FAST BIOMEDICAL COMPLETES SUCCESSFUL PHASE II TRIAL; RESEARCH FEATURED IN PEER-REVIEWED PUBLICATION CARDIORENAL MEDICINE
Carmel, IN, March 20, 2019 — FAST BioMedical announced today the recent publication of their Phase II clinical trial data on Plasma Volume (PV) measurements in CardioRenal Medicine.
The company’s globally-patented, first-in-class technology directly measures blood volume and kidney function in a clinically-actionable way, which has the potential for profound impact on the care of heart failure, cardio-renal, major surgery, sepsis, critical care, and kidney disease patients. Each year more than 35 million hospitalizations worldwide would benefit from a plasma volume measurement.
The study was conducted at two sites in the U.S. in healthy subjects and patients with varying levels of chronic kidney disease. Included in the study was a measurement of how healthy subjects handled the administration of a volume challenge as evaluated by FAST’s Plasma Volume technology. The primary and the secondary endpoints of pharmacokinetics, safety and accuracy were achieved.
Highlights of the Phase 2 Trial results:
- The FAST injectable proved to be safe and well tolerated.
- The FAST PV technology delivered clinically meaningful results as demonstrated by its ability to stratify patients into the appropriate clinical group.
- The FAST injectable distributes in a manner consistent with the vascular volume and the PV marker remains stable in the vasculature for a period of at least 6 hours, allowing repeat measurements of PV during that time period without re-dosing.
- The FAST PV technology responded precisely and proportionally to a volume challenge given in healthy subjects.
- The technology displayed excellent reproducibility
“I am very pleased with the excellent accuracy and repeatability the FAST BioMedical technique to quantify plasma volume has shown. The demonstrated ability to closely track a fluid challenge is especially compelling. This technology can allow the clinician to have new understanding for both diagnosis and therapy. Congestive heart failure, sepsis and acute kidney injury are conditions where the value of an accurate PV is critical to understand. However, other difficult to diagnose and manage diseases such as hyponatremia, hypertension and chronic kidney disease also will benefit from the test,” stated Bruce A. Molitoris, M.D., FASN, FAST BioMedical’s medical director and co-founder and professor of medicine at Indiana University, and a lead author of the report.
FAST BioMedical’s Plasma Volume measurement technology is being developed to address the shortcomings of the current clinical standard of care for patients with volume instability. In patients presenting with the potential of volume abnormalities, an accurate determination of volume status is critical for appropriate diagnosis and management. Unfortunately, volume assessment is challenging. Current misdiagnosis rates are high and existing standard of care methodologies lack an accurate quantitative measurement. Less accurate indications of volume status have potential negative impact on medical outcomes.
FAST BioMedical’s technology has the potential to provide a clinician with a PV measurement as quickly as 30 to 45 minutes, and provide updated measurements for up to six hours. This allows for the evaluation of volume changes impacted by clinical treatment, throughout that time. The technology uses a patented fluorescent injectable that works in concert with a patented measurement device.
“There is currently no technology in clinical care that can quickly and easily provide an accurate plasma volume measurement. The FAST BioMedical Technology has the potential to provide this, and, is an advantage for all types of patient care. For example, the management of congestive heart failure patients could be greatly improved by having such a tool,” said Co-author, FAST BioMedical Medical Advisory Board Member and Associate Chief of Emergency Medicine Research at Baylor College of Medicine Dr. Frank Peacock.
CardioRenal Medicine, a peer-reviewed medical journal, recently published a research article on FAST’s Plasma Volume technology. The full article can be found viahttps://www.karger.com/Article/FullText/496480
FAST BioMedical also had an additional peer-reviewed paper published in the Journal of the American Society of Nephrology (JASN). The publication highlighted FAST’s kidney function data from a successful Phase 2 clinical study. The FAST technology demonstrated impressive measurement accuracy via a high correlation (99%) to the research gold standard. The full article can be found via https://jasn.asnjournals.org/content/29/6/1609.abstract
In January 2019, FAST BioMedical was highlighted in the American Association of Kidney Patients (AAKP), RENALIFE Magazine as its featured Innovation.
About FAST BioMedical
FAST BioMedical is a privately held, late clinical-stage medical technology company based in Carmel, Indiana. The company’s globally-patented, first-in-class technology directly measures blood volume and kidney function in a clinically-actionable way. This has the potential for profound impact on the care of heart failure, cardio-renal, major surgery, sepsis, critical care, and kidney disease patients. The company has been financially supported by the NIH, Elevate Ventures, the Indiana 21st Century Fund, Rose-Hulman Ventures, BioCrossroads, Indiana University Medical Group, The Purdue Foundry Fund, Ellipsis Ventures, VisionTech Partners, and private single family office investors. The FDA has determined the company’s technology met the requirements for an Expedited Review. These products are investigational and not yet approved for human use.