Pressure BioSciences, Inc. Announces CE Mark Approval and Compliance with the IEC 61010-1 Standard for a Second PCT-based Instrument, the Barocycler NEP2320
WEST BRIDGEWATER, Mass., Sept. 5 /PRNewswire-FirstCall/ -- Pressure BioSciences, Inc. (Nasdaq: PBIO) today announced that it has received approval to CE Mark the Barocycler NEP2320, a patent-pending, lightweight, compressed air driven pressure cycling technology (PCT) instrument. The Company also announced that it has been issued a CB Scheme Test Certificate and Report indicating that the Barocycler NEP2320 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 NEP2320 is the second PCT-based instrument for which PBI has received CE Marking approval and CB Scheme compliance. On May 1, 2007, the Company announced approval and compliance for the Barocycler NEP3229, the current centerpiece of its PCT Sample Preparation System (PCT SPS).
Dr. Nathan P. Lawrence, Vice President of Marketing and Sales for PBI, said: "We are very pleased to have received CE Mark approval and IEC 61010-1 compliance for the Barocycler NEP2320. With approvals and compliance now in hand for both instruments of the PCT SPS, we now plan to accelerate our efforts toward reaching our goal of initiating international commercialization of the PCT Sample Preparation System in 2008. To that end, we have meetings scheduled over the next six weeks with our current distributors in France and Japan, and with potential distributors in Germany, Australia, and South Korea, all of whom have been anxiously awaiting our CE Mark and IEC 61010-1 approvals. In addition to these meetings, we also plan to immediately seek additional distributors for the PCT SPS in other countries around the world, especially in Europe and Asia."
About the Barocycler NEP2320
The NEP2320 offers a similar "look and feel" to the NEP3229, but has a system weight of approximately 75 verses 350 pounds, and processes one sample at a time, verses three for the NEP3229. Originally designed to be a demonstration unit for the larger NEP3229, the Company's market research suggested that there may be a niche in genomics and proteomics research laboratories for a Barocycler instrument with a lower sample throughput and a lower price, but with many of the technical capabilities of the higher throughput Barocycler NEP3229. Increasing European interest in PCT and the PCT SPS over the past several months has helped confirm the Company's initial market research findings.
About CE Mark and IEC 61010-1 Compliance
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 NEP2320, 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 NEP2320 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 NEP2320 to a number of countries worldwide, including some that do not accept the CE Mark.
About Pressure BioSciences, Inc.
Pressure BioSciences, Inc. (PBI) is a publicly traded 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 6 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 NEP2320 and NEP3229 instruments in 2008; and the expected market acceptance of the Barocycler NEP2320, 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 actual demand for the lighter weight and less expensive Barocycler NEP2320 may not meet the Company's expectations based on the Company's market research; the possibility that the Company may be unable to sell the Barocycler NEP2320 and NEP3229 instruments that it plans to market internationally in 2008; the possibility that the Company may be unsuccessful in engaging suitable distributors upon acceptable terms to sell the Barocycler NEP2320 and NEP3229 internationally; 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.
Visit us at our website http://www.pressurebiosciences.com
Investor Contacts:
Richard T. Schumacher, President & CEO
Edward H. Myles, Sr. Vice President of Finance & CFO
Pressure BioSciences, Inc.
(508) 580-1818 (T)
SOURCE Pressure BioSciences, Inc.
Released September 5, 2007