Technology Pipeline

Critical care is all about adapting to a shifting landscape. From emergency rooms to ambulances to combat zones—or even in a fully-equipped ICU—whenever and wherever crisis hits, time to respond is limited.

 

From experiences treating critically-injured military personnel in a war zone to facing some of the most extreme situations in the emergency room and intensive care unit, we witnessed, first-hand, lives lost from severe hemorrhage that we thought could be saved—if we just had more time to intervene.

We believed today’s technology could give us that time, however the medical research and innovation needed to save these lives hadn't caught up yet. We needed to step back and re-evaluate the science.   

What we discovered was more revolutionary than we anticipated. Not only could we improve trauma from hemorrhage with our new insights, but we could also improve treatments for cardiac arrest and stroke. Our discoveries would also allow us to provide precise, continuous control of blood pressure on a level never before possible, opening up possibilities for innovation in other areas of critical care. And we can do all of it in clinical settings everywhere: from the battlefield to the ICU, from a rural hospital to the back of an ambulance.

 

A Critical Need

The strategies employed in treating a critically ill or injured patient have remained relatively the same for decades. Critical care is plagued by:

 

Too Much Data, Too Little Interpretation

 

Current medical monitoring devices generate volumes of data about individual patients, but lack precision in reporting and translating this information. Providers only receive alerts about large changes in a patient’s state, unable to respond in real-time to smaller trends that could influence a patient’s course of care.  

 

Outdated Technology

 

The technologies used in critical care settings lag behind today’s computing potential and are susceptible to electrical and mechanical interference, causing unreliable, low-quality data. With technological advances in microprocessors, solid state sensors, and complex algorithms employing AI, the ability to automate aspects of critical care can offer precision at a level humans can’t provide.

 

Limitations of Therapeutic Solutions

 

Interventions used in critical care today rely on aggressive administration of therapies like blood products, vasopressors, and IV fluids to provide damage control. These strategies don’t account for the dynamic nature of a patient’s physiology because we can’t measure and analyze the effectiveness of a treatment quickly enough to respond in ways tailored to an individual’s needs. This lack of nuance and precision is unavoidable with the current standard of care and can sometimes mean the difference between life and death.

 

Cognitive Burdens on Providers

 

For health care providers, the confluence of a myriad of data without context and interpretation, antiquated technology, and the difficulty of delivering timely and custom therapeutic interventions, creates cognitive challenges in caring for their patients. Already, providers struggle to continually assess and administer therapeutic adjustments. When multiplied by the number of patients in today’s critical care settings and severe shortages of medically-trained support staff, the cognitive load rapidly exceeds what can be managed by a single individual. Errors and delays in care ensue, resulting in increased complications and death.

The Critical Solution

Certus’ technologies pairs the power of precision sensing and intervention with a level of continuous care never before achievable in critical care. By creating the possibility of tailoring treatment to the exact needs of an individual, our technologies will reduce the length of hospitalization and decrease the risks of negative functional outcomes and mortality.

  • Precision Sensing & Intervention

    The proprietary solid state sensors in Certus technologies measure absolute blood pressure and, unlike standard sensors, are less susceptible to external interference, such as a patient or provider touching the external components of the monitoring equipment. Certus technologies generate continuous, high-fidelity data, allowing for incremental changes, whether it be in medication levels, blood pressure, and breathing rates, that are beyond a medical professional’s capabilities to manually measure and apply. This level of precision and “intelligent” control facilitates personalized treatment that keeps patients in the most stable condition possible, improving outcomes and saving lives.

  • Continuous Care

    In critical care today, treatment relies on physicians’ assessments to make interventions for a patient. Gaps and delays in evaluation or therapeutic administration can compound and, ultimately, have tragic effects on a patient’s outcomes. The algorithms built into the Certus technologies decrease the burden on caregivers by reading an individual patient’s physiology and providing continuous adjustments through machine learning on a second-by-second basis. This continuity helps patients recover more quickly, which allows them to return home sooner and increases the capacity of hospitals to treat more patients.

These technologies will give critical care providers—first responders, ED staff, surgeons, combat medics, and others—the opportunity to provide automated, personalized care to every patient on a level never before possible. 

 
 

Pending Products

Born out of our military-funded research, our initial products in development address the fundamental problem of controlling blood pressure in patients suffering from hemorrhage, cardiac arrest, and stroke. These products are not yet approved by the FDA, but we are working diligently towards that goal.

The Endovascular Aortic Control (EVAC) System

The EVAC system is a single-use aortic balloon occlusion catheter that provides precise and variable control of blood pressure and flow in critically ill and injured patients on a minute-by-minute basis. The EVAC system is a first-in-class endovascular device that incorporates patented sensor technology with unique aortic occlusion balloon characteristics and data analytics fueled by proprietary algorithms.

The EVAC is an improvement on the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure, the use of a balloon catheter to completely block the aorta and help control bleeding. Although gaining popularity in the treatment of cardiac arrest and severe hemorrhage, REBOA can result in severe negative outcomes. In contrast, the EVAC system uses automation to partially block the aorta to control bleeding while decreasing the negative side effects.

The platform can be used in any critical care setting by inserting the EVAC catheter through the femoral artery into the aorta using the standard REBOA procedure. The provider sets the desired blood pressure parameters, and the device manages the rest. The sensors placed on either side of the balloon transmit physiological data that the device interprets and uses to adjust the balloon, inflating to stop blood flow or deflating incrementally to increase flow. Reacting on a second-to-second basis to any change in pressure, EVAC stabilizes blood pressure and frees the provider to address the root cause of the emergency, whether it's cardiac arrest, hemorrhage, or stroke.

  • The EVAC system is an adaptive, intelligent endovascular device that controls blood pressure and flow to treat conditions such as hemorrhage, cardiac arrest, and stroke.

  • The EVAC system uses a single-use aortic balloon occlusion catheter that can be used in any critical care setting by inserting the EVAC catheter through the femoral artery into the aorta using the standard REBOA procedure.

  • The balloon catheter is automated, allowing providers to block the aorta fully or partially, tripling the length of time that the catheter can be used and increasing the time critical care providers have to treat a patient.

  • Certus’s proprietary solid state sensors, placed on either side of the balloon, measure absolute blood pressure and provides high-fidelity data that the device uses to adjust the balloon.

  • The EVAC system monitors and analyzes patient data on a minute-to-minute basis in order to update and alert providers in real-time.

EVAC Use Cases

Learn about the various disease states in which the EVAC can provide life-saving measures.

  • Worldwide, approximately 8 million people die from trauma every year, with 2.8 million dying directly from hemorrhage. The treatment of hemorrhage is also extremely important in postpartum care, where, despite years of improved care and the decrease of risk factors, the incidence of postpartum hemorrhage has increased. It remains the leading cause of mortality for pregnant women in the U.S.

    The mortality statistics of trauma remain high despite vast improvements in trauma care and surgical capabilities. For some traumatic and obstetric hemorrhages, REBOA has become a popular technique to stop blood flow and provide time to control bleeding. However, the length of time that REBOA catheter technologies can be used is very limited and can result in profound tissue death below the balloon.

    By precisely regulating the degree of aortic occlusion, the EVAC system optimizes the blood flow past the balloon catheter to slow bleeding without completely cutting off circulation to the lower half of the body, a frequent cause of early organ failure and eventual patient death. EVAC triples the time providers have to intervene.

    In addition to increasing survival rates and decreasing complications from standard REBOA catheters, the single-use EVAC system can be applied in pre-hospital settings, while a patient is transported to the nearest trauma center. It can also be used in high-risk surgical procedures with high anticipated blood loss, such as high-risk obstetric cases.

  • Every year, 350,000 people in the U.S. suffer an out-of-hospital cardiac arrest, while another 290,000 experience an arrest while a patient in the hospital. Even with the most advanced care, upwards of 80% of people who experience cardiac arrest die, and many of those who do survive have significant long-term disability. The direct cost of care for patients who have suffered a cardiac arrest is as high as $33 billion a year.

    Despite the obvious clinical need, effective cardiac arrest treatment options have actually decreased over the last 10 years. With such limited options for a lethal condition, the concept of using balloon catheters to treat cardiac arrest has garnered increasing attention in the fields of emergency medicine and pre-hospital care. While full occlusion of the aorta with a balloon catheter improves the chances of return of spontaneous circulation and neurologic recovery in the face of some slim odds, studies show that the balloon merely trades one problem for another. Subsequent deflation of the balloon frequently causes re-arrest, which is usually fatal.

    The innovative way that the Certus EVAC platform controls the balloon catheter significantly improves the chances of spontaneous circulation by transitioning to dynamic partial aortic occlusion, gradually weaning patients from the full occlusion, reducing the risk of re-arrest and mortality by 40% in preclinical testing. Unlike standard catheters, the EVAC catheter can dynamically and precisely control blood pressure and flow, filling a critical gap in cardiac arrest care.

  • In the U.S. and Europe, 450,000 people suffer an intracerebral hemorrhage (ICH) every year, with hospital costs of $4.5 billion in the U.S. alone. Compared to cardiac arrest, there are even fewer treatment options for patients with ICH, and the mortality rate is over 50%. Unfortunately, those who do survive often suffer severe long-term neurological damage.

    Current treatments for ICH focus on controlling blood pressure, as wide fluctuations in blood pressure can cause both short- and long-term neurological damage, but maintaining stable blood pressure minute-to-minute is incredibly difficult.

    The EVAC catheter reduces this blood pressure variability in patients suffering from catastrophic neurologic injuries. The EVAC catheter senses and corrects blood pressure fluctuation in real-time, using variable and incremental balloon volume changes to maintain a tightly-targeted blood pressure on a second-by-second basis. When used in concert with blood pressure medications, physicians can apply life-saving therapeutics more accurately, based on each individual patient’s needs, allowing for rapid adjustments of medication and decreasing the risk of overmedication.

    The EVAC catheter effectively decreases blood pressure variability in patients with ICH more quickly, making the device the first major therapeutic intervention for ICH developed in decades and providing treatment for patients facing limited options.

The EVAC system for hemorrhage has not entered the FDA clearance process. EVAC for cardiac arrrest and stroke is currently in product development and is slated for future clinical trials, ahead of a de novo 510(k) application for approval. Certus is currently seeking Series A funding to support commercialization of the EVAC system.

 

 Current technology is essentially a balloon on a stick—we’re creating something more intelligent.

— Luke Neff, MD, Founder

 

Explore More.

 

View the published research that undergirds our technologies and read the latest news on our milestones.

Learn about the broad scientific and clinical expertise behind the development of Certus technologies.