Nature Cell, certified for the Orphan Drug Designation Program

• Nature Cell’s Vascostem (a drug made from patients’ own stem cells) certified for the US FDA’s Orphan Drug Designation Program for the treatment of Buerger’s disease

Nature Cell announced on May 6 that its stem cell-based medicine to cure Buerger’s disease, Vascostem, had been approved for the US FDA’s Orphan Drug Designation Program. The approval was given a mere 100 days after the Biostar Stem Cell Research Institute had applied for it on January 18.

Nature Cell will visit the US FDA in June for a pre-IND meeting to confirm the schedule for its pivotal study and it will embark on the study in the US within the following year in order to launch the product on the US market.

Buerger’s disease is a rare disorder that damages and destroys blood vessels in the arteries and veins in an individual’s arms and legs. It is accompanied by severe pain even when patients are in a state of rest, and it may eventually lead to serious infection and gangrene that requires amputation.

However, there has been no cure available to those afflicted, and patients have long suffered from the associated pain and fear of amputation.

There are about 50,000 Buerger’s disease patients in the US and Europe combined, and the treatment market size is estimated at USD 2.5 billion.

The company’s President, Jeong-chan Ra, stated, “I am very happy and proud of our achievement. While we received reviews for the Orphan Drug Designation Program of Korea, we faced questions regarding whether there were any existing alternatives in the market. I am pleased with the designation by the US FDA reaffirming that we are the first to develop a stem cell treatment for Buerger’s disease in the world. I hope that Buerger’s disease patients will be able to recover their health and wellbeing through our stem cell treatment.”