Big news in the fight against COVID-19!
Happy Mother’s Day!
On this Mother’s Day I am excited to share a very special gift for mothers and their babies worldwide. With our “hot-off-the-press” breakthrough, we can prevent blindness, a lifetime of disability, or death among millions of newborns and infants every year. It is thanks to you this is now possible.
I must say I’m absolutely blown away by the outpouring of support we’ve received over the past 6 weeks. I sincerely thank each and every one of you for your support. We would not be where we are today without you.
Great Acts of Kindness
In addition to generous monetary contributions, we’ve had…
- 22 people, including 11 Harvard Medical Student volunteers, working tirelessly around the clock to assemble bubble CPAP kits (staying 6 feet apart of course).
- Requests and device shipments going all around the world including to Philadelphia, Indiana, Haiti, Nigeria, Canada, Italy, Bangladesh, Laos, Vietnam, Tanzania, India, Kenya, and to Cape Town and Johannesburg South Africa.
- Numerous live trainings on device usage, creation of a virtual course and certification, as well as a supporting mobile app to help us scale training delivery.
- Our engineers and legal team working through rigorous examinations and documentation for the FDA.
In my last update, I shared that the Vayu-bCPAP device not only helps newborns and infants in respiratory distress, but also has the potential to make a big impact in the fight against COVID-19.
It’s become clear that we can combat COVID-19 in three ways:
- We can provide direct medical support for newborns and infants suffering from respiratory distress due to COVID-19, pneumonia and other life-threatening conditions.
- We can free up ventilators to aid adult COVID-19 patients by providing high quality alternatives for the ~50,000 units that are currently deployed for newborn and infant use in NICUs, Special Care Units, and Level 2 Nurseries in the United States.
- We can distribute Vayu-bCPAP devices to lower-level hospitals in the US, Canada, and worldwide to assist with births occurring at home and in community level facilities, as many more births worldwide are occurring in the home setting and at community facilities due to COVID-19.
And now for the good news! Hospitals can immediately adopt our device throughout the U.S. and beyond because…
We have FDA Emergency Use Authorization!
The Food and Drug Administration saw the enormous potential impact of this device in the U.S. and abroad and gave us their stamp of approval to start helping with this crisis right away!
I’m excited to announce that we were granted FDA Emergency Use Approval (EUA) for use of the Vayu-bCPAP device!
Now that we have FDA EUA approval, the path is clear to make the devices accessible across our nation and worldwide. The floodgates have been opened and we are already fielding a large number of requests.
Ventilators Are in Critically Short Supply
Despite conflicting stories you may have read in the news, ventilators are still in short supply in many regions of the U.S. and worldwide. And they are likely to be in high demand for at least the next 12-24 months.
To help with this, Vayu plans to donate large quantities of bubble CPAP devices to hospitals in need at no cost.
To achieve this goal, we need financial help. We now have the infrastructure, the labor, and a clear distribution path. But we urgently need funds to pay for device components. At our current levels, we can produce one device for every $200 (that’s <1% the cost of a typical ventilator).
We suddenly have the opportunity to use Vayu bCPAP devices to help reduce COVID-19 deaths globally and right here in the U.S. But we need your help to act quickly.
We have a goal of producing 15,000 devices within 6 months which will require $3 million in parts and materials.
Please join me in the fight against this global pandemic at whatever level you can support. Our coordinated efforts have never been more critical!
This is too important to keep to ourselves so we’re trying to spread the word. Please consider forwarding or sharing this message with anyone you think could help.
Thank you again and warmest possible wishes to you and your family,
Thomas F. Burke, MD, FACEP, FRSM
Director Global Health Innovations Lab
Department of Emergency Medicine, Massachusetts General Hospital
Associate Professor, Harvard Medical School
Associate Professor, Harvard T.H. Chan School of Public Health
President, Vayu Global Health Foundation
President, Ujenzi Charitable Trust