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PESG Research Report: Revolutionary Surgical Infection Prevention: PolyPid's D-PLEX100 Approaches Critical Phase 3 Data Readout
New report from PESG Research brand covers PolyPid*, which is tackleing the $10 billion dollar a year surgeical site infections cost with its innovative PLEX technology New York, May 30, 2025 (GLOBE NEWSWIRE) -- PESG Research is releasing a report today examining PolyPid Ltd.*, an innovative late-stage biopharmaceutical company developing revolutionary localized drug delivery technologies for surgical infection prevention. The below report explores the company's breakthrough PLEX platform technology, its upcoming topline phase 3 data, and potential implications for transforming surgical care practices in the multi-billion dollar surgical site infection prevention market. This report contains sponsored content, please see refer to the disclaimers and disclosures included at the end of this report. Executive Summary The surgical site infection (SSI) prevention landscape stands at a potential inflection point as PolyPid Ltd. prepares to announce topline results from its pivotal SHIELD II Phase 3 trial by the end of Q2 2025. The company's D-PLEX100 represents a paradigm shift in infection prevention, utilizing novel polymer-lipid encapsulation matrix (PLEX) technology to deliver sustained antibiotic release directly at surgical sites for 30 days. With SSIs affecting up to 30% of colorectal surgeries and imposing substantial healthcare costs estimated at $10 billion annually in the US and EU, successful development of D-PLEX100 could address a critical unmet medical need. The FDA's assignment of Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations underscores the regulatory recognition of this approach's potential Critical Challenge of Surgical Site Infections Surgical site infections remain one of healthcare's most persistent challenges, representing 20% of all healthcare-associated infections in US hospitals. Despite advances in surgical techniques and prophylactic protocols, SSI rates in high-risk procedures like colorectal surgery can reach 30%, leading to extended hospital stays of 7-11 additional days and mortality risk increases of 2-11 fold. The economic burden is staggering, with direct costs averaging $11,000-26,000 per infection and total annual costs reaching approximately $10 billion in the US alone. Current prevention strategies rely primarily on systemic antibiotic prophylaxis administered intravenously 30-60 minutes before surgery. However, this approach faces fundamental limitations. Surgical incisions disrupt local blood flow, significantly limiting antibiotic penetration to the precise site where infections occur. Moreover, systemic administration exposes patients to higher drug concentrations throughout the body, potentially increasing toxicity risks and contributing to antimicrobial resistance development. PLEX Technology: A Novel Approach to Localized Drug Delivery PolyPid's proprietary PLEX technology represents a sophisticated advancement in controlled drug delivery systems. The platform creates thousands of alternating layers of biocompatible polymers and lipids that physically embed active pharmaceutical ingredients. As these outer layers gradually disintegrate upon exposure to body fluids, they enable precise, predetermined drug release rates spanning several days to months. For D-PLEX100, this technology pairs with doxycycline, a broad-spectrum antibiotic effective against both gram-positive and gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and other antibiotic-resistant strains. The formulation achieves local antibiotic concentrations 10-115 times higher than systemic administration while using only a fraction of the total drug amount, potentially minimizing systemic exposure and associated side effects. Clinical Development Progress and Regulatory Recognition The clinical development program for D-PLEX100 has demonstrated encouraging signals across multiple surgical contexts. In Phase 2 abdominal surgery trials, D-PLEX100 plus standard of care achieved a statistically significant 59% reduction in the primary endpoint compared to standard of care alone (p=0.0086). Perhaps more notably, the treatment group experienced zero deaths compared to five in the control arm within 60 days post-surgery. The pivotal SHIELD I Phase 3 trial, while not meeting its primary endpoint in the full intent-to-treat population, revealed compelling efficacy in a pre-specified subgroup analysis. Among patients with large surgical incisions (>20 cm), D-PLEX100 demonstrated a statistically significant 54% reduction in the composite primary endpoint of SSIs, reinterventions, and mortality (p=0.0032). This finding directly informed the design of the ongoing SHIELD II trial, which focuses specifically on this higher-risk patient FDA's regulatory designations reflect recognition of D-PLEX100's potential significance. Breakthrough Therapy designation is reserved for drugs that demonstrate substantial improvement over existing treatments for serious conditions. Fast Track designation facilitates more frequent FDA communications and potentially accelerated review timelines. The QIDP designation provides additional market exclusivity incentives for addressing antimicrobial resistance challenges. SHIELD II: A Potentially Definitive Study The ongoing SHIELD II Phase 3 trial represents a carefully designed study incorporating lessons learned from SHIELD I. Following an independent Data Safety Monitoring Board's review of unblinded efficacy data from the first 430 enrolled patients, the board recommended concluding the study at 800 patients—the lowest sample size reassessment option available. This recommendation, while requiring additional enrollment beyond the initially planned 624 patients, may suggest positive efficacy trends in the analyzed interim data. The study's multinational design spans approximately 60 centers across the United States, Europe, and Israel, enhancing the generalizability of results across different healthcare settings and patient populations. The primary endpoint focuses on a composite of SSI events, reinterventions, and mortality within 30 days post-surgery, as adjudicated by an independent committee. Broader Industry ImplicationsSuccess of D-PLEX100 could catalyze broader adoption of localized drug delivery approaches in surgical settings. The technology's platform nature suggests potential applications beyond infection prevention, including localized chemotherapy delivery through the company's OncoPLEX program, currently in preclinical development for solid tumor treatment. The substantial market opportunity—with approximately 12 million eligible procedures annually in the US and 8 million in Europe—underscores the potential healthcare impact. PolyPid has already secured European commercialization rights through a partnership with Advanz Pharma, valued at up to $115 million plus royalties, while advancing discussions for US market partnerships. Conclusion As the pharmaceutical industry grapples with antimicrobial resistance and healthcare systems seek cost-effective solutions to persistent clinical challenges, D-PLEX100's approaching data readout represents a potentially significant milestone. The convergence of compelling preclinical and early clinical data, regulatory recognition, and substantial unmet medical need positions this development as one to monitor closely in the evolving landscape of surgical infection News Highlight from PolyPid: PolyPid Announces Successful Completion of Enrollment in Phase 3 SHIELD II Trial of D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections >> Click here to Subscribe for more updates like this or go to * Legal Disclaimer & Disclosure: Nothing in this report constitutes medical, financial or any form professional or licensedadvice. This report is published by 'PESG Research', a digital promotional content brand who's operators are compensated to provide digestable and favorabel coverage of companies. This report contains and is a form of paid promotional content or advertising for PolyPid Ltd and was produced as part of the fee's they pay PESG's operators, Arx Advisory Ltd. This report has not been reviewed or approved by PolyPId prior to publication and it does not represent an official communication from PolyPid. The operators of PESG Research received or are expected to receive a monthly recurring fee of five thousand united states dollars via wire transfer from PolyPid as part of an ongoing agreement starting May 1, 2025 in return for distribution and promotional coverage services, and receive additional monthly compensation for non promotional unrelated data and advisory services on top of that. Please review the full disclaimers and compensation disclosures here for further details: Readers are advised to refer to the official materials of the company aforementioned. The report should not be treated as objective.
Associated Press
17-03-2025
- Business
- Associated Press
PESG Report: Silexion Therapeutics' Breakthrough Data Shows SIL204's impact on both Primary Tumors & Metastasis – Signaling a Potential Paradigm Shift in Cancer Treatment
PESG Research releases a report covering Silexion Therapeutics' (NASDAQ: SLXN)* latest developments: Silexion, a clinical-stage biotechnology company recently delivered potentially transformative preclinical data for its SIL204 therapeutic candidate. The latest findings represents a critical milestone in the fight against KRAS-driven cancers, particularly pancreatic cancer, showcasing significant potential in addressing one of oncology's most challenging targets. The Scientific Breakthrough: Redefining Cancer Treatment Paradigms Silexion's orthotopic model studies have unveiled remarkable capabilities of SIL204 that could revolutionize cancer treatment approaches. The research demonstrated unprecedented efficacy across multiple pancreatic cancer models, with results that challenge existing therapeutic limitations: In the AsPC-1 model (KRAS G12D mutation), the therapy showed approximately 70% reduction in tumor cell bioluminescence. The Panc-1 model revealed dose-dependent tumor cell reductions, while the BxPC-3 model exhibited up to 80% overall tumor cell reduction. Most critically, the study marks the first systematic validation of a therapy's ability to suppress metastatic spread through systemic administration. Market Context: Precision Oncology's Evolving Landscape The precision medicine market is experiencing explosive growth, projected to expand from $102 billion in 2024 to $470 billion by 2034. This growth is driven by innovative approaches like Silexion's RNAi technology, which targets the notoriously challenging KRAS mutations found in over 90% of pancreatic cancers. Industry dynamics in the past few years underscore the value of groundbreaking oncology assets. Notable acquisitions like Pfizer's $43 billion purchase of Seagen and AbbVie's $10.1 billion acquisition of Immunogen highlight the premium placed on innovative cancer therapies. Within this context, Silexion's approach to targeting multiple KRAS mutations through systemic siRNA delivery stands out as a potentially significant advancement. Wall Street's Bullish Take on Silexion: 'Buy' Rating Maxim Group has maintained its analysis of Silexion, rating the company a 'buy' and giving the stock a $9 dollar 12-month price target, representing an premium of almost ~600% over its current price. The anticipated progress with Silexion's expanded development strategy suggests potential for significant strategic evolution, leveraging the recent orthotopic model breakthrough to explore broader clinical applications for SIL204. Upcoming Catalysts: An Expanded Development Plan The company is preparing to unveil details of its expanded development plan, which could provide critical insights into: Potential expansion of SIL204's therapeutic reach, Strategy for advancing toward clinical trials, Exploration of additional cancer indications. With data analysis complete and initial results promising, Silexion appears positioned at a potentially transformative moment in its development of KRAS-targeting therapies. The precision oncology sector continues to evolve rapidly, and Silexion Therapeutics has demonstrated a capability to push the boundaries of current treatment paradigms. As the company moves forward, its innovative approach to addressing KRAS-driven cancers remains a critical development to watch. or go to * Disclaimer: Nothing in this report constitutes financial or investment advice, nor does it represent an offer to buy or sell securities. This report is published PESG Research, a promotional content brand which is part of the Wall Street Wire™ network. The operators of Wall Street Wire are not registered brokers, dealers, or investment advisers. This distribution contains paid promotional content related to Silexion Therapeutics and was produced as part of their paid subscription to Wall Street Wire. This alert has not been reviewed or approved by Silexion Therapeutics prior to publication. Please review the full disclaimers and compensation disclosures here: SOURCE: PESG Research Copyright Business Wire 2025. PUB: 03/17/2025 08:15 AM/DISC: 03/17/2025 08:17 AM
Associated Press
05-03-2025
- Business
- Associated Press
PESG Report: Inspira Technologies Breaks new Ground with Positive Clinical Data for AI-Powered Blood Sensor Exceeding Expectations
PESG Research releases an update following groundbreaking clinical evaluation results: Inspira Technologies* (NASDAQ: IINN) has reported exceptional clinical study outcomes for its HYLA blood sensor, with 96% accuracy achieved in a key parameter compared to traditional blood analyzers. This milestone achievement validates the company's AI-powered continuous blood monitoring technology and accelerates its path toward commercial deployment in multiple healthcare settings. Promising Clinical Validation at Premier Medical Institution The clinical study, conducted at Sheba Hospital (ranked among the world's top 8 hospitals by Newsweek), successfully demonstrated the HYLA sensor's capabilities across 6 patients undergoing open-heart surgery. The clip-on device monitored blood parameters in real-time as blood circulated through the cardiopulmonary bypass system, achieving impressive concordance with conventional laboratory testing methods. Notably, the study also validated a new indicator for identifying oxygen deficiencies, showing 92.3% accuracy – a critical capability for preventing hypoxia during surgical procedures. This clinical validation at one of the world's premier medical institutions represents a significant de-risking event for the company's core technology. As Dagi Ben-Noon, CEO of Inspira, noted, 'Achieving 96% accuracy as reflected in our clinical results in real-time blood monitoring without the need for blood draws represents a significant technological breakthrough.' Expanding Technology Ecosystem Shows Commercial Progress The successful HYLA clinical results come amid accelerating commercial momentum for Inspira's broader product ecosystem. The company's INSPIRA ART100 system, which received FDA 510(k) clearance in May 2024 for cardiopulmonary bypass procedures, is now being deployed at leading U.S. hospitals through distribution partner Glo-Med Networks. The system was recently enhanced with new support features designed to assist medical teams, reduce staff overhead, and improve efficiency during critical procedures. Additionally, in February 2025, Inspira reported positive initial results from its collaboration with Ennocure MedTech Ltd. to develop a novel bio-electronic treatment for preventing bloodstream infections. Ex-vivo testing demonstrated a 95% reduction in bacterial presence within 4 hours, showing promise for addressing the estimated 250,000 bloodstream infections related to intravenous lines occurring worldwide annually. Inspira's Strategy Targets Multiple High-Value Markets The successful clinical validation of the HYLA blood sensor represents a crucial step in Inspira's strategy to penetrate multiple high-value medical technology markets. As a standalone technology, HYLA targets the blood gas analyzer market, which the company projects will reach $5.7 billion by 2030 (up from previous estimates of $2.5 billion). When integrated with Inspira's respiratory support systems, the technology strengthens the company's position in the $19 billion mechanical ventilation market. Inspira's approach of combining AI-enhanced monitoring capabilities with innovative respiratory support solutions addresses a critical unmet need in healthcare. With approximately 20 million patients annually requiring mechanical ventilation globally and mortality rates exceeding 50% under current protocols, Inspira's technology ecosystem offers a potential paradigm shift in critical care management by enabling conscious patient treatment with continuous monitoring. * Disclaimer: Nothing in this report constitutes financial or investment advice, nor does it represent an offer to buy or sell securities. This report is published by PESG Research, a brand affiliated with the Wall Street Wire™ network. The operators of Wall Street Wire are not registered brokers, dealers, or investment advisers. This report contains paid promotional content related to Inspira Technologies and was produced as part of their paid subscription to Wall Street Wire. This report has not been reviewed or approved by Inspira prior to publication. Please review the full disclaimers and compensation disclosures here: SOURCE: PESG Research Copyright Business Wire 2025. PUB: 03/05/2025 08:46 AM/DISC: 03/05/2025 08:47 AM
