GET A PIECE OF ORTEK THERAPEUTICS
The Ortek-ECD is a revolutionary FDA cleared device that can help detect the earliest signs of tooth decay that X-rays often miss, while Ortek BasicBites are clinically shown to maintain enamel health by working with the body’s oral microbiome.
Tooth decay is the most prevalent chronic disease in the world, plus about one in four adults suffer from dry mouth.*
President and founder, Mitch Goldberg, has over 35 years of experience in the healthcare industry and previously co-founded Noven Pharmaceuticals, a publicly-traded company that was acquired for $428 million.
*Information provided by Research and Markets (source)
Overview
Ortek has already conquered the expensive, time consuming and risky hurdles of commercializing our products. The internationally patented Ortek-ECD has been cleared by the FDA and is already used by hundreds of dentists in the US. The ECD utilizes breakthrough electronic conductance technology and does not use radiation. By painlessly touching a tooth’s surface, the ECD immediately and accurately helps dental professionals detect tiny cavities in our vulnerable back teeth; decay that is often missed by X-rays.
Ortek’s BasicBites soft chews are clinically shown to help maintain enamel health using nature inspired oral microbiome technology. Both products are designed to help solve a major public health burden by the early diagnosis of tooth decay and taking an innovative approach to supporting enamel health.
Tooth decay is the world’s most common chronic disease (source)
and detecting it early is critical to avoid the pain of more advanced cavities, root canals, infections and tooth loss. Ortek has developed two revolutionary products to help people take back control of their oral health: The Ortek-ECD and BasicBites.
An experienced and highly successful team leads Ortek. President and founder, Mitch Goldberg, has over 35 years of experience in the healthcare industry and was previously the co-founder, Executive VP and Director of Noven Pharmaceuticals, a two-person startup that became a highly profitable, publicly traded prescription drug company that was acquired for $428 million in cash. Goldberg is responsible for the clinical development, FDA clearance, commercial scale up, manufacturing and commercialization for the Ortek-ECD and for the commercialization of BasicBites. Ortek’s revolutionary technology is the result of its long-standing strategic alliance with The Research Foundation for The State University of New York and the world-renowned researchers in the Department of Oral Biology and Pathology at Stony Brook University School of Dental Medicine.
The Problem
Close to one-third of the world's population suffers from tooth decay and X-rays often fail to detect certain prevalent cavities in time (source). An estimated 2.3 billion people worldwide suffer from tooth decay in their permanent teeth and more than 530 million children suffer from cavities in their baby teeth.1 According to the CDC, about one-fourth of young children, half of adolescents, and more than 90% of adults have experienced tooth decay (source).
1 CDC - Children’s Oral Health
Additionally, the back teeth (molars and premolars) are the sites most susceptible to cavities. These teeth have grooves, known as pits and fissures, that often trap cavity-causing bacteria (source). Dental X-rays and other methods often fail to detect cavities within the back teeth until there is advanced decay.2
The Solution
A remarkable advance in early cavity detection and an innovative microbiome approach to supporting enamel health
ECD
By painlessly measuring electrical conductance of enamel, the Ortek-ECD® can instantly detect cavities on the biting surfaces of the back teeth helping solve an everyday challenge for dental professionals. X-ray and other methods often miss early cavities on these extremely vulnerable surfaces until decay has advanced further into the tooth structure. The ECD is a small portable device that has a base unit with a digital display and a handpiece which utilizes disposable one-time use conductive stainless steel tips.
*The above is a computer-generated rendering of a functioning product that is currently available on the market.
For dentists and hygienists, this amazing point-of-care diagnostic tool enhances their dental practice by improving patient outcomes, retaining patients, and attracting new ones. The ECD is easy to use, painless, generates immediate and accurate results, and is extremely affordable, providing a new profit center for dental offices that can provide them a return on investment in just days.
*Study published in the Journal of Clinical Dentistry (J Clin Dent 2019;30:1-5)
Comparison of the Detection of Early Occlusal Caries in Extracted Human Permanent Molar Teeth by Electrical Conductance and Biopsy Means
Robi Chatterjee, Research Scientist; Ana Maria Acevedo, Full Professor and Research Scientist
Israel Kleinberg, Distinguished Professor, Director of Translational Oral Biology Stony Brook University, School of Dental Medicine Department of Oral Biology and Pathology, Division of Translational Oral Biology Stony Brook, NY, USA J Clin Dent. 2019 Jun,30 (2):1-5
Case Studies
First case study:
In this case, the patient had an obvious cavity on a section of their tooth (Site 1) and a slightly discolored or questionable spot (site 2). X-rays failed to detect any cavity for site 2 and visual examination was inconclusive, making the dentist's treatment decision very difficult.
Prior to initial preparation through the enamel layer, the ECD gave the following readings: site 1, 93 and site 2, 04. In this case, the ECD scores proved extremely reliable relative to the depth of the cavities. More importantly, the ECD was very effective in detecting a cavity that may have normally gone untreated.
Second case study:
In this case, two adjoining teeth displayed discoloration possibly due to staining. X-rays were taken and there was no sign of cavities. This case was a diagnostic challenge for the dentist.
Prior to initial preparation through the enamel layer, the ECD gave the following readings: 08 and 00. In this case, the ECD detected a cavity and the depth of the decay was over 2mm. The tooth with the 00 reading will be monitored, as the zero score by the ECD indicates that the stain or lesion did not extend through the enamel.
What Dental Professionals are Saying
Key opinion leaders Dr. Howard Glazer and Dr. Pamela Maragliano-Muniz recommend the Ortek-ECD.
*The above video was created and produced by the issuer prior to it determining to offer securities under Regulation CF. The discussion of investment return and image of ROI in the video applies to the issuer's customers and is not a guarantee of future performance or success.
*This testimonial may not be representative of the experience of other customers and is not a guarantee of future performance or success.
“The Ortek-ECD can pay for itself in just a few uses. No longer do we have to let our diagnosis of caries be a gut feeling. We can actually apply analytics.”
Joshua Austin, DDS, MAGD
Dental Economics, Pearls for your Practice
"I have used the ECD on numerous patients and it's extremely effective in detecting small cavitated lesions that may normally go untreated. The ECD scores are very reliable relative to the depth of the caries lesions."
Derek Zimbardi, DDS
Dentistry Today, Quick Technique
"I have used the ECD on over 200 patients and I have never had a false positive. It's an amazing device that should be incorporated into nearly every dental practice. The ECD dramatically helps my patients and it can pay for itself in no time. I was so impressed with Ortek's university based technologies that I purchased stock in the company."
Brian Rosen, DDS
"I have found the Ortek-ECD device to be one of my most useful go-to tools for the early detection of pit and fissure caries. It is easy to use and a great complement to an intraoral camera for patient communication and discussion regarding their oral health status."
Neville Hatfield, DMD, MBS
*These testimonials may not be representative of the experience of other customers and is not a guarantee of future performance or success.
BasicBites
BasicBites is are delicious sugar free, candy-like, soft chews designed for people who suffer from dry mouth and great for those with a “sweet tooth”. Recommended by leading dental professionals, these soft chews contain Ortek’s revolutionary oral microbiome technology and are available in two mouth-watering flavors, chocolate and caramel. Just two delicious BasicBites per day have been clinically shown to help maintain enamel health. BasicBites work differently than other oral care products. Renowned university researchers cracked nature’s code for supporting enamel health by discovering beneficial bacteria in dental plaque. These friendly bacteria produce buffers instead of harmful acids. The arginine bicarbonate in BasicBites nurtures and activates these beneficial pH-raising bacteria. This healthy and balanced oral pH environment allows the calcium carbonate in BasicBites to support the fortification of the enamel. By harnessing the power of nature, multi-action BasicBites immediately neutralizes harmful sugar acids, enriches enamel, and helps maintain a balanced and healthy oral pH environment.
What Dental Professionals are Saying
*These testimonials may not be representative of the experience of other customers and is not a guarantee of future performance or success.
The Market
The global dental services market was valued at $371.4 billion in 2020 and is expected to hit $698.8 billion by 2030 (source), while the worldwide dental equipment market was valued at $60.5 billion in 2019 and is predicted to reach $70.8 billion by 2024 (source). Globally, an estimated $298 billion is spent in direct costs associated with dental cavities, while an estimated $144 billion is spent on the indirect costs associated with dental cavities (source).
There’s a tremendous global opportunity for the ECD. With approximately 200,000 dentists in the US and nearly 1 million dentists in the world, capturing 25% market share of this large targeted audience could generate over 150 million in sales. Additionally, the ECD tips are disposable and for one time use which could lead to additional ongoing revenue streams (source, source).
The market for BasicBites is also vast. In 2020, the global oral care market was valued at $45 billion and is estimated to reach $53 billion by 2025 (source). In 2019, the worldwide functional food market had an estimated size of around $178 billion and is expected to reach around $268 billion by 2027 (source). Additionally, BasicBites are targeted for those individuals who suffer from dry mouth which is about one in four adults. The global market of dry mouth products was approximately $650 million in 2020 and projected to reach $825 million in 2027 (source).
We believe ECD and BasicBites are unlike any other products in the dental and oral care markets. The ECD does not use radiation and helps dentists diagnose cavities in our vulnerable back teeth at the earliest possible stage. X-rays and other methods often fail to detect early cavities in these susceptible sites until there is more advanced decay. By unlocking the power of the oral microbiome, BasicBites takes a new approach to oral care. The breakthrough prebiotic microbiome technology in BasicBites is based on decades of university research investigating how mixed oral bacterial communities naturally interact to help maintain enamel health.
Our Traction
The Ortek-ECD and BasicBites technology were developed and tested at a leading US dental school. The ECD is FDA cleared and being used by hundreds of dentists throughout the US. In a published peer-reviewed clinical study, the ECD demonstrated 100% sensitivity and 93% specificity in detecting and diagnosing early cavities in back teeth.3 Ortek has obtained global patent protection for ECD in numerous key markets and has two patent-pending variants for BasicBites.
BasicBites has been on the market since 2014 and is clinically shown to support and maintain enamel health. Recently, we finalized a formulation for a new patent-pending line extension of BasicBites. Cumulative sales of BasicBites have reached over $1 million to date, all with a limited marketing budget only focused on educating dental professionals.
3 Study published in the Journal of Clinical Dentistry (J Clin Dent 2019;30:1-5)
Through our long-standing strategic alliance with The Research Foundation for The State University of New York, Ortek also has worldwide exclusive licenses for two patents that naturally rebalance the body’s skin microbiome to suppress body odor and combat drug-resistant bacteria. These patented technologies are intended for topical administration for a wide array of over-the-counter and prescription products and Ortek is seeking strategic partners to further develop and commercialize these cutting-edge technologies.
Why Invest
Our vision for Ortek is to be a highly profitable global leader in the dental and oral care spaces, helping to alleviate a major global healthcare burden with our cutting-edge innovations. Our goal for the ECD is to have this breakthrough device in nearly every dental office throughout the world. For BasicBites, our mission is to target the huge dry mouth and consumer oral care markets across the US and the globe.
We are raising funds at this time so we can reach larger target audiences for the ECD and BasicBites. Our marketing programs will include social media, email, affiliate and influencer digital marketing strategies. Additionally, we will expand our professional print media, consumer and professional public relations campaigns, attendance at trade shows and further build our team of key opinion leaders. We will also leverage our existing professional and consumer database for repeat business, product referrals, and testimonials.
With the global dental services market expected to hit $698.8 billion by 2030 (source) and the global oral care market expected to reach $53 billion by 2025 (source), there is an ever-growing need for products like ours. And with tooth decay being the world’s most common chronic disease (source), Ortek has the power to truly make a difference. We’ve already conquered the expensive, time consuming and risky hurdles of commercializing our products. The Ortek-ECD is cleared by the FDA, patented internationally, and is now being successfully implemented by hundreds of dentists. BasicBites have been purchased by thousands of customers and we have only scratched the surface of the large dry mouth and oral care markets. We hope you will join us for this next phase of our growth, as we strive to truly make an impact improving oral health and create shareholder value.
Ortek Therapeutics, Inc. is a medical device and functional food company that has commercialized novel products for the multi-billion dollar professional and consumer oral care markets. Our cutting-edge FDA cleared and patented early cavity detection device, the Ortek-ECD®, helps dental professionals diagnose and monitor cavities without radiation. The ECD can detect early tooth decay often missed by X-rays and other methods. Ortek’s BasicBites® are delicious, candy-like, sugar-free soft chews that are clinically shown to help maintain enamel health using innovative oral microbiome science. Our breakthrough technologies were developed and tested at Stony Brook University School of Dental Medicine. Ortek has entered into an exclusive worldwide license to the ECD patents that are owned by The Research Foundation for The State University of New York.
Fred Confessore
Advisor
Dr. George Freedman
Advisor
Dr. Howard Glazer
Advisor
Anne Nugent Guignon, RDH, MPH, CSP
Advisor
Gordon Johnson
Advisor
Shannon Nanne, RDH
Advisor
Michelle Strange, RDH
Advisor
Maximum Number of Shares Offered subject to adjustment for bonus shares
*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 the first 7 days and receive an additional 20% bonus shares.
Super Early Bird Bonus
Invest within the first 15 days and receive an additional 15% bonus shares.
Early Bird Bonus
Invest within the first 30 days and receive an additional 10% bonus shares.
Amount-Based:
$250+ | 1st Perk
Invest $250+ and receive a onetime $5 off for a single bag of BasicBites.
$1,000+ | 2nd Perk
Invest 1,000 and receive 5% bonus shares
$2,500+ | 3rd Perk
Invest $2,500 and receive 10% bonus shares
$5,000+ | 4th Perk
Invest $5,000+ and receive two free bags of BasicBites and 15% bonus shares
$10,000+ | 5th Perk
Invest $10,000 and receive four free bags of BasicBites and 20% bonus shares
*All perks occur when the offering is completed.
The 10% StartEngine Owners' Bonus
Ortek Therapeutics, Inc 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 $1.00 / share, you will receive 110 shares of Common Stock, meaning you'll own 110 shares for $100. 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 investors' 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.
*Stacking perks only applies to the Owner's Bonus perk and Previous Backer perks. Time-based and Amount-based perks do not stack on top of each other, rather, the issuer will receive the greater of the two bonuses if they qualify for both.
Insider Investment Notice
Officers, directors, executives, and existing owners with a controlling stake in the company (or their immediate family members) may make investments in this offering. Any such investments will be included in the raised amount reflected on the campaign page.
Irregular Use of Proceeds
The Company will not incur any irregular use of proceeds.
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