AAKP Innovator Series: FAST BioMedical – Bruce Molitoris, Co-Founder and Medical Director, and Joe Muldoon, CEO
FAST BioMedical is a private, Indiana-based, late clinical stage medical technology company. They have developed technology for quantifying clinically relevant parameters that have been challenging or impossible to measure in the past. Founded in 2006, the Company is currently advancing technology for accurately quantifying volume status and kidney function in a clinically actionable timeframe. FAST BioMedical’s technology could have a significant impact on the treatment of patients with acute kidney injury (AKI) and chronic kidney disease (CKD).
FAST BioMedical has completed a Phase I Human Trial in Germany and Phase 2 Human Trials in the United States.
AAKP: Explain the need for a new mGFR technology in order to earlier detect decline in kidney function.
Bruce: At present the diagnostic techniques available to assist a nephrologist or critical care physician in understanding the true function of the kidney are extremely limited. Serum creatinine is used as a measure of kidney function, and it is insensitive to change in patients with normal kidney function and slow to change in acute kidney injury situations. In addition, since the kidney has reserve functional capacity, serum creatinine does not give an indication of the total kidney function available. Total kidney function may be what matters most when one considers progression of kidney disease.
AAKP: Please share how FASTBioMedical “First in Class Technology: mGFR and plasma volume” could have a significant impact on all kidney patients.
Bruce: The FAST BioMedical mGFR and plasma volume measurements will allow physicians to understand and quantify both glomerular filtration rate and blood volume. This is particularly important in hospitalized patients where a rapid understanding of GFR will enable physicians to determine the severity of injury and initiate dialysis in patients with severe kidney injury more rapidly and appropriately. An understanding of blood volume will help the physician maximize cardiac performance in patients with congestive heart failure, sepsis and cardiorenal syndrome. The ability to measure total kidney function with a stimulation test may be critical for correctly evaluating therapeutics in both acute and chronic kidney disease. The lack of sensitivity, specificity and accuracy in using eGFR, which is ± 30% has limited and compromised testing of drugs for AKI and CKD.
Joe: We are also receiving a large amount of interest from organizations doing clinical trials as they see these metrics being very useful in both identifying and monitoring patients
AAKP: We understand that you have conducted clinical trials. What were the outcomes? What is your next step?
Bruce: Our most important clinical trial was the Phase 2b study conducted at the University of Alabama, Birmingham. In this study, we quantified GFR across the spectrum of GFRs from normal subjects to subjects with stage 4 CKD and compared our results to the research gold standard, Iohexol. While our test takes only 3 hours for an answer, the lohexol tests takes weeks before results are available, as well as 6 hours of blood sampling. Another important difference is the FAST BioMedical technique can also measure total kidney function and Iohexol cannot.
Our next step is a meeting with the FDA to discuss our pivotal trial. This is an exciting time for us and we believe also for AKI and CKD patients.
Joe: We were very pleased with the accuracy of the results. We match up against the research gold standard, and the results were just published in Journal of the American Society of Nephrology (JASN). That publication has created a lot of interest in what we are doing.
AAKP: By the year 2020 – what do you expect to see in terms of how care is provided to kidney patients, what immediate changes do you think can occur?
Bruce: Hopefully by the year 2020 a number of new diagnostics will be available to improve the care of kidney patients. These diagnostics will range from new biomarkers to new physiologic markers such as FAST BioMedical’s mGFR and PV technology. I am particularly excited about our mGFR technology in facilitating therapeutic trials with accurate, reliable data that is sensitive to changes in GFR that previously have not been measured. The technology will also allow early diagnosis of hyperfiltration in states such as diabetic nephropathy and will lead to earlier therapies with medications prior to the development of proteinuria. The development of proteinuria is felt to be a mid to late change in diabetic nephropathy and I am excited about treating patients much earlier in the disease process to slow the progression of this relentless disease down.
Joe: Kidney patients will increasingly think of themselves as “demanding customers.” That is a powerful mindset shift that will improve the environment for innovations that matter.
AAKP: Final question – AAKP believes this can reveal a lot about a person – who is one of your heroes and why?
Bruce: Selecting one hero is a very difficult thing to do because I admire different characteristics in different individuals. However, the late Dr. Allen Alfrey, who I worked with at the VA Hospital in Denver, Colorado during my fellowship and early academic career, embodied many of the characteristics I admire. Dr. Alfrey is responsible for our understanding of aluminum toxicity in dialysis patients, and the important role of phosphorous in chronic kidney disease progression. These are two of the most important clinical advances in Nephrology. He was an understated individual of high principles and integrity. His satisfaction and reward in life came from what he had accomplished and the clinical significance of his findings to help patients with kidney disease. He was a true clinician-scientist who went from bedside to the laboratory and back to the bedside with discoveries that directly benefitted many patients. For his outstanding contributions he was awarded the Belding H. Scribner Award for “outstanding contributions that have a direct impact on the care of patients with renal disorders or have substantially changed the clinical practice of nephrology” presented by the American Society of Nephrology for his outstanding contributions to clinical nephrology. He retired with the respect and trust of his peers, the final and best achievement of anyone’s career.
Joe: I know its cliché, but it’s my Dad. He led an honorable life as an entrepreneur with uncompromising integrity and an amazing work ethic. He cared about all the people in his life and showed it with his daily actions. He always had a smile and an encouraging word. I only heard him raise his voice three times in my entire life. Each time was when someone upset Mom. (I learned not to do that.)
This article was originally published in aakpRENALIFE, January 2019 - click here.
Bruce A. Molitoris, M.D. is a Distinguished Professor of Medicine and Cellular and Integrative Physiology at Indiana University and a Past President of the American Society of Nephrology. He is a graduate of the University of Illinois, received his MD at Washington University in St. Louis, and his Internal Medicine and Nephrology training at the University of Colorado. His research interests include acute kidney injury from ischemia, sepsis and nephrotoxins, and the utilization of two photon microscopy to study in vivo cellular and subcellular processes within the kidney. He is the recipient of the University of Illinois Merit Award, the International Society of Nephrology Bywaters Award – recognizing outstanding contributions to the understanding of acute renal failure, the NKF Donald W. Seldin Distinguished Award and the NKFIndiana Career Achievement award. He has patents for AKI therapeutics and imaging techniques. He is a co-founder of FAST Biomedical, a company developing and commercializing a rapid plasma volume and GFR technique. He is funded by the NIH through RO1s, a NIH P-30 and SBIR grants.
Joe Muldoon is the Chief Executive Officer for FAST BioMedical, a privately held medical technology company in late stage clinical trials located in Carmel, Indiana. FAST has developed technology for quantifying blood volume and kidney function. This is a well validated unmet medical need, meeting the FDA‘s requirements for a rare Expedited Review. Joe leverages over 30 years of experience, from technology start-ups to publicly traded multi-national companies. His expertise is in culture building and value creation from inception, thru capitalization, commercialization and exit. He has worked with many high-growth entrepreneurial companies as a Board advisor, investor, and CEO. He serves on the Boards of Confluence Pharmaceuticals, The Kidney Health Initiative (FDA), Heart Reach Carmel and FAST BioMedical. He previously served on the Boards of Trust Bearer Labs (sold to Verisign) TGX Medical, Jameson, Inc., Venture Club of Indiana, and InfoDynamics.