry for innovation," says Mark Foley, President and Principal Executive Officer of Revance, in a news release. "As we manufacture our ain production in the Us, the BLA filing represents a monumental achievement for a company of our size, which was just made possible through the incredible dedication and delivery of our employees."

DAXI has been evaluated in three Phase three trials (SAKURA ane, 2, 3). Both SAKURA i and SAKURA 2 demonstrated that one-half of the patients treated maintained none or merely mild frown lines for at to the lowest degree 24 weeks (approximately six months), after a unmarried handling. Additionally, frown lines did not return to their pre-treatment severity for at to the lowest degree 26–28 weeks for one-half of the patients treated. Results from the two pivotal Phase 3 trials, SAKURA ane and SAKURA 2, were recently presented at the American Social club for Dermatologic Surgery (ASDS) 2019 Almanac Coming together and published in Plastic and Reconstructive Surgery as well as accustomed for future publication in the Journal of the American University of Dermatology.

Allergan, Exicure Enter Collaboration Deal to Discover and Develop SNA-based Treatments for Hair Loss Disorders

Exicure, Inc. and Allergan's wholly-owned subsidiary, Allergan Pharmaceuticals International Limited, have entered into a global collaboration understanding to notice and develop novel treatments for hair loss disorders based on Exicure's proprietary spherical nucleic acid (SNA) technology.

Nether terms of the understanding, Allergan will receive exclusive access and options to license SNA-based therapeutics arising from two collaboration programs related to the handling of hair loss disorders. Exicure volition receive an upfront payment of $25 million and volition deport discovery and development in 2 collaboration programs for hair loss disorders. In the outcome that Allergan exercises an pick, Allergan will be responsible for the clinical development and commercialization of the licensed products. Exicure will be eligible to receive evolution and regulatory milestones of up to $97.5 1000000 per programme and commercial milestones of up to $265 one thousand thousand per program. Exicure will likewise exist eligible to receive tiered royalties on worldwide internet product sales of mid-single-digit to mid-teens percentages on worldwide net product sales.

"We are excited to combine our knowledge of nucleic acid therapeutics with Allergan's deep expertise in medical aesthetics to develop and commercialize innovative treatments for hair loss disorders," says Dr. David Giljohann, CEO of Exicure. "This collaboration is an exciting opportunity to accelerate Exicure's SNA technology in an important new therapeutic surface area."

Dr. Roy Geronemus Awarded the Vic Narurkar, Md Innovations in Aesthetic Dermatology Lectureship Award

Roy Geronemus, Doctor of Laser and Skin Surgery Center of New York received, The American Society for Dermatologic Surgery inaugural Vic Narurkar, G.D., Innovations in Aesthetic Dermatology Lectureship Award.

Dr. Geronemus received the award at the 2019 ASDS annual meeting in Chicago. He delivered the lecture "Expanding the Telescopic of Dermatologic Surgery Through Lasers and Related Technologies" at the meeting. This lecture honors the legacy of Dr. Vic Narurkar.

Dr. Narurkar is a dandy educator and exercised excellent clinical judgment and care to his patients," Dr. Geronemus told Practical Dermatology®, Modern Aesthetics'®, sis publication, in a recent interview.

Merz: Cellfina for Cellulite Cleared for five Years of Benefit

The FDA has cleared a new indication for Cellfina that shows the benefits of treatment last for five years, an increment from the previous three-year indication. Cellfina from Merz demonstrated v-year improvement in the appearance of cellulite on the buttocks and thighs of developed females. Five-twelvemonth durability makes Cellfina the longest-lasting FDA-cleared treatment for cellulite on the market.

The new indication is based on observations by an contained physician using before and afterwards patient photographs at five years mail-treatment. Results showed that after a single in-role treatment, 100 percent of follow-upwards patients still had noticeable improvements. Follow-upward studies at 1, iii, and five years afterward a unmarried in-part treatment showed sustained improvements.

"Cellfina is the benchmark and continues raising the bar for whatever other cellulite treatments, with both longevity of results and effectiveness," said lath-certified Miami corrective dermatologist Jeremy Dark-green, MD "Cellulite is an emotionally charged medical condition that affects 85 per centum of women worldwide. While the data has conspicuously shown that Cellfina works, and does and then for five years, the FDA clearance indicates to consumers that they tin, and should, expect to see proven, long-lasting results after treatment with Cellfina."

"This formal recognition from the FDA is a significant milestone for Cellfina customers, their patients, and Merz. Research shows women oftentimes feel defeated by their boxing with cellulite, and we want to make sure our customers accept an effective cellulite handling option," says Merz Americas CEO Bob Rhatigan. "Cellfina is the just cellulite treatment FDA-cleared for visible results that terminal five years. We are proud of this new indication, and it is a true testament to Cellfina's efficacy and our delivery to bring customers the latest innovations in medical aesthetics."

American Society for Dermatologic Surgery Annual Coming together Updates

New and emerging technologies as well as innovative approaches to existing treatments took the spotlight at the 2019 annual coming together of the American Society for Dermatologic Surgery in Chicago this fall.

Presenters addressed artful topics like small volume filler placement. "Focus on certain areas," says Terrence Keaney, Medico. He notes that when using small volumes, "you tin can optimize filler by placing it in sure locations where you get bigger bang for your buck."

In a similar vein, Sabrina Fabi, Dr. explained how she achieves dramatic improvement in the lower face—including indirect lip enhancement—by injecting in the mentum. "With but 1cc of filler…in the mentum, you lot tin can have beautiful aesthetic outcomes," Dr. Fabi says.

In an interview with Joel L. Cohen, Md, dermatologist Nazanin Saedi, MD talked about maximizing treatments through combinations. For example, she frequently pairs a pico treatment for pigmentation with ablative or non-ablative lasers to address color and texture in a single session. RF microneedling plus low-free energy CO2 is another pop option, she says. (Dr. Cohen interviewed various speakers from the meeting for Modern Aesthetics® magazine'south sis publication Practical Dermatology®. You lot can watch the interviews online at PracticalDermatology.com.)

Merz Aesthetics brought spokesmodel Christie Brinkley to the exhibit hall, where she addressed changing attitudes about aesthetics. A generation ago, pilus coloring was considered taboo, she said with a nod to the old tagline "simply her barber knows for sure." Today, women are open about their aesthetic treatments, she says.

A affiche presentation from Endo included information from the RELEASE-1 and RELEASE-ii Phase iii studies, previously presented at the 2019 Aesthetic Society meeting. The identically designed, randomized, double-blinded, placebo-controlled trials assessed the efficacy, safety, and tolerability of collagenase clostridium histolyticum (CCH) for the treatment of cellulite in women. A greater percentage of the 843 women treated during the studies met the principal endpoint of response with CCH versus placebo in both studies. Most adverse events observed in CCH-treated patients were transient, mild/moderate, and injection-site related (east.g., bruising, pain, induration, pruritus, erythema, and discoloration).

Endo launched a "Redefining Scientific Artistry" campaign at the ASDS Annual Coming together with a mobile-first website intended to serve as an educational platform for consumers and physicians who desire to learn more than most the visitor and cellulite science.

Allergan historic the enrollment of six million members in its Brilliant Distinctions program at a reception during the coming together.

Galderma reported positive results of its randomized, controlled, evaluator-blinded, multi-heart study to evaluate the effectiveness and safety of HARK for lip augmentation, noting that the information are being used to support FDA submission of the novel injectable.

FDA Proposes Boxed Alert on Chest Implant Risks

The FDA released a statement on its continued efforts to protect women'due south health and enhance condom information available to patients considering breast implants.

In typhoon guidance issued in late Oct, the FDA proposed labeling recommendations to manufacturers of breast implants to assist ensure women receive and understand information regarding the benefits and risks of chest implants. The draft guidance offers numerous recommendations to help ensure women have access to this information, including that manufacturers incorporate a boxed alarm and patient decision checklist in the device'south labeling, update recommendations for patient screening for device rupture, and more.

The FDA guidance says that the boxed alert should aid communicate risks that patients may not know, including that breast implants are not lifetime devices; the chances of developing complications increment the longer a patient has the implant and additional surgery may exist required to address the complications; and that breast implants have been associated with the risk of developing breast implant-associated anaplastic large prison cell lymphoma (BIA-ALCL) and may be associated with systemic symptoms.

The draft guidance also includes a recommendation that manufacturers include a patient decision checklist to aid guide discussion during a patient's consultation with a surgeon. A checklist gives patients the opportunity to acknowledge individual risks of breast implants, such as potential risks from the surgery, the risk of BIA-ALCL and risk of implant rupture, amid others.

"Nosotros believe the information contained in the example of the patient decision checklist can contribute to a patient's understanding of both the benefits and risks of breast implants," the statement says.

Earlier this yr in July, but days later on surgeons from the British Association of Aesthetic Plastic Surgeons (BAAPS) and elsewhere called for warnings on silicone-filled breast implants due to risk of "breast implant disease," Allergan issued a voluntary worldwide recall of Biocell textured breast implants and tissue expanders due to concerns of BIA-ALCL.

Following the remember, Modern Aesthetics® spoke to Bryan Thousand. Forley, Md most what is known about the reported cases of BIA-ALCL. Scout the interview now: modernaesthetics.com/videos/breast-implants-assessing-the-risk-for-bia-alcl

Baring Private Disinterestedness Asia to Larn Lumenis

Baring Private Disinterestedness Asia's affiliated private equity funds are acquiring Lumenis. The transaction, which values Lumenis at an enterprise value of more than than $1 billion, remains subject to the customary regulatory approval process. It is expected to be completed in early 2020.

"Baring Individual Equity Asia's (BPEA) investment is a tremendous vote of conviction in Lumenis and in the achievements of our entire global organisation. In contempo years, we accept adult and introduced multiple groundbreaking technological solutions that have redefined our industry and opened entirely new market segments.," says Tzipi Ozer-Armon, CEO of Lumenis, in a news release.

Dr. Mary Lynn Moran Takes the Helm at AAFPRS

Mary Lynn Moran, MD is the new President of The American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS).

Dr. Moran, who will serve the 2019-2020 year term, is the first female person to serve equally AAFPRS president. She is a facial plastic surgeon in Franklin, TN.

Hologic to Sell Cynosure

Hologic is selling the Cynosure medical aesthetics business to an affiliate of investment funds managed by Clayton, Dubilier & Rice for a total buy price of $205 million in cash, subject to certain closing adjustments. This is a 10th of the $ane.6B that Hologic, a women'southward health care company, paid 2 years ago to acquire Cynosure.

Net of these adjustments, Hologic expects net cash proceeds of approximately $138 1000000, the company reports.

"Divesting our medical aesthetics business organisation will enable the states to focus on what nosotros practice best – helping women and their families live healthier lives through early detection of illness," says Steve MacMillan, the Company's Chairman, President and Chief Executive Officeholder, in a news release. "Since we acquired Cynosure in 2017, it has significantly underperformed our expectations. We believe this transaction will unlock value for Hologic shareholders, and at the aforementioned time provide Cynosure and its employees the best opportunity to succeed in the medical aesthetics market. Moving forward, our business development strategy remains focused on the smaller, constrict-in deals that accept been performing well for u.s.a. and strengthening our core franchises."

Venus Concept Completes Merger with Restoration Robotics

Following the completion of the merger, Venus Concept completed a $28 one thousand thousand equity financing past EW Healthcare Partners, HealthQuest Capital, SEDCO Capital letter and others.

Restoration Robotics changed its name to Venus Concept Inc. The combined visitor will commence trading on November 8, 2019 on the Nasdaq Global Market under the ticker symbol "VERO."

"We are pleased to announce the closing of our merger with Restoration Robotics," says Domenic Serafino, Primary Executive Officer of Venus Concept, in a news release. "We have fabricated significant progress in enhancing our financial status with our contempo financing activities. The outlook for Venus Concept is very positive and we believe the combined visitor is well-positioned as a leading player in both the global minimally invasive/non-invasive medical aesthetics market place and the minimally invasive surgical hair restoration market."

Following the merger, Restoration Robotics moved its corporate headquarters to Toronto, Canada.

Kylie Jenner Sells Majority Pale in Dazzler Concern to Coty

Kylie Jenner sold a $600M majority stake in Kylie Cosmetics and Kylie Skin to Coty Inc.

Under the terms of the agreement, Coty will acquire a 51 percent ownership in the partnership for $600M. The acquisition is expected to close in the third quarter of fiscal year 2020. Coty's family of brands includes Covergirl, Max Factor, Rimmel, Clairol, Sally Hansen, Adidas and Nautica.

MY NEW FAVORITE Thing: TEMPSURE FIRM

"Cynosure'south Tempsure House 60mm handpiece uses innovative technology to gently heat deep tissue. It allows me to confidently care for larger areas of the body quickly and effectively. The results I've been seeing are absolutely fantastic, and the quick treatment times are an added benefit from both a physician and patient perspective. TempSure Business firm's combination of radiofrequency heat and specialized massage head help the skin await more youthful and evenly textured—and considering information technology gently and gradually delivers heat, my clients actually enjoy the treatments and say it feels like beingness at the spa. With no downtime, they're complimentary to drive themselves home afterward their appointments. The addition of TempSure Business firm to the TempSure platform has been a total game changer for my practice and the results really do speak for themselves."

Bruce East. Katz, Doctor
Medical Director, JUVA Skin and Laser Heart, New York Urban center
Clinical Professor of Dermatology, The Mount Sinai School of Medicine
Manager, Cosmetic Surgery & Laser Clinic, Mountain Sinai Medical Center

Clarification

Delight note that in the September/October edition of Modern Aesthetics® magazine, our device listings inadvertantly contained indistinguishable listings for RF Microneedling devices.

Cutera'due south Undercover RF listing should have appeared on p. 46.

Hole-and-corner RF uses semi-insulated and non-insulated tips to evangelize RF free energy within various adjustable depths of skin from 0.5-iii.5mm. It has been joined by the company's newest device truSculpt flex, which is FDA-cleared for the improvement of intestinal tone, strengthening of the intestinal muscles, and evolution of a firmer abdomen. In addition, it is cleared for the strengthening, toning and firming of buttocks and thighs.

An updated PDF is available here.