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Nyxoah Announces the Signature of a Memorandum of Understanding with Sheikh Shakhbout Medical City Hospital to Improve OSA Therapy Management and Accelerate Access to Genio in the Middle East
Globenewswire· 2026-02-18 21:05
Core Insights - Nyxoah has signed a Memorandum of Understanding (MoU) with Sheikh Shakhbout Medical City (SSMC) to enhance Obstructive Sleep Apnea (OSA) therapy management and improve access to its Genio® therapy in the Middle East [1][2] Group 1: Partnership and Strategic Focus - The MoU aims to position SSMC as a leading regional center for Genio therapy, focusing on developing a high-volume implant program centered on patient care [2] - The collaboration includes establishing SSMC as a training hub for Genio therapy, educating surgeons, sleep physicians, and healthcare professionals across the region [3] Group 2: Clinical and Research Initiatives - Discussions are ongoing to explore clinical research and collaboration in sleep apnea and chronic disease management [3] - The initiative aligns with Nyxoah's vision to provide new treatment options for OSA patients and investigate the impact of advanced OSA management on chronic diseases like type 2 diabetes [4] Group 3: Company Overview and Product Information - Nyxoah specializes in developing innovative solutions for OSA, with its lead product being the Genio system, a leadless and battery-free hypoglossal neurostimulation therapy [5] - The Genio system received its European CE Mark in 2019 and has expanded its therapeutic indications following successful studies, including the BETTER SLEEP study and DREAM IDE pivotal study [6]
Ceribell to Participate in Upcoming March Investor Conferences
Globenewswire· 2026-02-18 21:05
Core Insights - CeriBell, Inc. is participating in two upcoming investor conferences to enhance investor engagement and showcase its innovative medical technology solutions [1][2]. Group 1: Upcoming Events - CeriBell will present at the Raymond James 47 Annual Institutional Investors Conference on March 2, 2026, at 1:00 p.m. PST / 4:00 p.m. EST [2]. - The company will also participate in a fireside chat at the TD Cowen 46 Annual Health Care Conference on March 3, 2026, at 10:50 a.m. PST / 1:50 p.m. EST [2]. Group 2: Company Overview - CeriBell is focused on transforming the diagnosis and management of patients with serious neurological conditions through its innovative Ceribell System [3]. - The Ceribell System is a point-of-care electroencephalography (EEG) platform designed for acute-care settings, enabling rapid diagnosis and continuous monitoring of neurological conditions [3]. - The system is FDA-cleared for detecting seizures and delirium in intensive care units and emergency rooms across the U.S. [3].
Anika To Present at the Canaccord Genuity 2026 Musculoskeletal Conference
Globenewswire· 2026-02-18 21:01
Group 1 - Anika Therapeutics, Inc. is a global joint preservation company focused on early intervention orthopedics, with a presentation scheduled at the Canaccord Genuity 2026 Musculoskeletal Conference on March 2, 2026 [1] - The presentation will be available via live webcast and archived for 30 days, allowing investors to access the information post-event [2] - Anika specializes in minimally invasive orthopedic products, particularly in Osteoarthritis Pain Management and Regenerative Solutions, leveraging expertise in hyaluronic acid and implant solutions [3] Group 2 - Anika's global operations are headquartered outside of Boston, Massachusetts, emphasizing its strategic location for industry engagement [3] - The company actively engages with investors through one-on-one meetings during events, showcasing its commitment to investor relations [1][2]
GEHC Expands BARDA Collaboration With $35M Boost for AI Ultrasound
ZACKS· 2026-02-18 19:10
Core Insights - GE HealthCare Technologies Inc. (GEHC) has expanded its contract with the Biomedical Advanced Research and Development Authority (BARDA) by $35 million to enhance the development of AI-enabled ultrasound technologies and next-generation imaging platforms [1][2][5] Company Developments - The additional investment aims to accelerate the development of AI-enabled ultrasound tools for trauma assessment and improve readiness for large-scale casualty incidents [2][5] - GEHC's partnership with BARDA focuses on advancing ultrasound innovation through AI-powered tools and specialized hardware designed for frontline healthcare providers [3][5] - The expanded clinical scope of the agreement will support the development of multiple AI-enabled tools to enhance diagnostic workflows and reduce reliance on specialized operators, making them usable by non-expert ultrasound users [9][11] Market Position and Financial Performance - Following the announcement, GEHC shares increased by 1.6%, with a 11.6% rise over the past six months, contrasting with a 12.9% decline in the industry [4] - GEHC currently holds a market capitalization of $36.61 billion [7] Strategic Initiatives - The contract expansion is expected to strengthen GE HealthCare's position in the growing AI-enabled medical imaging market, enhancing its innovation pipeline and driving long-term revenue opportunities [5][12] - GEHC plans to advance point-of-care ultrasound systems that are reliable, portable, and easy to use in high-intensity environments [10] - The program also includes collaboration with clinicians to generate real-world evidence and guide product development, aiming to validate the clinical effectiveness of innovations [11] Industry Prospects - The AI in the ultrasound imaging market is projected to reach $1.22 billion by 2026, with a CAGR of 8.4% through 2035, driven by the recognition of AI-based technologies' benefits [13]
Diabetes-Focused Insulet Forecasts Strong 2026 Growth, Stock Soars
Benzinga· 2026-02-18 18:57
Core Viewpoint - Insulet Corporation reported better-than-expected fourth-quarter earnings and provided optimistic guidance for 2026, leading to a rise in stock price [1] Financial Performance - Fourth-quarter adjusted earnings reached $1.55 per share, surpassing the consensus estimate of $1.45 [1] - Sales for the quarter were $783.8 million, reflecting a year-over-year increase of 31.2% or 29% in constant currency, exceeding the consensus of $768.69 million [2] - Total Omnipod revenue was $781.8 million, up 33.5% year-over-year or 31.3% in constant currency [2] - Gross margin improved to 72.5%, an increase of 40 basis points from the prior year [3] - Operating income was $146.3 million, representing 18.7% of revenue, also up 40 basis points year-over-year [3] Share Buyback - The board approved a $350 million increase in share repurchase authorization, with plans to allocate approximately $300 million toward repurchases in the first quarter of 2026 [4] 2026 Guidance - Insulet forecasts fiscal 2026 sales between $3.250 billion and $3.304 billion, indicating a year-over-year growth of 20%-22% [5] - The guidance includes total Omnipod Products growth projected between 21%-23% [5] - Adjusted operating margin is expected to expand by approximately 100 basis points, with adjusted earnings per share anticipated to grow by over 25% [6] - First-quarter 2026 sales are expected to be between $705.5 million and $716.94 million, compared to the consensus of $713.41 million [6]
Picard Medical, Inc. (PMI) Shareholders Who Lost Money Have Opportunity to Lead Securities Fraud Lawsuit
Prnewswire· 2026-02-18 17:00
Core Viewpoint - Picard Medical, Inc. (PMI) shareholders who incurred losses have the opportunity to lead a securities fraud class action lawsuit due to alleged undisclosed fraudulent activities by the company [1] Summary by Relevant Sections Lawsuit Details - The lawsuit alleges that between September 2, 2025, and October 31, 2025, Picard Medical failed to disclose critical information to investors, including involvement in a fraudulent stock promotion scheme utilizing social media misinformation and impersonation of financial professionals [1] - It is claimed that insiders or affiliates used offshore or nominee accounts to facilitate coordinated share dumping during a price inflation campaign [1] - The company's public statements and risk disclosures reportedly omitted any mention of false rumors and artificial trading activity that influenced the stock price [1] - As a result, the positive statements made by the defendants regarding the company's business, operations, and prospects were materially misleading and lacked a reasonable basis [1]
Glaukos Misses Q4 Earnings Estimates, Raises 2026 Revenue Outlook
ZACKS· 2026-02-18 16:55
Core Insights - Glaukos Corporation reported a fourth-quarter 2025 adjusted loss of 28 cents per share, missing the Zacks Consensus Estimate by 0.06%, but showing improvement from a loss of 40 cents per share in the same quarter last year [1] - For the full year, the adjusted loss per share was 90 cents, reflecting a 51.6% increase from the previous year [1] - The GAAP loss per share was $2.32, compared to a loss of 60 cents in the prior-year quarter [1] Revenue Details - Glaukos achieved revenues of $143.1 million in the fourth quarter, marking a 36% year-over-year increase and surpassing the Zacks Consensus Estimate by 6% [2] - Total revenues for 2025 reached $507.4 million, up 32% year over year [2] Quarter in Detail - The company recorded net sales of $119.2 million for Glaucoma, a 42% increase year over year, while sales in Corneal Health totaled $24 million [3] Margin Analysis - Adjusted gross profit rose 40.3% year over year to $121.8 million, with an adjusted gross margin of 85.1% compared to 82.3% in the previous year [4] - Selling, general and administrative expenses increased by 37.2% year over year to $94.7 million, while research and development expenses totaled $43.7 million, up 19.5% [4] - Total operating expenses were $138.4 million, reflecting a 31% increase from the prior year [4] Financial Update - Glaukos ended the fourth quarter of 2025 with cash and cash equivalents and short-term investments of $282.6 million, up from $277.5 million at the end of the third quarter [6] 2026 Guidance - The company raised its guidance for 2026 revenues, expecting net sales in the range of $600-$620 million, with the Zacks Consensus Estimate at $610.6 million [7] - The loss per share estimate for 2026 is projected at 33 cents, indicating a 60.9% improvement year over year [7] Growth Drivers - Key growth drivers include the continued adoption of iDose TR and the launch of Epioxa, which supports long-term growth through ROI-focused investment and cash flow management [9] - U.S. glaucoma growth is driven by rapid adoption of iDose TR, broader physician utilization, and strong clinical confidence in the therapy's long-term outcomes [10] - International growth reflects broad-based strength across key regions, supported by investments in international infrastructure [11] Epioxa Launch - The recent FDA approval of Epioxa introduces a new topical cross-linking therapy for keratoconus, with drug availability expected soon [12] - The company is building out its Epioxa site-of-care network, aiming to cover nearly 50% of the U.S. population, expanding to 90% over time [12] - Payer engagement for Epioxa has begun, reaching insurers covering 50% of U.S. commercial lives [13] Overall Assessment - The quarter reinforces Glaukos' transition into a diversified ophthalmic growth company, with multiple commercial catalysts and pipeline milestones positioning it for durable double-digit revenue expansion [14] - Shares of Glaukos have gained 18.4% over the past six months, contrasting with a 7.1% decline in the industry [14]
ResMed Stock Outlook: Is Wall Street Bullish or Bearish?
Yahoo Finance· 2026-02-18 16:10
Core Viewpoint - ResMed Inc. (RMD) is a leading player in the medical devices and cloud-based software applications market for respiratory disorders, with a market capitalization of $37.3 billion [1]. Performance Summary - Over the past 52 weeks, RMD shares have increased by 12.8%, outperforming the S&P 500 Index, which gained 11.9% during the same period [2]. - Year-to-date, RMD stock is up 8.3%, while the S&P 500 Index has experienced a slight decline [2]. - RMD has also outperformed the iShares U.S. Medical Devices ETF (IHI), which saw a decline of 8% over the past 52 weeks and 5% year-to-date [3]. Financial Results - In Q2, RMD reported a revenue increase of 11% year-over-year to $1.4 billion, exceeding consensus estimates by 2.2% [3]. - The adjusted EPS for the quarter was $2.81, reflecting a 15.6% increase from the previous year and surpassing analyst expectations of $2.69 [3]. Future Earnings Expectations - For fiscal 2026, analysts project RMD's EPS to grow by 14.9% year-over-year to $10.97 [4]. - RMD has consistently exceeded consensus earnings estimates in the last four quarters [4]. Analyst Ratings - Among 19 analysts covering RMD, the consensus rating is a "Moderate Buy," with a distribution of eight "Strong Buy," two "Moderate Buy," eight "Hold," and one "Strong Sell" [4]. - Morgan Stanley analyst David Bailey has maintained a "Buy" rating with a price target of $310, indicating a potential upside of 19.1% from current levels [5]. - The mean price target is $295.92, suggesting a 13.7% potential upside, while the highest price target of $345 indicates a potential upside of 32.5% [5].
SSKN Stock Falls Despite Meta-Analysis Backs Excimer Laser's Efficacy
ZACKS· 2026-02-18 15:55
Core Insights - STRATA Skin Sciences, Inc. (SSKN) has highlighted findings from a meta-analysis that supports the clinical efficacy of its 308 nm excimer laser technology for treating plaque psoriasis [1][12] - The meta-analysis, published in a peer-reviewed journal, indicates significant improvements in disease severity scores following targeted treatment protocols [1][10] Company Performance - Following the announcement of the meta-analysis, SSKN shares fell more than 8%, and the stock has decreased by 82.3% over the last six months, compared to a 37% decline in the industry [3][8] - The current market capitalization of SSKN is $2 million [6] Clinical Validation and Market Position - The findings from the meta-analysis provide independent validation of SSKN's excimer laser technology, which may enhance physician adoption and patient confidence [4][12] - The pooled data from the analysis showed PASI reductions of 56%-85% within 10-14 treatments, confirming the effectiveness of MED-guided dosing strategies [8][10] - The publication emphasizes the importance of MED-guided calibration for targeted UVB delivery, which can improve treatment outcomes while minimizing damage to healthy skin [11][12] Industry Outlook - The global psoriasis treatment market was valued at $34.14 billion in 2025 and is projected to grow to approximately $73.04 billion by 2035, with a CAGR of 7.9% [13] - The growth in the market is driven by increasing prevalence, better diagnosis, and demand for effective therapies, alongside innovations in biologics and device-based treatments [14]
Insulet Q4 Earnings Call Highlights
Yahoo Finance· 2026-02-18 14:36
Insulet said it achieved record new customer starts in the fourth quarter and for the full year across the U.S., international markets, and company-wide. CFO Flavia Pease noted that in the U.S. during the fourth quarter, more than 85% of new customer starts came from people transitioning from multiple daily injections (MDI), and type 2 represented more than 40% of all starts.For the full year, the company reported revenue of more than $2.7 billion , up 29.5% constant currency (30.7% reported). Management sa ...