CERN Corporation

Microbicidal Light Treatment for Fungal & Bacterial Vaginosis

CERN Corporation

Microbicidal Light Treatment for Fungal & Bacterial Vaginosis

Coto de Caza, CA
Health Tech
Cern Corporation, Inc. is pre-revenue. We are developing and commercializing an effective, non-drug therapeutic treatment for fungal and bacterial vaginosis. The Cern Device™ uses low-level microbicidal light to mitigate pathogens associated with yeast and bacterial vaginosis in order to promote a healthy microbiome without the need for drugs. The small, device, similar in size to a tampon, is designed for use at home, as needed when needed, based on familiar symptoms. Development to date includes supportive work performed in vitro, ex vivo as well as in vivo (safety). Current work in microbiology expands our understanding of microbicidal light and it's effects on key pathogens associated with yeast and bacterial indications. Results from test data will be used to develop devices suitable for human use which will be validated in an early feasibility study focused on mechanism of action as efficacious in a human model. Cern has been granted utility and design patents along with trademarks. Cern has also received supportive 3rd part assessment specific to Freedom to Operate. Cern Corporation is currently in the pre-revenue and prototype/testing stages of development.

$193,562

raised
20
Investors
$12M
Valuation
$0.80
Price per Share
$500.00
Min. Investment
Common
Shares Offered
Equity
Offering Type
$1.07M
Offering Max
Reg CF
Offering

$193,562

raised
20
Investors
$12M
Valuation
$0.80
Price per Share
$500.00
Min. Investment
Common
Shares Offered
Equity
Offering Type
$1.07M
Offering Max
Reg CF
Offering

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Reasons to Invest

  • We believe the Cern Device™ is the only patented Microbicidal Light device for the treatment of fungal, as well as bacterial vaginosis.
  • The global FemTech Market Size accounted for $46.3B in 2021 and is projected to grow an average CAGR of 13.3% from 2020 till 2025 (source).

  • Cern has received both utility and design patents along with independent review confirming Freedom to Operate. Our technology and application have been acknowledged by independent science and healthcare experts as what may be a significant break-through for women’s health.  






Overview


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




The Problem


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)

The Solution


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







The Market


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

Our Traction


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)








Why Invest


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!




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Offering Summary


Company

:

Cern Corporation

Corporate Address

:

31891 Via Oso, Coto de Caza, CA 92679

Offering Minimum

:

$10,000.00

Offering Maximum

:

$1,070,000.00

Minimum Investment Amount

(per investor)

:

$500.00











Terms


Offering Type

:

Equity

Security Name

:

Common Stock

Minimum Number of Shares Offered

:

12,500

Maximum Number of Shares Offered

:

1,337,500

Price per Share

:

$0.80

Pre-Money Valuation

:

$12,006,620.00











*Maximum number of shares offered subject to adjustment for bonus shares. See Bonus info below.

Voting Rights of Securities Sold in this Offering

Voting Proxy. Each Subscriber shall appoint the Chief Executive Officer of the Company (the “CEO”), or his or her successor, as the Subscriber’s true and lawful proxy and attorney, with the power to act alone and with full power of substitution, to, consistent with this instrument and on behalf of the Subscriber, (i) vote all Securities, (ii) give and receive notices and communications, (iii) execute any instrument or document that the CEO determines is necessary or appropriate in the exercise of its authority under this instrument, and (iv) take all actions necessary or appropriate in the judgment of the CEO for the accomplishment of the foregoing. The proxy and power granted by the Subscriber pursuant to this Section are coupled with an interest. Such proxy and power will be irrevocable. The proxy and power, so long as the Subscriber is an individual, will survive the death, incompetency and disability of the Subscriber and, so long as the Subscriber is an entity, will survive the merger or reorganization of the Subscriber or any other entity holding the Securities. However, the Proxy will terminate upon the closing of a firm-commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933 covering the offer and sale of Common Stock or the effectiveness of a registration statement under the Securities Exchange Act of 1934 covering the Common Stock.

Investment Incentives and Bonuses*

Time-Based:

Friends and Family Early Birds

Invest within 2 weeks + 72 hours and receive 10% bonus shares.

Early Bird Bonus

Invest within the next two weeks and receive 5% bonus shares.

Amount-Based:

$5,000+ | Tier 1

Invest $5,000+ and receive 3% bonus shares

 $10,000+ | Tier 2

Invest $10,000+ and receive 6% bonus shares

$20,000+ | Tier 3

Invest $20,000+ and receive 10% bonus shares + personal Zoom call with founder/CEO

Loyalty Bonus:

A Loyalty Bonus will be offered to Friends and Family for 5% bonus shares. 

*All perks occur when the offering is completed.

The 10% StartEngine Owners' Bonus

CERN Corporation will offer 10% additional bonus shares for all investments that are committed by investors that are eligible for the StartEngine Crowdfunding Inc. OWNer's bonus.

This means eligible StartEngine shareholders will receive a 10% bonus for any shares they purchase in this offering. For example, if you buy 100 shares of Common Stock at $0.80 / share, you will receive 110 shares of Common Stock, meaning you'll own 110 shares for $80. Fractional shares will not be distributed and share bonuses will be determined by rounding down to the nearest whole share.

This 10% Bonus is only valid during the investor's eligibility period. Investors eligible for this bonus will also have priority if they are on a waitlist to invest and the company surpasses its maximum funding goal. They will have the first opportunity to invest should room in the offering become available if prior investments are canceled or fail.

Investors will receive the highest single bonus they are eligible for among the bonuses based on the amount invested and time of offering elapsed (if any). Eligible investors will also receive the Owner’s Bonus in addition to the aforementioned bonus.

Irregular Use of Proceeds

The Company might incur Irregular Use of Proceeds that may include but are not limited to the following over $10,000: Vendor payments. Salary payments made to one’s self, a friend or relative.

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Most recent fiscal year-end:
Prior fiscal year-end:
Total Assets
$8,964.00 USD
$8,834.00 USD
Cash And Cash Equivalents
$8,964.00 USD
$8,834.00 USD
Accounts Receivable
$0.00 USD
$0.00 USD
Short Term Debt
$37,208.00 USD
$139,896.00 USD
Long Term Debt
$0.00 USD
$0.00 USD
Revenues And Sales
$0.00 USD
$0.00 USD
Costs Of Goods Sold
$0.00 USD
$0.00 USD
Taxes Paid
$0.00 USD
$0.00 USD
Net Income
-$43,711.00 USD
-$73,704.00 USD

Risks

A crowdfunding investment involves risk. You should not invest any funds in this offering unless you can afford to lose your entire investment. In making an investment decision, investors must rely on their own examination of the issuer and the terms of the offering, including the merits and risks involved. These securities have not been recommended or approved by any federal or state securities commission or regulatory authority. Furthermore, these authorities have not passed upon the accuracy or adequacy of this document. The U.S. Securities and Exchange Commission does not pass upon the merits of any securities offered or the terms of the offering, nor does it pass upon the accuracy or completeness of any offering document or literature. These securities are offered under an exemption from registration; however, the U.S. Securities and Exchange Commission has not made an independent determination that these securities are exempt from registration.


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