Introductory Comment
Throughout this Annual Report on Form 10-K, the terms “we,” “us,” “our,” “the Company” and “our company” refer to Pressure BioSciences, Inc., a Massachusetts corporation, and, unless the context indicates otherwise, also includes our wholly-owned subsidiary.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In some cases, forward-looking statements are identified by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential,” and similar expressions intended to identify forward-looking statements. Such statements include, without limitation, statements regarding:
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our need for, and our ability to raise, additional equity or debt financing on acceptable terms, if at all;
our need to take additional cost reduction measures, cease operations or sell our operating assets, if we are unable to obtain sufficient additional financing;
our belief that we have sufficient liquidity to finance normal operations until April 2012;
the options we may pursue in light of our financial condition;
the amount of cash necessary to operate our business;
the anticipated uses of grant revenue and the potential for increased grant revenue in future periods;
our plans and expectations with respect to our pressure cycling technology (“PCT”) operations;
our belief that PCT has achieved initial market acceptance in the mass spectrometry market;
the expected increase in number of PCT units installed and the increase in revenues from the sale of consumable products and extended service contracts;
the expected development and success of new product offerings;
the potential applications for PCT;
the expected expenses of, and benefits and results from, our research and development efforts;
the expected benefits and results from our collaboration programs, strategic alliances and joint ventures;
our expectation of obtaining additional research grants from the government in the future;
our expectations of the results of our development activities funded by government research grants;
the potential size of the market for biological sample preparation;
general economic conditions;
the anticipated future financial performance and business operations of our company;
our reasons for focusing our resources in the market for genomic, proteomic, lipidomic, and small molecule sample preparation;
the importance of mass spectrometry as a laboratory tool;
the advantages of PCT over other current technologies as a method of sample extraction and for other applications;
the capabilities and benefits of our PCT sample preparation system and consumable products;
our belief that laboratory scientists will achieve results comparable to those reported to date by certain research scientists who have published or presented publicly on PCT;
our ability to retain our core group of scientific, administrative, and sales personnel; and
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our ability to expand our customer base in sample preparation and for other applications of PCT.
These forward-looking statements are only predictions and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by such forward-looking statements. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this Annual Report on Form 10-K. Except as otherwise required by law, we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained in this Annual Report on Form 10-K to reflect any change in our expectations or any change in events, conditions, or circumstances on which any of our forward-looking statements are based. Factors that could cause or contribute to differences in our future financial results include those discussed in the risk factors set forth in Part I, Item 1A of this Annual Report on Form 10-K as well as those discussed elsewhere in this Report. We qualify all of our forward-looking statements by these cautionary statements.
ITEM 1.
BUSINESS.
Throughout this document we use the following terms: Barocycler®, PULSE®, and BioSeq®, which are registered trademarks of the Company. We also use the terms ProteoSolveTM, ProteoSolveLRSTM, the Power of PCTTM, the PCT ShredderTM, all of which are unregistered trademarks of the Company.
Overview
We are focused on solving the challenging problems inherent in biological sample preparation, a crucial laboratory step performed by scientists worldwide working in biological life sciences research. Sample preparation is a term that refers to a wide range of activities that precede most forms of scientific analysis. Sample preparation is often complex, time-consuming, and in our belief, one of the most error-prone steps of scientific research. It is a widely-used laboratory undertaking, the requirements of which drive what we believe is a large and growing worldwide market. We have developed and patented a novel, enabling technology platform that can control the sample preparation process. It is based on harnessing the unique properties of high hydrostatic pressure. This process, called pressure cycling technology, or PCT, uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels (35,000 psi or greater) to safely, conveniently and reproducibly control the actions of molecules in biological samples, such as cells and tissues from human, animal, plant, and microbial sources.
Our pressure cycling technology uses internally developed instrumentation that is capable of cycling pressure between ambient and ultra-high levels - at controlled temperatures and specific time intervals - to rapidly and repeatedly control the interactions of bio-molecules, such as DNA, RNA, proteins, lipids, and small molecules. Our laboratory instrument, the Barocycler®, and our internally developed consumables product line, including PULSE (Pressure Used to Lyse Samples for Extraction) Tubes, other processing tubes, and application specific kits (which include consumable products and reagents) together make up our PCT Sample Preparation System, or PCT SPS.
We hold 14 United States and 10 foreign patents covering multiple applications of PCT in the life sciences field. Our pressure cycling technology employs a unique approach that we believe has the potential for broad use in a number of established and emerging life sciences areas, including;
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Biological sample preparation, which includes sample preparation for genomic, proteomic, lipidomic,
metabolomic, and small molecule studies;
pathogen inactivation;
protein purification;
control of chemical (particularly enzymatic) reactions; and
immunodiagnostics (clinical laboratory testing).