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Grand Opening of Rongxiang Xu Bioscience Innovation Center

By Rick Shope

Flashback to Childhood: My father was a professor and researcher of veterinary virology at the University of Minnesota. I remember as a kid visiting his lab. There was always a purplish blue glow from the ultraviolet blacklight to keep the lab bench area sterile. UV light is harmful to living cells. That makes sense. But I was always mused by the glow…isn’t UV invisible to the human eye? Well, yes it is! The glow was the spillover into visible wavelengths of the near ultraviolet. It turns out that those wavelengths ALSO have microbicidal properties, without harm to human cells. And there begins a tale of innovation!

There is a Greek word eupheme (pronounced euphemy) that refers to the problem in life when we are faced with a traumatic, or even tragic event. How do we draw the good from a bad situation? Gregg Klang was faced with such a tragic event with the death of a friend’s son due to hospital acquired infection (HAI), which is the phenomenon of being in a hospital for treatment, and ending up catching something serious in the hospital!

As recently as March 21, 2023, the Washington Post reported that a deadly fungus, Candida auris, is spreading at an alarming rate in U. S. health facilities. “It’s just one of the infections acquired in health-care settings that is ripe for transmission because patients are on invasive devices and are susceptible to infections healthy people do not contract. There’s a wide range of other pathogens — from methicillin-resistant Staphylococcus aureus to E. coli bacteria that cause urinary tract infections — that are more rampant.”

When tragedy struck so close to home for Gregg, it spurred him to contemplate what might be done to improve the situation in some way. He is not a microbiologist; he’s a business guy with an MBA from Pepperdine. His focus was on the use of microbicidal light in the fast acting, ultraviolet range as a secondary measure for hand cleanliness. Whoa! UV light? Really? Okay, to be precise, it’s the NEAR-ultraviolet wavelengths. He learned that there were more nascent wavelengths of light in the visible spectrum which had microbicidal qualities, yet did NOT affect underlying tissue. It just so happened, he’d read how these visible light wavelengths could have an effect on yeasts and bacteria associated with both candidiasis in the vagina (vaginal yeast infection) and bacterial vaginosis (BV). Time to “Pivot”.

Gregg ended up inventing a novel, non-drug treatment which may be efficacious not only for yeast infection, but for bacterial vaginosis as well, based on the application of low-level, microbicidal light...and then went on to start a Femtech company, Cern Corporation to bring the device (The Cern Device™), to market!

There is nothing more irritating, annoying, itching, burning, and maddening than a vaginal yeast infection, also known as vaginal candidiasis. Don’t take my word for it. Ask the over 15 million women who seek treatment for it every year (as reported by the CDC)! Which most likely understates it because millions of women head for the drugstore for over-the-counter doses of Monistat (available as miconazole cream, ointment, ovule or suppositories). Over 12 million women are classified as “recurrent” sufferers of yeast infections.

All this misery is caused by a fungus called Candida! According to Dr. Shmuel Shoam at Johns Hopkins University, the most important species is C. albicans, which causes nearly all mucosal candidiasis and is generally the most common cause of invasive disease. However, epidemiology varies by geographical region, the extent of antifungal exposure and local hospital epidemiology. Other species of importance are C. glabrata (also known as Nakaseomyces glabrata), C. parapsilosis (especially in association with implanted devices), C. tropicalis, C. krusei (also known as Pichia kudriavzevii), C. guilliermondii, C. kefyr, C. lusitaniae and C. auris (which is associated with multidrug resistance and healthcare facility outbreaks). What a family!

By the way, Candida species are NOT to be confused with the commonly known yeast, Saccharomyces cerevisiae, a species of fungus first found growing on grapes, that we use to bake, cook, and brew with.

With regard to bacterial vaginosis or “BV”, there are over 3.5M women in the US under clinical care. When symptoms appear, it’s important to get clinical care as soon as possible which generally results in a prescription for antibiotics. Diagnosing BV can be difficult as only 16% of those who are afflicted are symptomatic. The other 84% are asymptomatic with no obvious symptoms which can present issues complications to both mother and child during pregnancy.

Most are familiar with issues associated with overuse of antibiotics and antifungals which may include increased drug resistance. It is also important to understand is that certain ESSENTIAL bacteria, that is GOOD bacteria such as lactobacillus are affected by these systemic drug based treatments. Without the appropriate balance of native yeasts and bacteria working together, a yeast and or bacterial indication will occur. In some cases, they appear together. A technology which has the ability to mitigate both yeast and bacterial issues, while minimizing any affect of key native and essential species, is a significant benefit.

Everyone knows that hand washing is a critical factor to prevent contamination and the spread of pathogens within healthcare facilities. Gregg started learning about microbicidal light and the potential application to use directly on hands to add a measure of cleanliness beyond washing.

So we know UV light is harmful to life. Toxicity of UV radiation varies with wavelengths and exposure doses. Which is why earthlings depend on a healthy ozone layer in the upper atmosphere to screen out the deadly UV-C (100-280 nanometers), and most of the harmful UV-B (280-315 nanometers). Only the more benign UV-A (315–400 nm) gets through easily. The concern is related to the effect of UV light on cell viability, DNA structure, and DNA damage repair mechanisms. So, the use of true ultraviolet light to sterilize hospital and areas makes sense. But it makes NO sense to expose human hands to those wavelengths.

However, the VISIBLE near ultraviolet wavelengths, that purplish blue glow in the 400-470 nanometer range, have been observed to have microbicidal properties. The blue light causes excitation within the microbe and in the medium around the microbe, which leads to the release of reactive oxygen species, and that’s what curtails the cell’s ability to reproduce and subsequently die off. Especially important is that visible blue light has exhibited the ability to inactivate fungal and viral pathogens and, multidrug-resistant bacteria as well as bacterial biofilms, while when dosed properly, is SAFE when exposed to human tissues.

All of this came together in Gregg Klang’s mind, but so what? Gregg thought, you know, “Innovation can come from anywhere, with a common thread being curiosity, need, interest, and drive to get "it" done.” What if he could devise a way to address a significant "unmet need", that being the development of an effective, non-drug treatment, devoid of the negative effects of systemic antifungals/antibiotics, applicable to BOTH yeast as well as bacterial indications (which often occur together) and avoiding development of drug resistant strains associated with antibiotic or antifungal chemo therapies.

Gregg’s response was to begin development of a therapeutic device that could radiate low level, microbicidal light in the visible spectrum to the affected areas of the yeast and bacterial vaginosis.

He submitted an abstract for review by a healthcare technology joint venture comprised of three major healthcare organizations– and indeed they were excited about the idea! Gregg had the business insight to get the idea patented!

Now the fun began! To take the concept and translate it into practical reality! What happened next was the turning point for success: participation in the LA BioStart Bootcamp for bioscience entrepreneurs. Gregg had met a PhD alumni from LA BioStart who recognized the significance of what Gregg was embarking on. Introductions were made and Gregg was selected in to the 5th cohort of the bootcamp in the summer of 2019. LA BioStart provides a group of experts who mentored and worked with participants from startup phase to patents to clinical trials and to bringing a product to market. For Gregg, it was a treasure trove of networking. He leveraged both the knowledge gained and the contacts made to emerge with a team and a startup concept to form a Femtech company, called CERN Corporation (cerndevice.com). Now with a viable design and a team of expert clinicians, CERN is preparing for prime time. The CERN Board is comprised of esteemed researchers in the field, such as Dr. Melanie Santos, MD, UroGynecologist, Medical Director of Pelvic Health at Providence St. Jude Medical Center, Hyunsook Park, Ph.D. Microbiology, Professor of Microbiology at Cal State Los Angeles, and Todd Peterson, PhD. Microbiology, Founder and Principal of GenApex Bio, a life sciences consulting, investment, and board practice company based in Coronado, California.

The CERN Corporation team plans to initiate clinical trials later this year and hopes to bring the device to market in the near future.

Related Literature

Microbicidal Effects of Blue Light
Leanse, L.G., dos Anjos, C., Mushtaq, S., Dai, T. Antimicrobial blue light: A ‘Magic Bullet’ for the 21st century and beyond?, Advanced Drug Delivery Reviews, 180, 114057 (2022), https://doi.org/10.1016/j.addr.2021.114057

Tsutsumi-Arai, C., Arai, Y., Terada-Ito, C. et al. Microbicidal effect of 405-nm blue LED light on Candida albicans and Streptococcus mutans dual-species biofilms on denture base resin. Lasers Med Sci 37, 857–866 (2022). https://doi.org/10.1007/s10103-021-03323-z

Blue Light Therapy
Pavie, M.C., Robatto, M., Bastos, M. et al. Blue light-emitting diode in healthy vaginal mucosa—a new therapeutic possibility. Lasers Med Sci 34, 921–927 (2019). https://doi.org/10.1007/s10103-018-2678-3

Robatto, M., Pavie, M.C., Garcia, I. et al. Ultraviolet A/blue light-emitting diode therapy for vulvovaginal candidiasis: a case presentation. Lasers Med Sci 34, 1819–1827 (2019). https://doi.org/10.1007/s10103-019-02782-9

Stasko, N., Kocher, J.F., Annas, A. et al. Visible blue light inhibits infection and replication of SARS-CoV-2 at doses that are well-tolerated by human respiratory tissue. Sci Rep 11, 20595 (2021). https://doi.org/10.1038/s41598-021-99917-2

Let there be Light, BLUE light!

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