Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Kempen Life Sciences Conference 2019
17 slides from Sequana Medical's conference presentation, Apr 16, 2019
Slide 1: Innovators in the management of liver disease, heart failure, malignant ascites
Innovators in the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders. Kempen Life Sciences Conference Amsterdam – 16 April 2019 Ian Crosbie, CEO
Slide 2: 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 3: Commercial stage medtech positioned for long-term growth
Commercial stage medtech positioned for long-term growth Focus alfapump® on liver disease and heart failure – large proven step change in the management of liver and growing markets disease and cancer; over 700 devices implanted FDA Breakthrough Device Designation alfapump® DSR Strong breakthrough a
Slide 4: Liver cirrhosis and refractory ascites
Liver cirrhosis and refractory ascites A key complication of liver cirrhosis, with a dramatic impact on quality of life Viral infections (Hepatitis B & C) High mortality rate Extreme discomfort Alcoholic Liver Disease (ALD) Healthy Refractory Non-Alcoholic liver NAFLD NASH Cirrhosis Ascites Ascites
Slide 5: Cancer and malignant ascites
Cancer and malignant ascites A severe complication of late-stage cancers – focus on breast and ovarian cancers Clear unmet need for improving Quality of Life and the ability to increase cancer treatment intensity 5 5
Slide 6: Heart failure and volume overload
Heart failure and volume overload A key clinical consequence of heart failure (HF) HF – US hospitalisations hospitalisations annually due to HF2 c.1m 90% due to volume overload2 90% Clear unmet need to reduce 24% Re-admission hospitalisations, rate at 30 days3 improve Quality of Life and reduce mort
Slide 7: Three platforms for growth
Three platforms for growth Balancing risk and reward North American North America & Europe Liver & Cancer Heart Failure • ~151K refractory ascites patients within • ~1m hospitalisations/y due to volume next 10-20y1 overload in US by 20263 • ~16K Malignant ascites patients/y2 • ~1.2m hospitalisations
Slide 8: alfapump
alfapump® Fully implanted, automatic, wireless charged system for the long-term treatment of refractory liver ascites and malignant ascites 4 alfapump® Smart Charger Programmer 2 1 3 8 8
Slide 9: Validated clinical performance
Validated clinical performance Over 700 implants, included in EASL clinical practice guidelines for decompensated liver cirrhosis and granted Breakthrough Device designation by the FDA Drastically Improved Improved reduced need patient quality nutrition for drainage of life arm was comparable to the
Slide 10: Building further clinical evidence
Building further clinical evidence For North American approval and broader international acceptance 2018 2019 2020 2021 POSEIDON (N. America Pivotal) FDA Breakthrough Device Designation ARIA PUMP (French health economics) Liver ascites1 TOPMOST (European Registry) Albumin study Stepcounter Malignant
Slide 11: Focused European commercial activities
Focused European commercial activities Targeted and specialist commercial team Direct markets Distributor markets 12 person team Focus on specialist centers 7 Raise awareness at 26 community hospital level 28 4 Current reimbursement: Switzerland: DRG Germany: DRG (NUB program2) UK: NICE guidan
Slide 12: Direct sodium removal (DSR)
Direct sodium removal (DSR) Breakthrough therapy in heart failure, tackling Sodium Removal Directly Volume overload Removing the Elimination of in heart failure sodium (DSR) excess fluid 12 12
Slide 13: alfapump DSR
alfapump DSR Fully implanted and convenient system leveraging on the alfapump experience Administer infusate to the peritoneal cavity Infusate extracts sodium from the body Remove extracted sodium from peritoneal cavity Implanted Port Body restores balance by eliminating excess fluid 13 13
Slide 14: DSR – clinically relevant removal of sodium
DSR – clinically relevant removal of sodium DSR proof of concept study in healthy pigs and pigs with simulated heart failure (HF) Absolute sodium removal after 2 hour dwell 18 N=5 p<0.0001 16 Recommended 14 weekly sodium intake1 Sodium (g) 12 10 8 N = 10 6 4 Recommended 2 daily sodium intake 0 mean
Slide 15: alfapump DSR development overview
alfapump® DSR Development overview Study description1 2018 2019 2020 2021 2022 2023 Pre-clinical DSR Study in healthy pigs, single dose Pre-clinical DSR Study in heart failure pigs, single dose First in Human Clinical Study: single dose, no alfapump® First in Human Clinical Study in heart failur
Slide 16: Three platforms for growth
Three platforms for growth Balancing risk and reward North American North America & Europe Liver & Cancer Heart Failure First in human studies: single dose POSEIDON commencing in (underway) and repeated dose with H2 2019 alfapump (commencing H2 2019) Europe Liver & Cancer Prospective study in malign
Slide 17: Upcoming news flow
Upcoming news flow Key catalysts and development milestones Completion of DSR study in pig heart failure model & presentation of results Presentation of clinical data on 17 malignant ascites patients in retrospective clinical study H2 2018 Outcome of NICE review of alfapump® Initiation of First in H
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