Tissue CO2 Clinical References – original

Richard K. Gordon

Chairman of the Board

Richard K. Gordon is the general partner of Juniper Capital L.P., Juniper Energy LP and JunCap Trona, L.P., and is a partner in Juniper Capital II, L.P. These partnerships have made in excess of $2.5 billion of investments in oil and gas exploration and production assets, in natural gas pipelines, in oilfield services businesses, in natural gas fired electric generating plants and in mineral royalties. Mr. Gordon is the lead Director and head of the Human Resources Committee of Atmos Energy Corporation, a $7 billion market cap energy company listed on the New York Stock Exchange; he is also a director of ExoStat Medical, Inc. Prior to working with Juniper, Mr. Gordon spent nearly 30 years working in the financial services industry with Dillon, Read & Co., Inc. where he was a Vice President, The First Boston Corporation where he was a Managing Director and Merrill Lynch & Co., Inc. where he was a Vice Chairman of Investment Banking. Mr. Gordon has founded or co-founded more than 15 companies engaged in such diverse industries as energy, power generation, leasing, telecommunications, real estate, food and beverage, and medical devices. Mr. Gordon holds a B.A. degree from Colgate University and an M.B.A. degree from Cornell University.

Kent Winger

President/Chief Operating Officer, Board Member

Mr. Winger has over 28 years of extensive medical device development and manufacturing experience. Mr. Winger’s career experience includes management positions within operations, manufacturing and quality engineering, production management, product and process development, purchasing, material control, and facilities management. Mr. Winger joined ExoStat Medical in 2009, yet he has extensive prior experience with the MicroStat system over ten plus years of employment with Vasamed. From 1998–2008, Mr. Winger was in charge of manufacturing at Vasamed, including production of probes and sensors for the predicate MicroTrend product and oversaw contract manufacturing of hardware for the device. He was intimately involved in the development of the predicate hand-held MicroTrend product. Mr. Winger’s prior experience includes Lumen Biomedical, Inc. (2008-2009) where he served as Vice President of Operations, Vasamed Inc. (1998-2008) where he served as Vice President of Operations, Boston Scientific Corp. (1986-1998) where he served as Operations Manager, Engineering and Process Development Manager, and Sr. Engineer, and Plastech Corp. (1984-1986) where he served as Project Manager. During Mr. Winger’s career he has been directly involved with the development and commercial launch of over 35 successful medical products. Mr. Winger holds an A.A.S. in Mechanical Engineering from Normandale College and an M.M.S.E. from University of St. Thomas – St. Paul, MN.

Jim Hays

CEO, Board Member

Mr. Hays has served ExoStat as President/CEO since 2012. Prior to his ExoStat involvement, Mr. Hays was active as management, investor, and Board positions in a myriad of private startups and early stage businesses in various industries including natural gas gathering/processing, oil and gas drilling, oil field services, commercial banking, commercial insurance, country club acquisitions/operations, high speed sorting technology, restaurant operations, and other medical ventures. ExoStat is his seventh startup in over 50 years of work.

Mr. Hays was CEO/Chairman of MEGA Natural Gas Co., a company he co-founded when it was sold in 1991. Due to a non-compete provision in the Sale Agreement for MEGA, Mr. Hays deviated from the business world to play professional golf on the U.S. and European PGA Senior Tours until he retired in 1999.

Mr. Hays has written numerous articles centered on entrepreneurship, business morals/ethics, and business preparation. He currently lectures advanced business classes at several selected universities.

Mr. Hays has served multiple charities and church organizations including the International Business Leaders Advisory Council with the mission to add business/management skills to seminaries in training at Santa Croce University, a pontifical university in Rome.

Mr. Hays served six years in the Army National Guard and was a scholarship recipient (Baseball) at Oklahoma State University where he received a BS/BA in Economics and Accounting.

Irvin Pierskalla

Senior Vice President/Chief Technical Officer

Mr. Pierskalla joined ExoStat Medical in 2012 and has over 20 years of experience in the medical device industry in a variety of functions: Project Management, Product Development, Research, Compliance and Operations. Mr. Pierskalla’s experience has been focused on consumables and non-invasive sensors including; blood gases, electrolytes, tissue pH, and tissue perfusion. Prior to his experience in the medical device industry, Mr. Pierskalla was an analytical chemist at an independent testing laboratory. In addition, Mr. Pierskalla is an inventor on 6 issued patents pertaining to medical device design and sensor technology. Mr. Pierskalla holds a B.S. in Chemistry from St. Cloud State University.

Non-Invasive Early Warning System of Systemic Hypoperfusion: Circulatory Shock and Sepsis

by Michael R. Pinsky, MD and Jacques Creteur, MD

The Problem: Circulatory shock is defined as an inadequate oxygen (O₂) delivery to tissue to sustain metabolic demand. If arterial oxygen content is adequate, then tissue ischemia develops only at the very extremes of low blood flow. Well before that time, normal physiologic adaptive mechanisms controlled by the autonomic nervous system and mediated primarily through increased sympathetic tone tend to sustain an adequate central arterial blood pressure despite falling total blood flow. Once this regulatory process is exhausted, however, systemic hypotension develops. Thus, systemic hypotension, defined as a mean arterial pressure <65 mmHg or a systolic arterial pressure <90 mmHg, occurs late in shock when tissue hypoperfusion is already compromising metabolic function. If circulatory shock associated with systemic hypotension persists, then generalized tissue ischemia manifests as end-organ failure, lactic acidosis and autonomic failure. If the bedside clinician waits for systemic hypotension to recognize circulatory insufficiency before treating their patient for circulatory shock, then he will have waited too long.

Tissue CO₂ as a Solution: What is needed is a monitoring device that can identify decreasing tissue blood flow prior to impaired metabolic function. Since tissue can sustain oxidative phosphorylation (the central process of energy production of the cell) well into low blood flow states, both O₂ extraction by the tissue and carbon dioxide (CO₂) production remain relatively constant in a tissue bed as local blood flow initially declines. Although tissue O₂ can be measured, owing to the heterogeneity of metabolic rates and the slow diffusion of O₂ into the tissues from the blood, its measure to assess early forms of circulatory shock is poor. CO₂ can also be measured and, in contrast to O₂ measurement, changes in tissue CO₂ levels can accurately track changes in local blood flow within physiologic limits owing to the high diffusing capacity of CO₂ to cross lipid barriers and fluid spaces. Thus, a device that measures tissue CO₂ levels could be very helpful in identifying early shock, as CO₂ levels will rise well before tissue ischemia. This same device could be used to tract the effectiveness of resuscitation efforts, as CO₂ levels will decline to their baseline values again once local blood flow returns to its baseline values.

Buccal CO₂ as a Measure of Convenience: The oral mucosal constitutes an ideal site to measure tissue CO₂, especially if the sensing probe is isolated from ambient air and can be seated in a patient’s mouth with minimal discomfort. Numerous studies have documented that both sublingual and buccal mucosal CO₂ levels track circulatory stress in a quantitative fashion. In experimental models of hemorrhagic shock, sublingual CO₂ levels rapidly rise before hypotension develops and fall during resuscitation only after total cardiac output is restored, even though blood pressure is restored earlier.

All forms of circulatory shock, if associated with an initial decrease in cardiac output, will be associated with a rise in buccal CO₂, and this rise will occur early during the adaptive stage of shock when blood pressure remains normal. The two most common forms of shock are hemorrhagic and septic shock. Both initially present with decreased blood flow, though for different reasons. Thus, monitoring buccal CO₂ levels for its increase in a patient at risk for sepsis or bleeding constitutes a reasonable cost-effective early warning monitor. Indeed, buccal CO₂ monitoring may represent an ideal tool for a non-invasive monitor that can be applied early so as to target high-risk patient subgroups without fear of iatrogenic complications or false negative results. Buccal CO₂ may also be used to titrate resuscitation therapies, although most clinical studies show that the major benefit of any monitoring in septic shock comes from its early identification, triggering early appropriate antibiotic use and initial fluid resuscitation.

Dona Christenson

Chief Financial Officer/Treasurer

Ms. Christenson brings over four decades of experience in Finance and Accounting from the manufacturing field to Exostat. She spent 25 years with Research Incorporated, a publicly held manufacturer of sophisticated process control and industrial heating equipment located in Eden Prairie, MN. As Controller, Ms. Christenson managed all areas of Finance and Accounting. Ms. Christenson moved on to take the role as Chief Financial Officer of Continental Machines, a manufacturer and distributor of industrial sawing and fabricating equipment located in Savage, MN. In the seven years Ms. Christenson worked for Continental Machines, she saw them through a major corporate restructuring and new business mission.

Ms. Christenson has both started and operated her own businesses as well as performed contract corporate consulting for a variety of businesses before taking on her current role at Exostat. Ms. Christenson holds degrees in Accounting and Business Management.

Brandon Reynolds

Director, Quality Controls and Compliance

Mr. Reynolds comes from Vasamed, ExoStat’s predecessor company, with 30 years of experience in research, product development, quality control systems, patent development, FDA support, and product line extensions. Mr. Reynolds has both a chemistry and engineering background both of which are critical to the commercialization of the MicroTrend System. Mr. Reynolds has developed several patents and been involved in the development of several commercially successful medical devices. Mr. Reynolds current responsibilities include QMS development, labeling, and other regulatory requirements of the Microtrend.

Wanchun Tang, MD

Senior Medical/Technical Advisor

Wanchun Tang, MD, Graduated from Shanghai Second Medical University in 1977. After completing his clinical training in surgery and cardiac surgery, he served as an Attending Surgeon and Assistant Professor of the Department of Cardiac Surgery of the same University. He has been particularly interested in cardiopulmonary resuscitation and emergency cardiac care research since he was a medical student. To pursue his career in this field, he joined the critical care medicine fellowship program of The Chicage Medical School as a research fellow in 1988 under the mentorship of Dr. Max Harry Weil. In 1996, he relocated to Rancho Mirage, CA with the Weil Institute and served as Professor and Vice President of Medical Research. He was Professor at the Weil Institute of Critical Care Medicine and USC/Keck School of Medicine. Dr. Tang served as the President and Chief Scientific Officer of the Weil Institute of Critical Care Medicine in California since January 2006 until March, 2016 when he became the Director of the Weil Institute of Emergency and Critical Care Medicine at Virginia Commonwealth University. Dr. Tang’s researches involve post resuscitation myocardial dysfunction and microcirsulation during circulatory failure. He has authored more than 160 peer reviewed articles and 14 US patents and has received numerous national and international awards for his work.

Michael R. Pinsky, MD

Senior Medical Advisor

Dr. Michael Pinsky is a Professor of Critical Care Medicine (primary), Bioengineering, Cardiovascular Diseases, Clinical & Translational Science, and Anesthesiology at the University of Pittsburgh. He is also Docteur Honoris Casusa at the Universite Rene Descartes Paris V, School of Medicine in Paris, France. Dr. Pinsky is currently an Attending Physician Emeritus at Presbyterian and Magee Hospitals UPMC as well as a faculty member of the Center for Critical Care Nephrology at Pitt.

Dr. Pinsky received his MD from McGill University in 1974. He completed his post-graduate internal medicine residency training and pulmonary fellowship training at Stanford University, Stanford, California; Senior Medical Residency at Orlando Regional Medical Center, Orlando, Florida; and advanced physiological training at Johns Hopkins Medical Institutes, Baltimore, Maryland.

Currently, Dr. Pinsky serves as the Principal Investigator of two R01 “Using biological time series analysis to identify cardiorespiratory insufficiency” in ICU patients (MLADI) and during emergency air transport (ADMIT), and Co-Principal Investigator of another R01 on “Predicting patient instability noninvasively for nursing care (PPINNC)” and scientific PI on a DoD contract “Trauma Care in A Rucksack” (TRACIR). He is also a Co-I on a related R01 on assessing instability in patients during surgery (MLORD). He has been the Director of the Cardiopulmonary Research Laboratory for the past 39 years. Dr. Pinsky was the program director for an NIH National Research Service Award entitled “Experimental Therapeutics in Critical Illness” until last month, a program he directed for the last 20 years. He was part of the inaugural group to receive Masters of Critical Care Medicine (MCCM) from the SCCM, part of the first North Americans to receive “Honorary membership” in ESICM and is a Fellow of the American Physiological Society and the American College of Chest Physicians.

Dr. Pinsky has edited 27 Medical Textbooks, authored >400 peer-reviewed publications, >250 chapters and supported >450 abstract presentations. Dr. Pinsky is the Editor-in-Chief of MedScape’s Critical Care Medicine section. Dr. Pinsky is on the editorial boards of the Critical Care, Journal of Critical Care, Current Opinion in Critical Care, the International Journal of Critical Care, the Annals of Critical Care, and Intensive Care Medicine. He is an ad hoc reviewer for NHLBI K and R awards annually. He also provides journal referring for numerous publications.

View a list of Dr. Pinsky’s publications here

David C. Gordon

Board Member

Mr. Gordon has provided investment banking services to the healthcare industry for over 25 years. Mr. Gordon has represented both not-for-profit and investor-owned companies and has extensive experience working with general acute care hospitals, long-term care facilities, specialty hospitals, physician practices, HMO’s and medical office buildings. Mr. Gordon is Co-Founder of Juniper Advisory, LLC in Chicago, IL. Prior to forming Juniper in 2006, Mr. Gordon co-led the healthcare M&A group of Ponder & Co. (2001–2006) and the healthcare services group at U.S. Bancorp/Piper Jaffray (1998–2001). Prior to rejoining Nuveen in 1998, Mr. Gordon was the Managing Director in charge of investment banking healthcare services for ABN AMRO, Inc. North America. While at ABN his group provided financial advisory services and secured private and public equity for healthcare clients. From 1986–1996, Mr. Gordon worked with Nuveen where he specialized in the firm’s healthcare, merger, acquisition, and divestiture practice. From 1979–1986, Mr. Gordon was employed by Ernst & Young in Chicago providing consulting services. His engagement experience, while with Ernst & Young, concentrated on M&A for middle-sized commercial companies and financial institutions. In addition, he was involved in various aspects of strategic and capital planning for large national and multi-national corporations. Mr. Gordon holds a B.A. from Ohio Wesleyan University (1977) and an M.B.A. from University of Notre Dame (1979).

Hayden R. Fleming

Co-Founder and Board Member

Mr. Fleming has been active in the development of ExoStat Medical, Inc. since its formation in August, 2009. From 1996~2011, Mr. Fleming was Owner and President of the brokerage firm, Fleming Securities, Inc. During that time, Mr. Fleming was also Manager of two private investment funds, Circle F Ventures, LLC and Circle F Ventures II, LLC, both of which made investments in companies in various industries and of various sizes. Mr. Fleming is a founder, Chairman of the Board and CEO of Resuscitation International, LLC which Is an early stage resuscitation company specializing in mechanical CPR. Mr. Fleming also serves on the board of Data Transfer of Nevada, LLC. Prior to 1996, Mr. Fleming was active in structuring and selling private placements and new public issues for various start-up and early stage companies. Mr. Fleming attended St. Cloud State University but his studies were interrupted due to military service in Vietnam.

Chanda J. Romain

Vice President/Chief Financial Officer

Mrs. Romain was one of the original team members of ExoStat Medical, Inc. in 2008. She has over 20 years of accounting experience, including 10+ years of medical research and manufacturing accounting and 2 years of public accounting. Mrs. Romain’s prior experience includes Virtual Radiological, Inc. (2012-2013) where she served as Manager of Accounting Operations, Sunshine Heart, Inc. (2011-2012) where she served as Controller, and Vasamed, Inc. (2007-2011) where she served as Controller. Mrs. Romain holds a B.A. in Accounting from Mount Marty College.

Tissue CO₂ Clinical References

Non-Invasive Early Warning System of Systemic Hypoperfusion: Circulatory Shock and Sepsis

by Michael R. Pinsky, MD and Jacques Creteur, MD

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I cannot wait to use the MicroTrend System in the critical care environments. It’s been a long time coming.”

Dr. Tor Inge Tonnessen, Oslo

ANESTHESIOLOLGIST, PROFESSOR, RESEARCHER AND INVENTOR OF THE FIRST ELECTRO CONDUCTANCE SENSOR FOR ISCHEMIA.

Richard K. Gordon

Kent Winger

Jim Hays

Irvin Pierskalla

Non-Invasive Early Warning System of Systemic Hypoperfusion: Circulatory Shock and Sepsis

by Michael R. Pinsky, MD and Jacques Creteur, MD

Dona Christenson

Brandon Reynolds

Wanchun Tang, MD

Michael R. Pinsky, MD

David C. Gordon

Hayden R. Fleming

Chanda J. Romain