Profound Medical Corp · TSX:PRN
Profound Medical — Investor Presentation (January 2018)
26 slides from Profound Medical's investor presentation, Jan 4, 2018
Slide 1: Incision-free Surgery: Real-Time MR Guided Ultrasound Therapies
Incision-free Surgery Real-Time MR Guided Ultrasound Therapies CORPORATE PRESENTATION | JANUARY 2018 © 2018 PROFOUND MEDICAL CORP. | TSXV: PRN | OTCQX: PRFMF
Slide 2: Forward-looking Statements
Forward-looking Statements Certain statements in this presentation and oral statements made during this meeting may contain “forward-looking statements” within the meaning of applicable securities laws, including the “safe harbour provisions” of the Securities Act (Ontario), with respect to Profound
Slide 3: Prostate Treatment
Prostate Treatment TSXV: PRN | OTCQX: PRFMF
Slide 4: Emerging Prostate Care Dynamics
Emerging Prostate Care Dynamics Precision Diagnosis will lead to Precise & Personalized Treatment with fewer side effects Precision Targeted Diagnosis Therapy Enhanced Diagnosis and Therapy capable of being: Targeted Identification • Personalized to each • MP-MRI patient’s anatomy and • MR Guided Bi
Slide 5: MR-Guided Transurethral Ablation of Prostate using ultrasound
MR-Guided Transurethral Ablation of Prostate using ultrasound to provide thermal energy & real time process control software for precision Precise ablation with millimeter accuracy • Real-Time MR Imaging • Real-Time process control of ablation using MR temperature map, thermal ultrasound and robotic
Slide 6: TULSA-PRO Equipment
TULSA-PRO Equipment Compatible with MR from leading companies – Philips and Siemens Robotic Arm, Energy Surgeon Console Disposable Computer Hardware System Control Room Applicators 6
Slide 7: Treatment Work Flow
Treatment Work Flow 1 2 3 4 MRI Adjust Power, Thermometry Frequency, Acquisition Rotation Rate 1 cm MRI Guided Device Precise Treatment Automated, Confirmation of Ablation Positioning Planning Robotically driven Margin with MRI 1. Controlled algorithm 2. Target temp 550 C 3. Ablation in 40 minutes 7
Slide 8: Enables Targeted to Whole-Gland Treatment
Enables Targeted to Whole-Gland Treatment • Over 90% of prostate cancers present with • Multi-focal nature of prostate cancer requires that multi-focal lesions 1 clinicians have tools that can provide them safe • Unilateral (one-sided) disease is estimated in and effective focal to whole gland range
Slide 9: TULSA Technology: Flexibility
TULSA Technology: Flexibility Salvage Therapy post Whole Gland Ablation Targeted Ablation Radiation Therapy Failure BPH • Treatment – natural follow-on to MRI guided diagnosis and MRI guided biopsy to diagnose disease with precision • Outpatient procedure – patients discharged within 24 hours • Pers
Slide 10: Prostate Cancer Therapies Today
Prostate Cancer Therapies Today Low Risk Intermediate Risk High Risk Active Surveillance Surgery Radiation Therapy Unmet needs: 1. Patients with active lives 2. Patients under active surveillance but don’t want to wait, or also have BPH 3. Patients with co-morbidities preventing surgical interventio
Slide 11: TULSA-PRO Addressing Unmet Needs
TULSA-PRO Addressing Unmet Needs Low Risk Intermediate Risk High Risk Active Surveillance TULSA-PRO Surgery TULSA-PRO Target Market: Radiation Therapy 1. Patients with active lives 2. Patients under active surveillance but don’t want to wait, or also have BPH 3. Patients with co-morbidities preventi
Slide 12: Targeted Ablation (Focal Therapy)
Targeted Ablation (Focal Therapy) Clinical Histology MRI Thermometry H&E Histology • Treat-and-resect clinical study, targeting MRI- visible lesion with TULSA (n=5) • TULSA followed by Radical Prostatectomy on same day • Demonstrated complete ablation of target lesion to prostate capsule on gold-sta
Slide 13: Phase I Clinical Trial Completed – 90% Prostate Ablation
Phase I Clinical Trial Completed – 90% Prostate Ablation Study Population • Low (80%) & intermediate (20%) risk prostate cancer patients, ≥ 65 years old (n=30) Primary Endpoints & Outcomes 1. Safety: Frequency and severity of adverse events − Erectile function (erection firmness sufficient for penet
Slide 14: TACT Pivotal Trial
TACT Pivotal Trial To Support FDA Application, Enrollment Completion Feb 2018 Phase I Study Population 55°C Expected median • Low & intermediate risk prostate cancer patients, 45 – 80 years old residual viable • n=110, 13 clinical sites prostate volume: U Treatment Plan A • Reduced margin, with < 1%
Slide 15: From Open Surgery to Incision-Free Surgery
From Open Surgery to Incision-Free Surgery Open Laparoscopic Robotic Laparoscopic Incision-Free Prostatectomy Prostatectomy Prostatectomy Targeted Surgery 1970 1974 1982 1986 1992 1993 1999 2001 2012 2017 FULL PROSTATE FLEXIBLE: FULL PROSTATE OR SURGERY TYPE REMOVAL TARGETED CANCER ABLATION Invasive
Slide 16: Target Customer Segments
Target Customer Segments US MR Installed Base Clinical Leadership Private Practice Clinical Hospitals Leadership • Academic/KOL • Private practice, including large urology practices • Best-in-class organizations • Organizations motivated • Interested in research and by financial results as well adva
Slide 17: SONALLEVE
SONALLEVE Technology platform for: • Uterine Fibroid Treatment • Bone Metastasis Pain • Pediatric bone • Hyperthermia Over 200 publications from leading US and European clinicians and hospitals CE Marked TSXV: PRN | OTCQX: PRFMF
Slide 18: Uterine Fibroid: Symptom Relief & Durability
Uterine Fibroid: Symptom Relief & Durability In normal commercial use, over 85% of patients experienced sustained symptom improvement Months Patients available Symptom improvement post-procedure for follow-up Improved No relief Worse 3 months 105 90 (85.7%) 14 (13.3%) 1 (1%) 6 months 99 92 (92.9%) 7
Slide 19: Sonalleve: Bone Metastasis Pain Therapy
Sonalleve: Bone Metastasis Pain Therapy Non-invasive alternative to radiotherapy Most patients with slow growing tumors develop bone metastasis in the later stage of the disease. Bone changes and malformations irritate nerve endings creating significant pain for patients. • Radiotherapy standard of
Slide 20: Exploring Further Indications on Current Platform
Exploring Further Indications on Current Platform Pediatrics, Hyperthermia Pediatrics: Osteoid osteoma • Very painful, benign bone tumor in children and young adults • MR-HIFU very effective, immediate pain relief and bone restructuring • Standard of care is radiofrequency ablation (RFA, invasive) P
Slide 21: Commercialization
Commercialization
Slide 22: Strong Global Network of Clinical Partners
Strong Global Network of Clinical Partners Johns Hopkins Univ. College London University, Baltimore Royal Marsden, Sunnybrook, Toronto London King’s College London UMC Utrecht National Institutes of University of Chicago Health, Bethesda UH Cologne LMU Munich Samsung Medical Center, Seoul University
Slide 23: Market Introduction Strategy
Market Introduction Strategy • Strategic Partnerships: expanded and existing collaborations with MR partners will drive revenue: • Capital Sales • Co-selling • Co-marketing • Build direct sales to drive procedure adoption and disposable sales • Focus Sonalleve sales in Asian market and academic hosp
Slide 24: Reimbursement Environment
Reimbursement Environment US APPROXIMATE APPROXIMATE PROCEDURE HOSPITAL PAYMENT SURGEON PAYMENT Laparoscopic Radical $10,000 $1,450 Prostatectomy Radiation Therapy Fee bundled $20,000 (IMRT Simple, 40 Sessions) into primary APC Brachytherapy $2,200 $8,000 Cryoablation $10,000 $800 Germany TULSA-PRO
Slide 25: European Pilot Commercial Launch
European Pilot Commercial Launch Revenue Ramp $1,600,000 $1,400,000 $1,200,000 $1,000,000 CDN$ $800,000 First-time revenue recognition $600,000 $400,000 $200,000 $0 Q1-2017 Q2-2017 Q3-2017 25
Slide 26: Profound Medical Summary
Profound Medical Summary INCISION-FREE PROCEDURES Ultrasound ‘Inside-Out’ REAL-TIME MR GUIDED TREATMENTS - Prostate Disease - CE marked - FDA expected 2019 1 Precise 2 Personalized Ultrasound ‘Outside-In’ 3 Safe - Uterine Fibroids - Bone Metastasis - CE marked - Extending indications 26
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