Therapeutic Areas

FAST BioMedical’s (FBM) intent is to quantify intravascular volume status and kidney function in clinically actionable timeframes. FBM’s Technology has the potential to favorably impact the treatment of a broad population of people across a broad spectrum of diseases, including Heart Failure, Cardiorenal Syndrome, Sepsis and Acute Kidney Injury. These patients present with a variety of symptoms and experience high hospitalization and mortality rates.

Intravascular volume and kidney function are two key measurements to help guide therapy for these patients. Accurate measurement of both parameters can help drive more precise treatment leading to better outcomes, especially in Heart Failure patients presenting with high fluid overload. Today, physicians make treatment decisions based on observation of edema, pulmonary function and rales, doing their best to estimate fluid volume.

FBM’s goal is to utilize their unique combination of injectable markers and measurement system to deliver accurate assessment of intravascular volume status and measured kidney function to enable physicians to better treat their patients.

Heart Failure

The economic burden of heart failure is enormous and rising. According to the American Heart Association, heart failure today costs Americans about $30 billion dollars per year, with those costs expected to rise to almost $70 billion by 2030. About 80% of those costs are due to hospitalization.

The front-line therapy to treat heart failure patients with fluid overload is to decongest them via diuresis. The challenge for physicians is determining the dosage of the drug to achieve optimum fluid removal without putting the patient into distress – WITHOUT accurate volume measurement before, during and after treatment.

An accurate and quantitative measurement of volume status gives physicians the potential to improve therapeutic timing and delivery and potentially decrease the chances for complications and days in the hospital.

Cardiorenal Syndrome

The cardiovascular and renal systems are interconnected. The cardio-renal system has an ability to calibrate and balance itself, which can add to the challenge in managing these patients.

The cardio-renal system requires an optimum level of fluid volume to operate efficiently and support other organ function. When a cardiologist is managing a patient’s heart failure, they often determine that they should remove fluid to relieve the heart. However, if too much volume is taken off and/or taken off too fast, the kidneys can suffer impairment and/or injury.

Timely, accurate measurement of both fluid volume and kidney function is essential for safe treatment of these patients. A technology that provides a measure of both volume status and kidney function has the rare potential to inform the physician regarding the function of the overall cardio-renal system, therefore allowing a physician to find the optimum balance in the cardio-renal system.

Sepsis

According to FBM’s primary market research, sepsis, a potentially deadly blood disease, is a primary concern of critical care physicians. According to the CDC, the mortality rate for patients who acquire sepsis is as high as 30%.

Sepsis patients are often hemodynamically unstable, and their volume levels vary greatly. Clinical data has suggested that if physicians could guide sepsis therapies by knowing a patient’s accurate plasma volume, it could greatly and favorably impact morbidity.

Acute Respiratory Distress Syndrome (ARDS)

The symptoms of ARDS are very similar to congestive heart failure. Specifically, these patients present with a very high fluid volume and are treated with diuretics to alleviate this condition.

Accurate measurement of both plasma volume and kidney function before and during treatment can help manage this condition. If patients lose too much volume and/or lose it too quickly, their overall kidney function could be impacted. Through precise monitoring of fluid volume, physicians can better understand the balance between diuretic use and kidney function, which could allow them to titrate therapy and improve management of ARDS.

Acute Kidney Injury (AKI)

AKI occurs quickly and is often hospital-acquired. Patients who develop hospital-acquired AKI typically have a hospital stay 2.4 times longer and a mortality rate up to five times higher than patients who do not develop the condition.

Patients often present to the emergency room with an infection that is treated with large amounts of antibiotics. Unfortunately, antibiotics are nephrotoxic – they treat the infection, but also hold a high potential to damage the kidneys. More sensitive measurements of kidney function could allow physicians to make more informed decisions on dosing nephrotoxins like antibiotics and reduce the chance of AKI.

Kidney Transplantation

Government and patient advocacy groups continue to promote kidney transplant over dialysis to improve patients’ quality of life.

The challenge is to determine the adequacy of kidney function in the donated kidney. eGFR is an estimate of kidney function and is the best measurement currently available. Using this measurement, medical professionals can only guess if the kidney is viable. Measured GFR (mGFR) readings in both living and life-supported cadaver donors would allow transplant physicians to determine if the kidney is working properly. This would allow physicians to titrate the dose of immunosuppressants needed to ensure the body does not reject a foreign kidney and potentially increase the number of kidneys available for transplants.

Chronic Kidney Disease (CKD)

Patients with Chronic Kidney Disease lose a small degree of kidney function over a long period of time. Without precise kidney function measurements, it is difficult to see these slight changes over time.

CKD leads to end-stage renal disease, with 80% of people dying within 3 years of end-stage renal disease diagnosis.

The ability to detect CKD and end-stage renal disease earlier gives a greater opportunity for physicians to monitor and manage the disease throughout its progression.

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