3. Vision: Creating Lives
愿景:创造生命
Crossing through the barrier
and increase Take-Home Baby Rate
A Drug Eluting Vaginal Ring For Fertility
Enhancement and Increasing Chances for a Safer,
a Quicker and a Healthier Pregnancy
4. A Vaginal Ring to Replace IVF
一种可替代IVF 的阴道环
IVF is a Painful, Invasive and Dangerous Procedure
FertiProt can Reduce the Need for IVF for 20% - 30% of
Couples, and increase Success Rates
FertiProt will Increase Probability of
Conception by Sexual Intercourse
5. The Problem
问题
WERE FOUND ELIGIBLE
IN CHINA
only
20%of donors
One of every Seven
(14.3%) couples encounters
fertility problems, this number
increases with age
9. Innovative solution
是创新型药物解决方案
Known drugs that enhance sperm quality, including Motility,
Endurance, Penetrability and Acrosome activation.
Increase Implantation rates following fertilization,
IUI or through IVF.
Allow for further options like gender
probability increase and selection.
A Drug Eluting Vaginal Ring that will Increase conception
rate with a normal Sexual Intercourse and without the need
for invasive measures like IVF, for 20% - 30% of couples.
10. A-Z New Drug Application in up to 6Y
为期6年的A-Z 新型药品申请
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6
Screening and POC
Formulation (CMC)
Preclinical and safety
Phase 1 (PK) - FIH
IND
Preclinical and safety (NDA enabling)
Phase 2 – 3 (efficacy studies)
NDA
$500 – 1M
$500 – 1M
$500K –
2M
$2 – 3M
$30 – 50M
$1 – 2M
• FDA Fast Track process (505(b)(2)) >> 7-10 years Exclusivity
• Repurposing of a known/marketed drug-device combination
• Pre clinical safety and PK (no efficacy needed in animals)
• No dedicated Phase-2 needed
• Short & clear cut Phase-3 (Yes/No pregnancy test)
11. Why Now? Why China?
为什么现在?为什么中国?
of Chinese young men
had a poor sperm quality
Following the new “2nd baby”
policy initiated in China
1/7 2nd Baby 80%couples suffer from
impaired fertility
12. Competitive Analysis
竞争力分析
Fertiprot's technology aims at reducing the need for
Assisted Reproductive Treatment and more particularly
IVF / ICSI
Fertiprot’s Vaginal Ring is safe and could be self
applied, at home with no medical intervention.
Fertiprot's technology will increase potential for Gender
selection
Fertiprot's Vaginal Ring might become an OTC product
15. Team
团队
Lior Wayn –
Co Founder & CEO
A serial entrepreneur in the life
sciences arena, where he led multiple
public and private companies and have
vast experience in taking concepts all
the way to the market.
Founder of 4 startups, holds 2 patents,
with 18 years of management,
entrepreneurship, innovation and
BizDev experience.
Dr. Ronen Shemesh –
Founder & VP R&D
Innovator and drug discovery expert.
22 years’ experience in the Biotech
Industry both as research manager and
business development. High expertise
in project management, and research
planning and execution (In all stages of
drug development).
Dr. Arik Kahane-
Fertility consultant
Deputy head of the ‘Assuta’ Hospital in
ISRAEL, Manager of the 2nd largest
fertility lab in ISRAEL and expert at
fertility medicine and women’s health,
head of the ‘Assuta’ Helsinki
committee.
16. “There is nothing like it, and if there was,
Fertility specialists would GLADLY suggest
this to patients either before going into any
conventional treatment, or alongside with
advanced treatment, be it any state of any
art...” (Dr. Arik Kahane)
Thank Y u !
谢谢您
Hinweis der Redaktion
Proud to be here… I thank you for the opportunity to present Fertiprot.
“Have anyone of you ever play with Dolls? Play ‘House’” Having kids is everyone’s dream.
Fertiprot was founded a few years ago with the aspiration of bringing happiness and fulfill the dream of many people: Start a family!!! and “Create Lives”.
We believe in “Crossing through the barrier for more efficient reproduction and increase Take-Home Baby Rate for infertile couples”, for which this dream could not be fulfilled.
For some of us, the dream has become a nightmare. One of seven couples trying to conceive will encounter problems, and the current solution, IVF, is a Painful, Invasive and Dangerous Procedure that involves painful daily injections, hormonal therapy, invasive procedures, stress, an emotional rollercoaster and side effects including obesity and even cancer.
FertiProt can Reduce the Need for IVF for 20% - 30% of couples, and increase success rates. Our solution resides in a drug formulation that will improve sperm activity, including Motility, Endurance and Penetrability. This will be achieved by: A Vaginal Ring that will Increase Probability of Sexual Conception, Implantation, and Allow Gender Probability Selection.
The problem of infertility is now an escalating problem. With almost 80% of sperm donors in China found non-suitable for donation, and one in every seven couples suffer from impaired fertility, and the number is growing.
Our solution is a simple device, a vaginal ring that slowly but continuously release a drug that will increase sperm activities within the female system. This device can be used at home, within fertility time window, with no pain or hassle.
FertiProt’s Innovative solution:
A Vaginal Ring that will Increase sperm activity, and thus fertilization and Take-Home Baby Rate with a normal Sexual Intercourse and without the need for invasive measures like IVF, for 20% - 30% of couples that are borderline or subfertile.
Our drug formulation will also Increase Implantation rates following fertilization, IUI or through IVF.
The increase in sperm activity will cause Enhancement of Intra-Uterine Insemination (IUI) efficiency and Success rates.
Selecting which sperm factor to enhance (motility for males and endurance for females) will Allow for further options like gender probability increase and selection.
A known drug – repurposing: Development is short and cheap with estimated time to market is under 6 years and cost is estimated at $50M- $80M.
FDA Fast Track process (505(b)(2) ) >> Exclusivity
Repurposing of a known/marketed drug device combination
Pre clinical safety and PK (no efficacy)
No Phase-2 needed as dose and safety are established
Short & clear cut Phase-3
These days, world infertility is as high as one in every seven couples, and especially in China, with the new 2nd baby law implemented and the fact that male fertility is so low, with only 20% of young men eligible for donating their sperm.
The only real competition is In Vitro Fertilization (IVF)…
Fertiprot's technology reducing the need for Assisted Reproductive Treatment and more particularly IVF / ICSI
Fertiprot's technology will increase potential for Gender selection
Fertiprot's Vaginal Ring might become an OTC product
A few words about gender selection: In the long run, Fertiprots technology will replace some non-validated traditional methods such as charts for gender selection.
Business opportunity:
Fertility and IVF market is estimated at $50B/year by 2017 - FertiProt’s market share will be around 15%
Our leading team includes a Fertility Expert, a Veteran Business and Marketing Expert and an Experienced Scientist and Innovator.
With that, I would like to thank you and leave you with a quote made by our fertility expert, Dr. Arik Kahane, while taking your questions.