PowerPoint Presentation€¦ · Launch Product Q1 2020 UltraSTAT 3mm Mini LS Thin Tissue $595 each...
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NOVUSON SURGICAL, INC. JUNE 2019
Transcript of PowerPoint Presentation€¦ · Launch Product Q1 2020 UltraSTAT 3mm Mini LS Thin Tissue $595 each...
NOVUSON SURGICAL, INC. JUNE 2019
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LigaSure - 1992Covidien (Medtronic)
Enseal - 1991Ethicon (J&J)
HarmonicAce - 1993Ethicon (J&J)
Market dominated by 1990’s technology
2019 – Direct Therapeutic Ultrasound
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25 year old
technology
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Smoke Bleeding
Charring Thermal Damage
33% of surgeries have complications
49% are avoidable
41% are bleeding related
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1 out of 200 Uses Result in Adverse Events
Massarweh, N. N., Cosgriff, N., & Slakey, D. P. (2006). Electrosurgery: history, principles, and current and future uses. Journal of the American College of
Surgeons, 202(3), 520-530
Healy et al and Stokes et al.
16.5M Patients (USA)
$215 Bn per year
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Premier Advanced Energy Surgical Device for
Safety & Precision
Control Console $21K eachLaunch Product Q1 2020
UltraSTAT 3mm Mini LSThin Tissue
$595 each MSRP
Q3 2020
UltraSTAT MaxxThick Tissue
$995 each MSRP
Q2 2020
UltraSTAT 5mm LSThin Tissue
$595 each MSRP
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DisposableEquipment
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UltraStat Hamonic Ace Ligasure Enseal
Energy Modality DTU Harmonic RF RF
3mm Shaft Diameter
Thermal Damage < 1mm
Hemostasis Efficacy > 90%
Burst Pressue > 240 mmHg
Seal & Divide
Seal 7mm Dia Artery
Adhesions < 1%
No Charring
No Smoke
Electrically Neutral
Articulating
Speed < 10 s
405K SURGICAL SUITES
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410M SURGICAL PROCEDURES $50BN GLOBAL SURGICAL DEVICE MARKET
Electrosurgical
Device Market $1.3BN $2.4BN
8% 8%
Initial Launch Roadmap
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15
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MinimallyInvasive12.4%
General16.5%
Robotics21.1%
Endoscopic6.4%
Bill
ions
2016 2021
$3.7BNTAM
USER EVALUATION – Q1 2020US – 10 TO 20 KOLS
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Key Opinion Leader
Sales Rep
Top 20 Populated Cities
Tom Jones
Pediatric Surgeon
Childrens - Seattle
Camran Nezhat
Gyn Laparoscopic
Stanford – Palo Alto
Ceana Nezhat
Gyn Laparoscopic
Emory – Atlanta
Farr Nezhat
Gyn Oncology
Cornell – New York
Kimberly Kho
Gyn/Uro Laparoscopic
UTSW - Dallas
Russell Jennings
Pediatric Surgeon
Childrens – Boston112
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Juan Asensio
Trauma Surgeon
Creighton – Omaha
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Cash Positive
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1% Surgical Suites
2% MIS Procedures
First Revenue
4 48 180 276 360 Consoles Sold
60 3752 32622 95130 195084 Handset Sold
Sales
Forecast
Executive Management
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Jean Maixner, DVM, MBAEVP Operations and Finance
• Entrepreneur w/Successful Exit
• Strategic Planning
• Financial Projections/Budgeting
Stuart B Mitchell, PhDCEO, CSO, Founder
• 35 yrs Business and Program Mgmt
• 25 yrs Biomedical Technology
• 15 yrs Therapeutic Ultrasound
Carla Corkern
Former CEO, Talyst
Sam Liao
CFO, Series A Investor
Shane Cerrato, MBAEVP Business Development
• 18 yrs Global Commercial Development
• Leadership Positions in Med Device
• Successful Launches of Niche Med Device
Marco Daoura, MS BioEEVP Program and Product Mgmt
• 20 years in healthcare industry
• Development and Regulatory
• Launch and Commercialization
Medical BoardBoard of DirectorsStuart B Mitchell, PhD
Chairman
JUAN A. ASENSIO, MD, FACS, FCCM,
FRCS (ENGLAND), KMAdvisor of Surgical and Trauma Surgery
Applications
DEREK KHORSAND, MD
Chief Medical OfficerResident Physician Diagnostic and Interventional
Radiology University of Washington Medical
Center
CAMRAN NEZHAT, MD, FACS, FACOGCamran Nezhat Institute, Minimally Invasive &
Robotic Surgery
RUSSELL JENNINGS, MDBoston Children’s Hospital Surgical Director
Esophageal and Airway Treatment Center
THOMAS K JONES, MDProfessor of Pediatrics & Medicine, University of
Washington, Director of Cardiac Catheterization
Laboratories, Seattle Children’s Hospital
FARR NEZHAT, MD, FACS, FACOGClinical Professor Obstetrics and Gynecology Weill
Cornell Medical College at Cornell University,
CEANA NEZHAT, MD, FACS, FACOGMedical Director, Nezhat Medical Center, Director of
Training and Education, Northside Hospital Fellow
Emory University School of Medicine
James Kaiser
Hoya Venture Capital
Director
• Founded 2014 by Stuart Mitchell
• Licensed from University of
Washington
• $3.2M NIH Grants
• 4 Patents Issued
• $2.63M Series A
2014 - 2016 2017 - 2018 2019
• 4 Patents Pending
• Conducted Pre-Meeting w/ FDA
• Validating pre-clinical
2018
• Capital Raise
• Strategic Partnerships
• Execute final development plan
• Q3 Complete development plan
• Q4
▫ User Evaluation Assessment
▫ File 510k – 3mm UltraStat
• Q4
▫ File CE Mark
• Q4
▫ Begin development of 5mm
Market Viable ProductFormation Validation
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Conservative acquisition price estimate = $250M
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Year Company Acquired By Price Investment Product
2011 PEAK Surgical Medtronic 120,000,000$ 29,000,000$ Plasmablade (RF
scalpel)
2011 Salient Surgical Medtronic 525,000,000$ 45,000,000$ RF + Saline ablation
2011 Interlace Medical Hologic 125,000,000$ 23,000,000$ MyoSure (Vibratory
scalpel)
2008 SurgRX Ethicon (J&J) 225,000,000$ 41,000,000$ Harmonic Scalpel
2015 Spinal Modulation St. Jude 175,000,000$ 109,400,000$ Neurostimulator
2014 Topera Abbott 250,000,000$ 25,000,000$ electrophysiological
arrhythmia
Enseal
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6 months to FDA
Submission
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THANK YOU!
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STUART B MITCHELL
FOUNDER AND CEO
(425) 238-6227
SHANE D. CERRATO
EVP OF BUSINESS DEVELOPMENT
(916) 803-6487
