Tuesday, March 6, 2018

Sernova Corp.’s (OTCQB: SEOVF) (TSX.V: SVA) (FSE: PSH) Continuous Glucose Monitoring System Approved to be Utilized in Clinical Trial

  • Food & Drug Administration grants Sernova Corp. notice of approval to utilize its Continuous Glucose Monitoring System in support of clinical trial of its Cell Pouch
  • Global treatment market for type 1 diabetes on pace to grow to $13.6 billion by 2023
  • Sernova is a clinical stage company focusing on treatment of type 1 diabetes, hemophilia and other chronic metabolic diseases
Sernova Corp. (OTCQB: SEOVF) (TSX.V: SVA) (FSE: PSH) has been approved to add its Continuous Glucose Monitoring System in support of the impending clinical trial of its Cell Pouch™ for the treatment of type 1 diabetes. The system will enable the tracking of transplanted cells and measurement of key efficacy at multiple times following the transplant of therapeutic cells into the Cell Pouch (http://nnw.fm/TyyZ8).
Sernova, based in London, Ontario, is a clinical stage company that develops disruptive regenerative medical technologies for the treatment of chronic diseases, such as diabetes and hemophilia. It is focused on treating type 1 diabetes and other chronic metabolic diseases requiring replacement of proteins or hormones that are missing or in short supply within the body.
A GlobalData research report, quoted by PM Live, found that the global treatment market for type 1 diabetes will reach $13.6 billion by 2023. The United States share, it reported, will reach 78 percent (http://nnw.fm/Kmic4).
The Cell Pouch is a scalable, proprietary and implantable device for the long-term survival of therapeutic cells, including donor or stem cell-derived cells. The device has already proven to be effective in animal models with diabetes. Recently, the Cell Pouch received a notice of approval from the Food & Drug Administration (FDA) to be studied as an investigational new drug (IND) in a new human clinical trial.
Type 1 diabetes is a life-threatening disease for which there is no cure. The body’s immune system mistakenly attacks and kills the pancreatic cells that produce insulin, an essential hormone to help the body use glucose. People living with the disease are dependent on insulin therapy and need to frequently monitor their blood sugar levels.
The Continuous Glucose Monitoring System involves the placement of a glucose sensor connected to a pager-sized monitoring device that stores glucose data over a six-day period.
“We believe continuous glucose monitoring of patients may be an important and sensitive method to closely track the function of the transplanted and therapeutic cells within the Cell Pouch,” Dr. Philip Toleikis, CEO and president of Sernova, stated in a news release. “We are pleased with our collaborators in this study who have shown the foresight to support Type 1 diabetes patients seeking treatment via next-generation regenerative medicine technologies.”
For six months following the study, the patients are monitored. If a second dose is transplanted, patient follow-up will continue for one year, the company said.
For more information, visit the company’s website at www.Sernova.com
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