PBIO now has Access to 31 Countries in Europe that Require Products to be CE Marked Prior to European Commercialization
Pressure BioSciences, Inc. (OTCQB: PBIO) a leader in the development and sale of broadly enabling, pressure cycling technology (“PCT”)-based sample preparation solutions to the worldwide life sciences industry, today announced that the Company has achieved CE Marking for the Barocycler 2320EXTREME (“2320EXT”), the Company’s recently released, next-generation PCT-based sample preparation instrument. PBI is now permitted to begin sales of the Barocycler 2320EXT in the European Economic Area (“EEA”).
Since 1985, achievement of CE Marking has been required for products in 24 different categories sold within the European Economic Area (“EEA”). Each product falls under one or more Directives, which determine the specific requirements the product must meet. When the CE Mark is affixed to a product, it signifies the manufacturer’s declaration that the product meets all applicable EU safety, health, or environmental requirements. Achieving CE Marking requires substantial cost, time, and effort from the manufacturer, but allows the product to be marketed and move freely throughout all 31 countries in the EEA that require the CE Mark.
The Barocycler 2320EXT is the most recent addition to, and the next generation of, PBI’s Barocycler family. It is a compact, bench top instrument offering many features and benefits not found in PBI’s earlier Barocycler models, such as data logging options, user-level security, computer-operated control with touch screen programming, and the ability to customize multiple pressure cycling parameters. These and other features have already positioned the Barocycler 2320EXT as an instrument of choice for life science key opinion leaders (“KOLs”) worldwide, when preparing protein samples for analysis.
Among these KOLs is Professor Ruedi Aebersold, a world-renowned protein chemist and Director of the Institute of Molecular Systems Biology in Zurich, Switzerland. Professor Aebersold has been a leading proponent of PBI’s PCT-based sample preparation methods prior to proteomic analyses for some time.
When asked to comment on the importance of sample preparation in research studies, and why his laboratory upgraded their sample preparation method to the Barocycler 2320EXT, Professor Aebersold said: “Not only do we need to consider the method of analyzing the proteome, but we must also recognize that the method of sample preparation used for protein extraction & digestion is equally important.”
Dr. Nate Lawrence, Vice President of Marketing and Sales for PBI, said: “Achievement of CE Marking for the Barocycler 2320EXT is an important next step in our commercialization plans for this powerful and enabling sample preparation instrument, especially since CE Marking is required prior to selling the Barocycler 2320EXT to the large and potentially lucrative biopharmaceutical market in Europe. We recently signed agreements with several strong distribution partners in Europe, our SCIEX co-marketing agreement is entering its second year (SCIEX is a global provider of laboratory instrumentation to the life sciences area, with a large presence in Europe), and Professor Ruedi Aebersold – one of the most recognized world leaders in proteomics – recently purchased two Barocycler 2320EXTs. We believe we are well prepared for our upcoming, planned launch of the CE Marked Barocycler 2320EXT in Europe. These are very exciting times for PBI.”
About Pressure BioSciences, Inc.
Pressure BioSciences, Inc. (“PBI”) (OTCQB: PBIO) develops, markets, and sells proprietary laboratory instrumentation and associated consumables to the estimated $6 billion life sciences sample preparation market. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or PCT) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions. To date, we have installed over 250 PCT systems in approximately 160 sites worldwide. There are over 100 publications citing the advantages of the PCT platform over competitive methods, many from key opinion leaders. Our primary application development and sales efforts are in the biomarker discovery and forensics areas. Customers also use our products in other areas, such as drug discovery & design, bio-therapeutics characterization, soil & plant biology, vaccine development, histology, and forensic applications.
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