Technology is the bastion of change. And, at the pace of better science, not only potential but actual changes to lifesaving services and procedures will soon become a reality. For patients in need of organ transplantation, for instance, an emerging company is working to bring to reality the opportunity to reduce many years of waiting time and decrease the exposure to a degraded quality of life standard, as needy patients wait impatiently for either a tissue or organ match compatible for transplantation.
NuLife Sciences believes that they are in a position to reign in the future and is on the cusp of inventing transformational change. While just a micro-cap stock, NULF may become one of the few biomedical companies to advance recellularized human organ transplant technology, and promote medical research that may eliminate the need to locate pre-determined and compatible organ or tissue donors. NULF even goes a step further by potentially eliminating the need for anti-rejection drugs. To those in the industry, they know that if NuLife can accomplish this leap in science that it can transform an industry, allowing organ recipients to eliminate long waiting periods for a matched organ, and can even reduce or eliminate the need for dialysis for patients that are waiting for an acceptable match. Beyond those two extraordinary measures, NuLife Sciences believes that they can also offer the technology to eliminate the need for anti-rejection drugs and to save patients substantial amounts of money just through the reduced cost of medication and the potential elimination of expensive therapies that only treat a disease, but has no curative value.
Put together, what NULF is dedicating its mission toward accomplishing can act as the next transformational step in organ transplantation, and if successful can help the over 123,000 candidates that are currently waiting for a compatible and life-saving organ in the United States alone.
NULF Deserves Better
Despite the fact that the share price is sitting at less than a dollar a share and the trading volume is a bit anemic, the progress made on the clinical front makes NULF a strong candidate for those investors looking for long-term, aggressive, high-risk/high-reward stock to add to their portfolio. As is the case for many emerging biotechs, NULF became part of a technical acquisition by an active, in good standing, publicly traded company. The strategy allowed NULF to immediately take advantages of the benefits of being a public company without the exorbitant costs and time associated with an initial listing application.
From a strategic standpoint, NULF is targeting the treatment of not only the approximate 31,000 organ transplant cases per year but also looking to mark and treat the remaining 120,000 plus patients that are waiting in line. And, the market is not shrinking. Instead, the market is growing, plagued by logistical problems which lead to the death of about 22 people each day, who die in wait for a compatible organ. Imagine, if NULF can generate the science and practices necessary to allow for expedited organ transplantation and eliminate the need for excessive screening, hundreds of lives will get saved each year. But, beyond those hundreds saved, thousands more can be served, not only making organ transplantation compatible to their body but can help to save the medical industry millions of dollars a year in drug cost savings, a portion of which Medicare only covers for three years.
Beyond the dollars saved though, which is a crude comparison when discussing human life, NULF brings much more to the table, benefits that may have a far-reaching effect on an entire industry. Thus, the story becomes ironic in that a small but emerging, sub-dollar stock may hold the key to altering the path of organ science and transplantation procedure. And, despite that the company is still a relatively unknown disruptor of science in a broad landscape of multi-billion dollar companies, NULF may be the one to cause a systemic shift in the industry.
How Will NuLife Pull It Off?
Initially, NULF is looking to target the kidney transplantation market, which since 2015 has averaged roughly 18,500 cases per year. Of all transplants performed, kidney procedures account for the bulk of the action, representing approximately 58% of all cases, followed by liver, heart, lung, and pancreas transplants. Unfortunately, most patients die while waiting for an organ, despite tens of thousands of dollars spent on dialysis, drugs, and treatment. Further complicating the landscape is that all current transplant patients require anti-rejection drugs, the most severe of medications that have been known to cause grave and adverse reactions in patients. But, at this point, or until NULF can produce otherwise, patients will remain mired in the specific drugs despite the debilitating effects. In some cases, notwithstanding the wait for an organ, the anti-rejection drugs prove incapable of doing their job, adding insult to an already dismal situation.
Although NULF only became its own publicly trading company about eight months ago, the science developed through 15 years of committed research, with resulting breakthroughs in both hematopoietic research and transplant techniques. Its goal of the study was to first address the issues of organ compatibility and the need for anti-rejection drugs in both the patient and the donor. During the studies, NULF conducted pilot studies, with its first animal surgery three years ago and an additional three animal patient surgeries in total since 2014.
The technique makes the difference and what NULF is trying to prove is the key to the progress. Like all transplants, the process begins with a healthy donor. From there, the organ goes through a decellularization process to isolate the extracellular matrix of tissue from its inhibiting cells, which is expected to provide an ECM scaffold of the original body tissue. Next, NULF initiates the cell culture process, where specific cells get harvested from the bone marrow of the intended recipient. But, the next step is where the process changes, and if NULF can substantiate its novel and patented technique to the recellularizing process, the method may become a mainstream practice for all transplant cases going forward.
The patented NULF recellularizing process takes particular hematopoietic cells that are used in the process and adds proprietary temperature and pressure factors. Through the associated vacuum process, specific cells get released from platelets without complete platelet degranulation. Coupled with those first two steps, the negative pressure created by the vacuum pulls the growth factors out of the platelets and puts it directly into the plasma. Then, once processed, the cells get reintroduced into the recipient with the intent of influencing the further growth of an already implanted and recellularized organ. Results from the animal studies have been extremely encouraging, and the swine kidneys used in the trial should provide reliable data, as they most closely resemble the kidney to that of humans. Thus, in the recently announced initiation of their pre-clinical study, NULF hopes to demonstrate that after the novel decellularization program, the creation of a kidney scaffold was produced upon which a new organ, unique to the recipient may get successfully rebuilt.
Organ Generation Is No Longer Science Fiction
Ten years ago, the thought of generating or growing an organ suitable for human use was taken seriously by a small handful of scientists. Now, just a decade later, scientists believe that they will soon have the capability to produce certain human organs with the use of 3D printers. While NULF is not prepared to use the 3D method just yet, they are in a way generating results that should demand significant industry attention.
What NULF is demonstrating is that in its animal (swine) studies, it can take a created kidney scaffold and populate it by injection from immature bone marrow cells from the recipient, and then allow the stem cells to differentiate into mature kidney cells. From that point, the growth of the kidney is genetically identical to that of the recipient, which is then provided processed blood to aid the recellularization process before and after the organ is implanted. Now, assuming that NULF continues to generate positive results, not only do potential partnership opportunities arise to expedite the company's program, but the direct impact that a successful trial can bring to the transplant industry can be enormous.
First things first, let's highlight the most beneficial aspect of a successful NULF procedure: it can change to days, from years, the time required for a patient to be identified and readied for transplant. This time decrease is in stark difference to the up to 15 years of waiting time seen in many transplant cases. NULF can help eliminate a substantial portion of the "attempt to match" diagnostic testings required before a procedure is performed, and can alter the entire logistical landscape of the industry by being able to work on local opportunities instead of care flight delivered organs, many of which prove to be non-compatible with the recipient. Beyond the logistical and life-saving measure, the direct cost-benefit and savings can be substantial, eliminating the over $17,000 per year required for anti-rejection medication and the upwards of $85,000 per year for dialysis treatment while a patient is waiting for a new kidney.
Yes, money and savings are significant, but it pales to the quality of life benefit that the NULF procedure can afford to patients, increasing mortality rates and at the same time allowing patients to stop taking the debilitating anti-rejection drugs required to remain healthy.
Is NULF close to approval? Well, investors should not assume that the company will be commercializing the procedure within the next year. However, NULF has identified a pathway to commercialization which offers an insight as to the progress made by the company. As stated earlier, the progress made is a culmination of over 15 years of dedicated science and research, which was initially used as a process to heal wounds. From the technology end, the discovery process was born, and patent applications were filed and granted in 2015 which provides critical protection over proprietary processes and intellectual property, enabling the company to enter into potential partnership agreements more securely.
From NULF discovery came the first preclinical experiments. During a three-month period, with one procedure per month on three different animals, the company produced approximately 12 different tests, each with a specialized focus on specific research and planned study outcomes. The current animal studies are being performed in collaborations with both Florida International University and Nova Southeastern University, with the aim of encouraging opinion that additional animal studies should be conducted to determine the direction of the program. The pre-clinical animal studies are expected to continue throughout 2017, with results announced soon after completion, also planned for late 2017. Once complete, NULF plans to complete appropriate documentation protocol, expand its advisory board, and to meet with the FDA to propose a clinical pathway to commercialization, also expected to process in the second half of 2017.
It's Not All About Transplants, Though
Although the primary target of NULF technology is to expedite organ transplantation, the technology has other far-reaching applications. With two patents granted that protect significant aspects of organ transplant procedure, the company has a 17-year window of protection that begins at the conclusion of its clinical investigator's program. In addition to the patent protection, NULF expects to file with the FDA an application to become fully licensed for the comprehensive use of cytokines and be granted a 14-year window of exclusivity for process and therapy.
Getting the help from both the patent board and the FDA will contribute to expediting clinical programs as well as to protect intellectual property. From where NULF currently sits, they can advance research for transplantation factors of other vital organs.
In addition to the role in transplant, NULF believes that they are well-placed to expand the technology into additional fields that can work to assist in the building of the immune system. Further research demonstrated the potential to improve chronic wound closures, offer preventive care and to bring to the market novel and innovative methods for treating an array of patient conditions having to do with cellular or wound technology.
Managed by a respectable team of medical professionals and advisers, NULF had slightly over 31 million shares outstanding as of May 2017. Like most emerging and potentially transformative companies, NULF will likely need to raise additional funds to shore up the cost of future studies. While other collaborations or partnerships may reduce the company's operating cost, NULF is getting to the point whereby raising cash on their own and not giving away excessive equity may indeed be a better long-term road to follow. For those with a long-term horizon and are more than willing to let this emerging company continue to prove its science, getting into the stock at these prices may be an exceptional long-term proposition. At less than a dollar per share, if the company does raise money, it will be dilutive, so taking a cost average approach into NULF may be advisable.
One thing is for certain, if NULF is successful in developing this revolutionary approach to transplantation, patients and investors will benefit. That, in and of itself, is an investable thesis and the value proposition in the technology already is worthy of a share price in excess of current market value.
This article was originally featured on CNA Finance.
Disclaimer - The author has no positions nor intention to open any positions in any stock mentioned herein within the next 72 hours.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.