NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally...
Transcript of NEW HOPE IN BLADDER CANCER TREATMENT · cryotherapy technology In-office, easy-to-use, minimally...
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NEW HOPE INBLADDER CANCERTREATMENT
Company Presentation | Winter 2019Eyal Kochavi | CEO & Founder
+972.52.523.5454
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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.
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VESSI MEDICAL - A NEW APPROACH
Vessi uses surface cryotherapy to treat superficial bladder cancer,a $1.2 billion market. Click icon to watch
animation
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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
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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
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$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
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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
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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
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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
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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
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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
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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)
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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
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Cryo activation inside the bladder (as observed via cystoscope):Before, During, After
Ready for Human Trials
DESIGN READY FOR FIRST HUMAN TRIALS
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REGULATORY AND REIMBUSEMENT
• 510(k) class II expected (pre-submission process is suggested)
• CE class IIA device expected (according to European MDD)
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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
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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)
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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}
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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
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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
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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