New subgroup analysis shows consistent, clinically meaningful pain reduction observed from Stage 2 through Stage 4 disease, including late-stage patients with otherwise limited treatment options THE WOODLANDS, TX, Jan. 09, 2026 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today announced new subgroup clinical data from its PoC study presented at the 2026 ASCO Gastrointestinal (G ...

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][3]. 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 [4][5]. Stock Price Decline - On October 23, 2025, Integer revised its 2025 sales guidance down to a range of $1.840 billion to $1.854 billion from a previous range of $1.850 billion to $1.876 billion, which was below analysts' expectations. The company also projected a net sales growth of -2% to 2% and organic sales growth of 0% to 4% 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].

QUEENSBURY, N.Y.--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath†or the "Company†), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced preliminary financial results and business updates for the fourth quarter and year-ended December 31, 2025. Preliminary Fourth Quarter and Full-Year 2025 Financial Results (unaudited) Final financial results for the fourth quarter and full year 2025 and a detailed business update will ...

Core Viewpoint - Haemonetics Corporation has announced the acquisition of Vivasure Medical Limited, enhancing its portfolio in the vessel closure market with innovative technology aimed at improving patient outcomes [1][4]. Acquisition Details - The acquisition involves an upfront cash payment of €100 million, approximately €52 million net after accounting for previous investments and loans, with potential additional contingent consideration of up to €85 million based on sales growth and milestone achievements [3]. - The transaction was financed through Haemonetics' available cash on hand [3]. Product Information - Vivasure's PerQseal Elite system utilizes a bioabsorbable patch for sealing large-bore arteriotomies and venotomies, providing a sutureless and fully absorbable solution for various medical procedures [2]. - The system has received CE Mark approval in Europe and a Premarket Approval application was submitted to the U.S. FDA in 2025 [2]. Strategic Implications - The acquisition is expected to expand Haemonetics' range of closure devices and strengthen its position in the growing structural heart and endovascular procedure markets [4]. - The clinical performance of the PerQseal Elite system, demonstrated by a 0% major complication rate at thirty-day follow-up, positions Haemonetics for increased leadership in advanced closure technologies [2][4]. Company Background - Haemonetics is a global medical technology company focused on improving healthcare quality and efficiency through innovative solutions [5]. - Vivasure Medical Limited specializes in advanced polymer implants and delivery systems for minimally invasive vessel closure [6].

Core Viewpoint - Insulet Corporation, a leader in tubeless insulin pump technology, is set to report its financial results for Q4 and the full year of 2025 on February 18, 2026, before market opening [1] Financial Reporting - The financial results will cover the fourth quarter and the full year of 2025 [1] - A conference call will be hosted by management on the same day at 8:00 a.m. Eastern Time [1]

Core Insights - Sanuwave announced preliminary revenues of $13.3 million to $13.4 million for Q4 2025, marking the highest quarterly revenues in the company's history [1][2] - Q4 2025 revenue increased by 29% to 30% compared to Q4 2024 [1][2] - Full Year 2025 revenue reached $44.3 million to $44.4 million, representing a 36% increase compared to Full Year 2024, setting an all-time record for the company [1][2] Financial Performance - Q4 2025 revenue is expected to be within the guidance range provided in the Q3 2025 earnings release [2] - The company experienced significant growth in revenue, with Q4 2025 revenues being the highest ever recorded [1][3] Market Context - The CEO highlighted that the second half of 2025 was a period of transition in the wound care market due to changes in reimbursement rates, which created opportunities for the company [3] - Sanuwave has been actively acquiring new partners and sales channels to adapt to market changes while maintaining focus on patient needs in advanced wound care [3] Company Overview - Sanuwave Health specializes in the research, development, and commercialization of patented, non-invasive directed energy systems for skin, musculoskeletal tissue, and vascular structure repair and regeneration [4] - The company's portfolio includes regenerative medicine products aimed at restoring normal healing processes across various medical conditions [5]

SI-BONE, Inc. (NASDAQ:SIBN) is one of the stocks Jim Cramer shared his takes on. A caller asked about the company during the episode’s lightning round, and Cramer replied: “Yeah, okay, so, you have to understand, this is a great, great speculation, I mean, terrific. And I’m glad you brought it to our viewers’ attention. I myself am going to huddle with research director Ben Stoto… and we are going to get to the bottom of this because I keep hearing this company’s name over and over and over again.” Pix ...

Core Viewpoint - The article discusses the challenges associated with abdominal wall suturing, highlighting its complexity and the high rates of complications such as wound dehiscence and hernias, which are linked to the variability in surgical techniques and the difficulty in standardizing the procedure [1][4]. Group 1: Background on Abdominal Wall Complications - Abdominal wall fascia has a weak healing process due to limited blood supply, making it reliant on sutures for mechanical support during the critical postoperative period of 14-28 days [3]. - Evidence-based medicine suggests that using continuous suturing with a small needle distance and ensuring a suture length to wound length ratio (SL/WL) of ≥4 can significantly reduce complications, but these techniques are often not consistently executed in real-world settings [3][4]. Group 2: Suturion's Approach - Suturion focuses on addressing the underappreciated yet common issue of abdominal wall closure, aiming to make the procedure more standardized rather than relying on individual surgeon skill [5]. - The Suture-TOOL integrates the recommended techniques directly into its design, transforming the way standards are achieved in suturing [7][10]. Group 3: Clinical Research and Performance - Clinical studies show that the Suture-TOOL achieves the SL/WL ≥4 ratio in 95-98% of cases, compared to 30-69% for traditional hand suturing, indicating a significant improvement in consistency [13]. - The Suture-TOOL also enhances suturing speed by approximately 30% and reduces the required clamping force, potentially minimizing tissue damage while maintaining quality [13]. Group 4: Market Entry and Implications - The Suture-TOOL has received CE approval and is entering the European market, with initial focus on the UK, Nordic countries, and the Benelux region [19]. - The tool is positioned not just as an efficiency tool but as a structural innovation that could lower overall healthcare costs across Europe [19]. Group 5: Insights for Innovators - The innovation represented by the Suture-TOOL serves as a reference for the medical device industry, addressing common yet difficult-to-standardize problems and embedding evidence-based practices into device design [21]. - The Suture-TOOL aims to reduce avoidable abdominal wall complications, decrease the need for reoperations, and optimize resource utilization in surgical settings [22].

Core Insights - Teleflex has parted ways with CEO Liam Kelly, appointing Stuart Randle as interim president and CEO while searching for a permanent replacement [3][8] - The leadership change is part of a transformation strategy following the announcement of divesting three business units for approximately $2 billion [5][8] - Teleflex has revised its revenue guidance for 2025 to $3.27 billion to $3.28 billion, down from a previous estimate of $3.31 billion to $3.32 billion, citing softer demand for certain medical devices [7][8] Leadership Changes - Liam Kelly, who became CEO in 2018, has left the company without a permanent successor [3] - Stuart Randle, a board member since 2009 and former CEO of Ivenix, has been appointed as interim president and CEO [4][5] - Stephen Klasko has taken over as chairman of the board following Kelly's departure [3] Business Strategy - Teleflex is in the process of closing the $1.5 billion sale of its OEM business and the $530 million sale of its acute care and interventional urology units [5][6] - The divestitures will allow Teleflex to focus on its vascular access, interventional, and surgical businesses [6] Financial Outlook - The company expects a revenue reduction of just over 1% at the midpoint due to lower-than-expected demand for intra-aortic balloon pumps and catheters in the U.S. and Asia [7] - The revised revenue guidance reflects challenges in the OEM business and delays in purchase orders [7]

Core Viewpoint - Elon Musk's Neuralink plans to start mass production of brain-machine interfaces by 2026, marking a significant step towards the commercialization of this technology [2] Industry Developments - The brain-machine interface sector in China is accelerating, with the country becoming the second to enter clinical trials for invasive brain-machine interfaces after the United States [2] - In 2025, there were 24 financing events in the domestic brain-machine interface field, a 30% year-on-year increase [3] - Hubei Province has set a price for invasive brain-machine interface medical services at approximately 6,552 yuan, indicating a move towards making this technology more accessible [3] Technology and Market Segmentation - Brain-machine interfaces serve as a bridge between the brain and external devices, with three main technological approaches: invasive, non-invasive, and semi-invasive [4][5] - The largest market segment for brain-machine interfaces is currently in healthcare, accounting for over 56% of applications, particularly for neurological diseases like epilepsy and Parkinson's [6] - McKinsey predicts that the global market for medical applications of brain-machine interfaces could reach $40 billion by 2030 and $145 billion by 2040 [6] Investment Opportunities - While the brain-machine interface sector shows promise, most companies are still far from profitability, with significant time needed for medical applications to gain approval [7] - Instead of focusing on individual companies, it may be more prudent to consider the broader medical device industry, particularly through medical device ETFs that encompass leading firms in this space [8]