BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation

Confirmatory Study of Substantial Equivalence Between cureVision cV and MolecuLight i:X in Detecting Bacterial Burden in Wounds

The study aims to demonstrate the substantial equivalence of the cureVision cV system's performance in detecting moderate to high bacterial loads in direct comparison to the comparator device for fluorescence imaging in wounds, the MolecuLight i:X , to be able to offer the complete cureVision cV system to the US market.

Inclusion Criteria:

• Age ≥ 22 years
• Eligible wounds include all wound etiologies including but not limited to DFUs, VLUs, pressure injuries, and open postsurgical wounds.
• Presence of at least one target wound of sufficient size to allow:

Complete imaging using the investigational device, and collection of tissue biopsy samples, as required by the study protocol

- The target wound must be located in an anatomical region that permits: Full visualization, appropriate positioning for imaging, and safe and feasible biopsy sampling.

• Written informed consent possible
• Wound suitable for fluorescence imaging under IFU conditions with the study device and the comparator device (e.g., no excessive exudate obscuring visualization

Exclusion Criteria:

• The target wound cannot be completely imaged by the comparator device due to anatomical location, such as wounds that are:

Too extensive to be captured within the device's field of view, positioned on curved, recessed, or otherwise inaccessible regions (e.g., deep sacral clefts, interdigital spaces).

• The target wound is too small to support the required biopsy procedures without compromising participant safety or data quality.
• Treatment with experimental medication within the last month
• Lack of ability to consent
• Contraindications for standard wound care or monitoring
• Strong therapeutic anticoagulation (e.g., direct oral anticoagulants and warfarin);
• Known bleeding diathesis or coagulation disorder that increases risk of biopsy-related complications
• Contraindications to local anesthesia or biopsy
• Patients with wounds that are not suitable for biopsy, including tunnelling wounds and wounds with fistula formation
• Wounds that cannot meet technical imaging requirements (e.g., excessive exudate, severe artifacts, calcification/crust preventing visualization).