2C Tech Corporation, Inc.
November 12, 2012 Issue
The Most Powerful Name In Corporate News and Information
With only a few Approved Therapies Available for the Sixteen Million Americans suffering from Degenerative Eye Diseases such as Diabetic Retinopathy and Macular Degeneration that can lead to Blindness, 2C Tech Corporation is Offering Hope with their Breakthrough Nanotechnology Based Medical Device the SeeQ
About 2C Tech Corporation, Inc.
Ramgopal Rao is a serial entrepreneur with 25 years of experience in the ophthalmic pharmaceutical and device industry. Currently he is Chief Executive Officer of 2C Tech Corporation, Inc., an emerging medical device company that is developing a novel nanotechnology application for preservation of vision for patients with macular degeneration and diabetic retinopathy.
Ram is inventor, founder and
CEO of LensGen, Inc., a start-up medical device company that is developing a
novel intraocular lens for presbyopia. This technology has potential to
restore youthful vision for everyone over the age of 40. The Company has
received support from one of the largest medical device companies in the
He was Chief Operating Officer and Director of Vitreoretinal Technologies, Inc., a venture funded ophthalmic pharmaceutical company that developed a drug for diabetic retinopathy.
Mr. Rao co-developed an
innovative corneal implant device for presbyopia and licensed the technology
to (venture funded) Acufocus, Inc. The company is now in its final stage of
US regulatory approval process.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – November 12, 2012
CEOCFO: Mr. Rao, what is the focus at 2C today?
Mr. Rao: We are trying to prevent a number of diseases that cause blindness. These are generally what we call in our business retinal degenerative diseases. That would be things like macular degeneration, retinitis pigmentosa and diabetic retinopathy.
CEOCFO: What approach are you taking? How does it differ from the approaches that have been taken so far?
Mr. Rao: This technology that we developed at the University of Colorado is quite unique and quite novel as well. It basically operates on the principal that if you take any degenerating cells in the retina and stimulate them with a small amount of electricity, as a natural defense mechanism they release a whole slew of neurotrophic factors and growth factors, and they in turn protect the cell from degeneration. That is how you arrest the progression of the disease and you may also reverse some of it, but not completely. This approach is pretty unique because we are using neuronal electro stimulationan nanotechnology. We actually inject semiconductor nanoparticles in a suspension into the eye. They migrate into the retina and they convert ordinary light coming into the eye into electricity, therefore you do not need external wires or batteries or any kind of implantation within the retina, none of that. It is minimally non-invasive and quite effective. These nanoparticles clear the eye in about three months and then you have to re-inject them.
CEOCFO: Are you injecting them right into the eye?
Mr. Rao: Yes, we inject them right into the eye; into the vitreous.
CEOCFO: How do you do that painlessly?
Mr. Rao: You just administer a topical anesthetic. This is not a new thing. Many drugs that are given for retinal diseases today are also injected into the eye. You use a very small thirty gauge needle and you generally do not need anything other than placing a few drops of anesthetic and an antibiotic with the injection. For example, there is a drug called Lucentis for the wet form of macular degeneration. This drug is sold by Genentech Roche. Those are monthly injections for those patients. Each injection costs two thousand dollars and is covered by Medicare.
CEOCFO: You say this is going to work for a variety of conditions. Is that because the root cause is all the same or covers the same areas?
Mr. Rao: The end stage in all of these diseases is that the photo receptor cells, those are the rods and cones in the retina, start degenerating. That is what really leads to the blindness. What we are doing is essentially preventing the degenerating process to continue. Whenever you start the treatment, hopefully that is where the degenerating process will stop.
CEOCFO: Where are you in the development process?
Mr. Rao: We have worked for about four years in the labs in the University working with various animal models. We can work with animal models which exactly mimic the disease process in humans. Through experimentation we try to prove the efficacy and the safety of the device, in terms of anatomic safety, physiological safety and also functional efficacy. It is much more difficult to do functional efficacy in animals but we have tried that. Once we have convinced ourselves that yes, the device is very safe and efficacious, then the device is a safe biomedical and biocompatible device. We already went through some processing steps and since this is such a new and novel technology there is not a lot of know-how here. We are creating it as we go, how to convert nanomaterials that we purchase from someone else into a safe medical device and how to assure that it is biocompatible, not harmful and how to process it without changing its properties. Those are all the processes that we have gone through over the last year to a year and a half and now we are very close to having what we call a clinical product that we can try in humans. This clinical product has been tried on animals again, to assure product safety. Once we know that it is safe in animals we will provide that data to institutions that will evaluate the data. If they consider that it is safe then they will allow for injection into humans. Initial patients in the Study will be nearly blind patients, or almost blind patients. We will assure ourselves of safety first and then gradually we will inject it into people who have a slight amount of sight.
CEOCFO: Is there a lot of research being done in this area? Is the community aware of what 2C has been working on?
Mr. Rao: At least, in ophthalmology, a number of people are aware of it. The problem that we are trying to solve is quite huge. These are large indications. In the US alone there are approximately sixteen million people who are going blind. They have nothing available today; no device, no approved drug and device. Therefore, these are the indications that attract investment. There is a lot of activity. One that comes closest to ours is a company also in this area called “Second Sight”. They actually surgically implant a silicone chip in the retina. They have to provide external power for it and it also works on the principal of electrical stimulation of the surrounding cells. That company is on the verge of getting FDA approval now. Because of the high risk of the surgery they are only implanting it in people who are blind. It would sell for about one hundred thousand dollars.
CEOCFO: That is a vast comparison from what you are able to do!
Mr. Rao: That is right.
CEOCFO: How do you increase awareness in the opthamologic community?
Mr. Rao: We need to have a human data. This is an important milestone. That is when we will receive a lot of interest from strategic partners and first tier venture capital companies. That is when they consider a device as a serious device, because now a lot of technology risk has been taken off of the table.
CEOCFO: Development is always expensive. How far will your current funding take 2C Tech Corporation?
Mr. Rao: Right now, we are in the early stages of negotiation with a strategic company. If they do invest with us, which will happen in the next couple of months, if it does happen then in about a year from now we will be able to prove the efficacy and safety in small clinical trials in humans. That is about a fifteen month away. We have sufficient funding to go through that process with this partnership.
CEOCFO: What is happening day to day in the company?
Mr. Rao: We are working on two or three different fronts. About a third of the activity is in financing. Right now, we are more focused on working with this company which is in the diligence phase, that we supply whatever information they need in order to conduct their diligence, working with their consultants and so on. That takes about a third of the time. Maybe another twenty percent of the time devoted to, day to day, working with out patent counsels. We have about two patents to be filed. They are filed through the University of Colorado and we license them. Those patents are now just starting to receive office action, both in the European office as well as in US, so now we are in a mode to respond to their questions and cover their objections and all of that. We are going through that process with our patent counsel. Rest of the time has to do with product development effort. One of the issues that we had in the past in acquiring materials from the vendors, some of the materials had some undesirable aspects. Now we are working with the vendors and trying to resolve some of those issues and improving on the process so that we will have the clinical products for clinical trials within the next four of five months. We are going through all of those steps. We are working with a number of vendors on that.
CEOCFO: How do you deal, personally and as a company, with the frustration that it takes so long to get an idea into trials and usage, when you feel that you have something that could really make such a major difference for people?
Mr. Rao: That is such a good question. If you have been in this business for as long as I have, this becomes almost a part of your DNA. It gets into your DNA. You recognize that it takes a long time. There is a lot of risk that investors, VC’s are unwilling to assume, particularly after the 2007 financial disaster, most of the venture community has become so conservative. They are reluctant to look at any company that is considered an early. Whatever funds they do have, they are allocating to companies that they are already in and companies in clinical stage. They can do this because they have the luxury right now. What we are finding out, that surprised me, is that there is now some funding available from various government sources; such as state governments and SBIR-NIH. Some of these funding sources have become a little bit more available than ever before. They have also become practical for many early stage companies. We did raise quite a bit of money from the State of Colorado. Some of the universities are also funding university based research. We have done that, too. We also raised funds from high net worth individuals who can put seed capital. In some cases philanthropic organizations focused on a particular disease - they are also making small investments in novel companies. We basically had to run around a lot. You find out that a disproportionate amount of your time really goes on hunting and chasing the capital rather than working on the technology. Your question is good because, as a society we should ask ourselves how we really fund innovation. How do we really identify a novelty quite quickly and fund it. We just do not have a good mechanism.
CEOCFO: Why should investors and people in the business community pay attention to 2C Tech?
It is a very innovative
idea. It is proven safe and effective already in animals models. The
evidence is overwhelmingly strong. There is good probability that the
technology will be practical, because there are already similar devices,
much more expensive and invasive already proven effective in humans. The
probability that this will work in humans in extremely high and the
milestones that we need to achieve are not too far away. Therefore, it is an
We are trying to prevent a number of diseases that cause blindness. These are generally what we call in our business retinal degenerative diseases. That would be things like macular degeneration, retinitis pigmentosa and diabetic retinopathy. - Ramgopal P. Rao
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