Measuring, Key Step Towards Better Heart Health...2020/02/12 · Presentation sponsored by Boston...
Transcript of Measuring, Key Step Towards Better Heart Health...2020/02/12 · Presentation sponsored by Boston...
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Measuring,Key Step Towards Better Heart Health
Louis LaflammePresident and CEO
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This corporate presentation contains forward-looking statements, which reflect the Company’s current expectations
regarding future events. The forward-looking statement involves risks and uncertainties. Actual events could differ
materially from those projected herein and depend on a number of factors, including the successful and timely
completion and the commercialization of the products herein. The reader of this document is forewarned concerning the
inherent variability and risk associated in terms of strategies or deliverables stated herein by the Company and is
cautioned prior to considering these forward-looking statements. The Company disclaims any obligation to update these
forward-looking statements.
Forward Looking Statement
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▪ Physiological measurement (FFR/dPR) to assess and guide treatment of coronary lesions
▪ Expansion into structural cardiology (TAVR)
▪ Optical technology applied in medical partnerships.
Optical Measurement in Cardiology
OpSens – Unique pressure measurement capability from physiology to structural
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OpSens – Legs for Growth and Value Creation
Physiology Measurement
$1B by 2025
Product: OptoWire
▪ Diagnosis & treatment of heart blockages
▪ Treatment of 100K patients▪ Worldwide sales channels▪ Medical publications▪ KOL support
Partnerships
Sensor can be used in several applications & markets
Examples of current partners:
Aortic Stenosis
$8B by 2025
▪ Fastest growing segment in cardiology
▪ First OpSens product for transcatheter aortic valve replacement (TAVR)
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OpSens Positioned for Growth and Value Creation
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2016 2017 2018 2019
OpSens Consolidated Revenue(in $millions)
▪ Continuous revenue growth
▪ Continuous margin improvement
Financial Performance
▪ Growing markets
▪ Solid foundation▪ Physiology products supported by KOL & medical publications
▪ 5-year supply agreement - Abiomed
▪ Versatile technology opens partnership opportunities
Business & Market Growth
▪ New product for large opportunity: TAVR
▪ Optimization of current products (performance & margin).
Innovation
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Measurement of PhysiologyFractional Flow Reserve (FFR) or Diastolic Pressure Ratio (dPR)
Diagnosis of patients▪ To evaluate the severity of a coronary artery blockage▪ Cardiologist measures blood pressure before / after blockage - obtains ratio▪ Ratio helps in selecting treatment (angioplasty, stenting, bypass, etc.)
Treatment of patients▪ Once cardiologist selects treatment, lesion can be stented immediately
Treatment validation▪ After treatment, with a simple reconnexion, cardiologist can measure effectiveness.
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0.80
Measurement of Physiology in Treatment of BlockagesCompelling Studies, FAME 1 & 2, DEFER, COURAGE: When a patient’s lesions are evaluated by physiological measurement (e.g. FFR) before treatment selection, rate of major cardiac events is significantly reduced
0.97 FFR (Non-Ischemic)
Intermediate (per Angiography)0.55 FFR (Ischemic)
<0.80 intervention needed - i.e. stent
>0.80 may be treatedwithout stent
Eyeballing Lesions ≠ Accurate Physiology Measurement to GuideDiagnosis & Treatment of Blockages
8* St-Jude Medical 2015 – Investor Conference, (2015-02-06) Based on growth projected in Global FFR Market 2016-2020
FFR Market (US$ M)*
FFR: Growing Market with UpsideOpSens - Potential for significant growth in U.S. market with GPO, and innovation
2017 - US$ 456 M**721,000 units
3%OpSens
7%Others
90%Electrical Wires
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n"The arrival of an optical FFR guidewire such as the OptoWire on the market is positive for interventional cardiologists and will be helpful to promote the use of FFR.“
—Dr. Nico Pijls, Catharina Hospital, Netherlands
Geography Approach CurrentMarket share (%)
Japan Distributor 15 – 20
U.S. Direct 1 – 2
Europe Distributor 5 – 7
Canada Direct 15
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Measurement of Physiology – Solid Business with Steady GrowthOpSens’ first venture in cardiology – Ongoing success in market to reach $1B by 2025
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2016 2017 2018 2019
FFR Medical Total Consolidated
OpSens Answered Unmet Needs with Improved Offer
WORKHORSE PERFORMANCE: Pressure guidewire design, excellent shape retention = control, torque, support for easy vessel access
ACCURACY: 2nd generation fiber optic sensor designed to provide lowest drift in the industry, consistent, repeatable measurements
CONNECTIVITY: Optical contact immune to procedural contaminants - Disconnect/reconnect with confidence to diagnose and deliver stents on the same guidewire.
One wire from start to finish saves time and
OPS revenue ($M)
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Guidewire Performance - OptoWire VS Competing Products
3 Electrical Wires
Small Stainless-Steel Core Large Central Nitinol Core
Central Fiber Optic Wire
Traditional Electrical GuidewIreCore offset from center = Whipping & limited torqueability
OptoWire – 2nd Gen Fiber Optic Central fiber optic core + stronger nitinol core
= No whipping & excellent torque
OpSens’ OptoWire - Workhorse characteristics to cross and deliver
111) OpSens Medical. Data on File2) Chambers, Jeff. Electric or Optical Fibers Based Pressure Measurements. Presentation sponsored by Boston Scientific, 19th Tremblant Internventional Cardiology Meeting. 20163) St. Jude. PressureWire Aeris, Instructions for Use, 20828 Rev 0F4) Acist. Rapid Exchange (Rxi) System and Navvus Catheter. 510(k) Filing, K132474. Jan 2014
Pressure Drift – 2nd Generation Fiber Optic OptoWire Stands Out
Next-Gen FFR Traditional FFR
OptoWire1
Boston ScientificCOMET2
St. Jude PressureWire Aeris3
AcistNavvus
Microcatheter4
Volcano Verrata
Drift from measure (mmHg/h)
<1 <3 <7 <7 Not specified
Drift in pressure wires
Electronic wires
▪ St Jude Medical < 7 mmHg / hour▪ PhilipsVolcano < 30 mmHg / hour
New fiberoptic wires
▪ OpSens < ~0 mmHg / hour
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OptoWire Scores Industry’s Lowest Drift in Medical Publications
DRIFT StudyDrift-Reduction for Improved FFR using Fiberoptic TechnologyManish A Parikh, MD - Columbia University Medical Center, May 2019
Drift (% of cases, >3 mm/hg drift)
Country OptoWire Competition
Circulation (2016) Europe 0%
30%Drift (Columbia) (2019) US 5.8%
Cardiovasc Interv (2017) JPN 4%
Circulation Journal
Official Journal of the Japanese Society
http://www.j-circ.or.jp
Cardiovasc Interv and TherDOI 10.1007/s12928-017-0481-x
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OptoWire – Worry-Free Reconnection
Immune to procedural contaminant
▪ Competitor’s electrical sensor affected by contaminants
Freedom with FFR reliability
▪ Disconnect, handle like standard PCI wire
▪ Reconnect and perform post-PCI FFR
▪ May save time and money with improved effectiveness.
"It was a pleasure to use the OptoWire in several patients, some of them with complex disease. It allowed me to appreciate its impressive zero drift performance during all cases performed while also acknowledging the constant connection reliability as well as its support during percutaneous coronary intervention.“
Dr. Bernard de Bruyne, Cardiovascular Center Aalst, Belgium
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Benefits of performing post-PCI FFR
• ↓ rate of major cardiac events with post-PCI FFR
• FFR can guide optimization
• Results suggest using post-PCI FFR for functional optimization (all lesions). Need for a pressure guidewire with workhorse features.
OptoWire (OW) to measure pre and post-PCI FFR
• Excellent handling characteristics
• Precision of measure
• Capacity to disconnect and reconnect.
Goal of Post-PCI FFR
• Identify the frequency of <0.8 FFR after stent
• Ability to ↑ FFR by additional intervention
Performance, Results and Conclusions
• Frequency <0.8 after stent: ≈ 20-30%
• Possible to ↑ FFR by 0.10 with additional intervention
With a guidewire with good mechanical characteristics it is possible to perform a routine intervention in severe lesions and to determine the presence/absence of ischemia after angiographic optimization.
Functional Optimization of Coronary Intervention Using Post-PCI FFR: A Prospective Registry*
Summary
* BF Uretsky MD, Shiv Agarwal MD, Kristin Miller RN, Malek Al-Hawwas MD, Abdul Hakeem MD - Hôpital Central Arkansas VA et UAMS, Little Rock, AR
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Transaortic Aortic-Valve Replacement (TAVR) – Compelling 2019 Studies TAVR (Transcatheter Aortic-Valve Replacement) vs SAVR (Surgical Aortic Valve Replacement)
PARTNER 31 - TAVR vs SAVRAfter 1 year
▪ Randomized 1,000 patients with severe aortic stenosis & low risk of death with surgery
▪ Patients received TAVR or SAVR
▪ Summary of results:▪ TAVR: ↓ Hospital stay - from 7 to 3 days
▪ TAVR: ↓ ≈ 50% death - from any cause and stroke or re-hospitalization
TAVR using the SAPIEN valve shown to be Superior to SAVR
EVOLUT1 - TAVR vs SAVRAfter 2 years
▪ Randomized 1,468 patients with severe aortic stenosis & low, intermediate, high risk of death with surgery
▪ Patients received TAVR or SAVR
▪ Summary of results:▪ TAVR better than or as good as surgery - disabling
strokes and deaths (all causes)
▪ Reasonable to consider moving all risk patients to TAVR
TAVR using the CoreValve shown to be Non-Inferior to SAVR
1. March 16, 2019, at NEJM.org.
TAVR: Clear winner and now poised for expansion in larger population
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TAVR – Unmet NeedsPositive wind for OpSens’ product for untapped market - OpSens could be 1st to offer product to solve unmet needs
▪ With TAVR becoming primary treatment for AS, comes desire to control/reduce costs▪ Streamline workflow - Fewer steps, device exchanges
▪ Reliable measurements pre- and post-implantation
Cardiologists, System
▪ Physiological assessment: best indication of efficacy of valve implementation
▪ Reliable hemodynamic measurements pre- and post-implantation has potential to improve patient safety and their outcomes.
Patients
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2017 2019 2021 2023 2025
Aortic Stenosis Market
(US$ Billion)1
1. Global TAVR/Implantation, Kenneth Research
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TAVR to Treat Aortic StenosisExplosive market expected to reach $8B by 2025
▪ New studies and indications support TAVR for nearly all patients
▪ Aging population
▪ Player with effective, efficient ancillary products could take market lead
Landscape
▪ Ease workflow, reduce complications, save time, money
▪ OpSens’ concept validated by top KOL and consultants.
Unmet Need
Player
TAVR1
Market share
(%)
Guidewire delivering
aortic valve
Continuous Pressure
Measurement
BSC 5% √ ꭗ
Edwards 70% ꭗ ꭗ
Medtronic 25% √ ꭗ
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Ancillary Product Could Give TAVR Player Field Advantage
1. Quantified Benefits of OpSens TAVR Wire Final Presentation, RNA Advisors, August 16, 2019
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TAVR – OpSens Has What it Takes to Win Strong similarities with existing physiology business allow OpSens to bring game-changing devices to TAVR
OpSens’ ProvenGuidewire Offer
FFR Business Requirements
TAVR Business Requirements
Sensing Technology2nd generationPowered by FidelaTM
Lowest-drift in the Industry
Accuracy in studies and clinical use √ √
Guidewire CapabilitiesOne wire toDiagnose & Deliver
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Sales ChannelsGrowing revenuesWorldwide networks
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Display DeviceThousands of OptoMonitor in labs
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Connectivity Flawless connection √ √
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2002First-in-man
TAVI
2011 FDA approves
Edwards Sapien
2014 FDA approves
Medtronic Corevalve
2019FDA approves
BSC Lotus Edge
NowFDA IDE
Clinical studies Abbott Portico
TAVR – Repositionable Valves Represent the Future for Treatment of Aortic Stenosis Pressure wire for structural cardiology will be the key to confirm valve positioning
Not re-positionable 75% repositionable 100% repositionable 100% repositionable
Example: Abbott Portico
▪ Valve fully functional when temporarily deployed
▪ Impossible to position another pressure catheterin the ventricle during deployment
▪ Positioning of the valve can be optimized with unique hemodynamics feedback ofpressure wire for structural cardiology.
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Milestones
▪ 2019 - Animal study – Completed (Success)
▪ 2020 - Completion of Design Phase
▪ 2020 - Commercial Development
▪ 2021 - Regulatory Filing and Commercialization
TAVR – Improving Procedure From Every Point of View - Aggressive VisionPhysiological assessment is best indication of efficiency of a valve implementation
Patient
▪ Faster recovery
▪ ↑ Outcomes
▪ ↓ Complications
▪ ↓ Re-hospitalizations
Cardiologist
▪ Streamline workflow
▪ Time saving
▪ ↑ Operator confidence
▪ ↑ Decision making info
Health Care System
▪ ↓$ Post-operative care
▪ ↓ Hospital stay
▪ ↓ Re-hospitalizations
Valve Provider
Proper ancilliary product
▪ Valve positioning could be optimized
▪ Could give valve provider an edge
OpSens’ Vision – development of a product portfolio for structural cardiology applications Repositionable valve = The future of TAVR
▪ All players are working on it▪ OpSens will be the optimal solution
Offer doctors the possibility to reposition the valve before final implantation.
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Industrial
Physiology
Subsidiary100%
Beyond the Medical Industry
OpSens: Medical Devices
OpSens Solutions
Markets: Laboratories, aerospace, semiconductors
Sensing: Pressure, Temperature, Displacement, Strain.
Markets: Cardiology (interventional and structural) & others
Sensing: Pressure & Temperature
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OpSens Operations (TSX:OPS – OTCQX:OPSSF)
Financial Operations
▪ FY 2019 Revenues - $33 M (36% growth)▪ Cash - $10 M▪ Shares - 90 M (96 diluted)▪ 52-week H/L - $1.05 / $0.39
▪ 160 employees▪ Lean Manufacturing Approach
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OpSens Operations (TSX:OPS – OTCQX:OPSSF)
Sales & Marketing
• Worldwide sales channels
• U.S. market penetration to increase as adoption rates grow
• Technology used in other exciting applications
• TAVR, licensing agreements - i.e. Abiomed (NASDAQ:ABMD)
OpSens - Clean roomOpSens headquarters, QC Canada
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VisionBecome a leaderin value creationand innovation
within a few years
OpSens has the Capability to Win Big
Growing Markets
▪ Aortic Stenosis: 8B$ by 2025▪ Physiology: 1B$ by 2025
Products: Advanced Pressure Guidewires
▪ Workhorse-type guidewire, no drift
Sales
▪ Improvement of sales channel▪ GPO
Strong IP Portfolio
▪ Physiology, up and coming market - Aortic stenosis▪ Applications partnerships: Abiomed, Monteris, US Navy
R&D
▪ Physiology - Improved versions of products▪ Structural Cardiology – Developing a full business
Solid foundation
▪ Products supported by KOL & medical publications▪ 5-year supply agreement - Abiomed