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NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally...

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NEW HOPE IN BLADDER CANCER TREATMENT Company Presentation | Winter 2019 Eyal Kochavi | CEO & Founder [email protected] +972.52.523.5454
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Page 1: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

NEW HOPE INBLADDER CANCERTREATMENT

Company Presentation | Winter 2019Eyal Kochavi | CEO & Founder

[email protected]

+972.52.523.5454

Page 2: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

LEGAL DISCLAIMER

IMPORTANT NOTICEThis presentation has been prepared by Vessi Medical Ltd. (the “Company”) solely for informational purposes. The information contained herein has been prepared to assist prospective investors in making their own evaluation of the Company and does not purport to be complete or to contain all of the information a prospective or existing investor may desire. In all cases, interested parties should conduct their own investigation and analysis of the Company and the data set forth in this information. The Company has prepared this presentation based on information available to it, including information derived from public sources that have not been independently verified. The Company makes no representation or warranty as to the accuracy or completeness of this information and shall not have any liability for any representations (expressed or implied) regarding information contained in, or for any errors omissions in, this presentation. This presentation includes certain statements and estimates provided by the Company with respect to the projected future performance of the Company. Such statements, estimates and projections reflect various assumptions by management concerning possible anticipated results, which assumptions may or may not be correct. No representations are made as to the accuracy of such statements, estimates or projections. This presentation may contain statements that are not historical facts, referred to as “forward looking statements.” The Company’s actual future results may differ materially from those suggested by such statements. No assurance can be given that future events will occur or that projections will be achieved. Past performance is not a reliable indication of future performance. This presentation is not, and nothing in it should be construed as, an offer, invitation or recommendation in respect of the Company’s securities, or an offer to sell, or a solicitation of an offer to buy, the Company’s securities in any jurisdiction. Neither this presentation nor anything in it shall form the basis of any contract or commitment. Prospective investors should not construe the contents of this presentation as business, legal, tax, investment or other advice. Each prospective investor should make his, her or its own inquiries and consult his, her or its own advisors as to the appropriateness and desirability of an investment in the Company and as to business, legal, tax and related matters concerning an investment in the Company.

An investment in the Company shall be allowed only to such number and category of investors in accordance with applicable laws and regulations and pursuant to a predetermined process. Accordingly, detailed information in connection with the investment shall be revealed and delivered only to a limited number of qualifying investors as provided by law.

Page 3: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

VESSI MEDICAL - A NEW APPROACH

Vessi uses surface cryotherapy to treat superficial bladder cancer,a $1.2 billion market. Click icon to watch

animation

Page 4: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

COMPANY HIGHLIGHTS

Changing the standardof care for superficial bladder cancer

Patent-pending, bladder-specific cryotherapy technology

First-line, in-office, minimally invasive treatment alternative to surgery

Successful proof of concept in animals; Design ready for first human trials

Backed by the Trendlines Group, a leading Israeli early stage healthcare investor, and the Israeli innovation authority

Highly-experienced leadership team with proven track record

Page 5: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

NON-MUSCLE-INVASIVEBLADDER CANCER (NMIBC)GREATLY AFFECTSQUALITY OF LIFE

Mental health impact1

Sexual dysfunction1

Pain & blood in urine2

Frequent need to urinate2

Urinary leakage3

1. Schmidt S et al,. 2015 Quality of life in patients with non-muscle-invasive bladder cancer: one-year results of a multicentreprospective cohort study. Urol Oncol. Jan;33(1):19.e7-19.e15. doi.

2. Impact of superficial bladder cancer and transurethral resection on general health-related quality of life: AN SF-36 survey Yoshimura, j.urology.2004.09.050

3. Non-muscle invasive bladder cancer is associated with decreased physical health-related quality of life: Wayne Brisbane

Page 6: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

$1.2 BILLION NMIBC MARKET POTENTIAL

NMIBC: Surface cancer on the inside lining of the bladder

Bladder cancer is the fourth most common cancer in men1

75% of all bladder cancersare NMIBC1

2 million suffer globallyfrom NMIBC2

300,000 new cases every year!1

4TH

75%

2M

300K

1. Kamat AM, Bağcıoğlu M, Huri E (2017). What is new in non-muscle-invasive bladder cancer in 2016 Turk J Urol. Mar; 43(1): 9–13.

2. Ploeg M, et al, The present and future burden of urinary bladder cancer in the word. World J Urol (2009) 27: 289-293

Page 7: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

THE STANDARD OF CARE HAS NUMEROUS LIMITATIONS

TURBT*: UP TO 80% NMIBC RECURRENCE1

Recurrences due to

- Missed tumors1,3

- Dispersion of cancer cells1,2,3

- Incomplete resection1,3

Result in

Multiple-repeat procedures4

TURBT*: bleeding, perforation1,2

Bladder muscle damage5

Hospitalization

Reduced QoL

1. Babjuk M. Transurethral Resection of Non–muscle-invasive Bladder Cancer. European Urology Suppl 2009, 8: 542-548. 2. Traxer O, Pasqui F, Gattegno B, Pearle MS. Technique and complications of transurethral surgery for bladder tumours. BJU Int. 2004 Sep;94: 492-6.3. Van der Heijden A. Progression, and Follow-up in Non-Muscle-Invasive-Bladder-Cancer. European Urology Suppl 2009, 8: 556-562. 4. AUA Guideline for the Management of Nonmuscle Invasive Bladder Cancer 2007 Update (Feb 12, 2014)5. Ozer K et al. Bladder injury secondary to obturator reflex is more common with plasmakinetic TUR than monopolar TRUBT. Cent Euro J Urol 2015; 68: 284-288

*TransUrethral Resection of Bladder Tumor

Page 8: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

FREEZES THE TUMOR.ELIMINATES THE CANCER.

• Successfully ablates unwanted tissue• Eliminates risk of dispersed cancer cells • No damage to bladder muscle • Reduces complications• Improves quality of life

Page 9: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

EASY-TO-USE, NOVEL CRYOTHERAPY SYSTEM TO TREAT NMIBC

Vessi Medical office-based console control (connected to canister)

Vessi’s cryo catheter device inserted into bladder via cystoscope (endoscope)

Using standard optics, physician identifies treatment area

Physician releases cryo spray; cryo process (ablation) begins

1

2

3

Surface Cryotherapy Systemfor Non-Muscle-Invasive Bladder Cancer

Standard 4mm rigid optics

Vessi’s disposable catheter

Page 10: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

Balances the ideal cooling temperature & pressurefor targeted cell destruction while protecting the bladder

Patent-pendingnational phase and PCT

Designed for the specific environment of the bladder

Intuitive “same style” TURBT procedurefor quick & easy user adoption

UNIQUE CRYO SPRAY TECHNOLOGY FOR HOLLOW ORGANS

Page 11: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

VESSI'S EASY IN-OFFICE TREATMENT: WIN-WIN FOR ALL

PATIENT PHYSICIAN HEALTH CARE SYSTEM

LESS INVASIVETREATMENT

SAFER& SIMPLER

ENHANCEDQUALITY OF LIFE

IMPROVEDTREATMENT OPTION

PATIENTRETENTION

INCREASEDREVENUE STREAM

REDUCED COSTS

IN-OFFICEPROCEDURE

Page 12: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

PROOF OF CONCEPT

SUCCESSFUL PROOF OF CONCEPT IN ANIMALS WITH ALPHA PRODUCT DEMONSTRATEDSAFETY & EFFICACY

• Effective ablation of treated tissue

• Excellent visualization of treated tissue

(during and between ablation cycles)

• Bladder muscle remained unharmed

Unharmedmuscle

Unharmed Muscle

Treated Tissue

Ablated transitional epithelium & lamina propria

Cryo activation inside the bladder (as observed via cystoscope)

Page 13: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

PHYSICIAN QUOTES“Surface cryotherapy is a potential paradigm

shift in the treatment of superficial bladder

cancer”

“Tissue response to the cryo spray can be seen

in real-time, allowing us to assess destruction of

the tissue”

“Visualization is excellent at all procedure stages

and is not affected by the cryo spray”

“Histology results demonstrated efficacy of

tissue destruction and safety since there was no

bladder perforation or bleeding. This gives us

confidence to proceed to first-in-human trials”

Prof. Gilad E. Amiel

Page 14: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

Cryo activation inside the bladder (as observed via cystoscope):Before, During, After

Ready for Human Trials

DESIGN READY FOR FIRST HUMAN TRIALS

Page 15: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

REGULATORY AND REIMBUSEMENT

• 510(k) class II expected (pre-submission process is suggested)

• CE class IIA device expected (according to European MDD)

Page 16: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

Localized/High efficacy

Systemic/Low efficacy

High side effects/damage

Low side effects/damage

A NEW HOPE IN NMIBC TREATMENT

TURBT

Laser

Immune / ChemoInstillations

Fulguration

Page 17: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

APPROACH TO MARKET

• End-user price $1,200/disposable catheter

• Expected COGS $55 (mass-production)

• Additional revenue from console unit

• Start with low-grade papillary tumors; $850 million approximated world-wide market

• Continue with high-grade and carcinoma in-situ NMIBC

Low-grade papillary tumors: ~70% of NMIBC1

1. AUA Guideline for the Management of Nonmuscle Invasive Bladder Cancer 2007 Update (Feb 12, 2014)

Page 18: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

UROLOGY AND CRYO TRANSACTIONS

$300 + $100 million {cash + milestones}

$725 + $325 million {cash + milestones}

$84.5 + $25.5 million {cash + milestones}

Planned Q1 2019{reg. approval needed}

Page 19: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

ROADMAP TO MARKET

2019Q1 Q2 Q3 Q4

2020Q1 Q2 Q3 Q4

2021Q1 Q2 Q3 Q4

2022Q1 Q2 Q3 Q4

Design freeze(FIH)

* Start first-in-human clinicals

(FIH)

*Start clinical trials for regulatory

submission

*Value creating event* Regulatory submission

*Start Commercialization

2019Q1 Q2 Q3 Q4

Vessi is raising funds in order to demonstrate the technology in humans

Page 20: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

Eyal Kochavi, Founder & CEO

Seasoned medical device manager with vast cryotherapy experience; prior positions with Motus GI, Galil Medical, Given Imaging; MSc, MBA, Technion Israel institute of Technology

Prof. Gilad E. Amiel,Scientific Advisor

Chairman, Department of Urology, Rambam, Israel; adjunct Associate Professor of Urology, Baylor College, Houston, Texas; former President of the American Association for Cancer Education (AACE)

Moti Simchon, Cryogenics Advisor

45 years' experiencein pneumatics, fine mechanics, and cryogenics; prior position at Raphael Defense Systems

Doron Birger,Business Advisor

Former President and CEO, Elron (NASDAQ-ELRN); former Chairman Given Imaging (NASDAQ-GIVN); chairman and board member of numerous medical device companies

HIGHLY EXPERIENCED LEADERSHIP; PROVEN TRACK RECORD

Prof. Yair Lotan,Scientific Advisor

Professor of Urology, Chief of Urologic Oncology, and holder of Professorship in Urology at UT Southwestern Medical Center; Medical Director of the Urology Clinic at Parkland Health and Hospital System

Page 21: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

WHY INVEST IN VESSI MEDICAL?

Unique, patent-pending, bladder-specific

cryotherapy technology

In-office, easy-to-use, minimally invasive

treatment for NMIBC

Billion dollar NMIBC market

Successful proof of concept in animals,

Design ready forFirst human trials

Highly-experienced leadership team with proven track record

Page 22: NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally invasive treatment for NMIBC Billion dollar NMIBC market Successful proof of concept

NEW HOPE INBLADDER CANCERTREATMENT

Eyal Kochavi | CEO & [email protected]+972.52.523.5454


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