Latest news with #FDA-cleared
Business Standard
8 hours ago
- Health
- Business Standard
Kaya Launches Aerolase Neo Elite - A Laser for Acne & Scars with up to 87% Proven Results
VMPL New Delhi [India], May 31: Kaya, India's leading chain of dermatology clinics, exclusively brings you Aerolase, a breakthrough laser treatment for active acne and acne scars that will be available only at Kaya clinics for the year ahead. This exclusive launch reinforces Kaya's commitment to offering world-class, non-invasive dermatological solutions that are safe, effective, and inclusive. Kaya become First Multi-Clinic Brand to Introduce This Revolutionary Acne Scar Solution in India Aerolase Neo Elite, widely recognized as the leading solution in non-invasive acne care, is now introduced by Kaya, the first multi-clinic brand in India to offer this revolutionary acne scar treatment. Utilizing a 650-microsecond, 1064-nm Nd: YAG laser, it penetrates deep to target active acne, oil glands, bacteria, and post-acne scarring without harming the skin's surface. This FDA-cleared laser treatment is suitable for all skin types, including sensitive and darker skin tones. It requires no anesthesia, gels, or downtime. Patients feel only a gentle warm sensation during the session and can resume daily activities immediately. The device's contactless handpiece ensures maximum hygiene, making it an excellent option for acne-prone skin. The Neo Elite offers a comprehensive approach by addressing active acne, scarring, post-inflammatory hyperpigmentation (PIH), and erythema in a single session, reducing the need for multiple treatment modalities or medications. It can also be safely used in conjunction with other therapies such as topical retinoids, oral antibiotics, or isotretinoin, without requiring patients to interrupt their current regimen. Most importantly, by effectively clearing acne and improving skin texture, the treatment significantly boosts self-esteem, with 94% of patients reporting increased confidence after completing their sessions. Speaking about the launch, Dr. Aparna Santhanam, Head Dermatologist, & Vice President at Kaya Ltd, said, "The Aerolase Neo Elite has truly raised the bar in acne and scar treatment. It is the only laser approved for acne treatment that gives efficacious results for active acne, without the need for a host of oral medications with potential side effects. We are delighted to introduce this for the first time in India, exclusively in our clinics. Our goal is to provide effective solutions that restore skin health and renew confidence, especially for the countless acne sufferers, and this technology does that and more extremely effectively." Highlighting Kaya's vision, Nishant Nayyar, Head of Marketing and Vice President at Kaya Ltd., remarked, "Acne remains one of the most persistent skin concerns in India, with many cases continuing into adulthood and often accompanied by post-acne pigmentation. Kaya is excited to introduce Aerolase Neo Elite, an FDA-cleared advanced laser treatment that delivers up to 87% reduction in acne lesions and 82% improvement in scarring. Safe, contactless, and effective for all skin types, this innovation reinforces our commitment to delivering breakthrough solutions that truly transform lives and restore confidence.'' With Aerolase Neo Elite, Kaya aims to deliver clearer, smoother, healthier skin through a technology-driven, patient-first approach. This innovation reinforces Kaya's position at the forefront of dermatological care, offering holistic solutions that enhance not just appearance but also confidence.
Business Wire
a day ago
- Business
- Business Wire
TriSalus Life Sciences Announces Chief Financial Officer Transition With Appointment of David B. Patience
DENVER--(BUSINESS WIRE)--TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the 'Company'), an oncology company integrating novel delivery technology with standard of care therapies and its investigational immunotherapeutic to transform treatment for patients with solid tumors, today announces the appointment of David B. Patience as Chief Financial Officer, effective July 1, 2025. Mr. Patience succeeds James Young, who stepped down for personal reasons effective May 30, 2025. Dan Giordano, Vice President of Finance for TriSalus, will serve as acting Chief Financial Officer during the transition period. Mr. Young remains available to the Company to support an orderly transition. 'We are thrilled to welcome David to our leadership team,' said Mary Szela, President and CEO of TriSalus Life Sciences. 'David's strong expertise in capital markets and proven track record of financial leadership and operational execution will be invaluable and play a crucial role as we drive our next phase of growth. On behalf of our leadership team, I also thank Jim Young for his service and contributions. We wish him the best in his future endeavors.' Mr. Patience joins TriSalus from Accelerate Diagnostics, where he served as CFO since 2023. He brings extensive experience in leading strategic product portfolio planning, in-depth market analysis of organic and in-organic portfolio opportunities and technical and commercial feasibility analysis of partnerships, mergers and acquisitions. Prior to his time at Accelerate, Mr. Patience held positions with Morgan Stanley's Investment Banking Division, Continental Advisors equity group, and various financial research roles at Nuveen Investments. Mr. Patience holds a Bachelor of Science in Business Administration from the University of Colorado Leeds School of Business and an M.B.A. from the University of Chicago Booth School of Business. About TriSalus TriSalus Life Sciences ® is an oncology focused medical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies, and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications. The Company's platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company's two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav ® Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The PEDD technology is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company's investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during early Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via the PEDD technology may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by the PEDD technology are commonly present as well. The Company is in the final stages of data completion for a number of phase 1 clinical trials and will begin exploring partnership opportunities for development. Forward Looking Statements Statements made in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the benefits and potential benefits of the Company's PEDD drug delivery technology, TriNav ® system and nelitolimod investigational immunotherapy, and the Company's ability to execute on its strategy. Risks that could cause actual results to differ from those expressed in these forward-looking statements include risks associated with clinical development and regulatory approval of drug delivery and pharmaceutical product candidates, including that future clinical results may not be consistent with patient data generated during the Company's clinical trials, the cost and timing of all development activities and clinical trials, unexpected safety and efficacy data observed during clinical studies, the risks associated with the credit facility, including the Company's ability to remain in compliance with all its obligations thereunder to avoid an event of default, the risk that the Company will continue to raise capital through the issuance and sale of its equity securities to fund its operations, the risk that the Company will not be able to achieve the applicable revenue requirements to access additional financing under the credit facility, the risk that the Company will not become profitable on its expected timeline, if at all, the risk that the reported financial results will differ from the estimates provided in this press release, changes in expected or existing competition or market conditions, changes in the regulatory environment, unexpected litigation or other disputes, unexpected expensed costs, and other risks described in the Company's filings with the Securities and Exchange Commission under the heading 'Risk Factors.' All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
Yahoo
2 days ago
- Business
- Yahoo
SANUWAVE Health, Inc. (SNWV): A Bull Case Theory
We came across a bullish thesis son SANUWAVE Health, Inc. (SNWV) on @rationalformula on X(Twitter). In this article, we will summarize the bulls' thesis on SNWV. SANUWAVE Health, Inc. (SNWV)'s share was trading at $27.97 as of 28th May. SNWV's trailing P/E was 2.44 according to Yahoo Finance. An assembly line of medical devices being packed for distribution. SANUWAVE ($SNWV) presents a compelling microcap investment opportunity with a rapidly maturing turnaround, a razor/blade business model, and strong operational momentum. The company's flagship product, UltraMIST, is an FDA-cleared, non-contact ultrasound device for chronic wound treatment, reimbursed by CMS at $420 per use. With a growing installed base at over 900 sites, including the Mayo Clinic ICU, and over 60% of revenue now coming from high-margin consumables, SANUWAVE generates predictable, recurring income while physicians earn attractive margins on procedures. After facing existential challenges—over 1B shares outstanding, debt default, and no cash flow—hedge fund manager Morgan Frank took the reins as CEO in May 2023, initiating a full-scale turnaround. A 1-for-375 reverse split, strategic PIPE financing, a restructured sales org, and Nasdaq uplisting have laid the groundwork for sustainable growth. Financials have rapidly improved, with FY 2024 revenue growing 60% to $32.6M and adjusted EBITDA reaching $7.2M. The company guided to 57–61% YoY growth in Q1 2025 and expects 50% of incremental revenue to fall to the bottom line. At $30/share, the market cap is ~$255M with ~$25M in net debt, implying a ~$280M EV. Management projects ~$48–50M in 2025 revenue and ~$0.82 EPS, putting SNWV at ~36x 2025 earnings and just ~21x 2026 EPS. The company has a strong patent moat, sticky recurring revenue, and limited competition, with real near-term catalysts including litigation proceeds and insurer outreach. While CMS dependence and leverage are risks, execution thus far supports the investment case. SNWV is a profitable, fast-growing microcap with multi-year upside. For a deeper look into another standout stock in the medical devices sector, we recommend checking out our article on Medtronic plc (MDT) wherein we summarized a bullish thesis by Magnus Ofstad on Substack. SANUWAVE Health, Inc. (SNWV) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 5 hedge fund portfolios held SNWV at the end of the first quarter which was 0 in the previous quarter. While we acknowledge the risk and potential of SNWV as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than SNWV but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
2 days ago
- Business
- Yahoo
Subtle Medical Expands in Latin America: SubtleHD™ Now Commercially Available in Chile, Distributed by Hospiline
MENLO PARK, Calif., May 29, 2025 /PRNewswire/ -- Subtle Medical, a global leader in AI-powered medical imaging software, announced today the commercial availability of SubtleHD™ in Chile, marking an important step in expanding access to advanced imaging solutions across Latin America. The company also confirmed it will partner with Hospiline, a trusted regional distributor that currently supports Subtle Medical's growth in Brazil. SubtleHD™ is an FDA-cleared and CE-marked deep learning technology that transforms the quality of MRI images and enables up to 80% time savings on some sequences. It integrates seamlessly into existing clinical workflows, extending the life and performance of existing MRI scanners, an especially critical need across Latin America, where aging imaging infrastructure is common. In Brazil, for example, over 66% of MRI scanners are more than six years old, while demand for MRI exams is growing rapidly, estimated at 30,000 scans per million inhabitants per year. As patient volumes rise, public institutions often face long wait times, and many providers are challenged to meet demand with outdated equipment. SubtleHD helps imaging providers unlock new scan slots without purchasing new hardware, improving operational efficiency and patient throughput. With SubtleHD, healthcare institutions in Chile can now benefit from: Improved image quality even on older MRI systems Faster exam times, helping reduce patient backlog Vendor-neutral compatibility with existing infrastructure "We're thrilled to expand access to SubtleHD in Chile," said Josh Gurewitz, Chief Commercial Officer, at Subtle Medical. "With the support of Hospiline, imaging providers across the region can now harness AI to overcome infrastructure gaps, boost productivity, and elevate diagnostic confidence." About Subtle Medical Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized as a CB Insights GenAI 50 company and a two-time CB Insights Top AI 100 and Digital Health 150 company, Subtle Medical is committed to driving innovation in medical imaging. Deployed globally across 900+ scanners worldwide, Subtle Medical's solutions help imaging centers and hospitals improve workflow efficiency, increase scanner sustainability, and elevate patient care. Learn more and request a demo at About Hospiline Hospiline is a trusted distributor of advanced medical technologies across Latin America, committed to delivering innovative solutions that elevate patient care and clinical performance. United by a vision of excellence, we partner with leading global healthcare innovators to bring the most modern, effective technologies to hospitals, clinics, and imaging centers throughout the region. Our mission is to support and optimize the healthcare ecosystem by ensuring access to cutting-edge medical products that enhance outcomes and drive operational efficiency. Media ContactAnna Menyhart-BorroniHead of Marketinganna@ Source: BrazilUMass Medical School eScholarship SOURCE Subtle Medical, Inc. Fehler beim Abrufen der Daten Melden Sie sich an, um Ihr Portfolio aufzurufen. Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten
Yahoo
3 days ago
- Business
- Yahoo
Relief Mental Health Opens First Colorado Clinic in Denver, Expanding Access to Rapid, Innovative Care
DENVER, May 28, 2025 /PRNewswire/ -- Relief Mental Health, an award-winning outpatient provider of innovative mental health services, proudly announces the opening of its 12th clinic—and first in Colorado—now serving patients in Denver. This expansion brings Relief's mission of expedited, personalized care to a state where mental health is a serious challenge and needs are urgent and growing. The Denver clinic launches with two core services: transcranial magnetic stimulation (TMS) administered by a board-certified psychiatrist and therapy provided by licensed professional counselor. Additional offerings, including SPRAVATO® (esketamine) and psychiatric medication management, will be introduced in the coming months. "Mental health doesn't wait—and neither should patients," said Susan Mueller, founder and CEO at Relief Mental Health, which opened in January 2020 in Oak Brook, Illinois. "We're committed to seeing new patients within a week of their first call, if not days, because timely access can make all the difference." Cutting-Edge Treatments Provide Relief TMS is a non-invasive, FDA-cleared treatment that uses magnetic pulses to stimulate areas of the brain associated with mood regulation. It is primarily used to treat depression and/or obsessive-compulsive disorder (OCD), especially in individuals who have not responded to traditional treatments like medication or talk therapy. Using BrainsWay Deep TMS™ technology, Relief's care is the most advanced and effective treatment available. Deep TMS is administered in a clinical setting, where patients sit comfortably while a specialized helmet delivers targeted magnetic stimulation to deeper brain structures. Treatments are typically done five days a week over several weeks, with sessions lasting about 20 minutes. Deep TMS is well-tolerated, does not require anesthesia, and allows patients to return to their daily activities immediately after. It is suitable for individuals seeking a medication-free, evidence-based approach to managing persistent depression or OCD symptoms. When medical criteria are met, Deep TMS is typically covered by insurance, making this advanced treatment an accessible option for individuals who qualify. Addressing Colorado's Mental Health Crisis Colorado faces significant mental health challenges. According to the 2023 Colorado Health Access Survey, more than one in four Coloradans reported poor mental health, the highest rate ever recorded by the survey. Furthermore, 17 percent of residents—approximately 880,000 people—said they were unable to get the mental health care they needed, with more than half citing the inability to secure timely appointments as the primary barrier. The situation is particularly acute among younger adults and marginalized communities. More than a third of individuals aged 18-50 reported serious mental health challenges, and LGBTQ+ Coloradans experienced poor mental health at a rate of 54.4 percent, nearly double that of their straight and cisgender counterparts, according to the Colorado Health Institute. Access issues are compounded by a shortage of mental health professionals. The Colorado Health Institute reports that 2.8 million Coloradans—48 percent of the state's population—live in areas designated as Mental Health Professional Shortage Areas. Relief's Commitment to Expedited, Personalized Care Relief Mental Health is dedicated to bridging these gaps by offering prompt, individualized treatment. With a focus on evidence-based therapies and an empathetic approach, Relief aims to reduce the burden of mental health diagnoses in Colorado communities. For more information about Relief Mental Health or to schedule a consultation, individuals can call 855.205.4764, email info@ or visit About Relief Mental Health Relief Mental Health is a leading outpatient provider of transcranial magnetic stimulation (TMS), SPRAVATO® (esketamine), ketamine infusions, psychiatry, and therapy, for the treatment of depression, obsessive-compulsive disorder, anxiety and other diagnoses. Founded in January 2020 and dedicated to delivering expedited care, Relief has 12 facilities in four states. Relief aims to create a new standard for mental health care, offering a continuum of innovative therapeutic interventions and responding to evolving patient needs. For more information, visit CONTACT: Melanie EilersChief Marketing Officermelanie@ View original content to download multimedia: SOURCE Relief Mental Health
