Technology & Innovation

AVIcure UVBI Medical Devices

Cutting-edge medical device engineering. Proven technology.

Ultraviolet light has been used to disinfect bacteria and viruses in commercial applications for decades. But only AVIcure has designed and engineered medical devices that make Ultraviolet Blood Irradiation (UVBI) practical for therapeutic applications. The ramifications of AVIcure’s clinical research on the effectiveness of AVIcure’s UVBI products in the treatment of illnesses ranging from Crohn’s Disease to diabetes are enormous—and hold great promise for patients suffering from the symptoms of such debilitating diseases.

The Basics of Ultraviolet Blood Irradiation (UVBI)

Ultraviolet light has been used for commercial sterilization for many years to sanitize water supplies and food and in the production of pharmaceuticals and cosmetics. And although many people are aware of the potential hazards of excessive exposure to the UV rays of the sun, few are even vaguely aware of the power of that same ultraviolet light to inactivate bacterial and viral pathogens. That power, essentially replicated, managed and carefully focused—is the basis for AVIcure therapeutic medical devices, including our flagship product, the ImmunoModulator™.

Dr. Niels Finsen
Circa 1903

While the clinical mechanism of UVBI action is incompletely understood, decades of laboratory research, along with clinical studies, support and explain its efficacy. The DNA of bacteria or viruses when irradiated by UV light induces the formation of “thymine dimers,” molecular lesions that prevent further replication of those targeted bacteria. When applied to ribonucleic acid (RNA)-based viruses, UV light induces the formation of molecular lesions known as “uracil dimers” which also prevent further viral replication. Normal lymphocytes and, it is presumed, other blood cells can repair that damage.

“Phototherapy” or “Photobiolumination,” as it was called in the early 20th century, was successfully used to treat Lupus Vulgaris or tuberculosis of the skin, by Dr. Niels Finsen, who won the Nobel Prize for Physiology and Medicine in 1903. 900 patients were treated by Dr. Finsen with remarkable results. His work led to the introduction of heliotherapy as standard therapy for tuberculosis patients before the advent of antibiotics.

Then in 1928, Dr. Emmet Knott and a medical student named Lester Edblom received a U.S. Patent for a “Means for Treating Blood-Stream Infection” that incorporated a rudimentary ultraviolet bulb, vacuum extraction system and a cuvette. The “Knott Hemo-Irradiator” was used from the 1930s through the 1950s on thousands of patients with multiple infectious diseases, with multiple reports of remarkable responses in the United States medical literature. Fundamentally, the same blood irradiation technology is the core to AVIcure’s medical devices.

Interestingly, the 1945 future Nobel Prize for Medicine-winning team—Ernst Chain, Howard Florey and Alexander Fleming—provided the impetus for the Knott Hemo-Irradiator’s demise from widespread use.

The group of researchers successfully created the first replicable, multi-use antibiotic: Penicillin. From that point on, as the history of modern medical history reflects, pharmaceuticals ruled while device-based therapies faded rapidly in popularity. Even proven, cost-effective technologies like UVBI were largely forgotten in favor of pills, syrups and injections.

Dr. Emmet Knott

Virtually every patient diagnosed with Crohn’s Disease, Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis, Ulcerative Colitis, type 1 diabetes mellitus, Systemic Lupus Erythematosus, Complex Regional Pain Syndrome and other debilitating disorders has heard the term autoimmune disease used to describe their illness.

But what, exactly, is an autoimmune disease? And how effective are conventional pharmaceutical-based therapies in treating them?

Medically speaking, the term autoimmune disease (AI) is simply a categorical, rather than a specific clinical description for roughly 80 different disorders that affect about 50 million Americans and tens of millions more worldwide. AI disorders develop when the body’s immune system attacks healthy body cells. The resulting symptoms can range from relatively modest (for example, mild psoriasis) to cripplingly painful—as in cases for many patients who suffer from Crohn’s Disease, Rheumatoid Arthritis and other chronic illnesses.

Unfortunately, this categorical description of so many different disorders with so many diverse and debilitating symptoms masks a simple medical fact: We don’t know with certainty what actually causes AI disorders. Thus, autoimmune disease has become a catch-all term, used to classify a dismayingly wide range of disorders with an equally discouragingly large number and variety of symptoms.

For many patients under treatment for an AI disorder, this might be something of a revelation: The therapy currently offered—almost invariably pharmaceutical— to manage patients’ pain and discomfort is in fact something of a “shotgun” approach to the root cause of those symptoms, and not necessarily a formulary conceived, designed and manufactured to cure the symptoms of the scientifically-identified cause of those symptoms.

Up until recently, researchers and physicians theorized that AI disorders could be triggered by bacteria, viruses, certain drugs, chemical or environmental irritants or a combination of any or all of these factors. But the current medical research, along with early-stage clinical trials of AVIcure’s ImmunoModulator UBVI medical device, point to a much more specific cause for some of the most prevalent AI disorders, particularly Crohn’s Disease.

That AI trigger, according to new studies, seems to a “gut bacterium” known as Mycobacterium avium, subspecies paratuberculosis (MAP). MAP is a bacterium that causes Johne’s disease, a chronic diarrheal wasting disease in cattle and sub-human primates and a chronic wasting disease in sheep and goats. It has been suggested for years that there may be an association between Crohn’s disease (CD) and Johne’s disease. Meta-analyses by researchers also have concluded that a majority of studies testing the association of MAP and CD show that most patients with CD do, in fact, have a MAP infection.

Given the increasing evidence that implicates MAP in the pathogenesis of the disease, there has been a corresponding increase in the use of antibiotics to treat Crohn’s symptoms. Unfortunately, however, even though we now have more insight than ever into the likely cause of Crohn’s Disease—and quite possibly other diseases traditionally considered autoimmune with links to MAP — the results of open label clinical trials using antibiotics fall far short of the relief CD patients hope for.

Simply put, there’s still a big piece of the medical puzzle missing in treating Crohn’s Disease effectively to achieve long-term, successful patient outcomes.

And at AVIcure, we believe we’ve found it.

Achieving profound remission from Crohn’s Disease:
The Case for using AVIcure UVBI products with targeted antibiotic therapy

We know that the most current medical research implicates a gut bacterium known as Mycobacterium avium, subspecies paratuberculosis (MAP) as the cause of Crohn’s disease and quite possibly other debilitating autoimmune (AI) disorders. Although a variety of antibiotics with antimycobacterial properties are having a more positive effect in the relief of CD symptoms than at any time in history, antibiotic regimens alone are thus far proving inadequate.

According to the Crohn’s and Colitis Foundation of America, the estimated direct cost for all patients with inflammatory bowel diseases (IBD) in the US is $1.84 billion. In the United States alone, 1.4 million suffer with the most common symptoms, including abdominal pain, persistent diarrhea, rectal bleeding, fever and weight loss. Many patients require numerous hospitalizations and surgery.

Crohn’s Disease, like all AI disorders, is considered incurable. The most fortunate patients — those who can afford the escalating costs of health insurance and conventional pharmaceutically-based therapy — can only look forward to the better management and mitigation of the painful symptoms and the unpredictable nature of CD. The less fortunate, lacking either the financial resources or the geographic proximity to best-in-class medical care, will likely continue to tolerate pain, discomfort, embarrassment and psychological and mental drain that invariably result from CD.

For AVIcure Bioscience’s founders, neither option was acceptable.

Dr. J. Todd Kuenstner, Chairman, Chief Medical Officer and Co-Founder, AVIcure Bioscience, LLC

Chairman, Chief Medical Officer, and co-founder of AVIcure Bioscience, Dr. J. Todd Kuenstner had a very personal stake in the search for, if not a cure, what he refers to as a “profound remission” in Crohn’s Disease: Two young members of his own family suffered from its symptoms. A pathologist and researcher, Dr. Kuenstner put his passion for solving the CD puzzle and his physician’s background to work.

His unique background and goal of developing a better, long-term answer for Crohn’s Disease ultimately led him to the same technology proven by a Nobel Prize Winner for Medicine a century ago, long before the dawn of antibiotics: Ultraviolet Blood Irradiation (UVBI). The only question was, how to most effectively meld the most promising anti-MAP pharmaceuticals with UVBI? Doing so would require a medical device that would pass muster under the US Food and Drug Administration’s (FDA) stringent medical device regulations—regulations that didn’t exist during the mid-twentieth century heyday of the rudimentary Knott Hemo-Irradiator.

Co-Founder and AVIcure Vice President of Engineering Thomas Petrie, a brilliant medical device engineer with an inventor’s mind, provided the answer. Incorporating modern materials and engineering practices, along with proprietary ultraviolet bulb technology from our manufacturing arm, Superior Quartz Products, Petrie designed the ImmunoModulator, our flagship product, and the HemaSterilizer.

After successfully passing US FDA Phase 1 and Phase 2 clinical trials, these sophisticated, best-in-class UVBI devices may represent the best hope for Crohn’s patients and others living with diseases traditionally considered autoimmune.

Thomas Petrie, Vice President of Engineering and Co-Founder, AVIcure Bioscience, LLC

The Path to Profound Remission...the AVIcure way.

Successful medical device companies, like their pharmaceutical brethren, are typically driven by two ambitions.

  1. A PASSION for research in a specific medical field that will ultimately result in a major benefit to patients—to heal, to reduce pain, to improve outcomes, and if humanly and scientifically possible... to cure.
  2. AN ACCEPTANCE OF THE REALITY that such a pursuit demands a combination of resources unlike that of any other entrepreneurial endeavor.

Joseph Losco, Vice President of Electrical Engineering, AVIcure Bioscience, LLC

World-class clinical expertise, a commitment to overcoming the inevitable challenges of rigorous clinical trials, relentless competition and sometimes a skeptical market all must converge—and be supported by very substantial financial reserves until success is achieved.

These are the principles that have guided and will continue to guide us at AVIcure. Every member of our dedicated team believes—and more importantly have already repeatedly demonstrated to others during studies and clinical trials—that our patented UVBI technology is unlike any similar approach to blood irradiation technology and that our ImmunoModulator and HemaSterilizer are therefore more effective than any similar devices ever built.

The path to market for any medical device is long, difficult and expensive. Companies aspiring to take such a journey who are motivated purely by potential economic profit eventually either become discouraged or simply lose their way. That’s not the AVIcure philosophy.

Our Chairman, Dr. J. Todd Kuenstner, puts it this way:

Our machines have the potential to create a profound remission — if not cure outright — several diseases traditionally considered autoimmune that were once thought to be ‘incurable.’

Other therapeutic approaches merely seek to manage and mitigate the debilitating and costly symptoms of disorders like Crohn’s Disease. That’s simply not good enough anymore. Even the most modern biologics and pharmaceuticals, used in isolation of UVBI, are still far too expensive and years away from widespread accessibility to patients suffering worldwide.

We can do better. And we will.

--J. Todd Kuenstner, M.D.