INCINTAS THERAPEUTICS, INC.
Optimized Uterine Genomics
for Improved Pregnancy Outcome
in Assisted Reproduction
via Targeted Delivery
Novel Route of Administration
Refined Uterine Preparation in IVF to Maximize Uterine Gene Expression and Embryonic Implantation
WHAT WE DO
(We intend to m(ove the needle pretty far in IVF)
We are an accomplished team of scientists, physicians 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.
( Not the Embryo......it's the Uterus!)
While the majority of IVF scientists remain focused upon improving embryo quality for hopeful improved pregnancy outcome, we realize that this technology has shown minimal improvement in IVF success, as even the most pristine transferred embryos fail to implant into the uterus while mosaic and poor quality embryos seemingly implant with ease.
Our focus is upon the main culprit for failed implantation: inadequate uterine preparation, (not the embryo). Incintas Therapeutics' technology is the only means possible for improved uterine priming prior to embryo transfer. 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.
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. This 24 hour Window of Implantation is dramatically shorter that the 6-10 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 three 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 targeted drug delivery methods and formulation capabilities in the US and Europe with global rights pending.
-Lead Investment Opportunity - Early to Mid Stage Entry
-Sound Preclinical Genomic Data (Human)
-Large Existing Market Potential (2M IVF Cycles/yr Globally)
-Growing Market in Women's Healthcare
-Applicable Technology to Livestock Breeding, Food Sustenance
-Established Intellectual Property (US and EU)
-Experienced Business Partners
-Supported by Prominent Global IVF Luminaries
-Expedited Regulatory Pathway: 505(b)(2), 2-3 yrs. to Exit
-Formulations Established with Proprietary Nanoformulation Protection
-Life Saving/Death-Preventing/Life Changing Technology (maternal and
-Rapid Scaling due to Inferior Competition in a 'Desparate' field of Medicine
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.