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Algernon Announces CAD $4 Million Non-Dilutive Financing to Open Four Brain-Specific PET Scan Clinics in the U.S. for Early Stage Alzheimer's Detection
Globenewswire· 2025-09-25 11:00
Core Insights - Algernon Pharmaceuticals has signed a definitive equipment order and financing agreement with Catalyst MedTech for four FDA-cleared Oncovision CareMiBrain™ PET scanner systems, valued at over CAD $4 million, to be used in planned neuroimaging clinics [1][2] - The PET scanner represents approximately 80% of the capital costs required to open a neuroimaging clinic, making this transaction crucial for the company's neuroimaging initiative [2] - The clinics will focus on early-stage detection of Alzheimer's Disease and other neurological conditions, addressing a significant market need as nearly 80% of Americans want to know if they have Alzheimer's before symptoms appear [3][4] Financial and Market Opportunity - The global economic burden of Alzheimer's was estimated at US$1 trillion in 2019, projected to rise to US$10 trillion by 2050, creating a substantial market opportunity for brain-specific PET scans and Alzheimer's treatments [4] - Each Alzheimer's PET brain scan will cost approximately US$5,000, with coverage from private insurance, Medicare, and Medicaid [6] - The current number of full-body PET/CT scanners in the U.S. is insufficient to meet the demand for Alzheimer's diagnostics, as 45% of existing scanners are primarily used for cancer and cardiac imaging [5] Technological Advancements - The CareMiBrain™ system is a dedicated brain PET scanner that reduces radiation exposure by up to 25% compared to full-body PET/CT units, enhancing patient safety [8][11] - The system features advanced technology for clarity and quantification, and is designed for patient comfort with ergonomic features [10][16] - Catalyst MedTech will provide consulting services to Algernon, including guidance on regulatory compliance and billing for the clinics [12] Strategic Partnerships and Future Plans - Algernon will collaborate with neurologists, geriatricians, and other medical professionals to generate patient referrals for the new clinics [3] - The company plans to change its name to Algernon Health Inc. to better reflect its focus on Alzheimer's diagnostics and neuroimaging clinics across North America [13] - Further updates on the company's expansion and growth plans, including the location of its first U.S. flagship neuroimaging clinic, will be provided soon [13]
Guerbet : Change in General Management
Globenewswire· 2025-09-22 15:45
Core Viewpoint - Guerbet has appointed Mr. Jérôme Estampes as interim Chief Executive Officer, succeeding Mr. David Hale, who is leaving the company to pursue new projects [2][3]. Company Management Changes - Mr. Jérôme Estampes has been with Guerbet since 2019 as Chief Administrative and Financial Officer, where he has developed a strong understanding of the company's financial, operational, and commercial challenges [3]. - The Board of Directors has expressed gratitude to Mr. David Hale for his contributions since joining in February 2018, first as Chief Commercial Officer and then as CEO from January 1, 2020 [2][4]. Transition and Future Leadership - The Board supports Mr. Estampes and he will have the assistance of Guerbet's Executive Committee to ensure a smooth transition and to continue implementing transformation measures and the commercial strategy [4]. - The Nominations and Remuneration Committee has initiated the recruitment process for a permanent Chief Executive Officer [4]. Company Overview - Guerbet is a global leader in medical imaging, focusing on improving patient care through innovation, with nearly a century of expertise [6]. - The company offers a comprehensive portfolio of pharmaceutical products, medical devices, and AI-driven solutions for diagnostic and interventional imaging [6]. - Guerbet invests 10% of its annual revenue in research and development and reported €786 million in revenue in 2023 [6].
Nanox Announces Multi-Segment Healthcare Collaboration with Monarch Medical Management to Expand Access to Advanced Medical Imaging
Globenewswire· 2025-09-18 12:00
Core Insights - Nanox Imaging Ltd has announced a collaboration with Monarch Medical Management and Billing LLC to deploy advanced imaging solutions across various healthcare segments, including workers' compensation, nursing homes, and outpatient clinics [1][2][4] Group 1: Collaboration Details - The collaboration aims to establish a comprehensive imaging network by deploying Nanox's technology across Monarch's associated healthcare facilities, with over a dozen initial sites identified for a proof-of-concept phase [2] - Nanox's advanced imaging services will be accessible to patients in multiple care settings, including the Nanox.ARC system, AI-powered software for analyzing CT scans, and teleradiology services [3][4] Group 2: Strategic Goals - The collaboration addresses critical imaging access challenges by providing faster access to high-quality imaging services, which can accelerate accurate diagnosis and treatment decisions for patients [4] - Nanox's vision includes expanding its technology reach beyond hospital settings, aiming for a seamless end-to-end solution from scan to diagnosis, leveraging AI for improved efficiency in medical imaging [6] Group 3: Company Background - Nanox is focused on transitioning the world to preventive healthcare through affordable medical imaging technologies based on advanced AI and proprietary digital X-ray sources [5] - The Nanox ecosystem includes various components such as Nanox.ARC, Nanox.AI, Nanox.CLOUD, and Nanox.MARKETPLACE, all aimed at enhancing early detection and treatment to improve health outcomes globally [6]
TD Cowen Remains Bullish on Butterfly (BFLY), iQ3 Results Bolster Adoption Potential
Yahoo Finance· 2025-09-17 18:18
Group 1 - Butterfly Network Inc. (NYSE:BFLY) is recognized as a promising emerging technology stock due to its innovative handheld ultrasound device that connects to smartphones, utilizing patented ultrasound-on-a-chip technology [1][5] - The handheld ultrasound device is expected to make medical imaging more affordable, user-friendly, and accessible, particularly in clinics and developing countries, potentially disrupting traditional healthcare diagnostics [2][5] - TD Cowen analyst Josh Jennings has reaffirmed a Buy rating on Butterfly Network with a price target of $3.50, following positive results from the POCUS-CARE trial, which demonstrated the device's ability to reduce hospital costs and shorten patient stays [2][3] Group 2 - Jennings attributes the stock's nearly 30% decline since late July to temporary and cyclical headwinds identified during the Q2 2025 earnings call, suggesting that the pullback is excessive when considering Butterfly's long-term fundamentals [4] - With new clinical evidence supporting its technology, Butterfly Network is positioned to effectively implement its rollout strategy, reinforcing the Buy rating [5]
TEM Strengthens Radiology Portfolio With Pixel's FDA Clearance
ZACKS· 2025-09-16 13:21
Company Overview - Tempus AI has developed advanced algorithms in radiology, enhancing precision and personalization in medical care through strategic acquisitions [1][4] - The company launched Tempus Pixel, an AI-powered cardiac imaging platform, which received FDA clearance for advanced cardiac MR image analysis [2][10] Market Insights - The AI in Radiology Market is projected to reach $15.7 billion by 2035, growing at a CAGR of 19.56% from 2025 to 2035, indicating significant growth opportunities for companies like Tempus [2] Product Features - Tempus Pixel offers advanced viewing and automated reporting of cardiac MR images, improving efficiency in flow visualization and tissue characterization [3] - The platform generates T1 and T2 inline maps, providing precise numerical values for cardiac tissue characteristics, aiding in the detection of conditions like fibrosis and inflammation [3] Strategic Acquisitions - In 2022, Tempus acquired Arterys, integrating its AI tools for analyzing various imaging data into Tempus' platform, thereby expanding its capabilities [4][10] Competitive Landscape - GE HealthCare launched the Voluson Performance series, enhancing women's health ultrasound with AI and automation [5] - GE HealthCare also acquired icometrix to integrate AI-powered brain imaging analysis into its MRI systems [6] Stock Performance - Year-to-date, Tempus AI shares have increased by 152.2%, outperforming the industry growth of 28.5% and the S&P 500's 12.8% [9] Valuation Metrics - Tempus AI currently trades at a forward Price-to-Sales (P/S) ratio of 10.02X, significantly higher than the industry average of 5.92X, indicating a potentially expensive valuation [11]
FONAR Announces Financial Results for Fiscal 2025
Newsfile· 2025-09-12 12:27
Core Insights - FONAR Corporation reported a 1% increase in total net revenues to $104.4 million for the fiscal year ended June 30, 2025, compared to $102.9 million for the previous fiscal year [3][7] - The company experienced a 30% decrease in income from operations, falling to $11.6 million, and a 24% decrease in net income to $10.7 million for the same period [9][12] - The diagnostic imaging management subsidiary, Health Management Company of America (HMCA), continues to grow, managing 44 MRI scanners and achieving a record scan volume of 216,317 in Fiscal 2025, a 3.3% increase from the previous year [13][14] Financial Performance - Total revenues increased by 1% to $104.4 million for the fiscal year ended June 30, 2025, compared to $102.9 million for the fiscal year ended June 30, 2024 [3][7] - Total costs and expenses rose by 7% to $92.8 million, up from $86.3 million in the previous fiscal year [3] - Income from operations decreased by 30% to $11.6 million, down from $16.5 million in the previous fiscal year [9] - Net income decreased by 24% to $10.7 million, compared to $14.1 million in the previous fiscal year [9][12] - Diluted net income per common share fell by 20% to $1.23 from $1.53 in the previous fiscal year [9] Revenue Breakdown - Revenues from the management of the diagnostic imaging center segment increased by 1% to $95.4 million for the fiscal year ended June 30, 2025, compared to $94.6 million for the previous fiscal year [4] - Revenues from product sales and upgrades, as well as service and repair fees, totaled $9.0 million, an increase from $8.3 million in the previous fiscal year [5] Cash and Assets - Cash and cash equivalents remained stable at $56.3 million as of June 30, 2025, compared to the previous fiscal year [7][10] - Total assets increased to $216.9 million from $214.2 million in the previous fiscal year [10] - Total stockholders' equity rose to $160.1 million from $156.8 million in the previous fiscal year [12] Operational Highlights - The company added two MRI scanners in Fiscal 2025, bringing the total to 44, with locations in New York and Florida [7][14] - Scan volume in New York increased by 4.4%, while Florida saw a modest increase of 1.6%, impacted by tort reform affecting MRI providers [13] - Research and development expenses decreased by 9% to $1.6 million, while selling, general, and administrative expenses increased by 11% to $29.7 million [8] Stock Repurchase and Future Plans - The stock repurchase plan initiated in September 2022 has repurchased 373,942 shares at a cost of approximately $6.07 million [15] - The company has temporarily suspended share repurchases due to a potential "Take Private" transaction announced in July 2025 [15]
LNTH LAWSUIT: Lantheus Holdings Inc. Sued For Securities Fraud; Investors Should Contact Block & Leviton to Potentially Recover Losses
Globenewswire· 2025-09-10 14:54
Core Viewpoint - A securities fraud lawsuit has been filed against Lantheus Holdings Inc. and its executives, alleging that they misled investors regarding the performance and pricing of its key product, Pylarify, leading to significant stock price declines [1][2]. Group 1: Allegations and Impact - The lawsuit claims that Lantheus and its executives provided false assurances about Pylarify's market leadership and pricing strength, while concealing competitive pressures and price erosion [2]. - Following the release of disappointing quarterly results in May and August 2025, Lantheus' stock experienced declines of over 23% and 28%, respectively, due to reduced revenue guidance and increased competition [2]. Group 2: Investor Eligibility - Investors who purchased Lantheus Holdings Inc. common stock between February 26, 2025, and August 5, 2025, and have experienced losses may be eligible to participate in the lawsuit, regardless of whether they sold their shares [3]. Group 3: Next Steps for Investors - The deadline for investors to seek appointment as lead plaintiff is November 10, 2025, and a class has not yet been certified [4]. - Investors are encouraged to contact Block & Leviton for more information on how to proceed if they have incurred losses [4]. Group 4: Whistleblower Information - Individuals with non-public information about Lantheus Holdings Inc. are encouraged to assist in the investigation or report to the SEC under the whistleblower program, potentially receiving rewards of up to 30% of any successful recovery [5]. Group 5: Firm Background - Block & Leviton is recognized as a leading securities class action firm, having recovered billions for defrauded investors and representing many top institutional investors [6].
Algernon Pharmaceuticals Announces Name Change to Algernon Health
Globenewswire· 2025-09-04 11:00
Core Viewpoint - Algernon Pharmaceuticals Inc. is rebranding to Algernon Health to focus on the Alzheimer's Disease diagnostic market and establish specialized neuroimaging clinics across North America [1][2] Company Strategy - The new clinics will utilize FDA-cleared, optimized brain-specific Positron Emission Tomography (PET) scanning systems to detect amyloid plaques, offering significantly lower radiation than standard PET/CT machines [2][5] - The PET scans will be covered by Medicare, Medicaid, and private insurance in the U.S., providing a clear revenue pathway for the company [5][11] Market Opportunity - There is a growing demand for Alzheimer's diagnostics, with 162 AD drugs currently under development, creating additional revenue opportunities for Algernon through imaging services for drug development companies and clinical trials [7][6] - The majority of existing PET/CT scanners in the U.S. are dedicated to cancer and cardiac imaging, leading to a shortage for brain-specific scanning, which Algernon aims to address [6][5] Future Plans - Algernon will soon announce its expansion and growth plans, including the location of its first U.S. flagship neuroimaging clinic [8] - The company continues to advance its subsidiary, Algernon NeuroScience, which is investigating a proprietary form of DMT for stroke and traumatic brain injury [9][11]
4DMedical's CT:VQ™ receives FDA 510(k) clearance; First-and-only CT-based VQ technology
Prnewswire· 2025-09-04 10:00
Core Insights - 4DMedical has received FDA 510(k) clearance for CT:VQ™, the first non-contrast ventilation–perfusion imaging solution, and Medicare has confirmed reimbursement for this technology under Category III CPT codes, enhancing access to this imaging method nationwide [1][4]. Company Overview - 4DMedical is a global medical technology company focused on transforming respiratory care through advanced imaging and artificial intelligence, with patented technologies that enable quantitative ventilation and perfusion analysis from non-contrast chest CT scans [6]. Technology and Implementation - CT:VQ converts standard non-contrast chest CTs into quantitative lobar ventilation and perfusion maps, integrating seamlessly with existing radiology workflows and utilizing the installed base of approximately 14,500 CT scanners in the U.S. [3][4]. - The technology allows hospitals to perform high-resolution ventilation–perfusion studies without the need for new hardware or complex workflows, making it accessible to facilities without nuclear medicine capabilities [4]. Clinical Validation and Partnerships - More than one million nuclear V/Q scans are performed annually in the U.S., and 4DMedical's CT:VQ has undergone clinical validation through quantitative performance testing against SPECT and real-world studies across various lung conditions [5]. - Early clinical partners include Stanford University and Brooke Army Medical Center, which have presented initial findings at the 2025 American Thoracic Society meeting [5].
Perimeter Medical Imaging AI Announces Second Quarter 2025 Financial Results
Prnewswire· 2025-08-26 20:15
Conference Call/Webcast Today at 5 pm ETTORONTO and DALLAS, Aug. 26, 2025 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today reported financial results for its second quarter ended June 30, 2025 and provided a corporate update. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars and are presented in accordance with International Financial Reporting Standards ...