Minze Health NV signed a three-year agreement with Medtronic plc to bring its Minze Diary Pod, an app-controlled automated urine collection device, to markets across the EMEA region. The partnership aims to enhance the support services available for patients with overactive bladder receiving sacral neuromodulation therapy with Medtronic’s Interstim system.
Biocartis Group NV received premarket approval from the U.S. FDA for its Idylla Cdx MSI test, developed in partnership with Bristol Myers Squibb Co., to help in the diagnosis and treatment of colorectal cancer. The cartridge-based, fully automated, sample-to-result test enables faster identification of patients with the disease who may benefit from therapeutic treatment.
Sequana Medical NV received premarket approval from the U.S. FDA for its Alfapump system to treat recurrent or refractory ascites due to liver cirrhosis. Data from the Poseidon pivotal study showed the implantable device, which removes ascites from the abdomen into the bladder, can eliminate the need for therapeutic paracentesis, improving the quality of life of patients.
Genflow Biosciences plc has received correspondence from Belgium’s Federal Agency for Medicines and Health Products (FAHMP) with a recommendation to initiate a phase I/II trial of GF-1002 in patients with nonalcoholic steatohepatitis (NASH), rather than in healthy volunteers.
Novigenix SA reported interim European validation data for its whole blood RNA signature for early detection of precancerous colorectal lesions. The data was presented in early July at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in Barcelona.
Sequana Medical NV has reported additional data on safety, survival and quality of life from its POSEIDON pivotal study in North America, evaluating its Alfapump device used in the treatment of patients with recurrent or refractory ascites caused by liver cirrhosis. The data were recently presented at the European Association for the Study of the Liver 2023 congress in Vienna.
Biocartis Group NV recent entered an agreement with Apis Assay Technologies Ltd. to develop Apis’ breast cancer subtyping assay on its Idylla platform, is part of the Belgium company’s mission to bring complex molecular testing to as many patients as possible, outgoing Biocartis CEO Herman Verrelst, told BioWorld. The Idylla platform is a fully automated, real-time PCR based molecular testing system. With the technology failing to penetrate the U.S. market, and the share price tanking in recent years, the Belgium-based company recently appointed Roger Moody to the top job, effective Apr. 24, 2023.
Nyxoah SA reported it successfully raised $3 million to ramp development of its Genio technology for the treatment of obstructive sleep apnea. This fundraising took the form of private placement of shares on the Nasdaq. They were acquired by Sydney-based Cochlear Ltd., an existing Nyxoah shareholder.
Amber Therapeutics Ltd. reported that three patients have been fitted with its closed loop bioelectrical stimulation device, which it says is the first to modulate the pudendal nerve to directly address urinary continence (UI).
