Cern hopes to enable healthier, empowered lives

As of July 2020, there are over 79 million women in the US between 15-49 (source Center for Disease Control/CDC). According to the CDC, over 21 million women are affected Bacterial Vaginosis (BV) (source). 

The Cern Device’ mechanism of action may prove efficacious for both yeast as well as bacterial infection which at times may occur simultaneously.

According to the CDC, over 21 million women are affected by Bacterial Vaginosis (BV) (source). Approximately 16% are considered symptomatic and are likely under a physician’s care Those that are asymptomatic remain at risk.  The Cern Device may have the ability to not only be used as a therapeutic but may be of value prophylactically as well. 

With regard to Fungal Vaginitis (Yeast Infection), the CDC reports an estimated 75% of women will have at least one episode of Vulvo Vaginal Candidiasis or VVC, 40%–45% will have two or more episodes. 10-20% of women with Vulvovaginal Candidiasis (yeast infection) can be classified as complicated VVC as well as recurrent which according to the CDC is four or more episodes per year, for which special diagnostic and therapeutic considerations are needed (source).

We are here to help the millions of women for whom drug based therapy may neither be effective nor appropriate and may be expanded to those who desire to avoid drug based treatment.

The Cern Device™ is designed to serve as an insertable vaginal device, enabling at-home treatment of fungal and bacterial vaginosis, without the need for oral or topical medications.  With that, we believe the Cern Device™ is the only patented Microbicidal Light device for these treatments, offering women a safe, convenient alternative for use at home when needed, as needed based on familiar symptoms.

^{*Images are computer generated demo versions. Product is still currently under development}

We believe we are serving a huge, unmet need

Vaginal infection can be painful, and overall uncomfortable. In fact, Bacterial Vaginosis is present in as many as 21 Million women, with about 16% of them being symptomatic under a doctor's care (source). The majority are undiagnosed, as symptoms may not be present or noticeable. The same technology is also relevant to fungal vaginitis or VVC. The CDC tracks recurrent fungal vaginitis, defined as 4 or more occurrences per year. CDC data indicates  as many as 12 Million women are recurrent under a doctor’s care, with perhaps 50% or more not responsive to treatment (source).  

Based on a National Science Foundation, I-Corp Discovery program conducted by Cern through the University of California at Irvine, Cern was made aware through interviews with physicians that many women do not wait until their fourth occurrence to seek treatment suggesting that CDC data on yeast infections, significant enough to warrant treatment by a doctor may be significantly under-reported and the potential market is significantly greater than statistics may suggest. 

The same device may have the ability to be used prophylactically and may be valuable to both women who seek to become pregnant so as to help avoid issues associated with bacterial vaginosis and pregnancy.  The Cern Device™ is also relevant to so many women who are immunocompromised where conventional drug based therapies may not be desired.

(source, source) 

With that, we believe the current standards of care are neither effective nor appropriate for all. In our view, current systemic antifungal, and antibiotic drugs deliver perhaps 2% of the medication to the targeted area. The remainder must be metabolized through the patient's organs. Not to mention, clinicians and patients alike are concerned with overuse of drugs - whose efficacy can be diminished as pathogens develop resistance (source, source, source).

(source, source, source)

Introducing Microbicidal Light

The Cern Device™ is designed to be available as a prescription, as it is intended for use at home as needed based on recurrent symptoms - so as to avoid having to repeatedly visit a physician. Instead, the physician will be able to make remote consults, and monitor device usage and outcome. 

^{*Images are computer generated demo versions. Product is still currently under development}

Shaped and sized similar to a tampon, the Cern Device™ can be inserted for 20-40 minutes - aiming to effectively control both bacterial and or fungal infection based on dosage. In a healthy microbiome, naturally occurring yeast and bacteria reside together in a symbiotic relationship. Infections tend to occur when an imbalance or dysbiosis occurs. 

The Cern Device™ will utilize specific wavelengths of light to disrupt the pathogen’s DNA - inhibiting the cell's ability to reproduce - and thus, will be able to restore the microbiome to a state of symbiosis.

^{*Images are computer generated demo versions. Product is still currently under development}

The FDA is familiar with low-level microbicidal light and its mechanism of action, yet surprisingly, we don’t think they’ve seen products on the market today for this application. Cern believes this creates what many view as a new white space opportunity, which Cern has identified, received patents for, and is addressing.

^{*Images are computer generated demo versions. Product is still currently under development}

We think Cern is more than an alternative 

In fact, we believe it can solve key issues in women’s health and potentially disrupt a large and growing FemTech market.

The global FemTech Market Size accounted for $46.3 Billion in 2021 and is projected to grow an average CAGR of 13.3% from 2020 till 2025. That means it could reach $79.4 billion by 2030 (source).

(source, source)

To us, our key differentiators when it comes to market penetration is that our device will potentially be: 

• A Non-Drug, avoiding negative drug interactions
• Science-Based Reactive Oxygen Species (“ROS”)
• A combatent for “Superbugs”
• Potential for use pre-pregnancy
• May address a significant need amongst  immunocompromised
• Platform for Telemedicine

On track to helping women everywhere

Cern is patented having received both utility and design patents in the US with international patents now filed with an ever-expanding IP portfolio evolving. Cern has also received independent review confirming Freedom to Operate and is being acknowledged as what may be a significant break-through for women’s health.  

^{*Images are computer generated demo versions. Product is still currently under development}

Here’s a look at some of our other milestones:

• Established a Board of Directors with prominent leaders in healthcare
• Compelling Approach: Selected to present at the International Society for the Study of Vulvovaginal Disease (ISSVD) XXVI World Congress (source)
• Patented (Utility and Design) with International Patents Filed
• Freedom to Operate indicates Cern may be unique and operate unfettered
• Trademarks with additional patents pending
• LA BioStart Life Science Development Program
• FDA Pre-Submission (Denovo 510K)
• Independent Market Assessment: Innovation Institute 
• Hospital/Healthcare Provider Interest
• Corporate Interest from organizations such as Medtronic / Bayer AG / J&J 
• In-vitro: OakCrest Inst. of Science (Los Angeles)
• In-vivo “Safety” Ovine model
• Univ of Georgia review of Cytology
• Ex-vivo Cytotoxicity/Dose Response: LSU School of Medicine
• National Science Foundation / UC Irvine: I-Corp Customer Discovery validating both need and interest of both clinicians (prescribers) and women (user)

We think women’s health should be more inclusive, and accessible

At Cern, we feel we are unique in our approach of:

• Leveraging low level microbicidal light in the visible spectrum
• Potentially mitigating pathogens associated with fungal and bacterial vaginosis through the mechanism of reactive oxygen species
• All done without drugs

Plus, we feel that the interest shown by both users and clinicians indicates there is a significant ready market of those interested in using the device, as well as those interested in prescribing the device. 

^{*Images are computer generated demo versions. Product is still currently under development}

Overall, we believe there isn’t another product on the market like the Cern Device™, especially one that’s been filed and granted extensive IP. 

Join us, and invest in what we believe will be a revolution in women’s health!