Business Opportunity

An innovative technology breakthrough.

The Market Opportunity

 

The urgent need for an early-warning system to monitor tissue pCO2 and alert medical caregivers to tissue hypoperfusion is clear and immediate, with the potential to save countless lives. ExoStat Medical has developed a novel, proprietary technology to meet this crucially important—and rapidly growing—need.

 

A noninvasive monitoring device, the MicroTrend™ System features a micro sensor embedded in a hands-free mouth clip located in the buccal mucosa tissue of the mouth. The sensor retrieves a continuous stream of data to measure partial pressure carbon dioxide (pCO2), an early indicator of tissue hypoperfusion. Patient populations include those in ERs, ICUs, perioperative units, dialysis centers, burn centers, nursing homes, recovery rooms, ventilation weaning units and environments where the critically ill and injured are located.

 

Sepsis-related illnesses such as hypoxia and hypercapnia represent a significant medical challenge and a potentially major market opportunity in addressing this pervasive, life threatening condition. According to the US Sepsis Alliance1:

  • Sepsis is the leading cause of death in US Hospitals.
  • Mortality from sepsis increases by as much as 8% for every hour that treatment is delayed. As many as 80% of sepsis deaths could be prevented with rapid diagnosis and treatment.
  • Approximately 6% of all hospitalizations are due to sepsis and 35% of all deaths in-hospital are due to sepsis.
  • Sepsis affects more than 30 million people worldwide each year and accounts for eight million lives lost each year, more than three million of which are children.
  • Sepsis is the #1 cost of hospitalization in the U.S. consuming more than $29 billion in 2013*.

 

Independent Market Assessment

In 2016, ExoStat Medical engaged Deloitte Consulting to provide ExoStat Medical with a three-phased market analysis that quantified the addressable markets in three subsets:

  • Sepsis/ICU/ER
  • Peri-operative, dialysis, burn centers, ventilator weanings, etc.
  • Total (domestic and international)

 

The report delivered by Deloitte included potential units sold, competition, pricing considerations, and other pertinent information. In summary, the revenue potential for the addressable market is substantial and there is currently no competitor for a real time, point of care, non-invasive, multi-hour monitoring sensor for tissue hypoperfusion.

 

The market potential for the MicroTrend System can only be estimated at this time as no direct competition (or comparable device) currently exists. All novel and disruptive products require time to educate users and time for supply to match demand. ExoStat has allocated valuable time and resources to the understanding of, and preparation for, these challenges.

1 Global Sepsis Alliance
2 National Inpatient Hospital Costs. Agency for Healthcare and CDC. gov.
3 In early 2016, ExoStat engaged Deloitte Consulting to provide an assessment of the domestic and international markets for the MicroTrend™ System, basing revenue projections on preliminary pricing assumptions and a reasonable and timely product rollout.
*In 2019, Medscape reported the costs as more than $62 billion

Strategic Market Advantages

 

Tissue Hypoperfusion is a medical emergency.  There is a large, unmet market for a technology solution that addresses this need. The MicroTrend System is the solution. Below are the market advantages of this device:

 

  • Hundreds of supporting studies, tests and peer-reviewed papers indicate the importance of early identification of tissue hypoperfusion.
  • The MicroTrend™ System is the first non-invasive oral mucosal sensor system to identify and monitor poor tissue perfusion (POMCO2).
  • The technology embedded in the MicroTrend System is novel, disruptive and proprietary and there is no direct competition.
  • ExoStat owns patents for both the design and application of the most distinguishable features of the MicroTrend technology.
  • A broad market study identifies a huge, unmet market for the MicroTrend System’s pCO2 monitoring technology
  • The MicroTrend System sensor is disposable, creating “a razorblade paradigm” for sales and marketing.

 

ExoStat Medical has established relationships with medical institutions and healthcare professionals, including physicians and clinical research experts who are expected to become early adopters of the MicroTrend System. Our highly skilled R&D team has more than 50 years of combined product design experience, and our company is guided by a highly experienced management team and Board of Directors. ExoStat Medical is fully funded and has no debt.

Intensive care physicians, anesthesiologists and surgeons need a simple and reliable tool to measure systemic tissue perfusion continuously and in real time. Data from pre-clinical and clinical studies on oral mucosa pCO2 are very promising, and MicroTrend™ has the potential to be that important tool. Clinical studies will be important to prove this.”

 

Tor Inge Tønnessen

Professor of Anesthesiology and Critical Care Medicine
Oslo University Hospital and University of Oslo, Norway