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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]
Hepion Pharmaceuticals Announces Dr. Kaouthar Lbiati as Interim Chief Executive Officer
Globenewswire· 2025-06-16 12:30
Core Insights - Hepion Pharmaceuticals has appointed Dr. Kaouthar Lbiati as interim CEO, effective June 16, 2025, replacing John Brancaccio who is retiring for personal reasons [1][2] - Dr. Lbiati's leadership is expected to focus on strategic renewal and innovation in diagnostics for unmet clinical needs, including celiac disease, respiratory multiplex testing, H. pylori, and HCC [2][4] - Dr. Lbiati has over 15 years of experience in biotech and pharmaceuticals, having held significant roles in advancing therapies from preclinical development to commercialization [3] Company Strategy - The company aims to reposition itself as a leader in precision diagnostics, targeting underdiagnosed conditions and leveraging scalable technologies [4] - Hepion plans to prioritize immediate revenue generation and long-term innovation, focusing on clinical utility for patients at risk of liver cancer and their caregivers [4] Recent Developments - In April 2024, Hepion announced the winding down of its ASCEND-NASH clinical trial, which had a target enrollment of 336 subjects but was paused with 151 subjects randomized [6] - On May 26, 2025, Hepion entered into an agreement to sell all patent assets and related data for Rencofilstat for a nominal amount, along with a contingent value right for stockholders [7]
ProPhase Labs Announces Financial Results for the Three Months Ended March 31, 2025
Globenewswire· 2025-05-20 12:00
Core Insights - ProPhase Labs is undergoing significant operational transformations aimed at reducing overhead and aligning resources with high-value opportunities, particularly in the biotech and genomics sectors [5][17] - The company anticipates multiple liquidity events in the coming months, including the potential sale of its subsidiary Nebula Genomics and recovery of insurance payments through Crown Medical Collections [7][10][11] Financial Performance - For Q1 2025, ProPhase reported net revenue of $1.4 million, a decrease from $2.4 million in Q1 2024, primarily due to a $1.0 million drop in consumer products revenue [20] - The cost of revenues for Q1 2025 was $0.9 million, leading to a gross margin profit of $0.5 million, compared to a gross margin loss of $0.1 million in Q1 2024 [21][22] - General and administrative expenses decreased to $4.1 million in Q1 2025 from $7.3 million in Q1 2024, reflecting cost-cutting measures [23] - The net loss from continuing operations for Q1 2025 was $4.7 million, or $(0.13) per share, an improvement from a loss of $5.5 million, or $(0.32) per share, in Q1 2024 [25] Strategic Developments - The company completed the divestiture of its Pharmaloz manufacturing operations for approximately $23 million, saving over $2 million annually [4] - ProPhase is pursuing strategic alternatives for Nebula Genomics, which has a unique 16-petabyte DNA dataset, and expects to receive letters of intent from potential acquirers soon [7][8] - The BE-Smart Esophageal Cancer Test has been submitted for peer review, with commercialization expected later this year, following a favorable ruling on laboratory-developed tests [12][14][16] Cash Flow and Liquidity - As of March 31, 2025, ProPhase had cash and cash equivalents of $88,000, down from $678,000 at the end of 2024, primarily due to cash used in operating activities [26] - The company is optimistic about generating significant cash flow from Crown Medical Collections, which estimates a recovery of approximately $50 million in insurance payments [10][11] Market Position and Future Outlook - ProPhase Labs aims to position itself as a leader in precision diagnostics, particularly in gastroenterology, with its proprietary BE-Smart platform [16] - The company is focused on unlocking value through strategic asset development and disciplined execution, with several major milestones anticipated in the near future [17]
MDxHealth Reports Q1-2025 Results
Globenewswire· 2025-05-14 20:00
Core Insights - MDxHealth reported a year-over-year revenue increase of 22% to $24.3 million for Q1 2025, marking the 16th consecutive quarter of revenue growth of 20% or more [1][2][6] - The company expects to achieve adjusted EBITDA profitability in Q2 2025 and has reiterated its revenue guidance for 2025 at $108-110 million [2][9] Financial Performance - Revenue for Q1 2025 was $24.3 million, up from $19.8 million in Q1 2024, representing a 22% increase [4][6] - Gross profit increased by 29% to $15.5 million, with gross margins improving to 63.8% from 60.8% year-over-year [7][9] - Operating expenses rose by 8% to $20.1 million, primarily due to increased clinical trial expenses and stock-based compensation [7][9] - The net loss for Q1 2025 was $9.2 million, an 8% increase from $8.5 million in the prior year, largely due to non-cash fair value adjustments [8][9] - Adjusted EBITDA improved by 71% to a loss of $1.3 million compared to a loss of $4.5 million in Q1 2024 [10][23] Operational Highlights - Tissue-based tests accounted for 85% of total revenue in Q1 2025, up from 79% in Q1 2024 [6] - Test volumes for tissue-based tests increased by 41% to 12,677, while liquid-based test volumes rose by 9% to 11,530 [9] - The company ended Q1 2025 with cash and cash equivalents of $65.7 million [10][22] Subsequent Events - On April 29, 2025, MDxHealth made a $28.0 million earnout payment to Exact Sciences, which would adjust the pro-forma cash balance to $37.7 million as of March 31, 2025 [11]