The Silicon Review
Better Embryo Selection – Better Chances of Pregnancy
When the balance between the production of free radicals and antioxidant defences 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. The firm’s technology and its potential contribution to reproductive success have been recognized with significant backing from the EU and from Merck Serono.
Need and Solutions
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 the 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.
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. The studies that have been done shows that the outcomes have improved by only about 10%.
Fertissimo: Noninvasive Testing For Optimal Embryo Selection
Based on proprietary technology, the Fertissimo TCL Analyzer measures oxidative stress, which is a powerful biomarker of embryo viability. This innovative approach allows examination of multiple embryos, without disrupting an embryo. Analysis time is extremely short, taking no more than eight minutes for each embryo.
About The Analyzer
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.
Future IVF Indications
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.
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.
Leading In the Front Line
TzaliCnaani has a proven track record in all facets of leading R&D and businesses, from inception to fundraising, product strategy, operations and sales management. Previously, MrCnaani was CEO of Lumitest, which developed a unique medical device to measure oxidative stress in biological fluids, establishing the technology through cooperation with medical centres and academia. Prior to that, he was CEO of SAE Afikim (Afimilk), a world leader in computerized dairy management systems. MrCnaani 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.
Dr Sergei Shnizer, Co-founder, CTO
Dr. Sergei Shnizer is the inventor of TCL technology and the first to apply it to medicine. Specializing in Anesthesiology and Intensive Care Medicine, he developed an interest in the effect and mechanisms of free radicals in critically ill patients. DrShnizer was also a co-founder of SPM Ltd. (now OZ Recovery Technologies), which developed a device for treatment of diabetic wounds using ozone. Prior to immigrating to Israel, he spent 15 years at Botkin Hospital in Moscow in the Department of Emergency Medicine and Hyperbaric Oxygen as Senior Physician. DrShnizer’s PhD thesis covered “Using Free Radical Activity Tests in Intensive Care Units.” He has published over 30 articles in peer-reviewed journals.
“We focus our efforts toward helping women conceive through our ThermoChemiLuminescence (TCL) technology.”