News

  • 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 …
  • Therapeutics

Fusion Pharmaceuticals appoints Donald Bergstrom, M.D., Ph.D., to Board of Directors

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines today announced the appointment of Donald A. Bergstrom, M.D., Ph.D., as a member of the Company’s Board of Directors. Dr Bergstrom, who currently serves as executive vice president, head of research and development at Relay Therapeutics, Inc., a clinical stage precision medicines company, …
  • 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 …
  • Therapeutics

Fusion Pharmaceuticals to expand pipeline with acquisition of IPN-1087, a small molecule targeting NTSR1, from Ipsen

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced it has entered into an asset purchase agreement (APA) to acquire Ipsen’s (Euronext: IPN; ADR; IPSEY) intellectual property and assets related to IPN-1087. IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types. …
  • 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 …
  • Therapeutics

Shorla Pharma announces U.S. industry veteran Nicholas Holsman as Chief Commercial Officer

Shorla Pharma Limited (‘Shorla’), a specialty pharmaceutical company, announces the appointment of Chief Commercial Officer Nicholas Holsman, a highly experienced U.S. industry executive with in-depth experience in scaling oncology & specialty pharma enterprises. Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers. With a strong team of scientists, clinicians and an extensive industry network, …
  • Therapeutics

Western Development Commission invests €2m in Atlantic Therapeutics

Atlantic Therapeutics, the Galway-based company pioneering a non-invasive, wearable treatment for urinary incontinence, today announced it has raised €2 million from The Western Development Commission’s investment fund. This is the largest single investment the WDC Investment Fund have made to date and is complemented by returning investors Seroba Life Sciences, Earlybird, LSP, Andera Partners and Atlantic Bridge, who continue their …
  • 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 …
  • Therapeutics

Fusion Pharmaceuticals initiates multi-dose portion of Phase 1 cancer trial

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 multi-dose portion of the Phase 1 study evaluating [225Ac]-FPI-1434 (FPI-1434) in patients with advanced solid tumors. FPI-1434 is a radioimmunoconjugate that utilizes Fusion’s proprietary Fast-Clear™ linker to connect a humanized monoclonal antibody …
  • 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, …
  • Therapeutics

Storm Therapeutics and Evotec Leverage Indigo platform to progress oncology project

Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) announced today that, as part of its ongoing collaboration with STORM Therapeutics (“STORM”), the leading biotechnology company focused on the discovery and development of small molecule therapies modulating RNA epigenetics, STORM has selected STC-15 as a first-in-class development candidate. STORM will now use INDiGO, Evotec’s unique integrated, accelerated IND-enabling platform, to …
  • 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 …
  • Medtech

Heidi Zak, CEO of ThirdLove, joins INNOVO® in advisory role

Seroba’s portfolio company, Atlantic Therapeutics, has announced that Heidi Zak, co-founder and CEO of ThirdLove will take on an advisory role in the acceleration of the INNOVO® brand. INNOVO® is a direct-to-consumer, FDA-approved medical device offering a clinically proven solution to stress urinary incontinence (SUI). INNOVO® is poised to disrupt the huge SUI category in which millions of women are …
  • Therapeutics

Fusion Pharmaceuticals announces collaboration with AstraZeneca to develop and commercialize next-generation Radiopharmaceuticals and combination therapies

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced a collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and commercialize next-generation alpha-emitting radiopharmaceuticals and combination therapies for the treatment of cancer. The collaboration leverages Fusion’s Targeted Alpha Therapies (TATs) platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of antibodies and …
  • Therapeutics

STORM Therapeutics selects first-in-class clinical candidate targeting METTL3

Seroba’s investee company, STORM Therapeutics, the leading biotechnology company focused on the discovery and development of small molecule therapies modulating RNA epigenetics, has announced that STC-15, its first-in-class drug candidate targeting METTL3, has been selected for development towards first in human clinical studies. The Company intends to submit an IND application in 2021. STC-15 is an orally bioavailable, small molecule …
  • Therapeutics

FutureNeuro partners with STORM Therapeutics to explore the role of RNA epigenetics in epilepsy

FutureNeuro has announced that it has entered into partnership with Seroba’s portfolio company, STORM Therapeutics, the leading biotechnology company focused on the discovery and development of small molecule therapies modulating RNA epigenetics, to explore new treatment options for people with epilepsy. The project, which will be led by Dr. Gary Brennan in UCD and Professor David Henshall in RCSI, will …
  • Medtech

PQ Bypass receives FDA “Breakthrough Device Designation” for the world’s first fully percutaneous femoral-popliteal Bypass device

PQ Bypass Inc, a medical device pioneer bringing new advancements to the treatment of advanced peripheral artery disease (PAD), announced today that they received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Detour System. The Detour System is the world’s first fully-percutaneous femoral-popliteal bypass device intended to treat extremely long, complex blockages in the superficial …
  • Therapeutics

Atlantic Therapeutics appoints Susan Trent as new CEO, based in the United States

Seroba’s portfolio company, Atlantic Therapeutics, a Galway-based MedTech and Femtech innovator, announces a transition in leadership to fulfill the potential of the INNOVO® brand in the large and under-served US Stress Urinary Incontinence market. Atlantic Therapeutics CEO Steve Atkinson will hand over the CEO role to Susan Trent. Susan joined Atlantic Therapeutics in November 2019 as SVP and GM, US. …
  • Therapeutics

Fusion Pharmaceuticals announces pricing of initial public offering

Fusion Pharmaceuticals Inc. (NASDAQ: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the pricing of its initial public offering of 12,500,000 common shares at a public offering price of $17.00 per share. All of the shares are being offered by Fusion. The gross proceeds of the offering, before deducting underwriting discounts and commissions …
  • Therapeutics

Novozymes acquires PrecisionBiotics Group

Seroba’s portfolio company, PrecisionBiotics Group has been acquired by Novozymes. Based in Cork, Ireland, PrecisionBiotics Group holds a leading position within probiotics for human gut health. Its products include the regular award-winning Alflorex for digestive health and Zenflore for stress reduction. Precision Biotics, which was a spin-out of UCC, has strong affiliations with the world-leading Alimentary Microbiome Ireland SFI Research …
  • Therapeutics

Shorla Pharma closes $8.3m Series A Funding Round

Shorla Pharma Limited (‘Shorla’), an Irish specialty pharmaceutical company has today announced the completion of a Series A investment of $8.3m. The financing was led by Seroba Life Sciences (‘Seroba’), a European Venture Capital firm headquartered in Dublin, Ireland with additional investment from Irish and Canadian based family offices and participation from Enterprise Ireland. Shorla has developed innovative oncology drugs …
  • Medtech

Quanta provides compact dialysis systems to NHS to support increased need caused by COVID-19 pandemic

Seroba’s portfolio company, Quanta Dialysis Technologies Ltd (“Quanta” or the “Company”), a medical technology innovation company, today announced that it has been proudly supporting the ongoing National Health Service (NHS) COVID-19 response for emergency dialysis provision by supplying its next-generation SC+ hemodialysis system to select NHS Trusts in the United Kingdom. Quanta delivered an initial batch of equipment and trained …
  • Medtech

Endotronix announces enrollment of the first patients in the PROACTIVE-HF Pivotal Trial

Seroba’s portfolio company, Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), today announced the enrollment of the first two patients in the PROACTIVE-HF pivotal trial. The trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella …
  • Therapeutics

Fusion Pharmaceuticals announces investment from Canada pension plan investment board

Seroba’s portfolio company, Fusion Pharmaceuticals Inc., a clinical-stage precision oncology company developing next-generation radiopharmaceuticals, today announced an investment commitment of up to US$20 million from Canada Pension Plan Investment Board (CPPIB). CPPIB joins Fusion’s existing group of top-tier investors adding to the US$105 million Series B announced in April 2019. The financing will primarily be used to expand the use …
  • Medtech

CMS approves coverage for PQ Bypass TORUS 2 IDE Trial

Seroba’s portfolio company, PQ Bypass Inc, a medical device company bringing new advancements to the treatment of peripheral artery disease (PAD), has announced that it has received approval for coverage from the Centers for Medicare and Medicaid Services (CMS) for the Investigational Device Exemption (IDE) study titled TORUS 2. This approval will affect coverage across all Medicare administrative regions. TORUS …
  • Medtech

Endotronix announces positive data from the SIRONA First-in-Human Trial for the Cordella™ PA Pressure Sensor System

Seroba’s portfolio company, Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), presented positive first-in-human data of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor). Data was presented at the 2019 American Heart Association (AHA) Scientific Sessions in Philadelphia, PA by Prof. Dr. Wilfried Mullens of the Hospital Oost-Limburg …
  • Medtech

PQ Bypass announces unconditional IDE Approval from U.S. FDA for pivotal study

PQ Bypass Announces Unconditional IDE Approval from U.S. FDA to Start TORUS SFA Stent Graft Pivotal Study (TORUS-2) Seroba’s portfolio company, PQ Bypass, Inc., a clinical-stage medical device company, today announced it has received full approval of its investigational device exemption (IDE) trial of the company’s TORUS stent graft, a novel stent graft platform designed for the treatment of peripheral …
  • Medtech

FDA approval for Endotronix 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 it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin the multi-center PROACTIVE-HF trial of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor). The innovative trial …
  • Medtech

Endotronix enrolls 1st patient in SIRONA II CE Mark Trial

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced enrollment of the first patient in its prospective, multi-center, SIRONA II trial, in Europe. The 60-patient study will evaluate safety and efficacy of the Cordella™ Pulmonary Artery Pressure Sensor System (Cordella Sensor) in support of its CE Mark submission. Cardiologist Prof. …
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