Tag: PR

  • 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 …
  • Therapeutics

Shorla Oncology appoints Dennis Purcell as Chairman of the Board of Directors

Shorla Oncology (‘Shorla’), an Irish specialty pharmaceutical company, today announced the appointment of Dennis Purcell as Board Chairman. As a preeminent leader in the biotech industry, Purcell brings significant experience that will help guide Shorla in bringing their novel oncology products to the U.S. market. Purcell is the original Founder of Aisling Capital LLC, a leading life sciences investment firm …
  • Medtech

Neurovascular Company Perfuze raises €22.5M ($25M) Series A for new stroke treatment

Perfuze, a medical device company developing next-generation catheter-based aspiration technology to treat large vessel occlusion acute ischemic stroke, has closed a €22.5 million Series A investment round. Proceeds from the financing will be used to drive the next stage of US clinical study and regulatory clearance of its Millipede System. The funds will also be used to support ongoing development …
  • Therapeutics

Fusion Pharmaceuticals announces nomination of first targeted alpha therapy candidate in collaboration with AstraZeneca to advance into IND-Enabling studies for phase 1 development

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced nomination of the first targeted alpha therapy (TAT) candidate under the Company’s collaboration agreement with AstraZeneca (LSE/STO/Nasdaq: AZN). Both companies will jointly develop through a Phase 1 study the novel TAT which utilizes Fusion’s Fast-Clear™ linker technology to radiolabel an AstraZeneca-owned …
  • Medtech

Endotronix announces FDA approval for PROACTIVE-HF pivotal trial design change to single-arm study

Seroba portfolio company, Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has granted approval for an amendment to the company’s PROACTIVE-HF study, a pivotal Investigational Device Exemption (IDE) trial investigating the Cordella Pulmonary Artery (PA) Pressure Sensor1, shifting the design from …
  • Therapeutics

INNOVO® Partners with Joan Lunden and Jamie Hess on Women’s health educational initiative

Women’s pelvic health brand INNOVO, an FDA-cleared medical device that delivers perfect Kegels through electrical stimulation, is partnering with journalist and author, Joan Lunden and her daughter, wellness expert Jamie Hess. Today, this powerful partnership launches a women’s health initiative aimed to educate women on aging and all the changes that occur during this time, including Stress Urinary Incontinence (SUI) …
  • Therapeutics

Exelixis and STORM Therapeutics enter into exclusive collaboration and license agreement to discover and develop inhibitors of Novel RNA Modifying Enzymes

STORM to deliver small molecule ADAR1 clinical candidate compounds discovered using its proprietary RNA modifying enzyme drug discovery platform. Exelixis, Inc. (Nasdaq: EXEL) and STORM Therapeutics (STORM) today announced that they have entered into an exclusive collaboration and license agreement under which the parties will discover and advance novel drug leads intended for the treatment of cancer. The collaboration will …
  • Therapeutics

Fusion Pharmaceuticals appoints Mohit Rawat as President and Chief Business Officer

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Mohit Rawat as President and Chief Business Officer. Mr. Rawat brings to Fusion more than 15 years of experience in the biopharmaceutical industry, with expertise in corporate strategy, business development and commercial execution, including product development, launch planning …
  • Therapeutics

Shorla announces partnership with EVERSANA to support the launch and commercialization of T-cell leukemia treatment

Seroba’s portfolio company, Shorla Pharma (‘Shorla’), a specialty pharmaceutical company and EVERSANA™, the pioneer of next generation commercial services to the global life sciences industry, today announced a partnership to support the launch and commercialization of Shorla’s oncology portfolio. The new partnership will initially focus on SH-111, an oncology drug designed to treat T-cell leukemia, currently pending U.S. FDA approval. …
  • Therapeutics

Fusion Pharmaceuticals announces FDA clearance of IND for FPI-1966, an investigational radiopharmaceutical for the treatment of head and neck and bladder cancers 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 U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) applications for [225Ac]-FPI-1966 (FPI-1966) and imaging agent [111In]-FPI-1967 (FPI-1967). FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to …
  • Therapeutics

Coave Therapeutics closes €33 million ($39 million) Series B financing to develop its gene therapy pipeline and next-generation vectors based on its AAV-Ligand conjugate platform

Coave Therapeutics (pronounced ‘cove’; formerly Horama), a clinical stage biotechnology company focused on developing life changing gene therapies in rare Ocular and CNS (Central Nervous System) diseases, announces a €21.2 million ($25.1 million) expansion of its Series B funding round, bringing the total raised to €33.1 million ($39 million). This financing was led by Seroba Life Sciences, supported by new …
  • Medtech

Palliare announces US FDA 510(k) clearance to extend the indications of its EVA15 insufflation technology for use in endoscopic surgery

Seroba portfolio company, Palliare, an emerging company with the vision to create a safer operating room, has announced that it has received FDA 510(k) clearance for its END-200 tubeset, which extends the capabilities of its EVA15 continuous pressure insufflation technology from laparoscopic surgery to endoscopic and endoluminal surgery. Commenting on the clearance, John O’Dea, CEO, said “We believe that this …
  • Medtech

Quanta raises $245 million to accelerate commercialization of its SC+ portable hemodialysis system

Quanta Dialysis Technologies Ltd (“Quanta” or the “Company”), a medical technology leader delivering on its vision for more flexible and accessible dialysis care, announced today that it has raised $245 million in an oversubscribed and upsized Series D round, the largest private funding round for a dialysis device company in history. “We are delighted to attract such a strong syndicate …
  • Therapeutics

Fusion Pharmaceuticals Announces Preliminary Safety and Dosimetry Results from its Single-Dose Portion of the Phase 1 Study of FPI-1434

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting. The presentations and posters highlight the potential of Fusion’s targeted alpha therapies (TATs) to …
  • Therapeutics

Fusion Pharmaceuticals announces clinical collaboration with Merck to evaluate Fusion’s Targeted Alpha Therapy (TAT) in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that it has entered into a clinical trial collaboration with a subsidiary of Merck (known as MSD outside the U.S. and Canada) to evaluate Fusion’s lead candidate, [225Ac]-FPI-1434 (FPI-1434), in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab), in …
  • Therapeutics

Shorla Pharma announces FDA filing acceptance and priority review for T-cell leukemia treatment

Seroba’s portfolio company, Shorla Pharma Limited (‘Shorla’), a specialty pharmaceutical company, has announced that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted for filing, its application for its SH-111 oncology drug designed to treat T-cell leukemia. SH-111 is a lifesaving treatment that is often in shortage and the company looks forward to working closely with …
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