MPO’s Most-Read Stories This Week—May 14

MPO loyalists accessing the website this week honed in on both good and bad news.

First, the good news driving site traffic: French startup Remedee Labs earned U.S. Food and Drug Administration Breakthrough Device Designation for its non-pharmaceutical endorphin stimulation technology for fibromyalgia. Remedee’s technology is a new approach to treating fibromyalgia pain and can help relieve other kinds of pain, fatigue, and stiffness as well as sleep disorders. The company began a 170-patient multicenter study in France late last year to assess its endorphin stimulator’s benefits for fibromyalgia treatment. Recruitment ended May 12 and results are expected early next year.

The other feel-good story gaining traction on the site was BD’s (Becton Dickinson and Company) expanded strategic partnership with Babson Diagnostics. The collaboration is designed to move blood sample collection into new care settings, including blood collection at home for diagnostic testing. The two firms have partnered since 2019. on creating a capillary blood collection and testing system that is now in advanced development. The system will allow lab-quality, small-volume capillary blood collection at retail settings by employees with no prior blood collection experience. 

Now the bad: Visitors just couldn’t help but be curious about Moderna CFO Jorge Gomez’s two-day tenure with the company. Having left his CFO position at Dentsply Sirona on May 6, Gomez worked just two days at Moderna before abruptly leaving the firm. Gomez joined Dentsply Sirona in. August 2019; his sudden departure from Moderna follows a May 10 public disclosure by Dentsply Sirona of its ongoing internal investigation into certain financial reporting matters. The company, as a result, has not yet finalized financial statements for the first quarter of 2022. Dentsply Sirona fired CEO Don Casey two days before Moderna revealed Gomez would be working there. Moderna’s recently retired CFO CFO David Meline will continue in his role while the company reopens its search for a new finance chief.

The other bad news item was the U.S. Food and Drug Administration (FDA) revelation that it is assessing the risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) present with 2008T, 2008K2, and 2008K hemodialysis machines made by Fresenius Medical Care. The source of these toxic compounds is from silicone tubing that is part of the machine’s hydraulics and dialysate lines. The company said testing to meet ISO-10993:2020 standards showed the chemicals could leach from silicone tubing made with a peroxide-based catalyst.

1. Remedee Labs’ Endorphin Stimulator for Fibromyalgia Earns Breakthrough Status

2. Moderna’s CFO Hire From Dentsply Sirona Leaves Just Days Into Job

3. FDA Warns of Toxic Risk From Fresenius Hemodialysis Machines

4. BD, Babson Expand Strategic Blood Collection Partnership

5. 3D Printing in Dental Prosthodontics, Orthodontics, and Surgery