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Out With The Old, In With The New

by | Jun 14, 2021 | Newsletter | 0 comments

AIRA Received EUA on April 7th

Our ventilator AIRA received EUA (Emergency Use Authorization) in one year. This means the next phase is all about growth and advancement. We will be moving onto making a direct impact by reaching out to hospitals and countries all around the globe.

We Made Some Changes

Due to the immense progress we have made in one year, our team is expanding. We are rebranding from The Ventilator Project to TVP Health. Our logo, name, and mission statement have all changed to reflect the future ahead. We have decided to expand our scope from just ventilators and find innovative ways to make affordable, typically high-cost medical devices.

Last summer we adjusted to social distancing and wearing masks. This summer it seems we will be able to soak up the sun and breathe some fresh air. The Centers for Disease Control and Prevention said that 169.7 million people have received at least one dose of a Covid-19 vaccine. That number also includes the 137.5 million people who have been fully vaccinated by Pfizer-BioNTech, Moderna, or Johnson and Johnson. Currently, about 63 percent of adults have received one shot but President Biden would like to see 70 percent of adults vaccinated by July 4th (New York Times).

While the United States focuses on vaccination, other nations are yet to declare victory over the coronavirus. The second wave of the coronavirus devastated India as the death toll soared. India experienced a shortage in oxygen, ventilators, hospital beds, and antiviral drugs. The country spends just above 1% of its gross domestic product (GDP) on public health. Since April, the United States and other nations extended their support to India by providing oxygen cylinders and antiviral drugs (NPR).

What is TVP Currently Doing?

TVP Health is working with Chakshu Saharan, a tech entrepreneur from the U.K. Originally from India, Saharan saw the devastation the country faced during the second wave of the coronavirus. Saharan was dedicated to helping this problem (sound familiar?) so he pulled his resources together to launch the Help India Breathe project, raising money to ship ventilators to India along with CPAP (continuous positive airway pressure) machines. TVP Health is working with Saharan to bring our low-cost ventilators to India as soon as possible.

Along with Saharan, TVP is working with Janvikas, an Indian nonprofit organization that is training healthcare workers on how to use new medical equipment, such as our ventilators. Our founder, Tyler Mantel, stressed the importance of training and support from manufacturers. “When countries are getting emergency donations some crucial components tend to be forgotten. The goal for the future is not to have thousands of ventilators in a stockpile, but to be prepared with a support model that helps when a pandemic starts.” Read more about our partnership with Help India Breathe in the Fast Company article.

TVP has also hired new Quality Analysts and Compliance Engineers as we continue to obtain regulatory clearances in foreign countries. After receiving EUA earlier this year, our current goal is to actively pursue sales of AIRA.

The Next Phase

We are focused on achieving EUA/510(k) equivalent clearance in India and South Africa. The team is working on creating contacts with external stakeholders for our target countries initiatives project. The goal is to make effective relationships with foreign regulatory bodies so that we can start sales in these foreign countries.