Rockland Technimed Ltd.
June 3, 2013 Issue
The Most Powerful Name In Corporate News and Information
Transforming the MRI to a Non-Radioactive Metabolic Medium of Cell Health through the Oxy-17®, Rockland Technimed Limited (RTL) is a Theranostic Imaging Company Committed to the Early Diagnosis and Treatment of Hypoxic Injury
About Rockland Technimed Ltd.
Rockland Technimed Limited (RTL)
is a theranostic imaging company committed to the early diagnosis and
treatment of hypoxic injury through Oxy-17®, its patented metabolic magnetic
resonance imaging medium. RTL has the world’s largest production source of
Oxy-17® Gas, an enriched form of naturally available oxygen, in compliance
with the cGMP requirement for medical gases, and commercially available in
the United States and European Union for more than 20 years. RTL’s lead
preclinical candidate, Oxy-17® Fusion, is the first ready-to-use intravenous
formulation of Oxy-17® Gas and is currently in regulatory marketing studies
in Germany (European Union) and the United States. Oxy-17® Fusion will be
commercialized in the United States by RTL and in the European Union by a
joint venture partnership company comprised of RTL and Nukem Isotopes GmbH.
Pradeep has authored more than 60 papers and 12 patents, and served on the editorial review board of the Journal of Clinical Engineering and Quest’s Prosthetics & Orthotics newsletter. In addition, Pradeep was an active contributor to the medical device standards for the American National Standards Institute and a member of the Technical Advisory Group (TAG) for European standards. Formerly a consultant and voting member of the FDA’s Device Good Manufacturing Practice Advisory Committee, Pradeep is currently a member of the American Heart Association, American Association for the Advancement of Science, New York Academy of Science, and the International Society of Magnetic Resonance in Medicine. Pradeep holds a B.S. in engineering from Gujarat University in India and a M.S. in biomedical Engineering from Farleigh Dickinson University. Pradeep completed his thesis in Patient Data Management in Critical Care Decision Making at the Columbia Presbyterian Medical Center of Columbia University.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – June 3, 2013
CEOCFO: Mr. Gupte, would you tell us the vision when you founded Rockland Technimed Ltd and where you are today?
Pradeep Gupte: The vision was to make an off the shelf ready to use non radioactive metabolic imaging medium available that could be used clinically, because that was the most important requirement as I saw it. In terms of the clinicians wanting to assess the patients, my assessment was that a metabolic measurement, easily done in a clinical setting, was what would solve most of the problems. To date, we have demonstrated and secured all of the components that can do that. The only other way to do this is by today’s technology using an injection of radio tracers in conjunction with nuclear and structural detectors. Therefore, we are transforming the MRI in to a non radioactive metabolic medium of cell health.
CEOCFO: What was involved in the process of developing your products?
Pradeep Gupte: We had discovered this phenomenon in the late 1980’s and early 1990’s, where a hypothesis was proven in an animal model. The difficulty was the sourcing of materials. There were no sources of Oxygen 17, which is fractionated from the air we breathe in high concentrations and commercial quantities. There was a source that was developed by the Russian Academy of Sciences, when it was the USSR, in the Republic of Georgia. That source used to supply research quantities throughout the world. The US also had a program with stable isotopes at Los Alamos, but that was shut down. There was a commercial producer in Miamisburg Ohio whose columns burst and they are not getting any approval to restart them. That company was basically acquired by Sigma Aldrich and is now just liquidating whatever inventory that they had. However, they able to provide Oxygen 17 gas in research quantities to various researchers from their depleting inventories. That was one component of the problem. The other component of the problem was how to deliver Oxygen 17 gas, which is very expensive to fractionate, to target tissue so that the product can be economically viable. The original science was around inhalation of Oxygen 17, because it is no different than Oxygen 16. However, that is a most inefficient way of doing it, because the material costs just for the Oxygen 17 was running around ten thousand dollars per test. In addition to that it has multiple other disadvantages of delivering it through the lungs, because the lungs do not deliver the same concentration that you breathe. It needs several breaths to adequately oxygenate the blood as a carrier, plus it has residual capacity. By the time the concentration goes to the cells it is much different than what you are breathing. Were we are today is that we have secured the Oxygen 17 gas in commercial quantities. We have also developed our carrier material; a synthetic oxygen carrying fluid on which Oxygen 17 is dissolved, because you cannot inject gas into the circulatory system. We have loaded that emulsion with Oxygen 17 and demonstrated that the system works in a biological system. There have been papers published to that effect and we can share the bibliographies. We have gotten funding through Phase III clinical trials. We are now in wrap up of our production of the pre-loaded emulsion, which required manufacturing of the oxygenating component in addition to making the emulsion. It is a room temperature stabled emulsion that now gets loaded with Oxygen 17 and gets administered by injection. We have done the packaging in syringes and in vials. Our manufacturing partners for that are BD Medical for the syringes and we are in that process. We have met with the German BfArM and US FDA. They have lowered the bar for us. In other words, they do not want us to make a comparison to Positive Emission Tomography (PET) a research Gold Standard, because PET is not an approved clinical test in Europe. What they suggested is to concentrate on showing that there is actionable information that can be gleaned after using our OxyFusion™ medium.
CEOCFO: Has the medical community been actively looking for a better solution?
Pradeep Gupte: Yes. The medical community has been very active and towards that end we have been holding user group meetings to basically discuss with all of the leading scientists in the world during the International Society of Magnetic Resonance Imaging in Medicine (ISMRM). We exhibit there and we also have been conducting Oxy-17® user group meetings, where we invite everyone who is interested in this particular technology to come. We have a following of over thirty to fifty people who come every year and consists of leading research institutions, including German Cancer Center Heidelberg, Juelich University, Tuebingen University, Oxford University, The University of Pennsylvania, University of Illinois in Chicago, Washington University in St Louis, University of Minnesota and Case Western Reserve University among others.
CEOCFO: Are you aware of any competing technologies that are in the works?
Pradeep Gupte: Yes and no. There is no direct competing technology, because we are a Non Capital Expenditure (Non CapEx) solution. In other words, the big giant companies, even big companies like Philips, GE and Siemens had come up with a similar solution, but using old technology. They are using MR or CT in conjunction with a PET insert. Positron Emission Tomography is still the old technology, injecting an ionizing radio tracer and then superimposing that image with the MRIor CT scanner. The reason that they have to do that is because you need to do co-registration to make sure that you are imaging within that same geometry. We do that with just a NON CAPEX solution by injecting our non radioactive OxyFusion medium and an MRI scanner takes picture, giving us both the function in the context of the anatomy with the highest resolution of the MRI.
CEOCFO: What is the timetable? Is it the next six months or a year?
Pradeep Gupte: The timetable is that we are now ramping up our production. We hope to begin the animal studies mid 2013. The reason why we have been asked to do animal studies is because it is a proprietary formulation for the carrier material and we are loading Oxygen 17 onto it. Therefore, we believe that this material has been used in many patient clinical trials as blood substitutes in the past. However, it is a stabilized emulsion that will require a five month program that will start on July first. Upon conclusion of that program we will file an Investigation New Drug (IND), both in Germany as well as in the US, because we have a global regulatory program. We have already recruited and worked with Dr Regenold GmbH as our regulatory advisor. We have identified ACR-Image Matrix (American College of Radiology), out of Philadelphia to be our Clinical Research Organization (CRO) in the US as well as collecting the data from Europe. We have already identified the sites where the Phase I, Phase II and Phase III trials will be conducted. We have met with and qualified those sites, and are now ready, as soon as we have finished our animal tests.
CEOCFO: How do you handle the frustration of how long the process takes?
Pradeep Gupte: Because I am motivated to bringing a clinically usable metabolic medium. That is my mission in life at the moment. Frustration is there, but that is not what I am looking to do. I am basically focused on getting a clinical medium for patient use and making it available. That is because this is a game changing, paradigm shifting technology which I am not willing to shelve because it is going to disrupt some of the existing paradigm.
CEOCFO: Is Rockland Technimed funded through the next steps?
Pradeep Gupte: We are funded through Phase III.
CEOCFO: Will you be doing partnerships or joint ventures as you go further? Do you have a plan in place yet?
Pradeep Gupte: Yes. We do have a plan in place. We will talk to marketing partners who will be interested in working with us at this stage. If they work with us and contribute they could have marketing rights for certain regions in the country and in the world, because we are still non-committed on this. In addition to that; this is as I mentioned a platform technology, so even though we are getting approved for one indication, it is a Theranostics product. Therefore, even though it is a diagnostic it has therapeutic impact, even though we are not seeking approval to make that claim. However, it is oxygen being delivered to hypoxic and ischemic tissue. It has multiple applications. It can go into any ischemic tissue; such as, the brain, the heart, in the vasculature, transplants, tumor oxygenation for effective radiation therapy, epilepsy mapping and so on. That is the reason why frustration is not something that deters me from pursuing this for all its major applications.
CEOCFO: Why should investors and people in the business community pay attention to Rockland Technimed?
Pradeep Gupte: Because it is a paradigm shifting technology. If they are investing in drugs or in equipment that is a current technology they are probably going to be blindsided by it when this comes to clinical use.
CEOCFO: Final thoughts?
That there is hope now
for stroke patients. There is hope for patients who get disabilities after
getting a stroke, because we believe that we can contribute to increasing
the treatment of stroke patients from the current 8-ten percent to about
thirty to forty percent, thereby reducing the residual disability, therefore
contributing towards the reduction in healthcare disability costs, but more
importantly, destabilizing families and all of their finances when the
families bread earner ends up with a stroke disability.
“Elevating MRI into Real-time Monitor of Cell Health”- Pradeep M. Gupte
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