Delee Co-Founder Liza Velarde on Improving and Personalizing Cancer Treatment

Delee is a company specializing in the development of medical devices. However, from the beginning, our main focus has been to create an innovative technology that allows the efficient isolation and analysis of circulating tumor cells from blood samples in order to enable early cancer detection and provide an appropriate monitoring of treatment effectiveness. What we have built will contribute to detecting cancer at stages where curing it is more likely while providing physicians with the necessary information to personalize each patient’s therapy and monitor its effectiveness throughout the course of the disease.

Cancer is one of the leading causes of death worldwide. It affects millions of people everywhere, and it is estimated that in the next 20 years, the number of new registered cases and fatalities per year will increase to 30.2 million and 16.3 million, respectively. If you take a look at the numbers and think about it, it is very hard to find someone who hasn’t been affected one way or another by this disease. Either you were diagnosed with it or you know someone one who has been, and you maybe even lost a loved one due to it. Sadly, this reality has hit close to home. My fellow co-founders, other members of the team, and I have all experienced how cancer can forever change every aspect in the life of a family.

When we began our journey as entrepreneurs, Alejandro, Juan, and I knew that we wanted to combine our love for science and technology with our desire to help people and make a difference. So, being aware of what cancer represented as a global health issue, we wanted to find a solution that could help mitigate this problem. That’s why we decided to create our own company where we could do our own research, come up with new developments, perform our own experiments, learn from each other, and continue growing from there. It has been very hard. In this business, a new challenge is always around the corner. But believing that our work can make a difference for those who suffer from cancer is what moves and inspires us to keep on working.

Alejandro, Juan, and I met in college. We had a couple classes together, and we were encouraged by a teacher to work on a project, something about starting a business and making a difference at the same time. We found out that the three of us all had someone in our lives that at some point had cancer, something that is not surprising considering the statistics. We knew that we wanted to combine our personal experiences with our passion for science and technology and the aspiration of doing something trascendental and good for others. We really wanted to help people, so we created a technology capable of isolating CTCs in order to enable early cancer detection and properly monitor the effectiveness of applied therapies.   

The early days were difficult since we had to work exhaustively, not only to improve the technology but also to get funding from grants that allowed us to continue with our research. It wasn’t until we had a working prototype that we were accepted into Y Combinator, and we raised our first round, which allowed us to start hiring brilliant people in order to expand the company and improve our technology. Currently, at Delee, there are 17 full-time employees specializing in the fields of biomedical engineering, molecular biology, physics, electronics, artificial intelligence, clinical oncology, product design, and manufacturing. Without them, we couldn’t have come so far.

As far as cancer is concerned, there are currently no blood tests with sufficient sensitivity and specificity that can reliably detect the disease at early stages, nor monitor the effectiveness of cancer treatments. This is mainly because, most of the time, the analyte measured by these tests is not specific to cancer. This need could be addressed by isolating and analyzing the circulating tumor cells that are shed directly from the primary and/or metastatic solid tumors in the patient’s body. However, distinguishing these cells from other cellular components of blood is a really complex task because of two reasons. The first one is that CTCs are very heterogeneous cells, meaning that their biological and physical characteristics differ from one another, which hinders their capture by conventional methods. The second reason is that the total number of CTCs that you can find are extremely low in comparison to blood cells. On average, you can spot around 40.5 billion cells in 7.5 milliliters of blood, while a cancer patient may have between one and 1,000 CTCs in the same volume. 

At Delee, we are transforming the industry by developing the technology that can tackle these challenges. We have created an automated device, the capture method of which is based on the size and deformability of the cells, enabling the effective isolation and analysis of the CTCs. Our technology’s sensitivity and specificity could allow physicians to detect cancer at early stages. It has the potential to provide them with the necessary information to tailor treatments according to each patient’s needs and also to monitor the effectiveness of said treatments.

The technology has been finished. At the moment, we are performing a final clinical validation using samples from prostate and breast cancer patients. Our plan is to begin commercializing our technology for research centers and pharmaceutical companies. This way, our technology could be used by these entities to study the molecular biology of these cells, identify novel therapeutic markers, and help them test new drugs. Our timeline is to pursue FDA clearance in the next three years in order to commercialize our technology as an in-vitro diagnostic medical device for hospitals and laboratories in order to impact as many patients as possible.

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 prostate-specific antigen (PSA), cancer antigen 125, and alpha-fetoprotein. However, these types of tests have 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. Take the PSA test as an example, which measures the amount of PSA in blood and is widely used for prostate cancer screening. Only 21% of men with prostate cancer have increased levels of PSA, whereas 11% of men with increased levels of PSA do not have cancer. This is only one of the many examples of why it’s necessary to develop blood tests capable of providing accurate information regarding each patients’ cancer. 

The isolation and analysis of CTCs from blood is a relatively new practice, and physicians are starting to recognize all of 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. 

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. Furthermore, our technology has several competitive advantages with regard to other platforms. For example, the technology has the sensitivity to isolate a single tumor cell from a background of more than 40 billion cells. In addition, all the processes involved, from sample preparation to the analysis of the captured CTCs, are completely automated. This increases the reliability and reproducibility of the assay by preventing human error. Also, unlike other technologies, ours can recover cells that are suitable for further molecular analysis, which can potentially provide more information regarding the type of therapy that will be more effective for each patient.

The funds from this round will be used to run a clinical study with samples from patients with prostate and breast cancer in order to clinically validate our technology, to start the commercialization of our technology for research centers and pharmaceutical companies as a research-use-only platform, and to begin the process to get FDA clearance for the commercialization of our technology as an in-vitro diagnostic medical device for use in hospitals and laboratories.

We are a solid and resilient company composed of several professionals specializing in different areas of science and technology. Our team is passionate and fully committed not only to the generation of knowledge but to the development of innovative technology with the potential to tackle transcendental and global health issues such as cancer.

Our technology aims to enable the early detection of cancer and to efficiently monitor the effectiveness of administered therapies, which would be translated into invaluable benefits for patients and their families, including the potential reduction of the incurred cost and negative side effects caused by cancer treatments and, most importantly, to significantly increase patients’ odds of defeating cancer.

Our technology is finished and patent-pending. The device is fully functional. Currently, we are successfully performing the necessary trials in order to get its clinical validation with prostate and breast 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.

To date, we have secured pre-orders from research centers of various hospitals that want to use our technology as an in-vitro diagnostic platform for research. These pre-orders have a potential value of more than $2.5 million. 

In the next 12 to 18 months, we are expecting to begin the process to get FDA clearance for the commercialization of our technology as an in-vitro diagnostic medical device for hospitals and laboratories.

Given that we are a medical technology company, recent success stories indicate that an acquisition or an IPO are the most likely exits for our company. On average, companies in the same field with previous exits take 10 years to exit. Taking all of this into consideration, I think an exit is achievable in the next five to eight years.

Historically, important positions at the social, political, and professional level have always been held by men, and the role of women used to be limited and underestimated. Fortunately, in the last few decades, the culture has been changing and has started accepting that women can perform the same roles as men in an outstanding way.

However, although society has made great strides on gender-equality issues, there is still a long way to go. Being a woman in the business world — let alone being a young Latina woman — is not an easy task. Although within the company there has always been an environment of equality, respect, and admiration toward both men and women, we have unfortunately not always encountered that same culture outside Delee.

It has been challenging to be a young Latina medtech company founder, especially when securing funding. Some people are still wary when they encounter a woman as CEO, and it’s hard for them to believe that someone like me can successfully run a company like Delee. I am delighted to witness that the industry seems to be making steps in the right direction, and now, with crowdfunding campaigns, these difficulties are reduced by allowing people from all fields to invest in a company they believe in, no matter who is behind it.

So, my advice to minorities, women, and anyone who wants to stand out in any business or project is to do your research and believe in yourself. It’s fundamental to surround yourself with people who share your dreams and values and who are willing to walk with you down even the roughest paths, and make sure that your partners have minds of their own, so together you can enrich each other. Pay attention to what others see in you as a liability and do what you can to turn it into a strength. Don’t listen to negativity, and let your actions prove them wrong. But the most important thing is to never give up. Always remember why you are doing what you are doing. Whatever you do, keep learning, keep growing, keep fighting, and keep working until you are satisfied with what you have achieved.