Pressure BioSciences, Inc. Awarded NIH SBIR Phase I Grant for the Development of an Automated, Pressure-Enhanced System for the Routine Processing of Cancer and Other Tissue Samples
South Easton, MA – Pressure BioSciences, Inc. today announced that it has been awarded a $160,978 SBIR Phase I grant (1R43GM090582-01A1) from the National Institute of General Medical Sciences of the National Institutes of Health (“NIH”). Entitled “Methods and Instrumentation for Hydrostatic Pressure-Enhanced Tissue Fixation”, the grant will help fund the development of a high pressure system for the automated processing and preservation of tissue samples to facilitate, standardize, and improve the tissue fixation process independent of sample size and tissue type. If the Phase I development efforts are successful, the Company expects to submit a request for SBIR Phase II funding; such funding is usually for approximately $1 million and is billed over a two year period.
As announced in May of 2010, the Company has a Cooperative Research and Development Agreement (“CRADA”) with the Armed Forces Institute of Pathology (“AFIP”), the American Registry of Pathology (“ARP”), and the Department of Veterans Affairs (“VA”). One of the purposes of the CRADA is to develop pressure-based methods to improve the quality and speed of preparing formalin fixed, paraffin embedded (“FFPE”) tissues. AFIP will provide PBI with laboratory analyses and histology services under the grant.
Formalin fixation followed by paraffin embedding is the most commonly used technique worldwide for the preservation of tissues for pathology evaluation. However, the quality and analysis of FFPE samples are highly problematic for a number of reasons, including a lack of standardization in both the times and methods currently used for tissue fixation, and the inconsistent penetration of formalin in various tissue types. Inconsistent formalin penetration can lead to uneven fixation and a subsequent “corruption” of the tissue sample.
Dr. Jeffrey T. Mason, Chairman of the Biophysics Department at AFIP, commented: “Formalin-based tissue histology has remained largely unchanged for nearly half a century. The slow rate of penetration of formalin into tissues results in uneven fixation and increases the time to diagnosis. Preliminary studies indicate that pressure-assisted histology has the potential to significantly decrease the time required for tissue processing and subsequent examination by a pathologist. Further, pressure-assisted histology results in more uniform chemical and antibody staining, both of which improve the ability of the pathologist to evaluate the cellular architecture of the tissue.”
Dr. Alexander V. Lazarev, Vice President of R&D for PBI, said: “We believe that there are over 35 million new FFPE tissue samples processed each year in the U.S. alone. In addition to their importance in pathology evaluation, an increasing number of these samples are being used for biomarker discovery, where the quality of fixation is crucial for the preservation of molecules vital to the understanding of disease mechanisms and drug development. We believe our pressure-enhanced fixation method can significantly increase the quality of the standard fixation process. Such improvement could lead to the generation of better data from FFPE samples, which could then lead to faster disease diagnosis, as well as the successful development of new diagnostics, therapeutics, and vaccines.”
About Pressure BioSciences, Inc.
Pressure BioSciences, Inc. (PBI) is a NASDAQ Capital Market listed company focused on the development and sale of instrumentation and consumables based on a novel, enabling technology platform 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 24 issued patents covering multiple applications of PCT in the life sciences field, including genomic and proteomic sample preparation, pathogen inactivation, the control of chemical reactions, immunodiagnostics, and protein purification. PBI currently focuses its efforts on the development and sale of PCT-enhanced bio-molecule extraction and enzymatic digestion products designed specifically for the mass spectrometry marketplace, as well as sample preparation products for biomarker discovery, soil and plant biology, forensics, histology, and counter-bioterror applications

