PARIS – Holistick Medical SAS reported a $5 million round for development of the first generation of a light-activated implant for a patent foramen ovale (PFO). Truffle Capital provided the startup with $4.6 million, while Bpifrance provided $470,000 in non-dilutive funding. “This robust financing provides us with the resources needed to catapult our strategy forward and reinvent the treatment of heart defects such as PFO, which can be associated with occurrence of stroke in young people,” Boris Warnack, CEO of Paris-based Holistick Medical, told BioWorld.
BERLIN – Lindis Blood Care GmbH launched a multicenter clinical EU certification study for Catuvab, which is used to eliminate tumor cells from surgical blood. The experiment, dubbed Remove, aims to confirm that Catuvab can reliably remove epithelial cell adhesion molecules (EPCAM)-positive tumor cells from patient blood during cancer surgery.
LONDON – The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) stood by its view that the benefits of Astrazeneca plc’s COVID-19 vaccine “continue to outweigh the risks,” as it published the latest summary of reported adverse events.
LONDON – A new route to the approval of drugs promises to smooth the path from clinical trials to approval, reimbursement and commissioning in the National Health Service, through closer and earlier collaboration between the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and health technology assessment bodies.
HONG KONG – SK Biopharmaceuticals Co. Ltd. partner Arvelle Therapeutics GmbH, now part of Angelini Pharma, has received European Commission (EC) approval for Ontozry (cenobamate), a treatment for drug-resistant focal-onset seizures. The approval was granted for focal-onset seizures with or without secondary generalization in adults who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicines.
PARIS – Barely one year after its formation, startup company Quantiq SAS has just closed an $825,000 seed round, to develop its contactless medical diagnostics technology. French business angels from the medical, artificial intelligence and fintech worlds participated in this initial fundraising.
“Our position has not changed,” said Emer Cooke, executive director of the EMA, giving an update on the agency’s investigation into cases of the rare clotting disorder cerebral venous sinus thrombosis (CVST) in people vaccinated with Astrazeneca plc’s COVID-19 vaccine. “There is no evidence to support restricting use of the vaccine in any population,” she said.
LONDON – Inbrain Neuroelectronics Ltd. has raised €14.35 million (US$16.9 million) in a series A round to take nanoscale graphene implants it says have the potential to interface one-on-one with neurons, into clinical development later this year. The technology promises significant improvements on current implants used for deep brain stimulation to treat conditions including Parkinson’s disease, epilepsy, obsessive compulsive disorder and neuropathic pain.
LONDON – Getting a handle on the specificity and sensitivity of rapid COVID-19 antibody tests, how they compare to each other and how they should be applied in population screening to understand who has had the virus and how it has spread, has been a source of difficulty and dispute between manufacturers, clinicians and public health experts.
Debx Medical BV has advanced to the pre-launch phase for its new topical desiccant gel for the treatment of chronic infected and necrotic wounds. Two months after obtaining CE mark approval for Debrichem, the Rotterdam, Netherlands-based company is starting distribution of its class IIb medical device in Europe – in the Netherlands, Italy and Spain – as well as in Hong Kong, South Africa, New Zealand and Australia.