I recently had the opportunity to interview John B. Hollister, CEO of NuLife Sciences (OTC: NULF) in order to gain a better understanding of the company. Here's what we discussed.

1. You mentioned that the human transplant technology “NuLife Technique” has patents. Exactly how many patents does it have? 

The NuLife Technique utilizes two core patents, as well as a number of trade secrets.  The patents are central to the efficient release of cytokines, the key proteins in our blood, from the platelet rich plasma of the soon-to-be recipient of the donated kidney.

2. What makes your NuLife Technique platform unique compared to other competitors in the same field? 

The NuLife Technique is an entirely novel approach to kidney or organ transplant.  Today, the transplant process is a race to harvest the donated organ, find a tissue-matched patient and get it to them as fast as possible (within hours).  Unfortunately, for those in need of the kidneys, they can spend years in dialysis centers waiting for the call.  In all cases, the result is a need for strong anti-rejection drugs post-surgery.  With our technique, the scramble will be off.  The process of receiving a kidney will be less a scramble and we hope to eliminate the need for anti-rejection medication post-transplant.

3. You mention that your NuLife Technique technology can eliminate the need for a donor tissue or organ match. How does it accomplish that? 

The NuLife Technique involves decellularizing (stripping the native cells) the donated kidney leaving only the structure of the kidney (known as the scaffolding).  We then use both the marrow and the blood from the soon-to-be recipient to re-set the donated kidney.  The process involves using some of the marrow, cytokines released from our patented process, and whole blood to prime the kidney before transplantation.  Our hope is that the new recipient’s body will receive the kidney as if it were its own.

4. You talk about the platform in terms of anti-rejection drug and being able to improve quality of life. Can you go into detail what anti-rejection drug means, and how it would help a patient’s quality of life? 

The potential quality of life impact for kidney disease patient is enormous.  Prior to a transplant, patients can be required to visit dialysis centers two or three times per week to have their blood clean.  The process is very difficult on the blood, uses tremendous amounts of time, is depressing, and very expensive ($85,000/year, not including supportive care medicines).  Sadly, some patients will do this for as long as ten years and never receive a kidney because either a good match is not found or their disease and complications have progressed.  Post-surgery, the use of expensive anti-rejection drugs are required.  These medications are very strong immune and inflammatory suppressing agents.  They put patients at risk for infection, as well as are damaging to other organ systems.

5. There is a talk about a high level entry barrier for competition? Can you talk about any competitors that have a similar or closely similar technology?

Most companies in the space are trying to develop methods for growing replacement organs using human stem cells and growing organs in a surrogate species or mechanical devices to replace them.  In either case, they are very much in early stage research and their paths are long.  The larger barrier is probably the commitment to the existing approach, which has been in place for many years.  Kidneys and other organs are procured through a government sponsored program (Organ Procurement Program) and distributed through a number of regional centers.  We will work with these groups, as we develop our Process to make certain they are our partners.

6. The platform is currently in pre-clinical testing according to the website, how long will it take to get the platform to the the FDA for marketing approval? Also for other countries as well? 

We are hopeful that the pre-clinical studies, which started last week, will provide enough positive information that we can meet with the FDA within a year.  Our goal is to present the Agency with enough information to conduct a limited study in a few kidney disease patients soon after that meeting.  As for FDA marketing authorization, we will need to present a reasonable path to the Agency but we believe the potential benefits and relatively small population make this attractive for a Priority review and/or Orphan Drug review.

As for other countries, we are exploring possibilities but are focused first on validating the process. If we are successful in the upcoming studies, we will be sure to receive interest from potential partners.

7. Kidney was chosen first as the primary target for the platform because of the market size for it. Does that mean that the liver will be the next target considering it is the 2nd best market? 

Actually, kidneys were chosen because the difficulty in tissue matching and absolute need for anti-rejection drugs were very high.  The costs associated, both financial and human, are so high and nearly 22 Americans die every day awaiting their organ.  The market size was the second most important driver.  We are not certain which organ will be the next target but are conducting some studies to address this question.

8. The first surgery was on animals 3 years ago. Why did the platform take so long to develop into the next stage of testing? 

Yes, two series of pilot studies were conducted a few years ago.  These studies helped give our transplant surgeons the confidence to know that the Technique could be utilized in the transplant process.  The pilots provided guidance in building the current study protocol.  Unfortunately, the first investment group struggled to find the necessary capital to keep the program moving.  That’s where NuLife stepped in. 

9. With the whole process of decellularization taking place, is there any side effect or harm the patient experiences before and after the procedure?

Prior to the surgery, we can only believe that there will be a benefit, as the wait for a kidney will not be dependent upon a tissue match and less time in dialysis.  On the post-transplant front, we hope the Technique limits or eliminates the need for the strong anti-rejection drugs.

10. The platform is mentioned as being able to have a kidney transplant done within days of a patient being identified. Is this the same process for all other organs as well? Or is that being researched further?

We don’t yet know the answer to the question whether the kidney transplant process is entirely transferable to other organs.  This will require additional work.

11. Is the company still on track for starting the next set of studies in 2017? 

As our pre-clinical work involves three different large institutions, the time to get everything in place took a few extra months.  Our pre-clinical protocol and team is ready to go now.  So, our study will initiate in the 2^nd half of 2017.

12. There are plans to meet with the FDA about the next steps of the NuLife Technique for regulatory approval. Is there a set date you can talk about on when such an item will be discussed? 

Not yet.  We will reach out to the FDA after the conclusion of the pre-clinical study.  In parallel, we will be conducting and presenting a series of validating studies to help support the case for the NuLife Technique.

13. Why is there a need to increase the size of the scientific advisory board? 

Scientific Advisory Boards (SABs) in the development of a process like this are essential.  They provide technical guidance but also help in disseminating the experience.  We also believe that getting a broader set of scientists in the SAB will give the organization more credibility with the transplant community and FDA.

14. How much of a role has each member of the company played in bringing NuLife from inception to its current stage of clinical testing? 

We are still a very small company.  So, everyone’s role is critical.

15. Was there other reasons why NuLife chose to move to a new facility in Nova Southeastern University’s CCR center, besides access to a bigger laboratory?

The selection of the Center for Collaborative Research at NSU was a function of the transplant teams’ relocation to Florida from UT Southwest in Dallas and the availability of this brand new facility.

16. Are there plans to seek approval for territories outside the United States?

Yes, we are assessing the best way to commercialize ex-US.

17. NuLife sciences stock trades on the OTC Market, are there any plans in the works to bring the stock to a larger exchange for more liquidity and exposure? 

Uplisting is certainly of interest at the right time.  We are familiar with the process and will evaluate it as an option.

18. What is the current cash on hand? And will you have to dilute in the near future? 

We have a solid plan for meeting our financing needs and are always sensitive to doing this in the best way possible for our shareholders.  If the pre-clinical studies are successful, we believe we will have access to government and other non-dilutive funding sources to complement the more traditional fund-raising approaches.

19. Are there any possible partnership talks that could help the company avoid dilution on its shareholders? 

Yes, there are potential partnerships or joint ventures that could provide nearer-term revenue and/or impact our financing needs.

20. Are there plans to hire new researchers to improve upon the technology? Or increase the ability to advance the platform to the next stage of trials? 

If the pre-clinical work is successful, we will definitely need to expand our research and development team but we have no plans to add staffing in the immediate near-future.

Thank you.