INCINTAS THERAPEUTICS, INC.
Optimized Bioavailability of Hormone within the Uterus
for Improved Pregnancy Outcome
in Assisted Reproductive Technology - ART
Using Genomic Data Sets that correlate Ideal Hormonal Concentration to successful Pregnancy, Incintas identified the molecular machinery behind Uterine Receptivity, leading to an entirely new novel treatment paradigm in IVF and IUI
Refined Uterine Preparation in IVF to Maximize Uterine Gene Expression, the Implantation Window, Embryonic Implantation and most importantly: Pregnancy Outcome
WHAT WE DO
(We intend to move the needle pretty far in IVF)
Incintas Therapeutics is comprised of an accomplished team of scientists, physicians, geneticists and business professionals who are focused upon improving pregnancy outcome in reproductive medicine.
Our sole purpose is to resolve the problem of failed embryonic implantation (the main hurdle in achieving pregnancy in IVF) to ultimately encourage Single Embryo Transfer (SET) which is more likely to result in a healthy singleton pregnancy for the infertile couple.
It's Not the Embryo......it's the Uterus!
While the majority ART science remains focused upon improving embryo quality for hopeful increased pregnancy outcome, Incintas Therapeutics overcomes conventional wisdom by realizing that this approach in trying to improve pregnancy has demonstrated minimal efficacy. The fact remains; even the most pristine transferred embryos fail to implant into the uterus while mosaic and poor quality embryos seemingly implant with ease. To date, no scientist has explained how nor why poor quality embryos implant into the uterus, which creates devastating congenital outcomes of genomic implications, fetal death and maternal issues, including maternal death. Nor has any scientist been able to explain why embryo quality should be the main criterion for such scientific focus at all.
Incintas is directed upon the main culprit for failed implantation: inadequate uterine preparation.. Incintas Therapeutics' technology is the only means possible for improved uterine priming prior to embryo transfer to sustain the Implantation Window beyond 24 hours.
Patented and genomically validated.
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. Unfortunately, these conventional methods moreoften fail to provide the proper range of progesterone sufficiently long enough for the complex gene expression within the lining of the uterus which establishes the "Window of Implantation". Just as in healthy pregnancy, the WOI is the only time a woman can achieve pregnancy and must be artificially re-created with progesterone in order for the IVF cycle to be successful.
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.
The 24 hour Window of Implantation created by conventional approaches is dramatically shorter that the 6-8 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 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 up to 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.
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 way to possibly sustain the Window of Implantation and improve overall pregnancy outcome in ART.
Interested in becoming part of this disruptive, groundbreaking technology?
Contact us, we'd like to talk with you!
Preclinical Data (Proprietary)
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.
Patent(s) - Overview
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. )
On a mission to help millions of fertility challenged families
Harald F. Stock, PhD
Kun Zoo Kim, MD
The Experts Behind Incintas Therapeutics' Breakthrough Technology
Carlo Bulletti, MD, CSO
Dr. Carlo Bulletti is Director of the Physiopathology Unit of Reproduction at Rimini General Hospital, University of Bologna, Italy. He has authored 10 medical text books, 130 medical book chapters and more than 160 scientific articles.
MD, PhD, CMO
Robert N. Taylor, MD PhD is
Professor, Reproductive Endocrinology and Infertility
University of Utah Health
Obstetrics & Gynecology Research Network
30 North 1900 East, Suite 2A242
Salt Lake City, Utah USA 84132
Santiago Munne, PhD
Jose Horcajadas, PhD
IM and PV endometrial concentrations (human biopsy data)
..........vs. the Incintas Advantage
Progesterone Concentration vs. Time
Genomic Data now confirms Endometrial Biopsy Data as depicted in a 1-1/3 day bioavailability of the proper hormonal concentration in order to achieve implantation of the embryo
Mitchell V. Pizolato,
Nov. 23 -Nov. 29, 2000.
Multiple IVF Birth
Lance D. Pizolato
Nov. 23 - Dec. 1, 2000
Multiple IVF Birth
Rest in Peace, my dear sons.