Biological Dynamics CEO Raj Krishnan and CFO Kevin Han shared what informs their vision for developing liquid biopsies to detect cancer at the earliest stages to ensure the best outcome for patients. This Q&A is based on emailed responses to questions.
Why did you start this company?
Raj: I feel like we’re put on this earth for a noble purpose and part of that goal for me is to build things that can help people. My motivation goes back to when I was growing up in the 1990s in the Bay area, where everybody was starting their own dot com companies. I always wanted to build something that would help save lives. I completed my PhD and ended up stumbling onto something that was pretty revolutionary—the ability to isolate biomarkers directly from high conductivity solutions—once thought to be theoretically impossible. The technology itself uses electrical engineering principles not typically seen in biological applications. We ended up patenting the technology and started looking for cancer biomarkers. I won several business plan competitions and used that momentum to launch the company. But I didn’t just want to build a company, I wanted to build a company that could make a true impact in the world.
Kevin: My interest in human health started during my high school years at North Carolina School of Science and Mathematics (NCSSM), where we were exposed to college-level biology classes. It definitely helped that during this time the Human Genome Project was being conducted, as my interest turned into a passion and curiosity for disruptive medical technologies. I finished my pre-med requirements at UNC-Chapel Hill and while the thought of helping patients in my local community was interesting, I felt that I could make a larger impact by advising companies dedicated to the mission of saving lives, globally.
After my studies, I took a job with Morgan Stanley and Goldman Sachs to research medical device and diagnostics companies and eventually became an investor in the healthcare space for over a decade. Fast forward to today, I am thrilled to be at Biological Dynamics during these exciting times. Given my career, I believe it is the perfect culmination of my past experiences, having been an investor in the diagnostics space as well as leading various financial and operational efforts for Bio-Rad Laboratories, an S&P 500 healthcare company. Biological Dynamics has a highly differentiated technology in the emerging and disruptive space of liquid biopsy. The ability to detect cancer at the earliest stages has the potential to save lives and deliver transformative improvements to the healthcare system.
What specific need/problem are you seeking to address in healthcare?
Raj: The earlier you detect cancer, the earlier you can treat cancer. The earlier you treat cancer, the higher the chance of survival. We want to focus on early cancer detection, beginning at stage 1A. At Biological Dynamics, we have developed a unique platform to enable early cancer detection, which will give oncologists the capability to intervene at the earliest stages of disease.
What does your product do? How does it work?
Raj: The difficulty that exists right now with early cancer detection is finding markers in the earliest stages. Current technologies are all limited by the methodology used to isolate molecules from blood, which often leads to errors. Biological Dynamics’ platform uses AC electric fields, similar to the kind that powers your wall socket, to isolate particles of a specific size range from blood, such as extracellular vesicles, long fragment DNA, RNA, or proteins. Our technology allows us to gently and non-destructively pull molecules of interest from solution without chemical or mechanical binding or subjecting them to shear stresses. Analyzing these molecules in their native state from a complex solution like blood provides a really good signal to noise ratio about whether or not cancer may be present. Our ultimate goal is to build an integrated infrastructure to identify and quantify markers of interest entirely on a chip without needing any additional technology.
Is this your first healthcare startup? What’s your background in healthcare?
Raj: Yes, this is my first healthcare startup. I have a PhD in bioengineering, and an undergraduate degree in electrical engineering. I got my start working at the Moores Cancer Center at UC San Diego. While I was around a lot of fantastic oncologists, I learned as much as I could to tackle one of the biggest problems facing humanity.
Kevin: I’ve been around the healthcare space for almost 20 years including my early studies and work in epidemiology, specifically studying the metabolic impact of various therapeutics on HIV patients. This research was presented at an international AIDS conference and resulted in the groundwork for many follow-on publications in leading academic journals. These achievements also led me to receive a full academic scholarship to UNC-Chapel Hill, where I continued to pursue my passion for human health. I was pre-med in university, and my organic chemistry professor, who helped develop the first bioabsorbable stent, was another inspiration of mine. As I got deeper into my studies and began shadowing doctors, I realized that I didn’t really like the hospital environment. I also started to realize that, even without performing surgeries or seeing patients face-to-face, you could positively impact patient lives with disruptive medical technologies. This ability to touch so many patients and impact their lives drew me to the investing side of healthcare. I started my career in equity research in New York City with Morgan Stanley and Goldman Sachs, covering medical technologies and diagnostics. Then, I managed a healthcare investment strategy at various investment management firms for over a decade, where I continued to focus on genomics related companies. And finally, before joining Biological Dynamics, I was Head of Investor Relations and Sustainability at Bio-Rad Laboratories, where I also supported various other functions such as corporate strategy, business development, corporate communications, and financial planning & analysis.
Who is your customer? How do you generate revenue?
Kevin: Our vision is for our multi-cancer screening test to become standard of medical care for everyone. Any time a patient visits their doctor for an annual screening, cholesterol or glucose testing, for example, a small blood sample could also be collected to screen for cancer. If we can make this part of the screening process for everybody, many more cancers will be caught at early, more treatable stages. If we are wildly successful, then we can all start to imagine a world, where being diagnosed with cancer at stage 3 or stage 4 is considered a rare event.
With that said, ultimately, the patient is our customer. However, the healthcare purchasing decision is more complex than your standard consumer or retail purchasing decision. In a standard purchasing decision, such as buying a computer, the person (or entity) that makes the decision of which computer to buy, also pays for the computer, and finally uses the computer for their needs. In the healthcare purchasing decision, such as a diagnostic test, the physician makes the decision which specific test is ordered, while the insurer/government pays for the product, and finally the patient is the one who benefits and/or uses the product. Therefore, although we view the patient as our final customer, we will require the support and buy-in from the entire healthcare system to fulfill our vision.
In the near-term, we plan to generate revenue through the LDT pathway as we have a CLIA lab at our headquarters in San Diego, CA. During the LDT revenue stage, we hope to generate revenue from larger self-insured employers and integrated health networks. Over time, we will pursue an FDA approval, which will be helpful to secure reimbursement through both commercial and government payors. The revenue through both the LDT and FDA pathways will be generated through a diagnostics-as-a-service (DaaS) model, which will not require our customers to buy any equipment or require annual CLIA waivers for our customers we will operate as a full-service lab, which will reduce friction for our customers while maintaining cost scale for ourselves.
Do you have clinical validation for your product?
Raj: Like other innovative types of diagnostic companies, we have to go through a proper regulatory process. Although our technology is not yet FDA approved, we are publishing data. This data gives us the confidence to proceed with the commercialization of our product.
Kevin: To support our clinical validation plans, we are currently in the final stages of a capital raise, which would be used for full analytical validation before setting up a larger clinical utility study. Our next focus is to launch our product through the LDT pathway and we will commensurately apply funds from the current fundraise to support this initiative. As you can tell, we are very excited about the company’s mission and we thank our teams for their dedication and support!
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