Our portfolio companies are making headlines by changing the life of patients. Stay up-to-date on their latest news.
- ニュートン・バイオキャピタル、株式会社PRISM BioLabに新規投資
- Newton Biocapital invests in PRISM BioLab to support development of a unique peptide mimetic technology platform to discover new drugs for intractable diseases
- Newton Biocapital invests in EditForce to support development of a unique DNA/RNA editing platform based on PPR protein technology
- Newton Biocapital invests in NeuVasQ: EUR 20 million Series A to develop unique blood-brain barrier therapy
- Acticor Biotech Announces appointment of Mr Alain Munoz as Chairman of the Board of Directors and Mrs Sophie Binay and Mr Yannick Pletan as General Managers.
- SEQUANA MEDICAL ANNOUNCES NEW SHARE CAPITAL AMOUNT AND NEW NUMBER OF SHARES
- Newton Biocapital invests in Flemish start-up DeuterOncology
- Newton Biocapital I invests in Perseus Proteomics Inc. in Japan to develop therapeutic antibodies for the treatment of blood cancers
- Sequana Medical announces positive interim data from North American pivotal alfapump® study (POSEIDON)
- Sequana Medical announces strong interim results from RED DESERT alfapump® DSR study and provides business update
- ACTICOR BIOTECH ANNOUNCES THE SUCCESS OF THE FIRST PHASE OF ITS ACTIMIS STUDY WITH GLENZOCIMAB IN PATIENTS WITH ACUTE ISCHEMIC STROKE
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- J-Pharma Raises 1,746 million JPY in Funding
- SEQUANA MEDICAL SUCCESSFULLY RAISES EUR 19.0 MILLION IN AN EQUITY PLACEMENT
- Sequana Medical announces first patient enrolled in RED DESERT – REpeated Dose alfapump® DSR study for Treatment of diuretic-resistant heart failure patients
- Sequana Medical appoints leading experts as Heart Failure Scientific Advisors
- Sequana Medical announces unconditional IDE approval from U.S. FDA to start alfapump® pivotal study (POSEIDON)
- SEQUANA MEDICAL announces inclusion of alfapump® in German treatment guidelines (DGVS) for complications of liver cirrhosis
- SEQUANA MEDICAL announces acceptance of late-breaking abstract of DSR therapy for volume overload in heart failure at Heart Failure 2019 Congress
- EditForce raises 870 million JPY
- エディットフォース株式会社 総額 8 億 7 千万円の資金調達完了について
- SEQUANA MEDICAL raises €27.5 million in successful Initial Public Offering
- SEQUANA MEDICAL announces the Coverage of the Base Offering of Its Initial Public Offering on Euronext Brussels
- SEQUANA MEDICAL Launches Its Initial Public Offering on Euronext Brussels
- SEQUANA MEDICAL receives Breakthrough Device designation from the FDA for its alfapump®
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- DBJ Signs Contract with Newton Biocapital I Pricaf Privee SA, a Japanese-European Venture Capital Fund for Early Stage Pharmaceuticals
- EPICS Therapeutics to Acquire Ogeda former assets, Adding Drug Discovery & Development Capabilities
- UK NICE recommends use of the alfapump® for the treatment of refractory ascites caused by cirrhosis under special arrangements
- SEQUANA MEDICAL establishes new corporate headquarters in Ghent, Belgium and raises €8.5 million from leading Belgian investors including Newton Biocapital, PMV and SFPI-FPIM as well as existing shareholders
- ACTICOR BIOTECH raises € 15.3 M in a Series B financing
- CHROMACURE S.A., a spin-off from the Université libre de Bruxelles (ULB),is launched with €17m committed equity investment to develop enhanced cancer therapies
- SYNERGIA raises €8.1 million in Series A
- ACTICOR BIOTECH ANNOUNCES THAT THE EUROPEAN MEDICINES AGENCY CLEARS THE ROUTE FOR A PHASE II OF ITS ACT017 PRODUCT IN STROKE
SEQUANA MEDICAL receives Breakthrough Device designation from the FDA for its alfapump®
Sequana Medical NV, a commercial stage medical device company focused on the development of innovative treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders, announces today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the alfapump® for the treatment of liver recurrent or refractory ascites.
The FDA’s Breakthrough Devices Program is designed to facilitate the development and expedite the review of devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and to provide patients and healthcare providers with timely access to these medical devices. Devices that receive this designation are eligible for more frequent interactions with the FDA’s experts to identify areas of agreement in a timely way and are eligible for prioritized review of the submission package to obtain regulatory approval in the U.S.
Ascites, a key complication of liver cirrhosis, is the accumulation of ascitic fluid in the abdomen. Patients may accumulate as much as 10 to 15 litres of ascitic fluid within the abdomen every 15 days. Patients suffering from liver recurrent or refractory ascites have limited treatment options and often have severely impacted quality of life due to the severe swelling of the abdomen, resulting in pain, difficulty breathing, moving, sleeping and eating, severe nausea and constipation. Existing treatment options carry the risk of significant or life-threatening side effects, provide only short-term symptomatic relief or have very limited availability.
The alfapump® is a fully-implanted, programmable, wireless, CE-marked system that automatically pumps ascites from the peritoneal cavity into the bladder, where the body eliminates the ascites naturally through urination. The potential of the alfapump® to address this unmet medical need in patients with liver recurrent or refractory ascites has been demonstrated in multiple clinical studies showing a significant reduction in the need for large volume paracentesis, which is paracentesis where at least 5 litres of fluid is removed (i.e., the current standard of care), and a significant improvement in patients’ quality of life.
A feasibility study in North America in patients with liver refractory or recurrent ascites has been completed and results were presented at the AASLD (American Association for the Study of Liver Diseases) annual meetings in October 2017 and November 2018. Preparations are underway to start a North American pivotal study in the second half of this year for approval of the alfapump® in North America.
Dr Patrick S. Kamath, Professor of Medicine at the Mayo Clinic, College of Medicine and Science Rochester MN commented:
“This is encouraging news for patients and their families. Patients suffering from recurrent or refractory ascites currently have limited treatment options. Ascites significantly reduces quality of life and requires frequent visits to a medical facility for treatment. The alfapump® treats ascites at home without the risk of hepatic encephalopathy and is associated with improved quality of life. The designation of FDA Breakthrough Device status for the alfapump® could make a much needed effective treatment of refractory or recurrent ascites available sooner for doctors and their patients.”
Ian Crosbie, Chief Executive Officer at Sequana Medical, added:
“The designation of Breakthrough Device status by the FDA is a recognition both of the high unmet medical need in patients with recurrent or refractory ascites and the potential for thealfapump® to improve the lives of these patients. The forecast growth in liver cirrhosis resulting from NASH makes the need for improved treatments all the more important. We look forward to continuing to work with the FDA to expedite the development process and bring the alfapump® to U.S. patients as quickly as possible.”
Update regarding the status of the Initial Public Offering on Euronext Brussels:
The administrative process for the move of Sequana Medical’s business from Switzerland to Belgium has been completed. Meanwhile, the IPO preparations continue being progressed according to plan, and the Company will provide a further update on the IPO process in due course.