Updated: April 27, 2021
At DiscGenics, we are actively monitoring developments in the ongoing coronavirus (COVID-19) pandemic and recommendations from the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Utah Department of Health. As the situation continues to rapidly evolve, our top priority remains the health, safety and well-being of our employees and patients, their families, and our community. I’d like to take a moment to update you on several of the steps we are taking to address this current issue.
Social Distancing Among Employees
To protect both the safety of our employees and the mission critical and time-sensitive nature of our laboratory-based initiatives during the current phase of COVID-19 containment, we implemented a Facility On-Site/Remote Work policy that applies to all employees. This policy allocates staff that are essential to performing work on-site and facilitates appropriate social distance through a rotating schedule, while enabling other “non-essential” staff to carry out their full-time work functions remotely from home. To maintain the healthiest possible environment for our on-site employees and their families, we have implemented enhanced cleaning procedures throughout our office and laboratory facilities.
Clinical Trial Protocol Amended to Accommodate Remote Monitoring
In early March, we announced completion of enrollment in our U.S. Phase I/2 clinical trial of IDCT for degenerative disc disease (DDD). All 60 subjects were successfully treated, and no safety issues have been reported. A key requirement of our clinical trial protocol is for the subjects to be followed through repeat office and imaging visits for a period of two years. Given that many of our patients were unable to attend in-person office visits during this period due to the COVID-19 policies in place at many of our clinical sites, we implemented remote monitoring procedures that are consistent with recent U.S. FDA Guidance related to conducting clinical trials during the COVID-19 pandemic.
Manufacturing Facility Construction Continues
Meanwhile, we maintained our construction timelines and safely completed the build-out of our 19,500 sq. ft. commercial cGMP manufacturing and support facility in early 2021.
During this period of ongoing uncertainty, we are continuing to focus on our mission of improving the lives of those suffering from the debilitating effects of chronic back pain. At the same time, we are committed to staying vigilant and to reacting reasonably, responsibly and promptly if the circumstances of our internal team, family or community change. We thank you for your continued support and look forward to seeing you soon!