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Elle Communications is Agency of Record for FDA-Cleared Neurostimulation Device
Accessnewswire· 2025-11-19 14:00
Core Insights - NET Recovery has announced national treatments utilizing its FDA-cleared neurostimulation device, the NET Device, to address the addiction crisis, particularly focusing on opioid and stimulant use [1] Company Overview - NET Recovery is associated with Elle Communications, a subsidiary of Dolphin (NASDAQ:DLPN) [1] - The NET Device has shown potential in recent research to significantly reduce both opioid and stimulant use following treatment [1] Industry Context - The announcement comes amid record-high overdose deaths and a lack of FDA-approved medications specifically for stimulant addiction [1] - A peer-reviewed study published in Frontiers in Psychiatry supports the efficacy of the NET Device in reducing substance use [1]
AptarGroup, Inc. (ATR) Presents at Jefferies London Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-11-19 13:53
Core Insights - Aptar Group has been in operation for approximately 80 years and has been publicly traded for 35 years, with the pharmaceutical segment contributing nearly 70% of EBITDA [2]. Company Overview - The company focuses on proprietary drug delivery devices, primarily for nasal and inhalation applications, as well as ophthalmic and dermal delivery systems [2]. - The beauty and closure segments also contribute to the company's portfolio, targeting demographics such as the aging population and health-conscious consumers [3]. Market Focus - Aptar Group's pharmaceutical applications are mainly aimed at chronic disease treatments, including asthma, COPD, and allergic rhinitis, which require daily medication [3]. - The company organizes its operations into three reporting segments but manages its business primarily through technology platforms [3].
Browning West Delivers Letter to The Cooper Companies Board of Directors
Globenewswire· 2025-11-19 13:45
Core Viewpoint - Browning West, an investment management firm, criticizes Cooper's lack of strategic focus, misaligned incentives, and inadequate board oversight, which have led to significant underperformance compared to market indices. The firm advocates for a restructuring of Cooper as a pure-play vision care company, suggesting that this could potentially double the stock price [1][2]. Group 1: Lack of Strategic Focus - Cooper operates two leading businesses: CooperVision, the largest contact lens company, and CooperSurgical, the largest fertility medical devices business, both of which have strong growth potential due to increasing myopia and infertility rates globally [2]. - Despite solid market positions, Cooper has underperformed the S&P 500 and related healthcare indices over the past 1, 3, and 5 years, with total revenue increasing by 47% but non-GAAP EPS growing only 20% from 2019 to 2024 [2][22]. - The current corporate structure dilutes management focus, leading to poor execution and failure to meet financial guidance, as evidenced by a significant drop in organic growth rates and a 13% share price decline following disappointing earnings [5][8]. Group 2: Misaligned Incentive Structure - Cooper's incentive structure promotes a "growth at all costs" mentality without considering free cash flow (FCF) or return on invested capital (ROIC), resulting in a cumulative ROIC of below 5% on approximately $4 billion invested in CooperSurgical over the past decade [6][27]. - Management's inability to define maintenance versus growth capital expenditures has raised concerns among shareholders, especially as FCF remains below 2019 levels despite a 54% revenue increase [7][28]. - Shareholders have experienced a 35% decline in Cooper's share price since September 2024, while management has continued to receive substantial compensation [7][28]. Group 3: Inadequate Board Oversight - The Board has rewarded management despite value-destructive acquisitions and capital misallocation, leading to a 100 percentage point underperformance compared to the S&P 500 over the past five years [8][15]. - The Board lacks essential expertise in vision care and medical devices, hindering effective oversight and strategic evaluation [8][10]. - The current Chairman, Robert Weiss, has been on the Board for nearly three decades and has sold over $100 million in stock since 2019, raising questions about his independence and the Board's ability to make sound strategic decisions [9][10]. Group 4: Recommendations for Change - Browning West urges the appointment of new directors with relevant sector expertise to enhance governance and align incentives with long-term shareholder value creation [11][12]. - A refreshed Board could drive initiatives to unlock Cooper's potential, potentially doubling EPS and improving the company's valuation multiple [12][14]. - The firm emphasizes the need for a thorough reassessment of operating plans and capital allocation strategies for both CooperVision and CooperSurgical [14].
Owlet and Locus Health Partner to Seamlessly Deliver Infant Health Data into Remote Patient Monitoring Programs
Businesswire· 2025-11-19 13:45
Core Insights - Owlet has partnered with Locus Health to enhance infant health management by integrating data from Owlet's FDA-cleared device, BabySat, into Locus Health's remote patient monitoring platform, allowing healthcare providers secure access to vital infant health information post-hospital discharge [2][3][4] Company Overview - Owlet, Inc. is a pioneer in smart infant monitoring, having monitored over 2.5 million babies and providing parents with reliable tools to track key vitals [9][10] - Locus Health specializes in remote care management software, particularly for vulnerable pediatric patients, and has been recognized for its outcomes-based solutions [6][11] Partnership Details - The collaboration aims to bridge the gap between hospital and home care for nearly 500,000 babies transitioning from ICU each year in the U.S., particularly those with ongoing medical needs [5] - The integration will allow clinicians to monitor key vital signs such as oxygen saturation and pulse rate, facilitating early detection of concerning trends and timely interventions [6] Strategic Goals - The partnership reflects Owlet's commitment to providing accessible, high-quality care for infants and their families, marking a significant step in expanding its clinical partnerships in pediatric healthcare [8] - Owlet's integration with Locus Health is expected to enhance workflow efficiency for healthcare providers while minimizing the burden on parents during challenging times [6]
Vivos Therapeutics Schedules Release of Third Quarter 2025 Financial Results and Conference Call
Globenewswire· 2025-11-19 13:30
Core Viewpoint - Vivos Therapeutics, Inc. is set to release its third quarter 2025 financial results and will discuss strategic collaborations that may impact revenue growth and cash burn during a conference call scheduled for November 19, 2025 [1][2]. Company Overview - Vivos Therapeutics, Inc. specializes in medical devices and healthcare services for sleep-related breathing disorders, particularly obstructive sleep apnea (OSA) [5]. - The company has developed proprietary treatments and diagnostic procedures, with its devices cleared by the FDA for various severity levels of OSA in both adults and children [5]. - Vivos' Complete Airway Repositioning and Expansion (CARE) devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the first for moderate to severe OSA in children [5]. Market Context - OSA affects over 1 billion people globally, with 90% undiagnosed, linking it to serious chronic health conditions [6]. - Traditional treatments like CPAP often fail to address the root causes of OSA, indicating a need for innovative solutions [6]. Strategic Initiatives - Vivos aims to enhance its market position through technology, education, and collaborations with sleep healthcare providers to better address OSA patients' needs [7]. - The company promotes The Vivos Method, a proprietary, clinically effective, nonsurgical, noninvasive, and nonpharmaceutical solution for OSA [8].
Dexcom Smart Basal Receives FDA Clearance Becoming the First and Only CGM-integrated Basal Insulin Dosing Optimizer for Type 2 Diabetes
Businesswire· 2025-11-19 13:30
Core Insights - DexCom, Inc. has received FDA clearance for Dexcom Smart Basal, the first and only CGM-integrated basal insulin dosing optimizer for adults with Type 2 diabetes on glargine U-100 long-acting insulin therapy [1] - The Dexcom Smart Basal will utilize data from the Dexcom G7 15 Day sensor and logged doses to provide personalized daily recommendations for optimizing long-acting insulin doses [1] Company Summary - DexCom, Inc. is recognized as the global leader in glucose biosensing technology [1] - The introduction of Dexcom Smart Basal represents a significant advancement in diabetes management, specifically targeting adults with Type 2 diabetes [1] Industry Impact - The FDA clearance of Dexcom Smart Basal is expected to enhance the management of Type 2 diabetes, potentially improving patient outcomes through personalized insulin dosing [1]
Odyssey Health, Inc. Secures Multi-Million-Dollar, Nine-Year Service Contract and Financing Facility for Up to $25 Million
Globenewswire· 2025-11-19 13:30
Service agreement and financing facility supports strategic growth and commercialization initiativesLAS VEGAS, Nov. 19, 2025 (GLOBE NEWSWIRE) -- Odyssey Health, Inc. (OTCQB: ODYY), a medical device company focused on developing and commercializing life-saving medical solutions, today announced it has entered into a multi-million-dollar, nine-year maintenance service contract for a commercial medical property. The long-term agreement creates a stable, recurring revenue stream and marks a significant step in ...
CVRx to Participate at the Piper Sandler 37th Annual Healthcare Conference
Globenewswire· 2025-11-19 13:30
Core Insights - CVRx, Inc. is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [3] - The management team will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025 [1] - The Barostim™ device is the first FDA-approved technology using neuromodulation to alleviate heart failure symptoms [3] Company Overview - CVRx specializes in developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases [3] - Barostim™ is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aimed at restoring balance to the autonomic nervous system [3] - The device has received FDA Breakthrough Device designation and is approved for use in heart failure patients in the U.S., as well as CE Mark approval for heart failure and resistant hypertension in the European Economic Area [3] Event Details - The fireside chat is scheduled for December 3, 2025, at 2:00 p.m. (ET) and will be available via webcast on the company's investor relations page [1][2]
RenovoRx CEO Shaun Bagai to Present at the Alliance Global Partners Emerging AgBiotech/Bio-Solutions Virtual Showcase on November 20th
Globenewswire· 2025-11-19 13:30
Core Insights - RenovoRx, Inc. is participating in the Alliance Global Partners Emerging AgBiotech/Bio-Solutions Virtual Showcase on November 20, 2025, where CEO Shaun Bagai will provide updates on the company's commercial efforts and market traction [1][2] Company Overview - RenovoRx is a life sciences company focused on developing targeted oncology therapies and commercializing RenovoCath, an FDA-cleared drug-delivery device [6][8] - The company aims to address high unmet medical needs through its patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, which allows for targeted therapeutic delivery while minimizing toxicities associated with systemic intravenous therapy [6][8] Financial Performance - For the third quarter of 2025, RenovoRx reported year-to-date revenue of approximately $900,000, indicating progress in its commercial efforts [2] Clinical Research and Development - The ongoing Phase III TIGeR-PaC clinical trial is evaluating intra-arterial gemcitabine delivered via RenovoCath in patients with locally advanced pancreatic cancer [3][7] - The company is also conducting a post-marketing registry study to gather real-world data on the safety and effectiveness of RenovoCath in patients with solid tumors [3] - Investigator-initiated trials are being supported for borderline resectable and oligometastatic pancreatic cancer, designed to be cost-neutral while providing meaningful data [3] Product Information - RenovoCath is designed for the isolation of blood flow and delivery of fluids to selected sites in the peripheral vascular system, with applications including arteriography and chemotherapeutic drug infusion [5][6] - The combination product candidate, intra-arterial gemcitabine (IAG), is under investigation and has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which grants seven years of market exclusivity upon FDA approval [8][9] Market Activity - RenovoRx has received its first commercial purchase orders for RenovoCath devices and is seeing repeat orders from customers, including high-volume National Cancer Institute-designated centers [9] - The company is exploring further revenue-generating activities to meet anticipated demand for its products [9]
BSX's Neuromodulation Prospect Looks Strong: What's Behind It?
ZACKS· 2025-11-19 13:26
Core Insights - The demand for global neuromodulation devices is driven by increasing incidences of chronic pain, neurological disorders, and mental health conditions, with a projected CAGR of 8.51% through 2030 [1] - Boston Scientific (BSX) maintains a leading position in the neuromodulation market, supported by technological advancements and strong sales growth [1][9] Company Performance - In Q3 2025, Boston Scientific's Neuromodulation business achieved a sales growth of 9%, continuing its strong performance for the year [2][9] - The Brain franchise experienced low single-digit growth, bolstered by positive results from the INTREPID study on Deep Brain Stimulation (DBS) for Parkinson's disease [2] - The Pain franchise grew in the high single digits, driven by strong double-digit growth in the U.S. from the Intracept system [3] Acquisitions and Expansion - The acquisition of Relievant in 2023 is contributing to growth by adding the Intracept Intraosseous Nerve Ablation System for treating vertebrogenic pain [3] - Boston Scientific has entered into an agreement to acquire the remaining stake in Nalu Medical for approximately $533 million, expanding its Neuromodulation offerings into peripheral nerve stimulation [4] Peer Comparisons - Medtronic reported a 4.5% year-over-year growth in its Neuroscience Portfolio, reaching $2.56 billion, with Neuromodulation growing by 7% [5] - Abbott's Neuromodulation sales grew by 7% year-over-year, driven by the Eterna rechargeable spinal cord stimulation device [6] Stock Performance and Valuation - Over the past 12 months, Boston Scientific shares have increased by 10.1%, contrasting with a 0.6% decline in the industry [7] - The company's shares trade at a forward five-year Price-to-Sales (P/S) ratio of 6.68, significantly higher than the industry average of 2.98 [10] Earnings Estimates - Earnings estimates for Boston Scientific show an upward trend, with current estimates for Q4 2025 at $0.78 and for the full year at $3.04 [12][13]