DELEE

Early cancer diagnosis and treatment monitoring

DELEE

Early cancer diagnosis and treatment monitoring

Laredo, TX
Health Tech
At Delee, we have created the CytoCatch™️ isolation platform and imaging system. These units enable the performance of a CTC blood-based assay that has the potential of being used for early cancer detection and monitoring the applied treatments’ effectiveness, allowing the optimization of each patient’s therapy throughout the course of the disease.

$161,517

raised
$1,070,000
previously crowdfunded
299
Investors
$22M
Valuation
$1.66
Price per Share
$199.20
Min. Investment
Preferred
Shares Offered
Equity
Offering Type
$5M
Offering Max
Reg CF
Offering

$161,517

raised
$1,070,000
previously crowdfunded
299
Investors
$22M
Valuation
$1.66
Price per Share
$199.20
Min. Investment
Preferred
Shares Offered
Equity
Offering Type
$5M
Offering Max
Reg CF
Offering

Rewards

Get rewarded for investing more into DELEE:

$199+
Investment
StartEngine Owner’s Bonus
This offering is eligible for the StartEngine Owner’s 10% Bonus program. For details on this program, please see the Offering Summary section below.
$5,000+
Investment
First Tier
$5,000 - 10% bonus shares
$10,000+
Investment
Second Tier
$10,000 - 12% bonus shares
$15,000+
Investment
Third Tier
$15,000 - 14% bonus shares
$20,000+
Investment
Fourth Tier
$20,000 - 16% bonus shares
$25,000+
Investment
Fifth Tier
$25,000 - 18% bonus shares
$30,000+
Investment
Sixth Tier
$30,000 - 20% bonus shares

Reasons to Invest

  • Blood-based assay for the early detection of cancer and monitoring of the applied treatments’ effectiveness, which is enabled by two independent devices created to effectively isolate and analyze circulating tumor cells (CTCs). Delee has a fully functional technology that is being successfully tested for prostate and breast cancer with pre-orders worth a potential value of over $2.5 million USD. 
  • Delee is backed by Y Combinator and StartX, and has raised over $2.4 million USD in funding. In 2020, the global circulating tumor cell market was valued at $8.4 billion USD, and it is expected to reach $18.3 billion USD by 2027.
  • We have built an experienced team of specialists in the fields of molecular biology, electronics, artificial intelligence, clinical oncology, product design, and manufacture.


*Images used in this photo are in the prototype phase, CytoCatch is not currently available on the market.

Since our last raise


Milestones Reached

  • We improved the capabilities of our previous prototypes to greatly increase the robustness and reliability of our CTC blood-based assay. 
  • We completed the commercial versions of the devices that enable the CTC blood-based assay. 
  • We expanded the number of collaborations with medical institutions, which will allow us to clinically validate our technology in less time.
  • We increased the number of processed patient samples to assess the feasibility of using our technology for various cancer-related clinical applications. 
  • We expanded our team in order to accelerate the commercial launch of our technology.


*Images used in this photo are in the prototype phase, CytoCatch is not currently available on the market.

The Problem



* Source


Cancer has become a major global health issue. According to the International Agency for Research on Cancer (IARC), in 2020, the number of new registered cases surpassed 19.2 M globally, whereas over 9.9 M deaths occurred due to this disease (Source). Despite all the recent breakthroughs in cancer treatments, it is estimated that by 2040, the number of new registered cases and fatalities per year will increase to 30.2 M and 16.3 M, respectively (Source, Source). The National Cancer Institute (NCI) estimates that 39.5% of Americans will be diagnosed with cancer at some point during their lifetime (Source), unfortunately, many of these people will lose their lives because of it. One of the main reasons cancer has such a high mortality rate is due to the current lack of tests with the required sensitivity and specificity to enable an early diagnosis of the disease. 


When it comes to cancer, the detection of tumors at an early stage is key because the survival rate in most types of cancer is directly related to the stage at which tumors are detected. For example, the 5-year relative survival rate for breast cancer when detected at early stages is 99%, but drops to 28% when detected at late stages (Source). Furthermore, early detection has the potential to reduce the financial burden of health care on individuals and public health services mainly because cancer treatments used for treating localized disease are less complex, and therefore, less expensive; according to the World Health Organization (WHO), studies made in high-income countries have shown that the cost of cancer treatment, when detected at early stages, is 2 to 4 times less expensive than at advanced stages (Source). 


Moreover, there is a lack of technological resources to provide effective monitoring of the applied cancer treatments’ efficacy, which may significantly reduce the patients’ chances of survival given that the right treatment at the right time for each cancer patient may not be administered due to the lack of information available for physicians. 


Since there is an unmet need for tests that can reliably detect cancer at early stages and monitor the applied treatments’ effectiveness, the research community has been actively searching for novel biomarkers that can provide clinical information for these purposes. The isolation of circulating tumor cells (CTCs) from blood is a recent alternative that could address this need. In the last decade, CTCs have attracted a significant amount of attention for their potential use as a blood-based biomarker for a broad range of cancer-related clinical applications. CTCs are malignant cells that are shed from the primary and/or metastatic solid tumors that infiltrate into the vascular and lymphatic systems; these cells play a fundamental role in the metastatic process of non-hematological cancers (Source, Source).



Technologies that detect and isolate CTCs from blood can be used to develop assays that could enable early cancer detection and monitor the applied treatments’ effectiveness. However, the isolation of these malignant cells from blood represents a major technological challenge due to their heterogeneity and extremely low numbers in comparison to blood cells (Source, Source); on average, you can find around 40.5 billion cells in 7.5 mL of blood, while a cancer patient may have between 1 and 1000 CTCs in the same volume (Source).

Even though there currently exists multiple cell sorting methods, such as fluorescent-activated cell sorting, magnetic-activated cell sorting, fluorescent-activated droplet sorting, and density gradient centrifugation, these are not compatible with whole blood samples and/or do not have the sufficient sensitivity and specificity to correctly isolate CTCs from blood, which have prevented the development of assays with potential clinical utility... until now.

Our Solution


At Delee, we have created the CytoCatch™  isolation platform and imaging system. These units enable the performance of a CTC blood-based assay that has the potential of being used for early cancer detection and monitoring of the applied treatments’ effectiveness, allowing the optimization of each patient’s therapy throughout the course of the disease.


*Images used in this photo are in the prototype phase, CytoCatch is not currently available on the market.

How it works



For the assay, a single blood tube is extracted by conventional venipuncture (the collection method that is usually used for laboratory testing). The blood sample along with several reagents are loaded on the CytoCatch™  isolation platform, which automatically performs the necessary steps to prepare and process the sample, capturing the contained CTCs. The unit has an outstanding performance, it has recovery rates above 94% when processing 7.5 mL blood samples spiked with tumor cells from prostate, breast, and colorectal cancer cell lines, meaning that the platform recovers at least 94 out of 100 tumor cells spiked into the sample (Source).


Once captured, the CytoCatch™  isolation platform executes an automated protocol to stain the collected cells with fluorescent antibodies for their further analysis with the CytoCatch™ imaging system, which possesses special routines and machine learning algorithms that analyze the captured cells based on their morphology and the expression of specific markers. The fact that all these processes are fully automated increases the reliability and reproducibility of the assay by preventing human error and cell loss due to manual steps.


Furthermore, the collected cells are compatible with traditional molecular biology techniques and next generation sequencing technologies, enabling the performance of molecular analyses to assess the genetic characteristics of the captured CTCs. Finally, the treating physician will get a report with the corresponding results.


*Images used in this photo are in the prototype phase, CytoCatch is not currently available on the market.

ONCOLOGICAL CLINICAL APPLICATIONS



Our technology has the specificity and sensibility required to successfully isolate and analyze CTCs from blood, which may enable the following clinical applications:


*Images used in this photo are in the prototype phase, CytoCatch is not currently available on the market.

BENEFITS OF OUR TECHNOLOGY



The early detection of cancer and the monitoring of the applied treatments’ effectiveness will be translated into invaluable benefits for patients and their families, being the most important, and the main reason for all our work, to greatly increase their chances of defeating cancer. Furthermore, monitoring the treatments’ effectiveness could also significantly increase the odds of defeating cancer by applying the most effective treatment for each patient throughout the course of the disease, while reducing the incurred costs and the negative side effects caused by drugs that wouldn’t be effective for a particular patient.


FOR WHAT TYPES OF CANCER?



Our technology can be used for a wide variety of cancer types. There is scientific evidence that indicates the feasibility of developing CTC assays to enable clinical applications in various types of cancer, including prostate, breast, colorectal, lung, cervical, skin, and ovarian cancer, just to name a few. Prostate, breast, colorectal, and lung cancer are responsible for over 40% of new cancer cases and a third of the deaths registered worldwide due to this disease (Source). 



Traction


Pre-orders worth a potential value of over $2.5 million USD

We’ve gotten great traction since the pre-commercial launch of our technology. To date, pre-orders worth a potential value of over $2.5 million USD have been secured from research centers of various hospitals in order to use our technology as an in vitro diagnostic platform for research use only, prior to FDA clearance.

Customers


Who buys it?

Prior to acquiring FDA clearance, Delee aims to commercialize the CytoCatch™ isolation platform and imaging system as research tools, being pharmaceutical companies and research centers our main customers. Once our technology obtains FDA clearance, it will be commercialized as an in vitro diagnostic medical device for hospitals and laboratories.


Business Model


Recurring revenue through consumable and reagent sales

Prior to FDA clearance, our devices will be commercialized as research tools, where the razor and blades business model will be followed, obtaining recurrent revenue by selling the necessary reagents and consumables to perform each test. This model will be maintained once FDA gives clearance for our technology to be commercialized as an in vitro diagnostic medical device for hospitals and laboratories.


*Images used in this photo are in the prototype phase, CytoCatch is not currently available on the market.


Market


An $18.3 billion USD market by 2027

According to a recent report published by Grand View Research, in 2020, the global circulating tumor cell market was valued at $8.4 billion USD, and it’s expected to reach an $18.3 billion USD valuation by 2027 (Source, Source). This growth is mainly driven by the increase in the number of cancer cases that will occur in the coming years.  



At Delee, we are initially validating our technology for prostate and breast cancer, to later expand it to lung and colorectal cancer, mainly because, in 2020 alone, these four types of cancer account for over 40% of the new cancer cases registered worldwide and were responsible for over 3.7 million deaths (Source).

Competitors


A more effective way to capture and analyze CTCs

Most of the blood tests employed as auxiliaries in the diagnosis of cancer and monitoring of the applied treatments’ effectiveness measure protein tumor markers levels, such as PSA, CA-125, and AFP. However, there are only a few protein tumor markers that are associated with a particular cancer and are clinically useful; most types of cancer have not been linked to an increase in the levels of a particular protein tumor marker (Source). Furthermore, these types of tests have a poor sensitivity and specificity, meaning that these markers may be elevated in people that do not have cancer and that not every person with a particular type of cancer will have an elevated level of the corresponding tumor marker (Source). Taking the PSA test as an example, which measures the amount of PSA in blood and is used to screen for prostate cancer, approximately 66% of men with increased levels of PSA do not have prostate cancer, whereas over 15% of the men with normal levels of PSA may have prostate cancer (Source).      


The isolation and analysis of CTCs is a relatively new practice, and physicians are starting to recognize all its potential benefits. Most of the current CTCs technologies, including the CellSearch® System, which is considered the gold standard, rely on the existence of specific proteins on the tumor cell membrane in order to capture them. However, CTCs are incredibly heterogeneous; when entering the bloodstream, they undergo a biological process that downregulates these proteins, limiting the efficiency with which these cells are captured and thereby losing valuable information (Source, Source). Our technology changes the norm by isolating CTCs irrespective of the proteins expressed in their membranes, allowing us to capture tumor cells that other technologies simply can’t.



*Images used in this photo are in the prototype phase, CytoCatch is not currently available on the market.

Our Vision



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Offering Summary


Company

:

DELEE CORP.

Corporate Address

:

1211 San Dario Ave #2068, Laredo, TX 78040

Offering Minimum

:

$9,999.84

Offering Maximum

:

$4,999,998.02

Minimum Investment Amount

(per investor)

:

$199.20











Terms


Offering Type

:

Equity

Security Name

:

Series Seed V Preferred Stock

Minimum Number of Shares Offered

:

6,024

Maximum Number of Shares Offered

:

3,012,047

Price per Share

:

$1.66

Pre-Money Valuation

:

$22,040,057.38











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

Investment Incentives*

Early Bird Bonus

Friends and Family - First 72 hours | 10% bonus shares

Super Early Bird - Next 7 days | 8% bonus shares

Early Bird Bonus - Next 10 days | 6% bonus shares

Volume-Based Bonus

$5,000 - 10% bonus shares

$10,000 - 12% bonus shares

$15,000 - 14% bonus shares

$20,000 - 16% bonus shares

$25,000 - 18% bonus shares

$30,000 - 20% bonus shares

*All perks occur when offering is complete.

The 10% StartEngine Owners' Bonus

Delee Corp. 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 Series Seed V Preferred Stock at $1.66 / share, you will receive 10 additional shares, meaning you'll own 110 shares for $166. 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 cancelled or fail.

Investors will only receive a single bonus, which will be the highest bonus rate they are eligible for.

Irregular Use of Proceeds

Example - The Company might incur Irregular Use of Proceeds that may include but are not limited to the following over $10,000: Vendor payments and salary made to one's self, a friend or relative; Any expense labeled "Administration Expenses" that is not strictly for administrative purposes; Any expense labeled "Travel and Entertainment"; Any expense that is for the purposes of inter-company debt or back payments.

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Most recent fiscal year-end:
Prior fiscal year-end:
Total Assets
$907,032.00 USD
$418,377.00 USD
Cash And Cash Equivalents
$344,289.00 USD
$1,594.00 USD
Accounts Receivable
$98,848.00 USD
$43,156.00 USD
Short Term Debt
$9,896.00 USD
$23,128.00 USD
Long Term Debt
$0.00 USD
$0.00 USD
Revenues And Sales
$0.00 USD
$55,613.00 USD
Costs Of Goods Sold
$0.00 USD
$1,454.00 USD
Taxes Paid
$0.00 USD
$0.00 USD
Net Income
-$622,364.00 USD
-$91,803.00 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.


Updates

Notice of Funds Disbursement

14 days ago

[The following is an automated notice from the StartEngine team].

Hello!

As you might know, DELEE has exceeded its minimum funding goal. When a company reaches its minimum on StartEngine, it's about to begin withdrawing funds. If you invested in DELEE be on the lookout for an email that describes more about the disbursement process.


This campaign will continue to accept investments until its indicated closing date.


Thanks for funding the future.

-StartEngine

Delee has been selected as a UCSF Health Hub Quarterfinalist 🔥

about 1 month ago


We are honored to be chosen as a UCSF Health Hub Quarterfinalist in the New Life Sciences Diagnostic category 🥳. The UCSF Health Awards honors outstanding technologies that are radically transforming healthcare and improving patient outcomes. This event is sponsored by some of the most renowned big tech and big pharma companies, such as Eli Lilly, Genentech, Johnson and Johnson, and Astellas. Our application was selected among the 8 finalists by a panel of 300+ eminent judges that are experts in the field 😎. This recognition further validates the importance of developing a technology for early cancer detection and monitoring the applied treatments’ effectiveness.


Delee reaches $100k in investments! 🚀

about 1 month ago

We are thrilled to announce that our Reg CF crowdfunding campaign on StartEngine has raised over $100k from 216 investors in less than a week! 🔥


Thank you to all the people who are helping us revolutionize the way cancer is diagnosed and managed. We are working really hard so our technology could benefit as many patients as possible. 🙏


Keep following our campaign for more exciting updates. 


Sincerely, 


Delee Team 💙

Our campaign is officially live!

about 2 months ago

Dear Investors,


Our crowdfunding campaign on StartEngine is officially live! 🚀 


If you reserved shares during our TTW remember that the bonus shares you received will stack with the bonus shares offered during the campaign. If you confirm your investment in the first 72 hours after launch you will receive at least an additional 10% bonus shares regardless of the amount invested. If you couldn’t reserve during our TTW you can also receive the bonus shares if you invest during the first 72 hours after launch.


Thank you very much for all the incredible support you have given us and for spreading the word of our campaign with others, it truly means a lot 🙏. Exciting times are ahead, we are glad to have you on board to enjoy them together.

 
Sincerely,

Delee Team 💙

We are a few days away from launching!

about 2 months ago

Dear investors,

As you may know, at the moment, we are still in the TTW stage; but we are very excited to announce that we are just a few days away from the launch of our StartEngine campaign 🚀.

On behalf of our team, I would like to thank all of you for reserving your investment with us. It means the world to know that so many people believe in our work and are joining us on this journey. We are ending this phase with over $275k in reservations 😀. Rest assured that your support is greatly appreciated and it keeps us moving forward 💪.  Stay tuned, because once the campaign goes live, if you confirm your investment you can increase the number of bonus shares that you got during our TTW.

Once again, thank you very much! And please, stay safe.


Sincerely, 

Liza Velarde

Delee Corp.

The final version of the CytoCatch™️ imaging system is finally here 🙌

3 months ago

We hope that you and yours are well and safe 😄

 

A few weeks ago we announced that the final version of the CytoCatch™️ isolation platform had been completed. Today we have another exciting announcement, the final version of the CytoCatch™️ imaging system is finally completed 🥳

 

microscope 1 gif


After concluding our previous crowdfunding campaign we found ourselves in a very difficult situation, with the pandemic raging we had to coordinate with every member of our team to efficiently work both from our homes and lab. To be able to share this news with you fills every member of the team with a tremendous amount of joy. 

 

The CytoCatch™️ imaging system is the most complex unit that constitutes our technology. This system was specially designed to acquire high-resolution micrographs of the CTCs that were previously captured by our isolation platform. It possesses special routines and machine learning algorithms that analyze the captured cells based on their morphology and the expression of specific markers. All these processes, ranging from image acquisition to image analysis, are fully automated, which increases the reliability and reproducibility of the assay by preventing human error.

 

 

microscope 2 gif c


Our StartEngine campaign launching soon, remember that you can still reserve your investment and receive 10% bonus shares

 

We are deeply grateful for your unwavering support, we know that none of these amazing achievements would have been possible without each and every one of you. From the bottom of our hearts, thank you!

 

Sincerely, 

 

Delee Team 💙

Delee has started the analytical validation of the CytoCatch™ isolation platform.

3 months ago

Hello everyone! 


We hope you’re doing well 😄.


We would like to share with you that last week we began the analytical validation of the final version of the CytoCatch™ isolation platform, one of the two devices that constitute our technology and makes it possible to isolate CTCs from other blood components. 



This validation is fundamental for any medical or scientific device built to measure an analyte (the constituent of the sample to be analyzed, in our case the CTCs). The tests carried out during this validation are designed to ensure that our platform’s performance is optimal and the results obtained are reproducible. Here, our device will be extensively tested to assess key parameters, such as capture efficiency, purity, sensitivity, working range, precision, and accuracy. This has to be made before the device’s clinical validation, where a clinical study is going to be conducted in order to collect clinical data. 


Even though this is just the beginning, and this validation will last for several months, we are thrilled because the first tests carried out yielded very positive results. Our device consistently had over 94% capture efficiency when processing blood samples of 7.5 mL spiked with 100 cancer cells. This means that our device was able to capture over 94 of these cells in every run performed, which is in line or even higher than our competitors’ yield 😎.



We are deeply thankful to all the people who already reserved their investment 🤗. At the moment, we are still in the Test The Waters (TTW) stage, in which you can reserve your investment without committing until the campaign goes officially live. If you reserve during the TTW stage you will receive 10% bonus shares when you confirm the investment.


Once again, thank you for all your support!


Sincerely, 


Delee Team 💙

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