Research news

December 2024 update

A summary of the Parkinson's research in this month's update from Zhittya Genesis Medicine, with the complete update underneath.

Back to the research page · Open the original update (PDF)

In short

Participants continued to send reports about movement and thinking. The team was waiting on follow-up MRI scans at Washington University in St. Louis to measure blood flow in the brain.

The December update centered on follow-up brain scans and a look back at the year in the Parkinson's research.

Follow-up scans in St. Louis

CEO Dan Montano and Vika Montano had just returned from the dosing of the 31st group of participants. Before that, they made two visits to the Washington University School of Medicine in St. Louis for functional MRI scans of two participants. These scans measure blood flow in the brain. The team hoped the method would be sensitive enough to detect any change in blood flow linked to FGF-1.

For one of the two, this was the six-month follow-up to a scan taken before he began dosing. The comparison images had not yet arrived. Mr. Montano hoped to have them soon.

He described meeting this participant at the first scan and again six months later, and wrote that the difference in his walking, balance, voice and memory was striking. The participant's wife gave her own six-month account in the comments section. She described a stretch of several weeks of clear improvement, followed by a return of some symptoms, along with some lasting changes.

Mr. Montano stressed that the main question had not been answered. "The scientific question still remains open: why is he doing better?" he wrote.

The team's belief is that FGF-1 prompted new blood vessels to grow, a process called angiogenesis, and that fresh blood was reaching undernourished cells. The scan images were meant to test that belief. More scans were under way.

The year in Parkinson's research

The update said more than 200 people with Parkinson's had now received FGF-1 in the research studies. According to Mr. Montano, most had shown clear improvement and others more modest improvement.

The team's main lesson from the year was about dosing. The first participants, two and a half years earlier, received Protocol 1, a single round of FGF-1 with no repeat doses. Current participants receive Protocol 17, which the update said gives more than 16 times as much FGF-1 over two years. Mr. Montano wrote that more FGF-1 over a longer period had led to better outcomes than the original plan.

The dose and length of dosing were being raised slowly. He expected the team might move to higher dosing levels in 2025.

What was still unknown

Mr. Montano wrote that he did not know when the team would be able to say it had found the best protocol for Parkinson's, which it needs before moving into the clinical trials required for FDA approval. He thought the studies could include 400 participants with Parkinson's by the end of 2025. He doubted that this alone would satisfy the FDA.

Upcoming talks

Dr. Jack Jacobs was named to receive a "Man of the Year" award from the Nevada Bio organization at its annual dinner in Las Vegas on April 2, 2025, where he would give a short talk on the Parkinson's research. He was also invited to speak at an autism conference in Texas in late May.

The update shared four comments from participants and family members. They covered alertness, appetite, walking, tremor and hand use. One participant wrote that she had no big improvements to report. The rest of the update covered policy opinions, other research areas and company matters, which are not carried here.

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

Read the complete December 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.

December 17, 2024, Monthly Update

Preface:

We wish you and all those you love a Merry Christmas, Happy Hanukkah, Happy New Year and best wishes for all the ideals and beliefs you cherish.

Vika and I have just returned from the British Virgin Islands (BVIs) for the dosing of Cohort #31. Prior to coming to the BVIs, Vika and I had two visits to the Washington University School of Medicine in St. Louis for functional MRI (fMRI) scans of two of our patients, Tyler and Al. These scans measure blood flow in the brain and hopefully the technique is sensitive enough to detect FGF-1 induced improvements in blood perfusion in the brain. I hope to have the comparative images soon for Al, so we can compare and see if there is enhanced blood flow in his brain from 6 months of FGF-1 dosing. In Vika’s section on “patient comments”, Al’s wife, Kate, has written her observations of his conditions over the last six months you should read it!

Dr. Jacobs, Vika and I met Al & Kate in St. Louis six months ago for his first fMRI brain scan, and he was quiet, moved slowly and cautiously, and seldom spoke. He was a very nice person; however, he moved like a zombie. Seeing him in St. Louis for this six-month follow-up scan, it was amazing to see his improvement. He is walking strong, has good balance, was talking at a normal volume, and was full of jokes and laughs. Kate and others who have seen him recently told us his improvement was nothing short of miraculous. He was full of stories, recalling events from 50 years ago in detail. It was a great confirmation to us that the FGF- 1 is working in reversing his Parkinson’s disease.

The scientific question still remains open: why is he doing better? We believe that the FGF-1 has triggered the growth of new blood vessels in his brain (a biological process called “angiogenesis”) and that fresh blood is now reaching undernourished cells and returning them to fully functioning cells. I hope and pray that the functional MRI shows increased blood flow in his brain resulting from newly formed blood vessels, thereby reversing his neurodegenerative condition.

This would add great support to why our stroke patients are doing better, why our dementia patients are doing better and more. I know many of you only read the first page of our Monthly Updates, this time I beg you to read Kate’s six- month report on Al’s improvements. Hear from her on how Al has improved and wait with me to see if the MRI images we receive from Washington University show enhanced blood flow in his brain.

I believe that dysfunctional vascular blood flow in the brain is responsible for 90% of all brain diseases (excluding cancer). I believe that there is one simple cause for such disorders as stroke, dementia, Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, epilepsy, autism, type-2 diabetes, and more — and that is insufficient blood flow in the brain. If Al’s MRI shows enhanced blood flow, then we are at the dawning of a new era in treating brain disorders. A mere 70 years ago, when I was a child, we lived with the fear of polio. Parents and children worried every day about getting polio and having their lives distorted forever.

Today, in 2024, parents do not worry about polio and many have no idea anymore that this was a cruel and terrorizing childhood disease, which has now been effectively eradicated. If Al’s MRI shows enhanced blood flow in his brain, then maybe 40 years from now, when you are at age 110 (with a sharp mind from FGF-1), you can explain to a young 65-year-old person what the of fear dementia, Alzheimer’s disease and Parkinson’s disease was like back before FGF-1 therapy vanquished it.

I pray for everyone with these diseases every night. I just pray a little bit more for Al to show us the way and give us the empirical proof we need to show the world that FGF-1 is a viable therapy for these brain disorders.

The year 2024 is drawing to an end. Zhittya and our efforts to advance our medicine to treat the major causes of death and suffering have made substantial progress in 2024, especially in patients with Parkinson’s disease.

Parkinson’s Disease: We have treated over 200 Parkinson’s disease sufferers in our Medical Research Studies. We have seen some amazing improvements in most of the test subjects. Others have had more modest improvements, but to date, no one has declined to below when they first started our treatment. We have seen zero adverse events and we have learned a great deal of important data from our test subjects. We see, without a doubt, that more FGF-1 over a longer period of time is definitely better for patient outcomes than the original protocol. The first test subjects (2 ½ years ago) receiving FGF-1 for their Parkinson’s disease received Protocol 1, or dosing level one, and that was a one- time dosing with FGF-1 with no additional redosings. Now our test subjects are getting Protocol 17, which represents over 16 times more FGF-1 (given over a two-year period) than the first test subjects received. We are slowly increasing the dose and duration of dosing as we confirm that FGF-1 is a very safe drug without any apparent side effects. This coming year of 2025 should advance our knowledge even more.

Zhittya looks at 2025 as being a possible “break-out” year for our efforts to advance our medicines. I hope we have data from animal studies to allow us to file Investigational New Drug (IND) applications with the FDA to perform advanced clinical studies for our heart treatment. We are continuing our Medical Research Studies in brain disorders, diabetes, leg diseases, type-2 diabetes, diabetic foot ulcers and more. We have endured through the financial crisis, COVID-19, and more obstacles, but we still have advanced — sometimes slowly, sometimes quickly. I see ahead of us 4 years of fair seas for our efforts.

Discussions about reforming the FDA to make its slow and expensive bureaucracy more efficient is an answer to my prayers. We have great data on being able to treat “small vessel heart disease”, the number one cause of death in the world.

We have four completed human studies with no adverse events and dramatic improvements in heart function and a dramatic enhancement of patients’ lives.

Heart patients, who had been given one year to live when first dosed with FGF-1, in some cases lived another 15 years of a decent life.

We are starting 2025 with impressive data on 200 Parkinson’s disease patients.

We are dosing at Protocol 17 and I believe in 2025 we may move to higher dosing levels, as we continue to see the drug is safe. I do not know when we will be able to finally say we have the best Protocol to treat Parkinson’s Disease so we can advance through the FDA to conduct the important clinical trials for approval. I believe at the end of 2025 we could have 400 Parkinson’s disease test subjects showing good safety and efficacy results, but will that impress the FDA? I do not think so. I do believe it will impress rational leaders who realize that the present FDA approval process (according to the London School of Economics takes 18 years and costs 1 to 2 billion dollars) is ridiculous. It is sad to think that a 70-year- old person, now suffering with stage 3 Parkinson’s disease, will have to wait another ten years to get a medicine that could greatly alleviate his or her suffering now.

The US Congress in 1962 changed the law so the FDA had to study the efficacy of a medicine before approving it. Before that law, the only question was “is the medicine safe?”. Back in 1962, it took two years to get a medicine approved through the FDA. We could meet those standards easily today with the heart, the brain, the legs, diabetic foot ulcers and more saving millions of lives NOW!!

Every medicine approved by the USA FDA still comes with the expectation that your doctor will monitor you and manage your medicines. Why does any rational person believe a government bureaucrat working from their home for the FDA is going to be receptive to innovation and change and even knows what is best?

Why do we trust experts, who are not in the real world of practicing medicine more than the medical doctors working with the patients directly? Did the COVID- 19 experts impress you?

What if Zhittya, with great data on 400 people with Parkinson’s disease, showed the FDA and other enlightened leaders that our drug is safe and effective and we explored whether those patients can access our FGF-1 through the “Right to Try” law and have it paid for with Medicare insurance in 2026? That would make our treatment available to tens of thousands of regular Americans who would benefit from our drug now. Note that Medicare is going bankrupt, and that nearly all private and government health care plans are going bankrupt. Those medical insurance plans pay to maintain sick people for decades and it is expensive. I believe that the cost to Medicare for one Parkinson’s disease patient with ongoing disease (~15 years) will cost 5 times more than what FGF-1 would cost in reversing their disease and making the patient healthier with no pain or suffering.

For this to happen, it only requires some legislative adjustments in the language of the “Right to Try Law”. I believe changing only 3 sentences allows millions of Americans a better life now! Call me simple, but what good is the Right to Try Law if no one can use it? Call me simple, but if Medicare is going to pay big money over 15 years for a suffering Parkinson’s disease patient, why not save 80% of that cost by curing the patient now with FGF-1 and let them have a better life? The Parkinson’s disease patient is better off and Medicare is better off, and that is what I call a “win/win” situation.

I am happy to show you a picture of me and my friend Steve Moore; who has been appointed to Head President-elect Trump’s transition team for economics. I have high hopes.

Please look at the Events Section of this Update; Zhittya is hitting the road hard to get our message out in 2025 that (1) our medicines are safe and improve patients’ health; (2) suffering people have a Right to Try and (3) Medicare and Health Insurance plans are all better off financially by curing people rather than allowing them to continue to suffer.

Yes, 2025 could be very interesting!

Vika Montano’s Patients’ Comments Section: Every month, I receive emails and phone calls from our test subjects. Here I have selected a few of their comments so you can read what those who have joined our Medical Research Studies are reporting to us.

#1) From Kate (Al’s wife)

This is a synopsis of Al‘s journey. In April 2024, we flew to St. Louis to have Al have an MRI of Al’s brain at Washington University.

In May 2024, we flew to the BVI for Al’s first dosing of FGF-1. There were 11 fabulous people in our cohort. Many of us continue to meet on Zoom once a month to encourage each other.

From May until October, I would see glimpses of the old Al. But mostly, I was seeing the Parkinson’s Al with the glaze in his eyes and the shuffle in his gait with lots of constipation and confusion in his mind.

On October 12, Al got up early without the alarm. He was bright eyed and alert. I saw that the Parkinson’s cloud had lifted from his eyes because they were bright blue and the glaze over his eyes was gone! His gait was strong, and his mind was clear and he was able to add to the conversations that we had with other people.

On October 16, Bonnie Lyons came to visit. She started her FGF-1 dosing two years ago. We had seen her in June at the Freedom Fest trade show in Las Vegas.

She couldn’t believe the difference in Al. He had continued to stay alert and unmasked for weeks.

Later in October, Al’s uncle Henry passed away, he was from El Paso, Texas. Al wanted to go to the funeral, but I was unable to go. So, he and his brother, Richard, went to El Paso for four nights. This was the first time in nine years that we had been apart for this long of a period of time. Richard updated me and told me that he could see a difference in his brother, and he talked about him being alert and having less fatigue.

A few days after his return from El Paso, he started reverting back to his Parkinson’s behavior, sleeping a lot and being dizzy, cognitively slow, and his gait was back to a shuffle. His cloud had lifted for over four weeks, and I was grateful to see the improvement that I had seen, which gave me hope for what was yet to come!

Some other symptoms that have permanently changed are: Al is enjoying food again and he’s even gained a little bit of weight, his constipation is basically gone which really makes him happy. Some of the symptoms that come and go are: his tremors have stayed with him- (we both agree that tremors are the least of his problem — cognitive issues are far more important to us) being able to have conversations comes and go at this point. Where before he would stop talking because he was fatigued and couldn’t remember where the conversation was going. My favorite thing that keeps coming and going is his sense of humor. He was never really good at telling jokes, but he always had a great zinger at the end of somebody else’s story! Which means he could follow the story (which is huge) and add a zinger to the end of story which surprises everyone!

I cried every morning that I woke up and found him clear eyed and eager to take on the day! I know that my sweet husband is still in there and not lost in the Parkinson’s cloud.

In our family we have given each other three squeezes to silently tell each other, I love you. We are sending three squeezes to each of the people at Zhittya to tell you how much we love you for your persistence and diligence to bring FGF-1 to those who definitely can benefit from it! Parkinson’s is a horrible disease and for 50 years they have been using the same drugs to treat it! And Now We Have Hope!! A special Squeeze to Dan & Vika Montano and their family, who have sacrificed a lot to make this happen. And to Dr Jack Jacobs who pushes through to make sure all the testing and academia gets addressed correctly! We would have no hope without you!

Here is a picture of Al at his 6-month scan in St. Louis and Kate, Al, and Vika:

  1. Toni Hi Vika - just a note to let you know I'm following your protocol from September.

Thank you so much for caring. I have no big improvements to report but I do feel my dystonia in my hand has loosened up a bit. Wish the foot would follow! I can't tell you how important for me it is to have Zhittya as my hope for improvement.

My neurologist has told me there is nothing more she can do since I can't take any of the medicines other than a tiny bit of amantadine and has relegated me to palliative care where I can get a social worker and physical therapy. Nice but...

Also, my podiatrist said he couldn't do anything either other than giving me a brace to wear. Walking is slow and difficult! I have kept up with some of the cohort group and get hope from them too. Thanks again for being there

  • Toni
  1. Bob has cut back on his carbidopa/levodopa to three pills a day from 5-6, before.

We went to his neurologist in October and he asked if he was still taking the FGF1 and he said yes. He said Bob was doing much better than he expected. He also commented that this gives him (the doctor) hope.

The doctor was aware that Bob had cut back on his pills.

We are going to try to lower this even more in the future.

Bob has fallen several times but is learning to be more careful when he moves.

Still plays golf 2 times a week and has been exercising more. God Bless you guys for all you are doing for us.

4)

To Vika:

Let's just say I am daily thankful for you guys! His downward slide stopped in BVI, and there has been progress. I think I already told you that his typing ability is back up to "speed" — well, he's never been a great typer, but he is no longer hunting and pecking. Before BVI, his 8-hour day of 13 or so patients half killed him. Now, he's moved to tens--up to 19 patients, and he is killing it!!

He rarely drags his left leg when he walks (he used to look like Lurch).

He has no trace of a "mask," and no longer has occasional trouble with finding the right words.

So many different things.

Again, thanks!! Jacque

Cross Border Medical Tourism Cross Border Medical Tourism services is for 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 and The Bahamas, 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 #32: January 7 – 12, 2025

Cohort #33: February 11 – 16, 2025

Cohort #34: March 10 – 15, 2025

I am showing cohorts further out in time since we are filling up faster and have fewer spots open each month.

Please contact Sam Cross at Cross Border Medical if you wish to be considered for the BVI cohorts or slots in The Bahamas. 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 are a finite number of slots for the imaging studies. These studies will look at brain blood flow before and after treatment with FGF-1. There has been no reported pain associated with the MRI scan.

Heart Disease Clinical Trials and Medical Research Studies:

Zhittya is proud to announce that we are actively recruiting and selecting patients suffering from late-stage heart disease. FGF-1 was originally used in USA FDA clinical trials to treat severe coronary artery disease. The treatment was shown to be safe and a potentially efficacious treatment for those suffering from coronary heart disease. Watch this ABC Nightly News’ clip on Zhittya’s drug being used for the heart indication: https://www.youtube.com/watch?v=IPtv_0LWK4k Zhittya is now actively recruiting patients to participate in Zhittya’s Medical Research Studies in The Bahamas, as well as future USA FDA clinical trials. If you are interested in participating in these studies, please reach out to Sergiy Montano, our Vice President of Marketing at: sergiy@zhittyamedicine.com and he will assist you from there.

Pre-IPO Private Placement

We will be closing the Pre-IPO investment opportunity at the end of December

2024. Bart Vossen is still working with people interested in learning more about the Pre-IPO placement we are conducting. If you are an investor and wish to learn more, please email Bart at: bhvossen.rmena@gmail.com Upcoming events:

Nevada Bio Organization: Annual Awards Dinner

April 2, 2025 Las Vegas, Nevada

The Nevada Bio Organization, since its founding in 2006 has been the Premier organization for Biotechnology in the State of Nevada. On April 2, 2025 they are having their “Annual Awards Dinner” at the Durango Hotel and Casino in Las Vegas.

I am pleased to announce that our Dr. Jack Jacobs will be the recipient of the “Man of the Year Award”. This is for Dr. Jacobs' discoveries and development of FGF-1 to treat the major causes of death and suffering in the world today. Dr. Jacobs brilliant career and outstanding accomplishments over the last 40 years has earned him the honor, which he well deserves. Jack will give a short presentation on:

“Parkinson’s Disease: Reversed by Nevada Biotech Company. Nevada: Where Biotech Prospers.”

I have been informed that important elected officials and the media (TV and press) will be attending to learn more about what Zhittya’s breakthrough medicine is accomplishing. I have been told they expect around 300 attendees, and we are bringing some of our Parkinson’s disease patients there to show these elected officials that Parkinson’s disease, stroke, dementia, Alzheimer’s disease and diabetes sufferers do not have to be abandoned and mistreated — those diseases can be reversed. I believe small changes in the wording of the “Right to Try Law” would give access to thousands of people who would be better off sooner and Zhittya has to fight for those changes in that law.

We will have more data on this event in future Updates.

I think of this event as “Zhittya’s Coming Out Party”, we are going to show the world what we are doing!

Autism One 2025 Convention

Thursday, May 29 – Sunday, June 1

Sheraton Austin Georgetown Hotel & Conference in Austin, Texas.

With the impressive improvements we have seen in one of the autism patients we have treated, Dr. Jacobs has been invited to present at this in-person event on this topic:

"Autism: Is This a Vascular Disease and would Therapeutic Angiogenesis with FGF-1 be a Potential Treatment?"

I am hoping to have another person join Dr. Jacobs, the father of the young lady we treated and who is an author of a New York Times bestselling book on Autism.

His book has been very controversial, however now with Robert Kennedy Jr. in the Trump administration, who is his friend and they share a common belief. Our hopes is this event could enhance awareness that autism can be successfully treated.

If you want more information on this you can go to: The AutismOne 2025 Conference website is go.autismone.org.

Freedom Fest 2025

June 11 – 14, Palm Springs, California

Dr. Jacobs and I will both be presenting at the FreedomFest where normally many elected government officials attend. Last year, I believe they had over 2,500 attendees and in 2023 at the Freedom Fest they hosted Robert Kennedy Jr., as a Keynote Speaker and we were able to chat with him then.

Dr. Jacobs will present an Update on our medical progress in several diseases and I will present my case that changing a few words in the “Right to Try Law” could accelerate medical innovation and lessen the pain and suffering of hundreds of thousands of people now!

Equally Important: Nevada has its own “Right to Try” legislation and I believe if a few words were changed in that law, it would make Nevada the leader in the world of Regenerative Medicine biotechnology and create a new industry for Nevada.

Dr. Jack Jacobs

Right to Try: Unapproved Drugs or Biologics

The Right to Try Act signed into law at both the federal level (2018) and state level (46 states, including Nevada, have passed Right to Try acts) enable drug manufacturers and physicians to provide investigational products to eligible patients without risk of liability. These “Right to Try” laws also prohibit medical boards from taking disciplinary action against physicians. The laws specify that a patient with a “life-threatening” disease or condition can have access to investigational drugs and biologics that have completed Phase 1 FDA testing and have not been placed on clinical hold.

In order to receive an investigational drug or biologic under the Right to Try acts, the patient must:

  • Have a life-threatening disease or condition;
  • Have exhausted treatment options, as certified by the physician;
  • Be unable to participate in a clinical trial involving the investigational drug, as certified by the physician; and
  • Have given his or her written informed consent (or consent of a legally authorized representative) to the treating physician regarding use of the investigational drug.

Use of an investigational drug under the Right to Try is exempt from FDA requirements for review and authorization, so long as the sponsor or manufacturer of the drug is in compliance with FDA requirements applicable to investigational drugs.

The Right to Try acts do require sponsors and manufacturers who have made their investigational drugs available to annually report to the FDA the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events. In turn, the FDA must make this information publicly available on its website.

Patients may be charged the direct costs of making the investigational drug available for their use. The Right to Try acts incentivize sponsors and manufacturers to make their investigational drugs available by protecting them against liability with respect to acts and omissions regarding the investigational drug. The Act also protects prescribers, dispensers, and other individuals from liability, unless the act or omission constitutes reckless or willful misconduct or gross negligence.

Below are the most cited reasons that are used to justify the Right to Try acts:

  1. Right to Try is needed because most terminal patients cannot participate in clinical trials. Most people with a terminal illness are too sick to be selected.
  2. Right to Try is needed because dying people don’t have access to promising treatments once clinical trials are over, even if the drug was successful and will be later approved. For the lucky few terminal patients who get selected for clinical trials, their luck runs out once the trials are over.
  3. Right to Try is needed because the FDA compassionate use process doesn’t help enough people. The compassionate use application process is complicated, time-consuming, and expensive.
  4. Right to Try is needed because it takes too long for promising treatments to be approved. On average, it takes more than ten years for drugs to make it through the clinical trial process and receive approval in the U.S.
  5. Right to Try is needed because one should not have to ask the federal government for permission to try and save one’s own life.

There is no more fundamental freedom a person has; than the freedom to try to save one’s own life.

Conclusion by Dan Montano

Zhittya has made great progress these last 12 months. Over 200 Parkinson’s disease test subjects, two patients with dementia, one patient with Alzheimer’s disease, two patients with autism, one patient with Type-2 diabetes and one patient with ALS and some more diseases are advancing along our pathway of discovery. We have more going on; however, we will reveal those items when we have the data that confirms our medicines are effective.

I believe 2025 will be a very important year for everyone. I believe the economies of Europe, China, Asia, Canada and the United States have reached a critical economic/financial moment which Prime Minister Margret Thatcher stated as:

“the problem with socialism is eventually you run out of other people’s money to spend.” I believe this critical economic reality is happening now and that many governments are broke both financially and morally. It will take real leadership to open the doors to “Free Market Economics” and let people be free to solve their problems with the government getting out of the way. As many of you know, I spent 30 years (1968 to 1998) as an Investment Banker, financing hundreds of young innovative companies. What most of you may not know is I was also a lecturer/professor for 7 years at two major Universities teaching finance and economics. I have given hundreds of presentations all over the world on “Free Market Economics and why it is the only economic system that has delivered peace and prosperity to people in history.”

As government reach has grown over the last 50 years and with politicians and so- called experts seeking more and more power, they have extended the reach of government. Just look at what we saw during the COVID-19 crisis. If you don't take this vaccine whose benefits are unknown and its side effects have not been studied, you can be thrown out of the United States military. You cannot fight and die for your country, because you will not take an unknown injection from experts that you do not trust? If it is your personal belief that you wish to go to your place of worship to find solace, you can not only be denied that, but you can be arrested for going to a place of worship.

I started this project to advance this medicine (FGF-1) 27 years ago. We have expended over $180 million USD. We have experienced 100% safety with our medicine and very material improvements in patient outcomes. And in spite of that great success, we are caught in a “Catch 22 Loop” of it being safe and working, therefore we need to study it more. Every person we treated for their “No Option Heart Condition” had been given by their doctor less than two years to live (to be included in the study you have a real sick heart). Amazingly, in all the heart patients we have treated, we have seen zero adverse events and dramatic improvement in heart function, which extended their lives materially (15 years).

We have to keep starting over and over with the FDA; while over 10 million people die every year from a disease we could treat and save millions of people’s lives. We have seen dramatic improvements in Parkinson’s disease patients we have treated and with no adverse events and yet we could be looking at 7 to 15 more years to get USA FDA approval — because the medicine is safe and it works?

Recently, I saw a cartoon, where two cavemen were sitting around looking at a fire. The title of the cartoon was “government bureaucrats” and their conversation was “this fire thing is a dangerous thing; someone will get hurt if we do not stop it!”

Keep this in mind: the governments of almost all nations over the last 50 years have taken a path of those governments promising (politicians) more and more; so, they are now paying for health care, defense, social benefits, education, the climate, and more. They are all running out of money and no accountant (other than government accountants) in the world can understand how you can sustain taking in x amount of money and spending 2x amount of money. Government health care and all healthcare insurance are doomed. We have 4 years ahead for us to lower the cost of healthcare and make it affordable to people, so how do we do it? The Free Market Economic answer is: get the government out of the way; so, people can figure out how to solve their problems. I have not had health insurance for the last 17 years. I pay cash for any medical services needed. A few years ago, one of my family members needed surgery. I told the doctor I would be paying cash in advance, since I had no insurance. He was shocked, so he called the hospital and we paid 30% of what the insurance company would have been quoted. Why? Because the insurance company denies paying for many treatments, the insurance company takes forever to pay, the insurance companies will demand lower prices or they will exclude the doctor or the hospital and more. I calculated that if I had bought health insurance and made 17 years of payments, the insurance would have cost me 4 times more than I actually paid for the medical treatments (and that assumes the health insurance company did not deny my claim and I would have to pay it anyway!). Please keep in mind that it is now reported that United Health Care (the largest private health insurance company in the United States) denies 32% of all coverage requested.

Do you think they deny just small money requests for care, or do they deny the critical expensive care requests? Hospitals and doctors will not proceed on a treatment plan until they are assured that it is covered and with United Health Care rejecting about 1/3 of all requests, I do not blame them!

How do you lower health care prices? Free market competition! How can Big Pharma keep selling billions of dollars of stents for heart treatment, which only delay and, in many cases, make it worse (restenosis) when we have a superior treatment outcome with FGF-1 and at a much lower cost? We have a natural treatment that solves the heart issue for many years at 1/5th the price they pay now. They can keep on selling that because of the lack of competition created by the government protecting you from innovation that would improve your life.

Just like the caveman with their fire – the government protects you from using fire because it may hurt someone someday, so it must be stopped. A No Option Heart patient with a year to live does not have 18 years to wait for a stay-at-home bureaucrat to bless a treatment that could extend their life now, which needs to be blessed by an expert; who does not understand and does not care about the realities of your life.

I conclude with these two thoughts:

One: I wish you all the blessings that exist. To you, your family, your friends and to everyone you meet.

Two: We all have to understand that our freedom to have a healthier life is now being denied by the government's “Catch 22 Rules”. If it makes you healthy and it's less expensive there must be years more of investigation as to why this occurs?

Yes, I expect a volatile 2025 for Zhittya, as we must push to treat millions of people who need our medicine. I also know if we do not push it, it will remain locked away while people suffer. That is unacceptable to us. We have to get it done. There are people’s health and lives depending on our success then failure is not an option!

Bless you all!

Dan Montano, CEO

Zhittya Genesis Medicine

1120 North Town Center Drive, Suite #270,

Las Vegas, Nevada 89144

United States of America zgm.care

[mailto:sam.crossbordermedical@gmail.com](mailto:sam.crossbordermedical@gmail.com)

<https://www.youtube.com/watch?v=IPtv_0LWK4k>

[mailto:sergiy@zhittyamedicine.com](mailto:sergiy@zhittyamedicine.com)

[mailto:bhvossen.rmena@gmail.com](mailto:bhvossen.rmena@gmail.com)

<http://go.autismone.org/>

<https://www.zgm.care/>

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