Nuwellis, Inc. · NASDAQ:NUWE
Nuwellis — Sunshine Heart — Corporate Update (March 2016)
14 slides from Nuwellis's corporate update, Mar 8, 2016
Slide 1: Forward Looking Statement
TThhisis imimagagee ccaannnnoott ccuurrrrenenttllyy bbee didissppllaayy eed.d. Forward Looking Statement • This presentation contains forward-looking statements. All forward-looking statements are management’s present expectations of future events and are subject to a number of risks and uncertainti
Slide 2: Our Vision
TThhisis imimagagee ccaannnnoott ccuurrrrenenttllyy bbee didissppllaayy eed.d. Our Vision Offering minimally invasive therapies for moderate to severe heart failure that provide: symptomatic relief improved quality of life slowed disease progression, and reduced re-hospitalization rates © 2016 Sunsh
Slide 3: Business Update
TThhisis imimagagee ccaannnnoott ccuurrrrenenttllyy bbee didissppllaayy eed.d. Business Update • John Erb named full-time CEO on March 1, 2016 • On March 3, 2016 announced strategic changes focused on pursuing a more optimal clinical strategy that expedites approval of C-Pulse therapy • Announced st
Slide 4: COUNTER HF US IDE Trial
TThhisis imimagagee ccaannnnoott ccuurrrrenenttllyy bbee didissppllaayy eed.d. COUNTER HF US IDE Trial • The Challenges: – Slow enrollment would extend the trial >7 years • Trial requires 388 randomized patients; since September of 2012 only 38 patients have been randomized Implanting current C-Puls
Slide 5: OPTIONS HF Post-market EU Study
TThhisis imimagagee ccaannnnoott ccuurrrrenenttllyy bbee didissppllaayy eed.d. OPTIONS HF Post-market EU Study • Data from 15 patient implants: – – – – – – Short hospital stays and minimal perioperative One patient weaned - asymptomatic complications Clinically significant improvements in ejection f
Slide 6: OPTIONS HF Efficacy: Structural Remodeling
TThhisis imimagagee ccaannnnoott ccuurrrrenenttllyy bbee didissppllaayy eed.d. OPTIONS HF™ Efficacy: Structural Remodeling 55 50 45 40 35 30 25 20 15 10 5 Baseline 18M 12M 6M Complete dataset to be presented HFA 2016 Florence, Italy © 2016 Sunshine Heart, Inc. 7 E jection F rac tion (% )
Slide 7: Revised Clinical Strategy
TThhisis imimagagee ccaannnnoott ccuurrrrenenttllyy bbee didissppllaayy eed.d. Revised Clinical Strategy • The Company’s Feasibility Study (20 patients) and OPTIONS HF post-marketing study (15 patients) provided very positive results for counterpulsation, but still represents limited clinical eviden
Slide 8: New 2016 US Clinical Trial Objectives
TThhisis imimagagee ccaannnnoott ccuurrrrenenttllyy bbee didissppllaayy eed.d. New 2016 US Clinical Trial Objectives • • • • Implant will be a minimally invasive procedure External drive line will be removed after 12-months Quantify staying power of > 6-12 month patient benefits Results to be demons
Slide 9: C-Pulse: Unique Therapy for HF
TThhisis imimagagee ccaannnnoott ccuurrrrenenttllyy bbee didissppllaayy eed.d. C-Pulse: Unique Therapy for HF • Placement on ascending aorta optimal location for hemodynamic and neural effects; strong IP protection • Compatible with any device and pharmacologic therapy • Mechanical compression and r
Slide 10: What makes C-Pulse Unique?
TThhisis imimagagee ccaannnnoott ccuurrrrenenttllyy bbee didissppllaayy eed.d. What makes C-Pulse Unique? • • Mechanical unloading No blood contact – lower likelihood of clot or stroke Ability to disconnect – enhanced patient comfort and convenience Potential to wean – 6 patients weaned Baroreceptor
Slide 11: C-Pulse U.S. Market Opportunity
TThhisis imimagagee ccaannnnoott ccuurrrrenenttllyy bbee didissppllaayy eed.d. C-Pulse U.S. Market Opportunity* • C-Pulse population Class III Heart Failure Market - - - - Class III/ambulatory INTERMACS 4-7 ACC Stage C Failed CRT and OMT Class IV 1.5 M patients Europe U.S. 3.7 M patients • • Average
Slide 12: Key Financial Metrics Summary
TThhisis imimagagee ccaannnnoott ccuurrrrenenttllyy bbee didissppllaayy eed.d. Key Financial Metrics Summary Balance Sheet (*) Excludes impact of equity compensation costs, which are non cash items. Equity compensation costs were $2.2M in the year 2015, and $2.7M in the year 2014. © 2016 Sunshine He
Slide 13: Conclusion
TThhisis imimagagee ccaannnnoott ccuurrrrenenttllyy bbee didissppllaayy eed.d. Conclusion • Clinical Benefits – C-Pulse provides benefit based on traditional concepts of counterpulsation; increase coronary perfusion and afterload reduction Advanced hemodynamic analysis from patients indicates afterl
Slide 14: Conclusion
ic ictciicisl @ Conclusion ance HEART * Clinical Benefits — C-Pulse provides benefit based on traditional concepts of counterpulsation; increase coronary perfusion and afterload reduction — Advanced hemodynamic analysis from patients indicates afterload reduction due to peripheral effects, similar t