Drew was one of “those” patients.

Drew Hughes was an active, vibrant 13-year-old boy from North Carolina. In June of 2013, Drew was out skateboarding with his friends and fell backward, striking his head on the pavement. After visiting the local emergency department, the decision was made to transport Drew to the Level I Trauma Center. He was alert and conscious in the Emergency Department, but as a safety precaution the medical staff recommended Drew be sedated and a life sustaining breathing tube be placed in his airway for the long transport. En route, Drew woke up in the ambulance and removed the breathing tube from his airway–an event called unplanned extubation. The paramedics responded by injecting Drew with a medication to paralyze him so they could replace the breathing tube before continuing the transport. Over the next 30 minutes, Drew’s oxygen levels fell dramatically because his breathing tube had been improperly positioned in his esophagus rather than his trachea. As a result, Drew lost his life. If Drew’s breathing tube had been adequately stabilized, this preventable tragedy would never had occurred.

Unfortunately, Drew’s story isn’t unique. Every year, more than 33,000 people die from unplanned extubation.  

We believe one death is one too many. 

How is this acceptable as the standard of care? 

In health care, a significant threat to ventilated patient safety is Unplanned Extubation, which occurs when a patient or other external force pulls an inadequately stabilized breathing tube out of the airway. Every year, Unplanned Extubation causes 33,000 preventable deaths, 121,000 life-threatening events, and racks up over $4.9 billion in wasteful healthcare spending. The median incidence rate of Unplanned Extubation is 7.3% in all ventilated ICU patients. As the current standard of care, this is unacceptable.

SolidAIRity is the only fully integrated airway stabilization system designed and patented to provide unmatched airway stability for ventilated patients. It’s unique ribbed endotracheal tube and interlocking stabilizer stands up to significantly more force than the leading competition, while maintaining unrestricted air flow. Competitor devices pinch, squeeze, or adhese to the breathing tube, decreasing air flow by as much as 40%. According to independent testing by biomedical engineers, SolidAIRity is so secure, the breathing tube will break before our system hits its fail point.   

High Likelihood of Acceptance

75.12M endotracheal tubes sold annually worldwide

$4.9B spent on complications of inadequately secured airways in US ICU’s

And an aging population along with increased incidence in chronic respiratory disease are expected to grow that number. 

These leading clinical, safety/risk and performance improvement organizations have committed to a national collaborative for driving increased awareness, data capture and best practice sharing to improve unplanned extubation rates. 

Those we have cleared:

The remaining few:

*Average clearance time frame for medical device traditional 510(k) applications reviewed by the US Food and Drug Administration in 2016 was 177 days based on data published by Emergo.

Our Team

We are a proven, passionate, and committed commercialization team with strong clinical, industry and business backing from key opinion leaders.  Our collective focus, experience and will to win strongly position us to become the industry leader for airway safety and device securement with the most recognized and favored solution in prevention of Unplanned Extubation.  

Our Board Leaders

We'd love to hear from you

For additional information, please use the form below or contact:

Elyse Blazevich, COO & CFO
eblaze@securisyn.com
303.594.6895

References:

1. Moons, P., et al., Development of a risk assessment tool for deliberate self-extubation in intensive care patients. Intensive Care Med, 2004. 30(7): p. 1348-55.
2. de Lassence, A., et al., Impact of unplanned extubation and reintubation after weaning on nosocomial pneumonia risk in the intensive care unit: a prospective multicenter stdy. Anesthesiology, 2002. 97(1): p. 148-56.
3. Medicine, S.f.C.C. Critical Care Statistics. 2017; Available from: http://www.sccm.org/Communications/Pages/CriticalCareStats.aspx.
4. Wunsch, H., et al., ICU occupancy and mechanical ventilator use in the United States. Crit Care Med, 2013. 41(12): p. 2712-9.
5. Needham, D.M. and P.J. Pronovost, The importance of understanding the costs of critical care and mechanical ventilation. Crit Care Med, 2005. 33(6): p. 1434-5.
6. Fisher, D.F., et al., Comparison of commercial and noncommercial endotracheal tube-securing devices. Respir Care, 2014. 59(9): p. 1315-23.

Notices: 

Descriptions and discussions, if any, of properties, personnel, specific business plans, anticipated future results of operations and financial condition and other material information are not included in full, and the descriptions of the business and operations contained in this profile are brief.  Nothing contained herein is, or should be relied on as, a promise, guarantee or representation as to the present or future performance of the company or its products. The technology and/or product described in this overview have not received market clearance by the FDA and are not for sale in the United Sales.  Descriptions of product attributes and benefits are not intended to be marketing claims, but are set forth to assist in the evaluation of the potential risks and benefits of the technology should FDA clearance be secured.  This summary does not constitute an offer to sell securities. Any and all such offers will be made only on an individual basis by an authorized officer or agent of Securisyn Medical.