Core Viewpoint - A securities class action lawsuit has been filed against Inspire Medical Systems, Inc. (NYSE: INSP) for allegedly misleading investors about operational failures related to the launch of its Inspire V device for obstructive sleep apnea [1][3]. Group 1: Allegations and Impact - The lawsuit claims that Inspire Medical assured investors of its "operational readiness" for the Inspire V launch, which concealed significant operational failures that ultimately led to a drastic cut in guidance and a stock price crash [3][5]. - Key undisclosed operational issues include: - Medicare claims software updates were not effective until July 1, 2025, delaying the rollout and revenue generation [4]. - An excess inventory of the older Inspire IV device impacted demand for the new Inspire V, leading to a significant reduction in 2025 earnings per share (EPS) guidance by over 80% [4]. - Many treatment centers had not completed necessary training and onboarding for the new device, contributing to a $42.04 per share drop and a 32.4% decline in stock value [4]. Group 2: Legal Actions and Investor Guidance - Investors who purchased Inspire Medical securities between August 6, 2024, and August 4, 2025, are encouraged to contact Hagens Berman before the Lead Plaintiff Deadline of January 5, 2026, to discuss their legal rights [2][3]. - Hagens Berman is focusing on the alleged concealment of critical operational issues, emphasizing that the stock collapse was due to management prioritizing a narrative over operational reality [5].

Nyxoah to Present at the 44th Annual J.P. Morgan Healthcare Conference Mont-Saint-Guibert, Belgium – December 29, 2025, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the management team will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, Jan. 15, 2026. The ...

As filed with the U.S. Securities and Exchange Commission on December 29, 2025. (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 6770 85-1728920 (Primary Standard Industrial Classification Code No.) Registration No. 333-291237 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 QT Imaging Holdings, Inc. (I.R.S. Employer Identifi ...

As filed with the U.S. Securities and Exchange Commission on December 29, 2025. Registration No. 333-291237 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 QT Imaging Holdings, Inc. (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 6770 85-1728920 (Primary Standard Industrial Classification Code No.) (I.R.S. Employer Identifi ...

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].

Core Viewpoint - A class action lawsuit has been filed against Inspire Medical Systems, Inc. and certain senior executives for securities fraud following a significant stock drop due to potential violations of federal securities laws [1][3]. Company Overview - Inspire Medical Systems develops and manufactures an implantable medical device for the treatment of sleep apnea, with the latest version being Inspire V, which received FDA approval on August 2, 2024 [4]. Allegations and Issues - The lawsuit claims that Inspire misled investors by assuring them that all necessary steps were taken for the launch of Inspire V, which was supposed to meet high demand [5]. - Contrary to these assurances, Inspire allegedly failed to prepare clinicians and payors adequately, leading to significant delays in the device's adoption and weak demand due to excess inventory of older devices [6]. Stock Performance and Impact - On August 4, 2025, Inspire disclosed that the launch of Inspire V would face an "elongated timeframe," resulting in a reduction of its 2025 earnings per share guidance by over 80% [7]. - The stock price dropped by $42.04 per share, or more than 32%, from $129.95 on August 4, 2025, to $87.91 on August 5, 2025, following this announcement [8].

Core Viewpoint - Pharma Equity Group A/S has provided a strategic update indicating a significant adjustment in revenue and earnings expectations for the financial year 2025, shifting from an expected revenue of approximately DKK 11 million to no revenue, and increasing the pre-tax loss expectation from DKK 4-7 million to DKK 18-20 million, reflecting a strategic decision to prioritize long-term value creation over short-term gains [2][3]. Revenue and Earnings Expectations - The company has revised its revenue expectations for the financial year 2025 to zero, a significant change from the previously communicated expectation of DKK 11 million [2]. - The pre-tax loss expectation for the financial year 2025 has been adjusted to a range of DKK 18 to 20 million, up from the earlier estimate of DKK 4 to 7 million [3]. Strategic Decisions - The adjustments in revenue and earnings do not indicate a decline in the quality or potential of the underlying assets but are a result of a strategic choice to focus on long-term value creation rather than short-term agreements [3]. - The company has updated its Expected Credit Loss (ECL) model, which reflects a more conservative accounting practice but does not impact liquidity or strategic options for commercializing pipeline projects [4]. Pipeline Projects RNX-051 - Pharma Equity Group is engaged in advanced discussions with potential industrial partners regarding RNX-051, aiming to conclude these discussions in the first half of 2026 [5]. - The company has identified and addressed regulatory and operational barriers for international clinical studies with RNX-051, confirming that no material obstacles remain [8]. - The clinical study protocols for RNX-051 are in sub-final draft form and are expected to meet the requirements of potential licensing partners [7][9]. RNX-011 - Significant progress has been made in the development of RNX-011, with a clear strategy established for its continued advancement [11]. - The clinical study protocol for RNX-011 has been approved but will undergo targeted adjustments to enhance its design in line with partner expectations [12]. - Encouraging results have been previously demonstrated for RNX-011, and the company is focused on ensuring the study design supports its attractiveness for future licensing discussions [13]. Overall Strategy - The Board of Directors and Executive Management believe that the decision to forego short-term revenue is the most responsible approach for shareholder value creation [15]. - The company maintains a solid strategic foundation with a focus on maximizing long-term value through partnerships and licensing agreements [18].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Inspire Medical Systems, Inc. due to allegations of misleading statements regarding the launch of its Inspire V device, which has faced significant setbacks and resulted in a substantial drop in stock price [2][4][6]. Group 1: Legal Investigation - Faruqi & Faruqi, LLP is encouraging investors who suffered losses in Inspire Medical to contact them to discuss their legal options [1]. - The firm is reminding investors of the January 5, 2026 deadline to seek the role of lead plaintiff in a federal securities class action against Inspire Medical [2]. Group 2: Company Performance and Issues - Inspire Medical announced on August 4, 2025, that the launch of its Inspire V device faced significant delays due to treatment centers not completing necessary training and onboarding [5]. - The company also reported billing and reimbursement challenges, stating that while Medicare approved a CPT code for Inspire V, software updates for claims processing were not effective until July 1, 2025, leading to continued use of the older Inspire IV system [5]. - Inspire Medical's launch of Inspire V has been affected by weak demand and excess inventory, resulting in a more than 80% cut in its 2025 earnings guidance [6]. - Following these issues, Inspire Medical's stock price plummeted over 32% in one day, from $129.95 to $87.91, erasing approximately $1.2 billion in market capitalization [6].

Core Viewpoint - WORK Medical Technology Group LTD has announced a one-year exclusive distribution agreement with Shanghai Benke Medical Technology Co., Ltd. for its AI-Automated Blood Cell Morphology Analyzer (CM-B600) in East China, aiming to enhance market access and commercialization of the product throughout 2026 [1][2]. Group 1: Distribution Agreement - Hunan Saitumofei has granted Shanghai Benke exclusive distribution rights for the Analyzer in East China, covering Jiangsu Province, Shanghai Municipality, and Zhejiang Province, with a minimum annual sales target of RMB 10 million (approximately US$1.4 million) [2]. - Shanghai Benke has prepaid a performance bond of RMB 1 million, which will be deducted from the final payment or refunded upon achieving the sales target [2]. Group 2: Product Details - The Analyzer received manufacturing approval as a Class II medical device in November 2025 and is certified under national and industry standards, including GB 4793.1 and YY 0648 [3]. - The Analyzer utilizes high-resolution digital imaging technology and advanced algorithms to automate sample scanning, identification, and classification, simulating manual microscopic examination [3][4]. - It can process up to 150 samples per batch, achieving an average detection time of no more than three minutes per blood smear, with a classification accuracy of no less than 90% for various white blood cell types [4]. Group 3: Technology and Features - The Analyzer employs non-deep-learning feature extraction algorithms, providing high interpretability and reducing potential clinical risks [5]. - It can identify 17 subtypes of white blood cells and offers detailed morphological analyses of red blood cells and platelets [4]. Group 4: Company Strategy - The CEO of WORK Medical expressed confidence that the agreement highlights the commercial readiness of the Analyzer and aims to leverage Shanghai Benke's established sales network to accelerate market penetration and strengthen the company's brand presence in East China [6].

NEW YORK, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Leading international securities law firm Bleichmar Fonti & Auld LLP announces that a class action lawsuit has been filed against Integer Holdings Corporation (NYSE: ITGR) 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 Integer, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases/int ...