FDA Clears Revelle’s Avéli for Cellulite

Revelle Aesthetics, Inc. is launching Avéli, a new FDA-cleared device that reduces the appearance of cellulite on the buttocks and thighs temporarily in a one-time procedure.

“It has taken many years to understand the etiology of cellulite, in particular the structural cause—the fibrous septa—making it complicated to treat,” says Michael Kaminer, MD, dermatologist and co-founder of SkinCare Physicians in Boston. “With the help of the engineering team at Revelle, we confirmed that the septa are a network of fibrous bands versus a singular, perpendicular band, and are significantly more complicated than we appreciated. Building on this knowledge, Avéli not only gives physicians control over identifying and releasing the complex structure of septa that are tethering the skin, but also allows verification of that release in real-time.”

Avéli is a one-time-use disposable device for cellulite designed to be used in a single in-office procedure using a Targeted, Verifiable Subcision method. During an advanced minimally invasive procedure with local anesthesia, a provider can treat both the buttocks and thighs for a variety of women across the spectrum of cellulite severity and complexity. Women can experience visible, meaningful results quickly after the procedure, with little-to-no downtime.

Revelle Aesthetics plans a targeted rollout to cellulite and body treatment experts in the fields of plastic surgery and dermatology. The focus early on is to replicate compelling patient outcomes from the clinical studies in a real-world environment with the help of clinician partners.

WATCH NOW

The Aesthetics Innovation Summit, held in April, brought together experts from all corners of the industry, including the clinical, corporate, and capital sectors, to drive aesthetic innovation and new trends. The summit, co-chaired by Dr. Grant Stevens, Brent Saunders and Alisa Lask, showcased novel treatments, devices, and technologies.
Visit ModernAesthetics.com/AIS to watch speakers share highlights from the meeting.

Crown Laboratories to Acquire Eclipse Aesthetics Assets

Crown Laboratories will acquire the global aesthetics-focused assets of Eclipse. Crown says the acquisition expands its aesthetics’ product portfolio and enhances Crown’s overall value proposition as a global leader in science-based aesthetic skincare solutions.

“We pride ourselves on being at the forefront of today’s aesthetics market by developing and delivering best-in-class medical technologies and products that are exceptionally safe and effective,” says Jeff Bedard, President and CEO of Crown. “This strategic acquisition furthers Crown’s mission to drive innovation and provide superior products and customer service to aesthetics providers around the world. Eclipse’s excellent products will broaden our product line and customer base, domestically and internationally.”

As an innovative company focused on skin science, Crown will integrate the Eclipse products into the Aesthetics business unit of Crown to complement its SkinPen® Precision and other brands. Eclipse customers can expect to continue receiving superior customer service, medical education, and access to Crown’s expanded range of highly effective aesthetic products.

Take Five Scott Carson, CEO, Powered by MRP

Online marketplaces have revolutionized how consumers purchase most everything in their daily lives. The idea of an online marketplace for medical equipment is not a new concept. However, for Powered by MRP, the $34 billion aesthetic device resale market has proven to be prosperous. Scott Carson, CEO of Powered by MRP, sat down with Modern Aesthetics® magazine to discuss the importance of the current market, his company, and the future of this everchanging landscape.

Why the pre-owned aesthetic device space IS attractive.

“After analyzing various industries, the decision to focus on the aesthetics device sector came naturally. There are three key components that make a marketplace thrive, and we believe the aesthetics device resale space matches these characteristics perfectly. It’s a hyper-growth market, growing 10 to 15 percent or more a year compounded. Second, it’s cash-based versus most hospital and clinical purchasing. Third, it’s a highly emotional industry.

“Once we identified our marketplace, we focused on enablers. These tools or services allow the consumer to make the leap to the online market. Think of an online marketplace like eBay Motors. An example would be eBay motors, whose enablers are tool extensions such as CARFAX, financing options, and money-back guarantees.

“We built the largest pre-owned processing center in the world. We now have a thousand systems that we own with 10,000 parts, handpieces, and peripherals, and in tandem, we established other platforms such as MedEquipTech.io or MET, a side-by-side Angies/Iber like side for Techs and Trainers.”

MRP is dominant and growing.

“Since Powered by MRP’s founding in 2015, our mission has been to create a fair market for physicians to access biomedical energy-based devices at GPO-level pricing to lower the physician’s overhead cost and generate more access to care for patients as a result.

“Throughout the ongoing Covid-19 pandemic, our services have been a vital element in aiding medical practices globally ensuring the market’s return to its average growth trend by 2023.

“We’ve expanded to include brand new equipment in our portfolio of services and are also branching into general medical and pharma prescribed items. Our ongoing partnership with McKesson has enabled us to have 60,000 SKUs, and we will be adding another 150,000 SKUs within the next few months.”

Online solutions May upend the current sales model.

“For businesses to be successful in the long term, an online marketplace must be consumer-centric. Aesthetic manufacturers tend to be stakeholder and shareholder centric. Our focal point and number one priority is to build ultimate trust. To do so, we developed the Tech Stacks needed to support the consumer in selecting and acquiring the right device for their needs.

“We will witness a vast reduction of field sales reps within the next five years. Tech Stacks will provide peer-to-peer reviews, best pricing options, full transparency services, and warranty costs with broader options and uptimes. We were heading in this direction pre-Covid, but the pandemic dramatically accelerated this trajectory.”

Clinicians Can recoup their equity.

“Manufacturers make the resale market for devices challenging for clinicians. For example, a doctor might determine the device they purchased for roughly $100,000 is not a good fit. They might reach out to a colleague and offer to sell the unit for $70,000. A local sales rep may undercut the pricing and offer the colleague a new system for the same or even less money.

“The selling of a device online or through advertising channels is complicated. Doctors must worry that they now will be in a successor liability stream for the equipment they sell. The seller could conceivably be sued if the buyer has an unfavorable outcome. Traditional resellers or the original manufacturer may buy the device but will charge a re-certification fee, thus paying a minimal price and citing the relatively low resale price of the system.

“Clinicians can easily connect with interested buyers to sell their used system for a highly competitive price with our trusted platform. Both buyer and seller determine the cost of the system. The platform then initiates the sale, examines, calibrates, and certifies the device resulting in a trusted and facilitated transaction. We take a nominal fee for processing the device, and the seller can feel confident that the majority of their available equity has been recouped.”

The market will continue to evolve and expand.

“The aesthetic device market is vastly growing. This pre-owned market accounts for approximately 20 to 30% of overall gross sales. There is new device innovation in aesthetics that includes improvements on existing technologies. We see an increase coming from emerging markets such as Korea and other parts of Asia, where manufacturing costs are more favorable, resulting in downward pressure on the overall cost of these devices.”

The tide is shifting toward consumer-centricity.

“Hundreds of millions of dollars of unused equipment are sitting in offices across the United States. The pre-owned space has a bad reputation, in some cases, justifiably. That’s not to say that there are not some exceptional pre-owned resellers out there.

“Competition opens the industry up to a customer-centric approach. Platforms such as MRP.io will continue to change the landscape giving clinicians back the power. In the next five to ten years, we could see the single largest reduction in healthcare costs, thanks to Tech Stacks being delivered in a way that consumers can make their own decisions without sales representatives influencing the bottom line.”

Plastic Surgery Residents Report Barriers to Affordable Childcare

Plastic surgery residents face persistent barriers accessing affordable childcare, with high costs and a major impact on surgical training. Most of the burden falls on women residents, finds a study in the June issue of Plastic and Reconstructive Surgery.

Researchers sent an anonymous survey to current plastic surgery residents. The survey focused on current childcare accommodations and availability, along with attitudes and issues surrounding childrearing during residency.

Of 32 residents responding to the survey, 21 were women. Thirty-eight percent of respondents had at least one child. Of these, 75 percent of men reported that their spouse was the primary source of childcare, compared to 12 percent of women.

“One hundred percent of respondents with children reported childcare creates a financial burden,” write study authors, led by Chelsea Cernosek Wallace, MD of University of Kentucky, Lexington. Median costs of childcare per child were $2,150 per month, or $25,800 per year. For married residents, median gross household income was $109,000 per year—thus these couples were paying nearly one-fourth of their income for childcare. Because of their inflexible work hours and the limited hours of daycare facilities, many residents had to use a nanny or other in-home childcare.

None of the residents with children said their institution provided access to on-site childcare—but 75 percent said they would use this service if it were available. Most residents said that their institution didn’t provide flexibility to accommodate childcare needs. Women residents were twice as likely to miss work due to problems with childcare arrangements, compared to men.

Two-thirds of women residents said that if they were choosing a plastic surgery training program, the availability of on-site childcare would influence their decision. One fourth of women residents with children said they had seriously considered leaving their residency program due to difficulties with childcare accommodations.

ISHRS: Hair Procedures Getting More Efficient

According to results of a new member survey conducted by the International Society of Hair Restoration Surgery (ISHRS), 68 percent of members reported performing an average of one procedure per patient in 2021 to achieve the desired hair restoration result. This represents a significant improvement, as ISHRS members estimated an average of 3.4 procedures in 2019 and 5 procedures in 2016 were needed per patient to achieve the desired result.

The COVID-19 pandemic continued to impact non-essential surgeries in mostly the early part of 2021; the survey reported that ISHRS members treated more patients seeking nonsurgical treatments for hair loss than those opting for surgical procedures. Specifically, 1,592,588 nonsurgical patients sought treatment in 2021 (a 14 percent increase from 2019), with 628,604 surgical patients treated in 2021 (an eight percent decrease from 2019). The three most commonly prescribed nonsurgical treatments in 2021 included oral finasteride, topical minoxidil and platelet-rich plasma (PRP).

Another consequence of the pandemic in 2021 was the “Zoom effect.” To gauge this new phenomenon of being more conscious of looking good on camera while working or socializing from home, ISHRS physicians were asked about how this trend affected new patients’ decisions to address their hair loss. In fact, 25 percent of ISHRS members reported that the majority of their new patients indicated regular Zoom/video meetings influenced their decision to seek treatment for hair loss.

The ISHRS 2022 Practice Census survey also revealed:

• The total market size for hair restoration surgery in 2021 was $4.5 billion USD.
• More than half of both male and female surgical patients worldwide fell between the ages of 30 to 49 years old, 57.2 and 54.8 percent respectively.
• In 2021, ISHRS members treated a higher percentage of men with surgical hair restoration procedures (87.3 percent) than women (12.7 percent).
• Body hair transplantation remains popular. Among men, 13 percent of procedures targeted non-scalp areas of the body, of which beards/moustaches accounted for four percent of procedures. Among women, 17 percent of procedures targeted non-scalp areas of the body, of which eyebrows accounted for 11 percent of procedures.
• Roughly half (51 percent) of ISHRS members reported Black Market hair transplant clinics in their cities.

Revance: FDA Accepts BLA Resubmission for DaxibotulinumtoxinA

The FDA accepted Revance’s Biologics License Application (BLA) resubmission for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines.

The FDA designated the BLA as a Class 2 resubmission, which has a six-month review period and includes a required reinspection of the company’s manufacturing facility.

Revance was provided a Prescription Drug User Fee Act (PDUFA) goal date of September 8, 2022.