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Product approval

Mederi's Stretta Therapy for GERD approved in China

Clinically proven and cost effective solution for gastroesophageal reflux disease recently launched in China

Mederi Therapeutics Inc. has announced regulatory approval by CFDA and product launch in China for Stretta Therapy, a non-surgical treatment for chronic gastroesophageal reflux disease (GERD). Stretta procedures were recently performed and broadcast live during the Chinese Congress of Digestive Endoscopy, by Professor Jun Liu, Director of Endoscopy at Wuhan Union Hospital, and Stretta was also performed at Beijing General Army Hospital (301 hospital).

"This is a proven solution for patients who still have GERD symptoms despite taking medications and want to avoid surgery,” said Dr Enqiang Linghu, Chief of Gastroenterology at Beijing General Army Hospital. “Stretta will be an important offering for our patient base as we see a lot these patients in our hospital.” 

Stretta is a non-surgical procedure for GERD that delivers low power, low temperature RF energy to remodel the valve known as the lower oesophageal sphincter (LES) at the junction of the oesophagus and the stomach. Stretta reduces or eliminates regurgitation of stomach contents by improving muscle tone and reducing random openings of the LES that are known to cause GERD. Stretta treatment results in elimination or significant reductions of GERD symptoms and medication use, and significant improvement in a patient's quality of life.

Stretta therapy delivers low power, low temperature radiofrequency energy to remodel the valve known as the lower oesophageal sphincter (LES) at the junction of the oesophagus (Credit: PRNewsFoto/Mederi Therapeutics Inc.)

Studies show that the prevalence of GERD as well as obesity, are on the rise in China. In 2014, The Lancet reported that China has the second highest obesity rate in the world, behind the United States. In addition to other more serious co-morbidities such as heart disease and diabetes, GERD is present in a much higher percentage of the obese population, at an average rate of 60-70 percent, versus 10-20 percent of the average population.

"We are very pleased that Mederi products are now available in China. Our technology, especially Stretta for GERD, is experiencing dramatic growth worldwide. Driving this growth, are the key benefits of clinical safety and effectiveness, as well as the versatility and lower cost of Stretta compared to other GERD treatments. Stretta is a non-surgical technology, that is delivered transorally and reduces symptoms of GERD by improving lower esophageal sphincter (LES) function. It is an ideal alternative to medications and surgery for chronic GERD," said Mederi CEO, Bob Knarr. "It is very exciting to launch in China, where we are privileged to have an excellent distribution partner, Beijing Kanglian Medical."

"Stretta is positioned to help many kinds of chronic GERD patients, including those who have incomplete relief from medications, have extra-esophageal symptoms of GERD or have GERD after bariatric or anti-reflux surgery,” said Wuman Zhang, principal of Kanglian Medical. “Surgeons and gastroenterologists throughout China are eager to offer Stretta to their patients."

In addition to China, other recent international regulatory approvals for Mederi products include: India, Brazil, Egypt, South Korea, Philippines, Sri Lanka, Costa Rica and Panama.

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