Carmel Diagnostics – Delivering Hope to Infertile Couples by Bettering Embryo Selection for IVF Pregnancy

A child completes the family; how you accomplish parenthood should never matter. IVF treatment is always an option if normal conceiving is not possible. There is a correlation between that pregnancy through Assisted Reproductive Technologies and natural conception; but even though many people believe that these treatments are different from each other. It has nothing to do with reality. The truth is that IVF only occurs outside the body, but it is the same as normal pregnancy after the egg has transferred into the womb. In the first two weeks, there are some variations between an IVF pregnancy and a normal pregnancy, but after that, everything is the same.

To optimize success rates of IVF, selection of the most viable embryo(s) for transfer has always been essential, as embryos that are cryopreserved are thought to have a reduced chance of implanting after thawing. Recent developments challenge this concept. Evidence is accumulating that all embryos can now be cryopreserved and transferred in subsequent cycles without impairing pregnancy rates or maybe even with an improvement in pregnancy rates. In such a scenario no selection method will ever lead to improved live birth rates, as, by definition, the live birth rate per stimulated IVF cycle can never be improved when all embryos are serially transferred. In fact, selection could then only lower the live birth rate after IVF. The only parameter that could possibly be improved by embryo selection would be time to pregnancy, if embryos with the highest implantation potential are transferred first.

When the balance between the production of free radicals and antioxidant defenses occurs, it is referred to as oxidative stress. It is an underlying cause for multiple diseases and an early detector of the potential for many conditions from heart failure to diabetes. Carmel Diagnostics is excited to be the first company in the world to create a benchtop system that measures oxidative stress in body fluids at the point of care and within minutes. While the potential applications for its ThermoChemiLuminescence (TCL) technology is diverse, as the company is focusing on helping women conceive. Carmel Diagnostics is developing a test that will show the chances of pregnancy in a given cycle (individual aspiration of the follicular fluids and the oocytes from each follicle) after a clinical study demonstrated a clear correlation between measured TCL parameters and pregnancy rates. This new application is patent pending.

Why Carmel Diagnostics

Impressive Results: A 2016 pilot study on 76 embryos demonstrated a 20% average increase in embryos carrying on to successful conception. A current follow-up retrospective study on 732 embryos demonstrated an increase in successful conception via detection of 231 samples. This adds up to at least a 15% increase in successful IVF pregnancies, compared with the existing gold standard.

Publications: Numerous peer reviewed articles were written about Carmel Diagnostic’s proprietary ThermoChemiLuminescence  (TCL) technology. These related to its clinical validation, and potential applications. Some studies were published in leading peer-reviewed journals. See the list of publications below. For a full copy, please contact us directly.

Precise Parameters: Parameters obtained [by the analyzer]show higher levels of oxidation levels in group culture, transferred embryos, and successful implantation. Current evidence between embryo outcome and implantation potential indicates an improved clinical biomarker

Fertissimo TCL Analyzer: Noninvasive Testing for Optimal Embryo Selection

Fertissimo TCL Analyzer is an innovative, noninvasive embryo selection system for the IVF market, offering up to 20% increase in successful IVF pregnancies. Effective embryo viability assessment significantly improves success rate and reduces the risk of multiple births. Successful clinical trials were performed in Israel and in Europe (Spain). New generation of the product will soon start extensive clinical validation and will be launched in 2020. CE Mark is expected in two months. Business model is pay-per-test using the disposable and software control, while the devices will be sold with nominal price.

Accurate,scientifically based, NON-INVASIVE solution to the embryo selection application - the "holy grail" of the IVF process.- Low cost device, minimal initial investment for the users- Very friendly,easy-to-use system- Optional oocyte quality testing- Examining the patient's probability for pregnancy - not just on embryo base- Testing cryopreserved - thawed embryos. The device can also be used for additional applications such as: Risk stratification for Heart Failure patients, Diagnosis and treatment monitoring of AMD, early diagnosis of Parkinson and Alzheimer's, assessment of damage in TBI - Traumatic Brain injury. They base their solution on using oxidative stress as a novel efficient biomarker. The potential market is each and every IVF clinic in the world. There are more than 3000 clinics worldwide and over 2 Million IVF procedures (Cycles) every year with expected growth of 5-7%. The market size of embryo selection is 500M$. The product is needed worldwide in every IVF clinic. Improving success rate in the procedure is very important considering high cost, pain and stress to the patients and couples in general.

Tzali Cnaani | Founder and CEO

Tzali is a senior executive with demonstrated success leading mature businesses and start-ups, from numerous markets including enterprise software across domains in the enterprise, computer communication, high-tech in agriculture, medical technology, and energy. He has proven track record in all facets of leading businesses from vision setting and definition of company and product strategy, through fund raising, executing operational plans achieving healthy profit, strategic marketing, sales management, leading complicated R&D projects, business and product development and successful world-wide implementation to achieve market leadership and profitable growth.

"Our technology and our potential contribution to reproductive success have been recognized with significant backing from the EU and from Merck Serono."