Aspire breathing tube

31% of COVID-19 patients who are put on a breathing machine, contract a bacterial pneumonia, 96% of which will die as a result of this secondary infection. The presence of a medically essential breathing tube increase the risk of a bacterial pneumonia by 600-2000%. 

We have created a breathing tube that effectively suctions the fluid and bacteria before it has a chance to leak into the lungs. 

The device is proven to reduce a patient's time on mechanical ventilation, decrease antibiotic use, decrease respiratory therapy needs, reduce the rate of concurrent bacterial pneumonia, and reduce mortality. 

If every patient in US ICUs used this tube, we would save $12B/yr. This breathing tube has the potential to mitigate the impact of COVID-19, the exact impact will depend on the number of hospitalizations. 

Patients undergoing mechanical ventilation are at high risk of contracting bacterial pneumonia. The chief risk factor is the placement of a breathing tube. 

By creating a safer breathing tube, we can make invasive mechanical ventilation safer for 200M people annually. 

Specifically, for COVID-19 cases, our breathing tube can reduce transmission of the virus inside the hospital and ensure better outcomes for patients.

The NeVap Aspire Subglottic Suction Endotracheal tube is the only multi-port subglottic suction endotracheal tube. This breathing tube utilizes a suction appendage that prevents tissue herniation and suction blockage while distributing suctioning along a semi circular region where fluid and bacteria can accumulate. 

The Aspire is the only suction breathing tube that can apply suctioning during intubation, ventilation and extubation to reduce the creation of infectious aerosol particles. 

The Aspire can also be used safely with the need for suction pressure regulation, which is usually only available in the ICU. As a consequence, the benefits of the Aspire can be extended to other settings like the OR, ED, EMS, and resource restricted environments.

The NeVap breathing tube serves all hospital stakeholders. 

For clinicians, the tube can be used to remove aerosol particles during aerosol generating procedures (AGP). The WHO classifies intubation and extubation as high risk AGPs. 

For patients, this tube has been proven to reduce time on mechanical ventilation, antibiotic use, respiratory needs, concurrent bacterial pneumonias, and mortality. 

For hospitals, each case of ventilator associated or post operative pneumonia related to a breathing tube costs between $43,000-$46,000/case. It is estimate that the use of our breathing tube can save the hospitals system thousands of dollars per patient. 

We are focused on providing a safer more effective breathing tube to hospitals and clinicians treating COVID-19 patients all around the world. As our device is FDA/CE mark cleared our focus areas are foremost the United States and European Union. 

However, we have donated a large number of devices in Mexico and are in contact with distribution partners in South Africa and Peru. 

Single suction port breathing tubes utilize 1 suction port that comes into direct contact with airway tissue and rapidly herniates tissue. Competitors include the Medtronic Taperguard EVAC, Avanos Kimvent with Suctioning, Teleflex ISIS HVT, and Smith Medical SACKETT.

The NeVap Aspire utilizes a suction appendage with 24 suction fenestrations that are directed away from tissue, making the suctioning virtually unblockable. 

Single suction port breathing tubes have a tissue blockage rate of 95% after 5-15mins. These specialties tubes require suction pressure regulation and are only utilized in the ICU setting. 

The NeVap Aspire suction breathing tube utilizes a suction appendage to provide subglottic suctioning. This appendage disperses suctioning away from airway tissue and acts as a tissue spacer. Thus, the suctioning is on the NeVap Aspire is virtually unblockable, even after several days of clinical use. The lack of tissue entrapment also means that the Aspire does not require suction pressure regulation and can operate in a number of clinical settings including the operating room, intensive care, emergent care, and EMS settings. The appendage is also radiopaque and allows for superior radiofrequency positioning of the breathing tube. 

Abstracts, presentations, and papers submitted to the American Academy of Respiratory Care and Society of Critical Care Medicine have demonstrated that NeVap Aspire breathing tube has significantly better fluid recovery when compared to industry gold standards. 

"A 48-HOUR COMPARISON OF 4 SUBGLOTTIC SUCTION ENDOTRACHEAL TUBE MODELS IN EX-VIVO PORCINE TRACHEAS"

"Performance Characteristics Of Endotracheal Tubes During Single Port Subglottic Suctioning versus Multi Port Subglottic Suctioning in an Ex Vivo Porcine Trachea Model"

It is well documented that breathing tubes cause pneumonia at a rate of 0.01%-27% depending on the patient's health and time on mechanical ventilation. In 2009, the US reported 350,000 cases of ventilator associated pneumonia in the ICU setting. 

Single suction breathing tubes have been proven through meta-analysis to reduce the rate of pneumonia by 40-66%. However, the rate of rapid suction blockage of these tubes is between 50-95%, with case studies that demonstrate airway damage. 

The NeVap multi-port suction breathing tube has been proven through clinical study to have virtually no suction blockage and recover 10-15X the volume of secretions. As a consequence, the clinical and financial impact of this tube is likely to be significant.

We are on track to sell 20,000 breathing tubes this year. 

Next year we anticipate selling 50,000 breathing tubes.

In five years, we hope to sell 1M breathing tubes.

By proving the NeVap Aspire breathing tube can reduce the rates of post operative pneumonia the operating room for patients undergoing Cardiac, Neurological, Orthopedic, Gastrointestinal, Trauma, Burns, or Pulmonary surgery, this device could quickly become a standard of medicine. 

By reducing the incidence of pneumonia in patients undergoing mechanical ventilation, this tube can extend the useful life of our current antibiotics, save lives, reduce perioperative costs, and increase the supply of critical medical services.

In order to further scale our solution, NeVap will need to raise funding in order to conduct a high quality, high powered clinical study. In addition to key clinical opinion leaders and recruiting additional talent, NeVap needs to raise additional funding to support sales and marketing activities. 

Covid-19 has also changed the way medical devices are brought into hospitals. The pandemic has frozen contracting and normal sales channels. 

In order to introduce the NeVap breathing tube into hospitals in a time of a pandemic, NeVap has identified distributors who do not rely on a hospital sales force to introduce products into hospitals. NeVap has also created an innovative marketing message and strategy to position our solution as not just "another breathing tube", but a mitigating factor to help protect clinicians from cross infections.

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Full time staff includes 3 people. 

Part time staff includes 4 people.

30 years of C-level medical device management experience

20 years of direct patient care experience

30 years of medical device engineering experience

10 years of medical device regulatory/quality experience.

Manufacturing partnership in place. Our Taiwanese manufacturing partner helps manage supply chain and quality. 

Selling products.

Our product is currently being manufactured at scale. Our gross margins are 85% and we have signed up a number of distribution partners. 

The COVID-19 pandemic has shown that improvements in Invasive mechanical ventilation, the last line of defense against the pandemic, are badly needed. 30% of COVID patients are dying from bacterial infections due to placement of a breathing tube. At the same moment, placing a breathing tube is estimated to infect 1 in 10 healthcare workers involved, globally.

Our healthcare heroes and patients are paying too high a cost. 

NeVap Inc has developed, patented, scaled, and receive US & EU clearance for a multi-port suction breathing tube that is 10-15X more effective at removing pathogens. This class of device has been proven to reduce time on mechanical ventilation, antibiotic use, ventilator weaning time (2-3 days), and mortality. The NeVap breathing tube is the only device that has been successfully deployed in additional settings including the Operating Room, Emergency Department, ICU, EMS, Veterinarian, and resource restrictive environments. All the while, reducing respiratory/nursing care needs, anesthetic medications, capital equipment and preventing cross infections.

Making invasive mechanical ventilation safer and more efficient is badly needed right now. The device is already impacting care in the US, UK, Mexico, Chile, Paraguay, and Taiwan, but with more attention and partnerships, could save countless more lives.

COVID-19 is spreading human suffering all over the world and it is disproportionately hurting people in poorer countries and highlighting huge disparities. ICU care and mechanical ventilation is the most resource intensive field of medicine and during this pandemic demand is outstripping supply. Countries without adequate mechanical ventilation equipment are suffering the most. This is a critical time, where cost-effective improvements to maximize the supply of mechanical ventilation will have a lasting and meaningful impact. These improvements can also improve health emergency preparedness for future pandemics and serve as a model for cost effective global pandemic innovation.

The NeVap breathing tube is a clinically proven tool that has been shown to reduce time on mechanical ventilation, reduce antibiotic use, reduce concurrent bacterial pneumonias, reduce ventilator weaning time, and overall mortality. All of these clinical benefits can rapidly optimize mechanical ventilation care and supply, at an infinitesimal cost when compared to the cost of additional mechanical ventilation, ICU capacity, and training healthcare workers. 

This device is already being deployed at scale in Mexico, Chile, Peru, and Paraguay to help combat the pandemic and support healthcare systems in resource restrictive indigenous communities.

COVID-19 has demonstrated that improvements in invasive mechanical ventilation are badly needed, not just for ICU patients or future pandemics, but for the 100M annual patients undergoing mechanical ventilation for allergic reactions, surgical procedures, and long term care. 

Hospital acquired, ventilator associated, post-operative, and aspiration pneumonia are all cause and exacerbated by the presence of a breathing tube. Though medically necessary, breathing tubes increase the risk of pneumonia 600-2000% and subsequent pneumonias are often antibiotic resistant, costly, and deadly. 

NeVap has developed a better breathing tube that is currently being sold globally. The COVID-19 pandemic has accelerated the adoption of our breathing tube dramatically and we can expect our impact on clinical care to grow exponentially. 

As antibiotic resistance becomes more common and widespread, healthcare infrastructure will continue to invest more heavily in infection control and prevention devices. Currently, the NeVap breathing tube is being commercialized and manufactured at scale. Current gross margins for the device at upwards of 85%.