Respiratory illness is a leading cause of hospitalization and death in developing and developed nations alike. Each year thousands of patients die because of lack of early access to mechanical ventilation. India for example makes up more than 50% of the world’s pneumonia deaths and traffic accidents claim more than 120,000 lives each year. Pneumonia and thoracic trauma are the number one and two reasons for needing a ventilator in most hospitals. Despite improvements in infrastructure and economies, ventilators remain out of reach for many facilities and pre-hospital care is in its infancy. For example, in the United States there are approximately 205,000 ventilators for a population of 300 million. In India, where the population exceeds 1.1 billion, there are only 35,000 intensive care ventilators available leading to a 1 million unit gap. New machines are too expensive, too complex, and too fragile for use in harsh environments. Many hospitals use poorly maintained refurbished devices and emergency facilities and transporters often forgo mechanical ventilation altogether.
In developed countries, government planners have described a need for many thousands of additional ventilators in the event of a pandemic influenza or other large-scale medical emergency. In anticipation of a ventilator shortage, many healthcare facilities have established triage protocols to determine ventilator allocation based on severity of illness, age and co-morbidities. A decision-making process for resource allocation in the face of a shortage is important, but it does not solve the underlying need for more ventilators.
OneBreath is an early stage medical device company that has developed a fundamentally simpler platform to provide mechanical ventilation. By discarding existing paradigms, OneBreath has dramatically lowered the cost of ventilation while maintaining a high level of accuracy. Our first product is designed to penetrate the vastly underserved markets in developing countries and pandemic stockpiling. OneBreath, Inc. is a US corporation in Palo Alto, CA and OneBreath India Pvt Ltd is a wholly owned subsidiary based in Bangalore. Our technology was developed by a team of physicians and engineers at Stanford University. The OneBreath team consists of A. Vijay Simha, CEO (25+ years in medical device businesses; previously with BPL, India), Matthew Callaghan MD, CMO (Founder and physician), Bryan Loomas, COO (30 years in growing start-up medical device businesses; respiratory, sleep, general surgery, and ophthalmology) plus a founding team of engineers and software designers located in Silicon Valley.
The First Product: The first OneBreath ventilator is a full‐featured ventilator intended for hospital and pre-hospital use in emerging markets. It is optimized for low resource environments, novice users, and adult and pediatric patients. By starting with a clean sheet of paper, our engineers developed a far simpler and less expensive design architecture, making OneBreath’s cost of goods a fraction of currently available ventilators while providing class-leading performance and features. The OneBreath platform enables quick and easy repairs and minimal preventative maintenance – critical in markets with demanding physical environments and less robust maintenance and repair infrastructure.
Market Size: The mechanical ventilation market is estimated at $3.6 billion globally and growing at 6.7% and our addressable market in emerging economies is more than $600 million. U.S. and EU transport, auxiliary and home care markets are good targets for expansion. Our platform can also be used to increase margins in higher-cost equipment or to build a full line of ventilators for specific markets.
Intellectual Property: Multiple global filings with broad device claims protect the mechanical architecture and software solutions. Two highly respected law firms with deep medical device experience in the US and India confirmed patentability and freedom to operate.
Development: The OneBreath device is eligible for CE Mark based on technical file submission only (class IIb) and will not require clinical trials. Data used for CE approval can be applied towards 510(k) clearance in the U.S. and CFDA approval in China. OneBreath is expected to achieve CE Mark in early 2015 and open sales soon after. FDA approval will follow in 2016.