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.
Two-and-a-half years after regenerative medicine company Mimedx Group Inc. came under federal investigation for improper sales and marketing practices and nearly two years since it was delisted by Nasdaq, the company is back on track financially and pursuing an active pipeline of new products. Marietta, Ga.-based Mimedx recently reported second quarter sales of $61.7 million, a 7.2% decline from the same period the prior year. The second quarter 10Q Form – one of seven SEC financial statements submitted in the last five months as the company worked to regain compliance – brings Mimedx up to date, paving the way for it to relist its stock.
PERTH, Australia – Startup Inventia Life Science Pty. Ltd. has received two major investments from the Australian government to accelerate the development of a robotic device that prints a patient’s own skin cells directly onto a burn or wound. Named Ligō from the Latin “to bind,” the device could revolutionize the way surgeons approach wound repair.
PARIS – Grapheal SAS, of Grenoble, France, is developing a new generation of dressings integrating an embedded electronic biosensor. The Grapheal device consists of monolayer graphene on a polymer layer 0.3 nanometers thick. “This noninvasive embedded device collects data from the wound. The wireless e-health wound monitoring system, or smart patch, remotely reports the status of chronic wounds to the care team,” Vincent Bouchiat, co-founder and CEO at Grapheal, told BioWorld MedTech.
Toronto-based Moleculight Inc. has received U.S. FDA 510(k) clearance for its i:X hand-held fluorescence imaging device for use in detecting bacteria in wounds at the point of care. The milestone comes a little over a year after the agency granted de novo clearance for the device in August 2018 and lends additional credence to the device’s benefits in wound evaluation and management. “The granting of our 510(k) clearance by the FDA for the i:X hand-held fluorescence imaging device is very exciting and is a further validation of the growing clinical evidence supporting the utility of our imaging platform,” said Anil Amlani, Moleculight’s CEO.
