advanced surgical technology
Partner with Ukrainian orthopaedic surgeons to enhance patient treatment
We are moving the needle on how fractures are repaired, through new technology called fluorescence-guided debridement*. We are committed to bringing this technology to the brave men and women in Ukrainian hospitals to help their patients.
OUR MISSION
To provide advanced surgical-guidance technology to Ukrainian surgeons
New technology called “Fluorescence Guided Debridement” has the potential to make a huge impact in Ukraine.
We seek funds to send devices to the front lines, deploy them, and investigate their potential to
improve surgeon precision and patient outcomes*.
the device indicates the risk that bone and tissue will become infected.
*Caution: Investigational Device, Limited by Federal (or United States) Law to Investigational Use.
FGD is not approved for clinical use and clinical investigations will be funded by Lumine Trauma Foundation to determine the effectiveness of FGD in preventing infection, non-union and amputation.
DEBRIDEMENT SURGERY IS CRITICAL
Up to 75% of injured civilians and soldiers in Ukraine have extremity fractures. Often, these must be surgically repaired.
The procedure is called DEBRIDEMENT— a critical process of removing dead tissue before repairing broken bones.
Debridement is the mainstay of infection prevention and treatment. However, it is very challenging to do completely, because there is no way for the surgeon to see which tissue is dead during the procedure.
If debridement is not thorough, infection can set in, leading to sepsis and amputation.
clinical trial results
FGD has the potential to decrease infection by up to 50%† in certain patients undergoing debridement.
† In a clinical trial of 110 patients (NCT04403204), a large amount of retained low-perfusion tissue was associated with a 29% recurrence rate after 6 months compared with 12% when a small amount was retained.
The next step of our effort to bring this technology to places like Ukraine where it has the greatest potential to be helpful is to fund a clinical trial in Ukraine, building five of these devices and sending them to surgeons in the field.
We are using the social entrepreneurship model for bringing this late-stage research to patients.
+200
Patients
3
Clinical Trials
Join us in our efforts to reduce
infection and improve patient wellbeing
Join our mailing list to stay updated on our mission to provide new technology for orthopaedic trauma surgery in Ukraine. Make a pledge to donate once our 501(c)(3) status has been approved.
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✓ Your support will directly fund cutting-edge research
Steps to bring FGD to fruition…
Our vision is a multi-step process to bring advanced technology to Ukraine, partner with local surgeons, improve the care for patients, and publish impactful work in collaboration with our international partners. Research advances arising from this program will be made available to the Ukrainian people without any profit motives, forever.
01
Colaboration
Working with surgeons in Eastern Ukraine as well as the Ukrainian State Health Department and local IRB.
02
Training
Virtual training sessions on using FGD and interacting with the user interface, to make surgeon-driven design changes.
03
Deployment
Building and sending our portable, rugged, battery-powered imaging systems to partner hospitals in places like Dnipro and Kharkiv.
04
Follow-Up
Patients are imaged before and after debridement and their outcomes (infection, no. of procedures, return to duty, amputation) are recorded.
05
Feedback
Ukrainian surgeons will provide feedback as a collaborative team, empowering them to make improvements and adjustments to suit their needs.
06
Report Findings
We will publish all data, both in academic journals, and through correspondence with all contributors, showing the progress made with funds.
07
Learning & AI
Data is cleaned and incorporated into base models to improve infection risk prediction. Software is refined to a production-ready solution.
08
510k Submission & CE marking
Using the small-business / non-profit pathway with reduced fees and regulatory burden, 510k submission and CE Medical Devices Regulation paperwork will be filed in order to market FGD.
09
Scale Production
Following 510k / CE approval we will scale up production to supply Ukraine with all requested devices. Other contracts will be considered, and revenues generated will further the Foundations mission.