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Perfuze Presents Preliminary Results from MARRS Pivotal Trial at SNIS, Highlighting Millipede 88 Performance in Acute Ischemic Stroke
Perfuze Presents Preliminary Results from MARRS Pivotal Trial at SNIS, Highlighting Millipede 88 Performance in Acute Ischemic Stroke

Business Wire

time16 hours ago

  • Health
  • Business Wire

Perfuze Presents Preliminary Results from MARRS Pivotal Trial at SNIS, Highlighting Millipede 88 Performance in Acute Ischemic Stroke

GALWAY, Ireland--(BUSINESS WIRE)--Perfuze, a medical device company developing catheter technology for interventional stroke care, today announced positive preliminary results from its pivotal IDE clinical trial, MARRS (Millipede Aspiration for Revascularization in Stroke Study). These preliminary results were presented at the Society for NeuroInterventional Surgery (SNIS) Annual Meeting in Nashville, Tennessee, USA. 'The MARRS data are truly exceptional. Achieving 77% First Pass Effect for M1 occlusions in a pivotal study is a major advance for stroke care," said Dr. Raul G. Nogueira, Principal Investigator of the MARRS Study. Share The trial is evaluating the safety and effectiveness of the Millipede System for revascularization in acute ischemic stroke. Conducted across a network of leading stroke centers in the U.S. and Europe, the study included patients with occlusions in the ICA, M1, M2 and basilar, or vertebral arteries. The Millipede System includes the Millipede 88 aspiration catheter, Perfuze's flagship Superbore aspiration catheter. The MARRS trial enrolled 180 evaluable subjects, with first pass direct aspiration being performed with the Millipede 88 in 101 of these patients. The preliminary analysis shows a high rate of First Pass Effect (FPE), defined as complete or near-complete revascularization (mTICI 2c) following a single device pass. For patients treated with Millipede 88, an FPE rate of 61% was observed across all target vessels in the Per Protocol (PP) population. Specifically, for M1 artery occlusions treated with Millipede 88 in the PP population, an FPE rate of 77% was achieved. 'The MARRS data are truly exceptional. Achieving 77% First Pass Effect for M1 occlusions in a pivotal study is a major advance for stroke care. The ability to reliably achieve rapid, complete reperfusion with a single aspiration pass is exactly what we need to improve efficacy. This technology is a powerful tool that simplifies thrombectomy and delivers outstanding performance,' said Dr. Raul G. Nogueira, Principal Investigator of the MARRS Study and Professor of Neurology and Neurosurgery at the University of Pittsburgh School of Medicine. Across the 180 patients enrolled, delivery success of the Millipede System was 99%, and the median number of passes was 1. Preliminary safety analysis showed a symptomatic intracranial hemorrhage (sICH) rate of 1.7%. Perforation was reported at 0% and the rate of intracranial dissection was 1.1%, indicating a promising safety profile. ' The MARRS study represents several years of work by the Perfuze team and our clinical partners,' said Wayne Allen, CEO and Co-Founder of Perfuze. ' We designed the Millipede 88 to navigate seamlessly to the clot face, enabling a superbore catheter that improves the likelihood of achieving First Pass Effect. This early data reflects that intent, and we're encouraged by the physician feedback we've received to date.' The MARRS trial completed enrollment earlier this year, executed ahead of schedule, reflecting strong engagement from stroke centers and interest in next-generation aspiration technology. These clinical results follow several successful milestones for Perfuze, including FDA 510(k) clearance for its Zipline™ Access Catheters and a €22 million funding round to support commercial expansion and operational scale-up. With these preliminary MARRS data, Perfuze is preparing for FDA submission. ' This is a significant inflection point for the company, ' said Perfuze Chairperson, Hooman Hakami. ' Preliminary MARRS results support the Millipede 88 catheter's safety and effectiveness and underpin our vision to advance stroke intervention.' About the Millipede System and MARRS Trial Millipede 88 is a superbore aspiration catheter developed to support effective clot retrieval while maintaining navigability through challenging cerebrovascular anatomy. The MARRS trial is a prospective, multicenter, single-arm pivotal IDE study designed to evaluate the safety and effectiveness of the Millipede System in patients with large vessel occlusion stroke. Revascularization outcomes were adjudicated by an independent core laboratory. About Perfuze Perfuze is a privately held medical device company based in Galway, Ireland. The company is dedicated to developing advanced catheter technologies that simplify stroke procedures and aim to improve outcomes for patients suffering from acute ischemic stroke. For more information, visit Follow us on LinkedIn and X (formerly Twitter). Disclaimer: United States: CAUTION – Investigational device. Limited by Federal law to investigational use. Europe: Exclusively for use in a clinical investigation. These are preliminary results from an ongoing clinical investigation. The Clinical Study Report has not yet been approved or reviewed by regulatory authorities. Data may be subject to change and may not fully reflect the contents of the Clinical Study Report.

Marea Therapeutics Presents Preclinical Data on Novel Growth Hormone Receptor Antagonist Antibody, MAR002, for the Treatment of Acromegaly at ENDO 2025
Marea Therapeutics Presents Preclinical Data on Novel Growth Hormone Receptor Antagonist Antibody, MAR002, for the Treatment of Acromegaly at ENDO 2025

Yahoo

time3 days ago

  • Business
  • Yahoo

Marea Therapeutics Presents Preclinical Data on Novel Growth Hormone Receptor Antagonist Antibody, MAR002, for the Treatment of Acromegaly at ENDO 2025

SOUTH SAN FRANCISCO, Calif., July 14, 2025--(BUSINESS WIRE)--Marea Therapeutics, Inc., a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine diseases, today announced the presentation of preclinical data on MAR002, a novel growth hormone receptor (GHR) antagonist antibody for the treatment of acromegaly, at the 2025 Annual Meeting of the Endocrine Society (ENDO). The oral presentation, titled "Development of a Novel Growth Hormone Receptor Antagonist Antibody for the Treatment of Acromegaly," highlights the significant potential of MAR002 to address critical unmet needs in patients suffering from this rare and highly morbid disease. Presentation highlights include: Highly potent GHR antagonism: MAR002 is a novel, highly potent antagonist of growth hormone (GH) signaling. It demonstrates superior GHR binding relative to pegvisomant and approximates the affinity of native GH. Allosteric mechanism of action: MAR002 does not prevent GH binding to the GHR in vitro and potently antagonizes downstream signaling across a broad range of GH concentrations. Superior suppression: MAR002 suppresses GHR signaling in vitro, achieving 93% suppression of human GHR compared to 24% for pegvisomant. Enhanced durability: MAR002 exhibited potent and sustained insulin-like growth factor-1 (IGF-1) suppression in vivo in non-human primates (NHPs). Compared head-to-head to pegvisomant, a single dose of MAR002 resulted in a similar maximum IGF-1 suppression, but with a considerably longer duration of effect. Marea Therapeutics has completed a GLP-toxicology study to assess MAR002's safety. The preclinical pharmacology data strongly support advancing MAR002 into clinical development; a Phase 1 first-in-human study is expected to begin in the third quarter of 2025. Marea's development strategy aims for rapid advancement into acromegaly patients after achieving proof of mechanism in healthy volunteers, with a clear path to approval guided by FDA guidance for IGF-1 normalization. "The preclinical data presented at ENDO 2025 underscore the potential of MAR002 to meaningfully transform the treatment landscape for acromegaly," said Ethan Weiss, M.D., chief scientific officer of Marea Therapeutics. "With its strong potency, enhanced durability, and favorable developability profile, MAR002 is uniquely positioned to overcome the limitations of current therapies and offer a more effective, targeted approach for patients. We are excited to advance MAR002 into clinical development and bring forward a next generation and potential best-in-class GHR antagonist." Marea Therapeutics believes MAR002 represents a significant opportunity to replace and expand the market for existing growth hormone receptor antagonists (GHRAs) and could also be used in combination with somatostatin receptor ligands (SRLs), offering a more effective and convenient treatment option for patients with acromegaly. About MAR002 MAR002 is a novel, potent and selective half-life-extended, allosteric, human monoclonal GHRA antibody being developed for the treatment of acromegaly. The PK and PD properties of MAR002 are predictable and typical of a half-life extended human antibody, showing a long duration of action compatible with infrequent subcutaneous dose administration in humans. These characteristics support its potential to offer an effective and convenient treatment for patients with acromegaly. About Acromegaly Acromegaly is an orphan disease characterized by the excess secretion of growth hormone (GH) from a benign pituitary adenoma. Acromegaly affects approximately 30,000 patients in the U.S. If left untreated, acromegaly is highly morbid, leading to significant comorbidities such as GH-induced insulin resistance and diabetes, and serious cardiovascular pathology. The median lifespan of patients can be shortened by 10 years without effective therapy, and incomplete IGF-1 normalization is associated with increased mortality. Despite its severity, acromegaly is often under or misdiagnosed, with an average time from symptom onset to diagnosis of approximately eight years. The current treatment paradigm for acromegaly often involves surgery, performed in over 90% of patients, which achieves remission in about 50% of cases, though this can degrade over time. Medical therapy is required for approximately 65% (around 20,000 in the U.S.) of patients during their disease journey, regardless of their surgical history. Current medical treatments include somatostatin receptor ligands (SRLs) and growth hormone receptor antagonists (GHRAs), such as pegvisomant. However, many patients do not achieve biochemical control with existing therapies. About Marea Therapeutics Marea Therapeutics is a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine diseases. The company's lead therapy, MAR001, is in Phase 2 clinical development for adults with metabolic dysfunction and high risk for atherosclerotic cardiovascular disease. The company is also advancing MAR002 for the treatment of acromegaly. To learn more, please visit and follow us on LinkedIn and X. View source version on Contacts Media:1ABKatie Englemankatie@ Investors:Meru AdvisorsLauren Glaserlglaser@ Sign in to access your portfolio

CBE Governor Attends Meeting of Council of Arab Central Banks in Abu Dhabi
CBE Governor Attends Meeting of Council of Arab Central Banks in Abu Dhabi

See - Sada Elbalad

time3 days ago

  • Business
  • See - Sada Elbalad

CBE Governor Attends Meeting of Council of Arab Central Banks in Abu Dhabi

Taarek Refaat Press Statement Hassan Abdalla, Governor of the Central Bank of Egypt (CBE), participated in the Annual Meeting of the Permanent Bureau of the Council of Arab Central Banks and Monetary Authorities' Governors, held in Abu Dhabi on Sunday. This meeting is a key step in preparing for the 49th Annual Meetings of the Council, scheduled for September 2025. On this occasion, Abdallah reaffirmed CBE's unwavering commitment to robust participation in all committees and working groups affiliated with the Council, emphasizing the significance of unified efforts to enhance integration among Arab central banks and strengthen joint coordination. He further highlighted the collective mission to establish resilient Arab banking frameworks capable of addressing regional and international economic and financial challenges. In the same context, the meeting reviewed the outcomes of the specialized Arab Committees across various banking sectors, including: The Arab Committee on Banking Supervision, the Arab Committee on Payment and Settlement Systems, the Arab Committee on Credit Information, the Arab Financial Inclusion Task Force, the Financial Stability Task Force, the Arab Regional FinTech Working Group, and the Arab Green and Sustainable Finance Network. The meeting also explored the progress made in preparing the Arab Financial Stability Report and the Joint Arab Economic Report for 2025, in preparation for their approval at the upcoming meeting of the Council of Arab Central Banks and Monetary Authorities' Governors scheduled for September 2025. Additionally, the meeting discussed the proposed issues for inclusion in the 2025 Unified Arab Discourse, which will be presented during the Annual Meetings of the World Bank Group and International Monetary Fund in October, reflecting the aspirations and perspectives of the Arab countries. read more CBE: Deposits in Local Currency Hit EGP 5.25 Trillion Morocco Plans to Spend $1 Billion to Mitigate Drought Effect Gov't Approves Final Version of State Ownership Policy Document Egypt's Economy Expected to Grow 5% by the end of 2022/23- Minister Qatar Agrees to Supply Germany with LNG for 15 Years Business Oil Prices Descend amid Anticipation of Additional US Strategic Petroleum Reserves Business Suez Canal Records $704 Million, Historically Highest Monthly Revenue Business Egypt's Stock Exchange Earns EGP 4.9 Billion on Tuesday Business Wheat delivery season commences on April 15 News Israeli-Linked Hadassah Clinic in Moscow Treats Wounded Iranian IRGC Fighters News China Launches Largest Ever Aircraft Carrier Sports Former Al Zamalek Player Ibrahim Shika Passes away after Long Battle with Cancer Videos & Features Tragedy Overshadows MC Alger Championship Celebration: One Fan Dead, 11 Injured After Stadium Fall Lifestyle Get to Know 2025 Eid Al Adha Prayer Times in Egypt Business Fear & Greed Index Plummets to Lowest Level Ever Recorded amid Global Trade War News "Tensions Escalate: Iran Probes Allegations of Indian Tech Collaboration with Israeli Intelligence" News Flights suspended at Port Sudan Airport after Drone Attacks Arts & Culture Hawass Foundation Launches 1st Course to Teach Ancient Egyptian Language Videos & Features Video: Trending Lifestyle TikToker Valeria Márquez Shot Dead during Live Stream

Egypt participates in permanent bureau meeting of Arab Central Bank Governors in Abu Dhabi
Egypt participates in permanent bureau meeting of Arab Central Bank Governors in Abu Dhabi

Daily News Egypt

time4 days ago

  • Business
  • Daily News Egypt

Egypt participates in permanent bureau meeting of Arab Central Bank Governors in Abu Dhabi

Hassan Abdalla, Governor of the Central Bank of Egypt (CBE), took part in the Annual Meeting of the Permanent Bureau of the Council of Arab Central Banks and Monetary Authorities' Governors, held on Sunday, 13 July 2025, in Abu Dhabi. The meeting is a preparatory step ahead of the Council's 49th Annual Meetings, scheduled for September 2025. On this occasion, Abdalla reaffirmed the CBE's strong commitment to active participation in all committees and working groups under the Council's umbrella. He underscored the importance of unified efforts to deepen integration among Arab central banks and reinforce joint coordination. Abdalla also stressed the shared goal of establishing resilient Arab banking frameworks capable of responding effectively to regional and global economic and financial challenges. During the meeting, participants reviewed the outcomes of several specialized Arab committees operating across key banking and financial sectors. These included the Arab Committee on Banking Supervision, the Arab Committee on Payment and Settlement Systems, the Arab Committee on Credit Information, the Arab Financial Inclusion Task Force, the Financial Stability Task Force, the Arab Regional FinTech Working Group, and the Arab Green and Sustainable Finance Network. The meeting further discussed progress on the preparation of the Arab Financial Stability Report and the Joint Arab Economic Report for 2025, which are slated for approval at the Council's upcoming annual gathering. Additionally, participants reviewed and proposed topics for inclusion in the 2025 Unified Arab Discourse, which will be presented at the Annual Meetings of the World Bank Group and the International Monetary Fund in October. This discourse aims to reflect the collective priorities and perspectives of Arab countries on global economic issues.

Angel Oak Financial Strategies Income Term Trust Announces Certified Results from 2025 Annual Meeting of Shareholders
Angel Oak Financial Strategies Income Term Trust Announces Certified Results from 2025 Annual Meeting of Shareholders

Business Wire

time7 days ago

  • Business
  • Business Wire

Angel Oak Financial Strategies Income Term Trust Announces Certified Results from 2025 Annual Meeting of Shareholders

ATLANTA--(BUSINESS WIRE)--Angel Oak Financial Strategies Income Term Trust (NYSE: FINS) (the "Fund") has announced the final certified voting results from the 2025 Annual Meeting of Shareholders held on June 26, 2025 (the 'Annual Meeting'). Proposal 1: Approval of New Investment Advisory Agreement For Against Abstain 11,417,091 4,840,580 126,687 Expand Proposal 2: Election of Trustees Nominees For Against Abstain Keith M. Schappert (Incumbent) 9,045,421 1,056,841 132,174 Andrea N. Mullins (Incumbent) 1,030,778 132,652 Trevor Montano (Challenger) 7,655,890 73,367 6,881 Expand Proposal 3: Ratification of Auditor A total of 25,062,638.4 shares were entitled to vote as of the record date of April 16, 2025, out of which 17,970,576 were present at the Annual Meeting. Despite the strong support, neither the new investment advisory agreement nor the Trustees received enough votes to pass the required vote thresholds. In the coming months, FINS will communicate with shareholders regarding a special shareholder meeting after accounting for the results from the Annual Meeting. In addition, FINS will continue engaging with shareholders as it evaluates several shareholder-friendly enhancements for the Fund. FINS appreciates its shareholders' continued support of the Fund and of Angel Oak Capital Advisors, LLC, the Fund's adviser ('Angel Oak'). Angel Oak has successfully managed FINS since its inception in 2019. FINS has focused on enhancing long-term shareholder value with proactive actions aimed at improving liquidity, efficiency, and performance. Shareholders most recently demonstrated their support of FINS' performance through significant oversubscription in its recent rights offering in May 2025. The final voting results have been certified by First Coast Results, Inc., the independent Inspector of Election, and will be included in FINS' next semi-annual or annual report to shareholders, as applicable. ABOUT FINS Led by Angel Oak's experienced financial services team, FINS invests predominantly in U.S. financial sector debt as well as selective opportunities across financial sector preferred and common equity. Under normal circumstances, at least 50% of FINS' portfolio is publicly rated investment grade or, if unrated, judged to be of investment grade quality by Angel Oak. ABOUT ANGEL OAK CAPITAL ADVISORS, LLC Angel Oak is an investment management firm focused on providing compelling fixed-income investment solutions to its clients. Backed by a value-driven approach, Angel Oak seeks to deliver attractive, risk-adjusted returns through a combination of stable current income and price appreciation. Its experienced investment team seeks the best opportunities in fixed income, with a specialization in mortgage-backed securities and other areas of structured credit. On April 1, 2025, Angel Oak Companies, LP, the parent of Angel Oak Asset Management Holdings, LLC, itself the parent company of Angel Oak, announced that it signed a definitive agreement pursuant to which Brookfield Asset Management Ltd. will acquire a majority interest in Angel Oak Companies, LP and its subsidiaries, including Angel Oak (the 'Transaction'). The closing of the Transaction is expected to be completed by September 30, 2025. The Transaction is not expected to result in any material change in the day-to-day management of the Fund. However, the closing of the Transaction is subject to certain conditions, and there can be no assurance that the Transaction will be completed as planned, or that the necessary conditions will be satisfied. If successful, the closing of the Transaction would be deemed to be a change of 'control' of Angel Oak Companies, LP and its subsidiaries (collectively, the 'Angel Oak Companies'), including Angel Oak, under the Investment Company Act of 1940, and deemed 'assignment' of the Fund's investment advisory agreement (the 'Existing Advisory Agreement'), which would result in the automatic termination of the Existing Advisory Agreement. However, following the closing of the Transaction, the existing management team of the Angel Oak Companies will continue to independently manage the day-to-day business of the Angel Oak Companies and Angel Oak, and will control the boards of directors of the Angel Oak Companies. Information regarding the Fund and Angel Oak can be found at Past performance is neither indicative nor a guarantee of future results. Investors should read the prospectus supplement and accompanying prospectus and consider the investment objective and policies, risk considerations, charges and ongoing expenses of an investment carefully before investing. For more information, please contact your investment representative or EQ Fund Solutions LLC, the Fund's proxy solicitor, at 866-751-6314.

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