In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests.
Today is our fourth and final post in our October series, and today we’re talking about another breakthrough device that has yet to hit the U.S. market. And since it’s almost Halloween, what a perfect time to talk about Dracula’s favorite topic: blood! T
he Aethlon Hemopurifier® is a first-in-class device developed for rapid elimination of circulating viruses and cancer-promoting-exosomes from the body. In simpler terms, the device acts like a filter by straining out impurities— in this case, viruses and cancer cells— from the blood. The device has been awarded the breakthrough status because it fulfills one of the conditions for the breakthrough designation; namely, its ability to provide a more effective treatment for a life-threatening or irreversibly debilitating human diseases.
The hemopurifier is a one-time use, disposable cartridge that can be attached to dialysis and other blood circulatory equipment commonly used in health care settings. The entire circulatory system of a patient can pass through the cartridge about one time every 20 minutes. The cartridge consists of a biocompatible plasma membrane (with 200 nm diameter pores) coated with a plant-derived lectin known as Galanthus nivalis agglutinin (GNA). GNA binds to polymeric structures called glycans found on the surface of the viruses and exosomes, capturing them, and keeping them from re-entering the patient’s circulatory system. Viruses and exosomes are known to use this “glycan shield” in order to camouflage and subvert the body’s immune system. GNA selectively binds to a broad spectrum of infectious viruses while having limited interactions with most human proteins. You can really put this into perspective and understand how incredible this is when you evaluate the other anti-viral drug regimens that are used today, and the prolonged amount of time patients must participate in those regimens. Studies have shown that GNA is capable of inhibiting many viral pathogens such as Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Dengue Virus, Ebola Virus and Severe Acute Respiratory Syndrome Coronavirus.
Recently, we have seen the emergence of new viruses and the reemergence of old viruses that cause severe and fatal infections. The increase of these viruses is often induced by international travel, global warming, and densely populated urban environments. The majority of these viruses have no vaccines or treatments available, and depend solely on the body’s immune system to fight off the infection. Ebola, Zika, and Chikungunya are examples of such viruses capable of causing lethal infections for which no approved treatments exist. The outbreak of Ebola and Zika infections in the recent past are reminders of the need to develop therapies to prevent future epidemics.
Aethlon hemopurifier therapy has been successful in curing patients infected with Ebola virus, Hepatitis C virus (HCV) and the Human Immunodeficiency virus (HIV). In 2014, the device was successful in treating a comatose Ebola-infected physician. In fact, a single administration of the hemopurifier therapy was successful in saving the patient with multiple organ failure. This led to Time Magazine naming the Hemopurifier as one of the "Top 25 Inventions," as well as one of the "Eleven Most Remarkable Advances in Healthcare." The company is currently conducting pre-clinical studies on mosquito-borne viruses like Chikungunya, Dengue, and West Nile virus, as well as Vaccinia and Monkey pox, which serve as models for human Smallpox infection.
Hemopurifier therapy is also being applied to the capture of exosomes. Exosomes are vesicles that are released by cells into the circulatory system where they are distributed throughout the body. They have been implicated in intercellular communication and the transmission of certain diseases within the body. Compared to normal cells, tumor-derived exosomes (TEX) are released by cancer cells in exponentially greater numbers. TEX is associated with cancer progression, immune suppression and chronic inflammation. In fact, 90% of all cancer-related deaths are attributed to metastasis involving exosomes. Moreover, studies have shown that TEX is resistant to a wide range of anti-cancer drugs. In addition to their role in cancer metastasis, exosomes have also been implicated in the progression of Alzheimer and Parkinson’s, as well as numerous inflammatory diseases. Thus, therapeutic approaches targeting the exosomes, such as the hemopurifier therapy, address a significant unmet need in the medical field.
It is devices like the Hemopurifier that FDA aims to safely get on the U.S. market. Breakthrough Devices often offer solutions for diseases where no cleared or approved treatments exist, or they provide significant advantages over already-existing therapeutic approaches. Clean blood is something both patients and Dracula can smile about!
Have a safe, effective, and happy Halloween, everyone!