In early 2018, Amylex received FDA Approval for BETACLEAR®. It is a medical device technology and procedure that can rapidly reduce the level of toxic beta-amyloid in the blood. In the research field, beta-amyloid reduction is one of the most common targets in the search for potential therapeutic applications. Unfortunately, many have failed because of the side-effects that have plagued traditional western medicine approaches. BETACLEAR®’s FDA approval is significant because it is the first commercial application in the world to allow rapid beta-amyloid detoxification to take place.
The product’s current approved use is limited to beta-amyloid extraction without any therapeutic claims.
Efficacy studies for diseases are generally long because of various factors, and Amylex is currently studying the full therapeutic impact. However, since BETACLEAR® does not allow its proprietary compound to enter into the bloodstream, it will allow patients to take advantage of this procedure while the technology is continuously being studied.
BETACLEAR® contains a proprietary binding reagent incorporated in a sodium bicarbonate concentrate. This concentrate is added to a dialysate solution in a hemodialysis procedure.
Its function is to do one thing exceedingly well: extract toxic soluble beta-amyloids from human blood. Using commercially available dialysis machines, it performs a quick, simple hours-long mechanical extraction process designed to rid the body of disease-causing beta-amyloid proteins.
The process involves the use of a synthetic “nano-molecular machine” that hyper-specifically and mechanically binds to a receptor in the beta-amyloid protein. Being mechanical, this binding process does not trigger the usual chemical pathways associated with undesirable side-effects of other products. It is also non-immunogenic as Amylex’s extensive studies have determined that this molecule does not stimulate the immune system.
Beta-amyloid reduction has been attempted as a therapeutic mode of action through a number of methods including active immunization with vaccines, passive immunization with monoclonal beta‐amyloid antibodies, and BACE and Presenilin protease inhibitors, which all seek to stop the function in the cell that trigger the production of the beta-amyloids. Unfortunately, all these methods have experienced a high of level of immune responses and side-effects requiring larger studies to reduce dosage levels. This resulted in reduced efficacy of the tested products during these trials.
On the other hand, the BETACLEAR® product, registered as an FDA-approved medical device and not a drug or pharmaceutical, through its dialysis procedure does not introduce its proprietary beta-amyloid binding reagent into the body. It is therefore extracorporeal (exerting its effect outside the body). It is neither metabolized (not broken down) nor does it trigger an immune response. Furthermore, the beta-amyloid reduction process relies on the peripheral sink. This means that the transfer rate of beta-amyloids from the brain is limited to what the body can naturally handle. With all these applications, potential side effects are minimized. The procedure will also be supervised by certified physicians trained in the use of the technology.
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