◎ Company overview

BAIBYS™ - AI and robotics-based autonomous sperm selection for IVF

Israeli-based fertility tech company that has built a solution for fertility clinics to leverage artificial intelligence, big data, micro-robotics, and automation. The technology is used to improve male fertility by revolutionizing Assisted Reproductive Technology (ART) to improve fertility success rates, reduce birth defects, lower cost and increase clinics‘ throughput

For the mother-to-be it decreases the number of cycles needed which decreases the time and cost to fertility.

A booming market

Globally, 1 in 8 couples undergo IVF and only 30-40% of IVF cycles are successful. According to all market reports, IVF is expected to boom, due to both male and female factors.

Male factors, equally contributing to infertility cases are on a dramatic rise as sperm count is decreasing by 50% in the last 50 years and dropping and the quality of the cells drops as well - evidenced in *this NY Times article.* In approx 40% of infertile couples, the male partner is responsible for the infertility, 85-95% are treated with drugs or surgery.   Female factors are on the rise as well as more women delay the age of marriage and conception (2016 was the first year in the US where more women gave birth in their 30’s than their 20’s), while IVF success declines with age (30% success for women about 35 vs 3% for 44 yo).

The problem

In natural fertilization, millions of sperm cells compete on one egg, thus ensuring that an optimal cell is fertilizing it. However, in IVF today, sperm cells are selected arbitrarily, although >96% are abnormal – Leading to lower success rates, more birth defects, and higher costs:

• IVF clinicians manually select viable sperm cells, a process that has a low accuracy rate given its susceptibility to bias, error, and the existence of complex trends invisible to the human eye.
• Manual sperm selection is not widely adopted as it relies on trained professionals to select ‘optimal’ sperm cells. This is very costly (€1000 - €5000 extra per cycle) and time consuming (3+ hours).

Each year fertility clinics need to publish their success rate, which is what potential clients use to select their preferred clinic.

AI-based autonomous robotic sperm selection platform. Hardware plus cartridge which is used to monitor and select the most optimal live sperm cell in real time. This is faster than manual selection, more accurate (magnification at 6100x) and increases the success rate for clinics.

The solution

BAIBYS™ develops an AI and robotics-based COMPLETELY AUTONOMOUS system for sperm selection at high magnification for ICSI (including the physical pick-up and isolation of the optimal cells), which will improve success rates, reduce birth defects, and raise clinics’ throughput.

BAIBYS’ autonomous sperm selection solution for In-Vitro Fertilization (IVF) is designed to:

1. Analyze living sperm cells in real-time using Machine Vision (MV) and Artificial Intelligence (AI)
2. Recognize structures in motion in order to evaluate the quality of living sperm cells according to previously established criteria using state-of-the-art AI algorithms
3. Autonomously select and collect the sperm with the highest fertilization potential to microinject into the egg in IVF procedures.

<aside> 🙌🏼 Major Achievements

1. Previous funding round of €2m was over subscribed. Most investors were fertility clinic owners.
2. A working prototype completed and is operating in two locations.
3. System successfully selects sperm within minutes without any human involvement.
4. Secured non-dilutive financing from the Israeli Innovation Authority. </aside>

<aside> 🔒 STRICTLY CONFIDENTIAL

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🚀 Current traction

<aside> 💶 Financial

Total funding raised: € 1.71M (since establishment in Jan. 2020). This was made up by a pre-seed round € 100k, Israel Innovation Authority grant of € 27k and a seed round € 1.583m from 14 private investors (11 IVF clinic owners and experts)

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<aside> 🔬 Product Both the system and the disposable cartridges of the fully functional prototype have been completed (see video of working prototype in action below)

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<aside> 📉 Commercial Started initial engagement with FDA approval process**,** product is regulatory safe and recognizable – FDA 510k or De Novo. Interested clinics clients in EU, pending CE Mark approval.

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<aside> ✅ Intellectual Property The Essential clinical data has been published.

• 1st Patent application: Process for selecting spermatozoa in particular view of a MAP has been granted (France).
• 2nd Patent application: Automated spermatozoa candidate identification is in the national stage.

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BAIBYS™ has two fully functional prototype units which can autonomously detect in minutes (analysing for morphological and motility defects) and select the sperm cells with the highest fertilization potential using AI. The unit uses disposable cartridges, which are the source for reoccurring revenue.

🔬 Product & Tech

Sperm Selection at High Magnification BAIBYS™ product does a detailed evaluation of sperm cell morphology and mobility. It examines sperm cells at high magnification showing morphological defects, which correlate with low success rate and birth defects.

• What are the benefits of Sperm Selection?

• How Does AI Classification work?

• How Does Robotic Selection work?

• Why is High Magnification Critical?

https://www.youtube.com/watch?v=-f7Hf9k5rOc

Feasible technology

Based on already-proven technological components

Simple, fast, objective, affordable solution

Increase clinic throughput & revenue

Increased birth rate & decreased birth defects

Using AI where it matters: 96% of sperm cells are abnormal