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Seattle Children's lands major funding with hopes of saving thousands of infant lives

SEATTLE August 16, 2011 Seattle Children's Research Institute today announced the receipt of a two-year, $2.3 million grant from the Bill & Melinda Gates Foundation to complete prototype development of its new respiratory support device, called Seattle Children's Positive Airway Pressure (Sea-PAP.) Sea-PAP, designed to be an affordable and simple Bubble Continuous Positive Airway Pressure (B-CPAP) device, will provide breathing support to premature infants who suffer from respiratory distress. Upon completion, Sea-PAP will be significantly cheaper to produce, operate, and maintain than other ventilators and respiratory support devices.

Children's expects the affordability of Sea-PAP will lead to rapid adoption in the developing world and beyond. The simple design shrinks the cost to a fraction of the $30,000 price tag for conventional ventilators, making Sea-PAP and its life-saving therapy accessible to healthcare systems that lack the resources to purchase and operate complex, expensive equipment.

"The worldwide need for low-cost, safe, and easy to use respirator technology is clear. Many premature infants who require only basic assistance with their breathing die for a lack of a simple, affordable alternative to expensive ventilators," said Charles V. Smith, PhD, Director of the Center for Developmental Therapeutics at Seattle Children's Research Institute, and co-inventor of Sea-PAP. "Sea-PAP's low cost and ease of use will make it accessible to all."

More than four million infants worldwide die each year, and one million of those deaths are attributed to respiratory insufficiency, suffocation due to underdeveloped lungs. These deaths are largely attributed to the lack of respiratory support devices in resource-limited countries. Children's estimates that Sea-PAP could save the lives of many thousands of these babies each year, if broadly adopted.

"Cost of technology should not be the deciding factor for which life is saved. Sea-PAP will provide more communities, even in the most rural areas, with the tools to save premature infants with respiratory distress," said Thomas N. Hansen, MD, CEO at Children's and co-inventor of Sea-PAP. "If we could even make a dent of a few percentage points in infant mortality rates, the impact would be staggering."

Preterm birth is the 7th leading U.S. healthcare expenditure today, costing approximately $26 billion a year. A simple tool like Sea-PAP could also help address the financial burden that prematurity brings to care.

Benefits of Simplified Technology and Other Key Differentiators

What differentiates Sea-PAP from most other respiratory support devices is that it is simpler to assemble and maintain, thus enabling a low cost of ownership. To build and operate Sea-PAP, only a small tool kit of supplies are needed, including a continuous air supply, a breathing circuit tube, a tube for the nose, water, and a competent human operator. The breathing and nose tubes can be used multiple times, if sterilized.

Sea-PAP works like conventional B-CPAP devices providing a continuous flow of air via tubes inserted in an infant's nostrils. Sea-PAP's key differentiator from other B-CPAP devices is that its breathing circuit tube is placed in water at a 135 degree slope, which creates fluctuations in the positive airway pressure. These fluctuations keep the lungs open, which lessens the work required from respiratory muscles, thus making it easier to breathe.

Respiratory muscle exhaustion is a major cause of failure in conventional B-CPAP therapy. These failures often necessitate the need for tracheal intubation, mechanical ventilation, and exposure of the infant to high concentrations of oxygen, which carry the risk of tissue damage, infection, and inflammation - all of which are major factors in the development of chronic lung disease. By reducing the work that an infant has to do to breathe, Sea-PAP will eliminate the need for tracheal intubation and mechanical ventilation in many infants.

"Removing the cost barriers of life saving respiratory support technology ensures more infants have a chance at a healthy life," said Gary Darmstadt, Director of Family Health at the Bill & Melinda Gates Foundation. "We are excited for the completion of Sea-PAP, as we believe it will have a significant impact on reducing infant mortality rates worldwide."

Commercialization Timeline and Continued Development Plans

Children's expects to complete development of Sea-PAP in 2012, and for commercial distribution to begin in 2013.

Ongoing development will be led by Dr. Hansen, Dr. Smith, and C. Peter Richardson, PhD, (co-inventor), who have been working together on various respiratory care initiatives since the 1980s. Other collaborators on the project include: Robert M. DiBlasi, RRT-NPS, FAARC (co-inventor); Kathleen D. Bongiovanni, MIPH, MS; Christopher R. Howard, MBA; Jack Hildebrandt, PhD; and John Walton.

Sea-PAP can also work in conjunction with the Hansen Ventilator, a separate respiratory device prototype the Children's team is developing, named after Dr. Hansen. If used together, even more premature infants with respiratory distress could be saved.

"Sea-PAP by itself is the quickest and cheapest way we can save thousands of infants with respiratory distress," said Dr. Hansen. "If used in conjunction with the Hansen Ventilator, that number could increase substantially. We hope to have the combined offering in market later in this decade."

The Hansen Ventilator is being developed by the same team working on Sea-PAP.


Contact: Kathy Porada
Seattle Children's

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