FDA Clears Aluna Asthma Management Platform for Consumer Sale & Use

(San Francisco, CA - March 25, 2020) Aluna, the San Francisco Bay Area-based asthma management company, today announced that the FDA has cleared its flagship device and companion smartphone app for consumer sale and use. The Aluna platform was designed from the ground up by a team of asthmatics and healthcare providers to help patients, particularly pediatric patients, better manage their asthma by recording and tracking their lung function scores. Better tracking of lung function can help prevent asthma attacks and flare-ups, resulting in controlled and managed asthma.

"This FDA clearance is a watershed moment for our company and for asthmatics everywhere," said Aluna co-founder and CEO Charvi Shetty. "As asthmatics ourselves, my co-founders and I are personally and acutely aware of the daily struggle of living with asthma. Children often struggle to effectively communicate the symptoms that they are experiencing or recognize certain triggers that should alter their behaviour. Now, with our device, kids have the ability to instantly measure their lung health, track and monitor ongoing symptoms, and can see their data over time - ultimately helping them better self-manage their asthma. We believe that the Aluna will help asthmatics everywhere better manage their condition, empowering them to live life to its fullest. Use of Aluna will enable more informed and open dialog between patients and their doctors about how to best cope with this chronic disease."

Aluna is an innovative, mobile respiratory management platform that monitors lung function scores, effectively duplicating the spirometry exams typically performed in a doctor's office. It consists of a small spirometer (about the size of a deck of cards) that pairs, via Bluetooth, with a companion iPhone app. To use, patients exhale forcefully into the device, just as they would for a physician's spirometry exam. Their progress and score are displayed in the paired app, which is carefully designed to be fun and engaging for daily use.

To view Aluna in action, please watch this brief demo video: https://www.youtube.com/watch?v=uxQG1LBw5pY.

When used regularly, Aluna provides a wealth of insight to better manage this chronic disease. It records and outputs real-time data, in PDF format, for both patient and doctor review, providing a more holistic view of the patient's lung function than is possible with occasional visits to doctors' offices. This has several key benefits. Using Aluna teaches children to develop autonomy over their asthma action plans by keeping them, along with their parents and physicians, informed about their lung function. This allows parents to more closely monitor their children's asthma on a daily basis and physicians can adjust asthma action plans as needed with a greater understanding of potential asthma triggers. Most importantly, better management of asthma should result in fewer asthma attacks and flare-ups, and therefore less need of emergency rescue medication, the kind of which is administered in the event of an asthma attack. These rescue medications are linked to a variety of side effects and tolerances can be developed over time, potentially resulting in less effective asthma relief.

"As a pediatric pulmonologist, I directly oversee the care of many asthmatic children," said Ngoc Ly, MD, MPH, Co-Director of the Cystic Fibrosis Center at the University of California - San Francisco (Dr. Ly contributed to the development of the Aluna platform). "The development and FDA clearance of Aluna will help asthmatics everywhere, especially children, gain a better understanding of and more effectively manage this disease."

There is a tremendous need for Aluna and for better asthma management. According to the Centers for Disease Control and the Asthma and Allergy Foundation of America, more than 26 million Americans have asthma, with the rate increasing over the past four decades. 47.5 percent of children age 18 and younger who had asthma reported having one or more asthma attacks in the past year. The unpredictability of asthma attacks can make it difficult for many children to pursue activities such as sports, music, and much more. CDC research estimates that asthma directly costs the United States economy more than $80 billion each year. This number does not factor in indirect costs, which include lost time and productivity, including lost school days due to asthma. Better asthma management will result in improved quality of life for asthmatics while also relieving stress on the national economy.

Aluna is not yet available for sale but is planned for a consumer launch in the Spring of 2020. Though a prescription is not required, Aluna recommends consulting with one's physician when using the Aluna platform. To learn more, please visit aluna.io.

Physicians that are interested in purchasing the Aluna Asthma Management platform for their practice, should contact Aluna directly at hello@aluna.io.

ABOUT ALUNA

Aluna was founded in the San Francisco Bay Area by three asthmatics who met at the University of California - Berkeley. This shared experience amongst the founders drives Aluna's mission to bring clarity and peace of mind to children, parents, caregivers, and medical professionals who live with asthma and other chronic respiratory diseases. The Aluna platform was developed in close consultation with physicians at some of the US's leading academic medical centers to ensure that it is safe, effective, and fits into existing asthma treatment plans. For more information, please visit aluna.io.

345 California Street, Suite 600, San Francisco, CA 94104

Helping kids self-manage their asthma anytime, anywhere. Gain insight to your child's lung health with our lightweight, portable Aluna device and the app. With this duo you can quickly measure lung health (FEV1 & PEF), track symptoms, log medication in minutes.

This release was published on openPR.