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Articles from 2018 In June


3 financial metrics to drive better practice performance

Article-3 financial metrics to drive better practice performance

©Evlakhov Valeriy / Shutterstock.com

“You can’t manage what you don’t measure.”

This is so true in so many things we do in everyday life. But this is especially true if you are a doctor today responsible for the management of a medical practice.

Unfortunately, too many physicians go to work every day unaware of how better reporting can drive higher performance of their medical practice.

The good news is by understanding three simple indices and metrics, any physician can begin to dramatically change the financial outcome of a medical practice and realize the return on investment of their efforts and an increased valuation of what is likely their most valuable asset.

Collection rate

A collection rate is the measure of the practice’s effectiveness in collecting all legitimate reimbursements. This takes into account the payers who the practice has contracted with and agree to write off the difference between the standard fee and the payer reimbursement rate.

By comparing the difference between the allowed amounts and actual reimbursements, a practice can determine how much is being lost to write-offs, untimely filing, non-contractual adjustments, and inferior collection practices.

Gross collection rate is calculated by dividing payments received from insurers and patients by gross charges. The gross collection rate can sometimes be misleading since most medical practices inflate charges billed to most insurers.

Net collection rate is calculated by dividing payments received from insurers and patients by allowed or contractual amounts. This is often more indicative of the physician’s true collections performance. As an effective benchmark of the practice’s financial health, it represents the percentage of reimbursement achieved out of the reimbursement allowed based on contractual obligations with payers.

Medical practices can also analyze their performance by looking at their net collections by payer. If a medical practice sees unacceptably low net collections for a particular payer, it may consider alternatives such as requiring patients to pay up front for services or renegotiating payer contacts.

Days in accounts receivable

Days in accounts receivable (A/R) is an industry standard for measuring how many days amounts owed to the practice by insurance payers, patients, and third parties will take to be paid.

For example, if you see a patient today, days in A/R represent the average number of days it takes before you are fully paid for the services provided. The industry benchmark for this is typically 30 days but can vary by type of specialty and payer mix. This is one of the best single indicators of the performance of the revenue cycle and regular monitoring can provide insight into the efficiency of the revenue cycle.

Most practice management (PM) applications have built in capability to run a report for the desired timeframe, namely monthly, quarterly or yearly. If the PM application does not have the reporting capability, days in A/R can be calculated using the following formula:

(Total receivables – credit balance)/Average daily gross charges (Gross charges/#days)

  • For example:
    • Receivables=$80,000
    • Credit balance-$5,000
    • Gross charges= $600,000
    • [80,000 – ($5,000)]/($600,000/365 days)
    • $75,000/1644 = 45.62 days in A/R

In order to appropriately reflect the practice’s performance, it is important to understand and consider some of the nuances that could have an impact on the result, such as carrier that are slower to pay, recognition of accounts in collection, and claims that have aged past 90 or 120 days. It is financially prudent to compute this metric with and without these categories so that performance is accurately captured and not biased by factors that may negatively impact the finances.

Accounts receivable aging

A/R aging analysis is a comparison of the actual accounts receivable aging to the expected accounts receivable aging. Disproportionate percentages indicate an inconsistent policy or procedure in how insurance payer and patient collections are being performed.

The proportion by percentage of the total amount of accounts receivable should be:

Percent of total A/RDays
70%0-30
10%31-60
10%61-90
10%Over 90 days

Most PM applications can generate an A/R aging report that breaks down claims based on the number of days they have been unpaid, totaled by payer. This helps to identify potential issues from a high level view so that you can prioritize how best to manage the A/R follow-up by dollar amount and by payer.

Days in A/R and A/R aging demonstrate a practice’s ability to quickly turn over A/R and collect all money due.

The bottom line is: You can’t know where you are going until you know where you are. Understanding the importance of your collection rate, days in A/R, and your accounts receivable aging is just the start to uncovering a breath of information that will put you on the path to higher medical practice performance.

Gregory Cutrona is CEO of AssuranceMD.

Regenerative aesthetics: a global revolution

Article-Regenerative aesthetics: a global revolution

Regenerative aesthetics: a global revolution

A global revolution is taking hold throughout the medical aesthetic field. Increasingly, regenerative and cell-based techniques are starting to reduce or replace the need for more invasive surgery, drug or chemical-based therapies.

New approaches involve the use of stem cell-based solutions in advanced fat grafting and volumization technologies, platelet-rich plasma (PRP), platelet-rich fibrin (PRF), adipose-derived stem cell (ADSC)-based therapies and the use of stromal vascular fraction (SVF), growth factors and other anti-aging modalities.

While stem cell-based treatments and other biocellular tools are currently outlawed in some countries, the general consensus is that this will change over time as technologies and techniques improve and gain regulatory approval.

Despite the slowness of regulatory bodies to adopt standards and legal frameworks, many physicians around the world are developing regenerative procedures anyway, and aesthetic medicine is poised to drive some of these developments.

According to Luiz Toledo, M.D., a plastic surgeon in Dubai, United Arab Emirates, “We now have specialized labs devoted to the safety and efficacy of these new methods. For instance, ADSCs have the potential to differentiate towards a variety of cell lineages both in vitro and in vivo. They can be used to replace soft tissue in breast reconstruction after tumor surgery, breast asymmetry and soft tissue defects, after trauma or burns.”

Biocellular therapies combine important biological chemicals, such as growth factors, with “undifferentiated” cells that carry out tissue repair and regeneration. “Fat transfer is a starting point for many regenerative treatments,” stated Adrian Gaspar, M.D., director at Prima Piel Clinic Aesthetics, Anti Aging & Gynecology in Mendoza, Argentina.

“At the beginning of this century, we started using growth factors from platelets, or PRP, and physicians began working with stem cells derived from bone marrow,” Dr. Gaspar continued. “In the last 15 to 20 years, though, the medical community discovered that we can harvest stem cells from fat tissue.”

We harvest the fat and destroy the adipocytes in order to obtain the small, adherent cells that are attached to the extracellular matrix,” Dr. Gaspar explained. “This SVF can be used to improve stretch marks, cellulite, acne scars, melasma, wrinkles and alopecia, among other conditions. We have been conducting research to use these stem cells for vaginal rejuvenation and aesthetics of the genital area, as well.”

Globally, the industry is moving towards a convergence of biologics and medical devices, expressed Chiara Schiraldi, M.D., Ph.D., associate professor of Molecular and Cellular Biology at the Second University of Naples, Italy.

“We are still trying to understand the best and most effective ways to deal with biological substances. In addition, the medical community is working hard to simplify the problem, in order to make it easy for physicians,” she said. “One thing we do know is many practitioners employ energy-based devices to stimulate collagen growth, as well as use injectables, growth factors and other forms of stimulation that encourage the biosynthesis of collagen and promote rejuvenation.”

Overall, regenerative aesthetic procedures hold tremendous potential, noted Dr. Gaspar. “Little by little, this concept is emerging around the world. It is the combination of growth factors and stem cells.”

“Growth factors have the potential to speed up the differentiation of stem cells. Stem cells are found in white cells produced by the bone marrow, but they live in our fat,” Dr. Gaspar advised.

“These cells can differentiate approximately 100 to 150 times in our bodies. We can inject these cells into any area where the skin, tissue or wound can be healed, and the cells will differentiate,” he elaborated.

“The growth factors that exist in the granules of the platelets are essential to promote a differentiation of these stem cells,” he continued. “These are cytokines, which is the ‘language’ spoken by cells. You get stem cells to start talking with other cells and they start differentiating.”

A common denominator in regenerative aesthetics is PRP, which is employed not only in skin rejuvenation and body shaping, but also to address androgenetic alopecia, scars, striae and even vaginal and penile enhancement.

“I’ve used PRP in a wide range of procedures at my clinic,” stated Atchima Suwanchinda, M.D., a dermatologic surgeon in Bangkok, Thailand. “For instance, PRP used for facial rejuvenation after I have already treated the patient with an energy- based device, such as a laser. I’ve also combined PRP with laser treatments to address striae on the body with very good results.”

I use PRP for hair restoration, in particular when I’m treating female pattern baldness, which can be very difficult to treat,” Dr. Suwanchinda added. “Along those lines, I’ve used PRP in addressing the scalp, in general.”

These are becoming popular therapies because they work, Dr. Suwanchinda continued.

“In some cases, patients come in with complications from dermal fillers, and some of them have skin necrosis. I have seen the combination of PRP and the patient’s stem cells achieve substantial and amazing clinical results in terms of renewed and repaired skin. I’ve used PRP to inject over acupuncture points, and it could represent the future when treating some recalcitrant problems like melasma, burn scars and striae.”

According to Dr. Toledo, “A PRP injection contains two to 14 times the concentration of platelets found in normal blood. It appears that these platelets release protein and other particles to help the body start a process of self-healing.”

In plastic surgery we have used PRP mixed with fat, in a proportion of 20% PRP to 80% fat to increase the success rate of the fat grafts, Dr. Toledo reported. “So far, the results are still in their initial phase and we will need more research before we can say for sure that PRP makes a difference.”

Across the APAC region and beyond, the introduction of nanofat and micronized fat has reignited physician interest in fat transfer, noted Dr. Suwanchinda. “In my region, we have seen practitioners discovering nanofat and the results are wonderful. I’ve used this approach to address very difficult-to-treat scars, with great results. These procedures really give patients hope and provide a very impactful result.”

While regenerative approaches have already enhanced traditional fat transfer procedures, new techniques allow for a higher chance of fat survival versus traditional fat transfer. The sky may be the limit regarding regenerative aesthetics, but any time evolutionary or groundbreaking techniques are applied at the clinic level the question always arises: How does a physician manage patient expectations regarding such new therapies?

“Expectations can be very difficult to manage, especially now with ‘Dr. Google’ being present in everyone’s smartphone,” noted Dr. Toledo. “Anyone can publish whatever they want on the Internet and patients immediately see ‘miracles’ that are impossible to obtain. These patients believe what they see and come to the plastic surgeon demanding the same results they see online. If the surgeon has enough experience to convince the patient of realistic results both surgeon and patient will be pleased.”

In the near future, count on a steady increase in the use of regenerative therapies, devices and products that gain a better biologic response. While still on the fringes, evidence suggests that tissue banking; genetics-based therapies; and the expansive use of botanicals, especially anti-inflammatory botanicals, will soon move closer to the mainstream.

Even though the industry has not reached that level of sophistication, “At the very least, in aesthetics, we are discovering new techniques to enhance skin quality, improve fat regeneration after grafting, and restore volume to the face and body affected by aging,” Dr. Toledo noted.

“I have a positive feeling about how regenerative techniques can be employed in aesthetic dermatology,” stated Dr. Suwanchinda. “We still have a long way to go, but the future ahead is bright.”

IMCAS & ICAD 2018

Article-IMCAS & ICAD 2018

IMCAS & ICAD 2018 Preview

As the fastest growing, most diverse market for aesthetic medicine, the Asia-Pacific (APAC) region is experiencing an upsurge in new clinics and spas, increased equipment sales and robust growth in non-invasive procedure volume. This ongoing progression, and recent technological advances have also driven an expansion of educational conferences in the region.

In particular, two upcoming meetings – the 12th annual International Master Course on Aging Science (IMCAS) Asia, taking place July 13 – 15, 2018 in Bangkok Thailand; and the 20th annual International Conference on Aesthetic Dermatology (ICAD), also set for Bangkok on November 22 – 24, 2018 – draw a distinguished crowd of plastic surgeons, dermatologists and aesthetic practitioners looking to stay current on today’s technological breakthroughs and in-depth scientific research in the field of anti-aging and aesthetic medicine.

As more spas and clinics open across the APAC region, the number of new multifunctional energy-based platforms, advanced injectable formulations and practice management solutions has increased.

As a result, both IMCAS Asia and ICAD will focus on cutting edge treatments, creative approaches to popular procedures, reviews of digital marketing and other business-related issues, along with the latest research supporting these advances.

This year’s IMCAS Asia event is a joint congress with the Thai Society of Cosmetic Dermatology and Surgery (THAICOSDERM). The event will have a global reach, with a wide ranging, comprehensive educational curriculum focused on Asian-centric approaches and techniques.

IMCAS Asia 2018 is expecting over 1,500 attendees from around the world, offering a scientific program featuring approximately 80 renowned speakers who will present over 130 sessions. Key themes include injectables; energy-based devices; hair restoration; genital treatments; threads; facial, breast and body surgery; clinical dermatology; non-surgical body shaping; cosmeceuticals; regenerative medicine and lipofilling; peels; mesotherapy; research and development; and practice management.

IMCAS has incorporated several innovative session formats into the program, comprising lectures, live patient demonstrations, economic forums, interactive workshops, and of course the Anatomy on Cadaver workshop – one of their most popular sessions. This half-day module combines live broadcasts of a cadaver dissection with live patient demonstrations, which show the impact of specific treatment techniques above and below the skin.

Other live demonstrations will cover lasers and energy-based devices, threads and injectables. Sponsored by leading aesthetic companies, these workshops provide attendees with the opportunity to explore specific products and interact with the manufacturers. Attendees can also sign up for video-based classes to gain in-depth practical training on facial injections, platelet-rich plasma (PRP), blepharoplasty and rhinoplasty.

Symposia on non-surgical treatments will zero in on energy-based devices used for specific Asian skin conditions, such as lasers for pigmentation in skin of color, procedural management of melasma and pigmentary changes following treatment with picosecond lasers in Asian patients. Top faculty will also present insights into new techniques and technologies employed in combination therapies, male treatments and more.

On the business side of aesthetic medicine, other sessions will cover practice management, approaches to patient retention, digital marketing, as well as the latest economic trends in the region. Finally, attendees can participate in high touch networking events, such as the gala dinner taking place on the second evening of the conference.

ICAD 2018 offers a venue for leading academic scientists, researchers and scholars to exchange experiences and clinical data in the field of aesthetic dermatology. The educational program is focused on new trends and developments in cosmetic dermatology, with the strong presence of leading Thailand-based dermatologists and aesthetic practitioners. Like the IMCAS Asia meeting, ICAD has partnered with a leading regional society, the Dermatological Society of Thailand (DST).

While ICAD 2018’s program remains mainly focused on the Southeast Asia markets, key discussions of current trends in aesthetic medicine will include updates from Taiwan, India and South Korea. ICAD’s pre-congress course, Diversity in Facial Beauty – An Aesthetic Perspective, covers non-invasive facial treatments using a variety of injectables.

While clinical dermatology is also covered – such as cancer, skin infections, eczema, dermatitis and dermatopathology – this year’s event will delve deeply into non-surgical cosmetic treatments such as laser resurfacing, skin grafting and hair restoration.

Live patient demonstrations will address both female and male aesthetic concerns, with a spotlight on treating the submental area, and even transgender transformations. Other content addresses advanced neurotoxin treatments, new versus traditional pigmentation therapies, feminine rejuvenation, technology improvements, chemical peels, experts sharing best practices for performing thread lifting procedures, and more.

Many cases and procedures will be presented via live streaming events, in which attendees can receive practical lessons and advice on how to treat patients of different ages, Eastern versus Western approaches to injectables, and the ABCs of preventative treatment.

Of all the technology types being considered by practitioners in the APAC region, lasers and other energy-based devices lead the way. Multimodality platforms, which are designed to treat several indications in one system, are often a good choice for well-rounded clinics.

Attendees at both IMCAS Asia 2018 and ICAD 2018 will have ample opportunity to discover the newest products and technology innovations being introduced to the APAC region, with both shows expecting over 70 top manufacturers, developers and laboratories to fill their respective exhibit halls.

Cutera (Brisbane, California, U.S.) will highlight enlighten SR. This new, novel picosecond platform features two proven wavelengths: 532 nm and 1064 nm, as well as high pulse energy, to treat unwanted multicolor tattoos, epidermal and dermal pigment, and to address skin revitalization concerns across all skin types. Additional applications include treatment of scars, fine lines and wrinkles. For difficult-to-treat skin concerns and tattoo removal, the enlighten SR’s PICO Genesis FX is a non-thermal, two-in-one laser procedure for skin rejuvenation that results in a brighter, more radiant and uniform skin tone.

The Dynamis Pro laser system from Fotona (Ljubljana, Slovenia) is designed to perform an exceptionally wide range of applications in aesthetics, surgery and gynecology. This award-winning, all-in-one anti-aging laser platform incorporates three modalities: Er:YAG, Nd:YAG and a surgical QCW Nd:YAG, and can be employed for body contouring, fat removal and acne scar treatments. Fotona’s YAG laser works with a proprietary technology that can be adjusted according to patient needs during the procedure.

The company will also highlight its Q-switched StarWalker laser system, which combines four wavelengths and 14 modalities with the revolutionary capability of ASP™ technology. Offering high-powered picosecond pulses, StarWalker’s breakthrough technology increases instantaneous power and overall energy, resulting in more control. In addition, an unprecedented 10 J of Q-switched energy in a single pulse enables larger spot sizes and faster treatments.

GSD / Shenzhen (China) will present the newest edition to its Excimer light system product line – the Eximal Mini. This third-generation handheld device is a cost-effective, portable 308 nm excimer light that can induce apoptosis of T-cells and pigment synthesis. It has been clinically proven as an effective treatment for vitiligo and psoriasis, with fewer adverse effects and maximum patient comfort. Other benefits include low operating costs and no consumables.

MedixSysteme (Ruggell, Liechtenstein) will feature the multi-use Sygmalift. Featuring three technologies in a single platform (laser, focal ultrasound and tri-micro focal ultrasound), this non-surgical treatment concentrates 1,000 intersecting beams of ultrasound energy at a target depth in skin tissue. Each beam creates a progressive thermal action that enhances the elimination of fat cells, resulting in improved facial contours. This low level laser emits photons to improve cell function, thus accelerating the healing process and quickly calming any inflammation. SygmaLift’s contouring facial not only shapes the chin and jawline, but also tightens the skin and softens fine lines.

Forever Young BBL from Sciton (Palo Alto, California, U.S.) is an innovative technology that uniquely delivers light-based therapy targeting the signs of aging and sun damage, effectively providing patients with a more refreshed, rejuvenated and youthful appearance. It treats a wide variety of conditions, including age spots, freckles, redness, small vessels, unwanted hair, active acne, and more. In addition, Forever Young BBL has been shown to change the expression of genes associated with aging, longevity and increased lifespan. With regular Forever Young BBL treatments, skin looks clearer, smoother and much younger.

As an integrated aesthetic treatment platform, the GentleMax Pro from Syneron Candela (Irvine, California, U.S.) combines 755 nm Alexandrite and 1064 nm Nd:YAG wavelengths to deliver numerous high efficacy treatments from hair removal to benign epidermal pigmentations, vascular lesions and tightening for all skin types. The operator independent, cryogen based Dynamic Cooling Device™ (DCD™) provides maximum and consistent protection of the epidermis, providing patients with a comfortable treatment. The system’s large spot delivery system offers the fastest dual wavelength hair removal laser in the market. In addition, the unit’s 5 mm spot size enables treatment of nail fungus.

Combining the Z Lipo cryolipolysis system with the Z Wave Pro shockwave therapy unit, both from Zimmer MedizinSysteme (New Ulm, Germany), allows practitioners to target fat deposits and reduce them permanently and noninvasively. Z Lipo cools fat cells over a longer period of time in a controlled and safe temperature range, while Z Wave Pro transmits powerful acoustic waves into tissue, employing radial pulse energy that is delivered via an electromagnetic applicator, which disperses radially to enhance the treatment effect. Studies have shown that delivery of intensive, pain-free shockwave treatment after cryolipolysis procedures not only ensures improved fat loss, but also stimulates lymphatic drainage and tightens the skin.

DermapenWorld (Sydney, Australia) will focus on the newest addition to its product line – the Dermapen™ 4. This advanced 16-needle cartridge design is capable of precise, drag-free penetration up to 3 mm deep, with regulated suction release that generates 1,920 puncture channels per second, resulting in more microchannels. These enhancements enable skin rejuvenation and the infusion of active substances at faster rates, while providing safer treatments. The unit’s patented radiofrequency identification (RFID) system provides accurate penetration depth by automatically and consistently calibrating the needle cartridge with the device. In addition, proprietary Advanced Oscillating Vertical Needle (AOVN) technology mechanically calibrates the motor speed, pressure and penetration.

Microneedling for asian skin types

Article-Microneedling for asian skin types

Sponsored

DermapenWorld (Sydney, Australia) is setting a new benchmark in microneedling technology with the recent release of Dermapen™ 4. Featuring an advanced 16-needle cartridge design for drag-free penetration with regulated suction release, Dermapen’s 33-gauge stainless steel gamma sterilized needles create 1,920 puncture channels per second.

In addition, the upgraded Dermapen 4 features a patented radiofrequency identification (RFID) system for accurate needle penetration, and Advanced Oscillating Vertical Needle (AOVN™) technology, which mechanically calibrates motor speed, pressure and penetration for scar treatment at 3.0 mm.

“This version is faster than the previous device, has more needles and does even more micro-perforations per time frame,” said Danijela Schenker, an intensive care nurse and microneedling specialist at the Frisch Institute of Skin and Figure (Zurich, Switzerland). “This means shorter treatment times and more comfort for the client.”

“The superior AOVN technology allows me to deliver a smooth, drag-free procedure and optimal results,” stated Ratna Tallo, M.D., a dermatologist in Kupang, Indonesia.

“Dermapen can be one of the most affordable, yet effective solutions to address fine lines and wrinkles, atrophied and sun damaged skin, multiple forms of scarring, and stretch marks,” Dr. Tallo noted. “It has also been used to enhance the results of various applications targeting alopecia, keloid scarring and vitiligo, among others. Dermapen is more versatile, as it enables us to more easily treat hard-to-reach areas, such as around the eyes and nose.”

According to Melanie Lambrechts, M.D., an aesthetic practitioner and owner of The Center of Wellness in Johannesburg, South Africa, “The microneedling trend is huge, and this device treats so many more indications.”

Practical for Asian Skin Types

The device works well on Asian skin and darker skin types, Dr. Lambrechts reported.

“We have a growing population of clientele with darker skin types and my laser does not treat darker skin types very well,” she elaborated. “One of the benefits of medical microneedling in general is that it is ideal for patients that are sensitive to the heat and thermal impact of other energy-based treatments.”

In addition, Asian and darker skin types are very prone to pigmentation, stated Dr. Lambrechts. “They are vulnerable to the sun or light-induced pigmentation and seem to have a lot of hormonal pigmentation, as well. If you traumatize their skin too much in any way, you can cause post-inflammatory hyperpigmentation. Dermapen is safe on these patients but they require a lot more care.”

Extra care includes a series of treatments, starting with skin preparation, Dr. Lambrechts indicated. “We prepare the skin around one month prior to the actual treatment, utilizing specific topical products that calm the skin, in a way tranquilizing the melanocytes,” she shared. “We employ very careful after care, as well.”

Enhanced Functionality Improves Efficiency

The new Dermapen 4 offers an onboard real-time display, as well as integrated Bluetooth connectivity, allowing practitioners to wirelessly update the system’s calibration tables and firmware, which can be continually upgraded.

Additionally, the system now incorporates a rechargeable battery, in addition to the standard power cord. The versatility of having both corded and battery power is highly desirable, Dr. Lambrechts expressed.

“Unfortunately, in many parts of the world there are power outages, so having battery power means a lot,” she explained. “As the battery runs down with other portable pens, the treatments become uneven and you’ll get dragging of the skin. However, the battery technology behind this new pen ensures it will maintain its charge right up to the moment you switch it off.”

Along with these technical enhancements, Dermapen 4’s handheld ergonomics are a major advancement over earlier versions.

Dermapen offers more aggressive skin remodeling treatments, as well as deeper rejuvenation procedures, Dr. Tallo shared. “It has the functionality of a fractional microneedle skin therapy system and is very lightweight, which really helps my hand’s movement during procedures and saves time, as well.”

Versatile Applications

Traditional microneedling treatment modalities address scars, and this is where Dermapen 4 really shines, offering dedicated treatment practices for scar revision, including deep, atrophic scars, striae and post-acne scars. Beyond scar procedures, Dermapen 4 can be customized to expand the number of indications that can be treated compared to its earlier versions and other microneedling devices on the market.

Users have also found that the system works synergistically with various modalities such as energy-based systems and other therapies.

The company’s separate Dermapen Tattoo Activator Infusion Device and new Tattoo needle cartridge allow for non-laser, all color tattoo removal that can be used alone or combined with standard laser-based techniques to achieve full tattoo clearance.

In addition, Dermapen 4 also infuses PRP, mesotherapy and other serums utilizing the company’s new Meso-Infuse needle cartridge, which promotes pinpoint delivery and precision.

Responding to Contamination Concerns

When it comes to microneedling, an important concern is needle sterility. Dermapen 4’s gamma-sterilized cartridge and needles include retention valves that alleviate the build-up of procedural pressure within the needle cartridge.

Furthermore, a built-in anti-contamination management system removes the risk of cross-contamination while confirming pressure-free contact with the skin during treatment.

A lot of pens out there don’t have that level of attention to patient safety, Dr. Lambrechts pointed out. “There are bodily fluids associated with this device. Often, your endpoint is to try to draw blood from the patient’s skin. Dermapen 4’s technology guarantees no back flow of patient’s fluid into the pen, to maintain treatment safety.”

Overall, Dermapen is advancing microneedling therapy in innovative ways.

Whether practitioners use Dermapen as a standalone procedure or in combination with other modalities, “patient satisfaction is high with Dermapen, Ms. Schenker maintained. “Patients love microneedling. It is minimally invasive, safe and quick, delivering beautifully natural and lasting results with no downtime.”

In addition, “Dermapen helps me produce subtle to markedly improved results, which meets both our patients’ expectations and mine as the practitioner. Managing patient expectations is as important as choosing the most suitable treatment option possible,” Dr. Tallo noted.

“The global market of microneedling devices is driven by the increasing incidence of chronic hyperpigmentation, infectious skin diseases, etc.,” expressed Dr. Tallo. “Changes in lifestyle will increase the incidence of skin related diseases, which will ultimately enhance the growth of the global microneedling market. The high cost of other surgical options may also expand market growth, propositionally.”

FDA stem cell crackdown in cosmetic clinics

Article-FDA stem cell crackdown in cosmetic clinics

The FDA announced May 9 that it is seeking permanent injunctions against a stem cell clinic in Florida and one in California to stop marketing stem cell products that lack FDA approval. The clinics also have deviated from “good manufacturing practice requirements,” putting patients’ health at risk, according to the FDA.

The actions are part of a comprehensive approach to the government’s oversight of regenerative medicine products — products promoted in many medical specialties, including aesthetic medicine. In fact, one of the physicians named in the FDA’s May 9 press release is cosmetic surgeon Mark Berman, M.D.

“The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients stem cell products without FDA approval. Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center. The FDA is seeking an order of permanent injunction requiring California Stem Cell Treatment Center Inc. and Cell Surgical Network Corporation and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements,” according to the FDA.

Stem cell clinic openings have been on the rise in the U.S. in recent years, according to Bradford E. Adatto, an attorney and partner at the ByrdAdatto law firm, which specializes in legal issues impacting healthcare and aesthetic providers.

“The growth of the stem cell market has brought more businesses into the medical market attempting to offer quick, alternative ways of improving an individual’s health,” according to Adatto. “According to the FDA’s website, it has not approved any stem cell-based products for use other than cord blood-derived cells.”

While the FDA does not have control over a physician’s ability to prescribe “off-label” or conduct “experimental use” of a drug, physicians taking such actions are subjected to the oversight of their medical boards, according to Adatto.  For example, he says, the Texas Medical Board allows limited use of stem cells that are not FDA approved if certain conditions are met, which include: (1) institutional review board approval for stem cell use; and, (2) special informed consents from the patients on the use of unapproved investigational therapy.

“Physicians that are interested in providing stem cells need to also confirm they are meeting the supervision required of those healthcare practitioners providing the medical services,” Adatto says. “What the medical community is witnessing is the growing trend of patients attempting to find other methods, including nonsurgical methods, to alleviate pain and discomfort. For those physicians that determine that stem cell-based therapy is a viable alternative method of treatment for their patients, they need to make sure they are compliant with their state medical boards and laws.

Tissue structure post-ThermiVa

Article-Tissue structure post-ThermiVa

Clinical and patient-reported results show transcutaneous temperature-controlled radiofrequency (RF) treatment, with ThermiVa (Thermi), improves sexual satisfaction, atrophic vaginitis and vulvovaginal laxity. Now, histological findings are helping to validate results, including, for the first time, showing evidence of treatment-related neurogenesis, according to a small study published May 2018 in Dermatologic Surgery.

Ten women, ages 23 to 60 years, with mild-to-moderate vulvovaginal laxity, underwent ThermiVA treatment. Five of those women agreed to pre- and post-treatment biopsies. The women had three ThermiVa treatments, performed four weeks apart.

Researchers found significant improvement in mild-to-moderate vulvovaginal laxity through 120 days post-treatment. They also found sexual satisfaction improved significantly by day 60. Atrophic vaginitis significantly improved by day 120. And while orgasmic dysfunction, which impacted 80% of subjects, and stress urinary incontinence, affecting 90% of the women, improved steadily through 120 days, those were not significant changes.

Histology showed post-treatment increases in collagen, elastin, vascularity and small nerve endings, according to the study.

Sexual Satisfaction Measures

Subjects reported a mean 2.8 in sexual satisfaction scoring at the study’s start. At baseline, day 10, 30, 60 and 120, subjects completed the Millheiser Sexual Satisfaction Questionnaire, rating satisfaction from vaginal intercourse as 1 (none) to 6 (excellent). They also completed the Female Sexual Function Index, looking at sexual function and satisfaction. According to the study, there was an insignificant uptick in the mean sexual satisfaction score at day 10 and a significant change, with a mean 4.9 score, at day 60. At day 120, the mean was 4.3.

Interestingly, women in the study reported a significant uptick in sexual interest from baseline at day 120. They also reported a notable increase in sexual arousal during intercourse.

“Perhaps more importantly, subjects reported improved confidence in their ability to become aroused during sexual activity from baseline,” the authors write.

About the Histologic Findings

Post-treatment biopsies confirmed subtle but significant results linked with rejuvenated skin and mucosa. This included improved epithelial maturation, vaginal transudate restoration, increased collagen, new elastic fibers and increased vascularity, they write.

In what the researchers write is the first report of neurogenesis or neuroregeneration post transcutaneous temperature controlled RF treatment, they found a subtle increase in nerve fibers in three of the five samples. But they note their assessment of small nerve fiber density using neuronal stain was not done in an ideal manner and should be confirmed using more standardized methods for such an assessment.

Orgasmic dysfunction improvement with ThermiVa treatment was more evident in a clinical report by ThermiVa’s inventor Red Alinsod, M.D., published in Lasers in Surgery and Medicine in 2016. In that study of 25 women, 23 subjects reported an average 50% reduction in time to orgasm, post ThermiVa treatment. While two of the women had a minimal response, the others reported vaginal tightening, increased vaginal moisture and improved sensitivity.

“All anorgasmic patients reported the ability to achieve orgasms,” according to Dr. Alinsod, a uro-gynecologist and aesthetic vulvovaginal surgeon, who practices in Laguna Beach, Calif.

Nine patients in Dr. Alinsod’s study reported experiencing more intense orgasms.

Dr. Alinsod, says that, since 2015, when ThermiVa was launched, about 85,000 treatments have been performed worldwide. No serious adverse reactions, including blisters, burns or scarring, have been reported. 


Disclosure:
ThermiGen supported the study in Dermatologic Surgery. Dr. Alinsod is a consultant for and receives royalties from Thermi and Cooper Surgical, and is a consultant for Hautlabs, BTL and Lutronic.

Off-label Ultherapy treatment

Article-Off-label Ultherapy treatment

Ultherapy’s lifting and tightening effects go beyond FDA-cleared indications for treating eyebrows, the submental area, neck and décolleté, according to Bingham Farms, Mich., based medical aesthetician Holly Cutler, who uses the technology off-label to lift the buttocks.

Cutler tells The Aesthetic Channel that noninvasive Ultherapy [Merz Aesthetics] uses focused ultrasound that not only targets skin, but also muscle. A one-time treatment lifts the muscle and stimulates the body’s collagen and elasticity, during the course of 90 days. Ultherapy treatment has lasting effects, and there’s no downtime or bruising associated with it.

Researchers studying Ultherapy treatment’s long-term efficacy report that the lifting and tightening from customized micro-focused ultrasound with visualization treatment with vertical vectoring on the face and neck lasts for up to a year, according a study published February 2016 in the Journal of Clinical and Aesthetic Dermatology

“It’s a great option for people of any gender, any skin type and any age — though, typically over 30 — looking to improve the appearance of maturing skin on the face and neck without the pain and downtime of traditional surgery,” according to Cutler.

In addition to using it for cleared indications, Cutler uses Ultherapy for noninvasive butt lifting.

“The Ultherapy butt lift is for those individuals who may have a more flat and sagging appearance in the buttocks, and desire a more toned, lifted, contoured and defined appearance to restore youth and shape, without surgical intervention…,” she writes.

To better mimic surgical results without performing surgery, Cutler combines Ultherapy treatment for butt lifting and Sculptra (injectable poly-L-lactic acid, Galderma) filler injections, which help to create a more youthful shape to the buttocks.

“The procedure takes about 90 minutes for the Ultherapy and additional time if adding Sculptra,” Cutler writes. “Sculptra injectable, if added, can take two to three sessions, spaced six weeks apart, and the effects can last two to three years.”

While providers should inject and apply topical anesthetic when treating the face with Ultherapy, Cutler writes that she uses only a topical anesthetic when treating the buttocks. Pain from Ultherapy during treatment tends to be worse on bony areas, but, in general, is tolerable.

Cutler writes that her practice charges from $2500 to $3500 for an Ultherapy butt lift, depending on the size of the area. Sculptra injections are an additional cost.

While this doesn’t provide the more dramatic outcomes possible with a surgical approach, the combination offers patients advantages compared to other cosmetic options for the buttocks: Fat injections don’t take well and are invasive. Surgical procedures don’t have a high rate of patient satisfaction; they’re painful and put patients at risk for complications; and surgery is costly, she writes.

Ultherapy can be costly, too, especially if targeting multiple areas of the body. And while Ultherapy works to tighten and lift, it isn’t the best option to treat stretch marks and doesn’t reduce fat, according to Cutler.

“You have to really look at the person’s needs and concerns to determine what will work best for them,” she writes.


 Holly Cutler reports no relevant disclosures.

Advanced techniques for practice success

Article-Advanced techniques for practice success

With today’s ever-changing practice management and marketing landscape, building a thriving aesthetic business involves more than achieving exceptional treatment outcomes. The business of aesthetic medicine is quite complex. Physicians face operational challenges, as well as constant pressure to keep up with local competition, patient trends and today’s new digital media landscape.

As the most influential multispecialty medical education conference and exhibition in the industry, The Aesthetic Show (TAS) provides a broad educational curriculum that includes a number of opportunities to expand your practice management expertise and gain the tools needed to run a successful aesthetic practice. 

“Aesthetic medicine is a business and physicians need to treat it like one,” said Jay Shorr, managing partner of Shorr Solutions (Boca Raton, Fla.) and co-moderator of the Advanced Techniques for Practice Success special focus courses taking place on day one and two of the main program (Friday, July 6 and Saturday, July 7). “Understanding what does and does not work in the current marketplace is a valuable reality check.”

Comprised of three modules that can be taken individually or combined, these courses are designed to assist practices with building, growing and marketing an aesthetic business. Instructors include experts in practice marketing, patient counseling and office management. 

These modules will discuss the power of new media; how to analyze your business model, including how to expand your practice and profitability; mastering patient consultations; improving staff management skills; and real-world examples of success.

With over 20 lectures across the three modules, some specific topics include: How to Respond to Negative Review with Success by Lisa Wark; Best Practices in Asset Protection by David Mandell; Patient Economics – How Financing Can Remove Cost as a Barrier by Nayson Rouhipour; Drive Demand From Your Existing Patient Base by Suneel Chilukuri, M.D.; Marketing to Millennials by Tim Sawyer; Facebook and Snapchat Live Surgery Videos by Thomas Jeneby, M.D.; and Adding Cash-Pay Services to a Typically Insurance-Based Practice by Jay Shorr and Mara Shorr.

Each module has a separate fee to attend and offers unique information so attendees can participate in one, two, or all three modules for incomparable breadth and depth of information and training.

Learn more about these special focus courses, including the dates and time each module is offered.

The Aesthetic Show is a multidisciplinary medical education meeting focused on the rapidly expanding field of aesthetic medicine. This unique show brings new procedures, products and technologies, as well as a group of the top physicians in the aesthetic industry, together in a highly condensed and effective venue. The weekend will include everything that is relevant, progressive and contemporary in aesthetic medicine.

Register now!

Women’s health through science

Article-Women’s health through science

Women’s healthcare company Viveve (Denver, Colo.), makers of the Viveve System, a patented Cryogen-Cooled Monopolar Radiofrequency (CMRF) device, is committed to providing clinically-proven, cutting-edge treatments for women. Its robust clinical team, patented RF technology, and well-demonstrated commitment to science with Level I clinical evidence has set the company apart from the field. The device itself is designed specifically for intimate use, unlike many competitors which were adapted for this indication in response to growing demand.

“Viveve’s ongoing commitment to science and Level I clinical evidence is demonstrated in the dedicated resources and funding devoted to building a highly experienced clinical/medical team,” said Stacie Bell, Ph.D., senior director of preclinical research and clinical affairs at Viveve.

“We have intentionally selected veteran clinical program managers to oversee therapeutic areas and conduct studies properly, as well as leaders with years of experience in medicine, technology and clinical research to guide the team, projects and ongoing research. Also, the continued support from leadership to conduct proper research, both clinically and preclinically, is phenomenal.”

The Viveve System delivers cooled monopolar RF in a comfortable, 30-minute treatment with no downtime. The CMRF technology is purpose-built to target vaginal tissue. The integrated cooling allows RF energy to penetrate 3 to 5 mm deep without surface heat build-up, more deeply than competing RF devices, according to Dr. Bell.

“People often ask us why this device cannot be used in different areas of the body, but that goes back to the unique design of the system,” she explained. “Every part of the device is strategically crafted for the treatment of the vaginal canal to provide optimal outcomes for women. From the handpiece, to the size of the treatment tip, every part is ergonomically engineered to enter the vaginal canal comfortably and safely, while effectively treating tissue. We not only administer RF across the treatment tip consistently, we protect the mucosal surface with our cryogen cooling system,” Dr. Bell continued. “This allows more time on tissue for deep, volumetric heating of the lamina propria connective tissue down to the muscularis. Every component of the device was intentionally created to treat tissue layers of the vaginal canal,” she said.

“With the original VIVEVE I Study, the largest randomized, double-blinded and sham-controlled study in this space, we showed our commitment to high quality scientific research,” Dr. Bell stated. “We’ve conducted or supported many studies and continue to build our clinical database with further Viveve-sponsored research.”

Dr. Bell added that Viveve recently received an Investigational Device Exemption (IDE) from the FDA to evaluate the Viveve System in the United States for the treatment of sexual function in women after childbirth.

“We also plan to sponsor studies for stress urinary incontinence (SUI) in Canada (LIBERATE International) and file an IDE in the U.S. to conduct a large randomized, blinded, sham-controlled study (LIBERATE US). Also, there are several investigator-sponsored trials underway domestically and internationally, including an SUI pilot study in Canada with 36 enrolled patients, and the data look very good at interim analysis.”

Women’s health through science

Article-Women’s health through science

Women’s healthcare company Viveve (Denver, Colo.), makers of the Viveve System, a patented Cryogen-Cooled Monopolar Radiofrequency (CMRF) device, is committed to providing clinically-proven, cutting-edge treatments for women. Its robust clinical team, patented RF technology, and well-demonstrated commitment to science with Level I clinical evidence has set the company apart from the field. The device itself is designed specifically for intimate use, unlike many competitors which were adapted for this indication in response to growing demand.

“Viveve’s ongoing commitment to science and Level I clinical evidence is demonstrated in the dedicated resources and funding devoted to building a highly experienced clinical/medical team,” said Stacie Bell, Ph.D., senior director of preclinical research and clinical affairs at Viveve.

“We have intentionally selected veteran clinical program managers to oversee therapeutic areas and conduct studies properly, as well as leaders with years of experience in medicine, technology and clinical research to guide the team, projects and ongoing research. Also, the continued support from leadership to conduct proper research, both clinically and preclinically, is phenomenal.”

The Viveve System delivers cooled monopolar RF in a comfortable, 30-minute treatment with no downtime. The CMRF technology is purpose-built to target vaginal tissue. The integrated cooling allows RF energy to penetrate 3 to 5 mm deep without surface heat build-up, more deeply than competing RF devices, according to Dr. Bell.

“People often ask us why this device cannot be used in different areas of the body, but that goes back to the unique design of the system,” she explained. “Every part of the device is strategically crafted for the treatment of the vaginal canal to provide optimal outcomes for women. From the handpiece, to the size of the treatment tip, every part is ergonomically engineered to enter the vaginal canal comfortably and safely, while effectively treating tissue. We not only administer RF across the treatment tip consistently, we protect the mucosal surface with our cryogen cooling system,” Dr. Bell continued. “This allows more time on tissue for deep, volumetric heating of the lamina propria connective tissue down to the muscularis. Every component of the device was intentionally created to treat tissue layers of the vaginal canal,” she said.

“With the original VIVEVE I Study, the largest randomized, double-blinded and sham-controlled study in this space, we showed our commitment to high quality scientific research,” Dr. Bell stated. “We’ve conducted or supported many studies and continue to build our clinical database with further Viveve-sponsored research.”

Dr. Bell added that Viveve recently received an Investigational Device Exemption (IDE) from the FDA to evaluate the Viveve System in the United States for the treatment of sexual function in women after childbirth.

“We also plan to sponsor studies for stress urinary incontinence (SUI) in Canada (LIBERATE International) and file an IDE in the U.S. to conduct a large randomized, blinded, sham-controlled study (LIBERATE US). Also, there are several investigator-sponsored trials underway domestically and internationally, including an SUI pilot study in Canada with 36 enrolled patients, and the data look very good at interim analysis.”