ActivAir – first wearable PPE with active air disinfection

ActivAir is the first PPE providing individual virus-free air supply for a person to inhale without the risk of contracting a disease. Built around a common baseball cap, this battery-powered device features an air disinfection chamber utilizing internal ultraviolet lights to destroy most airborne viruses/bacteria, including COVID-19 and influenza.

Boris Leschinsky is a medical device inventor and entrepreneur with 55 patents and 30 years of experience building complex medical devices and starting two successful companies.

LinkedIn Profile, Boris Leschinsky

Inhaling the COVID-19 virus is the main route of disease transmission. The only two protective measures are social distance and a facemask. Conventional fabric and paper facemasks provide limited protection even when fitted properly. They also limit our ability to speak, eat, and rink. Covering the face suppresses our non-verbal communication.

The problem is exacerbated greatly for immunocompromised people. An estimated 30 million Americans or 6.5% of adults and up to 30% of elderly, are immunocompromised to some extent. This group includes most cancer patients, AIDS patients, transplant recipients, and patients with a number of rare or inherited diseases. Many of these patients are in double jeopardy - not only they run a higher risk of contracting and dying from a COVID-19 or influenza infection, for many, COVID-19 vaccination is not effective. A recent study showed that only 17% of transplant recipients have developed antibodies in response to a COVID-19 vaccine. Inability to be vaccinated and a higher risk of serious consequences or even death is terrifying for these people. Many stay home and isolate themselves from society, but that has its own negative mental effects.

A solution offering strong COVID-19 protection is in high demand for immunocompromised patients.

The ActivAir is the only staged PPE actively disinfecting aerosolized virus and protecting from Covid-19 superspreaders, which is especially critical for the elderly, immunocompromised, and other vulnerable populations. The product is especially useful indoors, where the risk of encountering airborne COID-19 virus is high.

As the product does not require a close fit around the face, it eliminates the common complaints of breathing difficulties and sweaty skin under the facemask, improving ease of use and comfort. This makes ActivAir is easy to wear for a long time.

Close resemblance to a conventional baseball cap makes the product more acceptable for everyday use by a variety of users, including both men and women, young and old.

The product requires very little training if any, which is advantageous for the elderly and other users that may suffer from cognitive impairments.

Importantly, active air disinfection improves the peace of mind for the most vulnerable users and their caregivers, allowing them to leave the house and live a better, more fulfilling life even during a pandemic of this scale. 

A broad public good for this product is protecting the most vulnerable populations, such as the elderly and immunocompromised, against virus transmission. As the cost of the product is low (under $30 when mass-produced) and its use does not require much training, making the product widely accessible will reduce COVID-19 transmission regardless of which variant emerges as dominant. The product will also be useful in future pandemics as it protects against a broad range of airborne pathogens, not just the COVID-19 virus.

An immediate benefit of the product is to allow immunocompromised to continue or return to work without fear of contracting the COVID-19 virus.

Since the ActivAir is fully reusable, broad public protection can be achieved without polluting the environment, such as without discarding used face masks and replacement filters.

Manufacturing of the product does not include any exotic or hard-to-make components so it can be produced quickly and in large quantities and started in multiple locations in different countries.

Non-discriminatory distribution of the product may be achieved at low cost among broad cross-sections of the population, starting with the most vulnerable. 

While the ActivAir can be used by anyone, its most impactful use is expected for specific patient populations that are immunocompromised. These patients have a much higher risk of extensive damage or even death from COVID-19, while at the same time, these people are less likely to be adequately protected by a vaccine.

The use of the ActivAir will allow these people to significantly reduce the risk of contracting the disease, and as a result, will provide peace of mind when they leave the house and participate in daily activities. Ability to eat while protected by the product will encourage them to eat at restaurants again, which by itself will have a positive effect on the local economy. The product will also encourage other activities that these people have to avoid. Not only it will provide a measurable increase in economic activity by reducing “avoidance behavior”, but it will improve morale and address many of the mental problems associated with self-isolation.

In addition, the product will help immunocompromised to get back to work, providing further individual and societal benefits.  

30 million Americans and much more people globally are immunocompromised. These people will see the greatest benefit from the ActivAir to immediately allow them to resume most of their activities without the fear of contracting COVID-19, which in their case is especially worrisome as it may be deadly.

A target list of support groups is already identified for various cancer patients, transplant recipients, AIDS patients, elderly and their caregivers – with the aim of making them aware of the product once it is close to being available.

Independent interviews with a number of these people over the past few months confirm a strong interest in the product. Moreover, frequent air travelers, school teachers, and other potential users who are in close contact with other people during the day, have also expressed interest in the product as yet another layer of protection to build their confidence in a variety of daily activities.

Ease of manufacturing allows manufacturing in multiple locations at the same time.

Year 3 production will start at 1,000 units and increase to 50,000 by year end, with anticipated production of 500,000 – 750,000 units or more in year 4 and over 2M units in year 5.

Two versions of the product are envisioned. The initial version will be marketed with a limited claim of reducing virus presence in the air that the user breathes based on acquired laboratory data.

Once the first version of the product is introduced, a clinical study of immunosuppressed and/or very elderly patients will be conducted with the endpoint of detecting a reduction in hospitalizations and ICU stay not only from COVID-19 but also from other airborne pathogens. Although immunocompromised patients are a minority of the overall population at about 6.5%, they constitute a majority of ICU hospital admissions. The goal of the study will be to obtain a reduction of ICU admissions by at least 25% or more.

Initial discussions about the study design and its endpoints are already underway. It is estimated that no more than 200 patients are needed to be followed by about 6 months to achieve a statistically significant reduction in the endpoint of ICU admissions.

Once the study is complete, the second version of the product will be marketed with a clinical claim of protecting immunocompromised patients as a medical device, obviously following FDA approval and approval of other similar regulatory agencies in other countries.

The goal for the next year is to finish design, conduct lab tests, obtain regulatory registrations, initiate a clinical study, and determine a manufacturer for the product. To that end, the challenge is to increase the number of people working on the product and secure enough funding to complete the process. In terms of people for the project, Fresh Concept Design Corp., a small business developing ActivAir, will team up with the Northeastern University that has sufficient resources and expertise to complete the design.

The goal for the next two years is manufacturing and distribution of the product on a broad scale. As the design is not difficult to produce, we will contact many contract manufacturers of PPE and medical devices that have ample capacity to produce the device in large quantities.

We are seeking necessary funding to make this project a reality, including participation in this Challenge, as well as filing grant applications and seeking private capital from investors.

Fresh Concept Design Corp. is a small business providing engineering solutions and patent services to medtech industry. 

The Trinity Challenge may help with two critical needs of the project:

• facilitate connections with interested parties, and
• provide necessary funding for the project.

Moving along the application process, we have already benefited from The Trinity Challenge by establishing a valuable early connection with Northeastern University, a Trinity Member. We have developed a detailed collaboration plan on how to complete the development of this novel PPE product and jointly make it happen.

Developing a project plan for The Trinity Challenge moved us to outline a detailed budget, project plan and think through all challenges with final development, testing, and scaling up the production of the device. We now have a credible action plan that we hope will be supported by The Trinity Challenge to make it a reality. 

The ActivAir project has already benefited from participating in The Trinity Challenge even before the challenge results are determined. A significant realized benefit is establishing a close working relationship with Northeastern University (Dr. Mark Sivak, Associate Teaching Professor) which will provide critically needed access to additional talent and prototyping facilities to expand on personnel working on the project. Not only Dr. Sivak has access to additional technical resources, but he is also a core faculty member of the Center for Design and the 3D Specialist, which will be instrumental to create the best esthetic appearance for the product, a necessary component to assure broad market acceptance.

We hope to still connect with a suitable broad-scale manufacturer through The Trinity Challenge. Even if this connection is not established, we will seek an appropriate contract manufacturer, which we anticipate finding without much difficulty as the product is designed for ease of manufacturing.