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Endovascular Engineering Presents Positive Results from ENGULF Feasibility Trial with its Hēlo™ PE Thrombectomy System for the Treatment of Pulmonary Embolism

MENLO PARK, Calif., May 6, 2024 /PRNewswire/ — Endovascular Engineering, Inc. (“E2”), a pioneering medical device company at the forefront of advancing clot removal technologies for venous thromboembolism (VTE), proudly announced positive safety and feasibility results from its ENGULF US clinical trial as late-breaking science at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions and …

Endovascular Engineering Presents Positive Results from ENGULF Feasibility Trial with its Hēlo™ PE Thrombectomy System for the Treatment of Pulmonary Embolism Read More »

Boston Scientific experiences high growth rate from pulsed-field ablation sales

Physicians are showing a strong preference for Boston’s Farapulse over Medtronic’s PulseSelect in the US. fter receiving FDA approval in December 2023 for its PulseSelect Pulsed-Field Ablation (PFA) system, Medtronic had a brief monopoly in the US PFA market. However, its monopoly abruptly ended when Boston Scientific received FDA approval one month later for its …

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Sensorium Therapeutics Appoints Sam Rasty as Chief Business Officer

Dr. Rasty brings 25+ years of experience in R&D, strategy, commercial, BD&L, and corporate leadership as the company advances novel, best-in-class medicines to treat CNS disorders BOSTON, April 17, 2024 /PRNewswire/ — Sensorium Therapeutics (Sensorium), a biotechnology company developing novel, best-in-class medicines to treat a variety of CNS diseases, today announced the appointment of Sam Rasty, Ph.D., as Chief …

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Study Investigators Conclude RapidPulse™ Precise Cyclic Aspiration Is Highly Effective and Safe for Ischemic Stroke Large Vessel Occlusions

MIAMI, April 04, 2024 (GLOBE NEWSWIRE) — A study recently published on-line at Interventional Neuroradiology provided results from a multi-center trial giving promise to the use of precise cyclic aspiration in acute ischemic stroke (AIS). Researchers compared their ability to restore blood flow in AIS patients using standard (also known as static) aspiration to an innovative, patented, …

Study Investigators Conclude RapidPulse™ Precise Cyclic Aspiration Is Highly Effective and Safe for Ischemic Stroke Large Vessel Occlusions Read More »

Geneos Therapeutics Announces Positive Phase 1/2 Data for GT-30 Trial of Personalized Therapeutic Cancer Vaccine

Trial has met primary endpoints of safety and immunogenicity and secondary endpoint for efficacy based on response rate Trial data published today in Nature Medicine Selected clinical trial data also presented at the 2024 AACR Annual Meeting PHILADELPHIA, April 7, 2024 /PRNewswire/ — Geneos Therapeutics, a clinical stage biotherapeutics company focused on the development of …

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Solu Therapeutics Appoints Michael Boretti, Ph.D., as Chief Business Officer

MEDFORD, Mass.–(BUSINESS WIRE)–Solu Therapeutics, a biotechnology company focused on developing therapeutics to eliminate disease-driving cells using its CyTaCTM (Cytotoxicity Targeting Chimera) platform, today announced the appointment of Michael I. Boretti, Ph.D., as Chief Business Officer (CBO). Dr. Boretti brings over 15 years of biotechnology leadership experience to Solu, including an extensive track record of company-building and …

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Reprieve Cardiovascular secures multimillion dollar financing

Reprieve Cardiovascular, a development stage company focused on pioneering an automated diuretic and fluid management approach for acute decompensated heart failure (ADHF) treatment, announced it has raised a total of US$42 million in series A financing. The total round was co-led by Lightstone Ventures and Sante Ventures and joined by Deerfield Management, Genesis Capital, and …

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Endovascular Engineering Announces First Patient Enrolled in ENGULF Pivotal Trial with its Hēlo™ PE Thrombectomy System for the Treatment of Pulmonary Embolism

MENLO PARK, Calif., Feb. 20, 2024 /PRNewswire/ — Endovascular Engineering, Inc. (“E2”), a pioneering medical device company at the forefront of advancing clot removal technologies for venous thromboembolism (VTE), proudly announces the enrollment and treatment of the first patient in the pivotal phase of its ENGULF US clinical trial. This IDE trial will further evaluate the safety …

Endovascular Engineering Announces First Patient Enrolled in ENGULF Pivotal Trial with its Hēlo™ PE Thrombectomy System for the Treatment of Pulmonary Embolism Read More »

Boston Scientific Receives FDA Approval for FARAPULSE™ Pulsed Field Ablation System

Strong clinical evidence base, largest volume of real-world use reinforce safety, efficacy and efficiency advantages of the system MARLBOROUGH, Mass., Jan. 31, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of …

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Endogenex Receives IDE Approval to Initiate Pivotal Clinical Study

A Prospective, Randomized, Multicenter Study Assessing the Safety and Efficacy of the ReCET™ System in Adult Patients with Type 2 Diabetes MINNEAPOLIS, Jan. 31, 2024 /PRNewswire/ — Endogenex, Inc., a clinical stage medical device company dedicated to improving outcomes in patients with Type 2 Diabetes (T2D), announced that the U.S. Food and Drug Administration (FDA) granted an …

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How a virtual company leveraged data to accelerate drug development for neurodegenerative diseases

Libra Therapeutics is a San Diego-based biotech focused on developing novel disease-modifying therapeutics, which restore the cellular balance that is disrupted in neurodegenerative diseases.   Established in 2020, Libra is leveraging proprietary technologies and therapeutic assets. The Libra portfolio includes three small molecule programs, including their lead non-clinical program targeting TRPML1 (based on an innovative …

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Shining a glaring light on surgery: technology that records every move aims to improve safety

Faulkner Hospital is trying out a system called the “OR Black Box,” which collects data to pinpoint missteps during operations. The operating room has long functioned in secrecy, a sanctum where a team works in quiet synchrony to cut open and, hopefully, repair an unconscious patient’s body. Those who do the work rarely talk about it …

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Endovascular Engineering’s HēloTM Thrombectomy System Receives IDE Approval to Start ENGULF Pivotal Trial for the Treatment of Pulmonary Embolism

Menlo Park, Calif., January XX, 2024 — Endovascular Engineering (“E2”), a medical device company focused on the development and deployment of groundbreaking clot removal technologies that target venous thromboembolism (VTE), announced today FDA Investigational Device Exemption (IDE) approval for its ENGULF US pivotal trial. This study will evaluate the safety and effectiveness of the Hēlo …

Endovascular Engineering’s HēloTM Thrombectomy System Receives IDE Approval to Start ENGULF Pivotal Trial for the Treatment of Pulmonary Embolism Read More »

Reimagine Care Secures Strategic Investment from Oncology Ventures

NASHVILLE, Tenn.–(BUSINESS WIRE)–Reimagine Care, the nation’s leading provider of virtual-first cancer care, has announced an investment from Oncology Ventures, a cancer-focused venture capital fund. This investment marks a significant milestone in the combined pursuit of innovative and patient-centric approaches to cancer care delivery. Oncology Ventures, renowned for its commitment to advancing oncology care and patient …

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BeeKeeperAI Expands Privacy-Enhancing Innovation with New Patent, New Product, and New Advantages to Accelerate Responsible AI in Healthcare

SAN FRANCISCO–(BUSINESS WIRE)–BeeKeeperAI, Inc., a pioneer in privacy-enhancing, multi-party collaboration software, today announced the next step in its innovation strategy for EscrowAI™ with automated, privacy-enhancing workflows to advance the responsible development and deployment of AI for healthcare. The company is expanding its novel privacy-enhancing capabilities to address confidential federation and confidential training in ways that …

BeeKeeperAI Expands Privacy-Enhancing Innovation with New Patent, New Product, and New Advantages to Accelerate Responsible AI in Healthcare Read More »

ABK Biomedical announces that its Eye90 microspheres® device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA)

HALIFAX, NS, Dec. 5, 2023 /PRNewswire/ – ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces its Eye90 microspheres device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).  This designation is for the proposed Eye90 microspheres indication for the treatment of …

ABK Biomedical announces that its Eye90 microspheres® device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) Read More »

Sensorium Therapeutics Announces Appointment of Veteran Biotech Executive Alexandra Glucksmann, Ph.D., as CEO as the Company Progresses Toward the Clinic

Glucksmann succeeds current Sensorium CEO and Co-Founder Dick Simon, who will transition to an advisory role and continue to serve on the Board of Directors The company announces a $3 million National Institutes of Health/National Institute on Aging grant to expand the capabilities of its nature-inspired approach/platform to address Alzheimer’s-related dementia Company progresses its platform and lead candidate, SENS-01, …

Sensorium Therapeutics Announces Appointment of Veteran Biotech Executive Alexandra Glucksmann, Ph.D., as CEO as the Company Progresses Toward the Clinic Read More »

Laminar, Inc. Acquired by Johnson & Johnson Medtech for $400 Million Upfront with Additional Clinical and Regulatory Milestone Payments in 2024 and Beyond

Santé Ventures was the sole venture capital investor in Laminar, which aims to treat persistent atrial fibrillation (AFib) with an innovative solution for the left atrial appendage (LAA) AUSTIN, Texas, Nov. 30, 2023 /PRNewswire/ — Santé Ventures (Santé), an early-stage healthcare and life sciences investment firm, has announced the acquisition of its Fund III portfolio company, Laminar, Inc., by …

Laminar, Inc. Acquired by Johnson & Johnson Medtech for $400 Million Upfront with Additional Clinical and Regulatory Milestone Payments in 2024 and Beyond Read More »

Geneos Therapeutics’ Cancer Vaccine Shows Potential for Shrinking ‘Difficult’ Tumors

NEW YORK – Geneos Therapeutics has set out to prove that cancer vaccines can do more than prevent disease recurrence in the adjuvant setting, and in a Phase I/IIa trial, the firm wants to show that its personalized DNA vaccine GNOS-PV02 can also treat advanced tumors. In August, Geneos reported data from the GT-30 trial showing that …

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