MolecuLight i:X uses the principle of fluorescence to capture and document either still images or videos of wounds as well as their surrounding areas where potentially harmful bacteria may be present, without the need of contrast agents.
MolecuLight’s first product, the i:X, is a handheld fluorescence imaging device that allows clinicians to quickly, safely, and easily visualize and precisely target bacterial presence and distribution in and around wounds, in real-time at the point-of-care. The device provides instant detection of potentially harmful bacteria. The technology is based on the detection and analysis of intrinsic fluorescence signals emitted by tissues and microbes when illuminated with specific wavelengths of light.
“This CE Mark approval is a major milestone for both our company and wound care as a whole,” says Craig Kennedy, MolecuLight’s CEO. “With our device already approved for use in Canada and now available in the EU, we believe that in time the MolecuLight i:X will become the stethoscope of wound care worldwide. We are eager to begin our commercialization efforts in Europe starting with the WUWHS Congress in Florence later this month.”
Dr. Ralph S. DaCosta, Founder, Chief Scientific Officer and Board Director adds: “By helping clinicians see potentially harmful bacteria levels in real-time at the bedside, we are advancing wound healing by providing a more personalized and effective approach. Soon, we will be including additional functionality to also easily and quickly measure wound size. All integrated on the same device.”
Traditionally, chronic wound infection is diagnosed and treated based on visual inspection under white light (WL) and microbiological sampling. These methods are suboptimal because they are subjective and do not accurately represent the overall bacterial load in the wound. To address this, we have developed a novel handheld fluorescence imaging device that enables non-contact, real-time, high-resolution visualization of key pathogenic bacteria through their endogenous autofluorescence (FL).
Objectives:
To demonstrate the feasibility of autofluorescence imaging in guiding wound treatment and quantitatively assessing treatment response.
Methods:
A pilot-phase, non-randomized trial of 12 patients with diagnosed chronic and/or acute wounds was conducted in Toronto, Canada. In this group, wound area was tracked over 6 months, comprising of three sequential 2-month periods, to compare treatment delivered without (control) and with FL guidance (guided). FL imaging was used to locally guide debridement and target antibiotic application.
Results:
During the first standard treatment period, there was a slight decrease in average wound area over time, but this was statistically insignificant (slope -0.005cm2/day). However, when FL imaging was used to guide treatment, a larger decrease in average wound area was observed (slope -0.046 cm2/day), which was significantly different (p=0.015) compared to the first control period. In the second control period, a slight increase in average wound area (slope +0.007 cm2/day) was observed, which was significantly different from the rate of change seen in the FL guided period (p=0.010). The significance of the slope for each 2-month period was p=0.579, p<0.001 and p=0.501, respectively.