LASEROPTEK PicoLO Laser Receives FDA 510(k) Clearance

PicoLO-Silver-HP

LASEROPTEK Co Ltd announces that its PicoLO picosecond Nd:YAG laser recently received US Food and Drug Administration 510(k) clearance for use in dermatology and general and plastic surgery.

PicoLO generates high peak power and consistent picosecond pulse duration producing strong photomechanical forces within the skin to quickly and effectively break down and fragment pigments such as those found in tattoos. In addition, PicoLO incorporates LASEROPTEK’s patented Diffractive Optical Element (DOE) fractional technology consistently creating Laser-induced Optical Breakdown (LIOB) in the dermis even at low power.

This combination of photomechanical effect and LIOB gives PicoLO a significant point of difference with picosecond lasers on the market and delivers numerous advantages to both patients and providers, according to a company news release.

“Exceptionally stable energy output and picosecond pulse duration are key technological developments integrated into PicoLO further distancing it from the competition. High stability in both laser output and pulse duration is central to delivering consistently efficacious treatment outcomes while simultaneously minimizing patient discomfort,” says C.J. Lee, CEO of LASEROPTEK, in the release.

[Source(s): LASEROPTEK Co Ltd, PR Newswire]

Alma Lasers Debuts BeautiFill Fat Transfer System

BeautiFill

Alma Lasers Inc announces the North American debut of BeautiFill, reportedly the first laser-based system designed to optimize the process, time and quality of autologous fat transfer for complete aesthetic contouring.

BeautiFill combines laser, suction and fat processing into one simple step, allowing physicians to quickly harvest and process high-quality fat for immediate reimplantation to address volume loss.

The device will officially debut at the Annual Meeting of the American Academy of Dermatology, which will take place March 1 to 5 in Washington, DC.

Autologous fat transfer is the next frontier in aesthetic medicine, according to the company, in a news release.

“Losing volume is a natural part of the aging process, but the options to satisfy larger quantities of volume loss have been limited and cost-prohibitive for patients,” says Daniel Friedmann, MD, FAAD, a board-certified dermatologist at Westlake Dermatology & Cosmetic Surgery in Austin, Tex.

“BeautiFill is more than just a complete system for autologous fat transfer, it’s a comprehensive solution,” he adds in the release. “With BeautiFill we now can achieve consistency in high fat viability, and together with Alma’s investment in training, providers can expect to maximize the longevity of their fat transfer results.”

BeautiFill features a proprietary conical tip laser fiber encased in a protective glass sheath. This design diffuses the power density to protect the adipose and further allows the energy to be distributed in a 360-degree radius for efficient detachment of fat for simultaneous aspiration.

In a controlled study, the adipose tissue from BeautiFill consistently achieved high fat cell viability in the high 90s and 40% more injectable fat over mechanical liposuction, the release suggests.

“The launch of BeautiFill addresses two demands in our market — an alternative method to achieve fat reduction for body contouring and an all-in-one solution for fat transfer,” says Avi Farbstein, CEO of Alma Lasers, North America, in the release. “BeautiFill offers physicians the opportunity to be on the cutting edge of aesthetic medicine and for some, a new procedure and revenue stream for their practice.”

For more information, visit Alma Lasers Inc or visit the company’s Booth #2009 at the AAD show.

[Source(s): Alma Lasers Inc, PR Newswire]

Lutronic Genius Intelligent RF Delivery Platform Receives FDA Clearance

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Lutronic, a global business focused on developing intelligent energy-based medical devices, announces the US FDA clearance of the Lutronic Genius platform.

The radiofrequency microneedling device is designed to transmit energy more precisely into the skin.

The Lutronic Intelligent Care products also incorporate “smart” features to help practitioners provide outstanding care, according to a company news release.

“The Genius system is the best system that Lutronic has come up with,” shares E. Victor Ross, MD, Director Laser and Cosmetic Center at Scripps Clinic San Diego, in the release. “It has a quiet motor, a more ergonomically friendly handpiece, and it also has a real-time feedback. The intelligent interrogation of the skin allows you to be assured that you are precisely delivering the energy that you intended at your chosen depth.”

The “genius” is in the innovation, according to the company:

• The system’s sophisticated sensing and feedback algorithms provide novel real-time feedback to deliver more consistent energy during the treatment.
• Treatments can be optimized for age, skin type, sun exposure habits, anatomical area, tissue thickness and depth, and other variables.
• The neocollagenesis and neoelastinogenesis resulting from a Genius treatment can lead to healthier tissue and desired patient outcomes.

“Genius is our newest flagship device in our suite of Lutronic Intelligent Care systems which are optimized for the perfect combination of comfort, recovery, and outcomes,” states Lee Pannell, COO of Lutronic Global, in the release. “Furthermore, we are excited about the collaboration between our Korean and USA teams, which has yielded our first system to be assembled in the USA.”

For more information, visit Lutronic.

[Source: Lutronic]

SkinTE Aims to Provide Full-Thickness Skin Regeneration

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The dozens of skin substitute products on the market today fall short of delivering what patients and providers have always wanted – the patient’s own skin. But now, this long-sought-after outcome is possible with a product called SkinTE.

Released in December 2017, SkinTE is currently being used on patients with acute and chronic burns, wounds, and contracting scars to replace, reconstruct, or supplement damaged or missing skin. SkinTE, which is made by activating the natural capabilities of a patient’s healthy skin sample, is a paste-like construct that is spread over a prepared wound bed and allowed to heal to full-thickness skin on the patient over time.

Unlike other treatment options, SkinTE regenerates skin with all of the layers and appendages of normal skin, which are critical for functional outcomes and improvement of patients’ lives.

SkinTE was developed by PolarityTE, a commercial-stage biotechnology and regenerative biomaterials company founded by plastic surgeons from Johns Hopkins Hospital who wanted to improve patient outcomes by bringing to market new therapies that challenge the long-standing standards of care within the healthcare industry. Thanks to these efforts, today, healthcare providers have a viable alternative to skin grafts and skin substitutes, with SkinTE.

To learn more about SkinTE and PolarityTE, visit www.PolarityTE.com.

[Source: PolarityTE]

L’Oréal Unveils My Skin Track pH Wearable Sensor at CES 2019

My Skin Track pH by La Roche-Posay, introduced recently at the 2019 Consumer Electronics Show in Las Vegas, is a wearable microfluidic sensor and companion app designed to measure personal skin pH levels and create customized product regimens to better care for skin.

The sensor, developed by L’Oréal along with its skincare brand La Roche-Posay, received a CES 2019 Innovation Award, named a “Best of Innovation” winner in the Wearable Technology Products category.

“The scientific and medical communities have long known the link between skin pH levels and common skin concerns that millions of people experience every day,” says Guive Balooch, global vice president of the L’Oréal Technology Incubator, an arm of L’Oréal’s Research & Innovation Division, in a media release from L’Oréal USA.

“Our goal is to use this advanced technology to empower consumers with meaningful information about their skin, so that they can find the products that are right for their individual needs. At L’Oréal, we know that health is the future of beauty and we are committed to leveraging technology to bring powerful insights and solutions to our consumers,” Balooch adds.

My Skin Track pH provides an accurate pH reading via a simple two-step process, per the release:

  1. The wearer places the sensor on their inner arm, leaving it in place for 5-15 minutes—until the center two dots take on color.
  2. Next, the wearer opens the My Skin Track pH app and photographs the sensor. Utilizing an advanced algorithm, the app reads the pH measurement, as well as the wearer’s local sweat loss—the rate of perspiration on the skin’s surface—to assess skin health and make customized La Roche-Posay product recommendations to care for skin and balance pH.

My Skin Track pH was created by L’Oréal in partnership with Epicore Biosystems, a manufacturer of microfluidic platforms and soft wearable sensors.

“Epicore is thrilled to collaborate with L’Oréal, an expert in skincare science, to create a new use-case for this technology that drives new research and understanding around skin pH,” says Roozbeh Ghaffari, PhD, co-founder and CEO of Epicore Biosystems, in the release.

My Skin Track pH is an expansion of L’Oréal’s efforts to deploy new technologies to support skin health. In November 2018, L’Oréal launched a personal UV sensor, My Skin Track UV by La Roche-Posay, exclusively at select U.S. Apple stores and on apple.com.

“This new prototype represents the next step in La Roche-Posay’s beauty tech journey. We are committed to bringing scientific progress directly to consumers, to help them take great care of their skin,” states Laetitia Toupet, global general manager of La Roche-Posay.

My Skin Track pH will initially be introduced in 2019 through select La Roche-Posay dermatologists in the US, with the goal of amassing new research and ultimately launching a direct-to-consumer product, per the release.

[Source(s): L’Oréal USA]

lululab’s LUMINI Receives CES 2019 Innovation Award

lululab, a member company of the K-ICT Born2Global Centre, has received a CES Innovation Award in the “Fitness, Sports, and Biotech” category, ahead of the consumer electronics show CES 2019, to be held in Las Vegas in January.

lululab, a spinoff company of C-Lab—Samsung Electronics’ in-house venture program—developed the AI skincare assistant LUMINI. Based on AI technology, the device scans and analyzes the user’s skin condition in only 10 seconds and recommends the most suitable cosmetic products.

LUMINI quantifies skin condition based on six criteria, including wrinkles, pores, skin trouble, and melasma, which are the most common skin problems, and recommends the best solution. Lumini systematically manages the user’s skin condition based on skin-related data and helps the user use that information to improve his or her skin in the future, explains a media release from K-ICT Born2Global Centre.

“LUMINI is the first AI technology-based beauty solution that allows you to complete a skin test in only 10 seconds by taking photos, without ever touching your skin,” says lululab CEO Yongjoon Choe, in the release. “By collecting big data on skin types related to ethnic origin and environment, we aim to transform LUMINI into an AI solution that recommends customized lifestyles and foods for all kinds of users.”

According to the company, its AI skincare assistant LUMINI is designed to provide customers with a new offline shopping experience that includes everything from AI skin analysis to product recommendation and purchase.

[Source(s): K-ICT Born2Global Centre, PR Newswire]

Galderma Labs Expands Collaborations Roster

Galderma Laboratories LP announces an expansion to its roster of collaborations in the US with professional-grade skincare brands, REVISION SKINCARE, ALASTIN Skincare, and SENTÉ, to bring additional value to aesthetic providers and their patients.

The expansion is a strategic move due largely to the proven success of Galderma’s long-standing, ongoing collaborations with Colorescience and Mentor Breast Implants, the company notes in a news release.

“Galderma strives to build new relationships within the aesthetic market and develop innovative marketing promotions to benefit our customers and their patients,” says Alisa Lask, vice president and general manager of Galderma’s US Aesthetic Business.

“Through these unique collaborations, aesthetic providers can now offer their patients a variety of premium skincare products along with their facial injectable treatments.”

The collaborations include certain Galderma aesthetic dermal fillers and physician-dispensed skincare products. With a qualifying purchase of Galderma dermal fillers, aesthetic injectors will receive the skincare products to offer to their patients to use as part of their ongoing beauty routine.

“The popularity of non-surgical treatments is rising and providing distinct offers to my patients is important because it allows me to deliver customized and memorable patient experiences,” states Dr Robyn Siperstein, MD, a board-certified dermatologist at Siperstein Dermatology Group, the release continues.

“With Galderma’s new professional skincare brand collaborations, it allows me to focus on obtaining patient long-term loyalty and trust, as well as incentivizing my patients to come back for additional treatments and services.”

Consumers can learn about these offerings from participating aesthetic providers. In the future, Galderma is planning to leverage the one million members of the ASPIRE Galderma Rewards program to reach patients directly with unique benefits they can redeem from participating aesthetic providers.

[Source(s): Galderma, PR Newswire]

New FDA-Cleared Illuvinate System Treats Psoriasis at Home

Luma Therapeutics launches the illuvinate System, an FDA-cleared  in-home treatment designed to provide lasting relief from psoriasis symptoms.

The system can now be prescribed either by a dermatologist or via Luma’s telehealth provider, HealthLens, it notes in a media release.

“As a psoriasis sufferer, I knew how important it was to find a better solution than what was currently available,” says founder and CEO Evan Anderson, in the release. “We are pleased that the illuvinate System is now available to help people in California with psoriasis, a condition that often has a serious impact on quality of life. We look forward to launching nationally next year.

The most effective treatment for psoriasis is the Goeckerman Regimen, a 100-year-old proven therapy that results in long periods of remission lasting between 8 months to over a year. However this treatment is only available at a handful of specialized academic centers and often requires multiple day-long clinic visits over a period of weeks, creating barriers to widespread adoption.

Luma Therapeutics has redesigned the key elements of the Goeckerman Regimen to make it available to patients in their own home, the release explains.

“Psoriasis is a chronic condition for which there is no cure, and there is a need for better treatment options. Most available treatments require ongoing compliance in order to achieve optimal results, and many patients are hesitant to consistently use medications, which may have long-term side effects,” states Jeffrey Sugarman, MD, PhD, of Redwood Family Dermatology in Santa Rosa, Calif, and UCSF Health in San Francisco, who serves as Luma Therapeutic’s chief medical officer and principal investigator of studies of the illuvinate System.

“As a result, patients become discouraged and stop seeking treatment from a dermatologist. I believe that the illuvinate System will be a great option for many patients.”

Dr Sugarman’s patient Georgios Kladis participated in the clinical trials of the system.

“I have had psoriasis for many years and have tried all kinds of psoriasis treatments, and none of them worked. The illuvinate System cleared my skin quickly,” Georgios shares, in the release. “Even more exciting was how long my skin stayed clear after the treatment. I like that it does not involve the side effects of a drug and takes just minutes a day in my home. I would recommend it to other people dealing with psoriasis.”

Illuvinate has been demonstrated to reduce local inflammation, rehydrate the skin, and restore normal skin cells. The system includes patented hydrating technology, a narrowband UV LED light system, and a proprietary app-based dosing algorithm. The therapy is applied for just minutes each day over a 6-week period from the comfort and convenience of home.

“We are excited to partner with Luma Therapeutics to offer the illuvinate System to psoriasis patients,” comments Christopher Schmidt, MD, board-certified dermatologist and founder of HealthLens, a multi-specialty telemedicine platform, as well as a clinical faculty member of Stanford University, the release continues.

“Telehealth is the next frontier in medicine, enabling patients easy access to treatments that can dramatically improve their condition and quality of life. Dermatology is uniquely suited to telehealth. In fact, recent research concluded that an online, collaborative health model was as effective as in-person management in improving clinical outcomes among patients with psoriasis.”

[Source(s): Luma Therapeutics, Business Wire]

Hologic Launches TempSure Surgical RF Technology in North America

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Hologic Inc’s Cynosure division announces the North American launch of the FDA-cleared TempSure Surgical RF technology, a new offering of the TempSure radiofrequency (RF) platform that provides clinicians the ability to perform both surgical and nonsurgical aesthetic procedures across a variety of specialties, on a single device.

Cynosure also has returned TempSure Vitalia hand pieces and probes to the market and will continue to market its MonaLisa Touch CO2 laser following the US Food and Drug Administration (FDA) inquiry on products used in energy-based women’s health procedures. Over the past several months, Cynosure worked closely with the FDA and reviewed and updated all its marketing and promotional materials to ensure they are consistent with the FDA’s labeling expectations, the company explains in a media release.

TempSure Surgical RF technology harnesses a 300-watt and 4-MHz radiofrequency platform that enables precise incisions with minimal lateral thermal damage to surrounding tissues. The resulting high-quality coagulation lessens sparking and charring during procedures, which promotes quicker recovery and better healing for patients. The device is designed to improve patient satisfaction and aesthetic outcomes, and can be used by clinicians across a variety of specialties including plastic surgery, dermatology, gynecology and ophthalmology.

“We’re continually innovating to ensure our customers set themselves apart with effective and diverse treatment offerings, and this enhanced platform is a game-changer across specialties,” says Kevin Thornal, Hologic’s Division President, Cynosure, in the release. “The cutting-edge technology of the TempSure platform will now allow doctors to transition seamlessly from invasive to non-invasive treatments on one device.”

Thornal adds, “We’re pleased to reintroduce TempSure Vitalia and to continue offering MonaLisa Touch to provide clinically strong products for women’s wellness. Cynosure is the only medical aesthetic manufacturer to offer two different energy-based modalities for women’s wellness — radiofrequency and CO2 — and we remain committed to advancing women’s pelvic health around the globe.”

TempSure Surgical RF technology is designed to enhance the existing TempSure radiofrequency platform, and includes a variety of electrodes that integrate seamlessly with the main TempSure unit. In January 2018, Cynosure launched the TempSure radiofrequency platform with TempSure Envi, a device for treating facial fine lines and wrinkles, tightening the skin through soft tissue coagulation, and temporarily reducing the appearance of cellulite.

New and existing customers now have the opportunity to customize their TempSure Envi system to include TempSure Surgical RF technology, TempSure Vitalia hand pieces, or a combination of all three to help meet different clinical needs at their practice, the release continues.

[Source: Hologic Inc]

The HydraFacial Company and SENTÉ Partner, Launch Booster

The HydraFacial Company announces a new partnership with SENTÉ, a specialty aesthetics company.

This partnership aims to offer HydraFacial clients and consumers the opportunity to experience SENTÉ’s patented Sulfated Glycosaminoglycan (SuGAG) analog technology developed to deliver rapid skin rejuvenation.

Through the partnership, SENTÉ and HydraFacial are launching a new booster, SENTÉ Dermal Repair, to medical providers. The SENTÉ booster can be added to HydraFacial treatments providing additional customization and targeted results for patients including increased superficial and deep hydration, minimizing the appearance of fine lines and wrinkles and redness reduction, explains a media release from The HydraFacial Company.

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“We are always happy to partner with brands that work synergistically with the HydraFacial treatment to provide the best possible experience for our partners and consumers,” says Clint Carnell, chief executive officer of The HydraFacial Company. “Partnering with SENTÉ was a perfect fit because the treatment is innovative and provides proven skin improvements, just like HydraFacial. We know that our partners and consumers will love the SENTÉ booster and the benefits it will provide.”

“As a first for SENTÉ, this partnership will contribute to our overall strategy to further educate on the brand’s advanced Sulfated Glycosaminoglycan analog technology,” states Laurent Combredet, president and chief executive officer of SENTÉ, in the release. “By partnering with a leading skin care company like HydraFacial, we are able to bring our unparalleled product formulations to a wider range of skin care users across the country.”

[Source(s): The HydraFacial Company, PR Newswire]