Tetra’s development and manufacturing partner, PS Innovations, will be seeking CE Marking for Tetra’s Rx Princeps™ Inhalation Device, which is used in conjunction with a dried loose cannabis, such as Rx Princeps™, to provide relief for advanced cancer pain and non-cancer pain patients.
Rx Princeps™ is a unique blend of 3 strains of medical cannabis. Its production has been standardized in order to ensure a lot-to-lot consistent composition in its active ingredients (THC and CBD). Rx Princeps™ is composed of the same medical cannabis blend used to produce PPP001, the lead product in Tetra’s pipeline of five cannabinoid-based prescription drugs seeking Health Canada and FDA approval in Canada and the United States.
“CE marking” is the process that guarantees a product’s conformity to the European regulations and is required to allow Tetra to commercialize and trade on the European and European Economic Area markets. Under the European regulation, Rx Princeps™ Inhalation Device will be considered as a Class 1 Medical Device.
“This is significant for Tetra since there are a number of European countries, with Germany at the forefront, where medical cannabis has been legalized,” said Bernard Fortier, Tetra’s CEO.
The annual potential estimate for the medical cannabis European market value is EUR35.7b, according to the European cannabis report from a Prohibition Partners November 2017 report. In the US, the consumption devices market grew 116.5% in 2016 (year over year growth, New Frontier data report 2016).
“We know that more than half the people who consume cannabis choose to smoke it,” said Mr. Fortier. “This first step into Europe with a strong partner like PS Innovations solidifies our strategic focus on global expansion and potentially offers the European medical community and their patients the most innovative therapeutic options.”
PS Innovations will ensure that the Rx Princeps™ Inhalation Device meets all the relevant Essential Requirements of the European Medical Device Directive and then register the product with the Competent Authority and affix the CE marking.
About PS Innovations:
PS Innovations was created in 2017 to bring new devices for the use of Cannabis products, and the creation of machinery dedicated to the manufacture of Cannabis based dosage forms. Current devices on the market today are designed for the use of tobacco, and not cannabis derived products. Cannabis is unique in many ways, and does not always behave in the manner that tobacco products do. PS Innovations has been able to bring to the market a Class I medical device, namely an inhalation device (pipe) specific to the ACMPR [Access to Cannabis for Medical Purposes Regulations] use of dry loose cannabis.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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