Philips MR-Anwendertreffen DACH 10. Nov. 2017

Transcription

1 MR-HIFU Women s Health Oncology Incision-free Surgery Real-Time MR Guided Ultrasound Therapies Prostate Disease Philips MR-Anwendertreffen DACH 10. Nov Hartmut Warnken, VP International Sales, GF Profound Medical GmbH Dr. Thomas Andreae, Marketing Director 2017 PROFOUND MEDICAL CORP. TSXV: PRN OTCQX: PRFMF

2 WHO WE ARE AND WHAT HAPPENED TO SONALLEVE 1998 Dr. R. Chopra, Dr. M. Bronskill and Dr. L. Klotz initiate research on transurethral ultrasound therapy of the prostate at Sunnybrook Research Institute 2008 Profound Medical established in Toronto, Canada 2012 Pre-clinical and clinical pilot treat & resect studies completed 2013 Innitiated Phase I trial, 30 patients, 12 month follow-up with biopsy 2015 Phase I trial completed with 12 month follow-up 2016 CE Mark for TULSA-PRO TACT Pivotal Trial started at 15 centers in North America and Europe, 110 patients, 12 month follow-up with biopsy Company listed on Toronto Stock Exchange European Sales Office established in Hamburg, Germany 2017 Expanded strategic collaboration with Philips - Philips MR-HIFU business transferred to Profound - Profound subsidiary established in Helsinki/ Vantaa, Finland - Profound takes over Sonalleve product development - Philips will continue to distribute Sonalleve for use in combination with its Ingenia and Achieva MR imaging systems - Philips provides additional services to Profound incl. manufacturing and services. - With the acquisition of Sonalleve, Philips owns about 10% of Profound Medical Strong and close collaboration between both companies TSXV: PRN OTCQX: PRFMF 2

3 INCISION-FREE PROCEDURES REAL-TIME MR GUIDED TREATMENTS Real-Time MR Imaging Ultrasound Inside-Out + Energy Source Ultrasound Outside-In Only company to provide a therapeutics platform that provides the precision of real-time MR imaging combined with the safety and ablation power of directional (inside-out) and focused (outside-in) ultrasound technology for the incision-free ablation of diseased tissue TSXV: PRN OTCQX: PRFMF 3

4 TULSA-PRO & SONALLEVE PLATFORM: REAL-TIME MR THERMOMETRY & CLOSED LOOP TEMPERATURE CONTROL Current applications Prostate (TULSA-PRO), uterine fibroids & bone metastases (Sonalleve) Future potential Abdominal cancers, hyperthermia for cancer therapy, pediatrics, breast TSXV: PRN OTCQX: PRFMF 4

5 FROM OPEN SURGERY TO INCISION-FREE SURGERY PROSTATE CANCER Open Prostatectomy Laparoscopic Prostatectomy Robotic Laparoscopic Prostatectomy Incision-Free Targeted Surgery UTERINE FIBROIDS Open Hysterectomy Laparoscopic Hysterectomy Robotic Laparoscopic Hysterectomy Incision-Free Targete Surgery TSXV: PRN OTCQX: PRFMF 5

6 INCISION-FREE PROCEDURES REAL-TIME MR GUIDED TREATMENTS Therapeutic solutions that are 1 Precise 2 Personalized 3 One and done TSXV: PRN OTCQX: PRFMF 6

7 REGULATORY CURRENT STATUS CE Mark Prostate ablation: 2016 FDA clinical trial Expected enrollment completion: Year End Expected filing for 510(k): Year End-2018 US launch expected H CE Mark Uterine fibroid treatment: 2009 Bone metastases treatment: 2011 FDA clinical trial: TBA TSXV: PRN OTCQX: PRFMF 7

8 STRONG GLOBAL NETWORK OF CLINICAL PARTNERS Sunnybrook, Toronto Johns Hopkins University, Baltimore Univ. College London Royal Marsden, London University of Chicago National Institutes of Health, Bethesda King s College London UMC Utrecht UH Cologne LMU Munich Samsung Medical Center, Seoul University of Texas Southwestern, Dallas Vanderbilt University, Tennessee King Khalid UH, Riad SIDRA, Qatar Indicates TULSA-PRO site Indicates Sonalleve site Indicates Sonalleve & TULSA-PRO site TSXV: PRN OTCQX: PRFMF 8

9 STRONG GLOBAL NETWORK OF CLINICAL PARTNERS - WITH FOCUS IN EUROPE Univ. College London Radboud UMC, Nijmegen UMC Utrecht Univ. Hospital Turku King s College London Royal Marsden, London Marienhospital, Stuttgart Kantonspital, Winterthur UKSH Lübeck Univ. Hosp. Cologne Uni. Hosp./ ICCAS Leipzig ProFamilia, Rzeszow, Poland Univ. Hosp./ DKFZ Heidelberg Barmherzige Brüder Vienna LMU Munich Indicates TULSA-PRO site Indicates Sonalleve site Indicates Sonalleve & TULSA-PRO site TSXV: PRN OTCQX: PRFMF 9

10 Prostate Treatment TSXV: PRN OTCQX: PRFMF 1 0

11 TULSA-PRO ULTRASOUND INSIDE-OUT TRANSURETHRAL ULTRASOUND ABLATION PROSTATE Ultrasound Applicator (UA) Prostate Ultrasound Transducers Bladder Urethra Heating Pattern Thermal Ablation Boundary Endorectal Cooling Device (ECD) TSXV: PRN OTCQX: PRFMF 11

12 Clinical Value Proposition Data for US & EUROPE TULSA-PRO Precise Safe Personalized Patient benefit Low side effects and good quality of life prostate cancer therapy Patient selection Patients on active surveillance who prefer a safe intervention after Patients with prostate confined prostate cancer who opt for a low side effect therapy Patients who are not suitable for surgery Active Surveillance 5.8 Million patients Live with psychological stress for 10-to-15 years Monitoring costs up to $29,000 Radiation 300,000 patients per year High rates of side effects Multiple treatments over 30-to-60 days 30% patients fail treatment Prostatectomy 200,000 patients per year Removal of whole prostate and associated tissue Side effects surgeon skill dependent Relatively longer recovery time Less frequent treatments: HIFU, Cryotherapy, Brachytherapy, Hormone Therapy, Laser TSXV: PRN OTCQX: PRFMF 12

13 VERGÜTUNG TULSA-PRO WEG FREI FÜR NUB ANTRÄGE OPS Code: Transurethrale Exzision und Destruktion von Prostatagewebe a Destruktion durch Magnetresonanz-gesteuerten Ultraschall Privatabrechnung jederzeit möglich Bewertung der Methode nach 137h SGB V: Muss nicht angewendet werden, keine spezielle Nutzenbewertung erforderlich Weg frei für NUB Anträge und Zusatzentgelte TSXV: PRN OTCQX: PRFMF 13

14 Women s Health and Oncology TSXV: PRN OTCQX: PRFMF 1 4

15 SONALLEVE MR-HIFU ULTRASOUND OUTSIDE-IN CE-Mark approval for: Uterine Fibroid Therapy Bone Mets Pain Therapy > 100 peer reviewed publications Compatible with Philips MRI Ingenia 1.5T and 3.0T Achieva 1.5T & 3.0T MR-guided: Treatment planning based on 3D MR images Focused ultrasound heats noninvasively through intact skin Real-time MR imaging & temperature measurement Verify treatment success Risk mitigation TSXV: PRN OTCQX: PRFMF 15

16 UTERINE FIBROID ABLATION MOST MATURE INDICATION OVER 85% SUSTAINED SYMPTOM IMPROVEMENT In normal commercial use, over 85% of patients experienced sustained symptom improvement Months post-procedure Patients available for follow-up Symptom improvement Improved No relief Worse 3 months (85.7%) 14 (13.3%) 1 (1%) 6 months (92.9%) 7 (7.1%) 0 12 months (87.6%) 11 (12.4%) 0 Durability of the therapeutic effect compared to other uterine preserving treatments Need for alternative month References Myomectomy 10.6 % % 1,2,3,4 UAE (Uterine Artery Embolization) 7-10 % % 5,6,7 MR-HIFU/MRgFUSNPV >60% 6 % 13 % 8 TSXV: PRN OTCQX: PRFMF Volumetric MR-guided high-intensity focused ultrasound ablation of uterine fibroids: treatment speed and factors influencing speed, M. J. Park, 16 Y. S. Kim, B. Keserci, H. Rhim, and H. K. Lim, Eur Radiol, vol. 23, no. 4, pp , Apr

17 UTERINE FIBROID ABLATION MOST MATURE INDICATION Volume clinical use with excellent long term patient benefit once reimbursement established In South Korea Samsung Medical Center introduced Sonalleve in 2009, part of initial trial Continues to deliver superior results Experience from large number of treatments basis for product development Multiple private women s health clinics, owned by gynecologist groups buying their first MRI for HIFU Premium reimbursement for MR guided HIFU vs. US guided for UF Therapy ProFamilia Poland Private women s health clinic Installed Sonalleve MR-HIFU in 2014 Hospital owned and decision driven by a group of gynecologists Large opening campaign created nationwide awareness resulting in long waiting list Treating 4-5 UF patients with MR-HIFU per week with excellent results Reimbursed via donations TSXV: PRN OTCQX: PRFMF 17

18 VERGÜTUNG SONALLEVE MYOMTHERAPIE ERPROBUNGSRICHTLINIE NACH 137E SGB V DRG N25Z, OPS mit 2 Tagen G-BA Beschluss: Erprobungsstudie Vergleich MR-HIFU mit Myomektomie als klinisches Standardverfahren Primäre Endpunkte: Rückkehr zu normaler Aktivität Symptome nach 12(?) Monaten Multizentrisch Randomisiert aber wie? Studienleitung wird noch ausgeschrieben Start in 2018 erwartet NUB Anträge für Zusatzentgelte Präzedenzfälle für Vergütung während der Studie Wärend der Studie werden Behandlungskosten von ges. Kassen übernommen Unabhängig davon ob Patientin in Studie eingeschlossen wird od. nicht TSXV: PRN OTCQX: PRFMF 18

19 BONE METS TREATMENT PROVIDES SUBSTANTIAL PAIN RELIEF AND ABILITY TO REGAIN QOL FOR CANCER PATIENTS Breast cancer patient Humerus Metastasis, Excellent response e.g. Pain scores (0-10 scale): Baseline = 8-9 Day 2 = 1-2 Day 30 = 0 and Day 90 = 0 Substantial improvement in quality of life e.g. patient able to play a tennis match with her daughter again This helped me believe pain can be treated and be optimistic about where we re going Breast cancer patient, The Royal Marsden Hospital, Sutton, U.K. TSXV: PRN OTCQX: PRFMF 19

20 EXPLORING FURTHER INDICATIONS ON CURRENT PLATFORM BONE AND SOFT TISSUE TUMORS, HYPERTHERMIA Osteoid osteoma Very painful, benign bone tumor in teenagers and young adults MR-HIFU very effective, immediate pain relief and bone restructuring Standard of care is radiofrequency ablation (RFA, invasive) Relatively rare condition, pediatric specialty hospitals Desmoid tumors (Fibromatosis) Benign aggressively growing tumors, everywhere in the body Can cause severe (bulk) symptoms Surgery (+/- radiotherapy) is standard of care, but high risk of recurrence Successful MR-HIFU treatments presented as individual case studies Relatively rare condition but good HIFU proposition (repeatability) Hyperthermia Increase tumor sensitivity to Radiation and Chemo Therapy Local heating to C, precise control of temperature and lesion size Adjuvant therapy to chemo or radiation therapy. Enabling technology for Local Drug Delivery once such drugs are clin. available TSXV: PRN OTCQX: PRFMF 20

21 PROFOUND MEDICAL IN SUMMARY INCISION-FREE PROCEDURES REAL-TIME MR GUIDED TREATMENTS 1 Precise Ultrasound Inside-Out - Prostate Disease - CE marked - FDA expected Personalized 3 One and done Ultrasound Outside-In - Uterine Fibroids - Bone Metastasis - CE marked - Extending indications TSXV: PRN OTCQX: PRFMF 21

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