OMNIA case results: Lumee Oxygen measurements representative for CLI wound healing prognosis. M Werner 1 Feb 2018
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1 OMNIA case results: Lumee Oxygen measurements representative for CLI wound healing prognosis M Werner 1 Feb 2018
2 Disclosure Speaker name:... I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest
3 Lumee Oxygen Platform is designed to provide immediate feedback on the quality of revascularization along the entire course of the patient s recovery OMNIA is a study designed to understand the relationship between revascularization success, traditional measures of gross hemodynamic characterization and Lumee measurement of tissue perfusion
4 How does LUMEE work? Excitation light from surface reader reaches hydrogel in tissue. Fluorescence chemistry on hydrogel responds based on oxygen concentration The fluorescent signal from hydrogel is captured by the reader. Data sent to cloud.
5 OMNIA - Oxygen Monitoring Near Ischemic Areas A prospective, single-arm, open-label, multicenter study Four Lumee sensors injected with 3 in the foot, and 1 reference sensor in the arm Lumee measurements performed continuously during endovascular revascularization procedures Lumee measurements also performed during functional assessment tests performed before and after revascularization, and at follow ups Traditional clinical metrics sampled throughout visit schedule include: arterial duplex, toe and ankle brachial index, WIFI scores, wound characterization and photographs Consent, Enrollment Sensor Injection Revascularization 1-29 days Functional Assessment Pre-operative Discharge 1 month 3 months 6 months
6 OMNIA: enrollment and safety A total of 3 study sites are actively enrolling: Prof. M. Brodmann, Med University of Graz / Austria Drs. T. Bisdas, A. Schwindt, St. Franziskus Hospital Münster / Germany Dr. M. Werner, Hanusch Hospital Vienna, Austria 21 subjects have been enrolled through end of /21 were Rutherford Class 5 upon enrollment 19/21 received endovascular treatment 2/21 had bypass surgery after endo attempt 50 adverse events have been reported 27 are SAEs, all unrelated to study device 23 are AEs, 1 possibly related to study device (swelling described as mild and resolved at follow-up) 6
7 LOI [-] What information do we extract from Lumee Intra-Surgically? Reperfusion Modulation Defined as difference in LOI between baseline and maximum after intervention Baseline Therapeutic interventions Maximum during/after interventions Larger values are associated with greater increases in tissue oxygen during the procedure Reperfusion Modulation (Unitless) Data can be averaged across all Lumees, or selected from a Lumee of interest
8 What information do we extract from Lumee Post-Surgically? Recovery Modulation Baseline Leg Lift Defined as maximal change in LOI over a 5 minute window after the end of leg lift. It is expressed as a percentage of the baseline LOI before provocation Designed to capture the ability of vasculature to autoregulate following a leg lift (e.g. hyperemia) Larger values (above 100%) may represent extended hyperemia associated with poor vascular function Recovery Modulation = (1.7/2.2) = 77%
9 Provocation-response data at 1 month may provide metric of microvascular function Response from subject that healed Response from subject that failed Hypothesis: ability of vessels to regulate blood flow after ischemic challenge may be an indicator of vascular health 9
10 Tissue oxygen index Case report OMNIA trial Sex M Age (yrs) 65 Diabetes Type 2 Foot Side Right Rutherford Class 5 Wound Right second toe Therapy 1. Treated popliteal during this time via 1 set of balloon inflate/deflate 2. Treated anterior tibial during this time via 5 sets of balloon inflate/deflate 3. Use DCB (Lutonix 2.0/80mm) at anterior tibial and DP, 1 set of balloon inflate/deflate (1) (2) (3)
11 Lumee is responsive to the interventions delivered during revascularization Treated popliteal during this time via 1 set of balloon inflate/deflate Treated anterior tibial during this time via 5 sets of balloon inflate/deflate Use DCB (Lutonix 2.0/80mm) at anterior tibial and DP, 1 set of balloon inflate/deflate Catheter exchange during this time
12 Provocation response Case report OMNIA trial 200% Sex M Age (yrs) 65 Diabetes Type 2 Foot Side Right Rutherford Class 5 180% 160% 140% 120% 100% 80% 60% 40% 20% 0% Before PTA 3 Months 1 month
13 Provocation response Fallbeispiel OMNIA Studie Sex M Age (yrs) 65 Diabetes Type 2 Foot Side Right Rutherford Class 5 200% 150% 100% 50% 0% 1 month 6 months Before PTA 3 Months 6 Months
![Tissue oxygen index Provocation response Wound Area cm^2 TBI [-] ABI [-] Subject: 03-001 Demographics Sex M Age (yrs) 65 Diabetes Type 2 Foot Side Right Rutherford Class 5 Wound Right second toe](/docs-images/94/121063497/images/14-1.jpg "Therapy 1. Treated popliteal during this time via 1 set of balloon inflate/deflate 2. Treated anterior tibial during this time via 5 sets of balloon inflate/deflate 3. Use DCB (Lutonix 2.")
14 Tissue oxygen index Provocation response Wound Area cm^2 TBI [-] ABI [-] Subject: Demographics Sex M Age (yrs) 65 Diabetes Type 2 Foot Side Right Rutherford Class 5 Wound Right second toe Therapy 1. Treated popliteal during this time via 1 set of balloon inflate/deflate 2. Treated anterior tibial during this time via 5 sets of balloon inflate/deflate 3. Use DCB (Lutonix 2.0/80mm) at anterior tibial and DP, 1 set of balloon inflate/deflate Lumee: Intra-operative reperfusion Average LOI increase was 20.5 [-] was very high (in 93 rd percentile out of 19 sampled subjects) Lumee: Functional Assessment Recovery modulation at 1-3 months of >100% of baseline is a feature consistent with non-responding patients Pre-Op Discharge 1 Month 3 Month 6 Month Wound Gangrene Ischemia N/A 3 Infection 2 2 N/A N/A 2 WIFI Risk Toe Pressure [mmhg] ABI TBI Wound Images Pre-Tx 1 month 3 month 6 month No photo available (1) (2) (3) Pre Dis 1mo 3mo 6mo Pre Dis 1mo 3mo 6mo Pre Dis 1mo 3mo 6mo 200% 150% 100% 50% 0% Pre Dis 1mo 3mo 6mo
15 Pre-procedure (day 1) Discharge (day2 ) Provocation response data 1- Month (day 23) 3-Month (day 96) 2 3 Extended hyperemia observed at 1- and 3- month follow ups 4 15
![Tissue oxygen index Provocation response Wound Area cm^2 TBI [-] ABI [-] Subject: 03-002 Demographics Sex M Age (yrs) 79 Diabetes Type 2 Foot Side Left Rutherford Class 5 Pre-Op Discharge 1 Month 3](/docs-images/94/121063497/images/16-1.jpg "Month 6 Month Wound 1 1 0 0 0 Gangrene 1 0 0 0 0 Ischemia 3 1 0 0 0 Infection N/A N/A N/A N/A 0 WIFI Risk 3 1 1 1 1 Pre Dis 1mo 3mo 6mo Wound Left first toe Therapy 1. Treated SFA and popliteal a.")
16 Tissue oxygen index Provocation response Wound Area cm^2 TBI [-] ABI [-] Subject: Demographics Sex M Age (yrs) 79 Diabetes Type 2 Foot Side Left Rutherford Class 5 Pre-Op Discharge 1 Month 3 Month 6 Month Wound Gangrene Ischemia Infection N/A N/A N/A N/A 0 WIFI Risk Pre Dis 1mo 3mo 6mo Wound Left first toe Therapy 1. Treated SFA and popliteal a. via 4 sets of balloon inflate/deflate 2. Treated fibularis a. via 3 sets of balloon inflate/deflate and stent 3. Balloon 1X Lumee: Intra-operative reperfusion Average LOI increase of 15.6 [-] was high (in 73 rd percentile out of 19 sampled subjects) Lumee: Functional Assessment Maximal recovery modulation at 1-3 months of <100% is a feature consistent with healing patients Toe Pressure [mmhg] ABI TBI (1) (2) (3) Pre Dis 1mo 3mo 6mo 0,02 0,01 0 Pre Dis 1mo 3mo 6mo 200% 150% 100% 50% 0% Pre Dis 1mo 3mo 6mo
17 Lumee sensors show slow response until last balloon treatment and catheter removal Treated SFA and popliteal a. via 4 sets of balloon inflate/deflate Treated fibularis a. via 3 sets of balloon inflate/deflate and stent 1 x 2 3 Unable to locate sensor
18 Pre-procedure (day 1) Discharge (day2 ) Provocation response data 1- Month (day 23) 3-Month (day 96) 2 3 No hyperemia observed at 1- and 3- month follow ups 4 18
19 OMNIA compares measures of reperfusion with wound healing Clinical observations Lumee Intrasurgical [LOI] Lumee 1-mo Functional Assessment [%] Site Subject Diabetes WIFI month Wound Area Toe Pressure Angiosome Channel 2 Channel 3 Channel 4 Channel 2 Channel 3 Channel Type II 4 Improved Improved Improved N/A Bypass Bypass Bypass Type II 1 No Change Worsening Worsening Maybe Type II 1 Improved Improved Worsening No Type II 4 Worsening Worsening Worsening Maybe Type II 1 No Change Improved Improved Yes Type II 2 No Change No Change No Change Maybe Type II 1 Worsening Improved Improved Yes Type II 2 Improved Improved N/A Type II 1 Improved Improved Yes WIFI Risk Clinical observations None 4 Improved Improved Improved Yes Risk 002 of amputation Wound healing transitions between follow Intra-op, reperfusion modulation Unconfirm 2 Maybe assessed 003 Unconfirm by WIFI at 1 Worsening Worsening up visits assessed Improved from clinical observations Post-op, recovery modulation Maybe enrollment 004 Type II 2 No Change Improved Evaluated Improved by Profusa using photos and No Type II 1 N/A Characterizes initial wound burden wound size Lumee Results Type II 4 No Change Improved Key Worsening Wound status Maybe None 3 Improved Improved Improved Healing Yes Positive Reperfusion Type I 3 No Change Improved No Change No Elevated Hyperemia Type II 2 Improved Improved Maybe Worsening None 3 Worsening Maybe Key Lumee Response
20 Intra-op LOI [-] Intra-operative LOI change is correlated with TBI Analysis performed on subjects completing 3-month follow up with TBI reported (n=9) r=0.53 p<0.03 For each subject, change in TBI after revascularization is plotted on x-axis, and intra-op change in LOI is plotted on y-axis Marker size indicates risk of amputation assessed by WIFI scores at enrollment Marker color represents wound healing (green), no change (yellow), or worsening (red) through 3 month follow up TBI change post-op [-] Results show highly positive correlation between LOI and TBI
21 Summary and Future Plans Initial phase of study: (first 21 subjects enrolled) Goal: establish feasibility and generate hypotheses Preliminary findings: Intra-op LOI measurements of reperfusion reveal functional benefit of intervention Post-op LOI evaluation of microvascular function may be indicator of long term healing Next phase of study: (next 30 subjects enrolled) Goal: refine methods and test hypotheses Ongoing questions: Refine classification algorithms using both intraop and post-op measurements to predict wound healing
22 Acknowledgements Clinical Research Team Medical University Graz, Austria Marianne Brodmann M.D. St Franziskus-Hospital Munster, Germany Theo Bisdas, M.D. Arne Schwindt M.D. Hanusch Hospital Vienna, Austria OMNIA PIs Martin Werner M.D. Profusa San Francisco, USA Kerstin Rebrin, M.D., Ph.D. Kit Yee Au-Yeung, Ph.D. Wayne Menzie, Ph.D. Stephen Kanick, Ph.D. Medical Advisory Committee Peter Schneider, M.D. Miguel Montero-Baker M.D. Medhi Shishehbor, D.O, Ph.D. Michael Conte, M.D. 22
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