Biological Dynamics Inc.
May 19, 2014 Issue
The Most Powerful Name In Corporate News and Information
AC Electrokinetic Technology for Physiological Solutions
Biological Dynamics Inc.
Dynamics Inc. is an early stage company that has developed a proprietary AC
Electrokinetic technology to rapidly extract nanoparticles in
high-conductance physiological solutions.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – May 19, 2014
CEOCFO: Dr. Krishnan, what is the concept at Biological Dynamics?
Dr. Krishnan: We are an Engineering nanotechnology firm rooted in developing quantitative medical devices to help advance the field of clinical diagnostics and therapy monitoring. Our proprietary technology uses AC Electrokinetics to rapidly isolate blood based biomarkers that are indicative of disease and disease process. We can extract these informative biomarkers directly from whole blood without any pre-processing in under 20 to 30 minutes.
CEOCFO: What part of that is novel? What is the history around what you are doing?
Dr. Krishnan: The field of AC electrokinetics started in the early 60s and 70s and many academics and commercial firms have used AC electrokinetics (which is a combination of Dielectrophoresis, AC Electrothermal flow, and AC ElectroOsmostic Flow) to isolate and quantify interesting particles from a variety of fluids. Some of these fluids have included blood, plasma and serum. All groups from the past had to dilute the raw sample by 100 to 1000 times in order to allow the AC Electrokinetic force to be strong enough extract nanoparticles from the solution. This renders the technique virtually useless for direct clinical applications because the low concentrations of nanoparticles become much harder to find when you dilute by that much. Think of a needle in a haystack, and the haystack is thrown in the ocean. Good luck finding it. We at Biological Dynamics have developed a method to utilize the AC Electrokinetic phenomenon without needing to dilute. This enables us to develop rapid point of care style applications for the clinical diagnostic and treatment monitoring market.
CEOCFO: What is on the chip? What have you learned will do the job?
Dr. Krishnan: For my PhD thesis at UC San Diego, I worked with microelectrode arrays and explored their utility in detecting biomarkers in some cancer, heart disease and stem cell models. My undergraduate background is in Electrical Engineering and I did my PhD research in Bioengineering in Dr. Michael Heller’s Lab. We initially tinkered with the microarrays to isolate nanoparticles just to see if it could even work. It was very vague, but at the same time pretty cool. The real fun started when we began working with the Moore’s Cancer Center. We started getting some biological samples of patients, running it through our systems and realized when we turned on an electric field in a specific pattern, we were able to pull out biomarkers found in cancer patient samples that did not show up in normal patient samples. We followed this thread and identified that these particles were actually cell free circulating markers like exosomes and DNA. This has been a hot topic at many conferences like AACR and ASCO, where people are trying to isolate these biomarkers and look for specific properties like concentration and mutation analysis. So normally, your blood has two size ranges of particles in it. Really tiny particles like ions, immunoglobulins, serum ablumin and apoptotic size normal DNA. There are also really big particles like red blood cells, white blood cells and platelets. With rare exceptions, anything in between those size ranges is not supposed to exist in your blood. This is because your body naturally filters them out. In disease, especially chronic inflammatory diseases like cancer, there is a continued release the in-between size range particles that your body can’t filter out fast enough. If you can isolate those specific particles, you can get a completely different look at the state of the disease. We, at Biological Dynamics, believe that those biomarkers can be used as specific and sensitive biomarkers in disease detection and tracking.
CEOCFO: Is all cancer the same in this insistence?
Dr. Krishnan: So what is the definition of cancer that we use? It is basically a bunch of cells dividing uncontrollably and replicating like crazy. As this process continues, most of the replicated cells are not healthy viable cells and they die rapidly because they are not able to get enough nutrients. When they explode, they release these huge chunks of DNA and other particles into your blood stream. Our technology is able to extract those chunks, the unnatural disease related chunks. Because we do that, we believe we have a unique secondary biomarker that can potentially span many cancer models. This is the beauty of the technology. Most other groups are trying to characterize tumor nucleic acids using PCR or sequencing. They take a sample of your blood or tissue, go through complicated sample prep steps to extract DNA or RNA, and look for are specific tumor mutations like EGFR or BRAF that work for specific cancers. This is a great approach, but it is limited because mutations aren’t present in everybody or in every cancer. For instance, there are a couple drugs out there if you have a specific set of mutations in lung cancer. These mutations however, only encompass about 12 to 25 percent of all lung cancer patients worldwide. The remaining 75 or more percent do not have these mutations at all and therefore mutation characterization can’t help them. What we do instead is look for a secondary biomarker, like cell free DNA that exists as a result of your cancer penetrating the tissue around it.
CEOCFO: Why not have it a part of standard blood testing?
Dr. Krishnan: Having a general screening test to detect cancer is a tall challenge. Cancer is so heterogeneous, it might be impossible to screen using a simple blood test. That being said, we believe that in at-risk populations such a simple blood test might be a low-cost viable option to track the increase in onset of dangerous cancer. Whole body imaging is able to show strange blips in the body, but most of them aren’t dangerous and go away on their own. Our goal is to develop actionable blood tests that help clinicians make better decisions regarding diagnosis and therapy as fast as possible. Our goal is to pursue FDA approval for treatment monitoring, prognosis, early recurrence, and eventually early detection. We want to do this step by step. One of the major challenges in cancer treatment right now is for the physician to know if the therapy they’ve prescribed is even working. Cancer therapy is essential toxic poison to kill the cancer cells. That poison kills normal cells as well. If doctors had a way to assess if the therapy were working early on, it can help them reduce the dosage of the toxic poisons and potentially stop giving them the poison earlier because they’ll know the cancer is gone. We, at Biological Dynamics, feel like that is the first challenge in cancer to solve. After that, going after early screening is the next one.
CEOCFO: Is the medical community aware of what you have developed or is it too early?
Dr. Krishnan: It is still a little early. We’ve taken the last few years to develop and ensure that our technology is robust, repeatable, and quantitative. We are currently scaling the technology to implement it in our clinical lab and pursue FDA clearance. We’ve decided to remain in stealth mode. We do have some active collaboration with the Moore’s Cancer Center and are going to start expanding our collaborations in the next few months. Our goal is to setup our assays in our CLIA and CAP accredited clinical lab and then make ourselves known to the larger medical community. We believe this will engender confidence in our future diagnostic and clinical partners because they’ll see that we’ve taken the time to do our diligence and make sure that what we’re doing has strong data sets backing it up. That is the true key to obtaining widespread clinical adoption.
CEOCFO: Are you funded for the next steps?
Dr. Krishnan: We are currently in our Series B round. We are proving the commercial viability of our technology, assay ideas and showing the technology can scale in terms of manufacturing. We are well funded for the next 18 months. We’ll be raising our Series C in early 2015.
CEOCFO: What do you see as a challenge as you move forward?
Dr. Krishnan: Since we are a start-up company undergoing the transformation to an early stage revenue company, the main challenges we see are: successfully getting through the proverbial “Valley of Death” for a Biotech company and generating revenue that makes us a successful commercial entity for many years to come.
CEOCFO: These are very exciting times for Biological Dynamics!
Dr. Krishnan: Yes indeed, but it is also nerve-wracking. It is one of those things where you get more anxious, cautious, and nervous the closer you get to the finish line. When we started, we saw the mountain and were very excited to get started on the journey. Now that we’re very close to the mountain top, we’re very excited and eager to reach the peak, but realize that there is more after reaching that goal. I stay up a little bit at night and worry about all the things that can derail us, but hopefully with a little luck and grace we can get through it.
CEOCFO: Put it together for our readers. Why Biological Dynamics?
We are doing
something unique and revolutionary. In addition to that, we have completely
proprietary technology. I’ve been able to put together a team of young
Molecular Biologists and Bioengineers all with Masters and PhDs and my team
is eager to help change the way clinical diagnostics work. With the changing
paradigms of healthcare and technology placement in the clinic, physicians
need tools that enable them to make better decisions regarding patient
health and hopefully enable better outcomes and lower costs. This is
especially needed in the fields of oncology and cardiovascular disease. My
group at Biological Dynamics utilizes our respective backgrounds to help
create quantitative, reliable, and robust tools that will, God willing,
enable this wave of change required to truly help save lives while lowering
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