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Climax Controlfor Premature Ejaculation
October 2019
visit us at:
www.virilitymedical.com | Animation Video
Premature Ejaculation (PE)
October 2019 2
25% of
adult men
Climax too soon…
Premature Ejaculation (PE)
October 2019 3
Loss of confidence
Avoidance of intimacy
Failed relationship
Our Mission
October 2019 4
Regain confidence
Maintain relationships
Reclaim sense of potency
VIRILITY HELPS MEN
At a Glance
October 2019 5
Technology Development
Patent I Application
Completed Safety Clinical Study
Patent II Application
2015 2016 2017 20182014
Article I Publication
Prototype Finalized
Completed Feasibility Clinical Study
Article II Publication
Climax Control US and EU Markets
(1) Technavio. Global Premature Ejaculation Treatment Market 2016-2020.
(2) Frost & Sullivan. Opportunity Assessment for the Preliminary Premature Ejaculation Market. April 2017.
310 Million
16 Million
80 Million
TOTAL AVAILABLE (Rx & OTC) MARKETAdult men
SERVED AVAILABLE (Rx & OTC) MARKETMen affected by PE(1)
SERVICEABLE & OBTAINABLE (Rx) MARKETActively approaching clinics(2)
October 2019 6
Our Solution - The vPatch
Wearable, discreet
and non-painful
Immediate effect Single-use &
disposable
Drug free
October 2019 7
How to Use
October 2019 8
Apply
Ready
Done
Remove liner and apply the patch. Device can be worn even hours before activation.
Press On button. Intensity will automatically ramp up. No additional attention is required.
Remove and discard of the patch.
How to Use
October 2019 9
Apply
Ready
Done
Remove liner and apply the patch. Device can be worn even hours before activation.
Press On button. Intensity will automatically ramp up. No additional attention is required.
Remove and discard of the patch.
Competitive Advantages
Parameter Virility Desensitizers SSRIs
Effect onset Immediate 15 mins. 2 – 4 hrs.
Range of effect localized localized systemic
Duration of effect specific to intercourse exceeds intercourse
Adverse events minorNumbness of penis,
transference to partner
nauseaerectile dysfunction
reduced libidoheadachesdrowsiness
October 2019 10
Comparative Analysis
Spontaneous On-demand Use
Planned Use
Drug Free
Contains Drug
*
*
* Rx products, direct competition
October 2019 11
01:32
05:25
00:00
01:12
02:24
03:36
04:48
06:00
Tim
e [
mm
:ss]
Efficacy Study (N=20)
85% Positive Responders
Baseline Treatment
Clinical Feasibility Studies
October 2019 12
94.80%
5.20%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
No Adverse Events Minor Adverse Events
% o
f p
ati
en
ts
Safety Study (N=19)
P < 0.001
X3.5
Regulatory Status
October 2019 13
US – Class II
• FDA approval planned for Q3 2020
• Positive feedback from FDA following pre-sub meeting
• De-Novo pathway
EU – Class IIa
• CE approval planned for Q3 2020
• Notified Body – BSI
• ISO13485:2016 compliance
FDA
IP Status
October 2019 14
Application # Priority Date Status Strategy Countries
WO2017089887A2
25 Nov 2015 National Phase
Using electrical stimulation for PE
& Erectile Dysfunction
USA, Canada, Brazil, EU, Israel,
Japan, China, India, Korea, Hong-Kong,
Australia
PCT/IL2018/051402
27 Dec 2017 PCTHW & SW features, activation methods,
Incontinence
Pivotal Study
Status
Currently conducting on-going study at Rambam
Medical Center, Israel
Completed initial safety stage and IRB approval
Initiated two additional sites in
Italy
Synopsis (following FDA pre-sub meeting)
Fully functional disposable prototype
Randomized, double blind, sham controlled
Up to 60 patients Home settings with partner
October 2019 15
Roadmap
16
2019 2020 2021
ClinicalInitiated pivotal study
Q4 2019
Product DevDevice optimization
completionQ1 2019
ClinicalPivotal study completion
Q1 2020
MarketingInitial sales expectedQ1 2021
ClinicalPost registration study completion
Q1 2021
RegulatoryFDA and CE mark
approvalsQ3 2020
ClinicalInitiate post
registration studiesQ4 2020
FundingOrdinary Shares
Q4 2019
October 2019
Distribution ChannelsMen’s Health & Wellness
17 October 2019
TelehealthDirect–to-Consumer
hims
Ro
Blink Health
Rory
Lemonaid
Virility Medical
Consumer
Online platform/
Telehealth
Distributor
Pharmacy/
Retailer
Conventional
Anonymous purchasedelivered at home
F52.4 Reimbursement Codefor Diagnosis
Pipeline
October 2019 18
Enhanced UX & Information
Personalized intensity
Cyber secured
Historical usage
User comparison
Reusable Product
With consumable component
Operational time7min, 10min, 15min
GEN II
Bluetooth Low Energy (BLE) App-controlled smart device
Additional Products
The Team
Tal Gollan
Founder & CTO
In the past 13 years Tal has served in a number of senior R&D positions in medical device startups, mainly in the field of percutaneous heart valve replacement.
Tal holds a B.Sc. in Biomedical Engineering of Ben-Gurion University.
Dr. Arik Shechter, MD
Chief Medical Officer
Dr. Shechter is the head of the Sexual Dysfunction Clinic at Rambam Medical Center, Israel,
Dr. Shechter is a member of the Executive Committee of European Society for Sexual Medicine. Dr. Shechter holds a M.D. of Ben Gurion University.
October 2019 19
Ron Mayron
Chairman of the Board
Ron has vast experience in the pharmaceutical & medical device industry, currently serving as a Director in several privately and publicly held companies. On his last position, Ron served as CEO of Teva Israel and V.P. Israel & Africa, Teva Pharmaceutical Industries Ltd. Ron’s core expertise are marketing, sales & distribution, M&A, Business, and Strategic Development.
Ron holds a B.Sc. in Industrial Engineering & Management of Ben Gurion University and MBA of Tel-Aviv University.
David (Dudi) Salton
CEO
David has 25 years of experience in Management of medical start-Up companies and Investment companies. Previously he was the CEO of Dentack Implants and led the company from R&D to commercialization. He also served as CEO of Dyn-Bioshaf (diagnostic) and Darly Pharmaceuticals. David managed Dyn Holdings, an incubator for medical ventures and was the CEO of DCL, an investment company listed in TASE with 13 start up companies under management.,
David holds B.Sc. in Economic & Management, Industrial Engineering Faculty, Technion , Haifa, Israel
Scientific Advisory Board
October 2019 20
Dr. Ege Can Serefoglu, M.D.
• Editor–in–Chief: International Journal of Impotence Research
• Ex Officio member of the Executive Committee of the European Society for Sexual Medicine (ESSM)
• ESSM Award of Excellence, 2018
Prof. Wayne Hellstrom, M.D.
• Chief, Section of Andrology (Male Sexual Dysfunction), Tulane Urology
• Past president of the International Society for Sexual Medicine
• Past president of the Sexual Medicine Society of North America
• Past President of the American Society of Andrology
Prof. Ilan Gruenwald, M.D.
• Director of the Neuro-Urology Unit, Rambam Medical Center
• Member of the Executive Committee of the Israeli Society for Sexual Medicine
• Member of the Educational Committee of the European Society for Sexual Medicine (ESSM)
Reasons to Invest
October 2019 21
• Superior and scalable innovative technology – First-line treatment
• Improving quality of life for men and couples
• Large and fast growing market1,2
• Short Go-to-Market timeframe
• Foreseeable exit strategy (proliferation of strategic initiatives)
• Highly experienced management team
(1) Technavio. Global Premature Ejaculation Treatment Market 2016-2020.
(2) Frost & Sullivan. Opportunity Assessment for the Preliminary Premature Ejaculation Market. April 2017.
