INCINTAS THERAPEUTICS, INC.
Unlocking the potential of successful pregnancy
in reproductive medicine
Infertility now effects one in six couples as the global population is in steep decline.
The need to improve pregnancy outcome in assisted reproduction has never been greater.
About Us
WHAT WE DO
"We intend to move the needle pretty far in assisted reproduction by mitigating the main hurdle in achieving pregnancy in IVF: failed implantation."
Incintas Therapeutics is comprised of an accomplished team of scientists, physicians, geneticists and business professionals who are determined to improve pregnancy outcome in reproductive medicine.
DISCOVERIES
- Receptivity within the uterus during IVF treatment only lasts for about 24 hours.* Compared to normal healthy pregnancy (during which time the uterine lining is receptive for six days), this brief period of receptivity has created a fertility plateau of ~33% that has stubbornly remained for several dacades causing millions of failed IVF and IUI treatments.
- Embryonic implantation is concentration dependent; too little or too much progesterone within the uterine lining hinders receptivity and ultimately, implantation and pregnancy outcome.
- Incintas Therapeutics, Inc. identified the ideal endometrial Progesterone Concentration Range associated with 73-81% implantation and pregnancy rate. It is impossible for this ideal P concentration range to be sustained using products currently available on today's market.
Why this happened?
For over four decades, clinicians have relied upon progesterone
concentration within a woman's bloodstream to identify uterine receptivity.
This improper assumption has misguided the entire field of assisted reproduction having clinicians believe uterine receptivity is established for 6 days by using conventional luteal phase support products.** In fact, most clinicians still believe that the uterus is receptive at the time of embryo transfer and remains receptive for days thereafter.
Nothing could be further from the truth as the duration of receptivity in an IVF cycle
has now been clinically shown to last only 24 hours (on average). This short time period is not adequate to complete the complex implantation process for most transferred embryos, resulting in consistently low fertility rates.
This abbreviated implantation window is the rate-limiting factor in achieving
high pregnancy outcomes and live birth rate in IVF and IUI treatment cycles.
*ER-Map Studies, (Enciso, et.al., 2016, 2018)
**Measuring serum progesterone is not a reliable means of determining uterine receptivity,
(Labarta, 2021 and Lawrenz/Fatemi, 2024)
HOW INCINTAS MITIGATES THE
33% FERTILITY PLATEAU:
Moreso than embryo quality, failed embryonic implantation continues to be
the biggest hurdle in achieving successful pregnancy in assisted reproduction.
Incintas Therapeutics' Scientific Team discovered how to precisely modulate and prolong
uterine receptivity by administering the ideal concentration of progesterone directly within the uterus, where implantation actually occurs and pregnancy begins.
Unlike all conventional luteal phase support products on the market, Incintas developed a proprietary formulated time-released liquid therapeutic specifically designed to achieve embryonic implantation using a unique novel patented intrauterine (IU) route of progesterone administration. The Incintas advantage circumvents the woman's systemic circulation which is the propagation route for progesterone in IM injections, PV-perivaginal suppositories, SC-subcutanesous injections and rectal suppositories. Incintas' novel IU route of administration enables precise control the necessary progesgterone concentration range within the endometrium where embryonic implantation takes place.
The proprietary time-release therapeutic improves molecular bioavailablity of progesterone within the uterine lining and extends endometrial receptivity five times longer than all conventional luteal phase support products currently on the market so that all the transferred embryos have sufficient time to complete the implantation process to achieve pregnancy. This translates to improved pregnancy outcome and a higher likelihood of acheiving pregnancy in a couple's very first IVF or IUI treatment, eliminating the stress, need and cost for subsequent treatment cycles.
ABOUT THE THERAPEUTIC
The liquid time-release therapeutic is likely a 505(b)(2) drug candidate that provides a shortened and dramatically less costly regulatory process for FDA Approval.
The therapeutic uses a fraction of the amount of progesterone that is already FDA approved for other luteal phase support products. Its targeted IU delivery, and low dose of API eliminates the typical undesirable side effects of progesterone found in most other hormonal products used in fertility treatment.
