Category: Medtech

  • Medtech

Shorla Oncology Announces FDA Approval of IMKELDI (imatinib) Oral Solution, an Oral Liquid for the Treatment of Certain Forms of Leukemia and Other Cancers

Shorla Oncology, (“Shorla”), a U.S.-Ireland specialty pharmaceutical company, announced today that the FDA has approved IMKELDI (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers. Leveraging Shorla’s novel technology, IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy. IMKELDI can help slow or prevent the growth …
  • Medtech

Quanta Dialysis Technologies closes oversubscribed Series E Funding

Quanta Dialysis Technologies, a leader in transforming kidney care through its award-winning Quanta™ Dialysis System, has successfully closed its oversubscribed Series E Preferred Stock financing round, raising more than $60 million of additional capital. Led by Novo Holdings, Glenview Capital and b2venture, with broad participation by existing shareholders, this latest funding round underscores strong investor confidence in Quanta’s market potential to revolutionize …
  • Medtech

ShiraTronics Raises $66 Million in Oversubscribed Series B Financing to Advance Pioneering Treatment for Chronic Migraine

Implantable Neuromodulation System Shows Early Promise in Improving Patient Quality of Life by Reducing Monthly Headache Days and Severity of Migraine Attacks. ShiraTronics, a clinical-stage medical device company developing neurostimulation therapies for chronic migraine patients, today announced the closing of a $66 million Series B financing. The round was led by new investor Norwest Venture Partners, with participation from additional new investors …
  • Medtech

Pillar 5: Making Medtech Innovation sustainable, durable and scalable in Europe

The following is an opinion piece written by Daniel O’Mahony, partner at Seroba. The piece was written September 2024. Continuous investment into Medtech Innovation, from concept through to clinical trials, regulatory approval, market launch and scalability can deliver patient-centric, digitally advanced, resilient and sustainable health care. Such deliverables will benefit all stakeholders in Europe including patients, doctors, hospitals and payors. …
  • Medtech

Seroba Announces Its investment in Ryme Medical as Part of Series A Financing

Seroba, a European life sciences venture capital firm headquartered in Dublin, with offices in Paris and Milan, is pleased to announce the addition of Ryme Medical to its portfolio of medtech investments, following the completion of a Series A financing. The funds will be used to reach clinical and regulatory milestones for Ryme’s cutting-edge technology. Investing from its fourth fund, …
  • Medtech

Edward Lifesciences Expands Structural Heart Portfolio With Acquisitions of JenaValve and Endotronix

Edwards Lifesciences (NYSE: EW) today announced investments that reflect the company’s deep commitment to advancing patient care through structural heart innovation, addressing large unmet patient needs and supporting sustainable long-term growth. Edwards has entered into an agreement to acquire JenaValve Technology, a pioneer in the transcatheter treatment of aortic regurgitation (AR), a deadly disease that impacts a significant and growing population …
  • Medtech

Loci Orthopaedics Closes €12.8 Million Series A Financing

Loci Orthopaedics Ltd, an orthopaedic medical device company, today announced the successful closing of an oversubscribed €12.8 million Series A financing. The financing round was led by new investors Seroba, Johnson & Johnson Innovation, JJDC, Inc., (JJDC) and the European Innovation Council (EIC) Fund. Loci Orthopaedics develops novel technologies that target major unmet clinical needs in orthopaedics extremities. The company’s …
  • Medtech

Endotronix Receives FDA Premarket Approval of the Cordella™ PA Sensor System for the Treatment of Heart Failure

Endotronix, Inc., a privately held company dedicated to advancing the treatment of heart failure (HF) at the intersection of digital health and medtech, today announced Premarket Approval (PMA) from the U.S Food and Drug Administration (FDA) of the company’s Cordella™ Pulmonary Artery (PA) Sensor System for the treatment of New York Heart Failure (NYHA) class III heart failure patients. The …
  • Medtech

Deciphex Enters into Collaboration Agreement with Novartis to Advance AI in Preclinical Studies

Collaboration Agreement Seeks to engage AI to Transform Non-clinical Pathology Assessments in Drug Discovery and Development Deciphex, a Dublin-based digital pathology company, has entered into a Collaboration Agreement with Novartis to develop artificial intelligence (AI)-based approaches with potential to transform preclinical pathology assessments in drug discovery and development. The collaboration seeks to develop a suite of AI tools that streamline …
  • 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 …
  • 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. …
  • 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 …
  • 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 …
  • 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 …
  • 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 …
  • 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 …
  • 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 …
  • 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 …
  • 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 …
  • 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 …
  • 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 …
  • 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 …
  • 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 …
  • 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 …
  • 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 …
  • Medtech

Endotronix celebrates 100th implant of the Cordella™ Pulmonary Artery Pressure Sensor for proactive, remote management of heart failure

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced the 100th global implant of the Cordella Pulmonary Artery Pressure Sensor (Cordella Sensor) by Cardiologist and top worldwide implanter Faisal Sharif, MD of Bon Secours Hospital and Director of Cardiovascular Research at NUIG, both in Galway, Ireland. The sensor provides key …
  • Medtech

Endotronix Appoints Industry Veteran Dan Dearen to Board of Directors

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the appointment of seasoned medical device industry executive Dan Dearen to its Board of Directors. Mr. Dearen currently serves as the President and Chief Financial Officer of Axonics Modulation Technologies, Inc. (Nasdaq: AXNX), a medical technology company he helped take …
  • Medtech

Quanta receives FDA 510(k) clearance for the SC+ hemodialysis system setting the stage for US market launch

Seroba’s portfolio company, Quanta Dialysis Technologies Ltd (“Quanta” or “the Company”), a medical technology pioneer developing innovative dialysis products and services for the global market, today announce it has received 510(k) clearance from the US Food and Drug Administration (“FDA”) to market its small and simple, high performance hemodialysis system SC+. This critical milestone enables Quanta to bring to the …
  • Medtech

John S. Lipman appointed as Quanta’s President, North America

Seroba’s portfolio company, Quanta Dialysis Technologies Ltd (“Quanta” or the “Company”), a medical technology company developing innovative dialysis products and services, has announced the appointment of John S. Lipman as Quanta’s President, North America. John will lead Quanta’s commercial operations and activities in the United States. He is already working to set up operations and to prepare for commercial launch, …
  • Medtech

PQ Bypass releases positive 24-month data from the DETOUR1 clinical trial

Seroba’s portfolio company, PQ Bypass, Inc, a medical device pioneer bringing new advancements to the treatment of complex peripheral artery disease (PAD), announced promising long-term safety and effectiveness results from 24-month follow-up data from the DETOUR1 Clinical Study, including a 79% primary patency, with 82% of patients maintaining freedom from major adverse events at 2 years post-procedure. The DETOUR1 trial …
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