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. Read More
With an eye toward launching its first product, Mobilion Systems Inc. has revealed a $35 million series B funding round led by Amoon. Todd Sone, partner at Amoon who also is joining the company’s board, highlighted the duo’s common vision to develop technologies that offer high resolution and speed. Read More
Life science companies doing business during a pandemic may believe that patients, judges and juries will look kindly on products that don’t perform as promised, but that may be an empty wish. Angela Seaton, an attorney with the D.C. office of Shook, Hardy & Bacon LLP, advised that companies that want to break into new markets because of pandemic-specific demand should do their homework, including a review of U.S. FDA warning letters. Read More
Big Health’s digital therapeutic Sleepio may not only improve insomnia but also reduce symptoms of depression, a study to be published Aug. 19 in the Journal of Sleep Research shows. Read More
PERTH, Australia – With 1 in 3 patients with type 2 diabetes likely to develop diabetic kidney disease (DKD), Perth-based Proteomics International Laboratories Ltd. has developed a blood-based diagnostic test that can predict the onset of DKD, enabling patients to get treatment sooner to prevent the onset of the disease. Read More
TORONTO – Virtual reality (VR) platform developer Realize Medical Inc. is collaborating with Lausanne, Switzerland’s Logitech International SA on what the Ottawa-based med tech calls “the world’s first VR platform for creating patient-specific 3D medical models.” Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cala Health, Edap, Gt Medical Technologies. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clearmask, Diazyme, Genosity, Illuminoss, Sensiva. Read More
Keeping you up to date on recent developments in oncology, including: New and less expensive approach to digital PCR may improve cancer detection; Stromal cell subtypes identified in TNBC; Microbiome metabolites as immunotherapy adjuvants; Pandemic significantly impeded breast cancer follow-up. Read More
