Profusa, Inc. · NASDAQ:PFSA
Profusa — Conference Presentation (November 2016)
33 slides from Profusa's conference presentation, November 2016
Slide 1: Profusa: Implantable Biosensor for Long-Term Continuous Monitoring of Body Chemistry
Profusa IMPLANTABLE BIOSENSOR FOR LONG-TERM CONTINOUS MONITORING OF BODY CHEMISTRY November 2016 Frederic GAUME
Slide 2: Vision/Opportunity, Technology and Current Applications, Future Developments
VISION/ OPPORTUNITY TECHNOLOGY AND CURRENT APPLICATIONS FUTURE DEVELOPMENTS 2
Slide 3: To Unleash Everyone's Real Time Biochemistry to Be Part of the Digital Toolbox
TO UNLEASH EVERYONE’S REAL TIME BIOCHEMISTRY TO BE A PART OF THE WORLD’S DIGITAL TOOLBOX
Slide 4: Grand Vision but Difficult to Accomplish – Our Design Principles
GRAND VISION BUT DIFFICULT TO ACCOMPLISH – OUR DESIGN PRINCIPLES, STARTING WITH PATIENTS 1 2 3 Clinical Grade Consumer Broad & On-Demand User Access Data Experience Triggering timely, actionable Passive data collection, Low COGS Combined with medical decisions no user action required mass adoption C
Slide 5: Profusa Achievements to Date & Current Pipeline
PROFUSA ACHIEVEMENTS TO DATE & CURRENT PIPELINE • Founded 2009 Market Programs Indications Uses Status Size • South Fan Francisco, CA and College Lumee Peripheral Intra & Post CE Sept 2-3B USD Station, TX Tissue O2 Arterial operative patient 2016 Disease monitoring • 27 Employees Glucose Pre-diabeti
Slide 6: Profusa Sites and Collaborators
PROFUSA SITES AND COLLABORATORS SF Dr. Tejal Desai • Synthetic chemistry • Nanosphere stability • Hydrogel development • Optics instrumentation Dr. Bruce Klitzman • Clinical testing • Physiology • Quality and manufacturing • Long-term rat studies • All business functions Dr. Mike McShane • Optical i
Slide 7: Vision/Opportunity, Technology and Current Applications
VISION/ OPPORTUNITY TECHNOLOGY AND CURRENT APPLICATIONS 7
Slide 8: Why Others Have Failed – The Avascular Foreign Body Response
WHY OTHERS HAVE FAILED – THE AVASCULAR FOREIGN BODY RESPONSE (FBR) Sensor Collagen Biological response that has Needle been the “death sentence” of in-body sensors Typical poor sensor performance BLOOD LEVEL Sensor signal ERROR Immune Cells Blood Vessel / Capillaries 8 Days to weeks FREQUENT SENSOR
Slide 9: Meet the Profusa Sensor
MEET THE PROFUSA SENSOR – SOLVES AN UNSOLVABLE BARRIER FOR MORE THAN 5 DECADES • Micro hydrogel sensor – 250 microns diameter; 3 mm length • Embedded fluorescence sensing chemistry • Hypodermic needle placement in the subcutaneous space • Non-invasive optical signal collection • Clinical-grade data
Slide 10: How Profusa Sensors Work… Oxygen Example
HOW PROFUSA SENSORS WORK… OXYGEN EXAMPLE Excitation light is Sensor is The fluorescent signal 1 shined on the skin 2 embedded with 3 from the sensor surface and fluorescent dye travels to the surface reaches the that is sensitive to of the skin, captured proprietary sensor oxygen. The by the reader.
Slide 11: Our Sensor Measures Oxygen Concentration in the Tissue
OUR SENSOR MEASURES OXYGEN CONCENTRATION IN THE TISSUE Lumee 11
Slide 12: O2 Tissue Monitoring - Profusa's First Biosensor
O2 TISSUE MONITORING - PROFUSA’S FIRST BIOSENSOR 2 years 15 3 and months months going… 12
Slide 13: Measuring Oxygen Sensors in Rats Using an IVIS Imager
MEASURING OXYGEN SENSORS IN RATS USING AN IVIS IMAGER Fiber optic probes (Oxylyte) are large and Fluorescent overlay of sensor disrupt the tissue. In contrast, our tissue- signal integrating hydrogel sensors do not cause mechanical stress and minimally displace tissue) 13
Slide 14: Example Experimental Setup on Pigs
EXAMPLE EXPERIMENTAL SETUP ON PIGS 32 Readers attached to anesthetized and awake pigs Anesthetized Awake (in sling) 14 CONFIDEN TIAL
Slide 15: Small, Adaptable Reader Form-Factor
SMALL, ADAPTABLE READER FORM-FACTOR 15
Slide 16: Tissue Oxygen Program – 1st Product: CE Mark in September 2016
TISSUE OXYGEN PROGRAM – 1ST PRODUCT: CE MARK IN SEPTEMBER 2016 Console Reader injector 16
Slide 17: PAD/CLI a Global Epidemic with a Large Impact on Healthcare
PAD/ CLI A GLOBAL EPIDEMIC WITH A LARGE IMPACT ON HEALTHCARE US Prevalence Cancer 12-15M PAD 15-19M US Annual Cost of PAD Key Risk Factors: 160 – 290 B USD • Age • Diabetes US 5Y Mortality Breast Cancer • Smoker 11% PAD 15-30% 17 CONFIDENTIAL 150,000 amputations / year from PAD/CLI
Slide 18: CLI as 1st Indication – Functional Limb Preservation
CLI AS 1ST INDICATION FUNCTIONAL LIMB PRESERVATION 1) REVASCULARIZATION TO INCREASE FOOT PERFUSION 2) WOUND CARE 3) SURVEILLANCE • Foot ulcers & infections = most common cause for hospital admission of diabetics • US foot ulcer cost: $10-20k / episode1 • 6-12 month to wound healing • Complete ulce
Slide 19: Unmet Need – Perfusion Is Key and Its Quantification Difficult
UNMET NEED – PERFUSION IS KEY AND ITS QUANTIFICATION DIFFICULT TASC-II RECOMMENDS TCPO2 MEASUREMENTS FOR ALL CLI PATIENTS ? ? BTK surgery Very diverse clinical outcome and costs Success, wound healed, no amputation ~20-30k USD When is good, Partial success, 2nd revascularization good enough? ~60-80k
Slide 20: Intra-op Lumee Data Collected from a 90 Y.O. CLI Patient
INTRA-OP, LUMEE DATA COLLECTED FROM A 90 Y.O., CLASS 4 CLI PATIENT 1.4 1.4 Balloon inflate Balloon deflate 1.2 1.2 2 1 1 A B 0.8 0.8 C 1 1 A A B B C C 0.8 0.8 3 Stent Recover y Rm. 0.6 0.6 20 30 40 50 20 40 60 80 Time elapsed (min) Time elapsed (min) 20
Slide 21: Post-op Lumee Data Collected from the Same Patient
POST-OP, LUMEE DATA COLLECTED FROM THE SAME PATIENT 1.3 1.1 4 0.9 0.7 0.5 3 Post-op D7 D14 D21 D28 2 ABI 1.0 NA NA 1.07 NA Sensilase NA 45 67 47 43 (mmHg) Summary of First-in-Man Study Results • 48 sensors were injected into a total of 14 people for a cumulative exposure time of 336 subject-days • P
Slide 22: Variety of Pre-clinical Applications
VARIETY OF PRE-CLINICAL APPLICATIONS Stroke/TBI Research Flaps/Reconstruction Hypoxia in Pigs Pasted Series Pasted Series 1 Relative sensor signal 0.8 ` Relative O2 0.6 0.5 0.4 0.2 0 0 10:30 11:00 11:30 11/26/2013 Tumor Metabolism Gut Microbiome O2 Porcine Diabetes Sensor 2 (Avg Rad) Sensor 3 (Avg R
Slide 23: Future Developments and Applications
VISION/ OPPORTUNITY TECHNOLOGY AND CURRENT APPLICATIONS FUTURE DEVELOPMENTS AND APPLICATIONS TINY SENSORS, GREAT BIG WORLD ! 23
Slide 24: Digital Health Transformation
DIGITAL HEALTH TRANSFORMATION Digital Health, by creating actionable patient data to aid in the treatment and/or prevention of diseases outside of the traditional care setting, will reduce inefficiencies and unlock significant value for all stakeholders About 40% of the $3T the US spends 400B USD on
Slide 25: Limitations of Current Technologies
LIMITATIONS OF CURRENT TECHNOLOGIES DESPITE A CLEAR VISION AND SIGNIFICANT INVESTMENT FROM ALL STAKEHOLDERS - FEW ADVANCES Seamless Experience Data Value Ease of Use X Clinical Grade Sweet spot Hospital Devices that enables Glucose, EEG, digital health!! Labs, MRI… Data of X clinical value Wearables
Slide 26: Profusa Sensor Platform
PROFUSA SENSOR PLATFORM DESIGN PRINCIPLES & TECHNOLOGY ENABLEMENT TO OWN THE “SWEET SPOT” Enablement Proof • Focus on clinical validated analytes Clinical grade • CLI management use case data • CGM impact on diabetic health • >2 years longevity in humans Seamless • Ease of sensor implantation Curren
Slide 27: Profusa's Data Can Help Transform Healthcare
PROFUSA’S DATA CAN HELP TRANSFORM HEALTHCARE How can I demonstrate the How am I doing ? value of my products? Real time information to Develop Integrated patient optimize self-management First Nbr Cost care approaches as services three Patients B USD How is my patient apps progressing? Industry Pati
Slide 28: New $7.5M DARPA Grant for Multi-Analyte Sensing
NEW $7.5M DARPA GRANT FOR MULTI-ANALYTE SENSING Multi-plexed panels 9 new single Metabolism sensors beyond Training optimization O2 and glucose Fatigue detection 1) lactate Trauma and sepsis 2) potassium 3) sodium Blood Gases 4) chloride COPD 5) calcium 6) pH Surgical trauma 7) bicarbonate
Slide 29: Technology Development Pathways
FUTURE TECHNOLOGY DEVELOPMENT PATHWAYS: Clothing-integrated readers TOMORROW TODAY Phone Readers for Intermittent Sensing Clinic-based cabled reader (O2 only) Helmet-based readers Thin-film, Disposable Mobile Blue-tooth from rechargeable Patch patches CONFIDENTIAL 29
Slide 30: Great Big World - The Data Ecosystem
GREAT BIG WORLD - THE DATA ECOSYSTEM Real-time Data Patient Patient Biochemistry Aggregation Engagement Behavior Modification Sensor Patient: luminescence • Biovotion signal • geolocation; • other physiologic data (HR, HRV) Patient Smartphone UI Skin reader patch Cloud DB Data processing Patient • D
Slide 31: Monitoring Human Health in a Way Never Possible Before
MONITORING HUMAN HEALTH IN A WAY NEVER POSSIBLE BEFORE • Tissue-integrating biosensors • Multiplexed parameters • Digital/mobile health
Slide 32: Profusa's Mission
PROFUSA’S MISSION IS TO MAKE OUR BODY’S CHEMISTRY EASILY ACCESSIBLE TO IMPROVE HEALTH AND WELLNESS. WE ARE DEDICATED TO BECOMING THE LEADER IN REAL-TIME BIOSENSORS THAT PROVIDE UNPRECEDENTED INSIGHTS INTO OUR OVERALL HEALTH STATUS AND PERFORMANCE.
Slide 33: Basic Copyright Notice & Disclaimer
Basic Copyright Notice & Disclaimer ©2016 This presentation is copyright protected. All rights reserved. You may download or print out a hard copy for your private or internal use. You are not permitted to create any modifications or derivatives of this presentation without the prior written permiss