Team AngelMD • June 19, 2017

ECOM Medical, Inc. (EMI) is a leader in the development and commercialization of Internal Impedance Cardiography for hemodynamic monitoring, which is a key component in administering Goal Directed Therapy consistent with ERAS practice guidelines.

EMI has developed, market tested, refined, and 510(k) cleared for market the Endotracheal Cardiac Output Monitoring System (ECOM), the first version of EMI’s approach to the development of what it calls “Smarter Anesthesia Devices.” Smarter Anesthesia Devices are capable of monitoring beat-to-beat changes in cardiovascular flow, electrocardiogram, blood oxygen saturation, body temperature and respiration.   

The ECOM is a standard endotracheal tube that has seven sensors printed on the cuff and shaft. Using information obtained from an arterial line placed in the patient’s radial artery, along with Internal Impedance Cardiography, it continuously monitors Cardiac Output (CO), Stroke Volume Variation (SVV) and Systemic Vascular Resistance (SVR).

angelMD had a chance to talk to ECOM Medical CEO Guy Lowery, and learn more about their important work. We hope you enjoy this conversation. If you’d like to know more about this exciting angelMD company, please CLICK HERE to be included in exclusive communications.

 

Can you tell us more about ECOM?

ECOM, the Endotracheal Cardiac Output Monitor system, was originally developed as an alternative to invasive cardiac output monitoring technologies such as the pulmonary artery catheter (PAC), as well as non-continuous technologies such as transesophageal echocardiography.

The premise behind the development of the product was to create a family of tools designed around standard devices that are used every day in the operating room and intensive care unit. The thinking was to reduce – or eliminate outright – any change in existing clinical practice. We have found this to be one of the greatest obstacles to adoption of new technology.

The existing ECOM product is based on a standard endotracheal tube, which is modified to incorporate a series of sensors that monitor the heart from the body core. The ECOM tube is inserted exactly like a regular tube but provides real-time, beat-to-beat hemodynamic readings within seconds of plugging in the ECOM cable.

The next generation of products being released in the near future will be based on the same premise of turning standard devices into smarter ones that give needed information without changing existing clinical practice.

 

What is Internal Impedance Cardiography and how accurate is it?

Internal Impedance Cardiography is a way to utilize Ohm’s Law, which relates current, voltage and resistance to extract useful information from the body. A very low-energy electrical field is established inside the patient, and changes in the property of this field caused by blood moving through the aorta are used as the basis of calculating cardiac output and other hemodynamic parameters.

The ECOM Internal Impedance Cardiography approach is in contrast to EXTERNAL bioimpedance platforms that have been around for decades. These early systems were non-invasive (electrodes placed on the chest and neck), but suffered from large signal-to-noise issues, as the aortic flow represents a very small signal within the entire thoracic cavity.

ECOM changes the paradigm by placing the field immediately adjacent to the ascending aorta. Upon intubation using standard techniques, the electrode array sits within millimeters of the heart, and as such is reading from core vasculature. In terms of accuracy, ECOM is statistically equivalent to the invasive gold standard (the PAC).

 

For those less familiar with ERAS (Enhanced Recovery after Surgery), can you describe the guidelines and explain how your technology improves outcomes?

One of the most significant advancements in anesthesiology in the past decade is the adoption of Enhanced Recovery after Surgery (ERAS) practice guidelines that are designed to improve patient outcomes, reduce patient morbidity and reduce the overall cost of treatment.

These ERAS guidelines are comprised of over 20 perioperative protocols that have been proven to reduce hospital Length Of Stay (LOS), reduce complications, improve patient cardiovascular function, and speed return to normal Active Daily Life (ADL). Key among these ERAS guidelines is the protocol known as “Goal-Directed Therapy” (GDT).

GDT uses key hemodynamic parameters to optimize tissue perfusion by perioperatively managing a patient’s fluid status. This real-time monitoring can reduce surgical complications by up to 50 percent. Clinical studies clearly demonstrate that optimal delivery of oxygen – in other words, tissue perfusion – to vital organs during surgery dramatically decreases complications and mortality while at the same time reducing recovery time and overall hospital costs.

While the concept of using a patient’s fluid status as an indicator of tissue perfusion dates back to the early 1990s, the challenge has been to provide the anesthesiologist with the tools necessary to obtain beat-to-beat hemodynamic information that can be used to actively manage the patient, and then intervene (and monitor the intervention) in real time.

These tools represent a significant departure from the traditional practice of using static parameters of a patient’s fluid responsiveness, such as central venous pressure, pulmonary wedge pressure and urine volume. Utilizing GDT represents a substantive change in the practice of anesthesia over the past 10 years, and the momentum of the past decade is only expected to increase as the clinical benefits dovetail with the concomitant reductions in healthcare costs.

Both the American Society of Anesthesiology and the European Society of Anesthesiology have recently endorsed GDT as part of their Enhanced Recovery After Surgery protocols. While this approach to perioperative care has been widely practiced in Europe since 2002, hospitals throughout the US are only now rapidly adopting ERAS protocols that include GDT because of economic pressures put in motion by changes in Medicare reimbursement (2007) and the Affordable Care Act (2010). These changes are only expected to accelerate as cost-containment pressures increase.

 

What advantages does the ECOM endotracheal tube offer over its competitors?

ECOM offers several advantages over competitive systems in terms of ease-of-use, robustness of signal and point of measurement.  As pointed out above, we started out with the premise that we wanted a system that was based on existing everyday technology so that we could eliminate the need for special (and repeated) training.

Using ECOM, if a clinician can intubate, they can get beat-to-beat hemodynamic monitoring. All other systems on the market require the setup and operation of specialized equipment and associated training.

These competitive systems also rely on a single input for their data – in some cases it’s arterial waveform analysis, in other cases it’s doppler ultrasound. This renders the system susceptible to changes in vascular tone (the relative “stiffness” of the arterial wall), or positionality of the doppler sensor.

ECOM’s algorithm incorporates input not only from internal impedance, but also from arterial waveform analysis as well as an internal ECG. This fusion algorithm allows ECOM to provide data display regardless of the position of the tube or patient, and makes the ECOM system not susceptible to changes in vascular tone – changes that take place every single time the anesthesiologist administers a vasoactive medication.

This latter point is reinforced by the position of the ECOM electrode array being very close to  the ascending aorta. Our thinking was that if you’re going to be measuring hemodynamic parameters, why would you want to measure from anywhere but right next to the heart?

 

What other devices are in production and how soon will they be market ready?

We have a number of truly revolutionary products coming down the line later this year, all of which are based on the idea of making “Smarter Anesthesia Devices” from everyday anesthesia products.

These products will be targeted not only into the operating room, but to other areas in the healthcare delivery matrix. We will be glad to discuss these on a confidential basis. In the immediate term, however, we can say that one of the products that is closest to market will be a double-lumen endobronchial tube that will used in thoracic cases such as pneumonectomies, wedge resections and the like. We anticipate having this in 2017 (depending on FDA review).  

This is a product that has been specifically requested by our customer base, and we’re really excited to be making plans for its market release.

 

What interest in EMI have you had from physicians and industry?

Sales are over twice what they were a year ago, and the trend is continuing upward. That can be attributed to two elements.

First, ERAS has made a lot of difference, because GDT works. It is documented, it is accepted, and it saves hospitals money – and hospitals have to watch every dime. Hospitals are genuinely interested in implementing ERAS protocols, so we’re in the right place at the right time.

Second, we find that we are performing very well against the competition once we enter into head-to-head evaluations. In fact, our strength really comes in the toughest surgical cases in which the patient is being subjected to the most aggressive protocols (vasoactive medications, repositioning, long duration, etc.).

Because internal impedance cardiography is measuring from the immediate vicinity of the ascending aorta, ECOM’s response time is very fast, which allows anesthesiologists to intervene more rapidly in critical situations. As a related side note, we believe that the double-lumen tube will help cement our strength in the toughest cases; thoracic patients are among the most clinically fragile patients in the surgical environment, and there are no good alternatives (in fact, none at all) in the minimally-invasive hemodynamic monitoring space.

 

How do you think syndicating an investment with angelMD will benefit EMI?

ECOM is entering into a very exciting period in its corporate history. The base technology has been developed, market tested, clinically validated and FDA-cleared. We are now at the stage where a slate of new products is on the immediate horizon.

Partnering with angelMD will allow EMI to release multiple ground-breaking innovations simultaneously. In other words, EMI has the potential to be more than innovative – funding that will be used in final product development and message enhancement will make EMI disruptive.

 

Tell us about your team and their unique capability in this specific field.

We have assembled a team of veterans, all of whom have spent several years of their career not just developing and launching medical devices, but ECOM itself. We are not spending time bringing each other up to speed, because we’ve spent a long time getting the product to its current state.

There is a real excitement on the team, because we know we’re on the edge of releasing the innovations that our customers have been demanding. Frankly, this is going to be a lot of fun.

 

What are your current status and goals for the next 12 months?

As I’ve mentioned above, ECOM Medical is in a very dynamic phase of its corporate history, particularly regarding the release of new products. In addition to the double lumen tube, we’re well underway on the development of a new ECOM monitor, along with several products that we can discuss in a different forum.

In addition to the significant focus on R&D, however, EMI is in the midst of transitioning its sales model from one of independent representation to one of regional and national dealers. We are also planning for an international rollout pending regulatory clearance of several of the new products that are nearing launch.

We have the right team in place, and the right products in the pipeline to make some serious progress in the next 12 months.

 

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