– 18,000 Stretta procedures performed since introduction, making Stretta the safest and most widely used endoluminal therapy for GERD
– Stretta expands reach with regulatory approvals added in large international markets
NORWALK, Conn., May 13, 2015 /PRNewswire/ — Mederi Therapeutics Inc. today announced two milestones in the worldwide growth of Stretta Therapy for GERD, which include the completion of the 18,000th Stretta procedure and new regulatory approvals in OUS markets of Mexico, India, South Africa, Australia, Argentina and South Korea.
Dr. Mark Noar, Director of the Heartburn and Reflux Study Center, Towson, MD, one of the first adopters and top practitioners of Stretta said, “It's rewarding to witness worldwide appreciation of how Stretta offers relief to patients with chronic GERD. More than 37 studies from five continents have clearly documented that Stretta is effective and safe, with the lowest reported complication rate of any non-drug option for GERD. These benefits offer value not just to patients, but also to health care providers and the entire health care system.” Dr. Noar is the author of the 10 year follow-up study of Stretta published in the journal Surgical Endoscopy in 2014.
Mederi also announced recent regulatory approvals with product launches underway in OUS markets including Mexico, India, South Africa, Australia, Argentina, and South Korea. During the launch in Mexico, Stretta cases were performed by Dr. David Aguirre, Director of Medical Arts Institute, at Doctors Hospital, and Hospital Angeles Valle Oriente, inMonterrey. Physician training programs were held at Hospital General Gea and The National Institute of Medical Science and Nutrition in Mexico City. Additionally, Stretta was the feature presentation at the recent Asociaciona Mexicana de Gastroenterologia – Semana Nacional de Gastroenterologia in Cancun, Mexico.
“Offering Stretta means we have a complete continuum of care for patients with chronic GERD,” Dr. Aguirre observed. “Patients now have an effective and safe option that doesn't involve surgery and provides significant relief from symptoms. Besides the clinical benefit, Stretta delivers a significant cost savings for our health system due to the lower cost and complication rates coupled with elimination or significant reduction of lifelong medication use. Stretta is a game changer for us.”
Mederi also expects imminent approval in China, as Stretta has already cleared the first phase of Chinese regulatory requirements, with final clearance expected shortly.
Will Rutan, Chief Executive Officer of Mederi noted that these regulatory approvals add significantly to the current product reach. “Physician and patient interest for Stretta is extremely high in these countries,” Rutan said. “We are confident that the coming year will see continued growth of Stretta worldwide.”
Other countries and regions due for regulatory approval for Stretta in 2015 include, Brazil, Panama, Costa Rica, Russia, Egypt, Taiwan and the GCC.