Kestrel Labs Staff, Medical Advisors, and Consultants


Kestrel Labs has assembled a world class team of scientists and engineers with proven records of innovation and achievement in the medical device field. The team has expertise in business management, product development, electrical, mechanical, and optical engineering, computer science, mathematics, quality and regulatory affairs, and high-volume, low-cost manufacturing. Kestrel Labs is also advised by a world-class Medical Advisory Board, representing a wide cross-section of medical disciplines.
 

STAFF

Jonas Pologe (Co-Founder, Chief Executive Officer) has over thirty years of engineering and research experience in the medical device industry and is considered one of the world's foremost experts on the science of pulse oximetry. He was an original member of BIOX, the company that developed the first commercially-viable pulse oximeter, and spent seventeen years with Datex-Ohmeda (now part of GE Healthcare) and its predecessor companies. In addition to his skills in electronic hardware and software engineering, Mr. Pologe's areas of research specialization are in photoplethysmographic monitoring and spectrophotometric analysis. In 1991, Mr. Pologe was a member of an expedition climbing Mt. Everest, during which he conducted a field research project on pulse oximetry at extreme high altitude. He is the author of over 20 patents related to pulse oximetry, as well as numerous articles and presentations at technical meetings in this field. Mr. Pologe holds a B.S. in Electrical Engineering from George Washington University. Prior to founding Kestrel Labs, Mr. Pologe held the positions of Vice President of R&D, Quartz Medical, and Manager of Research and Chief Scientist for Datex-Ohmeda's Pulse Oximetry business unit.

Ted Delianides, PhD (Co-Founder, Chief Operating Officer) has extensive experience with technology development and company operations in diverse product fields, including medical devices, optical networks, and lightweight composite materials. Dr. Delianides has worked with four other start-up companies, including Zolo Technologies, Inc., a subsystems provider of DWDM optical network components, ArmorWorks, Inc., a manufacturer of advanced ceramic-composite armor, and A3 Technologies, Inc., a technology spin-off from the 1992 America's Cup yacht races. He also worked as a staff scientist at Datex-Ohmeda on novel methods of blood pressure measurement. Dr. Delianides holds a B.S. and M.S. in Mechanical Engineering from George Washington University and a Ph.D. in Aeronautics/Astronautics (minor in Electrical Engineering / Optics) from Stanford University. Prior to founding Kestrel Labs, Dr. Delianides' positions included Project Director (Embedded Monitors) for Zolo Technologies, Inc. and VP of Research, Development, and Engineering at ArmorWorks, Inc.

Adriaan Verheij (Principal Software Design Engineer) has over twenty years of experience in system architecture, software and hardware design, and medical device design. As a project manager Mr. Verheij designed and developed an ultrasound-based biometer/pachymeter that measured the thickness of the tissues of the human eye with unprecedented accuracy. He also led the software development effort on a perfusion control system for a heart-lung machine. Joining Kestrel Labs in 2004, Mr. Verheij has had principal responsibility for the development of all instrumentation and manufacturing software for Kestrel Labs, including the embedded software for the advanced pulse oximeter currently under development. Mr. Verheij holds a B.S. in Electrical Engineering from HTS Dordrecht, The Netherlands, and a M.S. in Electrical Engineering from Eindhoven University of Technology, The Netherlands, with a specialization in Medical Electrical Engineering.



MEDICAL ADVISORY BOARD

Donald H Arnold, MD, MPH received his medical degree from Emory University School of Medicine and his masters of Public Health from the Johns Hopkins Bloomberg School of Public Health. He is currently Professor of Pediatrics and Emergency Medicine at the Vanderbilt University School of Medicine. He has received foundation and federal funding for his research pertaining to acute asthma exacerbations in children and to pulsus paradoxus technology.

“As a full-time faculty in pediatric emergency medicine I am called upon to assess the respiratory status of every patient I care for. Pulse oximetry represents one of the greatest advances in clinical medicine over the past 35 years because it enables noninvasive and continuous measurement of oxygen saturation. As such, use of pulse oximetry has meaningfully reduced deaths and permanent impairment after injury or illness.

The Kestrel Labs laser-based multi-wavelength pulse oximeter is the next frontier in noninvasive pulse oximetry and will advance clinical care of patients in ways at least as significant as the 2-wavelength pulse oximeters in use. First, it will provide more accurate, continuous measurement of both oxygenated and de-oxygenated hemoglobin. Of greater importance as an advance in clinical care, it accurately measures methemoglobin and carboxyhemoglobin, abnormal variants of the normal, oxygen-carrying hemoglobin that are deadly if not recognized.

Methemoglobin often results from treatments that we provide to patients, yet patients are not generally tested for this deadly complication.[see reference below] Carbon monoxide is a byproduct of fossil fuel (e.g., natural gas, kerosene, wood) combustion and is odorless. It converts normal hemoglobin to carboxyhemoglobin and causes symptoms that are frequently mistaken for the flu, a particular public health hazard in the winter when flu is prevalent and fossils fuels are used for heat. It may result in death or brain injury if not recognized, yet screening for carboxyhemoglobin is not routinely performed in ERs and other health care facilities. The ability to detect and measure methemoglobin and carboxyhemoglobin noninvasively, painlessly and continuously using the Kestrel Labs device will save lives. As such, it will become an essential tool for every ER, ICU, OR and inpatient bed at every hospital and in all outpatient medical facilities."

REFERENCES CITED

1. Cash C, Arnold DH. Extreme Methemoglobinemia After Topical Benzocaine: Recognition by Pulse Oximetry. The Journal of pediatrics. 2017;181:319. Epub 2016/11/25. doi: 10.1016/j.jpeds.2016.10.081. PubMed PMID: 27881239. ”



Philip E. Bickler, MD, PhD is Professor of Anesthesia at the University of California at San Francisco School of Medicine and Director of the Hypoxia Research Laboratory at UCSF, Chief of Neuroanesthesia at UCSF and an elected fellow of the California Academy of Sciences. He has published more than 150 peer-reviewed journal articles, book chapters, review articles and abstracts related to a number of biomedical research areas including oxygen monitoring in blood and tissues, human responses and adaptation to hypoxia, cellular and molecular signaling pathways involved in hypoxia sensing, and biomarkers in clinical outcomes. He directs a research laboratory with projects ranging from oxygen sensing in human neurons in culture, effects of high altitude on inflammation, global health technology development, and relationship of tissue oxygenation to clinical outcomes in spine surgery. Education and dates: BS Biology, University of California at Riverside, 1977, PhD Biology UCLA 1981, MD UCSD, 1986, Residency in Anesthesiology, UCSF 1991, Fellowships: Physiology UCSD 1985, Cardiovascular Research Institute, UCSF, 1987.

“Non-invasive CO-oximetry measurements with the NiCO system from Kestrel Laboratories enable accurate measurements of critical oxygenation parameters missing from conventional pulse oximeters. As a number of studies done at the UCSF Hypoxia Research Laboratory have shown, conventional (non-Kestrel) technology is unable to accurately measure more than two types of hemoglobin, probably due to the inherent limitations of LED-based sensor technology. Detecting carbon monoxide poisoning with current technology is one example. Carbon monoxide poisoning frequently is accompanied by hypoxemia, caused by smoke inhalation or decreased respiratory drive. Only an oximetry system with capabilities like the NiCO system, with highly tuned laser light sources from Kestrel Labs, can non-invasively and simultaneously detect carboxyhemoglobin, deoxyhemoglobin and oxyhemoglobin upon which accurate diagnosis and effective treatment of carbon monoxide poisoning depends."



Henry L. Galan, MD is presently Professor of Ob/Gyn in the Division of Maternal-Fetal Medicine (MFM) the University of Colorado School of Medicine (UCSOM) and Co-Director of the Colorado Fetal Care Center at Children’s Hospital. He is also Co-Director of the Colorado Fetal Care Center (CFCC); a center that is focus on ultrasound evaluation, genetic diagnosis and fetal intervention/surgery for fetal anomalies. The CFCC also represents the first fetal surgery center in the Rocky Mountain Region. He is Associate Program Director of the MFM Fellowship program focused on fellow research development and progress. Dr. Galan is also a co-editor for the textbook “Obstetrics: Normal and Problem Pregnancies”, which is the primary educational textbook for residents training in the field of Obstetrics & Gynecology. As a faculty member at the CUSOM, he is active in teaching medical students, OB/GYN residents and MFM fellows. He has extensive prior clinical and research experience in human placental nutrient transfer studies as well as human uterine, umbilical and placental blood flow studies. His laboratory work has been focused on placental vascular development and nutrient transfer in both human and ovine pregnancy with focus on physiologic and molecular mechanisms underlying normal fetal growth and IUGR. Umbilical volume blood flow studies developed in the ovine models with diffusion methodologies have validated the use of triplex mode ultrasound to determine volumetric flow in human pregnancies. These volume flow measurements have been used to assess relative placental transport rates of essential amino acids and polyols in human pregnancies. In the last few years, there has also been a focus on uterine blood flows recognizing that one must assess both blood flow from the mother to the uterus (uterine blood flow) and from the placenta to the fetus (umbilical circulation) in order to better understand disorders of fetal growth as it relates to placental insufficiency.

“As a maternal-fetal medicine specialist, I am focused on the evaluation, ultrasound diagnosis, and treatment of fetal anomalies. While many fetal anatomic abnormalities do not require a fetal intervention or surgical procedures, there are a some fetuses that will die in utero or during the fetal-newborn transition period without a maternal and or fetal procedure. One example of this is a fetal EXIT (Ex-Utero Intrapartum Treatment) procedure. The EXIT procedure in essence allows the fetus to be delivered at the time of cesarean section whereby the fetal-placental- uterine-maternal circulation remains intact. This type of continued in utero circulation functions essentially as a “placental by-pass” mechanism that allows up to one hour of time for other medical or surgical specialties to place monitors, IV lines, intubation, and/or perform cardiac or pulmonary related procedures to the fetus as needed to enhance and facilitate a smoother (more stable) transition of the fetus to neonatal life once the umbilical cord is clamped. Examples of conditions whereby the EXIT procedure is vital to the cardiopulmonary transition period of the newborn include congenital diaphragmatic hernia, micrognathia, chest masses, and congenital heart block (abstracts of two publications for examples pasted below). It is during this period of “placental-bypass” where the NiCO™ Noninvasive CO-Oximeter may provide an advantage over the historical SpO2 monitor. There is no capability of invasive monitoring of the fetus during the EXIT procedure and to have a device that can provide non-invasive information with the accuracy and precision of invasive O2 assessments is a true advantage for these types of procedures.”



William W. Hay, Jr., MD is Professor of Pediatrics, University of Colorado School of Medicine, Director of the Child Maternal Health Program and Perinatal Clinical Translational Research Center for the Colorado Clinical and Translational Sciences Institute, Scientific Director of the Perinatal Research Center, Director of the NICHD T32 Section of Neonatology Training Program in Perinatal Biology and Medicine, and Program Director of the NICHD K12 Department of Pediatrics Child Health Research Career Development Program. He is a former president of the Perinatal Research Society and former president of the American Pediatric Society. Dr. Hay is a leading authority on perinatal/neonatal nutrition and metabolism, fetal and neonatal growth and development, and fetal and neonatal oxygen metabolism. He has authored several hundred of peer-reviewed journal articles, book chapters, reviews, abstracts, and other publications. Education and Dates: B.A. Biology/Philosophy, Dartmouth College, Hanover, NH 1967; M.D. Yale University School of Medicine, New Haven, CT 1971; Internship/Residency in Pediatrics, University of Colorado Health Sciences Center, Denver, CO 1974; Fellowship in Neonatal-Perinatal Medicine, UCHSC, Denver, CO 1978.

“The neonatal intensive care unit (NICU) setting is one of many areas of medicine where accuracy and precision of oxygen saturation measurement (SaO2) are absolutely crucial to patient outcome. The results of the SUPPORT Study, where as little as a 3% difference in pulse oximetry saturation values (SpO2) had a profound impact on morbidity and mortality in preterm neonates, reinforced this essential requirement. Several such trials noted that it was the broad range of SpO2 values, which is the specific limitation of current pulse oximeters, that made it so difficult to determine the lower SpO2 values that led to increased mortality, particularly in very preterm growth restricted infants, and the higher values of SpO2 at which excess oxygen caused other injuries, particularly retinopathy of prematurity (ROP, formerly known as retrolental fibroplasia).

Many preterm infants also suffer from recurrent desaturation events, which are associated with neurodevelopmental and cardiopulmonary disorders (pulmonary hypertension, right heart failure, and bronchopulmonary dysplasia). Much more accurate noninvasive oxygen saturation measurements are needed to help nurses adjust supplemental oxygen administration more quickly and more accurately to help prevent these severe complications, and clearly will be needed for servo-controlled oxygen administration, which now is showing great promise for preventing frequent hypoxemia and hyperoxemia.

With the greater accuracy of the NiCO™ system (Kestrel Labs’ Noninvasive CO-Oximetry) approaching that of invasive oxygen saturation measurement, NiCO™ will not only provide a significant improvement in patient care by significantly reducing abnormal oxygenation in newborn, particularly preterm, infants in the NICU, but will, with widespread adoption, alter medical practice and reduce adverse outcomes in this vulnerable population.”




Business & Technical Consultants

Thomas Kroenke (Advisor, Quality System & Regulatory Affairs) is President and Principal Consultant of Speed to Market, Inc. and has more than 25 years experience in the medical device and defense industries. He has held research, manufacturing, quality, and regulatory positions at a variety of companies. Most recently, Mr. Kroenke was with Quartz Medical, Inc., a pulse oximetry startup company. As the Senior Manager of Quality and Regulatory Affairs, he authored and implemented a simple and effective Quality System resulting in initial self-certification for the EU market in 7 months. In the same time frame, he guided Quartz through the product development process and obtained FDA clearance in 29 days. Mr. Kroenke holds a BS in Electrical Engineering from the University of Nebraska, and a MS in Engineering Management from the University of Colorado. He is a Certified Quality Engineer, Regulatory Affairs Certified and trained as an ISO 9000 Lead Auditor.

Albert Palachek, PhD (Advisor, Mathematician/Bio-Statistician) has more than 30 years experience providing statistical consulting and performing statistical analyses. He has held research and quality positions with companies in the defense and medical device industries, and he has also held faculty positions at the University of Cincinnati and the University of Colorado - Boulder. Dr. Palachek worked as a Bio-Statistician at Datex-Ohmeda, where he provided statistical design and analysis to calibrate pulse oximetry devices and performed research on photoplethysmographic signal processing methods. Education and Dates: Dr. Palachek earned a bachelor’s degree in Mathematics in 1977 from McNeese State University, and master’s degree in 1979 and Ph.D. degree in 1981 in Statistics from Southern Methodist University. He has also held certifications as a Certified Quality Engineer, Certified Reliability Engineer, and Certified Quality Auditor.