Dr. Amit Vohra is the founder & CEO of Promaxo, a company tackling prostate disease management through the development of an office-based MRI. Brett Johnson interviewed Dr. Vohra to find out in part, what distinguishes Promaxo's technology from the conventional MRI, its benefits and future applications, and the current state of prostate diagnosis today.
Brett Johnson: Can you first tell us, what does Promaxo do?
Amit Vohra: Promaxo is focusing currently on changing the paradigm of prostate disease management. Our platform technology is a cost effective, office-based, high-resolution MRI, through which we can enable targeted biopsy and potentially focal treatment.
BJ: When you say "office-based", is that different than what's out there today?
AV: Yes. When you look at MRIs today, they require building infrastructure for them, that is entire MR suites. Typically, conventional MRIs weigh tens of thousands of pounds and the cost of the device could run into millions of dollars. What Promaxo is planning to do is have a compact system with a single-sided configuration that could be placed in an ambulatory surgical setting or an office space setting at a significantly cheaper price point.
BJ: Will the quality be comparable to a regular MRI?
AV: Exactly. The idea is that the whole technology is based upon getting extremely high spacial resolution, with a small magnet. That's where our technology and IP lie. We have shown that by using strong and fast rise and fall gradients, we can achieve extremely high spacial resolution. We are not comprising on the quality, so we believe it would be comparable to or better than a regular MRI.
BJ: That would be a pretty significant advance. Are there any limitations to this new approach?
AV: I think we will be able to do most of the things, except we would have a focused field of view, so this would not be a whole body scanner. That's why we are focusing on the pelvic region, and looking at the indication of prostate cancer. We would have a field of view of about six inches.
BJ: I would assume that there would be a substantial cost reduction. Can you speak a bit about the difference in cost?
AV: We are planning on having our system at a price point of less than half a million dollars. This would enable a much cheaper MRI solution, as opposed to the $2-3 million dollar cost of a conventional MRI. Another thing that I want to focus on, is that we are completely non-invasive. So, we do not require the use of endorectal coils, or anything that creates an invasive environment for patients.
BJ: How is prostate cancer diagnosed today?
AV: Prostate disease management is based upon an archaic pathway. We start with a screening tool, that is PSA (Prostate-Specific Antigen) which has been much maligned. U.S. Preventive Services even came back and said, "Don't use PSA.", however we currently do not have any better screening tool available today. The problem doesn't just stop there. Once you have a high PSA, which has a low specificity of around 35%, we confirm disease diagnosis through a blinded biopsy procedure, wherein less than 1% of the prostate gland is sampled/biopsied under 2D ultrasound.
In my previous companies, and over the last ten years, multi-parametric MRI has been shown to have high sensitivity and specificity for detecting clinically significant prostate cancers. However, the problem there is that it involves a convoluted pathway of using a $3M MRI, having the patient being shepherded between the urologist and radiologist, and a subjective scoring system that most radiologists are still not trained on or comfortable with.
Finally, mpMRI requires adding a fusion device, which is another quarter million dollars, with no existing reimbursements. What Promaxo is trying to do is, by placing an office-based MRI in the urologist or radiation oncologist's office, we can enable a point of care shift, where patient can be screened and diagnosed right there, leveraging existing CPT codes.
BJ: One of the issues that you mentioned earlier in previous conversations, is the biopsies. Can you discuss this, since you would be avoiding this process, correct?
AV: Yes. Currently, the PSA is not a good indicator, since it's not specific to prostate cancer. A lot of people who have a high PSA, end up going through a biopsy protocol. They could go through multiple rounds of biopsies before the cancer or legion is located in the body. Or, they might not even have prostate cancer, and they might be getting over-treated.
By creating a baseline on patients using MRI as a screening tool, along with genetic biomarkers, we could enable the physician to make a guided decision on which patients should undergo a biopsy protocol. Also, by bringing them a tool which could localize tumors, we enable them to do an MRI-guided biopsy in the clinic, which could lead to higher cancer detection rate.
BJ: You mentioned that PSA has been reduced in terms of its value. Can you talk a bit about the state of the art today, and what is accepted for identification of prostate cancer?
AV: PSA is the screening tool even now, despite the U.S. Preventative Services Task Force and AUA (American Urological Association) saying not to use it as much. That really is the conundrum. So, if you don't use PSA, what do you use?
We can see from the prostate cancer diagnosis and mortality data in the last few years, and more recently in publications, that if you don't use PSA as a screening tool, then the number of prostate cases drops down. However, it fails to impact the number of deaths happening from the disease. As a result, we are not sure if we are truly impacting the mortality rate.I sincerely believe that imaging has a role to play here. We need to follow how breast cancer is being diagnosed today. When you look at breast cancer, you have biomarkers which look at the disease from a early screening standpoint, and you use mammograms to supplement that information. That's how we see the prostate cancer diagnosis progressing. MRI could help screen and diagnose prostate cancer, and biomarkers, once they become available, can supplement the imaging capabilities that we can provide.
BJ: Can you talk about the origins of the business and this technology? Where did this idea come from?
AV: This is an amazing technology which was developed by our licensor, Weinberg Medical Physics, in North Bethesda, Maryland. WMP, which is led by Dr. Irving Weinberg, a diagnostic radiologist and a plasma physicist, developed this under NIH and NSF funding. Close to $9M of grant money has gone into this technology over the last eight plus years.
The technology is much more advanced than a typical start-up idea. We've performed safety trials with the technology, showing that it is safe for human subjects. We've done ex-vivo work on prosthetic tissue and demonstrated 30 microns spatial resolution over a limited field of view. The technology is protected by 17 patents, four of which are issued in the U.S. and China.
BJ: How did you become involved in the organization?
AV: Dr. Weinberg and I met at an NCBiotech event in 2014. Dr. Weinberg was showcasing his technology, and we started talking and spent about a good year developing the business strategy and the right business plan to start Promaxo.
That's where I got Michael Bartholomew, my co-founder involved in it, in August or September of 2015. We even presented non-confidential aspects of it to a couple of big players in the space to see what their take on it would be before we started the company. We received incredibly positive input from all of them, in that this technology could change the point of care and the paradigm of how this disease is being managed. We started the company earlier this year and have had great traction from the physician community and even from the investment community.
BJ: You indicated that the first application was prostate. Will there be future applications for the technology and if so, what would they be?
AV: We believe so. The MRI is currently targeted as a pelvic scanner, and when we talk about a pelvic scanner, we are not just talking about prostate cancer. The scanner could be used for benign conditions of the prostate, or potentially female urology indications, ovarian and cervical cancers.Our target customers segment for most of those would be urologists, radiation oncologists and OB-GYN specialists. We have also had interest from the sports medicine community, where office-based MR application could be explored for knee, foot and ankle scans.
BJ: In terms of the strategy going forward, what are the current big milestones for the company?
AV: The company is looking at our alpha clinical prototype to be ready by March or April of next year. Once we have that, we plan to do some animal studies, specific to the pelvic region. We are looking at having our first human studies in prostate scans around the fourth quarter of 2017. So that's where the company is right now. The MRI product itself is about a couple of years from market. We plan to launch it early 2019. From a regulatory standpoint, its a conventional 510(k) pathway, and we have had early conversations with FDA consultants. Within our management team, we've taken seven products in the medical imaging space through the 510(k) pathway. We are confident that we have a good, sound strategy around it.
BJ: Can you talk about strategic partnerships? Do you envision collaborating with any of the larger organizations in the space?
AV: The company is extremely focused on leveraging strategic partnerships. Our goal as a company is going to be the innovative platform, for large OEMs. We are already in conversations with a couple of them, one for the scanner itself, and another one for our consumables. We also have product in development where our MRI could localize brachytherapy. We are in conversations with a leading OEM in radiotherapy. So yes, the company believes that by leveraging its strategic partners, it could get to the right scale. We are extremely focused on that and we have great relationships in the space that we plan to leverage at the right points in time.
BJ: Sounds like a terrific success in the making. Thanks for much for joining us today.
AV: Thank you, Brett. I appreciate it.
BJ: That was Dr. Amit Vohra. He is the founder & CEO of Promaxo, developing an innovative technology in the diagnostics of prostate cancer._________________