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Ondine Research Laboratories Inc.
Ondine Biomedical is a Canadian company headquartered in Vancouver, BC with R&D facilities in Bothell. We are dedicated to the development of non-antibiotic, anti-infective photodisinfection therapies for bacterial, viral, and fungal infections. We are the recognized global leader in aPDT technology, having developed several products for the reduction of hospital-acquired infections.
Mission/Vision
Ondine is dedicated to the development of non-antibiotic, anti-infective photodisinfection therapies for bacterial, viral, and fungal infections.
Type of Organization
Startup - Newly established businesses, investable
Size of Organization
10-50
Organization Mailing Address
19017 120th Ave NE, Suite 102
Bothell, WA 98011
United States
SteriwaveTM Nasal Photodisinfection System
Antimicrobial device + formulation for decolonization of pathogenic microorganisms from the anterior nasal passages. The process rapidly and lethally disrupts the microbial cell wall, leaving human tissue unharmed. A topically applied photosensitizer formulation selectively stains bacteria by binding with microbial cell wall components. Low-intensity, non-thermal red light is absorbed by the photosensitizer molecules, producing reactive oxygen molecules that cause lethal cell wall disruption.
Read More
The nose is one of the few body openings where bacteria, viruses and fungi have direct access to get inside the body. The nasal passages are important for filtering the air that we breathe in and stopping tiny foreign particles or microorganisms from entering the body. What many people do not know is that the nose and nasal passages are, or can be, the perfect environment for some bacteria, good and bad. For example, Staphylococcus aureus, commonly referred to as Staph, is a bacterium that lives in the nose of approximately one-third of the general population. These nasal germs are easily spread as we breathe, sneeze, or touch our face with our hands and then inadvertently transfer the germs to objects in the environment, our friends and co-workers, as well as other parts of our body. If you have a wound, surgical site, or other break in the skin, these germs can invade and cause an infection.
The process of removing or reducing germs in the nose is called, "nasal decolonization". Nasal decolonization has been shown to reduce the risk of infection especially among high risk patients including those undergoing surgical procedures, immunocompromised, ICU patients and those requiring long-term and frequent healthcare services (e.g.; nursing homes, dialysis). Cleaning the nose of germs is part of good infection control practices such as frequent hand washing, skin preps before surgery, good oral care and a clean environment around us.
The process of removing or reducing germs in the nose is called, "nasal decolonization". Nasal decolonization has been shown to reduce the risk of infection especially among high risk patients including those undergoing surgical procedures, immunocompromised, ICU patients and those requiring long-term and frequent healthcare services (e.g.; nursing homes, dialysis). Cleaning the nose of germs is part of good infection control practices such as frequent hand washing, skin preps before surgery, good oral care and a clean environment around us.
Category of Innovation
Life Sciences - Life science solutions are those solutions that are delivered as a drug or device that typically require federal approval
Intended End User
Provider - Individuals or organizations responsible for providing care to patients (e.g. doctors, nurses, hospital/clinic administrators, etc.)
Impactful Innovation Stage (Click Here for Details)
Adoption
Idea/solution to the problem, if applicable
Photodynamic therapy (PDT) is a treatment modality that involves the administration of a light-sensitive compound, known as a photosensitizer (PS), followed by light irradiation at a specific wavelength that electrodynamically pumps the PS into an excited and cytotoxic state.
PDT is minimally invasive and already used clinically to treat a wide range of medical conditions. In its antimicrobial form, antimicrobial Photodisinfection Therapy (aPDT) has been shown to eradicate pathogenic microorganisms such as Gram-positive and Gram-negative bacteria, viruses, protozoa, and fungi and, unlike traditional antibiotics, does not induce resistance following repeated exposures to the therapy (Pedigo et al, 2009; Tavares et al, 2010; Costa et al, 2011; Cabiscol et al, 2000; Lauro et al, 2002; Jori & Coppellotti, 2007; Cassidy et al, 2010; Giuliani et al, 2010; Martins et al, 2018; Al-Mutairi et al, 2018).
For these reasons, we believe aPDT is an essential tool for infection control and should become a vital part of the solution to the global antimicrobial resistance (AMR) crisis.
PDT is minimally invasive and already used clinically to treat a wide range of medical conditions. In its antimicrobial form, antimicrobial Photodisinfection Therapy (aPDT) has been shown to eradicate pathogenic microorganisms such as Gram-positive and Gram-negative bacteria, viruses, protozoa, and fungi and, unlike traditional antibiotics, does not induce resistance following repeated exposures to the therapy (Pedigo et al, 2009; Tavares et al, 2010; Costa et al, 2011; Cabiscol et al, 2000; Lauro et al, 2002; Jori & Coppellotti, 2007; Cassidy et al, 2010; Giuliani et al, 2010; Martins et al, 2018; Al-Mutairi et al, 2018).
For these reasons, we believe aPDT is an essential tool for infection control and should become a vital part of the solution to the global antimicrobial resistance (AMR) crisis.
Level of adoption (i.e. list of customers/users, testimonials, etc.), if applicable
Ondine's antimicrobial photodisinfection technology has been approved by Health Canada for nasal decolonization and used in hospitals for 10 years, with >60,000 patients treated pre-surgically to reduce post-operative infection risk. In that time not a single significant adverse event has been reported.
The system is also CE marked for use in the EU.
In the U.S., Ondine holds an Investigational New Drug authorization for the photosensitizer formulation and is currently planning Phase II and Phase III clinical trials in humans in collaboration with one of the nation's largest healthcare providers. Ondine has been granted two significant designations by the FDA: Fast Track and Qualified Infectious Disease Product (QIDP), both of which confer expedited and/or rolling review of regulatory submissions.
The system is also CE marked for use in the EU.
In the U.S., Ondine holds an Investigational New Drug authorization for the photosensitizer formulation and is currently planning Phase II and Phase III clinical trials in humans in collaboration with one of the nation's largest healthcare providers. Ondine has been granted two significant designations by the FDA: Fast Track and Qualified Infectious Disease Product (QIDP), both of which confer expedited and/or rolling review of regulatory submissions.
Impact (i.e. measurable outcomes), if applicable
In October 2014 the results of a historical control study were published in the Journal of Hospital Infection (E. Bryce, et al., 2014). The aim of the study was to assess the effectiveness of immediate pre-operative decolonization therapy using intranasal antimicrobial photodisinfection therapy combined with chlorhexidine body wipes for the reduction of surgical site infections (SSIs). A 40% reduction of the SSI rate was observed between treated patients and the historical control group [1.6% vs 2.7%, P = 0.0004].
In 2019, Banaszek, et al. published the results of a related clinical study that investigated the efficacy and cost-effectiveness of chlorhexidine skin decolonization (CSD) and nasal photo-disinfection therapy (nPDT) on SSIs specifically for instrumented spine surgery. Since 2009, all patients received CSD and nPDT preoperatively. From 2009 to 2017 the SSI rate for spine cases decreased from 7.2% to 1.6%, the greatest magnitude of reduction of all surgery types (p < 0.01). The absolute risk reduction for spine was 5.6%, and the number needed to treat to prevent 1 infection was 18 patients, resulting in an average of 53 fewer cases of SSI per year with an estimated annual cost saving was CAD$4.24 million. The use of CSD/nPDT was not associated with any additional adverse events.
In 2019, Banaszek, et al. published the results of a related clinical study that investigated the efficacy and cost-effectiveness of chlorhexidine skin decolonization (CSD) and nasal photo-disinfection therapy (nPDT) on SSIs specifically for instrumented spine surgery. Since 2009, all patients received CSD and nPDT preoperatively. From 2009 to 2017 the SSI rate for spine cases decreased from 7.2% to 1.6%, the greatest magnitude of reduction of all surgery types (p < 0.01). The absolute risk reduction for spine was 5.6%, and the number needed to treat to prevent 1 infection was 18 patients, resulting in an average of 53 fewer cases of SSI per year with an estimated annual cost saving was CAD$4.24 million. The use of CSD/nPDT was not associated with any additional adverse events.
Funding Stage
Not Applicable
List of Funding Sources (if applicable)
Privately funded by founders
Certifications?
Yes
ISO 13485, MDSAP