Contact This Organization

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.
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
Problem (i.e. barrier, issue, complication, etc.) being solved for the end user
antiviral, antibacterial, antifungal, surgical site infections, SSI, infection control, hospital acquired infections, nosocomial infections, SARS-CoV-2, COVID-19, antimicrobial resistance, antibiotic resistance
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.
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.
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.
Funding Stage
Not Applicable
List of Funding Sources (if applicable)
Privately funded by founders
Certifications?
Yes
ISO 13485, MDSAP