The Silicon Review ^Asia

Tzali Cnaani has a proven track record in all facets of leading R&D and businesses, from inception to fund raising, product strategy, operations and sales management. Previously, Mr. Cnaani was CEO of Lumitest, which developed a unique medical device to measure oxidative stress in biological fluids, establishing the technology through cooperation with medical centers and academia. Prior to that, he was CEO of SAE Afikim (Afimilk), a world leader in computerized dairy management systems. Mr. Cnaani was EVP and member of the board of directors of Gambit Computer Communication. He holds a B.Sc. degree in physics from the Technion Israel Institute of Technology.

In vitro fertilization (IVF) is the most commonly implemented assisted reproductive technology (ART), and has helped thousands to realize their dreams of parenthood. IVF is a four-step process that consists of ovulation induction, egg retrieval, fertilization in a laboratory, and embryo transfer to the mother's uterus. The clearest advantage of IVF treatment is that it provides previously infertile couples the opportunity to conceive children of their own. IVF can provide hope for patients facing many different causes of infertility. Women with damage or blockages in their fallopian tubes have very low chances of becoming pregnant without fertility treatment, but IVF can circumvent this issue. Men who have a low sperm count or issues with sperm motility may have difficulty fertilizing their partner's eggs. Because the fertilization step takes place outside the body during IVF treatment, it provides a solution that bypasses the need for the male's sperm to navigate the woman's reproductive tract.

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 an Israel based firm 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 application for Carmel Diagnostics’ ThermoChemiLuminescence (TCL) technology is diverse, the company is focused towards helping women conceive.The company was awarded the prestigious €2.7M grant by Horizon 2020 SME Instrument program of the EU, a formidable achievement that is bestowed on a fraction of applicants.

Despite huge investments in technology, improvements in the outcome of IVF have still been limited. The main reason is that current IVF technologies are unable to identify the most viable embryos for transfer effectively. As a result, multiple embryos are transferred to increase the chances of pregnancy, a costly and risky procedure. However, growing scientific evidence points to single-embryo transfer being the most effective method of conception. That makes it more important than ever to choose the most viable single embryo, and several methods exist to do so

Fertissimo

Fertissimo is a powerful system that rapidly highlights the most viable embryos to conceive in IVF-induced pregnancy, using oxidative stress as a biomarker. The system makes a noninvasive analysis of the embryo’s reproductive potential by testing the culture media, leaving the embryo untouched.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. Main features of Fertissimo are

• At least 15% increase in successful IVF pregnancies
• 8-minute analysis to determine each embryo’s viability
• Provides information on a patient’s ability to conceive in a given cycle
• Offers viability assessment of cryopreserved embryos

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. 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.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.

MORPHOLOGY and TIME LAPSE

Morphology is still the gold standard for determining embryo viability and is used universally. A trained clinician examines the embryo using a microscope for symmetry, fragmentation, and cleavage rate under a microscope. Unfortunately, morphology tests are inaccurate and subject to human error. Different clinicians could score the embryos differently.Over the last few years, new time lapse technologies have been used in a growing number of IVF clinics. Zoomed pictures of the embryos taken from within the incubator at fixed intervals are used to calculate the cell-rate split time digitally from the zygote stage.

Tzali Cnaani, CEO of Carmel Diagnostics

Tzali Cnaani has a proven track record in all facets of leading R&D and businesses, from inception to fund raising, product strategy, operations and sales management. Previously, Mr. Cnaani was CEO of Lumitest, which developed a unique medical device to measure oxidative stress in biological fluids, establishing the technology through cooperation with medical centers and academia. Prior to that, he was CEO of SAE Afikim (Afimilk), a world leader in computerized dairy management systems. Mr. Cnaani was EVP and member of the board of directors of Gambit Computer Communication. He holds a B.Sc. degree in physics from the Technion Israel Institute of Technology.

“Giving birth to IVF Success, better embryo selection, better chances of pregnancy”