$511,724 raised out of $20,000
Overview
Platform
Indiegogo
Backers
111
Start date
May 06, 2020
Close date
May 07, 2020
Concept

Superior Respiratory Protection

Story

The B2 is a reusable respirator that filters 99% of common contaminants and reduces filter cost and waste by half. Unlike existing consumer masks, the B2 features a flexible, patent-pending facepiece that provides superior protection and comfort. The B2 is the culmination of 4+ years of design and development, and is now ready to be mass produced.

Awards & Recognition

We are proud to announce that we’ve been selected as a PRI recipient from the Venn Foundation and as winners of the Protolabs Cool Idea Award

Drawbacks of Existing Masks

Each of these mask types suffers from the following three issues.

Poor face seals: Existing masks don’t always achieve an adequate seal on the face, resulting in decreased protection [1]

High waste and cost: N95 masks are intended to be changed regularly, which is inconvenient and expensive in many use cases

Scalability of manufacturing: Face masks cannot be produced fast enough to meet the demands of both the health care system and general public

Is the B2 mask right for me?

The B2 Mask is designed to provide excellent protection to those who are most at risk from airborne contaminants, whether due to increased environmental exposure or preexisting conditions. People who may benefit from improved protection include:

 The B2 Mask is not recommended for those who need protection against oil-based particles or chemical vapors.

B2 Mask: Superior Breathing Protection

The B2 Mask addresses the problems with existing masks and offers clear advantages over competitive options. These benefits include:

  •  Comfortable, Airtight Seal: Flexible facepiece achieves Fit Factor above 100
  •  High-Efficiency Filters: 99% protection from contaminants down to .1 micron
  •  Reduced Cost & Waste: Scalable filter technology reduces waste and cost
  •  Durable, Reusable Design: Easily cleanable design provides years of use
 

Comfortable, Airtight Seal

 

The B2’s patent-pending facepiece provides excellent comfort and protection compared to existing face masks. The facepiece is constructed from FDA-compliant materials, folds in half for easy storage, and can accommodate a wide range of face shapes and sizes because of its flex-hinge design.

 

High-Efficiency Filters

The B2 Mask uses the latest advances in filter technology that provides 99% filtration against a range of airborne contaminants down to .1 micron.

 

 Particle Filtration Efficiency*: >99.5% at 32 LPM – tested according in accordance to TSI8130 NaCl .1 micron particle size

* Due to supply chain shortages, our 1st generation filters will not include melt-blown polypropylene. This does not compromise filtration level except for extended use in industrial settings. Refer to the following section regarding filter change frequency.

In addition to providing stellar protection, the B2’s filters are easy load with a simple twist-to-lock filter cap.

Reduced Filter Cost and Waste

 

B2 Mask uses the smallest, most affordable high-efficiency filters on the market. During normal use, the B2 filters offer 40-50 hours of protection before filtration efficiency starts to drop. How often you change them filters depends on how you use your B2 Mask. See the recommendations below:

  •  Low use (occasional use while going out in public): Change every 2-3 weeks
  •  Medium use (wearing consistently over the course of a week): Change weekly
  •  High use (wearing for multiple hours a day):  Change daily for best protection

Every B2 comes pre-packaged with 10 filters, or five filter changes (2 filters/change). You can purchase additional filters at the end of the campaign starting at $14 or only $2.30/month for 6 months of protection for standard users.

The B2’s filters are small and can be produced more rapidly than N95 masks. This means the B2 can scale to meet the demand of people around the world in search of high-quality breathing protection.

Durable, Reusable Design

 

 

The B2 Mask is designed to provide years of comfortable, sustainable protection. The B2’s facepiece is constructed from durable materials and is easy to clean by hand or in a dishwasher. The overlay can be cleaned by hand or in the washing machine for easy maintenance. 

Testing & Regulatory Details

The B2 Mask is designed to offer best-in-class protection for daily use. Our team is working with 3rd-party experts to test and validate the two critical facets of mask protection: filtration efficacy and anthropometric fit factor.

Filter Testing 

We’ve selected a high-efficiency, electrostatically charged filter media that removes >99% of particulate matter down to .1 micron. The material has been tested for particulate filtration efficiency at Superior Felt and Filtration and at Nelson Labs.

Fit Factor Testing

A well maintained face seal is critical to achieving high levels of protection. Initial tests using the FDA-approved Portacount 8030 system showed the B2 Mask had an average Fit Factor over 100 – the level required for NIOSH certification. Breathe99 is partnering with leading human factors design firm Anthrotech to conduct additional face fit testing with 25 participants that fill the NIOSH panel for face shape and head size 

 

 

Regulatory Approval

We have designed the B2 Mask to comply with NIOSH N99 standards per 42 CFR Part 84, but the B2 Mask has not yet gone through the regulatory approval process with either NIOSH or the FDA. In the short term, Breathe99 will work to receive through the FDA to receive Emergency Use Authorization (EUA).

Breathe99: Yesterday

The idea for a protective, lightweight, and stylish mask first took shape almost 6 years ago, while Max – our CEO and mechanical engineer – was living in Singapore.

Since then we’ve gone through hundreds of sketched concepts, several major prototype iterations, and validated our design with quantitative flow testing. The result is a design ready to ramp up in production very quickly and bring high-quality protection to people around the world.

Breathe99: Today

Now we’re a group of engineers and designers with a passion for public health and technology. Our team has over 10 years of experience in the medical device industry, and our advisers add extensive knowledge and experience in product development, atmospheric science, and business strategy.

  • Max Bock-Aronson – CEO, Mechanical Engineer
  • Coleman Rollins – Full-Stack Engineer
  • Julia Duvall – Product Designer
  • Prashan Subasinghe – Mechanical Engineer
  • Derek Mathers –  Sales & Business Development
  • Emma Gavala – Marketing & Business Development

Healthy Together: The Breathe99 Mission

Our mission is to make the highest quality public health products available to everyone. We believe that each of us plays a vital role in protecting our neighbors and communities, and that it is through collaborative action we can create a healthier, more equitable world. 

Key Partners

We’ve partnered with industry-leading experts in molding, filtration technology,  and soft goods design and production. Each of these key partners are based in the US and are either ISO 13485 or ISO 9001:2015 certified. Partnering with these businesses ensures we can ramp up quickly and deliver the highest quality product on-time to our backers.

We also have partnered with other leading groups including the Venn Foundation, Anthrotech, and Worrell Design to ensure we are achieving the highest of quality as we seek to further our social mission of making high-quality public health products available to all.

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