WITTEN, Germany, September 19, 2011
WITTEN, Germany, September 19, 2011 /PRNewswire/ --
Official registration as medical device granted / State of Tamaulipas indicates plans to start treatment in 22 hospitals
The Mexican Commission for the Authorization of Pharmaceuticals and Medical Devices officially registered the entire current range of Sangui developed wound management products as medical devices and granted permission to use this treatment on a nationwide basis.
In the meantime the Secretaria de Salud (Secretary of Health) of the Mexican State of Tamaulipas as a first legal entity in Mexico indicated in an official letter that it has the firm intention to actually apply the Sangui developed wound therapy in the 22 hospitals under its direction. It is to be recommended as the state of the art treatment of chronic wounds in the indications of leg ulcer and diabetic foot. An exact starting date for this program has not been fixed yet. SanguiBioTech GmbH and SastoMed GmbH as global licensee are ready to jointly enter negotiations about the terms of trade with customers in Mexico and beyond. It is being assumed that the official registration in Mexico may serve as a door opener for respective registrations in other Central American countries.
This is the first official authorization to use and distribute the Sangui developed wound treatment. Comprehensive clinical test treatments had been carried out in 2009 at the Hospital Civil in Ciudad Victoria, capital of the Mexican state of Tamaulipas. The tests were concluded successfully. In the course of the treatments the control group had been closed and patients shifted to the Sangui developed therapy for ethical reasons. In the event the total healing ratio was significantly higher than 75%.
The results were evaluated by the State Health Authorities of Tamaulipas and presented to the Mexican Federal Health Authorities as well as on the occasion of international dermatological and wound management congresses. The certification process in compliance with Mexican and international standards was carried out professionally by the staff and consultants of Sangui Latin America SA, the legally non-related local partners of Sangui BioTech International, Inc. in Mexico.
Eduardo Martinez Mena, CEO of Sangui Latin America SA, emphasized: "In close cooperation with our German partners we invested a considerable amount of time, money and diligence in this project over the past five years. We are more than glad that our continued efforts now have come to fruition and very excited about the huge opportunities this authorization will offer for the patients as well as for our company."
Sangui BioTech International, Inc., Director Hubertus Schmelz congratulated: "Our Mexican partners have attained the first manifest breakthrough for our products - and hence for Sangui as a whole. The Mexican authorization is the seal and first official confirmation of their therapeutic properties, and is the logic result of the studies conducted by the Tamaulipas Health Authorities. The certification processes worldwide are designed to protect the patients and, therefore, extensive, detailed and time consuming. But this event now shows that our joint professional and diligent approach is the right and only way to reach our business objectives."
Michael Sander, Managing Director of SastoMed, explained: "We are proud to find that the Mexican authorities are leading the way to give patients access to our novel and promising treatment of chronic wounds. To a considerable extent, the smooth registration process in Mexico was due to the comprehensive work we carried out to gain convincing data to prove the safeness and efficacy of the treatment. As authorities' demands regarding medical devices are broadly comparable we confirm our ambitious schedule towards an EU registration as the next step to a global market entry."
All parties agreed that their cooperation over the years has proved to be successful, resting solidly on their common trust in the properties of this unique wound healing therapy. Both SastoMed and Sangui underlined that the German side is ready to enter negotiations about terms and deliveries and is currently initiating the necessary preparations to have the products manufactured in the required qualities and quantities.
Mexican health authorities lay special emphasis on their continued efforts to abate the consequences of lifestyle diseases such as diabetes. Estimates indicate that more than 40% of the Mexican population suffers from venous diseases. Currently, there are 17 million identified diabetics in Mexico, this being the second largest diabetes rate in the world. In Mexico more than $30 bn per year are being spent on diabetics' treatments. It is being expected that the consistent use of the Sangui developed wound treatment will help to significantly reduce the costs in this particular sector.
SanguiBioTech GmbH is a ninety percent owned subsidiary of Sangui BioTech International, Inc. (http://www.pinksheets.com: SGBI)
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Last updated on: 20/09/2011