Tom Lendvay is a physician, surgeon, entrepreneur, innovator, researcher, and professor. Whether treating pediatric patients, supporting NASA through telerobotics, or aiding the Department of Defense in virtual reality simulation, Dr. Lendvay is always at the forefront of science and technology. This is where he operates, so to speak.
In the same vein, Singletto was founded with his colleague, Dr. James Chen, with a singular, big mission: use proven science and technology, along with new research, to create singlet oxygen solutions to fight Covid-19 and other pathogens.
Since April, he has been leading a team of researchers and collaborating with fellow scientists and researchers around the world in a World Health Organization consortium.
In this piece, we talk to Dr. Lendvay about his role in the WHO consortium's groundbreaking DeMaND Study.
Q. First of all, talk about your relationship with Dr. Chen and how Singletto came to be.
A. Dr. James “Jim” Chen and I were connected via his daughter, Carolyn. I have known Carolyn since 2012 when she, as a medical student, worked with me at the University of Washington on testing a hypothesis that crowds of laypeople can assess the skills of surgeons as well as expert surgeons. We invented and developed crowdsourcing feedback and credentialing technology that led to the formation of CSATS, Inc. which was acquired by Johnson & Johnson in 2018. We had stayed in touch over the years. I have always gravitated towards ideas that go against the grain or against convention, and, as soon as I heard her neurosurgeon father Jim's hypothesis for a new way of disinfecting PPE (Personal Protection Equipment), I was all in. It was unconventional; it had the potential for global impact; and, it looked to be a simple, low-cost solution. I wanted to test the idea immediately.
Q. How did you and Dr. Chen become involved in the WHO consortium studying decontamination methods for masks and PPE?
A. Everything moved pretty quickly after my first conversation with Dr. Chen. Through a series of phone calls that day and week, we began making a path forward. We were quickly connected to the CDC's Special Viral Pathogens Unit, where we presented the idea of using Methylene Blue and light to decontaminate PPE. A presentation to the WHO Covid-19 Task Force then followed. It was soon recommended that the Methylene Blue method be tested in a WHO DeMaND study (Development of Methods for Masks and N95 Decontamination) via its consortium of labs being led by Dr. May Chu, of the WHO experts group for infection control and prevention for the COVID-19 epidemic. Since Dr. Chen and I had proposed this method, they asked us to conduct research out of Seattle Children's Research Institute, the primary research site for Seattle Children’s Hospital, for which I work. We quickly received funding for the Amazon Catalyst Award through the University of Washington's CoMotion innovation center. We also gained access to a virology lab and team at Seattle Children's.
Q. As a surgeon, talk to us about what you have seen in hospitals as far as mask and PPE use and then decontamination. What is currently being done or not done?
A. Well, there has clearly been a change in common practice since the PPE shortages began. There are simply not enough N95s to wear a new one with every patient. We are reusing masks and then using "hot zone" gear, when possible, for known coronavirus-positive patients or emergency surgeries where we don't know a patient's status. It's certainly not uncommon for healthcare workers to wear the same mask for an 8-10 hour shift. At first, instructions were given to place masks in brown paper bags after a shift. If they didn't look dirty, they would be re-worn three or so days later. Some health systems have access to decontamination methods like UV Light and Vaporized Hydrogen Peroxide; but, most around the country, and especially the world, can't afford these technologies. So, desperate times call for desperate measures. Some colleagues of mine at other hospitals are having a hard time even finding gear at all. There are so many desperate and unfortunate scenarios out there – not just in hospitals, but in nursing homes, dental offices, home health, and more.
Q. The DeMaND study has just been released to the public; how do you feel about this?
A. We first set out to test Methylene Blue as a low-cost alternative for decontamination. As we continued to witness its effectiveness against every virus we tested, including SARS-CoV-2, the consortium increasingly appreciated the potential of Methylene Blue and singlet oxygen technologies as new frontline options. The process didn't degrade masks the way hydrogen peroxide does, and it didn't require a special room without humans present like the hydrogen peroxide, UV light, and ozone decontamination methods. A health worker can just simply spray the mask and allow it to dry.
Further, our research teams were amazed by the ability of dye, light, and singlet oxygen to not only inactivate SARS-CoV-2 as a decontaminate but also as a preventative measure.
So, I am excited for the world to have access to these groundbreaking findings. Society wants better means for protection. People want to be able to take back their lives, gain some control, and live again. I think this study is an amazing step towards the actualization of such.
Q. What specific roles did you and your team play in collecting data for the DeMaND study?
A. We first conducted pre-experimentation research to determine the right concentrations of Methylene Blue. We also tested the six different masks to understand their make-up and how they would react to fluid.
We set the Standard Operating Procedures (SOPs) based on these elements and then varying labs worldwide, our lab included, tested according to the same standards and procedures.
We then conducted "kill curves," which means testing the amount of virus loss achieved by adding differing amounts of Methylene Blue, at differing lights, for different amounts of time.
To test inactivation (the scientific term for "killing" the virus), we took at least 100,000 viral particles for each experiment, placed them on a mask or coupon (i.e., cut out) of a mask, let it dry, added Methylene Blue in different concentrations, then exposed the masks to varying lights for varying times. After such exposure to light, we took the mask coupon, dunked it into a solution to shake off the virus particles, diluted it, then put the diluted solutions in multi-welled plates to measure infectivity, or more simply, how many of those wells would show either cell death (caused by virus) or healthy cells. We would start counting the wells and see healthy well after healthy well after healthy well. It was so exciting – it's hard to put into words really – to see the destruction of the virus over and over again.
Q. How long were you dedicated to such research?
A. Due to hospital capacity restrictions, we had to operate our tests in the evenings into the middle of the night and weekends. After the initial SOPs were set, we compiled data for roughly four months. We knew very quickly in our study, however, that the theory was working – Methylene Blue, serving as a light-activated dye, was inactivating COVID-19 and other viruses.
Q. In your opinion, what made Methylene Blue the perfect light-activated dye to include in the DeMaND study research?
A. Methylene Blue was, and still is, interesting to me for several reasons. First of all, it's affordable and widely accessible, which is why Dr. Chen suggested it. Second, medical professionals are familiar with it as its already being used in various medical capacities (often at much higher concentrations than required in this application). In fact, I have used Methylene Blue in my pediatric urology practice. In operating rooms, we often injected Methylene Blue intravenously to find where urine drains down from the kidneys within the bladder. I knew it was safe to use clinically because I had used it. But, the idea of using Methylene Blue as a light-activated dye to fight COVID-19, well, that was new and intriguing.
Q. What do you consider to be the biggest takeaways from the DeMaND study?
A. The study intended to determine if a light-activated dye, Methylene Blue, could decontaminate masks and PPE. The answer is YES. This means there is a new, lost-cost, accessible way for frontline workers around the world to begin safely decontaminating and reusing their masks and other PPE. Even if this were the only outcome of the study, it would be groundbreaking. But, clearly, there's more.
When pre-treated with Methylene Blue, left to dry, and then exposed to light, we found masks were able to provide an enduring effect, literally making it possible for potential wearers to benefit from constant protection from the virus during use.
Also, we were pleasantly surprised to find that even low light levels were leading to virus destruction.
And another big takeaway: when our co-researchers in Belgium injected virus in between mask layers and sprayed the outside of the mask, the light-activated Methylene Blue was still able to create enough singlet oxygen to destroy the virus. The mere presence of singlet oxygen near the virus leads to its inactivation (i.e., destruction). I think I can speak for everyone involved; this was a pleasant surprise.
Q. What else should we know?
A. A very small amount of Methylene Blue, applied and activated by light, creates enough singlet oxygen to destroy SARS-CoV-2. Light is everywhere; we have constant access to light sources. That's the beauty of this technology – light is all you need to charge the decontamination. We are leveraging millions of years of R&D from nature. There are photosensitizers and light-activated dyes, as well as singlet oxygen creation, all around us every day. We are harnessing this power to destroy pathogens.
Q. So, what is next? How do you take this successful study forward?
A. Through this one study, we had involvement from 13 different universities and laboratories consisting of 52 contributors performing these tests in four different labs against four different coronaviruses. The results were clear and consistent – Methylene Blue, plus light, is an effective new way to decontaminate masks and other PPE.
We are already conducting follow-up testing, both as part of the consortium and in our own Singletto labs, to inform additional applications of this technology. Further, Singletto aims to take this bench research and translate it to global industry. To that end, we are working with healthcare-focused and general consumer brands and manufacturers to provide solutions to their existing and future products, technology, and systems. This low-cost method, especially in its function as a perpetual decontaminate, needs to be in the hands of both frontline workers and average citizens yesterday.
Q. Finally, for people who haven't yet heard of Singletto, can you describe the following in one word:
-Singletto Culture: Optimistic
-Singletto People: Happy
-Singletto Technology: Disruptive
-Singletto Innovation: Simple
-Singletto Mission: Protection, if I had to pick just one word. We are leveraging nature (light and oxygen) against nature (viruses, bacteria, and pathogens) … and we are doing so to protect humankind.
The Infection Control & Hospital Epidemiology medical journal has published the peer-reviewed DeMaND study. Singletto’s Dr. Tom Lendvay served as Lead Author.
Mike Butler spent over two decades in leadership at Providence Health, growing such from a $2 billion organization to $25 billion. Upon recently retiring, Mike knew he wanted to find ways to continue impacting the lives and health of others. Now at Singletto, Mike is on a mission to bring the novel Singletto technology to market – in healthcare and beyond. But, it’s not just a passion project … upon learning about the technology, Mike felt a moral obligation to get it in as many hands as possible. More with recently retired Providence Health President Mike Butler…
Dr. Belinda Heyne was recently featured in a CBC piece covering the DeMaND study’s findings and the life-giving potential of dye and light.
The World Health Organization (WHO) just added Methylene Blue and Light as a supported Personal Protective Equipment (PPE) decontamination method in the “Rational use of personal protective equipment for COVID-19 and considerations during severe shortages” interim guidelines.