A threat is currently hanging over the Swiss medical device industry, which is heavily reliant on trade with the EU. Upcoming changes to the CE marking regime will have the effect of making the mutual recognition agreement (MRA) obsolete. This currently allows Switzerland to enjoy unrestricted access to the medical device market in the 27 member states. Up until now, this bilateral agreement has regulated trade between Switzerland and the EU.
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.
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.
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.
PARIS – Implanet SA won approval from its founding shareholders to acquire a majority stake in spinal implant manufacturer Orthopaedic & Spine Development SAS (OSD). Implanet’s bid is aimed at acquiring majority control, and potentially the entire share capital, of Avignon, France-based OSD, valued at $5 million. OSD’s founding shareholders, representing 71.5% of the capital, have already committed to respond favorably to the bid, thus confirming the principles behind this merger.
PARIS – Whitelab Genomics SAS has signed a partnership agreement with Genethon, a French research center in the field of gene therapy, to ramp up development of genetic therapy techniques using artificial intelligence (AI). As part of this partnership, Genethon will use the Whitelab Genomics Catalyst platform to develop new capsids.
PARIS – Carmat SA has just completed a capital increase of $66.4 million to boost development of its total artificial heart. The Aeson system was awarded CE marking four months ago, as a total bridge to transplantation for patients suffering with end-stage biventricular heart failure who are not eligible for maximal medical therapy or a left ventricular assist device (LVAD), and who are likely to undergo a heart transplant within 180 days of the implantation.
According to the latest annual overview published by trade association France Biotech, French med-tech, biotech, and e-health companies have adapted rapidly to the COVID-19 pandemic. Many French health care companies have faced real difficulties in all areas of procurement, R&D, and sales. As of February, a quarter of these French companies were redirecting their research activity towards the coronavirus.
PARIS – Median Technologies SA has unveiled a new clinical development plan for its Ibiopsy platform to provide early diagnosis of lung cancer in at-risk populations using low dose CT scans. Median executives said they hope to demonstrate the potential of deep learning in identifying lung lesions and characterizing them as malignant or benign.
