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GET A PIECE OF CERN CORPORATION

Microbicidal Light Treatment for Fungal & Bacterial Vaginosis

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.

This Reg CF offering is made available through StartEngine Capital, LLC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

$422,177.90 Raised

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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ABOUT

HEADQUARTERS
31891 Via Oso
Coto de Caza, CA 92679

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.

TEAM

Annette M. Walker

Annette M. Walker

Board of Directors

Annette’s current position is President, City of Hope Orange County. An experienced healthcare executive with decades of experience that includes broad roles such as the President of Strategy for Providence St. Joseph Health, the third largest provider organization in the country. Annette has twice been recognized as one of the “Top 100” people in US Healthcare Modern Healthcare, the industry's leading trade journal. In her position at City of Hope, she is responsible for the development of an academic campus that will be Orange County, California's most advanced cancer prevention, treatment and research OP center and hospital. Annette is a solutions architect and nationally recognized strategist, thought leader and author/keynote speaker on transforming the health care industry.
Dr. David C. Lagrew

Dr. David C. Lagrew

Board of Directors

Chief of Service, Maternal Fetal Medicine at Hoag Hospital, Newport Beach, California. Past positions include Executive Medical Director, Women's Services at Providence St. Joseph Health where he manages development of the Ministry's Centers of Excellence and regional Clinical Institute of Women's Health within St. Joseph’s/Providence Health. David’s background also includes extensive executive experience having held the position of Medical Director at Long Beach Memorial as well as Medical Director, Women’s Services at Saddleback Memorial Medical Center prior to his appointment as Executive Director, Women’s Services at St. Joseph’s. David has recently retired from over 35 years of clinical practice and is regarded as a thought leader within the industry. David works part-time on Cern (2 hours/week).
Dr. Melanie Santos, MD FACOG, FPMRS

Dr. Melanie Santos, MD FACOG, FPMRS

Chief Medical Officer

Dr. Santos is a Urogynecology & Reconstructive Pelvic Surgery Specialist in Fullerton, CA with over 17 years of experience in the medical field. Dr. Santos graduated from Albert Einstein College of Medicine of Yeshiva University Medical School in 2004. She completed her residency in Obstetrics and Gynecology at Stanford University, followed by fellowship training for Pelvic Reconstructive Surgery at Emory University. She is affiliated with St. Jude Medical Center, within the Providence St. Joseph Healthcare system. Dr. Santos is Medical Director of Pelvic Health at St. Jude and on executive and national advisory boards for the Providence St. Joseph Women and Children's Institute, while also performing clinical work at St. Jude Heritage Women’s Center in Orange County California. Dr. Santos has considerable experience working in the medical device and pharma area as she consults to various entities and is a key-note speaker internal to Providence Health being responsible for communications with GYN related practitioners within the organization. She is also an advocate for women in medicine, developing the Women Physicans Group at her hospital as well as an annual summit for women in healthcare. Melanie works part-time on Cern (5 hours/week on Cern).
Hyunsook Park, PhD

Hyunsook Park, PhD

Director of Microbiology

Dr. Park is a Professor of Microbiology at California State University Los Angeles and has over twenty years of research experience on fungal pathogenesis. As a first-generation immigrant and a woman scientist, her research is naturally geared toward the direction of making a profound impact on improving women’s health. Using C. albicans as a model fungal pathogen, Dr. Park studied how human fungus recognizes the host environmental changes and initiates infection from a part of the normal microbiome. She also studied developing a combination therapy to overcome the limitation of the current antifungal agents to treat oral and vaginal candidiasis.Positions and Education: 2008 – Current, California State University, Los Angeles, 2002 – 2007, Fungal Pathogenesis Research Group at Harbor-UCLA Medical Center, 1998-2002. Ph.D. in Microbiology at Ewha Womans University, Korea. Hyunsook works part-time on Cern (20 hours/week on Cern).
Todd Peterson, PhD

Todd Peterson, PhD

Chief Science Advsior

Dr. Todd Peterson is the Founder and Principal of GenApex Bio, a life sciences advisory, investment, and board practice company based in Coronado, California. With over 35 years across academic research and industrial R&D, spanning molecular genetics, genomics, cell biology and synthetic biology engineering, his experience encompasses biotechnology, clinical diagnostics, life science research tools, drug discovery and industrial biotechnology markets, products, and technologies. Prior to GenApex Bio, Dr. Peterson was Chief Scientific Officer at the Allen Institute comprising foundational and applied research programs across its Brain Science, Cell Science, Immunology Institutes, and the Paul G. Allen Frontiers Group. Prior to the Allen Institute, Dr. Peterson was Chief Technology Officer at Synthetic Genomics (SGI) where he led an integrated team of scientists, engineers and informaticians to engineer diverse complex living systems. Before joining SGI, he led Synthetic Biology, Cloning and Protein Expression and Genomics R&D at Invitrogen/Life Technologies (now ThermoFisher), a global leader in life science research tools. Dr. Peterson has held industrial R&D leadership and bench scientist positions with increasing responsibilities at Genicon Sciences, Trega Biosciences, Hybritech, Gen-Probe and Immulok, focusing on technology development and product commercialization. Dr. Peterson was a postdoctoral fellow at the Max Planck Institute in Cologne, Germany, received his Ph.D. in Microbiology at the University of Southern California School of Medicine, and received his M.A. in Biological Sciences and his B.A. in Molecular Biology and Biochemistry from the University of California, Santa Barbara. Todd works part-time on Cern (5 hours/week).
Dr. Jack Sobel

Dr. Jack Sobel

Key Advisor

Dr. Sobel is a consulting Physician, Clinical Advisor, and one of the world’s foremost authorities on infectious diseases of the GYN tract. Dr. Sobel is a widely published and strongly funded physician-researcher. He has been involved in basic science, translational and clinical research since the inception of his Infectious Diseases Research Fellowship in 1976 at the NIH Laboratory of Clinical Investigation. He has served as a consultant for the U.S. Centers for Disease Control and Prevention’s special committee for recommending guidelines for the treatment of sexually transmitted disease. He has served as President of the Michigan Infectious Diseases Society from 1997 to 1999, a Member of the Infectious Diseases Society of America, and the National State President’s Committee and the Infectious Diseases Society of America, Practice Guidelines Committee. Jack works part-time on Cern (1 hour/week).
Vern Roohk, PhD

Vern Roohk, PhD

PhD, Physiology

Vern Roohk received his PhD in Physiology and Biochemistry from UC Davis in 1971 and did post-doctoral stints in bioengineering at USC and UCLA over the next few years. He has clinical experience as an ECMO (Extracorporeal Membrane Oxygenation) team member and lab supervisor with the original NIH-funded life-support team at UCI from the mid 1970s. Since then Dr. Roohk has served as lab director and/or IACUC chair for a number of both university and private pre-clinical testing facilities. Dr. Roohk has spent over 50 years in physiology associated with the development and testing of medical devices. Dr. Roohk co-founded American ImmunoTech, LLC, and Vestara in Costa Mesa, CA, which conducted sepsis research utilizing ultraviolet technology in an extracorporeal circuit. Dr Roohk is a recognized expert in Animal Physiology, and in vivo testing. Vern works part-time on Cern (2 hours/week).
Gregg A. Klang

Gregg A. Klang

CEO, President and Founder

Founder/Inventor of the Cern Device™. Gregg’s background is principally in business and marketing, with most of his career in technical sales and marketing for a Fortune 50 organization. Gregg has senior management experience, an extensive background in global sales and account management, and extensive training through the Boston Consulting Group. His interest in life sciences has generated multiple patents in the medical device space. In the summer of 2019, Cern Corp. was nominated to participate in the LA-BioStart program for CEOs who are bringing novel and disruptive technologies within the life sciences vertical to market. Education: MBA Pepperdine University, BA Economics University California, Irvine. Greg works full-time Cern.

TERMS

CERN Corporation
Overview
PRICE PER SHARE
$0.80
DEADLINE
Apr. 28, 2023 at 6:59 AM UTC
VALUATION
$12.01M
FUNDING GOAL
$10k - $1.07M
Breakdown
MIN INVESTMENT
$500
MAX INVESTMENT
$1,070,000
MIN NUMBER OF SHARES OFFERED
12,500
MAX NUMBER OF SHARES OFFERED
1,337,500
OFFERING TYPE
Equity
ASSET TYPE
Common Stock
SHARES OFFERED
Common Stock

Maximum Number of Shares Offered subject to adjustment for bonus shares

Most Recent Fiscal Year-End

Prior Fiscal Year-End

Total Assets

$8,964

$8,834

Cash & Cash Equivalents

$8,964

$8,834

Accounts Receivable

$0

$0

Short-Term Debt

$37,208

$139,896

Long-Term Debt

$0

$0

Revenue & Sales

$0

$0

Costs of Goods Sold

$0

$0

Taxes Paid

$0

$0

Net Income

-$43,711

-$73,704

*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.

ALL UPDATES










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10%

Stack Owner's Bonus & Rewards!

Members get an extra 10% shares in addition to rewards below!

Owners bonus

Owner’s Bonus

Owner’s Bonus Members earn 10% bonus shares on top of this and all eligible investments for an entire year. Not a member? Sign up at checkout ($275/year).

JOIN THE DISCUSSION

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GK
Gregg Klang

CERN Corporation

8 months ago

Hi Felix - Thx for the note. I'd received some feedback similar. Our issue is that "Form C" is filed with the SEC/FINRA and a key term is minimum investment. Once the form is filed, we could not change without major expense. My hope is that you see the value in what we are doing and such will consider. Kind regards, G

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FV
Felix Vayssieres

8 months ago

Very cool. Please reduce your investment minimum to $100-$250 so that more people are able to participate (which will help you raise more total). Thanks

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GK
Gregg Klang

CERN Corporation

9 months ago

Hi Ed - First, a big thank you! I'll go ahead and paste the issue below into an email with our support person at SE. Thx, G

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EM
Edward McIntyre

9 months ago

Hello Mr. Klang, I decided to invest and became your 50th investor on this site; however, there seems to be an issue with payment and I've made sure the problem is not on my end yesterday and today. Is there any way that you can get in contact with SE and inform them of the issue and stress to them- to ACTUALLY call me or have them give me their phone number so I can reach them ASAP to resolve the payment issue. I waited to be an investor but, if problem is not promptly handled, I will cancel this investment. I hope you are able to get through to them immediately and look forward to what a possible investment in you will bring us.

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GK
Gregg Klang

CERN Corporation

a year ago

Hi Ed - Yes, I could definitely tell you had a background in medical device/FDA. Nice, educated questions. We close the round the end of February. Our goal is acquisition in year three, so 36 months. The market for what we are doing is too large for us to scale in order to maximize opportunity. We have very specific milestones as discussed in business plan/Form C filing. There will likely be a data component here. Take for example a women with a history of BV. Only 16% of 100 are symptomatic. OB's are telling us the device may be of interest prophylactically. If there were a basal temp sensor the user integrated into the device communicating to her Smartphone as part of her treatment file, she could "opt in" to receive both educational and marketing materials. significant to one who may acquire Cern. The other aspect, not discussed ,is the device may have the opportunity to be used with a medication jointly, as appropriate for the user. Dual action. This make us interesting for a multinational drug/device company. Lastly, think about all the detail people selling drugs where negative drug interactions are the norm resulting in a yeast or bacterial issue...Something significant to get the attention of the Dr., not just OB/GYN but in a number of different segments of medicine.

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EM
Edward McIntyre

a year ago

Gregg, thank you for the quick response, I am retired from the medical field and this product fits right up my scope of interest. Now I have another question and need your best answer. I will certainly invest but, need to know if you plan on doing another raise after this round ends? I have two other investments to make by Feb 10th, so I need to know ASAP- if I should invest in you now OR can I wait until (only if) after you submit for an extension of this round in which I can and will invest 65% more than what I will contribute to this current round; henceforth, this is a one shot deal so I suppose steer me right? Oh by the way, what is your exist strategy or what do you {WISH} for this (our) corporation as far as ownership by the 5th year from now... of course looking at it from an investors point of view as well as your own?

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EM
Edward McIntyre

a year ago

1. Is this unit a one size fits all? 2. What's a range of how long it would take to consider the unit as successful in a case of a woman with mild vaginitis? 3. Has this product successfully treated and cured cases of severe vaginal inflammation without coinciding with other drugs? 4. Could & have you guys thought of using this technology in vaginal vibrators as a 2:1 affect 5. Is there a limit to how long a unit should stay in the vagina or is the light safe enough to suggest removal upon one's own discretion? 6. Will the unit have a timer to help people remind themselves of when the unit should be removed per treatment? 7. Has there been any trial complication and if so what? 8. Will the light be adjustable in any way as per treatment? 9. Are you considering this unit as also being a treatment procedure in a clinic setting; too therefore, will there be a reusable wand or unit that can be sterilized- hence more cashflow?

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GK
Gregg Klang

CERN Corporation

a year ago

Hi Richard - Thanks for your note. Our work with the FDA respective of a pre-submission indicates this will be a Class II medical device, made available as a prescriptive based on mechanism of action. (This is not to be confused with a "wellness device" that makes no claims nor uses technology which may not be effective.) We actually state in the offering information, I believe in the market/marketing section the positioning as a prescriptive (which is what we want as the FDA becomes a barrier to entry alongside our patent position). With regard to price, we have details in the offering of projections based on anticipated COGs, transfer price and end user acquisition pricing. Check out the "Business Plan" which is in the SE campaign material. The device will be priced to the patient at a very "affordable" level and is projected to be a re-useable. We have reviewed CMS information and this product will likely receive new coding for reimbursement. (Also keep in mind that reimbursement codes can not be applied for until after FDA clearance.) This is favorable as we would then not be curtailed by current reimbursement for a drug based therapy. Based on projected COGs, we anticipate that we will be able to subsidize acquisition of the device by those in need, not able to afford. Please feel free to reach out to me directly. Kind regards, Gregg

0

0

RK
Richard Koch

a year ago

Will the device be an over-the-counter (OTC) purchase, or will a PCM provide a prescription? The offering information sounds like OTC. Do you anticipate any insurance reimbursements or will the price point be sufficiently low enough to make it available to all income levels?

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RAISED
$422,177.90
INVESTORS
71
MIN INVEST
$500
VALUATION
$12.01M

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Important Message

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. INVESTMENTS ON STARTENGINE ARE SPECULATIVE, ILLIQUID, AND INVOLVE A HIGH DEGREE OF RISK, INCLUDING THE POSSIBLE LOSS OF YOUR ENTIRE INVESTMENT.

www.StartEngine.com is a website owned and operated by StartEngine Crowdfunding, Inc. (“StartEngine”), which is neither a registered broker-dealer, investment advisor nor funding portal.
Unless indicated otherwise with respect to a particular issuer, all securities-related activity is conducted by regulated affiliates of StartEngine: StartEngine Capital, LLC, a funding portal registered here with the US Securities and Exchange Commission (SEC) and here as a member of the Financial Industry Regulatory Authority (FINRA), or StartEngine Primary, LLC, a broker-dealer registered with the SEC and FINRA / SIPC . You can review the background of our broker-dealer and our investment professionals on FINRA’s BrokerCheck here. StartEngine Secondary is an alternative trading system regulated by the SEC and operated by StartEngine Primary, LLC, a broker dealer registered with the SEC and FINRA. StartEngine Primary, LLC is a member of SIPC and explanatory brochures are available upon request by contacting SIPC at (202) 371-8300.

Investment opportunities posted and accessible through the site are of three types:

1) Regulation A offerings (JOBS Act Title IV; known as Regulation A+), which are offered to non-accredited and accredited investors alike. These offerings are made through StartEngine Primary, LLC (unless otherwise indicated). 2) Regulation D offerings (Rule 506(c)), which are offered only to accredited investors. These offerings are made through StartEngine Primary, LLC. 3) Regulation Crowdfunding offerings (JOBS Act Title III), which are offered to non-accredited and accredited investors alike. These offerings are made through StartEngine Capital, LLC. Some of these offerings are open to the general public, however there are important differences and risks.

Any securities offered on this website have not been recommended or approved by any federal or state securities commission or regulatory authority. StartEngine and its affiliates do not provide any investment advice or recommendation and do not provide any legal or tax advice with respect to any securities. All securities listed on this site are being offered by, and all information included on this site is the responsibility of, the applicable issuer of such securities. StartEngine does not verify the adequacy, accuracy or completeness of any information. Neither StartEngine nor any of its officers, directors, agents and employees makes any warranty, express or implied, of any kind whatsoever related to the adequacy, accuracy, or completeness of any information on this site or the use of information on this site. See additional general disclosures here.
By accessing this site and any pages on this site, you agree to be bound by our Terms of use and Privacy Policy, as may be amended from time to time without notice or liability.

Canadian Investors Investment opportunities posted and accessible through the site will not be offered to Canadian resident investors. Potential investors are strongly advised to consult their legal, tax and financial advisors before investing. The securities offered on this site are not offered in jurisdictions where public solicitation for offerings is not permitted; it is solely your responsibility to comply with the laws and regulations of your country of residence.

California Investors Only – Do Not Sell My Personal Information

(800-317-2200). StartEngine does not sell personal information. For all customer inquiries, please write to contact@startengine.com.

StartEngine’s Reg A+ offering is made available through StartEngine Crowdfunding, Inc. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. For more information about this offering, please view StartEngine’s offering circular and risk associated with this offering.

The availability of company information does not indicate that the company has endorsed, supports, or otherwise participates with StartEngine.

None of the information displayed on or downloadable from www.startengine.com (the any security. It also does not constitute an offer to provide investment advice or service. any security. It also does not constitute an offer to provide investment advice or service. any security. It also does not constitute an offer to provide investment advice or service. StartEngine does not (1) make any recommendations or otherwise advise on the merits or advisability of a particular investment or transaction, or (2) assist in the determination of fair value of any security or investment, or (3) provide legal, tax, or transactional advisory services.

All investment opportunities are based on indicated interest from sellers and will need to be confirmed.

Investing in private company securities is not suitable for all investors. An investment in private company securities is highly speculative and involves a high degree of risk. It should only be considered a long-term investment. You must be prepared to withstand a total loss of your investment. Private company securities are also highly illiquid, and there is no guarantee that a market will develop for such securities. Each investment also carries its own specific risks, and you should complete your own independent due diligence regarding the investment. This includes obtaining additional information about the company, opinions, financial projections, and legal or other investment advice. Accordingly, investing in private company securities is appropriate only for those investors who can tolerate a high degree of risk and do not require a liquid investment.

StartEngine Marketplace (“SE Marketplace”) is a website operated by StartEngine Primary, LLC (“SE Primary”), a broker-dealer that is registered with the SEC and a member of FINRA and the SIPC. (“SE Marketplace”) is a website operated by StartEngine Primary, LLC (“SE Primary”), a broker-dealer that is registered with the SEC and a member of FINRA and the SIPC. (“SE Marketplace”) is a website operated by StartEngine Primary, LLC (“SE Primary”), a broker-dealer that is registered with the SEC and a member of FINRA and the SIPC.