Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Corporate Update (June 2019)
19 slides from Sequana Medical's corporate update, Jun 4, 2019
Slide 1: Unconditional IDE approval for alfapump pivotal study (POSEIDON)
Unconditional IDE approval for alfapump pivotal study (POSEIDON) Webcast & Conference Call – 4 June 2019
Slide 2: Today's presenters
Today’s presenters Ian Crosbie Gijs Klarenbeek Chief Executive Officer Chief Medical Officer 2 2
Slide 3: Disclaimer
Disclaimer Important Notice IMPORTANT: You must read the following before continuing. The following applies to this document, the oral presentation of the information in this document by Sequana Medical NV (the "Company") or any person on behalf of the Company, and any question-and-answer session th
Slide 4: Regulatory Disclaimer
Regulatory Disclaimer • The alfapump® has not yet received regulatory approval in the US and Canada. Any statement in this presentation about safety and efficacy of the alfapump does not apply to the US and Canada because the device is currently undergoing clinical investigation in these territories
Slide 5: Agenda
Agenda Welcome and introduction POSEIDON – the alfapump pivotal study to support approval in US & Canada Conclusions and next steps Q&A 5 5
Slide 6: Unconditional IDE approval for POSEIDON (alfapump pivotal study) in just 30 days
Unconditional IDE approval for POSEIDON (alfapump® pivotal study) in just 30 days • alfapump pivotal study for treatment of recurrent or refractory ascites due to liver cirrhosis • Unconditional approval by US FDA after 30 days • Optimised clinical trial design in up to 50 patients implanted with al
Slide 7: POSEIDON: alfapump pivotal study to support approval in US & Canada
POSEIDON: alfapump® pivotal study to support approval in US & Canada
Slide 8: Number of patients with recurrent & refractory liver ascites forecast to increase
“The number of patients with recurrent & refractory liver ascites is forecast to ~151K refractory ascites patients due to increase dramatically due to alcoholic liver disease and NASH within next 10-20y1 the growing prevalence of NASH” NASH: Non-alcoholic Steatohepatitis; Source 1: Management estima
Slide 9: Existing therapies have severe limitations
Existing therapies have severe limitations Large Volume Paracentesis Transjugular Intrahepatic Liver transplant (“drainage”) Portosystemic Shunt (TIPS) Dramatically reduces Increased risk of Limited availability and quality of life encephalopathy above 65 high costs (typical age of patient with asci
Slide 10: Evolution of liver cirrhosis to "mainstream disease"
Evolution of liver cirrhosis to “mainstream disease” • NASH and NASH-related cirrhosis will become more prevalent in mainstream society • We believe: • there are clear analogies to today’s coronary artery disease market • this will drive change in attitudes to liver cirrhosis, resulting in the need
Slide 11: POSEIDON – overview trial design
POSEIDON – overview trial design • Single arm, open-label, within subject crossover study reduces risk of study drop-out / reduces sample size • Up to 15 centers in US and Canada – site selection driven by clinical & reimbursement factors: • Clinical expertise of multidisciplinary team (hepatologi
Slide 12: POSEIDON – primary effectiveness outcome
POSEIDON – primary effectiveness outcome Proportion of patients with a 50% reduction in average number of paracentesis per month in the post-implant observation period vs. pre-implant observation period Previous alfapump studies in patients with refractory ascites due to liver cirrhosis support this
Slide 13: POSEIDON – alfapump pivotal study
POSEIDON – alfapump® pivotal study Single-arm, open-label, within subject crossover study Pre-implant Post-implant Post-implant Post-implant observation stabilisation observation long-term follow-up 3 months 3 months 3 months 18 months T-3M T0 T+3M T+6M T+24M Enrollment alfapump Primary outcomes Sec
Slide 14: POSEIDON – alfapump pivotal study: Primary and Secondary Outcomes
POSEIDON – alfapump® pivotal study Primary and Secondary Outcomes Primary effectiveness outcomes: • proportion of patients with a 50% reduction in average number of paracentesis per month in the post-implant observation period vs. pre-implant observation period • per-patient ratio of post-implant to
Slide 15: Proposed CMS rule on payment system for breakthrough devices
Proposed CMS rule on payment system for breakthrough devices is promising development for the alfapump® CMS: Centers for Medicare and Medicaid Services 15 15
Slide 16: Conclusions & next steps
Conclusions & next steps sequanamedical
Slide 17: Three platforms for growth
Three platforms for growth Balancing risk and reward North American North America & Europe Liver & Cancer Heart Failure POSEIDON pivotal study First in human studies: commencing in H2 2019 single dose (completed) o repeated dose with alfapump (commencing H2 2019) Europe Liver & Cancer Prospective
Slide 18: Strong newsflow since IPO
Strong newsflow since IPO EU US HF alfapump® included in FDA approves IDE with DSR clinical proof of German (DGVS) treatment optimised POSEIDON study concept delivered guidelines design 18 IPO: Initial Public Offering; DGVS: German Society of Gastroenterology Digestive and Metabolic Diseases; FDA: F
Slide 19: Q&A
Q&A