Core Insights - Kelyniam Global, Inc. has secured an exclusive U.S. license from Evonik Industries AG to market VESTAKEEP® Fusion, a bi-calcium phosphate-infused PEEK material for cranial, craniofacial, and maxillofacial implants, with a two-year exclusivity period and an option for renewal [1][2][3] Company Developments - The incorporation of VESTAKEEP® Fusion enhances Kelyniam's regenerative product lineup by leveraging its osteoconductive properties, which promote human bone growth and integration [2][4] - This strategic move is expected to add significant value for shareholders by expanding Kelyniam's regenerative medicine portfolio, positioning the company to meet the increasing demand for innovative cranial reconstruction solutions [3][4] Product and Market Positioning - Kelyniam's partnership with Modern Plastics ensures reliable access to PEEK materials, supporting the company's growth in advanced neurosurgical solutions [2][3] - The introduction of VESTAKEEP® Fusion reflects Kelyniam's commitment to delivering regenerative technologies that improve patient outcomes and advance the standard of care in cranial and craniofacial solutions [4]

Core Viewpoint - Johnson & Johnson's recent earnings report shows strong performance with earnings and sales exceeding estimates, but the company faces challenges from product exclusivity losses and competition in certain segments [2][3][22]. Financial Performance - Q3 2025 earnings were $2.80 per share, beating the Zacks Consensus Estimate of $2.77, and reflecting a 15.7% increase year-over-year [2]. - Reported earnings, including special items, were $2.12 per share, up 91% year-over-year [2]. - Sales reached $24.0 billion, surpassing the Zacks Consensus Estimate of $23.74 billion, with a 6.8% increase from the previous year [2][3]. Sales Breakdown - Domestic sales rose 6.2% to $13.7 billion, while international sales increased 7.6% to $10.3 billion [4]. - The Innovative Medicines segment saw sales rise 6.8% to $15.56 billion, driven by key products like Darzalex and Tremfya [5][6]. - The loss of exclusivity for Stelara negatively impacted revenue growth by 640 basis points [3]. Segment Performance - Oncology sales, particularly for Darzalex, grew 21.7% to $3.67 billion, while Imbruvica sales declined 7.8% to $695 million due to competitive pressures [8][9]. - Immunology segment sales were affected by Stelara's decline of 41.3% to $1.57 billion, attributed to biosimilar competition [13]. - The MedTech segment reported sales of $8.43 billion, up 6.8%, with strong performance in cardiovascular and surgical products [18][19]. Guidance and Outlook - The company raised its 2025 sales guidance to $93.5 billion-$93.9 billion, indicating growth of 5.4%-5.9% [22]. - Adjusted earnings per share guidance remains at $10.80-$10.90, with operational growth expected to increase by 8.2%-9.2% [24]. - For 2026, J&J anticipates top-line growth exceeding 5%, driven by key products and new launches in both Innovative Medicine and MedTech segments [26][27][28]. Market Position - Johnson & Johnson holds a Zacks Rank 3 (Hold), indicating an expectation of an in-line return from the stock in the coming months [31].

Core Insights - Three stocks with strong momentum and buy rankings are highlighted for investors: Flex Ltd., Insulet Corporation, and PRA Group, Inc. [1][2][3] Company Summaries - **Flex Ltd. (FLEX)**: - Provides design, engineering, manufacturing, and supply chain services to original equipment manufacturers - Holds a Zacks Rank 1 with a 5.4% increase in the Zacks Consensus Estimate for current year earnings over the last 60 days - Shares increased by 27.3% over the last three months, outperforming the S&P 500's 6% gain, and has a Momentum Score of A [1][2] - **Insulet Corporation (PODD)**: - Specializes in insulin delivery systems - Also holds a Zacks Rank 1 with a 6.5% increase in the Zacks Consensus Estimate for current year earnings over the last 60 days - Shares gained 6.7% over the last three months, matching the S&P 500's performance, and has a Momentum Score of A [2] - **PRA Group, Inc. (PRAA)**: - Operates in the financial services sector - Holds a Zacks Rank 1 with a 9.9% increase in the Zacks Consensus Estimate for current year earnings over the last 60 days - Shares increased by 11.5% over the last month, compared to the S&P 500's 3% gain, and has a Momentum Score of B [3]

Core Insights - Medtronic (MDT) is expected to report quarterly earnings of $1.31 per share, a 4% increase year-over-year, with revenues projected at $8.86 billion, reflecting a 5.4% increase from the previous year [1] Earnings Estimates - The consensus EPS estimate has been revised down by 0.1% in the last 30 days, indicating a reassessment by analysts [2] - Changes in earnings estimates are crucial for predicting investor reactions, as empirical studies show a strong correlation between earnings estimate revisions and short-term stock performance [3] Revenue Projections - Analysts project 'Net Sales- World Wide Revenue- Diabetes' at $749.45 million, a 9.3% increase year-over-year [5] - 'Net Sales- World Wide Revenue- Neuroscience' is expected to reach $2.49 billion, reflecting a 1.5% increase from the prior year [5] - 'Net Sales- World Wide Revenue- Cardiovascular' is forecasted at $3.36 billion, indicating an 8.5% increase year-over-year [6] - 'Net Sales- World Wide Revenue- Medical Surgical' is anticipated to be $2.24 billion, a 5.4% increase from the previous year [6] - 'Net Sales- U.S. Revenue' is projected at $4.53 billion, reflecting a 5.3% increase year-over-year [6] Specific Segment Estimates - 'Net Sales- U.S. Revenue- Medical Surgical' is expected to be $938.99 million, showing a slight decline of 0.5% year-over-year [7] - 'Net Sales- U.S. Revenue- Neuroscience- Neuromodulation' is projected at $351.65 million, a 5.6% increase from the prior year [7] - 'Net Sales- ROW- Neuroscience- Cranial & Spinal Technologies' is estimated at $326.68 million, indicating a 6.1% increase year-over-year [7] - 'Net Sales- ROW- Neuroscience- Specialty Therapies' is expected to be $319.41 million, reflecting a minimal change of +0.1% year-over-year [8] - 'Net Sales- ROW- Medical Surgical- Surgical & Endoscopy' is projected at $1.03 billion, indicating a 5.4% increase year-over-year [9] - 'Net Sales- ROW- Cardiovascular' is expected to reach $1.80 billion, reflecting a 7.8% increase from the prior year [9] Stock Performance - Over the past month, Medtronic shares have returned +0.5%, compared to the Zacks S&P 500 composite's +4.6% change, suggesting that MDT is likely to perform in line with the overall market [9]

Core Insights - Nexalin Technology, Inc. has entered into an exclusive distribution agreement with Carmi Masha Technologies Ltd. to market and sell its Gen-2 SYNC device in Israel following regulatory approval from the Israeli Ministry of Health [1][2][3] Group 1: Agreement Details - The agreement allows Carmi Masha to manage sales, marketing, clinical education, importation, registration, and distribution of the SYNC device across various healthcare facilities in Israel [2] - The Gen-2 SYNC device is a non-invasive neurostimulation device designed to treat mental health disorders such as insomnia, depression, and anxiety [2][4] Group 2: Future Applications - Nexalin and Carmi Masha plan to explore future applications of the SYNC technology for conditions like PTSD, TBI, Alzheimer's disease, and other forms of dementia [2] Group 3: Company Strategy - The partnership is part of Nexalin's broader strategy to expand its global presence in high-value international markets and strengthen its footprint in the Middle East [3] - Nexalin's products are designed to be non-invasive and aim to provide relief for mental health issues using bioelectronic frequency-based medical technology [4]

Core Insights - Teleflex Incorporated (TFX) reported third-quarter 2025 adjusted earnings per share (EPS) of $3.67, reflecting a 5.2% increase year-over-year and exceeding the Zacks Consensus Estimate by 8.6% [1][8] - The company experienced a significant revenue growth of 19.4% year-over-year, reaching $913 million, which also surpassed the Zacks Consensus Estimate by 2% [2][8] - Despite strong financial results, Teleflex lowered its 2025 guidance, impacting investor sentiment negatively [8][14] Revenue Breakdown - Net revenues in the Americas segment were $555.9 million, a 7.8% increase from the previous year, but below the projected $588.6 million [3] - EMEA segment revenues surged by 55.9% year-over-year to $234.2 million, significantly exceeding the expected $162.6 million [3] - Asia Pacific revenues rose by 25% to $122.9 million, falling short of the projected $142.1 million [4] Product Revenue Analysis - The Vascular Access segment generated $191 million in net revenues, up 5.6% year-over-year, surpassing the projection of $187.1 million [5] - The Interventional business saw a remarkable 77.8% increase in net revenues to $266.4 million, exceeding the expected $260.3 million [5] - The Anesthesia segment's revenues increased slightly by 0.4% to $101.4 million, above the projected $96.9 million [5] - The Surgical segment reported $122.9 million in revenues, a 10% increase year-over-year, surpassing the projection of $114.6 million [6] - Interventional Urology revenues decreased by 13.9% to $71.8 million, below the expected $76.9 million [6] - OEM revenues declined by 2.6% to $80.4 million, slightly below the projection of $81 million [6] - The Other product segment's revenues increased by 44.4% to $79.1 million, exceeding the projection of $76.4 million [7] Margin Performance - Gross profit was $451.6 million, a 5% increase year-over-year, but the gross margin contracted by 681 basis points to 49.5% due to a 38% rise in the cost of goods sold [9] - Adjusted operating profit decreased by 21.9% to $112.7 million, with the adjusted operating margin contracting by 652 basis points to 12.3% [9] Liquidity Position - Teleflex ended Q3 2025 with cash and cash equivalents of $354 million, up from $253.7 million at the end of Q2 [10] - Net cash flow from operating activities was $189 million, down from $435.6 million in the same period last year [10] Guidance Update - The company now expects GAAP revenue growth for 2025 to be in the range of 9.10-9.60%, down from the previous guidance of 9.00-10.00% [11] - Adjusted EPS from continuing operations is now anticipated to be between $14.00 and $14.20, reduced from the prior guidance of $13.90-$14.30 [12] Strategic Developments - Teleflex completed the acquisition of substantially all of the Vascular Intervention business from BIOTRONIK SE & Co. KG, enhancing its portfolio and global presence in the cath lab [14]

New York, New York--(Newsfile Corp. - November 13, 2025) - If you suffered a loss on your Inspire Medical Systems, Inc. (NYSE: INSP) investment and want to learn about a potential recovery under the federal securities laws, follow the link below for more information:https://zlk.com/pslra-1/inspire-medical-systems-inc-lawsuit-submission-form?prid=177137&wire=5&utm_campaign=5or contact Joseph E. Levi, Esq. via email at jlevi@levikorsinsky.com or call (212) 363-7500 to speak to our team of experienced shareho ...

Core Insights - Inspira Technologies has completed the clinical study for its non-invasive blood sensor, HYLA, and is preparing for regulatory submission and commercialization [1][2][4] - The HYLA sensor demonstrates an accuracy rate between 95% to 99% across various measured parameters, indicating its potential as a disruptive solution for real-time blood monitoring [2][4] - The company is integrating advanced Machine Learning algorithms to enhance the capabilities of the HYLA sensor, aiming to monitor critical physiological parameters not currently available through existing non-invasive systems [3][4] Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with its INSPIRA™ ART100 system cleared by the U.S. FDA for cardiopulmonary bypass and ECMO procedures [5] - The company is developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake and breathing spontaneously [5] - With a growing intellectual property portfolio and strategic operational streamlining, Inspira Technologies is positioning itself as an attractive player in the life-support and MedTech sectors [5]

Core Insights - Inspira Technologies has completed the clinical study for its non-invasive blood sensor, HYLA, and is preparing for regulatory submission and commercialization [1][2][4] - The HYLA sensor demonstrates an accuracy rate between 95% to 99% across various measured parameters, indicating its potential as a disruptive solution for real-time blood monitoring [2][4] - The company is integrating advanced Machine Learning algorithms to enhance the capabilities of the HYLA sensor, aiming to monitor critical physiological parameters not currently available through existing non-invasive systems [3][4] Company Overview - Inspira Technologies is a commercial-stage medical device company focused on advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA ART100 system [5] - The company is developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake, further expanding its product offerings [5] - Inspira Technologies is positioned as an attractive player in the life-support and MedTech landscape, with a growing intellectual property portfolio and strategic operational streamlining [5]

NEW YORK, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a class action lawsuit has been filed against Inspire Medical Systems, Inc. (NYSE: INSP) and certain of the Company’s senior executives for securities fraud after a significant stock drop resulting from the potential violations of the federal securities laws. If you invested in Inspire, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases/inspire-medical- ...