February 2024 update

In short

Zhittya presented its FGF-1 research at a cardiovascular conference in Dubai. Work continued on brain scanning studies designed to measure blood flow, and a new production batch of FGF-1 was completed for the Parkinson's studies.

The February update began with a new one-minute animation on Zhittya's video channel. It showed the team's current theory of how FGF-1 might act in the brain of a person with Parkinson's.

A conference in Dubai

In mid-February, members of the team attended a large cardiovascular medicine conference in Dubai, which the update said drew more than 400 doctors. Dr. Jack Jacobs gave three talks. One made the case that Parkinson's is a disorder of the blood vessels and asked whether growing new vessels could change its course.

According to the update, heart specialists readily accepted the idea that reduced blood flow in the brain weakens brain function, and many asked about Parkinson's on behalf of family and friends. People with Parkinson's traveled from Bangladesh and India to hear the talks.

Plans for brain scanning

The team was searching its records for people who might qualify for brain blood-flow scans at Washington University in St. Louis. It expected to handle two or three scan participants a month, with a goal of 16 people with Parkinson's in the first phase.

Each person would be scanned before receiving FGF-1 and again six months after dosing, with a third scan at 12 months under consideration. Under the current plan, called Protocol 17, participants are dosed again every six months over a 12-month period. The update said many participants had reported changes in short-term and long-term memory between months 6 and 12, and the team wanted to see whether blood flow kept changing during that window.

CEO Dan Montano wrote that if scans showed more blood flow in an area that had too little before dosing, the team would have a logical reason to believe FGF-1 was acting on poor blood flow in the brain. He described that as evidence still to be gathered.

Making more FGF-1

The update was sent later than usual because Dr. Jacobs and Vika Montano had been at the company's laboratory in Reno, Nevada, inspecting the latest FGF-1 production run. Zhittya was using FGF-1 faster than expected, both in the human research studies and in animal toxicity studies meant to support future applications to the U.S. Food and Drug Administration (FDA). Mr. Montano believed production in 2024 needed to be about 30 times what it was in 2023.

He also gave his personal hope that the FDA might clear a Phase I clinical trial in Parkinson's in 2025.

How FGF-1 spreads through the brain

Dr. Jacobs explained that FGF-1 given as a nasal spray reaches the cerebrospinal fluid, the clear fluid that bathes the whole brain. Collaborators at the University of Minnesota attached a radioactive label to FGF-1, gave it to rats through the nose, and then measured where it went. It was found throughout the brain, including the substantia nigra, the region involved in Parkinson's.

He gave reasons the brain takes up so much FGF-1. The adult brain has about 100 billion nerve cells, and each carries thousands of receptors for FGF-1 on its surface. Support cells and the brain's blood vessels, which he said run for an estimated 400 miles, carry these receptors too.

From this, Dr. Jacobs concluded that a single round of nasal dosing was not enough. Because Parkinson's is a progressive condition, the team's current view was that dosing should be repeated every six months. He called the work "a new medical frontier" and expected the dosing plan to change as the team learned more.

The update shared five comments from participants and caregivers. They covered energy, voice, walking, thinking and sleep, along with problems that had not improved, such as balance and freezing. The rest of the update covered other research areas and an upcoming conference.

This summary covers the Parkinson's research in the February 2024 update. The complete update, including the other topics it covered, is below.

Read the complete February 2024 update as published

The text of the update Zhittya sent, word for word. Pictures, charts and layout are in the PDF. Open the PDF.

February 27, 2024, Update

Introduction

For Zhittya, 2024 has started off as a very busy year. Here are just a few of the activities we have engaged in.

Our Theory: How FGF-1 Could Treat Parkinson’s Disease

Zhittya Genesis Medicine has published a new video on our YouTube channel which demonstrates our current theory of how FGF-1 could treat Parkinson’s Disease in those individuals that have been enrolled in our medical research studies or those looking to potentially enroll. I encourage you all to watch this one-minute animation of how we believe our medicine works to treat this disease: https://www.youtube.com/watch?v=JVhB8PwUeXQ Dubai Cardiovascular Conference (Feb 15th to 20th)

Members of the Zhittya Management and John Laub, CEO of RMENA, attended 4TS, a major conference on cardiovascular medicine for medical doctors in the Arab Gulf. There was a fantastic turnout with over 400 MDs in attendance and several hundred private individuals who were interested in cardiovascular disease.

Dr. Jacobs gave the flowing three presentations:

“Reversing Ischemia in Patients with Severe Coronary Heart Disease with Intramyocardial Injections of the Angiogenic Growth Factor, Human FGF-1”
“Parkinson’s Disease is a Vascular Disorder and Therapeutic Angiogenesis Can Reverse It”
“Heart Disease, Stroke, Parkinson's Disease and more: Can Therapeutic Angiogenesis Reverse these Diseases? Medical Breakthroughs are Happening Now!”

The first two presentations were given on the main floor of the conference to over 400 medical doctors, while the third presentation was presented to the public of over 100 people. Based on follow-up questions and the flurry around our exhibition booth, these doctors all saw a tremendous benefit of our medicine to grow new blood vessels in ischemic hearts suffering from “small vessel heart disease.” I believe small vessel heart disease is responsible for approximately 80% of all heart disease deaths in the United States. However, few doctors in the USA bring it up with their patients, because there is nothing they can do to treat it.

The only viable treatment for people suffering with small vessel heart disease, to my knowledge, is our FGF-1, which can grow new coronary blood vessels and extend those people’s lives. Small vessel heart disease is more common with women and certain ethnic groups such as people originating from the Arab Gulf, India, or China. In and around Dubai, this is a common heart condition and there is much discussion on this disorder. This made Zhittya’s possible treatment for small vessel disease a major hit at the 4TS Cardiovascular Conference in Dubai.

While Dr. Jacobs’s presentation on small vessel disease of the heart was the hit of the conference, we also had many people interested in his presentation on “Parkinson Disease is a Vascular Disorder and Therapeutic Angiogenesis Can Reverse It”.

Most medical doctors who specialize in cardiovascular disease immediately accept that reduced blood flow in the central nervous system diminishes brain functions. Dr. Jacobs’s presentation on Parkinson’s disease opened their minds to what was obvious to them after they thought about it, namely, that all cells need blood to survive. However, unlike growing new blood vessels in the heart, where fixing the heart is the business of these cardiologists, their interest in Parkinson’s disease was all about their family and friends who could possibly benefit from Zhittya’s FGF-1 treatment for Parkinson’s disease. We had a medical doctor who flew in from Riyadh, Saudi Arabia solely to meet with us. We had potential Parkinson’s disease patients who flew in from Bangladesh and India.

It was, in my opinion, the best response we have ever had from a medical/ scientific conference. The Parkinson’s disease sufferer who flew to Dubai from Bangladesh wanted to explore if Zhittya’s medicine is real or if it was “snake oil” as his neurologist warned him. He sat in a conference room surrounded by hundreds of medical doctors and saw them awed with our data. Then he sat at our exhibition booth and listened to the conversation we had with medical doctors who had patients, family and friends who needed our medicine. He heard them ask us to visit their clinics, their hospitals and their desire to be our partner providing our medicine. It was a great trip for Zhittya and we now have many medical doctors who believe our FGF-1 medicine could be a treatment for small vessel heart disease, Parkinson’s disease, dementia, stroke, Alzheimer’s disease, autism, multiple sclerosis, and more. It was a very successful trip!

Here is a picture of Dr. Jacobs presenting Zhittya’s data on our Parkinson’s disease treatment. You can see Dr. Jacobs in the front center left, and the picture shows about half of the room’s audience, since to show all of the audience would have made Dr. Jacobs too small to see.

Zhittya’s ability to participate in major medical conferences such as this one adds tremendous credibility to Zhittya as a biotechnology company and validates that our medicine could reverse both coronary heart disease and Parkinson’s disease.

Zhittya has found that it gets more respect from the Arab Gulf nations than it gets from the United States. In many of the USA Parkinson’s disease meetings we are not even offered a “PAID FOR” speaking slot, because the conference management has been warned by Big Pharma that they will not participate in their meeting if we are there presenting. I guess if you are Big Pharma selling Parkinson's disease medicine that the patient must take for a lifetime, and which only camouflages the disease symptoms, then you would not want a speaker discussing how Parkinson’s disease could be cured and how patients would not need Big Pharma’s medicine anymore.

Below is a picture of Dr. Jacobs being interviewed at our booth at the 4TS conference by the Dubai press and media.

Brain Scanning and Blood Flow Imaging

Dr. Jacobs, Vika, and Sam Cross have been searching our database to identify people who would potentially qualify to have their brains scanned at Washington University, St. Louis. The advancement of blood flow imaging in the brains of individuals suffering from neurodegenerative diseases will allow us to take before and after pictures of the effect of Zhittya’s FGF-1 treatment on stimulating increased blood perfusion in the brain. This represents a major advancement in our efforts.

At this time, I believe we can process two or three brain scan subjects every month and we are targeting to study 16 patients with Parkinson’s disease in the first phase of the study that will be conducted at Washington University in St. Louis. After the initial pre-treatment scan, the patients will travel to the British Virgin Islands to be dosed with FGF-1 and then have their brains rescanned 6 months post-dosing. We also are considering adding a third brain scan at 12 months post-dosing. With Protocol 17 (our present protocol) we redose test subjects with FGF-1 every six months over a 12-month period. Therefore, there could be continued blood vessels enhancement from month 6 to month 12. We have had many reports from test subjects of enhanced short-term and long-term memories, during this 6 to 12 month time frame. I believe this improvement is from enhanced blood flow caused by the continued dosing with FGF-1.

If we can show through brain imaging that an area of the brain with diminished blood flow before the treatment, has enhanced blood flow 6 and 12 months following the FGF-1 treatment, then we have a logical reason to believe our medicine is treating the underlying issues of poor blood perfusion in ischemic areas of the brain.

This is important to Zhittya and everyone suffering from brain disorders. Would it not be great if we can generate empirical evidence demonstrating that in various neurodegenerative diseases, including Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, ALS and more that there is a known underlying cause – disrupted blood flow in the brain?

Zhittya’s FGF-1 Biomanufacturing Production

A part of the reason for this Monthly Update being delivered later in the month than it normally is, is because we wanted to wait until Dr. Jacobs and Vika had returned from our Reno, Nevada laboratory after the inspection of our most recent FGF-1 production run. Zhittya is now going through our FGF-1 medicine faster than we ever imagined a year ago. Between using the FGF-1 in human Medical Research Studies for Parkinson’s disease, stroke, Alzheimer’s disease, autism, progressive supranuclear palsy (PSP), type-2 diabetes, and multiple systems atrophy (MSA), we are also conducting toxicity studies with FGF-1 in animals to support our USA FDA applications to study the use of FGF-1 in treating heart disease, Parkinson’s disease, stroke, type-2 diabetes, diabetic foot ulcers and more. Because of all these ongoing and future studies, our need for FGF-1 is, and will remain, overwhelming. Personally, I believe in 2024 (this year) Zhittya must increase its biomanufacturing of FGF-1 by 30 times what we produced in

2023. That is an increase of over 3,000% of the FGF-1 that we made last year. As we continue to see that FGF-1 is safe in the heart, safe in the brain and we see potentially amazing outcomes in test subjects, our needs for the production of FGF-1 dramatically increase. It is my belief that Zhittya is the largest producer of FGF-1 in the world, and that we are the only commercial producer of FGF-1 in the world.

Personally, I believe Zhittya could have USA FDA clearance for a Phase II clinical trial for the treatment of heart disease in 2025, and Phase I clinical trial approvals for the treatment of Parkinson’s disease, stroke, Alzheimer’s disease, type-2 diabetes and more in 2025. I believe after increasing our FGF-1 production 3,000 percent in 2024 we will need to triple it again in 2025 to keep up with the need for FGF-1 to treat all these medical conditions.

Important!

HEALinc Future Health Innovation Summit in the Bahamas | April 28th – 30th Zhittya is a primary sponsor of the HEALinc Future Health Innovation Summit that will be held in The Bahamas from April 28th – 30th.

Zhittya also has two Medical Research Applications on file with The Bahamas regulatory authorities to allow Zhittya and our clinical partner in The Bahamas to study the use of FGF-1 to treat:

Parkinson’s disease
“End stage” heart disease (small vessel disease)

The heart protocol we filed in The Bahamas is the exact same Protocol that the US FDA approved for a Phase I study in the United States.

While many of you who read this Update are only interested in our treatment for Parkinson’s disease and may not care about our treatment for coronary artery disease, you are missing a critical point: The number one cause of death in the world is heart disease. Heart disease, according to the World Health Organization (WHO), kills around 38% of all adults annually. More people die of heart disease every year than have Parkinson’s disease.

What’s even more important is that FGF-1 has been utilized in numerous human studies to treat heart disease since 1995. There have been no adverse events related to the use of FGF-1 in the heart and 100% of the patients have had improvement in their heart function. While Zhittya is exploring if FGF-1 can heal the brain, we know it heals the heart, the number one cause of death worldwide.

Data is available from a completed US FDA Phase I clinical trial where FGF-1 was administered to patients with severe coronary artery disease. Zhittya will use this data to file for a Phase II clinical trial application with the USA FDA in 2025. If we are able to obtain the FDA’s “Breakthrough Designation” (for medicines which address unmet medical needs, such as end stage heart disease) we could get accelerated approval for the FGF-1. This means it may be possible to obtain regulatory approval for the heart treatment in the USA from just the Phase II data that we could generate in 2025. If that occurred, 2026 could be an amazing year for millions of people suffering with heart disease with Zhittya’s FGF-1 able to extend their lives.

All the additional safety data we can collect on our human heart studies should greatly enhance our filings with the FDA, including, I believe, our application for Parkinson’s disease. Once the FDA acknowledges that the FGF-1 medicine is safe for the treatment of heart disease, the doors and opportunities to treat additional medical conditions should open up more quickly for Zhittya.

If you want more information on this conference in The Bahamas, here is the link to our heart summit: https://www.zgm-heart.com At the HEALinc Future Health Innovation Summit, Dr. Jacobs will be giving a presentation in the main conference room. In addition, Zhittya will also be hosting the following symposium following the main conference event:

Zhittya Cardiovascular Regeneration Symposium, April 30, 2024, 1 pm EST to 6 pm EST.

This conference will have both in-person and virtual attendees. People from all over the world will be able to watch the presentations over the internet. I am personally very excited that we may be treating “no-option” heart patients with our FGF-1 heart medicine this year in The Bahamas.

Just like in Dubai, when people see Zhittya’s medical science being accepted by the medical community, it enhances Zhittya’s ability to get our medicine approved by the USA FDA. At this time, I believe 90% of the people who need our medicine for treatment of their heart or brain disorders will need medical insurance to pay for it. That can only occur in the USA once the medicine is approved by the USA FDA. Zhittya’s success at these types of conferences contributes to getting the word out that our FGF-1 medicine is safe and effective and that it will ultimately get to the 90% of the people who need it.

Vika’s Patients’ Comments Section:

I receive many emails from our test subjects and I have chosen five to share with you. I have only copied and pasted the parts I believe matter to you as a reader and I hope you find these comments encouraging.

Patient 1)

This note is from Jaime, Devin’s caregiver. I thought I’d send out a picture and a video of Devin this week.

This is a picture of when we went for a walk in the neighborhood. He didn’t feel like it. He was pretty “parki” at the time, but he pushed through and did a lap around the block.

Also, here’s a video of him lifting weights. Again, he didn’t really feel like it but did it anyway. Go Devin!

One thing we’ve noticed is that when his energy and strength are good, they seem better than before the treatment. But when he crashes, he crashes pretty hard. Maybe because he’s not used to spending that kind of energy when he’s “on”? Also, the low days can be more discouraging after such good days.

Stay the course, dear ones. Better days are ahead!

You’re all in my prayers,

Jaime

Patient 2)

Doctor Jacobs, I thought that I would give you an update on my progression of my psp disease. First, I will give you areas that I have not improved in. 1.

My balance I still have problems with my balance in going backwards and turning to my left and with freezing of my feet! Now for the areas that I have shown some improvement in! My voice has improved noticeably. 2. I can get in and out of bed and my chair better, and my car. In fact, I recently went to my PCP doctor and she was really impressed with my walking ability since the last time I was in a wheelchair and this time I was just using my cane! 3. and my mind is a lot sharper. I still have a long way to go before I am comfortable with my progression. Thank you Jack XXXXXX.

Patient 3)

My dear Vika,

My husband and I came very close to flying to Dubai for your conference.

Although I have improved a great deal, I am not quite ready to travel comfortably. I hope it went well for you and can’t wait to read your next newsletter.

I am doing well, getting stronger and have much more energy. I would really like to continue my treatment. I am confident that I can beat this insidious disease and recover completely, as in be cured! But I don’t want to stop treatment until that happens.

Please let me know what you think.

Your very grateful Lab Rat # 107

Patient 4)

Vika,

We visited the neurologist yesterday. In their summary notes of visit"

Cognition improved.
Stiffness, rigidity, and bradykinesia improved This is a win!

[He] is working out for an hour a few days a week and carrying on conversations better.

He still has difficulty with reasoning and following directions.

He still sees people and thinks there is someone else here with us but it is less frequent.

Sleeping better at night.

I want to thank you from the bottom of my heart for this amazing opportunity. If there is anything we can do to help please let me know.

Blessings to you and your family,

Linda

Patient 5)

From: Joey

Feb. 21, 2024

Dear Friends and Cohort 20

We are sharing together our progress from our time together in British Isles. I want to share my improvements.

Voice and speaking – I am speaking louder and people are understanding me better.
Appetite is better – I am beginning to enjoy the smells and tastes of food.
Fewer hallucinations – only one the last month.
Cognitive improvements:

Less brain fog – less confusion, few tremors –mostly at night, still some posture issues Some walking issues – can’t walk too far without getting tired, have to sit and rest I am reminded of this quote: “Parkinsons is a chronic, progressive disease.” – How true. So glad that we are able to cope with it.

I feel better and am more optimistic about more improvements.

Blessings on you,

Joey

Upcoming Events

Saturday, March 2, 2024 | Las Vegas, Nevada

Las Vegas Review Journal - 2024 Spring Aging Well Expo

South Point Hotel & Casino

This is a health and aging conference sponsored every year by the largest newspaper in the Las Vegas Valley, The Las Vegas Review Journal. They expect between 600 to 1,000 people to attend and since Zhittya is a Las Vegas-based company we want to support our community. Also, we have many friends in the Las Vegas Valley who may wish to hear Dr. Jacobs’s presentation on “Heart Disease, Stroke, Parkinson's Disease and More:

Can Therapeutic Angiogenesis Reverse These Diseases?

Dr. Jacobs will be presenting at 11 am, Saturday, March 2nd at the Cyprus Room at the South Point Hotel & Casino.

Admission is free.

April 28 – 30: 2024 HEALinc Future Health Innovation Summit in the Bahamas At Atlantis Resort | Paradise Island | Bahamas At the HEALinc Future Health Innovation Summit, Dr. Jacobs will be giving a presentation. As noted above in this Update, Zhittya will also be hosting the following symposium:

Zhittya Cardiovascular Regeneration Symposium, which will be held on April 30, 2024, from 1 pm to 6 pm, Eastern Standard Time.

To learn more about this symposium, go to: https://www.zgm-heart.com Cross Border Medical Tourism Cross Border Medical Tourism services those people who want to be considered for Zhittya’s future clinical trials or its current Medical Research Studies. Cross Border’s focus is to fill all available slots in the Medical Research Studies in the British Virgin Islands (BVI), while we wait for other clinics to come online.

Cross Border is working on filling the available slots for the next BVI Medical Research Studies (intranasal FGF-1 for Parkinson’s disease) on the following dates:

Cohort #22: March 13, 2024 – March 18, 2024

Cohort #23: April 5, 2024 – April 10, 2024

Cohort #24: May 17, 2024 – May 22, 2024

Please contact Sam Cross at Cross Border Medical if you wish to be considered for a slot in one of these BVI cohorts. Sam’s email address is: sam.crossbordermedical@gmail.com.

In addition, if you are interested in participating in the brain scan studies, which will take place at Washington University in St. Louis, please let Sam know. There is a finite number of slots for the imaging studies.

Dr. Jack Jacobs As Dan Montano mentioned above, in the coming months we hope to begin treating heart disease patients with FGF-1 in the Bahamas. We are excited by this as FGF-1 has shown so much promise in previous heart studies. Over 100 so- called “no-option” heart disease patients have been treated to date with injections of FGF-1 directly into damaged or ischemic areas of the heart muscle.

After a 12-week period, the patients develop a robust growth of new coronary arteries at the site of FGF-1 injection leading to significantly less chest pain (angina) and better performance on exercise treadmill testing.

No adverse events were seen in any of the treated heart patients, so we feel strongly that FGF-1 represents a safe and efficacious treatment for these patients who have no other medical or surgical options for their heart disease.

One important point I would like to make with the heart treatment is that it represents a highly localized form of treatment. We only see new blood vessel growth directly around the area where FGF-1 is injected into the heart muscle as shown in the figure below. The new heart Clinical Protocol calls for 6 – 10 injections into ischemic areas of the heart to boost blood perfusion.

Figure 1. Growth of new coronary blood vessels in the human heart 12 weeks after an intramyocardial injection of FGF-1.

While the use of FGF-1 to treat coronary artery disease represents a localized form of treatment, the use of FGF-1 to treat brain disorders is a completely different situation. By squirting FGF-1 up the nose, our drug gains access to the cerebral spinal fluid (CSF) which bathes the entire brain and thus, the FGF-1 gets widely distributed throughout the brain as shown in work done by our collaborators at the University of Minnesota. They made our FGF-1 radioactive and administered it intranasally to rats and then examined where the FGF-1 went to in the brain. As shown in the Figure below it went everywhere in the brain!

Figure 2. Distribution of FGF-1 in the rat brain following intranasal dosing.

The bars in the graph above represent the quantity of FGF-1 found in different regions of the brain. We were pleased to see that significant quantities of FGF-1 made it to the substantia nigra region of the brain (region of the brain involved in Parkinson’s disease).

Why does the FGF-1 get so widely distributed in the brain following intranasal dosing? The answer is that there are approximately 100 billion neurons in the mature human brain and each neuron contains thousands of cell-surface FGF-1 receptors that are involved in the normal metabolic functioning of these cells. The brain literally “soaks up” FGF-1 when it is administered to the brain.

Scientists have discovered four fibroblast growth factor receptors (termed FGFR-1 through FGFR-4), which are highly conserved transmembrane proteins which when activated, regulate neuron cell growth and differentiation. When FGF-1 binds these receptors increased metabolic activity is readily apparent in these cells as shown in the figure below where FGF receptors are being activated in the hippocampus region of the brain, an area critical for memory, learning and emotion.

Figure 3. Visualization of activated FGF receptors (non-red areas) on cells in the hippocampus.

In addition to the billions of neurons in the human brain, there are also numerous other cells in the brain that actively express FGF receptors. Glial cells, which help support, connect, and protect the neurons of the central nervous systems actually outnumber neurons in the brain by 50:1! The glial cells possess cell surface FGF receptors and would represent an additional reservoir to soak up exogenously administered FGF-1. There are also billions of cells called astrocytes in the brain, which are critical for the repair of any damages that occur to brain neurons.

Astrocytes are also rich with FGF receptors.

Finally, blood vessels in the brain rely on FGFs for the repair of damaged blood vessels and to stimulate the growth of new blood vessels (angiogenesis). It is estimated that there are 400 miles of blood vessels that wind themselves through the brain (see Figure below) bringing nourishment to brain neurons and removing metabolic waste products.

Figure 4. Depiction of the vasculature of the brain showing the dense network of blood vessels that comprise this circulatory system.

During development of the central nervous system, FGFs play important roles in expanding the blood vessel supply network which is critical for the growing number of neurons and the glial cells that support those neurons. Finally, FGFs, including FGF-1, are involved in the regulation of synaptic plasticity, a process that refers to the ability of neurons to modify the strength of their connections to each other, which is an important process involved in brain reorganization after an insult or other brain damage.

So, what can we conclude from all of this? We believe in treating brain disorders (unlike the heart) that we need to make repeated intranasal dosing of FGF-1 to get sufficient quantities of the growth factor in the brain to stimulate angiogenesis and neurogenesis. A single intranasal dosing is just not enough. In addition, since brain diseases such as Parkinson’s disease are progressive disorders, we believe at present we need to repeat the FGF-1 dosing regimen every 6 months to be able to clear up new areas of brain ischemia as they develop. We are in a new medical frontier here and our FGF-1 dosing strategy will most likely be modified in the future as we learn more of what works best. For this we are ever thankful to our over 100 “Lab Rats” who have taken our FGF-1 treatment and to the hundreds more lab rats that will follow in the future.

Closing Comments (Dan Montano)

Every month passes so quickly when you are excited and busy about what you are doing. We are concentrating on treating multiple medical conditions and almost every month we add another target medical indication we believe FGF-1 can treat.

As we have discussed in this current Update, we hope to be initiating our heart treatment in The Bahamas in the coming months. Hundreds of millions of people suffer from coronary heart disease and over 17 million people die every year from this condition. I believe our medicine could defer the deaths of 80% of those people. I believe our FGF-1 can enhance their lives, and I have met those people we have treated and I have seen the improved outcomes from our medicine in treating their heart disease.

Brain disorders affect over 200 million people and I am very pleased with what we are seeing and the excellent medical outcomes we are achieving. With type-2 diabetes, Zhittya has a human research study going to confirm if FGF-1 can reverse that horrible disease. We have a lot going on!

I have been so busy with the many issues that Zhittya has to deal with, such as adding more clinics, manufacturing more FGF-1, imaging studies of the brain, and more, that I had momentarily lost sight of the “big picture” we are fighting for. I believe FGF-1 can enhance the lives of tens of millions of people and in the entire world, I only know of Zhittya advancing this miracle medicine. I know this extreme frustration that we cannot go faster to get our medicine to everyone. I know ahead of us are many years of USA FDA clinical trials, that will cost us many tens of millions of dollars and even if we have an “effective cure” for Parkinson’s disease, that does not mean the USA FDA will clear us for sale to the people in the United States. Every month I become a stronger believer that FGF-1 can reverse type-2 diabetes and perhaps be an “effective cure” for this disease which would benefit hundreds of millions of people around the world. That still does not assure that the tens of millions of dollars I must spend to obtain clearance from the FDA to sell the drug will be successful.

I have built companies from start-ups into billion-dollar market cap companies before. The joy of that success and making big money is nothing compared to watching our Parkinson’s disease patients improve and believing that we are on the path to maybe reversing that monster. When I read Vika’s patients' comments on how they are improving from their Parkinson’s disease and are getting better – that is a very satisfying reward to me.

Vika and I attend many of the Cohorts being conducted in the British Virgin Islands. I ask myself why do I attend these treatment sessions? There is nothing I have to contribute. Sam and Ann Cross, our doctor partner there, and others do everything, so I ask why do I do it? Meeting people on day one who are sick, tired and have little hope in surviving this monster Parkinson’s disease and then to experience after 6 days of FGF-1 treatment their new hope, their regeneration, and to see this with my own eyes every month and know it is real, puts fire in my belly, puts steel in my bones and reminds me of why we are doing this. In Cohort 20, one woman could not cross her arms and get up from the chair on day one.

This is a standard Parkinson’s disease test. On day four, she crossed her arms and lifted herself up to a standing position. Everyone in the room applauded and cried, a victory greater than winning the Super Bowl, and all realized she was starting her recovery from Parkinson’s disease. This is why I go, because I get strength and purpose from these people. When someone calls me and says, “Dan, I can now remember something from 40 years ago” it gives me a very powerful injection of energy into my soul. What an amazing joy to remember what we are fighting and pushing for, and why we are going where wise men fear to go, reaching for the “impossible dream.”

Conclusion: Zhittya and its growing band of brothers and sisters are going to make a difference, we have an obligation and a duty to succeed for the benefit of all mankind and we love it!

Each of our test subjects (affectionately known as “Lab Rats”) are making a path through the darkness to free millions of others from these horrible diseases. I thank each of you for your courage and strength. When sophisticated experts tell me we cannot succeed unless we have Big Pharma as our partner; I laugh at them, because they do not know I have you as my partner and together we shall succeed.

God Bless you all, as I have been blessed,

Dan Montano, CEO

Zhittya Genesis Medicine, Inc.

1120 North Town Center Drive, Suite #270

Las Vegas, Nevada, 89144

United States of America zgm.care

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