PowerPoint Presentation€¦ · Launch Product Q1 2020 UltraSTAT 3mm Mini LS Thin Tissue $595 each...

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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

4

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

0

5

10

15

20

25

30

35

40

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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5

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13

14

15

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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

THANK YOU!

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STUART B MITCHELL

FOUNDER AND CEO

SBMITCHELL@NOVUSON.COM

(425) 238-6227

SHANE D. CERRATO

EVP OF BUSINESS DEVELOPMENT

SCERRATO@NOVUSON.COM

(916) 803-6487