Category: Sinuwave Photodisinfection System

Photodisinfection Technology

“Photodisinfection”, or Antimicrobial Photodynamic Therapy (aPDT), is a non-antibiotic broad spectrum topical treatment that utilizes a light-activated (photosensitizer) compound to target and destroy bacterial biofilms, virulence factors and inflammatory proteins.[i]  The primary mechanism of action of Photodisinfection is the production of large quantities of reactive oxygen species (ROS) such as singlet oxygen, superoxide anion and hydroxyl radical in close proximity to the target cell, resulting in rapid lysis of the cell and destruction/crosslinking of membrane-associated proteins and lipopolysaccharides.  Photodisinfection has been demonstrated to reduce CRS antibiotic resistant polymicrobial biofilms by >99.9% after a single treatment.[ii]  The Photodisinfection induced effect is target-specific to only those organisms that have absorbed the photosensitizer and are exposed to a specific wavelength of light.[iii]  Because the photosensitizer is cationically charged, the process has little to no effect on electrostatically neutral human tissues.[iv]

In addition to antibiotic resistant strains, Photodisinfection is equally effective against normal strains of bacteria.  Furthermore, there is no evidence of bacterial resistance occurring after repeated Photodisinfection treatment cycles.[v]  The Photodisinfection mechanism of lethality is completely different from that of oral and systemic antimicrobial agents.  There is no primary metabolic or thermal action involved with this minimally invasive therapy. Sinuwave™ Photodisinfection therapy is targeted for those patients unresponsive to, or ineligible for medicinal or surgical interventions.

 



[i] Wainwright M., Photodynamic antimicrobial chemotherapy (PACT). Journal of Antimicrobial Chemotherapy (1998) 42, 13-28

[ii] Biel, M.A.. Pedigo L., Gibbs A., Loebel N., Photodynamic therapy of antibiotic-resistant biofilms in a maxillary sinus model. Int Forum Allergy Rhol. 2014 Jan 10.

[iii] Kharkwal G.B. et al, Photodynamic Therapy for Infections: Clinical Applications. Lasers in Surgery and Medicine 43:755-767 (2011)

[iv] Demidova T.N. et al, Photodynamic Therapy Targeted to Pathogens. Int J Immunopathol Pharmaco. 2004;17(3): 245-254

[v] Dai, T. et al, Photodynamic therapy for localized infections – state of the art. Photodiagnosis Photodyn Ther. 2009; 6(3-4): 170-188.

Invasive Fungal Rhinosinusitis (IFS)

In immunocompetent patients, IFS typically presents with nasal congestion and periorbital discomfort.  In immunocompromised patients however, IFS often presents with masses, proptosis and bony erosion, typically with rapid progression.

Acute invasive fungal rhinosinusitis (AIFR) is a rare but frequently fatal infection that occurs primarily in immunocompromised individuals and diabetics.i It is characterized by fungal invasion into the mucosa and submucosal structures of the paranasal sinuses with frequent extension into adjacent structures, including the paranasal soft tissues, orbit and cranial vault.  Short term mortality has been reported to range from 20-68% across studies.[i]i

Surgery is the primary approach to IFS. Photodisinfection is a potent anti-fungal therapy that can help to address the IFS patient population with its minimally invasive advantages. 



[i] http://www.medscape.com/viewarticle/408751_2

ii Monroe Marcus M. et al, Invasive Fungal Rhinosinusitis: A 15 Year Experience with 29 Patients. The Laryngoscope 2013 Feb.

 

Sinuwaveis only available in Canada 

Bacterial Biofilms Implicated in Chronic Rhinosinusitis

Blockages can occur in the sinuses due to a number of factors causing trapped mucus to accumulate inside the sinuses and encouraging the growth of microorganisms in sessile layers known as biofilms.   One recent study found that biofilms were present on the mucosa of 75% of patients undergoing surgery for CRS.[i]

Different biofilm species are associated with different disease phenotypes.  H. influenzae biofilms are found in patients with mild disease, whereas S. Aureus is associated with a more severe, surgically recalcitrant pattern.[ii] [iii] Recent studieshave demonstrated that biofilm infections, involving known super-antigen producing bacteria such as S. aureus and P. aeruginosa, are implicated in CRS and reduce the effectiveness of antibiotics.[iv]

Eradication of these biofilm infections and associated virulence factors is important in effectively and successfully dealing with the disease.  Repeated antibiotic exposure and increasing antibiotic resistance is a treatment challenge faced by this patient population.

Photodisinfection has been proven to effectively target and destroy biofilms and associated virulence factors, offering a clear advantage over other therapies.[v]

 



[i] Ragab A. et al., Evaluation of bacterial adherence and biofilm arrangements as new targets in treatment of chronic rhinosinusitis. Eur Arch Otorhinolaryngol. 2012 Feb; 269(2): 537-44.

[ii] Foreman A., et al. Different biofilms, different disease? A clinical outcomes study. Laryngoscope. 2010 Aug; 120(8): 1701-6.

[iii] Foreman A. et al. Do biofilms contribute to the initiation and recalcitrance of chronic rhinosinusitis? Laryngoscope. 2011 May; 121(5): 1085-91.

[iv] Leid Jeff G. et al., The Importance of Biofilms in Chronic Rhinosinusitis. Biofilm Infections. Chapter 8

[v] Darveau Richard,  DNA and Cell Biology, Volume 28, Number 8, 2009, Pg 1-7.

Sinuwave Photodisinfection: Making a Difference for Refractory Chronic Sinusitis Patients

Carolyn Cross (CEO) with Sinuwave patient

Christina is from Winnipeg, Manitoba. She has been suffering for about ten years from recurring Chronic Rhinosinusitis (CRS). Over time, Christina found that she has become unresponsive to the medical and surgical treatments currently available. She is dealing with tenacious biofilms in her sinuses that have become resistant to antibiotics. She has had 5 or 6 surgeries and countless trips to an array of specialists. Christina lives with debilitating pain from recurring sinus infections and the ongoing concern about her future. Affecting her head and her breathing, this painful condition is hugely disruptive to everyday living. She is frustrated also, that by affecting her, CRS also impacts her entire family.

Otherwise a very healthy person, Christina worries that one day her medical options will run out. New technologies, like Sinuwave™ Photodisinfection, are important to people like Christina as they offer hope for a better quality of life. Christina is one of about 50,000 Canadians suffering from recurring refractory Chronic Rhinosinusitis. In the US, the refractory CRS population exceeds 500,000 and is growing by about 10% (50,000) each year.

Christina came to Vancouver from Winnipeg seeking help with her uncontrollable sinus infections. I had the privilege of spending time this week getting to know Christina and got a better understanding of the nature of the suffering that she gallantly endures. Seen here with me having her second Sinuwave treatment, I was thrilled to learn that her initial Sinuwave treatment the day before had already yielded some positive results for her.  It has taken us about 14 years to develop our innovative non-antibiotic antimicrobial technology to the point where it is now helping refractory CRS patients like Christina. I would like to take this time to thank each member of my very talented team for their personal efforts, sacrifices and dedication that contributed to an important new CRS treatment to help people like Christina.

— Carolyn Cross, CEO

How does Photodisinfection Work?

Photodisinfection is a topical, non-antibiotic antimicrobial therapy that destroys a broad spectrum of pathogens including fungi, bacteria and virus without damaging human tissue. Unlike antibiotics, Photodisinfection selectively kills virulence factors such as the endotoxins and exotoxins produced by pathogens, leading to a clinically observable anti-inflammatory effect. The treatment process takes only minutes, making it over 1,000 times more effective at biofilm killing than antibiotics.

Photodisinfection is a minimally invasive non-thermal therapy involving the light activation of a photosensitizer to eliminate topical infections in a highly targeted approach. Photodisinfection has been proven to be safe and effective in other applications such as for the dental, sinusitis and hospital acquired infection prevention markets. In dentistry, Photodisinfection has been proven to be highly effective for the treatment of caries, endodontics, restorative dentistry, periodontitis, peri-implantitis and halitosis. Many new applications of Photodisinfection are now under development.

The Photodisinfection Process: Instant Antimicrobial Therapy

Apply Photosensitizer to Infection Site & Illuminate with Appropriate Wavelength for Several Minutes

A photosensitizing solution is applied to the treatment site where the photosensitizer molecules preferentially bind to the targeted microbes.  The photosensitizer molecules are inactive at this stage.  A light of a specific wavelength and intensity illuminates the treatment site and a photocatalytic reaction occurs.  The wavelength is carefully chosen to maximize absorption of light energy by the photosensitizer.

This 2 step procedure results in the destruction of the targeted microbes and their virulence factors without damaging host cells.  This reaction involves the formation of short-lived, highly reactive free-radical oxygen species.  These radicals cause a physical disruption of the microbial cell membrane through oxidative reactions, resulting in immediate rupture and destruction of the cell.  This process occurs in seconds with total kills completed in minutes.

The Photodisinfection process has also been shown to eliminate a multitude of virulence factors, unlike antibiotics. When the light isremoved, the photocatalytic reaction ceases along with all antimicrobial action. Photodisinfection does not promote the development of resistance.

The Photodisinfection process is both pain-free and stress-free due to lack of side-effects or damage to human tissue.

Source: Eastman Dental Institute, UK

Sinuwave Introduced to ENT Community at the American Rhinologic Society Conference

Clinicians attending the 59th Annual Meeting of the American Rhinologic Society Conference held on September 28th, 2013 in Vancouver were introduced to the Sinuwave™ Photodisinfection System. Sinuwave is the first Photodisinfection based therapy for the sinusitis market.  An abstract, entitled “Sinuwave Photodisinfection for the treatment of refractory chronic rhinosinusitis: a case series”, was submitted by researchers from the University of Montreal (Centre de Recherche du Centre Hospitalier de l’Université de Montréal (CRCHUM), Montreal, Canada) and presented at the Conference.

Sinuwave Photodisinfection System is Health Canada approved and was developed by Ondine Biomedical Inc. of Vancouver, the global leader in Photodisinfection, also known as antimicrobial Photodynamic Therapy (aPDT). Photodisinfection is a topical, non-antibiotic antimicrobial therapy that destroys a broad range of pathogens and their virulence factors, leading to a clinically observable anti-inflammatory effect.  Photodisinfection is a minimally invasive non-thermal therapy involving the light activation of a photosensitizer to eliminate topical infections in a highly targeted approach. Photodisinfection has been proven to be safe and effective in other applications such as for the dental and hospital acquired infection prevention markets. For more information about Sinuwave Photodisinfection, please visit www.sinuwave.com

The Advantages of Sinuwave for Refractory Chronic Rhinosinusitis

Sinusitis is a disease in which the sinus cavities around the nasal passages become inflamed and swollen. When symptoms last for longer than12 weeks, the patient is described as suffering from chronic rhinosinusitis (CRS).  Patients typically first seek medical therapy to alleviate their symptoms as well as trying to address the cause. However, 20% of patients are unresponsive to any of the medicines and continue to suffer from the debilitating symptoms associated with CRS.

There are roughly 22 million office visits and 500,000 emergency department visits in the United States alone relating to CRS, indicating that it is a major health concern. The treatment regimen usually consists of the prescription of broad spectrum antibiotics, corticosteroids, and saline nasal irrigation. This disease most commonly affects young and middle aged adults, but may affect other demographics as well. Common symptoms include nasal congestion, throbbing facial pain, fever, headaches, difficulty sleeping and sensations of swelling around the eyes and face.

Sinuwave™ Photodisinfection System offers a unique method of treatment which has several distinct advantages over both medical and surgical CRS treatments. Photodisinfection is a minimally invasive approach to eliminating the pathogens and inflammatory host response involved in the disease process.  Photodisinfection is a 2 step process involving the application of a photosensitizer which is then activated by non-thermal laser light generating singlet oxygen based molecules, or free radicals that are lethal to fungal spores, bacterial biofilms and their virulence factors while not harming human tissue.

The major advantages of Sinuwave™ Photodisinfection for CRS patients are:

* pain-free procedure not requiring anesthesia

* immediate patient relief,

* no antibiotics or developed resistances,

* no removal of tissues are involved,

* no patient compliance requirements

* ease of use

Photodisinfection for Refractory Chronic Rhinosinusitis Patients: A much needed advance for an under-served patient population

Chronic rhinosinusitis (CRS) is one of the most common chronic conditions in the United States. There is a significant subpopulation of CRS patients who remain resistant to cure despite rigorous treatment regimens including surgery, allergy therapy, and prolonged antibiotic therapy. This refractory patient population is thought to exceed 500,000 in the US.

Photodisinfection, also known as antimicrobial photodynamic therapy (aPDT), is a noninvasive, non-antibiotic broad spectrum antimicrobial treatment that can improve outcomes for this under-served patient population by reducing inflammation of sinus tissue and eliminating biofilm in the sinuses. Patients  suffering from refractory Chronic Rhinosinusitis are likely to be infected by super-antigen producing bacterial such as Staph aureus and Pseudomonas aeruginosa. Photodisinfection has been proven to be highly effective at targeting these two pathogens and inactivating inflammatory cytokines.

Sinuwave Presented at Leading Photodynamic Symposium

We’re pleased to announce our participation as a presenter at the  9th International Symposium  “Photodynamic Therapy and Photodiagnosis in Clinical Practice”  held at  the University of Padova, Brixen, South Tyrol, Italy October 16-20th, 2012.

The symposium, headed by Prof. Giulio Jori (University of Padova), Prof. Herwig Kostron, the Current President of the International Photodynamic Association (University of Innsbruck), and Prof. Heinrich Walt (University of Zürich), is a collaboration with the 4th International Meeting of the European Platform for Photodynamic Medicine (EPPM). Spanning the full range of basic research to pre-clinical and clinical studies in the the field of Photodiagnosis and Photodynamic Therapy, this symposium is an annual gathering of international PDT leaders.

Dr. Merrill Biel, our Chief Medical Officer, spoke on the clinical merits of Sinuwave for the treatment of chronic sinusitis, as well as the product development work done to date.  It is estimated that there are well over 7 million chronic sinusitis sufferers in the US alone who suffer from chronic pain, drainage, and headache. It is our goal to provide them with an immediate, safe, and effective therapy that will relief them from their pain and suffering.

Sinuwave – A Non-Antibiotic Approach To Treating Chronic Sinusitis

Chronic sinusitis is a debilitating disease that affects more than 7 million people in the U.S. Typically, each episode of chronic sinusitis can last more than 12 weeks and occur 2-4 times annually.  Symptoms of chronic sinusitis include inflammation of the sinus tissue, build up of mucus and pus inside the sinus cavities, nasal discharge, difficulty breathing, throbbing facial pain, headaches, and swelling of the eyes and nose.

Inflammation and swelling of the sinus tissues, due to infections or allergies, can cause mucus to remain trapped in the sinus cavities.  This mucus buildup becomes a breeding ground for more bacteria to grow and produce virulence factors that further contribute to inflammation. In what seems to be a vicious circle of increasing bacterial growth and inflammation, a rapid approach to killing bugs and inactivating inflammatory markers is desperately needed.

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