The LYMA Laser PRO Is Now Available In The U.S. And With FDA Clearance
LYMA Laser PRO
LYMA
The highly anticipated U.S. launch of the LYMA Laser PRO is finally here, and so is its FDA-clearance. The only at-home device of its kind, do not confuse this laser for an LED or red light machine. With 3x the lens size of the original LYMA Laser, the LYMA Laser PRO delivers in-clinic-grade results at home, and now with a larger lens, it is the only FDA-cleared beauty device of its kind — once again.
'We've been working on the LYMA Laser PRO since we finished the LYMA Laser,' said founder Lucy Goff in an exclusive interview from her UK home. Getting FDA-clearance in 2022 – two years post launch – the original LYMA Laser is a cult-favorite celebrity beauty device, loved and lauded by the likes of Gwyenth Paltrow, Hailey Bieber, Paris Hilton, Sofia Richie, celebrity dermatologists and estheticians, among many, many more.
Upon launch in 2020, the original LYMA Laser marked the start of a new category of cosmetic lasers in the US markets. 'No one had used cold-laser before.' Unlike traditional lasers that patients would find in a dermatologist's office for skin resurfacing, smoothing, or anti-aging, cold lasers –also known as non-thermal lasers– don't rely on controlled injury with heat and thermal damage to stimulate collagen production.
'The rest of the industry works off of what's known as the stress-damage approach to anti-aging or collagen production. The problem is when you damage your skin to simulate collagen production, the body prioritizes speed of healing over the quality of the reparative process,' explained Goff. 'By creating inflammation and damage, you get a disordered repairing process and the quality of collagen is not as good as the quality of collagen your body naturally produces.'
After launching in the U.K. last year, LYMA Laser PRO consumers and estheticians began raving about their before and after results on larger, stubborn areas of the body like the neck and under arms. With a price tag of $5,999, the new device received FDA clearance in February of this year, and utilizes a 500mW near-infrared laser. It matches the output of a professional in-office laser, and is the only FDA-cleared at-home device with this level of power and capability. While some at-home lasers (not LED lights) do exist, they operate at significantly lower power levels, unable to reach deep tissue or create any noticeable or structural skin changes. The LYMA Laser PRO, conversely, reaches past muscle tissue down to the bone. The brand promises results in 30 days with 3 minutes of use per treatment area, and now with a larger lens to treat larger areas.
LYMA Laser PRO under-arm treatment
LYMA
The global at-home laser device market is valued at 537 million USD, and based on current insights and research, is projected to grow by 10.5% within 10 years.
'This is the only technology that actually uses the near-infrared laser light that interacts with your cells in a certain way that triggers a genetic switch inside of your cells and the genes should be down-regulated are once again down-regulated, and the genes that should be up-regulated are once again up-regulated,' Goff explained while describing the genetic aging process. By contrast, at-home LED devices lack both the professional intensity of a laser and any kind of deep regenerative gene processes.
'We re-engineered this huge hospital machine into this little, portable device at the same power with the same treatment lens.'
LYMA Laser PRO
LYMA
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
36 minutes ago
- Yahoo
Fungi concerns spark nationwide recall of Zicam® and Orajel™ products
(WJW) – According to the U.S. Food and Drug Administration, Church & Dwight Co., Inc. is voluntarily recalling some Zicam® and Orajel™ products because fungi could be present in the items' cotton swab components. The recalled products include all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level. Consumers are advised to 'immediately' stop using the recalled products. Major grocery chain slashing prices for the summer 'Swabs found to contain microbial contamination can potentially present a significant risk to the health and safety of consumers including serious and life-threatening blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries,' reads the recall alert. 'The risk is highest (potentially severe or life-threatening) among children and individuals with compromised immune systems or other underlying medical conditions.' The FDA said, so far, no serious adverse events associated with the affected product have been reported. The recalled products were distributed nationwide in the United States and in Puerto Rico, said the FDA. Brain-eating amoeba: How are people infected? Here's the specific details to check for: Zicam® Cold Remedy Nasal Swabs, with UPC 732216301205, all lots: A zinc-free, homeopathic cold remedy swab designed to shorten the duration of the common cold. Zicam® Nasal AllClear Swabs, with UPC 732216301656, all lots: A nasal cleansing swab product (discontinued in December 2024). Orajel™ Baby Teething Swabs, with UPC 310310400002, all lots: Pre-moistened swabs designed to soothe teething discomfort in infants and toddlers. You can view images of the recalled products in the slideshow below: 'This recall is limited exclusively to Zicam and Orajel swab products. All other Zicam and Orajel products, including Zicam RapidMelts, are not affected by this recall,' states the FDA on its website. Consumers can CLICK HERE or call (800) 981-4710 for refund details. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Indianapolis Star
an hour ago
- Indianapolis Star
Jaguar Health Provides Update on Meeting with FDA Discussing Statistically Significant Results of Responder Analysis of Breast Cancer Patients in Phase 3 OnTarget Trial and Potential Approval Pathway for Crofelemer
Productive and collaborative discussion on proposed pathway by the company to bring crofelemer to approval for cancer therapy-related diarrhea (CTD) in patients with metastatic breast cancer receiving selected targeted therapies The currently estimated US metastatic breast cancer population would qualify as an orphan population, which aligns with company's core focus on orphan diseases Company plans to promptly pursue authorization to initiate expanded access program for patients with breast cancer who may not be eligible for a potential pivotal treatment trial with crofelemer in patients with metastatic breast cancer SAN FRANCISCO, CA / ACCESS Newswire / June 9, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today provided a recap on the company's assessment of the in-person Type C Meeting on May 28, 2025 with the Division of Gastroenterology of the U.S. Food and Drug Administration (FDA) to discuss the statistically significant responder analysis results for adult patients with breast cancer in Napo's recently conducted Phase 3 OnTarget trial. 'We were very happy to take part in the face-to-face Type C Meeting, the catalyst for which was the positive data in the subpopulation of breast cancer patients from our OnTarget trial,' said Lisa Conte, Jaguar's founder, president, and CEO. 'Napo proposed two simultaneous potential pathways during the meeting for making crofelemer available to metastatic breast cancer patients with the significant unmet medical need of CTD: conducting a pivotal treatment trial to facilitate approval of crofelemer for CTD in this focused patient population; and the prompt pursuit of authorization to initiate an expanded access program for breast cancer patients with CTD who may not be eligible for this study, including breast cancer patients in the adjuvant and neoadjuvant settings. We are pleased with the constructive and productive discussion that took place with the FDA during the meeting. Last week the FDA formally acknowledged both of these key discussion points in correspondence to Napo. We plan to submit a protocol to the FDA for a pivotal treatment trial for a smaller number of metastatic breast cancer patients using crofelemer.' Patient advocates participated in the Type C Meeting to share their raw and personal experience with CTD, including a metastatic breast cancer patient with uncontrollable diarrhea who received a prescription for crofelemer. 'The design of the protocol for OnTarget was based on a survey of cancer patients. Today there are close to 100 approved targeted cancer agents. Thanks to these amazing drugs, metastatic cancer patients are living longer, frequently rendering cancer, and CTD, chronic ailments with which to live. To deepen our understanding of the current population of metastatic cancer breast with CTD, and ensure the clinical meaningfulness of the design of the anticipated pivotal treatment trial, we plan to conduct a new survey of this cancer patient population,' Conte said. The currently estimated US metastatic breast cancer population potentially qualifies as an orphan population, in alignment with the company's core focus on orphan diseases. The company therefore intends to request orphan drug designation from the FDA for the CTD indication in this population. Given crofelemer's novel and paradigm-shifting mechanism of action, the company also plans to seek Breakthrough Therapy designation and/or Fast Track designation from the FDA to support potentially expedited regulatory approval in the US for crofelemer for CTD in metastatic breast cancer patients. 'Embracing a sharp strategic focus on orphan indications seems to fit with the new administration's efforts and philosophy,' said Conte. 'Dr. Marty Makary, the new Commissioner of the FDA, commented in April 2025 that the agency will open a new regulatory pathway based on what he called a 'plausible mechanism,' focusing mainly on rare or incurable diseases.' As expressed during the Type C Meeting, the data from the first-of-its-kind prophylactic OnTarget study is invaluable, providing new insights into the natural history of the important and debilitating side effect of CTD. Diarrhea is a common side effect of targeted cancer therapies and can lead to dose changes, treatment delays, and often cessation of lifesaving cancer therapy. The benefit to risk ratio of crofelemer is well-documented, as the active agent has been commercialized for the approved indication of HIV-related diarrhea since 2012, with no crofelemer-related reported serious adverse events. In both the US and European Union, crofelemer has been granted orphan drug designation for the orphan diseases of short bowel syndrome with intestinal failure and microvillus inclusion disease. Crofelemer has been granted orphan drug designation for treatment of diarrhea in cholera in the US, where cholera is an orphan disease. Orphan drug designation in the US qualifies the sponsor of a drug for various development incentives, including tax credits for qualified clinical testing and relief of filing fees. Additionally, orphan drug designation in the US provides a seven-year period of marketing exclusivity to the first sponsor who obtains marketing approval for the designated orphan drug. While the multicenter, double-blind, placebo-controlled OnTarget pivotal trial did not meet its primary endpoint, the subgroup of adult breast cancer patients achieved statistically significant results in the responder analysis. In the responder analysis of patients with breast cancer on targeted therapies, crofelemer CTD prophylaxis resulted in a greater proportion of monthly responders of diarrhea improvement compared to placebo. Patients with breast cancer accounted for 183 of the 287 participants in this unprecedented prophylactic clinical trial of crofelemer for diarrhea in adults with 10 solid tumor types receiving targeted therapy with or without standard chemotherapy. The OnTarget results in breast cancer patients were the subject of a poster presentation on December 11, 2024, at the San Antonio Breast Cancer Symposium, and additional significant results in adult breast cancer patients from the OnTarget study have been accepted for presentation as an oral rapid e-poster at the Multinational Association of Supportive Care in Cancer (MASCC) Annual Meeting in June 2025 in Seattle, Washington. About Crofelemer Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as 'dragon's blood,' of the Croton lechleri tree in the Amazon Rainforest. Napo has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi ® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute 'forward-looking statements.' These include statements regarding Jaguar's expectation that the currently estimated US metastatic breast cancer population qualifies as an orphan population, Jaguar's expectation that the company will submit a protocol to the FDA for a pivotal treatment trial for a smaller number of metastatic breast cancer patients using crofelemer, Jaguar's expectation that it will promptly pursue authorization to initiate an expanded access program for patients with breast cancer who may not be eligible for a potential pivotal treatment trial with crofelemer in patients with metastatic breast cancer patients, and that the expanded access program would potentially include breast cancer patients in the adjuvant and neoadjuvant settings, Jaguar's expectation that Napo will conduct a clinical trial of crofelemer for treatment of CTD in patients with metastatic breast cancer, Jaguar's plans to seek Breakthrough Therapy designation and/or Fast Track designation from the FDA to support potentially expedited regulatory approval in the US for crofelemer for CTD in metastatic breast cancer patients, and Jaguar's expectation that additional significant results in adult breast cancer patients from the OnTarget study will be presented at the 2025 MASCC Annual Meeting. In some cases, you can identify forward-looking statements by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'aim,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential' or 'continue' or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: hello@ Jaguar-JAGX SOURCE: Jaguar Health, Inc. View the original press release on ACCESS Newswire
Yahoo
2 hours ago
- Yahoo
Journey Medical Corporation Announces Emrosi™ Featured on 'The Balancing Act' Airing on Lifetime TV
National TV Segment Highlights FDA-Approved Treatment for Rosacea Segment premiered on Monday, June 9 and will be rebroadcast on Thursday, June 19, at 7:30 a.m. PT/ ET SCOTTSDALE, Ariz., June 09, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) ('Journey Medical' or 'the Company', 'we', or 'our'), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration ('FDA') approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that a new segment of 'The Balancing Act®' airing on Lifetime TV and sponsored by the Company featured Emrosi™ (40 mg Minocycline Hydrochloride Modified-Release Capsules), its FDA-approved treatment for inflammatory lesions of rosacea in adults. The segment premiered nationwide on Monday, June 9, at 7:30 a.m. PT / ET and provided expert insights on lifestyle considerations and treatment options for managing rosacea. 'We're proud to see Emrosi featured on 'The Balancing Act,' bringing national visibility to what we believe is a potential paradigm shift in the treatment of rosacea,' said Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical. 'This segment is an important opportunity to educate patients, caregivers and healthcare providers about Emrosi's unique formulation and benefits, as well as our broader commitment to advancing dermatologic care through innovative, patient-focused solutions.' The feature included insights from Pura Dermatology's Saurabh Lodha, MD, FAAD, who discussed Emrosi's unique formulation and its significance in the treatment landscape for rosacea. Approved by the U.S. Food and Drug Administration (FDA) in November 2024, Emrosi is the lowest-dose oral minocycline available, offering patients an effective treatment option with a favorable safety profile. It is available by prescription at specialty pharmacy chains. In addition to the June 9 premiere, the segment will be rebroadcast on Thursday, June 19, at 7:30 a.m. PT/ ET. It can also be viewed on the show's website, About RosaceaRosacea is a chronic, relapsing, inflammatory skin condition that most commonly presents with symptoms such as deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia). According to The National Rosacea Society, it is estimated that rosacea affects over 16 million Americans and as many as 415 million people worldwide. Rosacea is most frequently seen in adults between 30 and 50 years of age. Surveys conducted by The National Rosacea Society report that more than 90 percent of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent stated that it had caused them to avoid public contact or cancel social engagements. Among rosacea patients with severe symptoms, 88 percent said the disorder had adversely affected their professional interactions, and 51 percent said they had missed work because of their condition. Important Safety InformationIndication: EMROSI™ is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults. Adverse Events: The most common adverse reaction reported by ≥1% of subjects treated with EMROSI and more frequently than in subjects receiving placebo was dyspepsia. Contraindications: EMROSI should not be taken by patients who have a history of hypersensitivity to any of the tetracyclines. Warnings/Precautions: Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. If DRESS syndrome is recognized, discontinue EMROSI immediately. Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth and reversible inhibition of bone growth. Discontinue EMROSI use if Antibiotic-Associated Colitis occurs. Discontinue EMROSI if liver injury is suspected. Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery. Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue EMROSI immediately if symptoms occur. Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue EMROSI immediately if symptoms occur. Patients should minimize or avoid exposure to natural or artificial sunlight while using EMROSI. Tetracycline-class antibiotics are known to cause hyperpigmentation. EMROSI may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity, sclerae and heart valves. Because of the potential for drug-resistant bacteria to develop during the use of EMROSI, use EMROSI only as indicated. If superinfection occurs, discontinue EMROSI and institute appropriate therapy. Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088 For full prescribing information, please visit About The Balancing ActThe Balancing Act® is a morning show created and produced by BrandStar that offers sensible solutions and essential information in a fun, entertaining format; providing resources to help people do life better. The Balancing Act features everything from delicious recipes, style makeovers and dream getaways to parenting tips and the latest news in health and wealth. Tune in to The Balancing Act weekdays at 7:30 a.m. (ET/PT) on Lifetime® and find all previously aired episodes on About Journey Medical CorporationJourney Medical Corporation (Nasdaq: DERM) ('Journey Medical') is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently markets eight FDA approved prescription drugs that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology's most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical's common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission ('SEC'). For additional information about Journey Medical, visit Forward-Looking StatementsThis press release may contain 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words 'the Company', 'we', 'us' and 'our' may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words 'anticipate,' 'believe,' 'estimate,' 'may,' 'expect,' 'will,' 'could,' 'project,' 'intend,' 'potential' and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that may become subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products' commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful commercialization of our recently approved product, EmrosiTM, and any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and our clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties' cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders; as well as other risks described in Part I, Item 1A, 'Risk Factors,' in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact:Jaclyn Jaffe (781) 652-4500ir@ Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@ in to access your portfolio
