Pressure BioSciences, Inc. Announces CE Mark Approval and Compliance with IEC 61010-1 Standard for the Barocycler NEP3229
WEST BRIDGEWATER, Mass., May 8 /PRNewswire-FirstCall/ -- Pressure BioSciences, Inc. (Nasdaq: PBIO) today announced that it has received approval to CE Mark its Barocycler NEP3229 instrument, the centerpiece of its Pressure Cycling Technology Sample Preparation System (PCT SPS). The Company also announced that it has been issued a CB Scheme Test Certificate and Report indicating that the Barocycler NEP3229 has been found in compliance with the IEC 61010-1 international standard applicable to safety requirements for electrical equipment for measurement, control, and laboratory use.
The CE Mark is a mandatory European marking for certain products to indicate conformity with the essential health, safety, and environmental requirements detailed in European Directives. With the approval to CE Mark its Barocycler NEP3229, Pressure BioSciences (PBI) can now market this instrument to all countries within the European Union, as well as to countries in other parts of the world that accept the CE Mark.
The CB Scheme is an international program for the exchange and acceptance of product safety test results among participating laboratories and certification organizations. The CB Scheme process offers mutual recognition of test results among participating countries, normally without the need for additional testing. The issuance of the CB Scheme Test Certificate and Report, indicating that the Barocycler NEP3229 has met the requirements of the IEC 61010-1 international standard, is another important step in PBI's efforts to commercialize and market the Barocycler NEP3229 to a number of countries worldwide, including some that do not accept the CE Mark.
Dr. Nathan P. Lawrence, Vice President of Marketing and Sales for PBI, said: "CE Mark approval and IEC 61010-1 compliance were key milestones that we needed to achieve before our international marketing efforts could begin. With these achievements, and with a number of meetings planned with European, Pacific Rim, Canadian, and other companies attending BIO 2007 this week, we are well positioned to achieve our goal of commencing the global commercialization of PCT next year."
Richard T. Schumacher, Founder, President, and CEO of PBI, commented: "We view the approval to CE Mark and compliance with the IEC 61010-1 international standard as independent confirmation that the Barocycler NEP3229 meets or exceeds international product safety standards. This is a very important achievement for all stakeholders in PBI, not only because of the potential commercial opportunities that we may now pursue, but also because it manifests the drive and determination of our staff, who achieved these milestones while concomitantly making significant advances in many other areas of our company over the past six months."
About Pressure BioSciences, Inc.
Pressure BioSciences, Inc. (PBI) is a publicly traded, early-stage company focused on the development of a novel, enabling technology called Pressure Cycling Technology (PCT). PCT uses cycles of hydrostatic pressure between ambient and ultra-high levels (up to 35,000 psi and greater) to control bio- molecular interactions. PBI currently holds 13 US and 5 foreign patents covering multiple applications of PCT in the life sciences field, including such areas as genomic and proteomic sample preparation, pathogen inactivation, the control of chemical reactions (particularly enzymes), immunodiagnostics, and protein purification.
Forward Looking Statements
Statements contained in this press release regarding the Company's intentions, hopes, beliefs, expectations, or predictions of the future are "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward looking statements include statements regarding the approval to CE Mark and compliance with the IEC 61010-1 international standard; the expected international commercialization and market launch of the Barocycler NEP3229 instrument in 2008; any meetings and the potential results of such meetings with international companies attending Bio 2007; and the expected market acceptance of the Barocycler NEP3229 and the Company's PCT Sample Preparation System generally. These statements are based upon the Company's current expectations, forecasts, and assumptions that are subject to risks, uncertainties, and other factors that could cause actual outcomes and results to differ materially from those indicated by these forward-looking statements. These risks, uncertainties, and other factors include, but are not limited to: unforeseen technological difficulties that the Company may encounter in the development of the PCT technology and the PCT Sample Preparation System; the possibility that the Company may face regulatory impediments or other international standards or requirements that could delay or prevent the achievement of the Company's international commercialization efforts; the possibility that the Company's PCT technology may not be accepted by the commercial market as a needed improvement over current extraction methods and for other applications; the possibility that the Company may be unable to sell the Barocycler NEP3229 instruments that it plans to market internationally in 2008; and the other risks and uncertainties discussed under the heading "Risk Factors" in the Company's Annual Report on Form 10-KSB for the year ended December 31, 2006, and other reports filed by the Company from time to time with the SEC. The Company undertakes no obligation to update any of the information included in this release, except as otherwise required by law.
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SOURCE Pressure BioSciences, Inc.
Released May 8, 2007