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Nexalin Technology’s Q-Submission for Gen-2 SYNC Accepted by U.S. FDA for the Treatment of Alzheimer’s Disease and Dementia
Globenewswire· 2025-11-05 13:30
Core Insights - The FDA has accepted Nexalin Technology's Q-Submission for its Gen-2 Console system aimed at treating Alzheimer's disease and dementia, marking a significant step towards clinical studies in the U.S. [1][2][4] Regulatory Milestone - The acceptance of the Q-Submission allows for structured dialogue with the FDA regarding clinical trial design, study endpoints, and regulatory pathways for the Gen-2 SYNC system [2][6]. - This regulatory milestone is based on encouraging internal data and published studies that suggest the potential of Nexalin's neurostimulator to improve cognitive function and memory [3][4]. Product and Technology - Nexalin's Gen-2 SYNC platform utilizes a proprietary 15-milliamp waveform designed to stimulate brain structures related to cognition and mood without drugs or surgical procedures [3][10]. - The company is also evaluating strategic collaborations with research institutions to accelerate studies involving its Gen-2 SYNC and next-generation Gen-3 HALO platforms [7]. Clinical Evidence - Recent data and independent research indicate observed improvements in cognitive performance in pilot studies using Nexalin's technology, with no serious adverse events reported, highlighting a favorable safety profile [9][10]. - EEG and qEEG evidence suggests that the waveform induces modulation correlated with improved neural connectivity in dementia-related conditions [9].
Zimmer Biomet Reaffirms FY25 Adj. EPS, Revenue Outlook - Update
RTTNews· 2025-11-05 13:27
Core Viewpoint - Zimmer Biomet Holdings Inc. reaffirms its adjusted earnings and revenue growth guidance for fiscal year 2025, projecting stable performance despite previous estimates [1][2]. Financial Guidance - For fiscal 2025, the company projects adjusted earnings between $8.10 and $8.30 per share [1]. - Revenue growth is expected to be in the range of 6.7 to 7.7 percent from the previous year on a reported basis [1]. - Constant currency revenue growth is anticipated to be between 6.2 and 6.7 percent, while organic constant currency revenue growth is projected at 3.5 to 4.0 percent [1]. Analyst Expectations - Analysts expect the company to report earnings of $8.14 per share, with revenue growth estimated at 7.02 percent, reaching approximately $8.22 billion for the year [3].
Insulet, Uber And A Financial Stock On CNBC's 'Final Trades' - Apollo Asset Management (NYSE:APO), Insulet (NASDAQ:PODD)
Benzinga· 2025-11-05 13:26
Group 1: Insulet Corporation - Insulet Corporation, a maker of wearable devices for insulin management, was named as a final trade by Joseph Terranova from Virtus Investment Partners [1] - Stifel analyst Jonathan Block reinstated Insulet with a Buy rating and set a price target of $370 [1] - Insulet shares rose 0.5% to close at $320.27 on Tuesday [5] Group 2: Uber Technologies, Inc. - Uber reported a 20% year-over-year revenue growth to $13.47 billion, surpassing the analyst consensus estimate of $13.28 billion [2] - The company reported adjusted EPS of 81 cents, beating the analyst consensus estimate of 69 cents [2] - Uber shares dipped 5.1% to close at $94.67 during the session [5] Group 3: Apollo Global Management - Apollo Global Management reported adjusted earnings per share of $2.17, beating the consensus estimate of $1.91 [3] - The company reported sales of $9.82 billion, significantly exceeding the consensus estimate of $5.02 billion [3] - Apollo Global Management shares gained 5.3% to close at $130.51 on Tuesday [5]
DEXCOM CLASS ACTION LAWSUIT: DexCom, Inc. (NASDAQ:DXCM) Investors with Losses are Notified of the Upcoming December 26 Court Deadline – Contact BFA Law
Globenewswire· 2025-11-05 13:06
Core Viewpoint - A class action lawsuit has been filed against DexCom, Inc. and its senior executives for securities fraud following significant stock declines attributed to potential violations of federal securities laws [1][2]. Group 1: Lawsuit Details - Investors have until December 26, 2025, to request to lead the case, which is pending in the U.S. District Court for the Southern District of New York [2]. - The lawsuit asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of DexCom investors [2]. Group 2: Product Issues - DexCom manufactures continuous glucose monitoring systems, including the G6 and G7, which were marketed as highly accurate [3]. - Allegations state that unauthorized design changes were made to the G6 and G7, compromising their accuracy and exposing users to health risks [4]. Group 3: Stock Performance - DexCom's stock experienced significant declines due to quality issues with the G6 and G7, including a drop of $7.12 per share (over 9%) following an FDA warning letter on March 7, 2025 [5]. - After the FDA published the warning letter on March 25, 2025, the stock fell an additional $3.19 per share (over 4%) [6]. - A report by Hunterbrook on September 18, 2025, revealed serious safety concerns, leading to a nearly 12% drop in stock price, equating to $8.99 per share [7].
Beyond Air® Secures Up to $32 Million to Accelerate Growth
Globenewswire· 2025-11-05 13:00
Core Viewpoint - Beyond Air, Inc. has secured financing agreements with Streeterville Capital, providing up to $32 million to support its commercial expansion and potential profitability [2][3]. Financing Agreements - The company entered into a $12 million promissory note with a 15% annual interest rate, maturing in 24 months, with no payments due in the first year [3]. - Additionally, a $20 million Equity Line of Credit (ELOC) allows the company to sell newly issued shares over 24 months, with proceeds designated for various corporate purposes [4]. Financial Position - As of September 30, 2025, Beyond Air reported proforma cash and equivalents totaling $22.9 million, which includes the $12 million from the promissory note [1]. Strategic Goals - The financing is aimed at accelerating the commercial expansion of LungFit PH, with expectations of driving sales growth and achieving profitability by the anticipated launch of a second-generation product by the end of 2026 [3]. Company Overview - Beyond Air is focused on developing medical devices and biopharmaceuticals utilizing nitric oxide to treat respiratory illnesses and other conditions [6]. - The company has received FDA approval for its LungFit PH system, which is designed for treating neonates with hypoxic respiratory failure [6][10].
STRATA Skin Sciences to Report Third Quarter 2025 Financial Results on November 13, 2025 and Provide Corporate Update
Globenewswire· 2025-11-05 13:00
Core Insights - STRATA Skin Sciences, Inc. will report its third quarter 2025 financial results on November 13, 2025, after market close [1] - A conference call will be held on the same day at 4:30 p.m. ET to discuss the financial results and corporate developments [2] Company Overview - STRATA Skin Sciences is a medical technology company focused on developing, commercializing, and marketing innovative products for dermatologic conditions such as psoriasis, vitiligo, and acne [5] - The company's product offerings include the XTRAC excimer laser, VTRAC lamp systems, and the TheraClearX Acne Therapy System [5] Partnership Program - STRATA offers a unique Partnership Program in the U.S., which includes a fee per treatment cost structure instead of requiring equipment purchase [6] - The program provides on-site training, service and maintenance, dedicated account support, and co-op advertising to promote awareness [6]
LivaNova(LIVN) - 2025 Q3 - Earnings Call Presentation
2025-11-05 13:00
November 5, 2025 Third-Quarter 2025 Earnings Update Safe Harbor Certain statements in this material, other than statements of historical or current fact, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange Act. These statements include, but are not limited to, LivaNova's plans, objectives, strategies, financial performance and outlook, trends, the amount and timing of future cash distr ...
Philips reiterates FY25 outlook following steady Q3 performance
Yahoo Finance· 2025-11-05 12:22
Core Insights - Philips has maintained its fiscal year 2025 guidance, projecting growth between 1% to 3% despite a slight decline in total revenues for Q3 2025 [1][2] - The company reported Q3 comparable sales growth of 3% and an adjusted EBITDA increase of 12.3% to $531 million compared to $516 million in Q3 2024 [2] - The stock closed at €28.02 per share, reflecting a 0.64% decrease from the opening price on November 4 [3] Financial Performance - Total revenues for Q3 2025 were €4.3 billion, a decrease of approximately 1.7% from €4.37 billion in the same period of 2024 [1] - The personal health segment saw the highest comparable sales growth at 10.9%, while diagnosis and treatment grew by 1.3% and Connected Care by 5.1% [4] - The adjusted EBITDA margin is expected to be at the upper end of 11.3% to 11.8% for FY25 [2] Market Position and Strategy - Philips experienced strong order intake and sales growth, particularly in the North American market [5] - The company is focusing on AI-powered innovations and long-term partnerships to enhance its offerings [4] - Investments in the supply chain have been made to mitigate the impact of tariffs related to China on US operations [5]
“向新而行”系列活动走进中关村园区发布多个场景需求及能力
Core Insights - The "New Path Forward" series of events focuses on promoting industrial AI and health technology applications, facilitating precise matching of supply and demand in these sectors [1][2] Group 1: Industrial AI - The Industrial AI event highlighted the integration of "Artificial Intelligence + Industry," presenting six demand scenarios from state-owned enterprises like Sinopec and China National Petroleum [1] - A total of 50 scenario capabilities were showcased, including solutions for chemical safety monitoring and industrial decision-making [1] - Three typical demonstration projects were shared, illustrating successful applications of industrial AI technologies [1] Group 2: Health Technology - The Health Technology event featured five clinical demand scenarios from major hospitals, including Beijing Friendship Hospital and Peking University School of Stomatology [1] - Forty scenario capabilities were promoted, such as an intelligent diagnosis platform based on the APUS model and solutions for dental bone defect repair [1] - Two demonstration projects were presented, including a pioneering integrated surgical robot for cranial and spinal procedures [1] Group 3: Ecosystem Development - The events included signing ceremonies for collaborations, such as the establishment of a joint laboratory for medical device research and evaluation [2] - The "New Path Forward" series aims to continuously host thematic activities throughout the year, focusing on technology innovation and market matching [2] - Future efforts will enhance the city's technology innovation ecosystem, supporting rapid development of tech enterprises through scenario-driven approaches [2]
Siemens Healthineers slightly misses sales expectations in fourth quarter
Reuters· 2025-11-05 06:02
Siemens Healthineers on Wednesday reported fourth-quarter revenue slightly below analysts' consensus as higher U.S. import tariffs weigh. ...