Melanocytic Nevus Syndrome, Congenital

Researchers have designed a new genetic therapy that could alleviate debilitating giant moles in a rare skin condition. Researchers at the Francis Crick Institute, UCL Great Ormond Street Institute for Child Health and Great Ormond Street Hospital for Children (GOSH) have designed a new genetic therapy that could alleviate debilitating giant moles in a rare skin condition. In the future, the treatment could potentially be used to reverse the giant moles, and therefore reduce the risk of affected children and adults from developing cancer. It could also potentially reverse other more common types of at-risk moles as an alternative to surgery. Small skin moles are common in the population, but in congenital melanocytic naevus syndrome (CMN), children are born with up to 80% of their body covered in big, painful or itchy moles, caused by mutations acquired in the womb. These moles can sometimes develop into a severe type of cancer called melanoma. Published today in the Journal of Investigate Dermatology, the researchers silenced a gene called NRAS, which is mutated in the cells in these moles, in cells in a dish and in mice. NRAS belongs to a group of genes (RAS genes) that, when mutated, can cause moles, and can predispose to cancer. The team used a genetic therapy called silencing RNA, which silences the mutated NRAS in mole skin cells. The therapy was delivered in special particles directly to mole cells. They gave injections containing the therapy to mice with CMN, which reduced the silenced the NRAS gene after just 48 hours. They also tested it in cells and whole skin sections from children with CMN. Silencing the gene triggered the mole cells to self-destruct. Veronica Kinsler, Principal Group Leader of the Mosaicism and Precision Medicine Laboratory at the Crick, Professor of Paediatric Dermatology and Dermatogenetics at GOSH/UCL, and NIHR Research Professor, said: "CMN is physically and mentally challenging for children and adults living with this condition and for their families. These results are very exciting, as not only does the genetic therapy trigger self-destruction of the mole cells in the lab, but we have managed to deliver it into the skin in mice. This results suggest that the treatment in future could potentially reverse moles in people, however more testing will be needed before we can give it to patients. "We are very grateful to our patients at Great Ormond Street Hospital, who have been actively participating over many years to help us produce this new potential therapy. After more studies, we hope the therapy can soon enter clinical trials in people." This research was funded by the National Institute for Health and Care Research (NIHR), Caring Matters Now Charity and Patient Support Group, LifeArc and the NIHR Great Ormond Street Hospital Biomedical Research Centre. Jodi Whitehouse, CEO of Caring Matters Now, who helped to fund the research, said: "This breakthrough in finding a treatment for CMN could transform the lives of the families we support living with CMN. As someone who was born with CMN covering 70% of my body and having undergone 30+ operations in my childhood to try and remove the CMN because of the fear of melanoma, with no success, this news is awe-inspiring and exciting. It brings real hope to the lives of those living with CMN." Catriona Crombie, Head of Rare Disease at LifeArc, said: "This work is part of our commitment to improving the lives of people living with rare diseases, by investing in promising research and helping scientists to overcome translational research barriers. If successful, we hope to see human clinical trials for this therapy within the next few years." The researchers have been working closely with the Crick's Translation team to develop the technology towards patient benefit. This has included securing translational funds from LifeArc, to carry out more research in mice to understand how the treatment works over a longer period.

MARLBOROUGH, Mass., March 15, 2023 /PRNewswire/ -- Candela Corporation (Candela), a leading global medical aesthetic device company headquartered in Marlborough, MA, today announced that the PicoWay® laser system has received FDA clearance and Health Canada licensing for expanded indications, including the challenging condition of melasma. In addition to its earlier indications for wrinkles, benign pigmented lesions, tattoo removal, and acne scars, the new clearance and license expand the platform's capabilities to include treatment of melasma, lentigines, café au lait macules (CALMs), and Nevus of Ota.1-2 The award-winning PicoWay laser platform is a leading picosecond system globally. It has the broadest range of FDA cleared indications of any picosecond laser.* The platform has four true picosecond wavelengths (532, 730, 785 and 1064 nm) and offers treatment versatility with multiple available applicators and beam delivery technologies (full beam, microbeam and "Fusion" beam).1,3 The distinctive ultra-short pulse of the PicoWay laser delivers photoacoustic, rather than photothermal energy, reaching targets like pigment under the top layer of skin, while minimizing the risk of overheating the outer skin layer. The consistent photoacoustic treatment modality of the device allows for minimal post-treatment downtime, making PicoWay system the ideal laser for the growing skin rejuvenation** and tattoo removal markets, and for those with pigmentation disorders. For darker skin types who often experience pigmentary conditions, PicoWay is the laser of choice. Slower, longer-pulsed lasers, or those that do not consistently deliver advertised energy levels or pulse durations, place this demographic at higher risk of hypo- or hyperpigmentation that can result from excess heat delivery.3 Melasma is a skin condition that causes patches of spots, usually on the face, which are darker than one's natural skin tone.4 The condition is common in darker skin types and especially prevalent in pregnant women due to hormonal changes - between 15% to 50% of pregnant women*** will get melasma, leading the condition often to be referred to as the "mask of pregnancy".5,6 A complicated skin disorder, often attempted to be managed with topicals and frequently relapsing and remitting for long periods, melasma can be notoriously challenging to treat.7 "Addressing melasma with the PicoWay laser gives patients an important treatment modality to manage this difficult and often psychologically upsetting condition. Patients now have a treatment that specifically targets their pigmentary changes and can be used alongside other treatments like topicals to better manage this complex skin disorder," states double board-certified Dermatologist Douglas Wu, MD, PhD of Cosmetic Laser Dermatology in San Diego and Rejuvenation Dermatology in Canada. "The new PicoWay laser clearances add to the already impressive capabilities of this platform. Candela is committed to investing in clinical research and expanding our products' range of cleared clinical indications. The PicoWay system's newest clearances allow our customers to continue benefiting from their partnership with Candela and offer their patients another clinically proven option for the treatment of melasma," said Geoff Crouse, CEO of Candela. * As of January October 2022. **As defined by reduction in pigmentation, wrinkles and/or acne scarring. ***The PicoWay laser is contraindicated for use during pregnancy. References PicoWay Laser 510(k) clearance (K220853), October 2022. PicoWay Laser Health Canada Licence (94931), Amended 2023/2/13. Data on file, Candela, 2023. (Accessed February 13, 2023). Visit Candela or PicoWay Laser for further information. © 2023 Candela Corporation. This material contains registered and unregistered trademarks, trade-names, service marks, and brand names of Candela Corporation and its affiliates. All other trademarks are the property of their respective owners. All rights reserved. Media Contact: Laurel Sanderson [email protected] SOURCE Candela

AVAVA is a disruptive medical aesthetics technology platform company providing breakthrough treatments for all skin tones FDA Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration/Wikipedia) AVAVA Inc. (“AVAVA” or the “Company”), a disruptive medical aesthetics technology platform company providing breakthrough treatments for all skin tones, today announced that its AVAVA pigment disorder product has received FDA 510(k) clearance to treat benign pigmented lesions of the skin, including hyperpigmentation. This clearance marks AVAVA’s second received from the FDA for its new class of focused intradermal laser products powered by Focal Point Technology™ to deliver energy at any depth with pinpoint accuracy for ideal patient outcomes. Dr. Irina Erenburg, CEO of AVAVA, said, “We are thrilled to announce our FDA clearance, a key milestone achievement for AVAVA, as we move to address the unmet needs of over 4 million women with pigmentary disorders, a $1 billion annual procedure market.” Dr. Erenburg added, “In pioneering our technology, we harnessed over 30 years of clinical experience and developed an AI enabled, precise three-dimensional laser treatment that results in the optical breakdown of melanin (pigment), whether near the surface or deep under the skin. This achieves an optimal patient and provider experience without pain, downtime, or side effects. We look forward to continuing to build a body of clinical evidence supporting our indication and to finally offering to the clinical community a best-in-class solution for pigmentary disorders, a top 5 concern for skin of color patients in the US.” “In today’s treatment market, where the lack of effective solutions for pigment disorders is well understood, we warmly welcome and are excited to be able provide the AVAVA therapy to our patients. We believe that with AVAVA, there is finally hope for patients with hyperpigmentation, dark spots after acne, and other pigmentary disorders, who have given up or chosen to not seek treatment,” said Dr. Roy G. Geronemus, Director of the Laser & Skin Surgery Center of New York and CEO of Navaderm Partners. The AVAVA Focal Point Technology™ is complemented by a high-resolution interactive imaging system, which provides inter- and intra-treatment intelligence to map and guide real-time therapy with actionable data, to unlock safe and effective treatments for all skin tones. Source: Company Press Release