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.

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.

* 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.

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.

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.

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

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.

Who buys it?

Recurring revenue through consumable and reagent sales

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

An $18.3 billion USD market by 2027

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).

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.