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DexCom (DXCM) Releases Preliminary, Unaudited Results for Q4 2025
Yahoo Finance· 2026-01-14 15:57
Group 1 - DexCom, Inc. reported preliminary, unaudited Q4 2025 results with total revenue of approximately $1.260 billion, reflecting a 13% year-over-year increase [1][2] - US revenue for Q4 2025 is projected to be around $892 million, showing an 11% growth compared to Q4 2024 [1][2] - The company launched its latest sensor technology, the G7 15 Day system, contributing to its positive performance and growth outlook [2] Group 2 - For 2026, DexCom expects total revenue between $5.16 billion and $5.25 billion, indicating an anticipated growth of approximately 11%-13% over 2025 [3] - The growth outlook is supported by factors such as increased awareness of continuous glucose monitoring (CGM) among diabetes patients, the rollout of the Stelo system, and further international expansion [3] - DexCom focuses on the design, development, and commercialization of continuous glucose monitoring systems, positioning itself as a key player in the medical device industry [4]
Treace Medical Concepts (NasdaqGS:TMCI) FY Earnings Call Presentation
2026-01-14 15:30
Company Overview - Treace Medical Concepts is focused on the surgical treatment of bunions and related deformities[7] - The company reported preliminary FY 2025 revenue of $212.3 million to $212.7 million, representing approximately 2% year-over-year growth at the midpoint[7] - Approximately 1/3 of US Foot & Ankle Surgeons used Treace bunion systems in 2025[7] Market Opportunity - Approximately 67 million Americans are affected by bunions[9] - Annually, 4.4 million people seek medical treatment for bunions, with 1.1 million being surgical candidates, representing a $5 billion+ US market opportunity[9] - The current US market for bunion surgical procedures is $2.3 billion, with podiatrists performing 75% of the surgeries and orthopedists performing 25%[9, 11] Technology and Clinical Outcomes - In nearly 90% of bunions, the metatarsal bone is rotated in the frontal plane[15] - Failure to correct the frontal plane component can lead to a 10-12x greater risk of recurrence[18] - Lapiplasty patients experienced early weight bearing at 7.7 days (average) in a walking boot[23] - Lapiplasty patients experienced low recurrence rates of 0.8% (HVA >20°) & 8.4% (HVA >15°) at 48 months[23] - Lapiplasty patients experienced 81% pain reduction with 89% improvement in MOxFQ walking/standing scores at 48 months[23] Future Growth and Strategy - 58% of surgeons expect MIS osteotomies to be their fastest-growing bunion procedure in the next year[35] - 56% of bunion patients would "greatly increase interest" in surgery with an MIS option[36]
SHAREHOLDER INVESTIGATION: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Beta Bionics
TMX Newsfile· 2026-01-14 15:10
Core Viewpoint - Beta Bionics, Inc. has faced significant stock decline following disappointing preliminary fourth-quarter 2025 performance metrics, raising concerns among investors regarding the company's growth prospects [4][5]. Group 1: Company Performance - On January 9, 2026, Beta Bionics reported lower-than-expected new patient starts for its iLet automated insulin delivery system, which contributed to investor concerns about near-term adoption trends and revenue growth [5]. - Following the announcement, Beta Bionics' stock price dropped by approximately $11.85, or 37.04%, closing at $20.14 [5]. Group 2: Legal Investigation - Faruqi & Faruqi, LLP is investigating potential claims against Beta Bionics due to the significant losses suffered by investors [2]. - The law firm has a history of recovering hundreds of millions of dollars for investors since its establishment in 1995 [4].
Intuitive Announces Preliminary Fourth Quarter and Full Year 2025 Results
Globenewswire· 2026-01-14 14:05
Core Insights - Intuitive announced preliminary financial results for Q4 and full year 2025, highlighting significant revenue growth driven by increased procedure volume and system placements [1][3][10] Financial Performance - Q4 2025 revenue is expected to be approximately $2.87 billion, a 19% increase from $2.41 billion in Q4 2024 [3] - Full year 2025 revenue is projected at approximately $10.06 billion, reflecting a 21% increase compared to $8.35 billion in 2024 [3] - Instruments and accessories revenue for Q4 2025 increased by 17% to approximately $1.66 billion, up from $1.41 billion in Q4 2024, driven by an 18% growth in worldwide procedure volume [4] - Full year 2025 instruments and accessories revenue rose by 19% to approximately $6.02 billion, compared to $5.08 billion in 2024 [4] Procedure Volume - Q4 2025 da Vinci procedures increased by approximately 17% compared to Q4 2024, with a total of about 3,153,000 procedures performed in 2025, an 18% increase from approximately 2,683,000 in 2024 [5] - Growth in da Vinci procedure volume was largely due to an 18% increase in U.S. general surgery procedures and a 23% increase in procedures performed outside the U.S. [5] - Worldwide da Vinci procedures are expected to grow by approximately 13% to 15% in 2026 [5] System Placements - In Q4 2025, the company placed 532 da Vinci surgical systems, compared to 493 in Q4 2024, including 303 da Vinci 5 systems [6][8] - For the full year 2025, 1,721 da Vinci surgical systems were placed, an increase from 1,526 in 2024, with 870 being da Vinci 5 systems [9] Revenue Breakdown - Q4 2025 systems revenue was approximately $786 million, up from $655 million in Q4 2024, attributed to increased system placements and higher average selling prices [6][7] - Full year 2025 systems revenue reached approximately $2.47 billion, compared to $1.97 billion in 2024 [7] Company Outlook - CEO Dave Rosa expressed satisfaction with the company's performance, noting increased adoption and utilization of surgical platforms and over 3.1 million da Vinci procedures performed in 2025 [10] - The company is scheduled to present detailed financial results at the J.P. Morgan Healthcare Conference on January 14, 2026 [11]
Published Peer-Reviewed Study Demonstrates Nexalin’s DIFS™ Neurostimulation Improves Attention and Normalizes Brain Activity in Patients with ADHD
Globenewswire· 2026-01-14 14:00
Core Insights - Nexalin Technology, Inc. announced a peer-reviewed clinical study demonstrating that its Deep Intracranial Frequency Stimulation (DIFS™) technology leads to significant improvements in attention and cognitive performance in adults with ADHD, supported by objective brain imaging data [1][9] Group 1: Study Overview - The study was a randomized, double-blind, sham-controlled trial involving 56 adults with ADHD who underwent four weeks of Nexalin's non-invasive neurostimulation [2] - Participants receiving active treatment showed a 10.1-point average improvement on the Adult ADHD Self-Report Scale, compared to a 5.5-point improvement in the sham group, indicating a statistically significant difference (p < 0.001) [2] Group 2: Brain Imaging and Functionality - The study utilized magnetoencephalography (MEG) to assess real-time neural activity, revealing that Nexalin's DIFS™ technology reduced excessive gamma-frequency brain activity, which is often linked to ADHD symptoms [3][4] - Post-treatment, there was a normalization of communication between key brain networks involved in attention, memory, and cognitive control, suggesting improved coordination across critical brain regions [5] Group 3: Clinical Outcomes and Safety - Adults receiving active stimulation experienced significant improvements in concentration, reductions in ADHD symptoms, and enhancements in mood and sleep quality, with a safety profile comparable to sham stimulation [6] - The treatment was well tolerated, with no serious adverse events reported, reinforcing the safety of Nexalin's approach [6] Group 4: Broader Implications - The findings indicate a shift in understanding mental health conditions as disorders of brain network regulation rather than isolated chemical imbalances, positioning Nexalin's DIFS™ technology as a drug-free approach to neuromodulation [9] - Nexalin's neurostimulation devices are approved in multiple international markets, and the company continues to advance research across various neurological and psychiatric conditions [10]
Beyond Air Announces $5.0 Million Private Placement Priced At-the-Market Under Nasdaq Rules
Globenewswire· 2026-01-14 13:30
Core Viewpoint - Beyond Air, Inc. has entered into a securities purchase agreement to raise approximately $5.0 million through a private placement of common stock and warrants, aimed at enhancing its working capital and general corporate purposes [1][2]. Group 1: Securities Offering - The company will issue 3,930,818 shares of common stock and warrants to purchase an equal number of shares at a combined purchase price of $1.272 per share, with expected gross proceeds of around $5.0 million before expenses [1]. - The warrants will have an exercise price of $1.147 per share and will be exercisable immediately upon issuance for a term of five years [1]. - Rodman & Renshaw LLC is the exclusive placement agent for this private placement, with Roth Capital Partners and D. Boral Capital serving as financial advisors [2]. Group 2: Use of Proceeds - The net proceeds from the private placement will be utilized for working capital and general corporate purposes [2]. Group 3: Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on using nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors [5]. - The company has received FDA approval and CE Mark for its LungFit PH system, which treats neonates with hypoxic respiratory failure, and is advancing other LungFit systems in clinical trials for severe lung infections [5]. - An affiliate, Beyond Cancer, Ltd., is exploring ultra-high concentrations of nitric oxide for targeting solid tumors in pre-clinical settings [6].
ENvue Medical Launches Over-the-Counter Reusable ENFit Syringes to Support Feeding and Medication Delivery without a Prescription
Globenewswire· 2026-01-14 13:30
Core Insights - ENvue Medical, Inc. has launched a new line of over-the-counter ENFit Syringes aimed at enhancing enteral care in both clinical and home settings, addressing the need for reliable and high-quality solutions as care shifts beyond hospitals [1][2] Product Launch - The ENFit Syringes are designed for feeding and medication delivery, available in sizes of 2.5 mL, 5 mL, 10 mL, and 60 mL, and will be sold without a prescription through online retailers like Amazon [2] - These syringes comply with ISO 80369-3 global standards and can be reused for up to seven days or 20 uses, promoting safe and consistent enteral delivery [2] Company Overview - ENvue Medical specializes in intelligent, non-invasive solutions for enteral care, with headquarters in Tyler, Texas, and R&D facilities in Tel-Aviv and Nesher, Israel [3] - The company focuses on two technology platforms: the ENvue Navigation Platform for minimally invasive feeding tube placement and acoustic-based therapeutic technologies like PainShield® and UroShield® [4]
da Vinci 5 Expands Globally: Can ISRG Beat Overseas Cost Hurdles?
ZACKS· 2026-01-14 13:20
Core Insights - Intuitive Surgical's da Vinci 5 is in the early stages of international rollout, representing a long-term growth opportunity, but may face near-term hurdles [1][5] - The company is advancing regulatory clearances and early commercial activities outside the U.S., focusing on a country-specific approach for international adoption [2] - Pricing sensitivity and capital budget constraints are significant challenges in international markets, particularly in Europe and Japan [3] Company Strategy - Intuitive Surgical is adopting a portfolio-based approach to address challenges, utilizing leasing structures and alternative configurations to enhance affordability [4] - The company reported solid growth in utilization in several international markets, which is expected to support recurring revenues from instruments and accessories [4] Market Performance - Intuitive Surgical's shares have increased by 9.7% over the past six months, compared to a 12.8% increase for the industry [11] - The company trades at a forward price-to-earnings ratio of 58.13, which is above the industry average but lower than its five-year median of 71.52 [12] Earnings Estimates - The Zacks Consensus Estimate for Intuitive Surgical's 2026 earnings indicates an 11.1% rise from the previous year's level [13] - Current estimates for the upcoming quarters show a year-over-year growth estimate of 1.81% for the current quarter and 16.57% for the next quarter [16]
Axogen CEO Axed 25,000 Shares From His Direct Holdings
Yahoo Finance· 2026-01-14 12:27
Company Achievements - Axogen received FDA approval for its unique nerve graft on December 3, 2025, which is a human tissue-based product aimed at repairing damaged peripheral nerves without requiring nerve tissue from patients, granting the company 12 years of market exclusivity [1] - The company is expected to report approximately $225.2 million in annual revenue for FY 2025, marking its highest revenue to date [6] Stock Performance - Axogen's stock (AXGN) experienced a significant increase of 97.60% in 2025, with seven consecutive months of price gains [2] - CEO Michael D. Dale sold 25,000 shares on December 10, 2025, valued at $750,000, which represented 28.24% of his direct holdings prior to the transaction [5] Product and Market Focus - Axogen specializes in surgical solutions for peripheral nerve injuries, developing biologically active nerve grafts, nerve connectors, nerve protectors, nerve caps, and soft tissue membranes for surgical repair and protection of peripheral nerves [3]
ITGR SECURITIES: Integer Holdings Corporation Hit with Securities Fraud Class Action Over Weak Demand – Contact BFA Law before February 9 Deadline
Globenewswire· 2026-01-14 12:20
Core Viewpoint - A class action lawsuit has been filed against Integer Holdings Corporation and its senior executives for securities fraud following a significant drop in stock price due to alleged violations of federal securities laws [1]. Company Overview - Integer Holdings Corporation specializes in designing and manufacturing cardiac rhythm management and cardiovascular products, including electrophysiology devices that diagnose and treat arrhythmias [4]. Allegations of Securities Fraud - The lawsuit claims that Integer misrepresented the demand and revenue for its electrophysiology products, which had reportedly fallen sharply, contradicting the company's public statements about sales growth and market position [5][4]. Stock Price Decline - On October 23, 2025, Integer revised its 2025 sales guidance down to between $1.840 billion and $1.854 billion, below analysts' expectations, and projected poor net sales growth of -2% to 2% for 2026. This announcement led to a stock price drop of $35.22 per share, or over 32%, from $109.11 to $73.89 [6].