Better Diagnostics, Better Lives
SONDEFLUX™ THE FUTURE OF REFLUX DETECTION
RefloDx is developing *SondeFlux™, a patented device (US 10,617,387 B2) that uses ultrasound to non-invasively detect and characterize Gastroesophagael Reflux (GER) in a home setting. SondeFlux™ is an innovative solution that will disrupt the current diagnostic testing market, by providing standardized objective evidence that correlates symptoms with GER.
GER, which is the retrograde entry of gastric contents into the esophagus, is a physiologic phenomenon experienced by everyone. GER is associated with many serious health complications, including respiratory distress, upper airway disease, lower tract airway disease, poor growth, malnutrition, trouble swallowing, and excessive vomiting. Early diagnosis of GER is essential in treating Gastroesophageal Reflux Disease (GERD) and preventing it from progressing into a more serious condition.
Currently there are no affordable non-invasive diagnostic tools for early detection and characterization of reflux events to guide treatment. Current methods are costly, invasive and often inconclusive, lacking quantifiable data which correlate symptoms with reflux events. These methods include, nasal wire based conventional pH probe studies, combined pH/Multi-Channel Intraluminal Impedance (MII) studies or the Bravo pH-sensing capsule, which is pinned to the inside of the esophagus . These treatment paradigms are invasive, introduce artifact, require hospital observation, often include anesthesia, are based on subjective interpretations of observations by caregivers, and incur significant healthcare costs.
Utilizing ultrasound theory, SondeFlux™ transmits low pressure sound waves and analyzes the reflected sound waves or echoes to determine the physiologic state of the esophagus. The esophagus acts as a lumen that is collapsed when empty and expands when a bolus (mixture of solid and liquids) is present. During reflux events, a specific acoustic signal is present that can be characterized and detected. By utilizing multiple, externally placed, single point transducers located in several locations or transverse planes, the bolus’ direction, duration, frequency, and magnitude can be characterized and differentiated from other events occurring in the esophagus.
Unlike traditional ultrasound imaging (UI), SondeFlux™ is not encumbered by the complexities of image processing, or requiring observation by a trained clinician, enabling SondeFlux™ to be a small portable system capable of continuously monitoring and recording reflux events for periods of 24+ hours in a home setting. This extended recording capability allows clinicians to collect sufficient data to determine if the reflux events are excessive or linked to symptoms and signs of illness constituting GERD. SondeFlux™ is a non-invasive, painless, cheaper, risk free alternative to current GERD diagnostic testing.
THE STORY BEHIND REFLODX
JULY 7, 2023
MAY 16, 2023
RefloDx’s set out in 2015 to develop better diagnostic devices, which allow for earlier interventions, better experiences, and better lives.
Through collaboration with clinicians, problems were observed with the current so called "gold standard", Multi-Intraluminal Impedance (MII-pH) monitoring, as a method of detecting Gastroesophageal Reflux (GER). The highly invasive nature of MII-pH monitoring put RefloDx on a path to innovate new diagnostic devices and methods that focus on being non-invasive, while providing clinicians with a procedure that captures quantitative data in assessing the frequency, duration, and volume of reflux occurring in their patients.
RefloDx, at its core, is an R&D company. The 4 founders all have backgrounds in engineering, with specific emphasis on electrical, computer, mechanical, chemical, and biomedical. In addition to engineering backgrounds, they have been closely involved with medicine, material science, medical device design, and regulatory affairs. Operating from the limited budget of an early stage startup, the team has been able to achieve significant milestones. This is due to a keen ability to identify unknowns and devise a plan to answer them quickly and efficiently, as well as by leveraging the capabilities of the University of Utah and the State of Utah’s business accelerator program (USTAR). The founders have established a clinical advisory board of forward thinking physician mentors in the areas of Gastroenterology, Otolaryngology, Radiology, and Echocardiography. These clinicians have enabled the team to accelerate at customer discovery, feasibility evaluation, and provide access to the clinical environment, patients, physicians, and specialists. This access has been and continues to be instrumental in quickly performing hypothesis testing during the feasibility stage of design and development and in refining their business model canvas.
The founders are well embedded into the med-tech innovation ecosystem that is thriving in the Wasatch Front of Utah (Silicone Slopes). This ecosystem provides ample networking connections and opportunities with other successful entrepreneurs, business advisors, legal aide, financial consultants, regulatory experts, and qualified engineers. Having spun out of the University of Utah’s Center for Medical Innovation, RefloDx maintains close ties to the University of Utah, and are able to leverage many of the resources and capabilities that are available at an R1 research university that has a leading Academic Medical Center.
As a new venture, current funding efforts have been focused on raising non-dilutive capital through grants and business competitions. RefloDx is currently a recipient of an NSF SBIR Phase I award as well as a TAP grant from the state of Utah.