INCINTAS THERAPEUTICS, INC.

The efficacy of a drug is determined by how and where it is administered in the human body.

For over 40 years, since the success of the first test tube baby, doctors have been administering progesterone to the outside of the uterus via IM injection and vaginal suppositories. It's not enough to simply get progesterone to the uterus in order to achieve pregnancy; it is necessary to provide it in the proper concentration. Conventional methods more often fail to provide the proper concentration of progesterone (within the necessary range) sufficiently long enough for for the establishment of the "Window of Implantation". Just as in healthy pregnancy, this Implantation Window is the only time a woman can achieve pregnancy. The IVF Implantation Window is artificially re-created using several conventional means of progesterone administration, however, these methods yield very poor results / low fertility outcome with about 33% success.

Most OB/GYNs and Reproductive Endocrinologists don't know this fact*:

Recent human genomic data demonstrates how IVF practitioners have been artificially re-creating a receptive uterus for only 24 hours, (on average) in all IVF cycles for over four decades.

*Why does this happen?

Since IVF began, it has been thought that not enough progesterone was reaching the uterus via conventional uterine preparation methods, and thought of as a contributing factor in failed IVF pregnancy.

The fact is: there is an upper threshold concentration for progesterone whereby vital gene expression that establishes receptivity is breached using conventional IM and perivaginal suppositories. This "excess" concentration of progesterone within the endometrial tissue actually shuts down uterine biomarker expression and ceases the ability of the embryo to implant into the uterine lining. And, once this threshold is exceeded, it is impossible for the tissue concentration to return to an acceptable receptive level. At this point, the IVF cycle is doomed. Most transferred embryos are introduced to a uterus that is nearing a contraceptive state or has already breached the concentration threshold. (Enciso, et. al. - "post-receptive phase").

Incintas Therapeutics identified this crucial upper concentration threshold in humans and designed their novel therapeutic technology to provide optimal hormonal concentration to uterine tissue to avoid exceeding this contraceptive limit.

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The 24 hour Window of Implantation created by conventional approaches is dramatically shorter that the 4-5 day normal Implantation Window of a healthy woman's normal ovulation cycle and obviously too short a period of time to reliably facilitate the complex physiological genomic and histochemical processes of embryonic implantation.

Incintas Therapeutics resolved this problem by administering progesterone directly to the inside of the uterus using a controlled-release formulation of progesterone which provides optimal molecular bioavailability for up to 96 hrs. The sustained "proper" concentration results in prolonged endometrial gene expression and a lengthened WOI, which increases the likelihood of implantation for the embryo in the process. Human clinical data has demonstrated fertility outcome of 81.5% when endometrial gene expression is complete, ("receptive" genomic state of ER Map Technology findings, n=200+).

Incintas' liquid hormonal therapeutic is administered by the clinician prior to anticipated embryo transfer via standard IVF protocol using an ultrasound guided ET catheter, to ideally prime the endometrial lining for implantation and establishment of pregnancy.

Incintas' novel intrauterine "route of progesterone administration" sustains endometrial biomarker expression over four times longer than all conventional uterine preparation methods by having the hormone administered where it needs to be....inside the uterus, not the bloodstream.

Thanks to the reliability of genomics, we can comfortably predict the positive impact our therapeutic will have upon pregnancy outcome.

Plus , we patented the intrauterine targeted drug delivery methods and formulation capabilities in the US and Europe with international global rights pending.

Administering Progesterone to the INSIDE of the uterus is the ONLY possible way to sustain the Window of Implantation and improve overall pregnancy outcome in IVF, IUI, AI and timed intercourse procedures.

Interested in becoming part of this disruptive, groundbreaking technology?

Contact us, we'd like to talk with you!

info@incintas.com

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The precise hormonal range whereby progesterone becomes a pregnancy promoter to the upper limit which identifies the contraceptive effect (eg: IUD/the Pill) has been identified for the first time in medical history.

This ideal hormonal range defines the Incintas advantage for our controlled-release capabilities.

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Incintas achieved patentability in the US and EU for 2 novel concepts;

1.) Modified Embryo Transfer Catheter (Device) which provides demarcations on the internal (flexible) portion of the catheter to provide for accurate volumetric loading and precise depth of penetration into the uterus.

2.) Novel Route of Administration for Progesterone which provides the ability to administer this vitally important hormone to the inside of the uterus of all mammals for improved bioavailability.

Both of these concepts are mutually exclusive and available for separate sub-licensing of the Intellectual Property..

(Incintas' novel progesterone nano-therapeutic can be administered with any conventional embryo transfer catheter, using standard protocol under ultrasound guidance. )