Merit Medical Systems, Inc. · NASDAQ:MMSI
Merit Medical Systems — Investor Presentation (April 2018)
25 slides from Merit Medical Systems's investor presentation, April 2018
Slide 1: Prostatic Artery Embolization
Prostatic Artery Embolization Treatment for Patients with Symptomatic Benign Prostatic Hyperplasia
Slide 2: Prostatic Artery Embolization (PAE)
Prostatic Artery • Minimally invasive, non-surgical, Embolization outpatient treatment (PAE) • Embosphere® Microspheres (FDA-granted June 2017) are introduced into the arteries supplying blood to the prostate • Decreases blood flow to and shrinks the prostate • Embolization used since the 1970s to c
Slide 3: PAE Candidates
PAE Studies conclude that PAE is a safe and Candidates effective treatment for BPH patients who: are poor suffer from surgical hematuria6-7 candidates2-3 have urinary have large retention prostate glands with IBC4-5 (≥150 grams)8-10 *See Appendix for article summaries and bibliography 3
Slide 4: Clinical Evidence for PAE
Clinical • PAE is a safe and feasible procedure for the relief of LUTS related to BPH Evidence • BPH patients with failed medical treatment, who for PAE are considered high-risk for surgical procedures and/ Candidates or anesthesia can be treated safely and effectively through PAE2–3 • Patients with
Slide 5: Contraindications
Contraindications * Active UTI or prostatitis Bladder stones Prostate or bladder cancer Urinary obstruction due to causes other than BPH Chronic renal failure Excessive vessel tortuosity or severe atherosclerosis Bladder atonia Neurogenic bladder 5 *Embosphere PRO™ Prostatic Artery Embolization Kit
Slide 6: Patient Benefits
Patient Benefits Patient-focused studies published in more than 40 articles highlight the following benefits: Significant improvement in International Prostate Symptom Score (IPSS) and overall quality of life¹¹ Improvement in urine flow rate (Qmax)¹¹ Reduction in prostate volume,4, 12 especially lar
Slide 7: Symptom Relief & Recovery
Symptom Relief • Patients can be discharged same day & Recovery • Medication: Ibuprofen, Ciprofloxacin (antibiotics), Pyridium® (urinary analgesic), VESIcare® (bladder relaxant), Dulcolax® (laxative) ONE YEAR AFTER PAE: • Restrict activity for 2–3 days average prostate size reduced by • Relief of LU
Slide 8: Potential Complications
Potential “Post-PAE Syndrome” (AKA Post-Embolization Complications * Syndrome) can last two to three days following the procedure and can include nausea, vomiting, diarrhea, fever, pelvic pain Non-target embolization Skin burn Blood in urine, semen, or stool Bladder spasm Hematoma UTI Urinary retent
Slide 9: Coordinated Patient Care
Coordinated Patient Care Labs and Imaging Baseline History of Patient is Considered to Measure • PSA, CBC, CMP, Symptom Improvement PT, and INR • International Prostate • TRUS Symptom Score (IPSS) must • Urinalysis be ≥12 to be considered • Urodynamic • Sexual Health Inventory • Uroflowmetry (Qmax)
Slide 10: Summary
SUMMARY PAE is ideal for patients who are poor surgical candidates or who are seeking a less-invasive prostate-reduction procedure The treatment provides you and your patients with an additional safe and effective course of action when other options may be exhausted Collaboration between urologists
Slide 11: Appendix
APPENDIX
Slide 12: Clinical Evidence for Poor Surgical Candidates
Clinical Evidence for Poor Surgical Candidates2 Purpose Results To evaluate the efficacy and safety of PAE in Twenty-two patients with mean age of 72.50 BPH patients who are at high risk for surgery years and mean prostate volume of 77.30 ± and/or anesthesia. 14.89 cm3 were included. The PAE procedu
Slide 13: Clinical Evidence for Poor Surgical Candidates
Clinical Evidence for Poor Surgical Candidates3 Purpose • IBC removal achieved in 80.5% of patients To assess discontinuation of IBC and relief • Mean post-PAE IPSS was 9.8 ± 3.2 (range 5–16, of LUTS due to BPH following PAE in poor sign rank p = 0.0001 compared to baseline) surgical candidates. • M
Slide 14: Clinical Evidence for IBC Patients
Clinical Evidence for IBC Patients4 Purpose Follow up ranged from 19-48 months. After To show that PAE improves QoL and LUTS 1 year, mean prostate volume reduction was in patients with acute urinary retention caused greater than 30%, symptoms were mild (mean by BPH. IPSS, 2.8 ± 2.1; P = .04), no ere
Slide 15: Clinical Evidence for IBC Patients
Clinical Evidence for IBC Patients5 Purpose patients eligible at 3 and 6 months and 17 of 20 To evaluate efficacy and safety of PAE in (85.0%) patients eligible at 1 year: urinary catheter-dependent patients with large • Mean (range) IPSS-QoL improved prostate volumes and high comorbidity scores. si
Slide 16: Clinical Evidence for RHPO Patients
Clinical Evidence for RHPO Patients6 Purpose Results To describe our experience with PAE as a Technical and clinical successes were achieved minimally invasive alternative treatment option in all three patients. Hematuria resolved within in patients with RHPO secondary to iatrogenic a period of 24 h
Slide 17: Clinical Evidence for RHPO Patients
Clinical Evidence for RHPO Patients7 Purpose To describe the current management of RHPO and the technique of PAE and to review its efficacy and associated morbidity. Conclusion PAE has evolved as a safe and effective technique in the management of RHPO. Use of a superselective approach optimizes cli
Slide 18: Clinical Evidence for GPH Patients
Clinical Evidence for GPH Patients8 Purpose Results To present a case of giant prostatic hyperplasia There were no complications after the procedure. (GPH) with acute urinary retention that was At the 10-day voiding trial, the patient was able treated with PAE. to void with a moderate stream. Tamsul
Slide 19: Clinical Evidence for Large Prostate Volume Patients
Clinical Evidence for Large Prostate Volume Patients9 Purpose Results To describe the safety and efficacy of PAE Mean prostate size decreased significantly with spherical microparticles to treat LUTS from 135.1 g before PAE to 91.9 g at 3 months associated with BPH in patients with prostate of follo
Slide 20: Clinical Evidence for Large Prostate Volume Patients
Clinical Evidence for Large Prostate Volume Patients10 Purpose Results To investigate clinical benefits and safety of The mean IPSS (10.40 vs 23.98; P <.05) and PAE in patients with prostate volume ≥80 cm3 the mean Qmax (16.89 vs 7.28; P <.05) at 1 and Charlson comorbidity index (CCI) ≥2 and year we
Slide 21: Clinical Evidence for Embosphere Microspheres
Clinical • Composite database of 286 patients from 12 clinical sites Evidence for • All suffering from LUTS due to BPH with Embosphere® an IPSS of MODERATE to SEVERE Microspheres— • 12 months—Post PAE, 97% of patients The BEST dropped at least 1 symptom category Trial11 - SEVERE to MODERATE - MODERA
Slide 22: Bibliography
Bibliography 1. Mitchell, M. E., Waltman, A. C., Athanasoulis, C. A., et al. (1976). Control of massive prostatic bleeding with angiographic A full PAE bibliography is techniques. J Urol, Jun;115(6):692–695. available upon request https://www.ncbi.nlm.nih.gov/pubmed/940204 2. Gabr, A. H., Gabr, M. F
Slide 23: Bibliography
Bibliography 6. Kably, I., Pereira, K., Chong, W., et al. (2016). Prostate artery embolization (PAE) in the management of refractory hematuria of Continued from previous page prostatic origin secondary to iatrogenic urological trauma: A safe and effective technique. Urology, Feb;88:218–221. https://
Slide 24: Bibliography
Bibliography 11. Data on File 12. Grosso, M., Balderi, A., Arnò, M., et al. (2015). Prostatic artery Continued from previous page embolization in benign prostatic hyperplasia: Preliminary results in 13 patients. Radiol Med, Apr;120(4):361–368. https://www.ncbi.nlm.nih.gov/pubmed/25245496 13. Pisco,
Slide 25: Available Patient Tools
Available Patient Tools Brochures Office Flip Chart FAQ Sheet Ask4PAE.com 25 404659001/002 25
Merit Medical Systems — Investor Presentation (April 2018) on 6ix