Cyto Wave Technologies CEO: First Device to Detect Circulating Tumor Cells In Vivo

Cyto Wave Technologies’ iV3 device can detect circulating tumor cells in real time via laser technology and potentially destroy cells.

The company’s first-in-class platform technology — licensed from the University of Arkansas for Medical Sciences — could allow for the early non-invasive detection, capturing and targeted destruction of metastatic CTCs in vivo.

Cyto Wave is only a few months old — the company was first established in September 2012 — but has garnered significant support as well as displayed a unique market opportunity. The company has raised over $4.4M through the National Institutes of Health, Department of Defense and private investors — many of whom are cancer survivors.

Early-stage circulating tumor cell detection is an area of notable unmet medical need. Veridex — a Johnson and Johnson company — markets the only FDA-cleared test CTC test. Veridex’s CELLSEARCH test is an in vitro approach, which requires detection outside of the body; the technology results in a low sensitive system, and thus significant limitations for early and accurate detection — J&J’s test cannot detect less than 5,000 CTCs in the body. In vivo detection, on the other hand, could allow for detection of less CTCs in a smaller blood sample size.

iV3 will initially target melanoma, and the company will initiate human clinical trials in 70 patients by the end of June. Cyto Wave expects results in Q1 of 2014.

OneMedRadio spoke with Cyto Wave Technologies President and CEO George Yu about the favorable on-ramp to commercialization, clearing regulatory and reimbursement obstacles and the vast opportunity for in vivo CTC detection.

Click to listen to the audio, and view the transcript below.

Matt Margolis:      OneMedRadio welcomes George Yu, President and CEO of Cyto Wave Technologies. Cyto Wave is developing the product IV3, a first in class medical device that could allow early detection, capture and target destruction of metastatic circulating cancer cells in vivo. Cyto Wave will present at the upcoming OneMedForum taking place June 26th and 27th in New York City. Thank you for joining us George.

George Yu:      Pleasure to be here.

Matt Margolis:      I want to start with a snapshot of the company. What makes the IV3 device unique?

George Yu:      Cyto Wave was founded about six months ago and what we have done so far is licensing of technologies out of the University of Arkansas, that’s essentially a laser technology that could allow the early, non-invasive detection of metastatic cancer cells in vivo. So what’s unique about the technology is that we are using a laser that points to a blood vessel in the hand on your arm. And as cancer cells pass by in the blood stream, the laser gets absorbed by cancer cells and the cancer cells and emit an acoustic wave that we can detect through an ultrasound transduser, and we can literally count the individual cancer cells that are fairly separated from the background noise that are typically red blood cells.

MM:      So I understand that the only option that’s available right now is in vitro detection. So why does that come up short?

GY:      That’s correct. The current technologies on the market are in vitro assay technologies. The issue of in vitro detection is that you can only take a small blood sample, let’s say a milliliter of blood, and you are limited in terms of sensitivity by the small blood volume. So the human blood volume is about five liters, and we take one milliliter of blood as a sample for in vitro detection. If you only detect one cancer cell in one milliliter, that one milliliter actually translates into 5,000 cancer cells in the body, since you have five liters of blood flowing in the patient.

So you can really not detect less than 5,000 cancer cells in the body. And at that point it’s typically too late for the patient. You already have metastatic cancer manifested itself in the body, and you can’t really intervene. Physicians would like to be able to test metastatic cancer cells earlier.

That’s why we use the technology that uses the in vivo technology where you can literally measure the five liters of blood volume. So if you use the laser technology pointed to a blood vessel in the human body and you wait about an hour, you measure the entire five liters. If you detect 50 cancer cells in five liters, you basically have a 100-fold improvement of the sensitivity. If you can detect five cancer cells with our technology in five liters of the human body, you have a 1000-fold increase of sensitivity.

MM:      Give us a history of how the company was founded as well as the financial structure.

GY:      We started out this company about, nine months now, so we started basically in September 2012. The company, with a number of founders, was funded by a number of high net worth individuals and cancer survivors and some of them were both. Some initial founders and investors were somehow related to the University, had some kind of relationship with the University. To this point we raised about $1MM so far, which is enough funding for about a year or two, and to do the first clinical trial, as we are planning to initiate by the end of June of this year.

The plan right now is initially to test six to 10 patients with the technology, given that all the animal studies have been completed, all the pre-clinical proof of concept studies have been completed. Then the next set is really to demonstrate clinical proof of concept in patients for the next six to nine months, essentially.

And the plan there is really to optimize the prototype, and also to test a number of healthy volunteers so we can determine a baseline signal for the prototype. Then later this year probably in Q3 or Q4, 2013 we will start testing 30 to 60 melanoma patients with results expected in the first quarter of 2014.

MM:      Talk about your IP position.

GY:      We have three patents pending right now that basically protect the device and the method of detecting, not only metastatic cancer cells in the blood, but generally speaking objects that are floating in the blood volume, including blood clots. That’s another technology we could potentially develop. But our first goal is to develop technology for metastatic cancer cells. As we approach different milestones and potentially strategic partnership with larger commercial companies, we could then pursue the technology for other applications like clot detection.

MM:      I want to talk about some logistics facing the physicians. So firstly, go into some detail of the ease of use.

GY:      The prototype that we have right now is portable prototype. It’s about the size of a small desk and then you can basically roll it around in a hospital. The device itself will be used in a hospital setting and office setting. Typically what you do is, you need to have a patient sit or lie next to the device, and have the blood volume measured for about an hour. So that’s something that can be fairly easily done in a hospital or office setting. You have a real time read-out of the results, so that’s easy for the physician or a nurse or physician assistant to handle.

So you don’t really have to, as is the case right now with in vitro assays, take a blood sample, send it to the pathologist and wait for a certain time until you get the results back. With our device you have the results literally immediately, within an hour. It’s fairly easy to use.

MM:      What case studies exist for cost and reimbursement?

GY:      The only in vitro device that is approved by the FDA for detection of metastatic cancer cells is J&J’s — Johnson and Johnson — Cell Search System. That’s been approved for colorectal, breast, and prostate cancer. J&J has done a pretty good job in terms of preparing the market, or basically creating the market, in the oncology space. The Cell Search System is being reimbursed by Medicare right now, also given that a lot of the cancer patients are Medicare patients. Also a lot of the commercial plans are reimbursing for it. So we feel confident, given that the in vitro device is being reimbursed by most plans, that our in vivo device – which, when proven effective, clearly has a clinical benefit compared to an in vitro device – could also be reimbursed.

MM:      What initial markets are you targeting?

GY:      We are targeting the melanoma market right now. One of the reasons why we picked melanoma is that it’s an aggressive cancer with a high prevalence. Given the aggressiveness of the cancer, there are a lot of patients developing metastatic disease. So there is a lot of unmet need in the market for an in vivo detection system. Also given that there are not a lot of options right now – there is not even an in vitro assay or device specifically approved for melanoma cells.

The other reason why we picked that market is also that with our technology, we don’t need any, basically, contrast agents to detect melanoma cancer cells because we’re using the melanin that’s contained in the melanoma cancer cells as a contrast agent, which is basically an intrinsic contrast agent. I think a little bit later, once we develop that indication more, we will probably go into other indications, other cancer types. At this point we see for cancer types like breast cancer, rectal cancer, we will probably have to choose a contrast agent that we can basically develop by using antibody assays to use as contrast agents.

MM:      So what milestones can we expect in the near term?

GY:      We are going to initiate the first patient and test the first patients by the end of June, and we will have the read out of about six to 10 patients by the end of August of this year. That will be a fairly good clinical proof of concept trial for us. After that we will start testing various patients in different types of stages of cancer. So the first stage would be late-stage cancer patients where we just basically demonstrate that our technology is as good as an in vitro assay, and then with the other cohort we will test early stage cancer patients where we will demonstrate that we can detect a higher sensitivity than with in vitro assays. We will see those results probably in the first quarter of 2014.

MM:      Lastly I want to talk about some industry trends. How does non-dilutive financing help bridge the funding gap?

GY:      There are several options. There is venture debt out there right now, so we will certainly be open to consider that. The other option is to enter a strategic partnership, hopefully maybe early of 2014. If those partnerships include any milestone payments or royalty streams, we can monetize that. So that will be another option to non-dilutively finance the company.

MM:      That was a company snapshot of Cyto Wave Technologies with George Yu, President and CEO. Cyto Wave will be presenting at the upcoming OneMedForum, taking place June 26th and 27th at the Metropolitan Club in New York City. For more information about the company, visit the OneMedPlace database page.

The comments are closed.