May 27, 2013 Issue
The Most Powerful Name In Corporate News and Information
Through the Smart Drug Delivery System™ (SDDS), Pharmaco-Kinesis Corp Aims for a Proactive Approach by Using Advanced Technologies to Help People Avoid most Chronic Diseases through Early Detection and the Optimization of Healing
About Pharmaco-Kinesis Corp.
Corporation is a high technology medical device company at a pre
commercialization stage that aims to optimize healing of the human body
through proprietary local Smart Drug Delivery Systems™ (SDDS) and associated
advanced devices to measure biological responses.
Frank is an executive with over 20 years experience in strategic planning and marketing development for technology startup companies. He is experienced in developing marketing strategies designed for raising investor funds, as well as in negotiating strategic alliance programs. He focuses on recruiting high senior management teams and governing boards and introduced innovative technology to many fortune 500 clients such as GE, Intel, Pfizer, Merck, and Bristol-Myers Squibb. Frank also has developed extensive working relationships with the venture capital community. He is the recipient of the 2007 Congressional Order of Merit and a member of the 2006 Business Advisory Board of the National Republican Congressional Committee. Frank also received a Congressional Medal of Distinction from President George W. Bush in 2008 at the President’s Dinner in Washington, DC In 1985 he founded Newzaust, Inc., an International Marketing Consulting Firm that specializes in introducing innovative technology systems to Fortune 500 companies in the United States. Frank has worked with numerous government agencies, including the State Department and the US Federal Aviation Administration (FAA). In 1996, Frank received a letter of recognition from the FAA on behalf of President Clinton for his contributions to the security of the airline industry. Frank began his professional career in 1980 as a nuclear engineer at Bechtel Corporation after receiving a Bachelor of Science degree with emphasis in Nuclear Engineering from the University of Washington in Seattle.
Cancer Drug Delivery
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – May 27, 2013
Mr. Adell: Our vision at Pharmaco-Kinesis—and the DNA at the foundation of the company—is for us to cognitively assess the problems that face our healthcare system today and provide viable, world-changing solutions. As you know, we have excellent healthcare quality in terms of our technology, physicians and our hospitals, but the system is impacted. As of 2011, the cost of healthcare has reached a staggering $2.7 trillion or about 17% of our GDP. At this cost still there are 47 million Americans who still do not have health insurance. We have reached the inflection point with our healthcare system. By that, I mean, something has to give. This is similar to the computational limits posed by mechanical calculators a few decades ago. We, as a society, needed to transcend those limits technologically, and we did, by developing electronic computers that harnessed the power of the microprocessor. Similarly, our healthcare system has encountered limits in its ability to provide broad adequate care to our population at manageable cost. Again, something has to give. The vision of PKC—Pharmaco-Kinesis Corporation—is to apply the power of breakthrough technology, innovative methodology, and a completely new mindset to our entire existing healthcare system. Preventative medicine and individualized therapies are the most efficient, effective, humane approaches to health issues, and PKC intends to raise the bar of care to a whole new level with our exciting proprietary technology.
Instead of merely reacting to the onset of disease and illness, it is the PKC vision to be proactive, using advanced technologies that can help people avoid most chronic diseases—including cancer, Alzheimer’s, Parkinson’s and many others—through early detection. We seek a solution on a nano level, where the cancer cell starts to metastasize, leading to early treatment that could increase the cure rate to close to 100% at low cost and available to all American rich or poor.
We believe that by the time a person becomes sick, the disease has progressed to a point that it already may be too late; or, if it is not too late, it definitely stretches the resources of the healthcare system and society. A less-than-efficient universal system may not always succeed in preventing disease or providing early detection, but PKC can provide a new line of defense, using our Metronomic Biofeedback Pump (MBP) to help those patients who the disease is already progressed. Or Nano Impedance Biosensor (NIB) offers those who still are healthy and the disease is still at preventable stage. The MBP is a Smart Drug Delivery System™ (SDDS) that enhances the quality and efficacy of pharmaceuticals and customizes the drug regiment to each patient and reduces the side-effects of treatment significantly. The MBP can be externally programmed to tailor a cocktail of medications for the patient. The effects of treatment are available in real-time on an external monitor, so that the practitioner can track progress and make adjustments, as needed. To prevent the progression of the disease in a healthy human being, PKC utilizes its revolutionary and proprietary Nano-Impedance Biosensor (NIB), which is capable of detecting fewer than ten cancer cells in the body as they start to metastasize. This is the earliest stage of disease. This is where we can prevent serious illness and offer a huge payoff in terms of improving quality of life and reducing the burden on our resources.
CEOCFO: Would you please explain how the technology works? What is a concrete example of how you are detecting diseases?
Mr. Adell: Diseases start locally, not systemically. If a disease can be detected when it has only affected a very limited number of cells, treatments can be almost universally successful. A good example of this is cancer. We are born with cancer cells in our bodies, and every day more cancer cells emerge. Usually, though, our immune system protects us and defends against the foreign cells. Sometimes, however, the immune system is compromised or proves inadequate. In these cases, if a cancerous tumor grows but is detected before it reaches about 1 gram in weight, then standard, inexpensive, outpatient treatments generally can eliminate the tumor and protect the body. The issue, however, is that inexpensive, convenient, early-detection technology is lacking. PKC is developing that technology in our NIB. The NIB is highly advanced and pushes the limits of current nanotechnology and electronic. PKC’s tiny device, much like a little microprocessor, includes a substrate, attached to which are antibodies of the substance we seek to detect in the body. For example, there is a general biomarker in the human body called Vascular Endothelial Growth Factor, or VEGF, which is a protein that is secreted by some tumor cells, like gliomablastomas. VEGF assists in angiogenesis, a process by which new blood vessels are aggressively created around the tumor to feed it, while existing blood vessels are abandoned.
The normal VEGF-165 count is between forty and seventy in healthy people. In patients with cancer the count can shoot up to nine thousand. If a person had a device at home with which he or she could self-administer a test that samples blood and measures the VEGF165 every month or so, he or she could monitor the numbers indicating the presence or growth of cancer. Because PKC has brought the technology to a microprocessor level, or chip, we could add wireless capability or a battery to the NIB. Every disease has a biomarker, and we could then actually program the biosensor to detect literally any disease. We would have the capability to etch information into this little device, implant it into the body, and program it to monitor the blood for specific diseases and alert the physician, clinic, or hospital, if the blood count exceeds a predetermined level. This is what we, at PKC, call early detection. It is our vision for preventing illness—catching the disease at its earliest stage before it has a chance to progress. This could be available to all American at a cost of equal or lower that what we all pay for our monthly cable subscription fee.
CEOCFO: Is the medical community in agreement that these biomarkers can provide the answers that you say they can? Is it just a matter of how to get in there to reach them, or is there disagreement about whether these can actually be measured?
Mr. Adell: The fact about PKC NIB is that the impedance measurement can be taken wherever a linkage of proteins, RNA, DNA or genetic marker contacts the antibody or aptamer on the substrate. The measurement is based on a signal. The signal is very weak—at approximately 1.04 PicoAmp at pico level—and, traditionally deal with this level of sensitivity poses technical challenges and only be achieved in sophisticated laboratories with devices that cost hundreds of thousands of dollars. Our products, however, have the capability to detect those signals. It is part of our knowledge-how, knowledge-base and proprietary technology. As mentioned, the sensitivity of our NIB could measure as few as ten cancer cells. Currently, this level of selectivity most likely requires an in-laboratory device that costs around seventy thousand to a few hundred thousand dollars. But, it does not stop here either. What PKC NIB offers is bringing the few hundred thousand labs devices to level of a disposable chip that will cost between fifty cents to a few dollars. The way our device works is that as soon as a drop of blood containing even a few VEGF proteins or any disease biomarker touches its antibodies, on NIB NIB is capable to measurable the signal. The technology is very accurate. It does not lie. It can be verified and validated quickly. PKC business model is based on supplying various NIB for literally all diseases know to man to companies who offer healthcare consumer devices in the diagnostic market, such as those who sell devices to measure blood pressure or glucose meter. I envision PKC forms joint ventures with these companies. We also envision that any regulatory approval to be conduit through these companies. They will interface with the FDA to create new industry standards for applying these technologies. Therefore, we are confident in the accurately and the detection sensitivity of NIB.
The challenging question is: how will the road be paved going forward? We believe that—equipped with PKC technology --companies, such as Omron, Roche Diagnostics, and other similar manufacturers will pave the way.
CEOCFO: Are people in the medical community aware of what you are doing, or are you still under the radar?
Mr. Adell: We are still under the radar; however, we are just about to reach the stage that people hear more about us. We are excited, because I think that the American public should know about this technology—that there is hope, and a solution is coming. We have received a lot of attention recently. Frost & Sullivan, a leading worldwide strategic marketing company, recognized PKC NIB for 2013 the Best Practices Global Biosensor New Product Innovation Award. We have been approached by two production companies and invited to air a short video about our technology on various morning shows. We have two such opportunities scheduled before October of this year. That will really give us some buzz. One of these production ventures is the production company, Health Briefs, and another is Balancing Act, a Lifetime network morning show with Molly Mager. Our information will be provided to the television network—and I believe FOX News Channel is a part of this group—and it will broadcast the video in the top one hundred demographics within the U.S. Balancing Act is a show primarily geared toward a female viewing audience. We are interested in that, because PKC is working on a little device, the size of a match box, which addresses women’s specific needs. A woman has about a 1 in 8 chance of having invasive breast cancer at some point during her lifetime. This year, 40,676 women in the United States died from breast cancer. All women are at risk for ovarian cancer, but the likelihood increases with age. White women are more likely to die of ovarian cancer than any other group. Each year, 22,240 new cases will be diagnosed, and 14,030 women will die of ovarian cancer in the United States. Each day, another 33 women are diagnosed with cervical cancer in the United States—about 12,000 women per year. These three cancers kill about 180 women every day in U.S. alone. This little disposable device that PKC is developing is something we envision women buying from any local pharmacy. They can easily use the device to draw a tiny amount of blood, much like a glucose test, and, then, they can mail the device to a lab. Within a day, the lab can have the results. Although the device will detect the status of cancer in about 1.4 minutes, we prefer the results to be sent to the woman’s physician or hospital for appropriate follow-up care, if needed. I think this will have a big impact on our world and on our healthcare system, and we anticipate having this device ready for animal testing before December of this year. That will be a huge event.
CEOCFO: Do you see a movement in general amongst the public toward more self-testing and more self-responsibility?
Mr. Adell: We do. All of us, at some point, will have to make a major decision regarding our health. Traditionally, due to the way that people were raised and the way that society functions, we generally look to a physician to make that decision or to guide it. I believe that, going forward, “an in person doctor visit” will be replaced by iPhones and Androids. I know the first impact of PKC’s technology will be in breaking the umbilical bond that now exists between the patient and the doctor. In our case, we envision that future patients with chronic diseases, such as cancer or Alzheimer’s, will only go to the hospital for device implants initially. After an initial visit for it will not be necessary for the patient to go and see the physician for the follow-up. All of the interaction between patient, device, physician and hospital, will take place wirelessly and in real-time. Every six months to one year, a nurse will visit the patient to refill the device with medication, if necessary. Our devices will enable individuals to make better decisions, due to the accuracy of real-time infomatic data that provides early disease detection. This is the foundation for the new paradigm that I mentioned earlier, when I made the comparison between the mechanical calculator and the microprocessor. We are right at the beginning of this universal Tectonic plates healthcare shift. Therefore, with this in mind, I can confidently say that a movement toward more self-testing and more self-responsibility is around the corner, and PKC is positioned to contribute its share to this effort and capitalize on the opportunity since this is where future fortune and lucrative ROI for investors will be.
CEOCFO: You have a long history with high-tech firms and commercialization. What lessons learned over the years are most applicable to Pharmaco-Kinesis? What do you bring to the table from your experience?
Mr. Adell: Since 1985, I have been involved with all the various aspects of taking high-tech start-up companies from concept to commercialization. The formula is always the same. It starts with an entrepreneur’s vision. Around that vision, we build a company. We align stakeholders with our vision. That part is always the same. The success of each business entity, however, depends upon the magnitude of the vision and the solution it brings to a particular need. The more grandiose the vision, the more complex the problem, the more innovative the solution, the higher potential positive economic impact, that will, we hope, will give the founders and stakeholders a high financial reward. All visionary entrepreneurs literally start from the same point. What makes the enterprise commercially successful from there, turning it into a profitable business at the finish line, is dependent upon proper strategy, proper implementation of that strategy, speed of execution, market conditions, and a bit of luck. Since I have taken this journey before and have plenty of practice, I bring to the table the proper experience and the ability to structure PKC from the pre-commercialization stage to an operational and successful business. I also should point out that the current globalization phenomenon, and the challenging business and economical environment have created a rough battlefield for all companies planning to reach commercialization; however, for those who do make it, the reward has never been greater. I am confident that PKC will make it to the finish line, and, in fact, we are very close.
CEOCFO: Is Pharmaco-Kinesis funded for the next steps, or will you be seeking additional funding?
Mr. Adell: Actually, to date, the company has gone through three rounds of funding: Round A, Round B, and we are currently in Round C. Round A was $2 million. Round B was $5 million. Round C is $10.5 million. We are actually almost ready to start Round D, which will be $16 million. Additionally, we anticipate generating revenue from two of our products. The revenue from the Metronomic Biofeedback Pump is expected in 2015. The revenue from our Nano-Impedance Biosensor, or NIB, is projected for this year. The NIB, which is our detection technology, is a product that will bring us revenue fast. Moreover, we are in discussions with several major strategic partners from both the pharmaceutical and device industries. On the pharma side, we have reached the stage of a term sheet with Sandoz Inc. In terms of the Nano-Impedance Biosensor, we have approached and been in discussion with several major companies who could be potential strategic partners, including Roche, Millipore a division of Merck of Germany, ASE Chemunex from France, Siemens and Cargill in US, and there are many others we intend to approach. We anticipate that within the next several months, PKC will form partnerships with these companies to further commercialize our technology. I am confident that, because these big players share our vision, they will welcome a partnership with PKC and will make great strides in the healthcare industry using our disruptive technology.
CEOCFO: What makes Pharmaco-Kinesis stand out for investors and the business community?
Mr. Adell: What people should know about us is that we are about to bring to the forefront of the healthcare market, a technology that will positively impact every single one of us. The most important aspect of this technology is that it involves the development of new class of disposable household and industry diagnostic devices that truly give individuals the ability to detect disease at its earliest stage at a cost of just dollars and in the convenience of their own homes under supervision of their physician. The NIB should cost at the most a few dollars, and the electronics component should cost around $20.
With our technology, PKC offers unique solutions to resolve or improve some of the biggest problems that the greatest minds in the world have sought to solve regarding complexities in our healthcare system and, in particular, patient care. Additionally, our business model offers something very unique to investors. Over the last decade, except for maybe the last one to two years, there has been no growth in major stock in the market. Although there are exceptions, they are few. The last 10 years are referred to as the lost decade. We currently have a disconnected economy. Some Americans are working, making and spending money, while others cannot find jobs and are struggling. To turn this around, government has to do its share. This is now in the process through what is referred to as quantitative easing. In addition, our private sector should do its share too. I mean companies by introducing innovative solution through new products to resolve complex old problems where economic advantage creates value across all spectrum of society. In the process creating jobs that give opportunity to American to work and receive high paid jobs. But, yet the most effective catalyst that is needed is what is referred to as locomotives of growth—big growth engines that are going to expand the marketplace by al about 5% or more quarterly growth. Apple and Google are considered such locomotives. Industries could also become locomotive. If you look at the reason behind the phenomenal growth that took place during the rise of dot coms, you find that there were three industry locomotives working at the same time: telecommunications, Internet and computers. That incredible, simultaneous growth by three industries created a wealth in a few years of 16 to 18 trillion dollars. As the result of this phenomenon bountiful of new companies emerged from the eco-system that these three industries created the growth spilled to many other industries.
We envision that PKC is going to be a company that will offer investors meaningful and sustainable growth, due to our disruptive technology and our unique business model. We believe that within just a few years of bringing our products to market, we will provide incredible growth on a quarterly basis for our investors.
Our business model is very different than traditional models. Today, in both the device and pharmaceutical industries, there is a focus on developing products that have high efficacy and low side-effects to patients. This by itself is good. The draw back is that usually takes about 10 to 15 years and a billion dollars to develop a brand drug. Yet, in about 10 to twelve years the brand drug’s patent will expire. Which mean, a company generally loses its patent for that product? We believe that, today, things have to take shape and move faster. That’s where the PKC business model comes in. For example, our Metronomic Biofeedback Pump (MBP) increases efficacy of drug and reduces side effects due to its local delivery, access to biofeedback, and metronomic capability. In addition, we have a unique technique in that we can combine precise ratios of current FDA-approved brand or generic drugs in nanodroplet form. Combination therapy, for cancer, is more efficacious. Our first Nano Combinatorial drug which combines Temozolomide (Merck & Co., Inc) and Thalidomide (Celgene, Inc.) has already produced and we are currently conducting in vetro testing in both University of California in San Diego (UCSD) and University of Southern California (USC). We have given this Nano-Drug a Trade Mark of TNT. TNT Nanoparticles will be tested for Potential Drug Therapy to Treat Gliomas and other Cancers.
So, our business model is to take already-approved drugs, create new nanoformulated drugs, and deliver them via the MBP. In doing so, we quickly create new proprietary brand drug utilizing our technology that can greatly impact the industry. This is where we believe we have so much to offer investors. Currently, the company is about two years from entering the public marketplace. Investors generally look for opportunities to buy low and sell high, and I think PKC offers that opportunity.
believe that this is something that will empower and excite people and
create wealth for all stakeholders. We hope that what they will remember
about PKC as a company is that we seek to make an impact on the current
mindset that allows people to get sick, get admitted to a hospital, and
then receive treatment. We would like to be known as the company that
changes all that by making certain people do not get sick in the first
place. We want to help people avoid ending up in the hospital. This is what
we advocate to all of the people who desire to learn more about Pharmaco-Kinesis
“With our technology, PKC offers unique solutions to resolve or improve some of the biggest problems that the greatest minds in the world have sought to solve regarding complexities in our healthcare system and, in particular, patient care.”- Frank Adell
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