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Goodspeculatioron Aug 26, 2015 8:45am
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Why huge potential here : News Release Number 1 August 17th
Why huge potential here : News Release Number 1 August 17th
M Pharma signs Chinese manufacturer for Trimtec
2015-08-17 14:30 ET - News Release
Dr. Martin Mintchev reports
M PHARMACEUTICAL AND RISHENA ENTER INTO MANUFACTURING SUPPLY AGREEMENT FOR PRODUCTION OF TRIMTEC GASTRIC STIMULATION DEVICE
M Pharmaceutical Inc. has entered into a manufacturing supply agreement with Rishena Co. Ltd. of Changzhou, China, to manufacture the company's Trimtec gastric functional neuro-stimulation device. Under the terms of the agreement, Rishena will be the exclusive supplier of laparoscopically implantable Trimtec devices to M Pharmaceutical for the North American and South American markets. The devices will be fully programmable and rechargeable through an abdominal belt. Rishena commits, at its expense, to obtain ISO 13485 certification (1) for Trimtec manufacturing prior to the company's commercial launch of Trimtec.
"Our agreement with Rishena is an important step forward in the development of Trimtec for the North and South American markets," said Dr. Martin Mintchev, the president and chief executive officer of M Pharmaceutical. "We are delighted to collaborate with an experienced and respected medical device manufacturer such as Rishena, and look forward to successful collaboration with them."
About Rishena Co. Ltd.
Rishena Co. is a venture capital-backed medical device company located in the Changzhou, China, high-tech development zone. Rishena is focused on the development, production and sales of innovative implantable nerve stimulation products.
(1) ISO 13485 certification is considered the foremost internationally accepted model to demonstrate regulatory compliance and quality manufacturing in the medical device industry. ISO 13845 aligns with the manufacturing quality principles required by Health Canada, and the United States Food and Drug Administration for marketing a medical device in these countries, and can be considered a significant step toward full compliance with U.S. quality system regulations.
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