Tag: PR

  • 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. …
  • Therapeutics

Seroba Invests in Storm Therapeutics

STORM Therapeutics (“STORM”), the drug discovery company tackling disease through modulating RNA modifying enzymes, has announced that it has raised an additional £14 million bringing its total Series A financing to £30 million. The financing includes funding from Seroba, as a new investor. STORM’s existing investors, Cambridge Innovation Capital, M Ventures, Pfizer Ventures, Taiho Ventures and IP Group also participated …
  • Medtech

Quanta SC+ confirmed as safe and easy to use

Seroba’s portfolio company, Quanta Dialysis Technologies Ltd (“Quanta” or the “Company”), a pioneering medical technology company developing a personal haemodialysis system (SC+) for patient use in the clinic and the home, today announced that results from its human factors testing (HFT) of SC+ have been published in Hemodialysis International, a leading peer-reviewed journal for the renal community. SC+ was designed …
  • Therapeutics

Fusion Raises $105m in Series B Financing

Seroba’s portfolio company, Fusion Pharmaceuticals, a clinical-stage biopharmaceutical company developing targeted alpha-particle radiotherapeutics for treating cancer, today announced the completion of a $105 million Series B financing led by Varian and new investor OrbiMed Advisors. Seroba participated in the round alongside new investors including Perceptive Advisors, Pivotal bioVenture Partners, and Rock Springs Capital, and the existing group of leading international …
  • Therapeutics

First Patient Dosed in Fusion Phase I trial

Seroba portfolio company, Fusion Pharmaceuticals, a biopharmaceutical company focused on radiotherapeutics (targeted alpha therapeutics) has announced the first patient was dosed in a Phase 1, first-in-human clinical trial of lead product candidate [225Ac]-FPI-1434 in patients with advanced solid tumors. “The entire Fusion team takes tremendous pride in having developed a new targeted alpha therapeutic and in moving it from the …
  • Therapeutics

Atlantic Therapeutics Raise €28M in Series B Funding

Atlantic Therapeutics, the medical technology company developing garment-based pelvic floor muscle strengthening and nerve stimulation devices treating the cause of bladder leaks, has announced that it has closed €28 million in Series B funding to continue its rapid growth trajectory. Having recently gained FDA clearance for its INNOVO® therapy device, this latest round of funding will enable Atlantic Therapeutics to …
Subscribe to our Newsletter
* = required field