South Easton, MA, United States

Pressure Biosciences, Inc.

www.pressurebioscience.com
South Easton, MA, United States

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Patent
Pressure Biosciences, Inc. | Date: 2015-05-29

Devices and methods for sample preparation via pressure cycling technology are disclosed. The device for sample preparation comprises a tube having an inner surface, a top, and a bottom, the tube configured to contain a sample at the bottom and to be received into a pressure chamber for sample preparation, a cap detachably connected to the top of the tube, and a tapered elongate member extending from the cap into the tube, the tapered elongate member configured to contact the inner surface of the tube and the sample in the bottom of the tube, wherein the tube is deformable such that in operation under pressure the tube is deformed against the tapered elongate member to promote disruption of the sample.


Total Revenue, Products & Services Revenue, Consumable Sales, & Gross Margins All Increased While Operating Loss Decreased, Quarter-over-Quarter; CFO Hire, CE Marking Achievement, Sales & Marketing Expansion Expected to Help Drive Revenue, Expand Customer Base, and Increase Shareholder Value Throughout FY2017 SOUTH EASTON, MA--(Marketwired - May 16, 2017) - Pressure BioSciences, Inc. ( : PBIO) ("PBI" or the "Company"), 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 financial results for the first quarter of 2017, provided a business update, and offered limited guidance on its growth plan for FY2017. Products and services revenue increased 16% to $525,998 for Q1 2017 as compared to $454,350 for Q1 2016. This increase was primarily attributable to an increase of 19% in the sale of instrument systems, from $332,016 in Q1 2016 to $396,095 in the same quarter of 2017. Sales of consumables also increased during these same periods, from $44,234 in Q1 2016 to $63,264 in Q1 2017, an increase of 43%. Grant revenue decreased from $56,128 in Q1 2016 to $25,359 in Q1 2017. We believe grant revenue will increase over the remaining quarters in 2017. Despite this decrease in grant revenue, total revenue increased to $551,357 for the three months ended March 31, 2017 as compared to $510,478 during the three months ended March 31, 2016, an increase of $40,878 or 8%. This increase was attributable to increases in the sales of our products and services. Operating loss decreased to $999,103 in Q1 2017 from $1,045,945 for the same period in 2016, a reduction of $46,842 or 4%. This decrease was primarily due to reduced R&D expenses combined with increased sales of product and services. Loss per common share - basic and diluted - was $0.18 for Q1 2017 compared to a loss per common share of $0.26 for the same period in 2016. Mr. Joseph L. Damasio, Jr., VP of Finance and CFO, said: "As reported, we continued to show quarter-over-quarter revenue growth, especially in the important area of products and services. We also increased gross margins during the period. What makes these accomplishments even more rewarding was their achievement during a quarter in which we were also able to reduce operating expenses and operating loss. We believe the financial results of the first quarter 2017 have set us up well to significantly drive revenue and business growth for the rest of the fiscal 2017 year, and beyond." Mr. Richard T. Schumacher, President and CEO of PBI, commented: "Although pleased with the financial results of the first quarter, we are even more pleased with our operational accomplishments. During the first quarter, we made significant progress on our clearly-defined 2017 goals to (i) develop a clear and sustainable path to profitability and financial self-sufficiency; (ii) enhance and expand our current sales and marketing capabilities with the hiring of a minimum of four field sales directors, plus an external lead-generation service and internal operational personnel; and (iii) achieve an up-list to the NASDAQ Stock Exchange by or before the end of the 2017 second quarter. We believe that continued progress on or the achievement of these goals will position PBI to be a stronger, more valuable company, which in turn should increase shareholder value, which is our ultimate goal." Earnings Call The Company will hold an Earnings Conference Call at 4:30 PM EDT on Tuesday, May 16, 2017. To attend this teleconference via telephone, Dial-in: (877) 407-8031 (North America), (201) 689-8031 (International). Verbal Passcode: PBIO First Quarter 2017 Financial Call. Replay Number (877) 481-4010; (919) 882-2331 (International). Replay ID Number: 10404. Teleconference Replay Available for 30 days. About Pressure BioSciences, Inc. Pressure BioSciences, Inc. ("PBI") ( : 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 development and sales efforts are in the biomarker discovery, drug discovery and design, and forensics areas. Customers also use our products in other areas, such as bio-therapeutics characterization, soil & plant biology, vaccine development, and counter-bioterror applications. Forward Looking Statements  This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "would," "expects," "plans," "intends," "anticipates," "believes," estimates," "predicts," "projects," "potential" or "continue" or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. In evaluating these statements, you should specifically consider various factors. Actual events or results may differ materially. The Company's financial results for the year ended December 31, 2016 may not necessarily be indicative of future results. These and other factors may cause our actual results to differ materially from any forward-looking statement. These risks, uncertainties, and other factors include, but are not limited to, the risks and uncertainties discussed under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2016, 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. For more information about PBI and this press release, please click on the following website link:  http://www.pressurebiosciences.com Please visit us on Facebook, LinkedIn, and Twitter.


Patent
Pressure Biosciences, Inc. | Date: 2017-04-05

Devices and methods for sample preparation via pressure cycling technology are disclosed. The device for sample preparation comprises a tube having an inner surface, a top, and a bottom, the tube configured to contain a sample at the bottom and to be received into a pressure chamber for sample preparation, a cap detachably connected to the top of the tube, and a tapered elongate member extending from the cap into the tube, the tapered elongate member configured to contact the inner surface of the tube and the sample in the bottom of the tube, wherein the tube is deformable such that in operation under pressure the tube is deformed against the tapered elongate member to promote disruption of the sample.


Described herein is a sample preparation device including a sample delivery source, an inline means of transferring the sample from the sample source into a deformable channel within a pressure vessel, and out of the channel into downstream analysis components, a deformable channel disposed within the pressure vessel, the deformable channel having an inlet end and an outlet end fluidly connectable to high pressure valves and a means to measure the fluid pressure within the deformable channel, an external source of a controlled pressurized fluid fluidly connectable to the pressure vessel and a controller system that monitors and controls the sample fluid pressure by control of the external pressure vessel fluid.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 141.09K | Year: 2013

DESCRIPTION (provided by applicant): Encouraged by NIH's challenge to enable the 1000 genome, current developments in massively parallel sequencing (MPS) continue to increase throughput and reduce the cost of whole-genome sequencing. Unfortunately, the corresponding sample preparation methodologies now lag behind in throughput and DNA quality, thus slowing the pace of discovery and adoption of sequencing techniques in clinical diagnostics. This proposal's focus is to demonstrate the feasibility of controlled DNA shearing utilizing miniature (lt200 L sample) very high pressure (up to 400Mpa) single pass discharge under controlled and highly energetic conditions to generate the input sample for future massively parallel sequencing (MPS). The proposed systemsbuild on established hydrodynamic mechanism of fluid shear generated under high differential pressure nozzle flow. Long DNA fragments traversing though the nozzle's high velocity gradient are pulled apart due to intense viscous drag forces. For example, atthese high pressures, fluid flow velocity will reach 3 times the speed of sound within a very short transition distance. By varying the control parameters of pressure and flow, back pressure, different levels of fragmentation should be achieved. This fragmentation process is not probabilistic and acts upon every DNA molecule that transits the nozzle. The Phase I proposal is focuses on the optimization of control parameters to achieve desired DNA fragmentation performance, following up on preliminary work already done on several prototypes of the two alternative approaches to nozzle design described herein. Each of these approaches can be multiplexed for high throughput use. During Phase II, we intend to expand our studies into large parallel process demonstration. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: The proposed study aims to develop a high-throughput high pressure system for automated sample preparation for Next Generation Sequencing and other applications to facilitate better control of DNA shearing while minimizing losses and further reducing costs. Higher yields of DNA fragments of desired length, and less potential chemical DNA damage, are expected to improve DNA sequencing-based personalized diagnostics and lead to considerable benefits in healthcare and biomedical research fields.


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 749.99K | Year: 2011

We propose to develop an easy-to-use, safe, automated, field-portable high-throughput system, with related methods and consumables, to allow for the simultaneous inactivation and extraction of target molecules from pathogenic organisms, such as viruses, and rickettsia and non-rickettsial bacteria, that propagate and/or disseminate in arthropod hosts (herein referred to as Agents). The proposed System will use a combination of mechanical homogenization, high hydrostatic pressure, elevated temperature, and optimized chemical reagents to inactivate said Agents and extract the target molecules (DNA, RNA and proteins) from host organisms for subsequent separation and detection by a variety of conventional methods. We propose that the System would be equally effective in the field and in a laboratory environment. All sample processing will occur in sealed sample containers. These containers will facilitate sample homogenization, lysis, and rapid extraction of target molecules. Additionally, they will be suitable for sample collection, transportation, and storage (pre- and post analysis). Such containers will help ensure strict chain-of-custody, prevent sample cross-contamination, and reduce the likelihood of exposing personnel to infectious Agents. The System will be made rugged and portable; will be capable of automating the steps of sample inactivation, fractionation, enrichment, and extraction; and will be deployable in the field environment.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 160.98K | Year: 2011

DESCRIPTION (provided by applicant): Fixation of tissue samples with formalin and paraffin is an established approach for long-term storage of tissues for later histological analyses. These formalin-fixed paraffin-embedded tissues can also be used for DNA,RNA or protein extraction for retrospective molecular studies. Unfortunately, traditional preservation methods do not guarantee uniform fixation, frequently resulting in excessive cross-linking of molecules on the periphery of the specimen and slow degradation in its depth. Consequently, antigen retrieval, genomic or proteomic biomarker identification studies may generate inaccurate or misleading results. Attempts at alternative fixation methods, such as convectional heat or microwave radiation treatment,have also proven inadequate, since they fail to produce a uniform product, or result in perturbations to the biomolecular profiles. We propose to develop an automated tissue preservation system that uses high hydrostatic pressure to standardize the processof tissue fixation with precise thermodynamic control. High pressure has been shown to enhance rapid and uniform formaldehyde penetration into tissue blocks. The proposed Tissue Preservation System will enable better preservation of tissues through enhanced penetration of fixative while preserving tissue architecture. Such improvements should lead to the generation of better data from preserved samples, which may lead to faster disease diagnosis and successful development of therapeutics. 1 PUBLIC HEALTH RELEVANCE: The proposed study aims to develop a high pressure system for automated preservation of clinical tissue specimens to facilitate and standardize the tissue fixation process independent of specimen size and tissue type. Better, more consistent, and more uniform preservation of tissue architecture, and improved chemical integrity of potential biomarkers, are expected to lead to considerable benefits for future histopathology and retrospective molecular diagnostics studies using fixed sample repositories.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.02M | Year: 2015

DESCRIPTION provided by applicant Developments in next generation sequencing NGS continue to increase throughput and reduce the costs for whole genome sequencing Unfortunately DNA preparation methods lag behind in both throughput and DNA quality slowing the pace of adoption of new sequencing techniques This Phase II proposal focuses on the development of an automated commercial prototype DNA shearing device that matches the requirements of many popular and emerging NGS platforms In Phase II we will develop a miniature self cleaning active shearing nozzle and integrate it with a constant pressure pump to allow for a flow through shearing design and easy sample introduction and collection In addition we will build on our progress from Phase I to optimize the range of parameters pressure flow rate orifice diameter and design necessary for optimal DNA shearing to generate fragments in predictable narrow size ranges We will manufacture two prototype instruments for placement at our Randamp D laboratory and at a collaborator site and will characterize the performance of the automated system prototypes We have identified vendors for critical system components and secured academic collaborators to validate the performance of the new platform We expect to achieve manufacturing readiness by the conclusion of this Phase II period In Specific Aim we will develop a miniature automatic self cleaning active shearing nozzle followed by Specific Aim where we will integrate the shearing nozzle with a constant pressure pump and the means of sample introduction and collection In this Aim we will also develop computer software to facilitate automatic control of the active nozzle and sample management In Specific Aim we will identify the range of parameters pressure flow temperature and viscosity necessary for optimal performance of proposed integrated system In Specific Aim we will characterize the performance of the automated system prototypes for DNA shearing applications and develop corresponding applications Finally in Specific Aim we will evaluate the suitability of the system for cell lysis and homogenization and optimize the hardware components for that purpose We have identified vendors for most critical components and secured academic collaborators to validate performance of the new platform therefore we expect to achieve the manufacturing readiness by the conclusion of this Phase II periodPUBLIC HEALTH RELEVANCE The aim of this Phase II proposal is to develop a high throughput high pressure automatable hydrodynamic DNA shearing device prototype This device is designed to improve control of DNA fragmentation and minimize losses and potential chemical DNA damage while reducing costs for Next Generation Sequencing and other applications More efficient generation of DNA in the desired size range s will improve DNA sequencing based personalized diagnostics and lead to considerable benefits in biomedical research and healthcare


Patent
Pressure Biosciences, Inc. | Date: 2011-10-27

A pressurizable sample system includes a microplate having a planar plate surface and several sample wells. Each sample well has a flange positioned circumferentially around an outer surface of the sample well and against the planar plate surface. The sample system further includes a capping plate with a planar cap surface and several caps projecting from the planar cap surface. Each cap has a geometrical configuration in complementary correspondence with the configuration of the sample well.


Patent
Pressure Biosciences, Inc. | Date: 2012-10-04

The present invention is related to systems and methods for chemical and biological analysis and, in particular, to systems, apparatus, and methods of sample conditioning and analysis.

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