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Patent
CytoVale, Inc. | Date: 2016-12-13

A system for deforming and analyzing particles includes a substrate defining an inlet, and an outlet; a fluidic pathway fluidly coupled to the inlet and the outlet and defining a delivery region upstream of a deformation region configured to deform particles, wherein the fluidic pathway comprises a first branch configured to generate a first flow, and a second branch configured to generate a second flow that opposes the first flow, wherein an intersection of the first flow and the second flow defines the deformation region; a detection module including a sensor configured to generate a morphology dataset characterizing deformation of the particles, and a photodetector configured to generate a fluorescence dataset characterizing fluorescence of the particles; and a processor configured to output an analysis of the plurality of particles based at least in part on the deformation dataset and the fluorescent dataset for the plurality of particles.


Grant
Agency: NSF | Branch: Standard Grant | Program: | Phase: SMALL BUSINESS PHASE II | Award Amount: 919.61K | Year: 2014

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is in detecting sepsis early in its course, before end organ damage when it is most treatable. Sepsis, an uncontrolled systemic response to local infection by bacteria or fungi, is responsible for more deaths than prostate cancer, breast cancer, and AIDS combined and is associated with ~$17B in annual U.S. healthcare expenditures. We anticipate that providing emergency department physicians with an earlier diagnostic will profoundly influence clinical outcomes (currently ~40% mortality), costs (>$22,000/case), and the quality of life for survivors and their families. Accumulating evidence connects systemic immune activation ? a key process in sepsis ? with single-cell architectural changes that are mechanically measured by high-speed mechanical phenotyping technology. This technology is well-suited for adult sepsis screening in the emergency department (market size of $1.5B) due to: (1) the functional analysis of cell state the mechanical measurement provides, (2) its high achievable throughput and therefore statistical accuracy, (3) exceedingly short turnaround time, (4) low cost of goods, and (5) the clinically-actionable information it provides. Beyond the adult sepsis screening market, several additional indications include neonatal sepsis, bladder cancer detection, academic research tools, and drug development.


The proposed project brings an innovative new class of biomarkers to bear on a problem that has been intractable with current biomarkers. Briefly, the physical properties of cells have been known to be important for decades, but only with the advent of breakthrough microfluidic technology have we been able to measure these parameters in a high-throughput manner capable of diagnosing disease. This Small Business Innovation Research (SBIR) Phase II award will be used to develop and validate innovative sample preparation and image analysis modules for a sepsis screening technology as well as performance of proof-of-concept clinical studies that would be a flagship offering in using biomechanical biomarkers to diagnose disease. The technical objectives are designed to improve sensitivity to white blood cells, activated during sepsis, by microfluidic automation of sample preparation and optimization of the microscopic imaging optics. In addition to preparing the test for practical implementation in the emergency department, the test will be validated with a proof-of-concept clinical study, and a clinical scoring system will be devised.


Grant
Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 748.01K | Year: 2015

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is in detecting sepsis early in its course, before end organ damage when it is most treatable. Sepsis, an uncontrolled systemic response to local infection by bacteria or fungi, is responsible for more deaths than prostate cancer, breast cancer, and AIDS combined and is associated with ~$17B in annual U.S. healthcare expenditures. We anticipate that providing emergency department physicians with an earlier diagnostic will profoundly influence clinical outcomes (currently ~40% mortality), costs (>$22,000/case), and the quality of life for survivors and their families. Accumulating evidence connects systemic immune activation ? a key process in sepsis ? with single-cell architectural changes that are mechanically measured by high-speed mechanical phenotyping technology. This technology is well-suited for adult sepsis screening in the emergency department (market size of $1.5B) due to: (1) the functional analysis of cell state the mechanical measurement provides, (2) its high achievable throughput and therefore statistical accuracy, (3) exceedingly short turnaround time, (4) low cost of goods, and (5) the clinically-actionable information it provides. Beyond the adult sepsis screening market, several additional indications include neonatal sepsis, bladder cancer detection, academic research tools, and drug development. The proposed project brings an innovative new class of biomarkers to bear on a problem that has been intractable with current biomarkers. Briefly, the physical properties of cells have been known to be important for decades, but only with the advent of breakthrough microfluidic technology have we been able to measure these parameters in a high-throughput manner capable of diagnosing disease. This Small Business Innovation Research (SBIR) Phase II award will be used to develop and validate innovative sample preparation and image analysis modules for a sepsis screening technology as well as performance of proof-of-concept clinical studies that would be a flagship offering in using biomechanical biomarkers to diagnose disease. The technical objectives are designed to improve sensitivity to white blood cells, activated during sepsis, by microfluidic automation of sample preparation and optimization of the microscopic imaging optics. In addition to preparing the test for practical implementation in the emergency department, the test will be validated with a proof-of-concept clinical study, and a clinical scoring system will be devised.


Grant
Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 150.00K | Year: 2013

This Small Business Innovation Research (SBIR) Phase I project will address the challenge of integrating two powerful single-cell analysis tools with the aim of developing and validating new biomarkers for malignancy. The deformability of invasive cells has long been hypothesized to confer their ability to migrate through tight tissue barriers and form metastases. Recently, this idea has been supported by mechanical measurements of cells either isolated from or directly in biological fluid specimens. This convergence of ideas from both biological and physical sciences represents a mechanical biomarker, and tools to be employed clinically to assay these properties are rapidly being developed. Cytovale?s technology measures cell deformability at a throughput of several thousand cells per second, comparable to the ubiquitous flow cytometer, which allows immediate measurement of cells directly in biological fluids. This technology has a demonstrated utility: highly sensitive detection of malignancy in cellularly heterogeneous clinical pleural effusions. Its integration with fluorescence in this project will provide a transformational research and clinical tool, well-aligned with the critical aims of improving patient care and reducing costs through automation, early detection of disease, and use of quantitative, novel biomarkers. The broader impact/commercial potential of this project is realized by appreciating the applicability of the technology across research and clinical settings. Even without integration with fluorescence (flow) cytometry the technology has demonstrated its utility as a sensitive detector of malignancy in clinical specimens, specifically, pleural effusions. However, cell mechanics is an attractive biomarker for invasiveness, and is likely conserved throughout cells found in many biological fluids, including urine and fine needle aspirates. The proposed activity will further enhance the technology?s diagnostic accuracy. The instruments developed by Cytovale will be placed in clinical cytology labs to complement gold standard cytological methods, performing high sensitivity screens of biological fluids and eliminating unnecessary, invasive, and costly follow-up procedures. The hybrid instrument will also be an especially powerful tool for exploring connections between cell mechanics and traditional markers, which greatly extends the number of research laboratories which would benefit from this enabling technology.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 225.00K | Year: 2014

DESCRIPTION (provided by applicant): Sepsis, an uncontrolled systemic inflammatory immune response to local infection by bacteria or fungi, is responsible for more deaths than prostate cancer, breast cancer, and AIDS combined, accounts for more than 40% ofICU costs, and is the most expensive inpatient condition in the U.S. (~ 20B in annual U.S. healthcare expenditures in 2011). While it has been demonstrated that the time to initiating aggressive treatment is critical to improving outcomes (currently ~40%mortality) and decreasing costs (gt 22,000/case), the field suffers from a lack of compelling early diagnostic tools. CytoVale aims to improve the sepsis treatment paradigm by offering a platform to detect abnormal systemic inflammation at initial presentation. Our diagnostic platform will offer a cost-effective, robust, and rapid sample-to-decision assay (lt 5 minute), in which activated white blood cells that are indicative of uncontrolled systemic inflammation are identified in a label-free manner. I


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 750.00K | Year: 2016

Project Summary Sepsis an uncontrolled systemic inflammatory immune response to local infection by bacteria or fungi is responsible for more deaths than prostate cancer breast cancer and AIDS combined accounts for more than of ICU costs and is the most expensive inpatient condition in the U S $ B in annual U S healthcare expenditures in While it has been demonstrated that the time to initiating aggressive treatment is critical to improving outcomes currently mortality and decreasing costs andgt $ case emergency medicine physicians suffer from a lack of compelling diagnostic tools for detection of sepsis in the emergency department ED where andgt of sepsis cases originate in the hospital CytoVale aims to improve the sepsis treatment paradigm by offering a platform to detect abnormal systemic inflammation at initial presentation Our diagnostic platform will offer a cost effective robust and rapid sample to decision assay andlt minutes in which activated white blood cells that are indicative of uncontrolled systemic inflammation are interrogated in a label free manner In order to impact quality of care the instrument must be situated at the point of care POC where it can provide rapid results to impact patient care Currently this is not feasible due to manual operations required to prepare samples for the assay e g centrifugation pipetting and the lack of an in sample calibration Here we propose to capitalize on the success of our Phase progress of automating the process of sample preparation by now developing a fully integrated module that combines the sample preparation and deformability cytometry microfluidics into a single cartridge and instrument This will allow for the identification and triaging of patients earlier in their disease process at the ED POC from a finger prick of blood Additional cost and patient comfort benefits arise from the ability to track the course of disease and design treatments specific to patient response saving days spent in the hospital and associated costs Cytovale also proposes to develop and integrate a deformable sample control Mechanical standard particles will be used as internal controls within each sample run to ensure fidelity of the instrument readings and diagnostic accuracy Not only will this help verify reliability and consistency of experiments but will also supply a much needed calibration particle to the growing field of cellular biophysics Combined these aims will expand accessibility of powerful cell based assays at the POC Project Narrative Sepsis an uncontrolled systemic response to local infection by bacteria or fungi is responsible for more deaths than prostate cancer breast cancer and AIDS combined accounts for more than of ICU costs and is associated with $ B in annual U S healthcare expenditures There are no diagnostics that can detect sepsis early in its course in the emergency department when it is treatable with readily available antibiotics and fluids and before the onset of major organ failure which is detected by current diagnostics We propose to integrate complete automation of the first ED point of care sepsis diagnostic assay to enable rapid detection of sepsis at the point that will maximally improve patient outcomes from this deadly disease


Grant
Agency: NSF | Branch: Standard Grant | Program: | Phase: | Award Amount: 185.00K | Year: 2013

This Small Business Innovation Research (SBIR) Phase I project will address the challenge of integrating two powerful single-cell analysis tools with the aim of developing and validating new biomarkers for malignancy. The deformability of invasive cells has long been hypothesized to confer their ability to migrate through tight tissue barriers and form metastases. Recently, this idea has been supported by mechanical measurements of cells either isolated from or directly in biological fluid specimens. This convergence of ideas from both biological and physical sciences represents a mechanical biomarker, and tools to be employed clinically to assay these properties are rapidly being developed. Cytovale?s technology measures cell deformability at a throughput of several thousand cells per second, comparable to the ubiquitous flow cytometer, which allows immediate measurement of cells directly in biological fluids. This technology has a demonstrated utility: highly sensitive detection of malignancy in cellularly heterogeneous clinical pleural effusions. Its integration with fluorescence in this project will provide a transformational research and clinical tool, well-aligned with the critical aims of improving patient care and reducing costs through automation, early detection of disease, and use of quantitative, novel biomarkers.

The broader impact/commercial potential of this project is realized by appreciating the applicability of the technology across research and clinical settings. Even without integration with fluorescence (flow) cytometry the technology has demonstrated its utility as a sensitive detector of malignancy in clinical specimens, specifically, pleural effusions. However, cell mechanics is an attractive biomarker for invasiveness, and is likely conserved throughout cells found in many biological fluids, including urine and fine needle aspirates. The proposed activity will further enhance the technology?s diagnostic accuracy. The instruments developed by Cytovale will be placed in clinical cytology labs to complement gold standard cytological methods, performing high sensitivity screens of biological fluids and eliminating unnecessary, invasive, and costly follow-up procedures. The hybrid instrument will also be an especially powerful tool for exploring connections between cell mechanics and traditional markers, which greatly extends the number of research laboratories which would benefit from this enabling technology.


SAN FRANCISCO & FRANKLIN LAKES, N.J.--(BUSINESS WIRE)--Breakout Labs, Peter Thiel’s philanthropic revolving fund for early-stage science and technology companies, and BD (Becton, Dickinson and Company) (NYSE: BDX) announced today that they have established a strategic relationship to provide additional grant funding and professional expertise to qualifying Breakout Labs portfolio companies. Under the terms of the agreement, BD will periodically review Breakout Labs’ portfolio for companies developing cutting-edge technologies that are relevant to the strategic interests of BD’s Medical and Life Sciences business segments. Breakout Labs companies selected to participate will be given an unrestricted grant of up to $25,000 from BD, and assigned a business mentor responsible for providing guidance and connections to subject matter experts throughout the company. “At BD, our goal is to find and nurture cutting-edge technologies that will improve healthcare delivery and outcomes, realizing that such opportunities will not just come from within our walls,” said Ellen Strahlman, Executive Vice President R&D and Chief Medical Officer at BD. “Breakout Labs brings a fresh approach to finding and supporting the kind of desperately needed innovations that will improve health around the world. We’re excited to lend our financial assistance and subject matter expertise to help these companies flourish.” In a pilot run of this relationship, Breakout Labs portfolio company CytoVale received a grant from BD. CytoVale management was also connected with Dr. Andrea Liebmann-Vinson at BD’s Corporate Innovation Center in Research Triangle Park, N.C., who will forge relationships within BD that may provide the San Francisco startup with technical evaluations as well as assistance understanding regulatory, clinical, reimbursement and manufacturing challenges required to bring a product to market. “We’re excited to be partnering with an industry leader such as BD and deeply value BD’s financial and in-kind commitments towards accelerating commercialization of our cutting-edge cell analysis technology. We’ve already benefited from our early interaction with the team at BD, and look forward to continued engagement,” said Ajay Shah, CEO of CytoVale. “When radical scientific ideas advance from the lab and into the market, everyone wins,” said Lindy Fishburne, Executive Director of Breakout Labs. “BD deeply understands this and can help our companies tackle some of their technical and operational challenges much more efficiently and adeptly than they could on their own.” Breakout Labs, a program of the Thiel Foundation, is reshaping the way early-stage science and technology companies are funded. Founded in 2011, Breakout Labs has supported 22 companies in areas ranging from food science and biomedicine to clean energy. For many of these companies, Breakout Labs was the first external investor. Breakout Labs provides up to $350,000 for companies to achieve specific milestones that are critical to their development. In addition to funding, Breakout Labs companies benefit directly from a 2-year program of mentorship and networking, with access to the Thiel Foundation’s large community of investors, innovators, and entrepreneurs. Successful grantees return a capped royalty stream and a small percentage of equity in their company to Breakout Labs and thereby contribute to the next generation of scientific innovation. For more information, see www.BreakoutLabs.org. BD is a leading medical technology company that partners with customers and stakeholders to address many of the world’s most pressing and evolving health needs. Our innovative solutions are focused on improving medication management and patient safety; supporting infection prevention practices; equipping surgical and interventional procedures; improving drug delivery; aiding anesthesiology and respiratory care; advancing cellular research and applications; enhancing the diagnosis of infectious diseases and cancers; and supporting the management of diabetes. We are more than 45,000 associates in 50 countries who strive to fulfill our purpose of “Helping all people live healthy lives” by advancing the quality, accessibility, safety and affordability of healthcare around the world. In 2015, BD welcomed CareFusion and its products into the BD family of solutions. For more information on BD, please visit www.bd.com. CytoVale is a venture-backed life sciences tools and diagnostics startup based in the San Francisco Bay Area. Founded in 2013, the company is commercializing innovative cell handling and analysis technology developed at UCLA. This platform enables rapid, label-free, assessment of cells’ biophysical properties and is being used to power a range of applications in clinical diagnostics.


News Article | November 15, 2013
Site: www.finsmes.com

CytoVale, a San Francisco, CA-based developer of a new class of biomarkers based on the mechanical properties of individual cells, or mechanomics, received an investment of undisclosed amount. Breakout Labs, the program of the Thiel Foundation, which invests in early-stage science and technology companies, provided the funding. Led by CEO Ajay Shah, Ph.D., and co-founder Dino Di Carlo, Ph.D. (UCLA Professor), CytoVale uses microfluidics to route and physically probe individual cells. It can measure over 10 biophysical cell markers at rates above 2,000 cells per second, providing a high-throughput, low-cost method of detecting disease. The company had already received a $200k SBIR Award (read here).


SAN FRANCISCO & FRANKLIN LAKES, N.J.--(BUSINESS WIRE)--Breakout Labs, Peter Thiel’s philanthropic revolving fund for early-stage science and technology companies, and BD (Becton, Dickinson and Company) (NYSE: BDX) announced today that they have established a strategic relationship to provide additional grant funding and professional expertise to qualifying Breakout Labs portfolio companies. Under the terms of the agreement, BD will periodically review Breakout Labs’ portfolio for companies developing cutting-edge technologies that are relevant to the strategic interests of BD’s Medical and Life Sciences business segments. Breakout Labs companies selected to participate will be given an unrestricted grant of up to $25,000 from BD, and assigned a business mentor responsible for providing guidance and connections to subject matter experts throughout the company. “At BD, our goal is to find and nurture cutting-edge technologies that will improve healthcare delivery and outcomes, realizing that such opportunities will not just come from within our walls,” said Ellen Strahlman, Executive Vice President R&D and Chief Medical Officer at BD. “Breakout Labs brings a fresh approach to finding and supporting the kind of desperately needed innovations that will improve health around the world. We’re excited to lend our financial assistance and subject matter expertise to help these companies flourish.” In a pilot run of this relationship, Breakout Labs portfolio company CytoVale received a grant from BD. CytoVale management was also connected with Dr. Andrea Liebmann-Vinson at BD’s Corporate Innovation Center in Research Triangle Park, N.C., who will forge relationships within BD that may provide the San Francisco startup with technical evaluations as well as assistance understanding regulatory, clinical, reimbursement and manufacturing challenges required to bring a product to market. “We’re excited to be partnering with an industry leader such as BD and deeply value BD’s financial and in-kind commitments towards accelerating commercialization of our cutting-edge cell analysis technology. We’ve already benefited from our early interaction with the team at BD, and look forward to continued engagement,” said Ajay Shah, CEO of CytoVale. “When radical scientific ideas advance from the lab and into the market, everyone wins,” said Lindy Fishburne, Executive Director of Breakout Labs. “BD deeply understands this and can help our companies tackle some of their technical and operational challenges much more efficiently and adeptly than they could on their own.” Breakout Labs, a program of the Thiel Foundation, is reshaping the way early-stage science and technology companies are funded. Founded in 2011, Breakout Labs has supported 22 companies in areas ranging from food science and biomedicine to clean energy. For many of these companies, Breakout Labs was the first external investor. Breakout Labs provides up to $350,000 for companies to achieve specific milestones that are critical to their development. In addition to funding, Breakout Labs companies benefit directly from a 2-year program of mentorship and networking, with access to the Thiel Foundation’s large community of investors, innovators, and entrepreneurs. Successful grantees return a capped royalty stream and a small percentage of equity in their company to Breakout Labs and thereby contribute to the next generation of scientific innovation. For more information, see www.BreakoutLabs.org. BD is a leading medical technology company that partners with customers and stakeholders to address many of the world’s most pressing and evolving health needs. Our innovative solutions are focused on improving medication management and patient safety; supporting infection prevention practices; equipping surgical and interventional procedures; improving drug delivery; aiding anesthesiology and respiratory care; advancing cellular research and applications; enhancing the diagnosis of infectious diseases and cancers; and supporting the management of diabetes. We are more than 45,000 associates in 50 countries who strive to fulfill our purpose of “Helping all people live healthy lives” by advancing the quality, accessibility, safety and affordability of healthcare around the world. In 2015, BD welcomed CareFusion and its products into the BD family of solutions. For more information on BD, please visit www.bd.com. CytoVale is a venture-backed life sciences tools and diagnostics startup based in the San Francisco Bay Area. Founded in 2013, the company is commercializing innovative cell handling and analysis technology developed at UCLA. This platform enables rapid, label-free, assessment of cells’ biophysical properties and is being used to power a range of applications in clinical diagnostics.

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