In this presentation, a representative from Envita explains why the organization operates both a Scottsdale, Arizona clinic and an international facility in Hermosillo, Mexico. The narrative begins with the development of a natural killer (NK) cell vaccine in 2003‑2004, predating the modern biologics era. After an FDA warning letter in 2008, Envita filed an Investigational New Drug (IND) application, secured approval within two years, and became one of the first integrative centers in the United States to conduct a Phase I drug trial rather than a supplement trial. The speaker describes how the high cost and regulatory constraints of U.S. care motivated the creation of a Mexican lab that adheres to U.S. IND/FDA standards but benefits from lower operating costs and more flexible international regulations. The facility now produces advanced, seventh‑generation protocols that combine dendritic cell genetic modifications, genetically‑engineered NK cells, and other immune‑activating agents, leveraging partnerships with European and Asian companies. The presenter emphasizes the advantages of international care—reduced costs, faster technology evolution, and access to diverse global therapies—while maintaining a personalized, evidence‑based approach tailored to each patient’s genomics and clinical profile. Reported outcomes include improved quality of life for patients whose disease had otherwise plateaued. The talk concludes with a mission statement rooted in ethical and religious belief, asserting that extending human life is a divine gift and a responsibility of physicians and researchers.
Chapters
Thank you for joining me. We get the question asked, why does Envita have a location in Scottsdale and an international facility that we've established in Hermosillo, Mexico? Well, it's a little bit of a story, but I want to share this with you. Back in 2003 and four, we developed at Envita a natural killer cell vaccine that we began working on, which was teaching the immune system to attack cancer. Now, this was before biologics, or the area of using your own cells, started to become more popular as it is today. And we started evolving that technology. And in around 2006 and 07, food and drug, the FDA came to us and said, you know, this is a clinical trial you're doing. You need to apply for a study for this. Well, at the time, we didn't know because we thought we're taking patients own cells and giving them back to them. We're really not. We thought of it as minor manipulation. And so FDA gave us a warning letter in 2008 and told us, hey, you better file an institutional new drug application IND get that approved, and then we'll let you continue. And that usually can take many years. But our team, we buckled down, we wrote the studies, and in two years got approved. I think we were the first integrative centers in the country to have a phase one clinical drug trial. Not a supplement trial, a drug trial. We got approved and we talked to the FDA and we said, fda, hey, can you let us charge patients just the cost of care, really, no profitability, just so we can. They said, no, you need to fund all the care. You need to become a drug company because they have the right to do that. FDA can give you that permission to do that. And at that point, we realized how costly the care is here in the US and also how limiting the evolution of the technology is. Because as you improve the technology, you're writing new studies, submitting, changing. And so in those early years, we started developing. We met our medical team and built our medical team in Aramisillo. We have the head of hematology oncology of Sonora. We have one of the tops at the University of Sonora that are all working on our project. And we developed a lab and brought in all the U.S. standards, all the IND FDA standards that we would use here in the U.S. to those facilities to treat our patients. And we have just evolved that vaccine. Now, today, we do dendritic cell genetic modifications, natural killer cell targeting with genetic modifications, and build an entire protocol that's customized for our cancer patients, for those who are candidates and the care seems appropriate. But the beauty of international care is that you keep costs are better, even though overall it's quite expensive, but costs are better than a lot of times here in the United States. Your technology can evolve faster. And we were able to partner with European countries, Asian companies to bring in those various medicines into our laboratory so that we're able to enhance, activate different immune system cells to fight cancer. And of course now we've got a seventh generation improvement from the earlier. So this is significantly working better for us. So the advantage is that international laws many times can be better. And the other important thing to remember is that you need the care that's right for you. And when you look at the globe and the whole world, it's not a one size fits all. There are therapies and treatments evolving in different parts of the world. And what we've tried to do here at Envita is take the best that's available in the literature, that's scientifically based and customized to the person's individual needs, genomic, genetic, targeted, and evolve that whether it's the immune system, whether it's in the chemotherapy regimen, whether it's fighting our infections, looking at multi drug resistance, on and on and on, looking for toxicities in our patients, et cetera. And when you resolve those things for your patients, at least you're able to help them with some of those things. We see that our patients improve in quality of life. They tend to improve when sometimes they stop improving everywhere else. And so we feel very blessed to have this international capacity for our patients. So it's been a journey, it's been 17 years in the working of what we've been building. And we're continuing our commitment to help our patients bring in the best treatments from around the world and do all that we can to extend and improve human life. Because we believe human life is a gift given to us by God. And it's the job of doctors, physicians, medical teams, researchers, to work the best we can, to work as fast as we can to help this generation and improve their life. So I want to thank you for joining me and I want to wish you the best on your journey to healing. May God bless you.
