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References

Why it Matters

Nearly 6.5 million patients in the U.S. suffer chronic wounds from causes such as burns, infections and complications from diabetes: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810192/\
The U.S. healthcare system spends $25 billion each year on treating wound-related complications: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7949725/
Due to U.S. reimbursement rules, physicians are currently required to wait 30 days to designate a DFU as non-healing before using advanced wound care: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5793889/
Over one million people in the US and 250,000 in the UK seek evaluation for burn injuries in emergent or urgent care settings every year: https://www.britishburnassociation.org/wp-content/uploads/2017/07/NBCR2001.pdf and https://www.annemergmed.com/article/S0196-0644(22)00700-4/fulltext
Literature shows that burn care providers typically assess the depth of burn wounds incorrectly in about 25-30% of injuries, partly because burn wound evaluation has no adjunctive labs or diagnostics to aid in the determination of healing versus non-healing burn wounds: https://www.annemergmed.com/a rticle/S0196-0644(22)00700-4/fulltext

Clinical assessment of burn depth, even by experts in the field, has an accuracy of only 60-80%: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4991589/
Burn Experts: 70% accurate in assessing the viability of burned tissue: https://investors.spectral-ai.com/company-announcements/company-announcements/archive/2022/051022
Non-Specialists: <50% accurate in assessing the viability of burned tissue: https://investors.spectral-ai.com/company-announcements/company-announcements/archive/2022/051022
Physicians typically admit the patient for a period of up to 21 days to wait for the viable tissue to present itself as healing or non-healing before surgical intervention: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4528992/
DeepView®’s current accuracy in determining healing or non-healing burn wounds is 92%, compared with current physician accuracy of 50 to 70%: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4991589/

Diabetes is a problem that affects 37.3 million in the US and it’s growing with 1.4 million new diabetics being diagnosed every year: https://diabetes.org/about-us/statistics/about-diabetes
Diabetes is the 7th leading cause of death in the US: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6581547/
25% of diabetics will develop a Diabetic Foot Ulcer (DFU): https://bmcendocrdisord.biomedcentral.com/articles/10.1186/s12902-018-0327-2
DFU will affect 9.3 diabetics in the US and 26.1 million globally each year https://www.ncbi.nlm.nih.gov/books/NBK537328/
Unfortunately 70% of DFUs in diabetic patients will recur within 3 years https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7949075/
Other challenges such as amputation are preceded by DFU in 85% of lower extremity amputations https://pubmed.ncbi.nlm.nih.gov/33872198/
$109 billion in annual medical costs is attributed to DFUs. Additionally DFU patients lose $90 billion in their workforce productivity. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5761954/
Clinicians are 50% accurate in assessing healing potential of DFUs https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7950518/
The standard of care for DFU relies on physicians using a wait-and-see approach: https://www.uptodate.com/contents/management-of-diabetic-foot-ulcers

Survivability of DFU Amputations: 5 years https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7092527/
Annual DFU Treatment cost: $11,710: https://diabetesjournals.org/care/article/37/3/651/29343/Burden-of-Diabetic-Foot-Ulcers-for-Medicare-and
Clinicians are 50% accurate in assessing healing potential of DFUs https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7950518/
Cost of DFU patients: 63,100 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4525647/
Spectral MD’s DeepView technology provides 86% accuracy: Spectral MD data on file – DFU AI studies