Workflow
Medical Devices
icon
Search documents
Catheter Precision Announces the Start of Enrollment for the LockeT Compare Study
Globenewswire· 2025-08-21 12:00
Core Insights - Catheter Precision, Inc. has initiated the LockeT Compare Study, enrolling its first three patients, aimed at evaluating the safety profile of the LockeT suture retention device [1][2] - The study will enroll up to 100 patients and compare the LockeT device with internal closure devices, focusing on reducing groin complications post-cardiac catheter procedures [2] - The LockeT device has shown clinical data indicating safety, effectiveness, and cost reduction without altering hospital practices [2][3] Company Overview - Catheter Precision is a U.S.-based medical device company dedicated to improving cardiac arrhythmia treatment through innovative technology and collaboration with physicians [4] - The LockeT device is a Class 1 device registered with the FDA and has received CE Mark approval, designed for wound closure after percutaneous venous punctures [3][4]
BrainsWay Targets Expansion of its Total Addressable Market through a Strategic Investment in Neuromodulation Systems Developer, Neurolief Ltd.
GlobeNewswire News Room· 2025-08-21 11:30
This investment marks BrainsWay’s entrance into the market for mental health therapies that can be administered outside of a clinic, including at home Neurolief’s breakthrough Proliv™Rx device is pending Premarket Approval from the U.S. FDA, and if granted, will become the first FDA-cleared medical device for MDD treatment that can be delivered outside of the clinic BURLINGTON, Mass. and JERUSALEM, Aug. 21, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a glob ...
Five Point(FPH) - 2025 FY - Earnings Call Transcript
2025-08-21 03:02
Financial Data and Key Metrics Changes - Operating revenues surpassed $2,000,000,000 for the first time, reaching $2,020,000,000, which is a 14% increase in constant currency [34][13] - Net profit after tax was $377,200,000, reflecting a 30% increase in constant currency compared to the previous year [34][13] - Gross margin improved to 62.9%, an increase of 1.3% in constant currency [36] Business Line Data and Key Metrics Changes - Hospital business revenue was $1,280,000,000, up 16% in constant currency [34] - Home care business revenue reached $739,900,000, an 11% increase in constant currency [34] Market Data and Key Metrics Changes - The company’s products were used to treat 22 million patients in FY 2025, indicating strong market demand [30] - The manufacturing facility in China became fully operational, contributing to sales [31] Company Strategy and Development Direction - The company focuses on long-term planning, with a perspective extending beyond 15 years, guiding R&D and infrastructure investments [6][8] - Infrastructure investments include the construction of a fifth building at the East Tamaki campus and securing land for a second campus in New Zealand [8][7] - The company aims to double its revenue every five to six years sustainably [60] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the impact of global geopolitics and tariffs but emphasized a long-term strategy to mitigate cost increases through continuous improvements [9][12] - The outlook for FY 2026 anticipates revenue between $2,150,000,000 and $2,250,000,000, with net profit after tax expected to be between $390,000,000 and $440,000,000 [56] Other Important Information - The company is committed to maintaining a prudent balance sheet while investing in R&D and global sales [14] - The board approved a 2% increase in dividends, totaling $0.0425 per share, representing a payout ratio of about 66% [13][14] Q&A Session Summary Question: Why hasn't the company conducted a major investor day like Xero? - The company complies with New Zealand regulations and believes its disclosures are adequate, thus not planning to adopt the Australian remuneration report [66] Question: What are the expectations for FY 2026 underlying profit? - Management referred to the outlook provided earlier, indicating a long-term growth trajectory despite fluctuations during the COVID period [68] Question: How many shareholders voted in favor of the CEO's reelection? - The number of votes will be disclosed at the end of the meeting, but the focus will be on the number of votes rather than individual shareholders [84]
Why Medtronic Stock Raced Higher Today
The Motley Fool· 2025-08-20 22:06
The shares benefited from a clutch of analyst price target hikes. A clutch of post-earnings price target increases by analysts helped raise Medtronic's (MDT 3.59%) stock at a healthy rate on Wednesday. The sturdy medical device specialist's shares rose by almost 4% on the day as a consequence, a rate that looked especially good next to the S&P 500's (^GSPC -0.24%) 0.2% drop. The market, which collectively loves a crushing beat on analyst estimates, basically shrugged at this. Many investors traded out of Me ...
RXST Stockholders with Large Losses Should Contact Robbins LLP for Information About the RxSight, Inc. Class Action
Prnewswire· 2025-08-20 21:24
SAN DIEGO, Aug. 20, 2025 /PRNewswire/ -- Robbins LLP reminds stockholders that a class action was filed on behalf of investors who purchased or otherwise acquired RxSight, Inc. (NASDAQ: RXST) securities between November 7, 2024 and July 8, 2025. RxSight is a commercial-stage medical technology company, engaged in the research and development, manufacture, and sale of light adjustable intraocular lenses ("LAL") used in cataract surgery in the United States. The Company's primary product is the RxSight system ...
Medtronic Has Potential To Pursue Further Divestitures: Analyst
Benzinga· 2025-08-20 17:15
Core Insights - Medtronic Plc reported second-quarter earnings and announced key board appointments following Elliott Investment Management becoming the largest shareholder [1] - The company introduced a new Growth Committee to oversee strategic M&A, R&D investments, and potential divestitures, including the planned separation of its Diabetes business [1] Financial Performance - Medtronic's first-quarter 2026 sales reached $8.58 billion, exceeding the consensus estimate of $8.38 billion, representing an 8.4% year-over-year increase with organic growth of 4.8% [2] - Adjusted earnings per share were $1.26, surpassing expectations of $1.23 [2] Sales Guidance - The company raised its sales guidance for fiscal 2026 from a range of $35.15 billion to $35.25 billion to a new range of $35.72 billion to $35.82 billion, compared to the consensus of $35.32 billion [3] Analyst Reactions - Needham's analyst Mike Matson believes Medtronic is in the early stages of a strong product cycle and expects Elliott's involvement to enhance shareholder value, but maintains a Hold rating until organic growth shows meaningful acceleration beyond 5% [4] - Matson raised fiscal 2026 and 2027 revenue estimates to $35.81 billion from $35.29 billion and to $37.69 billion from $36.96 billion, respectively [5] - Bernstein maintains an Outperform rating on Medtronic, raising the price forecast from $97 to $98, while Baird maintains a Neutral rating, increasing the price forecast from $94 to $96 [6] Stock Performance - Medtronic's stock increased by 4.07%, reaching $93.56 at the last check on Wednesday [6]
DexCom Expands Access and Innovation While Balancing Headwinds
ZACKS· 2025-08-20 16:21
Key Takeaways DXCM posts strong growth, expanding access and raising FY25 revenue outlook.DXCM momentum led by type 2 wins, Stelo adoption and 15-day G7 launch.DXCM focuses on global growth, AI integration and margin recovery.DexCom, Inc. (DXCM) reported second-quarter 2025 results that highlighted robust top-line growth, continued progress in expanding access and meaningful product innovation. Revenues grew 15% year over year to $1.16 billion, with broad-based contributions from both the U.S. and internati ...
The Cooper Companies (COO) Earnings Expected to Grow: What to Know Ahead of Next Week's Release
ZACKS· 2025-08-20 15:00
Core Viewpoint - Wall Street anticipates a year-over-year increase in earnings for The Cooper Companies, driven by higher revenues, with a focus on how actual results compare to estimates impacting stock price [1][2]. Earnings Expectations - The Cooper Companies is expected to report quarterly earnings of $1.06 per share, reflecting a +10.4% year-over-year change, with revenues projected at $1.07 billion, up 6.2% from the previous year [3]. Estimate Revisions - The consensus EPS estimate has remained unchanged over the last 30 days, indicating stability in analyst expectations [4]. Earnings Surprise Prediction - The Zacks Earnings ESP model shows a positive Earnings ESP of +0.58% for The Cooper Companies, suggesting a likelihood of beating the consensus EPS estimate [12]. Historical Performance - The Cooper Companies has beaten consensus EPS estimates in three out of the last four quarters, with a recent surprise of +3.23% [13][14]. Additional Considerations - While an earnings beat may influence stock movement, other factors can also play a significant role in stock performance post-earnings release [15][17].
Alcon(ALC) - 2025 Q2 - Earnings Call Transcript
2025-08-20 13:02
Financial Data and Key Metrics Changes - The company's second quarter sales reached $2.6 billion, reflecting a 3% increase year-over-year, consistent with the first quarter performance [29] - Core gross margin for the second quarter was 62.2%, in line with the previous year, while core operating margin decreased by 100 basis points to 19.1% due to increased R&D investments [32] - Core diluted earnings per share were $0.76, broadly in line with the previous year on a constant currency basis [32] Business Line Data and Key Metrics Changes - Surgical franchise revenue increased by 1% year-over-year to $1.5 billion, with implantable sales down 2% to $456 million due to soft market conditions and competitive pressures [29] - Vision Care sales rose by 5% to $1.1 billion, driven by a 7% increase in contact lens sales, primarily due to product innovation and price increases [30] - Oculo Health sales were up 2% year-over-year to $430 million, led by eye drop products, although there were declines in contact lens care [31] Market Data and Key Metrics Changes - Global cataract volumes grew approximately low single digits in the second quarter, compared to a historical average of about 4% [27] - The retail market for contact lenses grew mid single digits during the same period [27] Company Strategy and Development Direction - The company is focused on acquiring transformative technologies in eye care, with recent acquisitions including the Voyager Direct device for glaucoma and STAR for refractive surgery [10][11] - The company aims to leverage its broader commercial infrastructure to accelerate adoption of new products and expand its presence in growing markets like China [13][14] - The company is committed to driving organic growth through innovation and execution, with several major product launches underway [9][18] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that while the second quarter results fell short of expectations, they remain confident in the long-term durability of end markets and the resilience of customers [8][9] - The company expects to see sales growth accelerate in the second half of the year, particularly in the fourth quarter, despite current market softness [35] - Management emphasized the importance of innovation and operational discipline to drive long-term growth and shareholder value [40][38] Other Important Information - The company incurred $27 million in tariff-related charges during the second quarter, with an expected full-year impact of approximately $100 million on cost of sales [33] - The company is maintaining its core diluted earnings guidance range of $3.05 to $3.15 per share, reflecting a year-over-year change of 2% in constant currency [37] Q&A Session Summary Question: Can you elaborate on the stability of PCIOL share in the U.S. and the situation outside the U.S.? - Management noted a sequential improvement of about four share points in the U.S. market, attributed to the positive reception of PanOptix Pro, while acknowledging competitive pressures in international markets [46][48] Question: What is the outlook for market weakness and its recovery? - Management expressed confidence in the long-term growth of the cataract market, citing an increasing prevalence of cataracts and treatment access, despite current procedural volume oscillations [56][58] Question: How is the Unity VCS performing since its launch? - Management reported over 1,000 qualified leads for Unity VCS within ten weeks of launch, emphasizing a deliberate ramp-up process to ensure proper training and installation [62][64] Question: What is the expected sustainable revenue growth rate for the EVO ICL platform? - Management indicated a solid outlook for EVO in China and elsewhere, emphasizing the low penetration of EVO relative to high myopes and the importance of training and business model adjustments [103] Question: How is the company addressing increased tariff headwinds? - Management highlighted that the weak dollar is a significant mitigation factor, while also considering potential adjustments to the manufacturing footprint in response to tariff pressures [105][106]
Femasys Secures UK Regulatory Approval of FemBloc Permanent Birth Control
Globenewswire· 2025-08-20 13:00
--Advances European commercialization strategy following CE mark approval-- ATLANTA, Aug. 20, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced that it received the Medicines and Healthcare products Regulatory Agency (MHRA) approval for its FemBloc Permanent Birth Control, which signifies the product has met the required standards for safety, quality, ...