Breathe Better™

Our Story

started with a global pandemic

Why We Developed M21®

Adjusting to mask-wearing mandates

Historically in the United States, mask-wearing (“masking”) was only on the minds of select individuals, primarily healthcare workers and people with certain medical conditions. However, in early 2020, our world was turned upside down with unprecedented lockdown, quarantine, and masking mandates.

As part of a global effort to help stop the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus), which causes the COVID-19 disease, government agencies from the United States and around the world either recommended or required mask-wearing in public spaces.1,2 By the end of 2021, an estimated 4.5 billion people worldwide (nearly 60% of the world population) were confronted with a face mask obligation.2,3

As mask-wearing became more and more commonplace, at first voluntarily and then due to enforced mandates, the inventors of M21® noticed that face masks were being blamed for an array of health issues. People complained of experiencing skin irritations/infections, shortness of breath, dizziness, headaches, and drowsiness while masking, especially for long periods of time.4-7 People, therefore, were not wearing masks properly – wearing below the nose rendering the mask ineffective. These issues raised the vexing question: Is mask-wearing healthy or can masking compromise an individual’s health?

Understanding the Problem

Are face masks compromising our health? 

At the height of the global COVID-19 pandemic, we knew something was not right and there was no indication that mask-wearing mandates would be lifted anytime soon, so we sought to understand the issues in more detail.

As we started paying more attention to news about face masks, we noticed that contradictory reports about their safety emerged. For example, during a controlled study at Stanford University, students demonstrated a 5-20% drop in oxygen (O2) concentrations with mask-wearing.8 On the other hand, other studies reported minimal O2 drops or insignificant carbon dioxide (CO2) rises while masking.9,10

The more we tried to understand the issues, the more questions we had. Therefore, we sought answers to our questions by taking a scientific approach to understanding the potential causes of the health issues reported with mask-wearing.

Although we suspected that a combination of O2 deprivation and CO2 toxicity was the main culprit, we wanted to know for certain. The only way to prove our hypothesis was to conduct experimental studies. Therefore, we performed several experiments to measure O2 concentrations and CO2 levels during mask-wearing with N95 and surgical masks.

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Our Solution

A two-chambered face mask design

Based on our research, we understood why traditional face masks were never intended to be worn for extended periods. As the next phase of our journey, we asked: What can be done to increase the amount of new (fresh) O2 that individuals inhale and, more importantly, ensure that individuals do not continuously inhale their own (exhaled) CO2 while masking? The answer to this question birthed the creation of the world’s first two-chambered mask design with Directional Airflow Technology™—M21® Mask and M21+® Mask Insert. Our M21 products are purposefully designed to support the natural breathing process for humans by allowing wearers to breathe O2 in through the nose and CO2 out from the mouth. We received “undeniable patentability” on all product claims from the international patent office, under the three main criteria for examination: (1) Novelty, (2) Inventive Step, and (3) Industrial Applicability. Thus, we are proud to offer the world a novel, face mask design that enables every wearer to Breathe Better.

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Supporting Scientific References
  1. Zhang YSD, Young Leslie H, Sharafaddin-Zadeh Y, et al. Public health messages about face masks early in the COVID-19 pandemic: perceptions of and impacts on Canadians. J Community Health. 2021;46(5):903-12. Epub 2021 Feb 20.
  2. Masks4All [Internet]. What Countries Require Masks in Public or Recommend Masks? Available from: https://masks4all.co/what-countries-require-masks-in-public/. Accessed 2024 Aug 27.
  3. Kisielinski K, Wagner S, Hirsch O, et al. Possible toxicity of chronic carbon dioxide exposure associated with face mask use, particularly in pregnant women, children and adolescents – A scoping review. Heliyon. 2023;9(4):e14117.
  4. World Health Organization. Advice on the use of masks in the context of COVID-19. Interim guidance. 2020 Jun 5. WHO Reference Number: WHO/2019-nCov/IPC_Masks/2020.4.
  5. Fikenzer S, Uhe T, Lavall D, et al. Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity. Clin Res Cardiol. 2020;109(12):1522-30.
  6. Kisielinski K, Giboni P, Prescher A, et al. Is a mask that covers the mouth and nose free from undesirable side effects in everyday use and free of potential hazards? Int J Environ Res Public Health. 2021;18(8):4344.
  7. Al-Allaff RGM, Al-Taee SMY, Baker STD. Some immunological impacts of face mask usage during the COVID-19 pandemic. Pak J Biol Sci. 2021;24(9):920-7.
  8. Myers A. COVID-19 Prompts Stanford Engineers to Rethink the Humble Face Mask. Stanford Report. April 14, 2020. Available from: https://news.stanford.edu/stories/2020/04/stanford-researchers-reengineer-covid-19-face-masks. Accessed 2024 Jul 14.
  9. Lubrano R, Bloise S, Testa A, et al. Assessment of respiratory function in infants and young children wearing face masks during the COVID-19 pandemic. JAMA Netw Open. 2021;4(3):e210414.
  10. Shein SL, Whitticar S, Mascho KK, et al. The effects of wearing facemasks on oxygenation and ventilation at rest and during physical activity. PLoS One. 2021;16(2):e0247414.