Toronto-based Moleculight Inc. has received U.S. FDA 510(k) clearance for its i:X hand-held fluorescence imaging device for use in detecting bacteria in wounds at the point of care. The milestone comes a little over a year after the agency granted de novo clearance for the device in August 2018 and lends additional credence to the device’s benefits in wound evaluation and management.

“The granting of our 510(k) clearance by the FDA for the i:X hand-held fluorescence imaging device is very exciting and is a further validation of the growing clinical evidence supporting the utility of our imaging platform,” said Anil Amlani, Moleculight’s CEO.

Clinical evidence

The 510(k) application was supported by a prospective, multicenter, single-blind study assessing the use of Moleculight i:X as an adjunctive fluorescence imaging tool to clinical signs and symptoms (CSS) for identifying bacteria-containing wounds. Data submitted to the FDA on 350 patients showed a three-fold increase in both sensitivity and diagnostic odds ratio in the number of wounds identified as having a bacterial load greater than 104 CFU/g when Moleculight i:X was used in combination with CSS vs. CSS alone. The heightened sensitivity was seen consistently across study sites, investigators and wound type and size, according to the company. The three-fold rise in diagnostic odds ratio, which measures overall effectiveness of diagnostic tests, was confirmed using microbiology.

“Bacteria at loads of 104 CFU/g have been shown to delay wound healing, resulting in poor patient quality of life and high wound care costs worldwide,” Amlani said. “Identifying wounds with bacterial loads of >104 CFU/g at the point-of-care enables the clinician using the Moleculight i:X to provide more appropriate targeted treatment.”

Portable, easy to use

The portable, easy-to-use i:X is designed to illuminate bacteria that can reside and grow in a wound, preventing it from healing. Molecules inside the bacteria, called porphyrins, emit a red fluorescent pattern when exposed to light. With excitation light, filters and sensors, the i:X lifts the bacteria out of the darkness and measures the wound area so that clinicians can better evaluate and triage patients.

Among the fluorescent microorganisms the device is capable of detecting are gram-positive and gram-negative Pseudomonas and aerobes and anaerobes, including Staphylococcus, E. coli, Klebsiella, Proteus, Enterobacter, Acinetobacter, Aeromonas and Bacteroides.

“There no comparable device that is available that provides such real-time insights to wound care practitioners,” Rob Sander, chief marketing officer at Moleculight, told BioWorld MedTech. “Clinical studies indicate that fluorescence information improves accuracy of cleansing, guides targeted debridement and facilitates evidence-based changes in treatment plans.”

Sander noted that international wound infection guidelines recommend reevaluating wounds to monitor the effectiveness of antimicrobial treatments. “This is now possible in real-time, at each step, without weeks of delay, with fluorescence imaging,” he said.

Founded in 2013, privately held Moleculight won CE mark and Health Canada approval in 2015 and markets the i:X via a direct sales force and clinical applications team in North America and Europe. The company has a distribution agreement with Smith & Nephew Ltd. for distribution of the device in certain parts of Europe, Asia and the Middle East.

Commercial expansion

To meet growing demand for its product, Moleculight secured a $7.5 million term loan from Oxford Finance LLC in August. The same month, the company sold its fluorescent imaging cancer platform, called Eagle, to SBI Alapharma Canada, a subsidiary of SBI Holdings Inc. Much of the proceeds went toward developing and scaling Moleculight’s commercial team.

Sandler said the customer-installed base for the i:X device is growing rapidly, as is the body of published evidence and clinical presentations by practitioners using the device. That evidence includes up to nine times faster healing and up to 89% savings in overall costs of wound care, compared with standard care, according to Moleculight’s website. In September, the American Medical Association’s CPT Editorial Panel accepted the addition of new Category III codes OX30T and OX31T to report “wound bacterial localization and treatment,” effective July 1, 2020, to provide a coverage pathway for point-of-care fluorescence wound imaging.

Meanwhile, Moleculight continues to build out a robust research program, focusing on questions about fluorescence detection of bacteria in biofilm, how such information affects clinical decisionmaking and rates of wound healing, Sandler said.

The company is also betting on economic data on the impact of appropriate, evidence-based wound care to underscore the i:X’s benefits. “More than $33 billion is spent annually on chronic wounds in the United States, leaving facilities and payers in search of key areas for cost reduction,” Sandler said. “Suboptimal identification of bacterial loads grossly inflates these costs.”

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