The FDA recently approved Daxxify (DaxibotulinumtoxinA-lanm) from Revance for the temporary improvement of moderate to severe glabellar lines in adults. Daxxify is the first and only neuromodulator stabilized with Peptide Exchange Technology (PXT) and is free of both human serum albumin and animal-based components.
Jeffrey Dover, MD, co-director of SkinCare Physicians of Chestnut Hill, says, “As a SAKURA investigator, I’m pleased to see Daxxify now approved as the first and only peptide-formulated, long-acting neuromodulator in the market. Compelling data from the largest Phase 3 clinical program ever conducted for glabellar lines demonstrated that Daxxify was well tolerated and achieved clinically significant improvement with long-lasting results and high patient satisfaction. Notably, Daxxify was able to demonstrate a long duration of effect while only utilizing 0.18 ng of core active ingredient in the 40-unit labeled indication for glabellar lines.”
In the SAKURA Phase 3 clinical trial program (SAKURA3), which included more than 2,700 patients and approximately 4,200 treatments:
- 74% of subjects achieved a > two-grade improvement in glabellar lines at week 4 per both investigator and patient assessment
- 88% achieved > two-grade improvement at week 4 per investigator assessment
- 98% of subjects achieved none or mild wrinkle severity at week 4 per investigator assessment
- 6-month median duration
- Some patients maintained treatment results at 9 months
- Results seen as early as one day after treatment, typically seen within two days
Daxxify is generally safe and well tolerated with no serious treatment-related adverse events reported in the clinical trials and has a safety profile consistent with other currently available neuromodulators in the aesthetics market.
Learn more: Watch our MATV News Extra interview with Dr. Dover here.
BTL Introduces EMFACE
BTL is taking on the minimally invasive facial aesthetic category with the launch of EMFACE. Emface simultaneously emits both synchronized radio frequency and HIFES-brand energies. The homogenous radiofrequency heats collagen and elastin fibers while the HIFES stimulation emits thousands of pulses per session to contract delicate facial muscles.
The recommended treatment course for the EMFACE therapy calls for four 20-minute sessions, with each session completed 2-14 days apart.
The findings from nine clinical studies found that participants who completed the recommended treatment course experienced, on average, a 37% reduction in wrinkles, 30% increase in facial muscle tone, and 23% lifting effect—with optimal results seen 6-12 weeks after final treatment. The procedure is needle- and injectable-free and requires no pre- or post-preparation or downtime.
Early Postop Microneedling May Improve Surgical Scars
Postsurgical scars treated with minimally invasive percutaneous collagen induction in the maturation and remodeling phase may have better aesthetic outcomes, according to a study published in the September issue of Plastic and Reconstructive Surgery.
Treatment initiated early (6- to 7-weeks postoperatively), while natural collagen formation was tapering off, demonstrated improved aesthetic outcomes compared to treatments late in the maturation phase (13 to 16 weeks postoperatively), the study showed.
Researchers examined the utility and safety of minimally invasive percutaneous collagen induction in acute postsurgical scars in 25 patients. In the postoperative period, patients received three treatments of minimally invasive percutaneous collagen induction.
Take 5 With Caroline Van Hove, CEO of Revelle Aesthetics
Cellulite treatment is one of the fastest growing categories in aesthetics, and there’s little women won’t try to get rid of this lumpy, dimpled skin. Revelle Aesthetics’ Avéli is now indicated for long-term reduction in the appearance of cellulite in women’s buttocks and thighs, demonstrating benefits through one year. We chatted with Caroline Van Hove, CEO of Revelle Aesthetics, about the company’s approach to treating cellulite as well as what we can expect from Revelle in the future. (Learn more about Ms. Van Hove in her July/August 2021 interview with Wendy Lewis as part of the exclusive Women in Aesthetics series.)
VC-backed Femtech
Revelle Aesthetics, founded in 2018, is a venture capital-backed med-tech company developing smart solutions grounded in deep anatomical insight that get to the root cause of women’s most bothersome aesthetic concerns.
The company was born out of ExploraMed, a Silicon Valley incubator known for engineering unique innovations in challenging-to-solve-for therapeutic areas like cardiology, urology, and ENT. Exploramed was founded in 1995 by Josh Makower, MD, a creator and director of the Stanford Byers Center for Biodesign and one of the most progressive entrepreneurs in MedTech. ExploraMed brings together scientific experts, researchers, and engineers with complementary expertise who focus on the etiology of a given medical problem or condition, like cellulite, before designing innovative, paradigm-shifting solutions. In forming our leadership team, we brought together a truly talented team with a perfect blend of med-tech, R&D, startup, and aesthetic experience. We spent our first few years in stealth mode focusing on deepening our understanding of the underlying anatomy and the challenges that need to be overcome when addressing cellulite, our first area of focus.
Meaningful outcomes
Our mission is to help women reveal their true, most authentic selves. The name “Revelle” comes from a combination of the terms “reveal” and “elle” as we are in the business to help women feel more comfortable and confident and have the best relationship with themselves. We identified cellulite as a key aesthetic problem that had yet to be solved. Cellulite is more common than people realize—up to 90% of women have it. Even though it is so common, many women are bothered by it. We saw in our extensive consumer research that women often think it is their fault they have cellulite and are ashamed to talk about it among family and friends. We want women to feel great about themselves—and to also know that cellulite is not their fault. It’s simply a common fact of life that is often caused by hormones and genetics.
We also learned that women and physicians are often skeptical that there are treatment options that produce meaningful results. Which is why we are pleased to introduce Avéli and deliver on our mission by providing meaningful outcomes to physicians and women alike. Avéli is an FDA-cleared, disposable device designed to safely and effectively reduce the appearance of cellulite dimples in the buttocks and thighs with lasting results. The Avéli device is used in a minimally invasive procedure performed in about an hour, in a single office visit with little-to-no downtime.
Inside-out approach
To understand how Avéli works, and why it is different, it’s important to first understand what causes cellulite—which is quite complex and can be complicated to treat. Septa are a major underlying cause of cellulite and are fibrous bands that tether the skin to the structures below. Some septa stiffen and shrink over time and lead to dimples on the surface of the skin that we call cellulite.
Historically, many women have been disappointed by lotions and potions, and other treatments that do not deliver meaningful results. That’s because many of them approach cellulite from the outside-in, making it difficult to release the problem septa and thus have a substantial impact on the appearance of cellulite. Avéli addresses cellulite from the inside out. It is the only cellulite device that allows a provider to identify and release culprit septa on the buttocks and thighs in a single, in-office procedure with real-time confirmation of the release. It gives the provider greater confidence that they are treating what they intended to treat—no guesswork about whether or not they have done the job they set out to do.
The procedure is suited for women with varying degrees of cellulite severity and complexity in the buttock and thigh. It’s just the right amount of invasive to effectively target and release the complex fibrous septa structure under the skin and Avéli can treat any septa-related irregularity on the surface of the skin defined by edges.
Lessons learned
We learned that women want a visibly meaningful reduction of dimples in one treatment or session. Physicians want a reliable, predictable treatment, one that treats the buttocks and thighs, and ideally no capital equipment.
Our extensive anatomical and clinical work enabled us to engineer Avéli to identify and release culprit septa causing a cellulite depression and deliver the visible and reproducible results that women and physicians want. With the launch of Avéli, we offer a “no-nonsense” approach to cellulite that delivers the meaningful results both patients and physicians want and deserve. And for physicians, Avéli does not require the expense of capital equipment; it is a skill-based, non-commoditized procedure that integrates easily into their practice and elevates their body and cellulite offerings.
Bright future
Right now, we are focusing all our attention on the introduction and commercialization of our new cellulite device, Avéli, to ensure a successful, controlled roll-out, yet widespread patient and physician satisfaction based on consistently positive clinical results. In the next few years, we will continue to grow our knowledge of and expansion in the cellulite market, and further our data-driven plan to explore other unmet aesthetic needs. We have an aggressive 5-year plan to expand our offerings beyond the US market and launch other complementary aesthetic treatment options.
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