News

  • Medtech

Endotronix presents positive PROACTIVE-HF clinical trial results for its cordella pulmonary artery sensor

Endotronix, Inc., a privately held company dedicated to advancing the treatment of heart failure (HF) at the intersection of digital health and medtech, presented 6-month results from its PROACTIVE-HF pivotal trial.  PROACTIVE-HF evaluated the company’s investigational Cordella Pulmonary Artery (PA) Sensor in New York Heart Association (NYHA) class III HF patients at risk of congestion.  The trial met primary safety …
  • Therapeutics

Shorla FDA Filing to treat breast and ovarian cancer

Shorla FDA Filing to Treat Breast and Ovarian Cancer U.S.-Ireland Specialty Pharmaceutical Company’s ready-to-dilute form of a drug for the treatment of adenocarcinoma of the breast or ovary Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the US Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for a novel formulation …
  • Medtech

Endotronix Submits PMA Application for its Cordella Pulmonary Artery Sensor System

Seroba’s portfolio company, Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the U.S. Food and Drug Administration (FDA). Cordella is an innovative HF patient management platform that delivers proactive PA pressure …
  • Medtech

Perfuze® announces FDA clearances for novel neurovascular aspiration and access catheters for stroke treatment

Perfuze, a private medical device company dedicated to developing pioneering technology to treat acute ischemic stroke, proudly announces FDA clearance for the Millipede 070 Aspiration Catheter and the 2nd generation of the Millipede 088 Access Catheter. The Millipede 070 Aspiration Catheter is built upon a pioneering, distinctive technology that enables physicians to address critical unmet needs in ischemic stroke treatment. …
  • Therapeutics

Shorla Oncology & EVERSANA announce U.S. commercial launch of FDA-Approved JYLAMVO, the first and only oral methotrexate solution approved in the U.S. for adults

Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, and EVERSANA®, a leading provider of commercialization services to the life science industry, today announced the commercial launch of JYLAMVO (methotrexate) oral solution, the first and only oral methotrexate solution approved in the United States for use in adults. JYLAMVO has been shown to have a sweet, palatable taste 1,2*and is approved …
  • Therapeutics

Complement Therapeutics Announces the Establishment of Medical Advisory Board

Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the formation of its Medical Advisory Board which will help guide the development of the company’s innovative therapeutic pipeline including its lead investigational product CTx001, a gene therapy for geographic atrophy. The Medical Advisory Board consists of six esteemed members, led by Chair, …
  • Corporate

Seroba confirme ses ambitions françaises Biotech Finances

Retrouvez l’article sur Biotech Finances LE FONDS IRLANDAIS SEROBA CONFIRME SES AMBITIONS FRANÇAISES, by Pierre Havez Fondé en 2002 à Dublin, le fonds irlandais Seroba renforce sa présence française afin d’accroître ses investissements sur le continent européen. Alors que nos investissements étaient historiquement majoritairement en Irlande et au Royaume-Uni, nous avons la volonté de nous développer en France, en Italie, …
  • Therapeutics

Complement Therapeutics enrols first US participant in the Non-interventional i-GAIN study of people diagnosed with geographic atrophy

Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the enrolment of their first participant in the United States, an important milestone for the i-GAIN natural history study of people who have been diagnosed with geographic atrophy (GA), secondary to age-related macular degeneration (AMD). The i-GAIN (investigating Geographic Atrophy Insights) study is …
  • Therapeutics

Artica Therapeutics Closes €12M Seed Investment to Develop Covalent Therapeutics for Autoimmune and Inflammatory Disorders

Artica Therapeutics B.V. (Artica), a biotechnology company unlocking the power of medicines with insurmountable binding characteristics, today announced it has raised €12 million in Seed financing. The round was co-led by Thuja Capital and Seroba, with participation from InnovationQuarter and founding investor BGV. Proceeds from the financing will be used to advance Artica’s small molecule pipeline of novel covalent therapies. …
  • Medtech

Perfuze® announces first stroke patient enrolled in the MARRS Pivotal Clinical Trial for the Millipede System

Perfuze, a private medical device company dedicated to developing pioneering technology to treat acute ischemic stroke, announced commencement of enrollment in its pivotal MARRS (Millipede AspiRation for Revascularization in Stroke) clinical study. MARRS is a multi-center trial to evaluate the performance of the Millipede System. The first patient was enrolled at Stony Brook University Hospital in Stony Brook, NY. MARRS …
  • Therapeutics

Shorla Oncology announces US acquisition of Jylamvo, an oncology and autoimmune drug from Therakind

Shorla Oncology (‘Shorla’), a US-Ireland specialty pharmaceutical company, and Therakind Ltd (‘Therakind’), a UK-based speciality pharmaceutical company have entered into an agreement under which Shorla has agreed to acquire Jylamvo, an oncology and autoimmune drug, for the US market. The therapy has been approved by the US Food and Drug Administration (FDA). Jylamvo is an easy-to-administer, sweet tasting oral methotrexate …
  • Medtech

Endotronix Receives IDE Approval for the Market Expanding PROACTIVE-HF 2 Clinical Trial

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), announced it has received Investigational Device Exemption (IDE) approval from the FDA for a subsequent multicenter study, PROACTIVE-HF 2, which will evaluate the company’s Cordella Sensor for pulmonary artery (PA) pressure-guided therapy. The prospective, dual-arm trial aims to expand access to New …
  • Therapeutics

Shorla Oncology Secures $35M Series B Funding Round to Advance its Oncology Product Portfolio

Seroba’s portfolio company, Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, today announced that it has raised $35 million in Series B funding, led by Kurma Partners’ Growth Opportunities Fund, with participation from existing investors Seroba Life Sciences and Irish, U.S. and Canadian based family offices and Enterprise Ireland. The funding will enable Shorla to accelerate the growth of its …
  • Medtech

New expanded indication will increase home hemodialysis device options available to patients with end-stage kidney disease

Seroba’s portfolio company, Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for indication expansion of the Quanta™ Dialysis System, a compact and easy-to-use hemodialysis device. The Quanta Dialysis System is currently indicated for use in chronic …
  • Medtech

Quanta™ Receives FDA 510(k) Clearance for Expanded Indication of Continuous Renal Replacement Therapies

Quanta Dialysis System becomes first-in-class to perform three standard-of-care dialysis modalities in one device. Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, today announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of the Quanta Dialysis System, a compact and easy-to-use hemodialysis device, for two modalities of …
  • Therapeutics

Complement Therapeutics appoints Dr Parisa Zamiri MD, as Chief Medical Officer

Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, has announced the appointment of Dr Parisa Zamiri as its Chief Medical Officer. Dr. Zamiri brings with her extensive experience in biopharmaceutical and small molecule drug discovery and development, drug and device safety, pharmacovigilance, and biomarker development across various therapeutic areas. Dr. Zamiri joins CTx …
  • Medtech

Palliare announces EU CE mark approval under new Medical Devices Regulation

Seroba’s portfolio company, Palliare, a leading developer of advanced insufflation technologies, has received EU CE Mark certification under the new EU Medical Devices Regulation (MDR) for its EVA15 insufflator and smoke evacuation system. This makes it one of the first laparoscopic and endoscopic insufflators to meet the new more extensive regulatory requirements introduced in 2021 for medical devices in Europe, …
  • Medtech

Perfuze announces appointment of New Chair of the Board

Seroba portfolio company, Perfuze, a medical device company developing next-generation ”super-bore” catheter technology to treat acute ischemic stroke, is pleased to announce the appointment of Hooman Hakami as the new Chair of the Board. This appointment reflects Perfuze’s commitment to bring devices to market that have the potential to transform the treatment of acute ischemic stroke. Hooman brings a wealth …
  • Therapeutics

Coave Therapeutics announces Positive 12-months data from Ongoing Phase I/II Clinical Trial of CTx-PDE6b in patients with retinitis pigmentosa caused by bi-allelic mutations in PDE6b

Seroba portfolio company, Coave Therapeutics (‘Coave’), a clinical-stage biotechnology company focused on developing life-changing gene therapies for CNS (Central Nervous System) and eye diseases, today announces the positive 12-month results from its Phase I/II trial evaluating the safety and efficacy of its innovative gene therapy, CTx-PDE6b, for retinitis pigmentosa (RP) caused by bi-allelic mutations in the PDE6B gene (PDE6b RP). …
  • Medtech

Endotronix extends positive outcomes with 12-month data release from the SIRONA 2 trial for remote heart failure management using the Cordella Pulmonary Artery Sensor

Seroba’s portfolio company, Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced positive 12-month data from the SIRONA 2 clinical trial that demonstrated long-term use of the Cordella Pulmonary Artery (PA) Sensor was associated with significant improvements in patient quality-of-life metrics and low HF hospitalization and death (HFH/D) event …
  • Therapeutics

Complement Therapeutics secures €72 Million in Series A financing to advance novel therapies targeting complement-mediated diseases

Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement mediated diseases, today announced the completion of a €72 million Series A financing. The round was led by Gimv, a Belgian-based private equity and venture capital fund, co-led by Forbion as existing investor and further joined by BioGeneration Ventures (BGV), Panakès Partners, Cambridge Innovation Capital (CIC), …
  • Medtech

Endotronix announces enrollment completion of PROACTIVE-HF pivotal trial

Seroba’s portfolio company, Endotronix Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced its PROACTIVE-HF pivotal study successfully completed enrolment. Designed to evaluate the safety and efficacy of the CordellaTM Pulmonary Artery (PA) Sensor, the data will support the pre-market approval (PMA) application for market access in the U.S. “Building …
  • Therapeutics

Shorla Oncology announces U.S. FDA approval of Nelarabine injection for the treatment of T-cell leukemia

Shorla Oncology (‘Shorla’), a US-Ireland pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the company’s oncology drug, Nelarabine Injection, for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL). Nelarabine Injection provides patients with an alternative to a product that has historically been in shortage. This marks the first product approved …
  • Medtech

Perfuze announces FDA clearance and first U.S. clinical use of Millipede 088 access catheter

Perfuze, a medical device company developing next-generation catheter-based technology to treat acute ischemic stroke, has secured its first product clearance from the U.S. Food and Drug Administration (FDA) for the company’s Millipede 088 Access Catheter. The first U.S. clinical procedures with Millipede 088 were successfully performed by physicians at Stony Brook University Hospital in Stony Brook, NY and the University …
  • Therapeutics

Fusion Pharmaceuticals to acquire phase 2 program for 225Ac-PSMA I&T, a radiopharmaceutical targeting metastatic castrate resistant prostate cancer

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) (“Fusion”), a clinical-stage oncology company focused on developing next-generation targeted alpha therapies (“TATs”) as precision medicines, today announced the acquisition from RadioMedix, Inc. (“RadioMedix”) of the investigational new drug application (“IND”) for an ongoing Phase 2 clinical trial (the “TATCIST” trial) evaluating 225Ac-PSMA I&T, a small molecule targeting prostate specific membrane antigen (“PSMA”) expressed on …
  • Medtech

U.S. FDA Grants 510(k) expanded indication for Palliare’s EVA15 insufflation technology to accommodate higher pressure range

Palliare, a leading developer of advanced insufflation technologies, has received an expanded 510(k) indication from the U.S. Food and Drug Administration for its EVA15 Insufflator to provide an extended pressure delivery range of up to 25mmHg. This increased pressure range represents the highest-performing robotic insufflator on the market to offer continuous pressure insufflation, with integrated smoke evacuation, and is designed …
  • Therapeutics

STORM Therapeutics announces closing of USD $30M Series B financing

STORM Therapeutics Ltd. (STORM), the clinical biotechnology company discovering and developing novel small molecule therapies targeting RNA modifying enzymes (RMEs) for oncology and other diseases, today announced the successful completion of a USD $30 million Series B financing round. The financing was co-led by existing investors M Ventures, Pfizer Ventures, Taiho Ventures LLC, Cambridge Innovation Capital (CIC) and new investors …
  • Therapeutics

STORM Therapeutics doses first patient with oral METTL3 targeting drug candidate in a solid tumor Phase 1 study

STORM Therapeutics Ltd. (STORM), the biotechnology company discovering and developing novel small molecule therapies targeting RNA modifying enzymes (RMEs) for oncology and other diseases, today announces that the first patient has been dosed with STC-15, the Company’s first-in-class clinical candidate. An orally bioavailable, highly selective METTL3 inhibitor, STC-15 is the first molecule specifically targeting an RNA methyltransferase enzyme to enter …
  • Therapeutics

Sibylla Biotech raises €23 million series A to advance protein degradation by folding interference pipeline and expand technology platform

Sibylla Biotech today announced the successful close of its €23 million Series A financing round to fund the further development of its Pharmacological Protein Inactivation by Folding Intermediate Targeting (PPI-FIT) approach, which provides access to a new class of pharmacological targets that transiently appear during the process of protein folding, and to advance its proprietary pipeline programs through preclinical evaluation. …
  • Medtech

Endotronix celebrates 400th implant of Cordella™ Pulmonary Artery Pressure Sensor for proactive, remote heart failure management

Seroba portfolio company, Endotronix, Inc., a privately-held digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced implantation of the 400th Cordella™ Pulmonary Artery (PA) Pressure Sensor. The milestone includes successful implants across the company’s completed European trials, SIRONA First-in-Human and SIRONA 2, as well as the currently enrolling global investigational device exemption …
  • Therapeutics

STORM Therapeutics appoints Dr. Jerry McMahon as Chief Executive Officer

Seroba portfolio company, STORM Therapeutics Ltd. (STORM), the biotechnology company discovering and developing novel small molecule therapies targeting RNA modification enzymes for oncology and other diseases, today announced the appointment of Dr. Gerald (Jerry) McMahon as President and Chief Executive Officer and Board Director. Dr. McMahon brings with him more than 30 years of biotechnology leadership, scientific innovation, creative deal-making, …
  • Therapeutics

Fusion Pharmaceuticals Announces First Patient Dosed In Phase 1/2 Study Of FPI-1966 In Patients With Advanced Solid Tumors Expressing FGFR3

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the first patient has been dosed in the Phase 1/2 study evaluating [225Ac]-FPI-1966 (FPI-1966) in patients with advanced solid tumors expressing fibroblast growth factor receptor three (FGFR3). FPI-1966 utilizes Fusion’s Fast-Clear™ linker to connect vofatamab, a human monoclonal antibody that …
  • Medtech

Atlantic Therapeutics Announces the Appointment of Russell Medford MD, PhD as New US-Based Chairman

Atlantic Therapeutics has announced the appointment of Russell Medford MD, PhD as Chairman. The addition of Dr Medford to the Board is a significant step to fulfill the potential of the INNOVO® brand in the large and under-served US stress urinary incontinence (SUI) market. Dr Medford is a senior healthcare and life sciences executive with extensive private and public company …
  • Therapeutics

Fusion Pharmaceuticals Announces FDA Clearance Of IND For FPI-2059, An Investigational Small Molecule-Based Radiopharmaceutical Targeting Solid Tumors Expressing NTSR1

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) applications for [225Ac]-FPI-2059 (FPI-2059) and the corresponding imaging analogue [111In]-FPI-2058 (FPI-2058). FPI-2059 is a targeted alpha therapy (TAT) designed to use a small molecule to …
  • Medtech

Endotronix announces positive data from SIRONA 2 in late-breaking clinical trial eession

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced positive data from the SIRONA 2 clinical trial evaluating safety and efficacy of its Cordella™ Pulmonary Artery Pressure Sensor System (Cordella Sensor) in New York Heart Association (NYHA) class III heart failure patients. The prospective, multi-center trial met all primary …
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