In July of 2024 Dr. Boyd Haley CEO asked the EmeraMed board to find his replacement because at 84 he was ready to relax and enjoy his retirement. Sadly, in November he began to have serious health issues and the Board was forced to decide on a new CEO. Thankfully, Dr. Haley is making steady progress in his recovery but is not able to go back to full time work.
Dr. Haley was invited to speak at the Salt Lake City IAOMT Scientific meeting in March but was unable to travel. Randall Moore using prior video he shot for his documentary Evidence of Harm put together a beautiful tribute to Boyd Haley that was shown at that meeting and is now on the EmeraMed website. The IAOMT President gave Dr. Haley’s daughter Shannon and grandchildren an award for Boyd’s many years of dedicated service.
In January of 2025, the EmeraMed Board chose David Kennedy, DDS, a major investor and former board member, who agreed to return as interim CEO and guide the company until a new CEO could be recruited. This is the first newsletter in some time that will explain where the company is and the plans going forward.
First it is important to understand the company is laser focused on obtaining orphan drug approval from the FDA and EMA or removal of the FDA’s 2010 cease and desist order or both. As of this date with the exception of chemical manufacturing controls (CMC) it appears that EmeraMed has completed most of the studies required to obtain drug approval. At the last type C meeting with the FDA hematology panel in 2021 they disagreed and demanded large human studies. Those studies began in 2021 and were approved to treat human subjects who were/are mercury toxic in Colombia SA. Unfortunately, it has become far too costly and difficult to recruit study trial participants due to violence in the gold mining areas and in July 2024 we paused all further recruitment until further notice.
Upon assuming the new position Dr. Kennedy began to work with a new Contract Research Organization (CRO), CTI Clinical, to evaluate the current state of our new drug application. MUMS stands for minor uses minor species minor uses. Orphan indication such as mercury is a minor use because the FDA believes few are mercury toxic. EmeraMed has had MUMS for kidney stone in dogs. In November 2024 the FDA adjusted the definition of minor species to any animal other than a human being. Once the review is completed we will immediately apply for MUMS Mercury based upon the research that has been completed. We expect to accomplish this by June 2025. CTI Clinical will also evaluate commercial uses like improving the quality of farm fish.
Research shows that almost all commercial pet foods are highly contaminated with heavy metals. Baby foods too. All cats that regularly eat fish are undoubtedly impacted by mercury. Since the cats are small they won’t need very much Emeramide to benefit and recover. We hope that by this approval EmeraMed can commercialize veterinary uses up to 75,000 animals to fund any additional animal requirements without further diluting existing shareholders investment.
The next step in late June or early July will be asked to do set up another meeting Type C meeting with the FDA and apply for emergency use for Emeramide during amalgam removal or placement. The FDA has acknowledged grudgingly 9/24/2020 that many people with mercury related disorders or females capable of reproducing or nursing are at high risk of excess mercury exposure during dental procedures with amalgam.
Every restorative dentist in the US drills out mercury/silver fillings daily. About half of those dentist still put in a new mercury filling that same day further exposing the patient for decades to mercury. This is what is called a serious unmet need and the fundamental requirement for orphan drug approval.
The FDA’s acknowledged the problem thanks to the lawsuits and petitions by the IAOMT and 20 years of argument. We intend to ask them to approve Emeramide in order protect the patients and the dental staff from mercury. Hopefully if they have additional questions or concerns they will give conditional approval of Emeramide to protect the dental patient when exposure is likely while we satisfy those concerns
There are a lot of moving parts to the company and one of the newest parts is the use of NBMI for environmental applications. In July of 2024 a new company Purify Water LLC was formed to sell excess compound as a water filter agent in powder form. This innovation stemmed from a scientific presentation many years ago that demonstrated the removal of high levels of arsenic (As) from drinking waters in India. NBMI reduced the As to below detect levels by simply passing it through a filtration column. Revenue from the environmental branch of NBMI Science is supporting EmeraMed.
David Kennedy recently wrote to RFK Jr. re our desire to help Make America Healthy Again (MAHA). That letter is appended below along with the title page of the original 2010 FDA Cease and Desist order. Please read it carefully as he explained to Mr. Kennedy exactly what this will require.
Because the explosion at PCI Synthesis destroyed our only stability standard it is impossible to use any of the NBMI for clinical trials because without that standard we cannot “prove” to the FDA’s satisfaction the compound is stable. Boyd has some he made two decades ago stored at room temperature in his desk drawer that has not appreciably changed but human drug regulations prohibit any use of the existing compound for humans, therefore we’ve reactivated the environmental branch of NBMI Science to treat water not humans with pure NBMI. Each 10-gram container is appropriately labeled “NOT FOR HUMAN USE” and buyers must acknowledge this in the disclaimers when they purchase it online from our website www.PurifyWaterLLC.com. This new corporation is now generating much needed funds that have paid for all of our valuable patents and daily operations for the last 12 months.
When it was first invented Professor Attwood and his graduate students began to test whether or not various heavy metals could be removed from drinking water. What they discovered was it had an outstanding capacity to remove arsenic from water when used in a percolation column. Most municipal drinking water drawn from rivers is first percolated through layers of sand. NBMI can be incorporated in almost any type of percolation system that slows the flow and allows the heavy metal to come in contact with NBMI. When it does they bond to form an inert particle that remains in the percolation sediment.
I know it has been a long road but that is not our fault and with a new sheriff in town things appear to be moving in the right direction. I am hopeful we can solve many of these problems moving forward toward a better day. You have our sincere thanks for your continued patients as we battle to bring this once-in-a-lifetime discovery back to those who desperately need it . . basically everyone. For investors who want to liquidate their investment you may soon be able to return your shares for a full refund.
One final thought about what else you can do with OSR#1. Boyd Haley told me that because of its powerful antioxidant activity it would reduce pain which we saw dramatically in the gold miners of Ecuador. Those who too 300 mg/day had markedly significant reductions in all kinds of pain. But what if it’s a mosquito bite or painful joint you ask. That’s when topical works best.
To test this out next time you have a mosquito bite put a little DMSO on it and sprinkle a tad bit of OSR#1 over the top. Then rub it in. If you’re lucky the itch goes away almost immediately. Why? The anticoagulant mosquitos use causes oxidative stress. OSR#1 stops oxidative stress. Let me know if it works for you. It certainly does for me but screens help as well.