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Photocure ASA: Results for the fourth quarter of 2025
Prnewswire· 2026-02-18 06:40
Core Insights - Photocure ASA reported Hexvix®/Cysview® revenues of NOK 135.1 million in Q4 2025, an increase from NOK 128.6 million in Q4 2024, indicating a positive revenue trend [1] - The company achieved a commercial EBITDA of NOK 8.4 million in Q4 2025, up from NOK 3.9 million in Q4 2024, reflecting improved operational efficiency [1] - For 2026, Photocure anticipates product revenue growth between 7% to 11% on a constant currency basis, supported by ongoing operational leverage [1] Financial Performance - Total revenues for Q4 2025 were NOK 136.7 million, down from NOK 141.7 million in Q4 2024, which included a milestone payment [1] - Group EBITDA for Q4 2025 was NOK 1.9 million, compared to NOK 8.5 million in Q4 2024, while EBIT was reported at NOK -5.5 million, down from NOK 1.2 million [1] - Cash and cash equivalents stood at NOK 238.9 million at the end of Q4 2025 [1] Strategic Initiatives - The company installed 7 new Saphira towers in the U.S. during Q4 2025, contributing to a 22% increase in active accounts, totaling 384 [1] - Photocure is expanding its blue light cystoscopy (BLC®) use and has installed 60 Olympus Visera Elite III systems in Europe since Q1 2025 [1] - The partnership with Claritas and other strategic initiatives aim to enhance the company's diagnostic capabilities and expand its market opportunities [1] Growth Drivers - Continued adoption of rigid kits, expansion of mobile BLC, and ongoing equipment upgrades are expected to drive growth in the base business [1] - Potential catalysts for growth include developments in CMS reimbursement, reintroduction of flexible BLC solutions, and a possible FDA reclassification of BLC [1] - The licensing agreement with Asieris for Cevira includes a significant milestone payment upon regulatory approval in China, along with future royalties based on sales [1]
TIAN RUIXIANG Unveils unprecedented Asia-Pacific AI Healthcare Revolution: Strategic Partnership & Acquisition of Singapore’s Top 3 Medical Leaders to Dominate AI-Driven Diagnostics Across Southeast Asia
Globenewswire· 2026-02-12 14:32
Core Insights - Tian Ruixiang Holdings Limited is expanding its AI-powered healthcare ecosystem, solidifying its leadership in the Asia-Pacific region [1][5] - The company is entering strategic partnerships and acquisition discussions with Singapore's top three medical technology leaders to enhance insurance-clinic integration and precision diagnostics [1][2] Strategic Partnership and Acquisitions - The proposed collaborations and acquisitions are expected to be finalized within the next 12 months, integrating Singapore's AI diagnostic expertise into TIRX's pan-Asia network [2][5] - This integration aims to create a fully integrated AI healthcare platform, enhancing precision, accessibility, and efficiency for patients, providers, and insurers [2][5] Transformative Pillars - **AI Diagnostic Supremacy**: The partnership will leverage Singaporean medical tech leaders' AI platforms to achieve over 95% accuracy in predictive diagnostics within TIRX's insurance clinic networks, improving early disease detection and treatment outcomes [3][4] - **Pan-Asia Integration**: Establishing a seamless network of insurance clinics across the Asia-Pacific, enabling real-time patient data integration and personalized treatment pathways [4] - **Operational Excellence**: Automating 70% of routine healthcare workflows, reducing operational costs by over 40%, and unlocking significant value across the healthcare value chain [4] Market Position and Growth Potential - The completion of the acquisitions and partnerships is subject to regulatory approvals and shareholder consent, with TIRX aiming to finalize these within the next 12 months [5] - This strategic move positions TIRX as a dominant player in the Asia-Pacific AI healthcare market, potentially catalyzing exponential growth in AI-related revenue [5][6]
MDxHealth Reports Preliminary Fourth Quarter and Full Year 2025 Revenues, Issues 2026 Revenue Guidance, and Amends Earnout Terms with Exact Sciences
Globenewswire· 2026-01-12 13:00
Core Insights - MDxHealth reported preliminary revenues for Q4 and full year 2025, with Q4 revenues of approximately $30.5 million and full year revenues of $109 million, reflecting year-over-year growth of 23% and 21% respectively [2][5] - The company issued revenue guidance for 2026, projecting revenues between $137 million and $140 million, indicating a year-over-year growth of 26-28% [3][5] - MDxHealth amended earnout terms with Exact Sciences, deferring payments related to the GPS acquisition, with payments scheduled for 2026, 2027, and 2028 totaling $54.5 million [4] Financial Performance - For Q4 2025, MDxHealth billed 11,201 tissue-based units and 27,486 liquid-based units, showing year-over-year growth of (5%) and 128% respectively [2] - For the full year 2025, the company billed 49,180 tissue-based units and 71,920 liquid-based units, representing year-over-year growth of 18% and 57% respectively [2] - The cash balance at year-end 2025 was reported at $29.0 million [2] Strategic Outlook - The CEO expressed confidence in the company's growth strategy, emphasizing the strength of the sales channel and expanded offerings to the urology customer base [5] - The company anticipates achieving an adjusted EBITDA margin run rate of 10% by the end of 2026 [5]
ZIRCON-X Analysis: TLX250-CDx Impacts Clinical Decision Making for Almost Half of Patients with Indeterminate Renal Masses
Globenewswire· 2025-11-19 19:00
Core Insights - The ZIRCON-X study indicates that nearly half of patients imaged with TLX250-CDx would experience a change in clinical management compared to standard imaging methods [1][2] - The study highlights the potential of TLX250-CDx to improve clinical decision-making in the management of indeterminate renal masses [5][6] Study Overview - ZIRCON-X was a non-interventional, prospective, post-hoc study involving 294 patients with indeterminate renal masses, assessing the impact of TLX250-CDx imaging versus standard contrast-enhanced imaging [2][6] - The study found that 143 patients (48.6%) would have had a change in clinical management, with over 20% potentially avoiding invasive biopsy [2][3] Clinical Management Changes - Among evaluable patients, 37.4% (110 out of 294) experienced major changes in clinical management, with approximately 30% having their treatment escalated or de-escalated [3] - The most common major changes included: - Biopsy to surgery (24 patients) - Surgery to biopsy (19 patients) - Additional diagnostic to surgery (18 patients) [4] Expert Commentary - Professor Karolien Goffin emphasized the significant potential of TLX250-CDx PET/CT to impact clinical decision-making for patients with small indeterminate renal masses [5] - Dr. David N. Cade noted that the analysis demonstrates the clinical usefulness of TLX250-CDx, which has been included in international guidelines for renal imaging [5] Product Information - TLX250-CDx is an investigational PET agent targeting carbonic anhydrase IX, expressed in over 95% of clear cell renal cell carcinoma (ccRCC) cells, providing high tumor-to-background imaging [8] - The pivotal Phase 3 ZIRCON trial showed TLX250-CDx achieved 86% sensitivity and 87% specificity for ccRCC [8]
Mdxhealth Reports Results for the Third Quarter and Nine-Month Period Ended September 30, 2025
Globenewswire· 2025-11-12 21:01
Core Viewpoint - MDxHealth reported strong financial results for Q3 2025, with an 18% increase in revenues and a positive adjusted EBITDA of $1 million, alongside the strategic acquisition of Exosome Diagnostics from Bio-Techne Corporation [1][2][3]. Financial Performance - Q3 revenues reached $27.4 million, an 18% increase from $23.3 million in the same period last year [5][6]. - Year-to-date revenue growth was 20%, totaling $78.3 million compared to $65.3 million in the prior year [10][11]. - Gross profit for Q3 increased by 25% to $17.9 million, with gross margins improving to 65.2% from 61.2% [8][9]. - Operating expenses remained flat at $20.5 million, despite $1.5 million in acquisition-related expenses [9][11]. - The net loss for Q3 decreased by 28% to $8.0 million, compared to $11.2 million in the prior year [9][12]. Strategic Developments - The acquisition of Exosome Diagnostics was completed on September 15, 2025, which is expected to enhance the company's product offerings and sales capabilities [3][4]. - The company plans to focus on integrating the ExoDx business and has expanded its direct sales team from 50 to 60 representatives to leverage cross-selling opportunities [3][4]. - The introduction of germline products has been suspended to allocate resources towards ExoDx, Confirm, and GPS, with a reevaluation planned for 2026 [3][4]. Future Outlook - MDxHealth reaffirmed its full-year revenue guidance of $108 million to $110 million, expecting Q4 growth to meet or exceed 20% [4][12]. - The company reported a positive adjusted EBITDA of $1 million for Q3, marking a significant improvement from a loss of $3.9 million in the prior year [10][12].
Molecular Diagnosis Firm BillionToOne Raises $273 Million in IPO
Yahoo Finance· 2025-11-06 03:08
Core Insights - BillionToOne Inc. successfully raised $273.1 million in an upsized US initial public offering despite the ongoing US government shutdown, which has complicated the listing process [1][4]. Company Overview - The company, based in Menlo Park, California, sold 4.55 million shares at $60 each, exceeding the initially marketed range of $49 to $55 for 3.85 million shares [2]. - Following the IPO, BillionToOne's market value is estimated to be over $2.6 billion, with co-founders holding 64% of the voting power [3]. Financial Performance - For the six months ending June 30, BillionToOne reported a net loss of $4.2 million on revenue of $125.5 million, an improvement from a net loss of $15.2 million on revenue of $69.1 million during the same period the previous year [5]. Product Offerings - The company specializes in precision diagnostics, with its flagship product, Unity Complete, being a non-invasive prenatal screening test. Additionally, it offers NorthStar liquid biopsy tests that can detect tumor mutations [5]. Investor Information - Major investors include Hummingbird Ventures, which is expected to hold 19.9% of Class A shares post-IPO, Neotribe Ventures with 11%, and Libertus Capital with 9% [6]. - The IPO is being led by JPMorgan Chase & Co., Piper Sandler Cos., Jefferies Financial Group Inc., and William Blair & Co. The shares are expected to begin trading on the Nasdaq Global Select Market under the symbol BLLN [6].
Mdxhealth to Release Third Quarter 2025 Financial Results on November 12
Globenewswire· 2025-11-03 21:01
Core Insights - MDxHealth SA will release its financial results for the third quarter ended September 30, 2025, after market close on November 12, 2025 [1] - A conference call with live Q&A will be held on the same day at 4:30 PM ET / 22:30 CET [2] Company Overview - MDxHealth is a leading precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment [3] - The company's tests are based on proprietary genomic, epigenomic, exosomal, and other molecular signatures, assisting physicians with the diagnosis and prognosis of prostate cancer and other urologic diseases [3] - The U.S. headquarters and laboratory operations are located in Irvine, California, with additional labs in Waltham, Massachusetts, and Plano, Texas; European headquarters are in Herstal, Belgium [3]
Bioxytran Unveils Revolutionary Precision Diagnostics on Tissue Oxygenation
Globenewswire· 2025-08-15 16:13
Core Insights - Bioxytran, Inc. has achieved a significant scientific milestone with the publication of a book by Prof. Avraham Mayevsky, focusing on oxygen regulation and mitochondrial health, which could transform treatments for stroke, Alzheimer's, and other critical conditions [1][2]. Group 1: Scientific Advancements - The research highlights the inadequacy of current medical practices that rely on peripheral oxygen measurements, which can overlook critical issues within vital organs, such as in stroke patients who may have "100% oxygen saturation" while their brain is deprived of oxygen [2]. - Prof. Mayevsky's work emphasizes the importance of transitioning to tissue-specific oxygenation monitoring, which can lead to improved outcomes in clinical settings, particularly in the operating room [2]. Group 2: Clinical Applications - Bioxytran is integrating insights from this research into its upcoming BXT-25 clinical trials, which aim to demonstrate that targeted oxygen delivery can effectively rescue damaged tissues and potentially change treatment paradigms [3]. - The technology developed by Bioxytran is expected to serve as a biomarker for advancing clinical trials of BXT-25, providing a powerful method to measure brain oxygen consumption during strokes [3]. Group 3: Future Potential - Avraham Mayevsky stated that Bioxytran is positioned to lead the oxygen therapeutics revolution, with the principles outlined in his book potentially accelerating treatments for stroke, chronic wounds, and Alzheimer's by restoring oxygen delivery [4]. - Bioxytran is focused on developing complex carbohydrate-based therapeutics to address unmet medical needs across various platforms, including virology, cancer metastasis, and oxygen transport [4].
Bio-Techne Q4 Earnings Beat Estimates, Gross Margin Down, Stock Falls
ZACKS· 2025-08-06 14:05
Core Insights - Bio-Techne (TECH) reported fourth-quarter fiscal 2025 adjusted earnings per share (EPS) of 53 cents, exceeding the Zacks Consensus Estimate by 6% and improving from 49 cents in the previous year [1][9] - The company experienced a GAAP loss per share of 11 cents compared to an EPS of 25 cents in the prior-year quarter [2] - For the full year, adjusted EPS was $1.92, surpassing the Zacks Consensus Estimate by 1.1% and reflecting an 8.5% increase from fiscal 2024 [2] Revenue Performance - In the fiscal fourth quarter, Bio-Techne's net sales reached $316.9 million, marking a 3.5% year-over-year increase on a reported basis and 3% on an organic basis, surpassing the Zacks Consensus Estimate by 0.48% [3][9] - Full-year revenues totaled $1.22 billion, a 5.2% improvement from fiscal 2024 on a reported basis and a 5% increase organically, matching the Zacks Consensus Estimate [3] Segment Analysis - Within the Protein Sciences segment, revenues were $226.5 million, up 6% year over year (4% organically) [4] - In the Diagnostics and Spatial Biology segment, sales decreased by 1% year over year to $89.7 million, with an impairment loss of $83.1 million incurred during the quarter due to the Exosome Diagnostics business being classified as held-for-sale [5] Margin and Expense Overview - Bio-Techne's gross profit fell by 2.2% to $198.8 million, with gross margin contracting by 371 basis points to 62.7% due to a 15% rise in the cost of sales [6][9] - Selling, general and administrative expenses increased by 47.2% to $196.6 million, while research and development expenses rose by 8.5% to $26 million [6] Operating Performance - The company reported an operating loss of $23.9 million in the fiscal fourth quarter, a significant decline from the $45.8 million operating profit in the same quarter of the previous year [7][9] Capital Structure - At the end of the fiscal fourth quarter, Bio-Techne had cash and equivalents of $162.2 million, up from $151.8 million at the end of fiscal 2024, while long-term debt obligations increased to $346 million from $319 million [10] Strategic Outlook - Despite market uncertainties, Bio-Techne's results aligned with company expectations, with strong performance in cell therapy and protein analysis instrumentation [11] - The decision to divest the Exosome Diagnostics business is anticipated to enhance profitability and allow a greater focus on high-growth areas, particularly in research and precision diagnostics [11]
Mdxhealth Appoints Michael Holder to Board of Directors and Announces Management Change
Globenewswire· 2025-07-03 17:00
Core Viewpoint - MDxHealth SA has appointed Michael Holder as the Chair of the Audit Committee, succeeding Regine Slagmulder, and announced the resignation of CFO Ron Kalfus, with Scott McMahan taking over interim CFO responsibilities [1][3][4] Group 1: Leadership Changes - Michael Holder brings over 30 years of experience in biotech, medtech, and pharma, having held multiple executive roles including CEO and CFO [2] - Ron Kalfus will continue as CFO until July 30, 2025, after which Scott McMahan will assume the role on an interim basis [3][4] Group 2: Company Background - MDxHealth is a precision diagnostics company focused on providing molecular information for personalized patient diagnosis and treatment, particularly in urologic cancers [5] - The company operates its U.S. headquarters in Irvine, California, and has additional laboratory operations in Plano, Texas, with European headquarters in Herstal, Belgium [5]