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◎ 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.
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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:
- Analyze living sperm cells in real-time using Machine Vision (MV) and Artificial Intelligence (AI)
- 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
- Autonomously select and collect the sperm with the highest fertilization potential to microinject into the egg in IVF procedures.
- Previous funding round of €2m was over subscribed. Most investors were fertility clinic owners.
- A working prototype completed and is operating in two locations.
- System successfully selects sperm within minutes without any human involvement.
- Secured non-dilutive financing from the Israeli Innovation Authority.
- ◎ Company overview
- BAIBYS™ - AI and robotics-based autonomous sperm selection for IVF
- 🚀 Current traction
- 🔬 Product & Tech
- 💸 Investment opportunity
- 📊 Financial overview
- 🌍 Market size
- 🥷🏽 Competitors
- 💬 Scientific Research and Evidence
- 🧲 Team
🚀 Current traction
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)
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.
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🔬 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.
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- An AI algorithm is trained on thousands of sperm cell images labeled by their quality according to trained embryologists.
- The algorithm extracts the fine statistical parameters of the images and their correlation to the sperm quality and then can replicate the evaluation of a human embryologist.
The robot replicates the operations of a human embryologist, including the control of an X-Y stage, a micro-manipulator that holds a pipette and a pump to isolate the selected sperm cell, aspire it using the pipette and the pump, and relocating it in the designated droplet.
Examining sperm cells at high magnification shows morphological defects, which correlate with low success rate and birth defects.
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
Substantial & fast growing market
Exp. $41B in 2026 CAGR>10%
Company de-risked
$2M seed raised from clinic owners (target customers). Clinical & regulatory validation
💸 Investment opportunity
- €1m on the same terms as the €2m secured
- €500k open to angels on a SAFE with a 15% discount (€150k has been committed to this already)
Next possible round: approximately €6m in 2025 Q1
- Complete productization: Engineering of a commercial system & Cost reduction
- Complete Clinical Study: Clinical validation & Regulatory submission
- Achieve Regulatory clearance
- FDA clearance within the next 2 years
- Increase the number of Take home healthy BAIBYS™ - Based on proprietary big-data, linking sperm morphology analysis at high magnification with the final clinical goal.
- Improving, refining, and expanding the current morphology & motility criteria of ‘optimal sperm cell’
| Startup | Location | Description | Raise |
|---|---|---|---|
🇺🇸 | Provides fertility benefits to employers | $75m | |
🇺🇸 | Focuses exclusively on male infertility | $10m | |
🇺🇸 | $110m | ||
🇺🇸 | Uses AI tools to lower costs and improve outcomes for IVF treatments | $22m | |
🇺🇸 | Combines fertility financing and care support | $25m | |
🇺🇸 | Kindbody provides fertility, gynecology, and family-building services at over 300 locations | $154m | |
🇬🇧 | “de-risk” the whole process of IVF fertility treatment | €23 | |
🇺🇸 | Reproductive support | $1.4m | |
🇮🇱 | AI software uses one of the largest and most diverse IVF datasets | $15m | |
🇮🇱 | AI-based in vitro fertilization software platform | $25m | |
🇮🇱 | AI that selects which embryo to implant in the patient. Developed algorithm to predict the probability of embryo implantation | $4m | |
🇪🇸 | Simplifying IVF process and make artificial insemination a more accessible option by lowering costs, optimising use of resources and increasing success rates. | $15 |
📊 Financial overview
Product economics ➤ The final system will be priced around €25,000 (COGS €12,000 - €15,000). The price point appetite for clinics for similar devices is around €40,000. For context, the current microscope used sells for €120,000. ➤ Each cartridge will be €200 (COGS €10), each cycle will require one cartridges, a large clinic does 10,000 - 15,0000 cycles per year.
🌍 Market size
By 2026, the IVF market is expected to reach $41B, Annual growth rate (CAGR) > 10%. In 2019 there were 2.5M cycles/yr.
An estimated 15% of couples will have trouble conceiving. Globally, 48.5 million couples experience infertility. The number of procedures is expected to double and reach 5 million by 2026, China currently offers IVF as a free service
A single IVF cycle in the U.S. costs around $12,000, and that price can rise up to $25,000 with medication. The average cost of an IVF baby in the United States is $66,000. In addition, because the success rate of a single cycle is close to 30%, most parents undergo multiple cycles to have a baby.
In general, the global market for assisted reproductive technologies (ART) is growing every year at the global level. With an average growth of around 10% per year, it is expected to reach $45 billion in 2025, with just over 11% growth for IVF. Free service in China started in Feb 2022 and is expected to push numbers even higher.
⏳ Cultural shift to having children later in life, as well as lifestyle and health issues increasing incidences of infertility 🏥 One of few healthcare service sectors in which clinical outcomes data are measured and reported, providing potential benefit to best-in-class providers 💵 Significant private pay component provides highly attractive reimbursement profile and insulation from pricing pressures relative to other healthcare sectors 🕰 Highly recession-resistant demand due to parents’ desire to build families and the ticking of the biological clock
Industry growth drivers in the US
- Employers gain from offering fertility coverage:
- It Attracts new talent in competitive job markets by providing cost-saving incentives and creating a “family-friendly” culture. Greater fertility coverage allows employees to choose the safest fertility option and minimizes time away from work.
- IVF treatments lead to fewer complications due to lower chance of multiple births and low birthweight compared to other fertility treatments. Alternative fertility treatments pose greater health risks and result in greater total expense burden placed on the employer
Two-thirds of large employers already offer some level of fertility coverage
🥷🏽 Competitors
| Logo | Company | Location | Technology | Main difference to Braibys | AI | CE | FDA |
|---|---|---|---|---|---|---|---|
🇬🇧 | Selects the best embryo and sperm through quantitative assessments impossible to be measured by the trained eye. | 1. Motility-based only, not by morphology and no high magnification
2. Evaluation one by one, not all at once, and no extraction of good cells, only ranking | |||||
🇮🇱 | Increases success rates of in vitro fertilization by providing new technologies for sperm visualization, analysis and selection. They do quantitative characterization of sperm cells to enable informed selection of the most promising cells for in-vitro fertilization. | 1. Uses 3D topographic imaging to characterize the morphology and composition of individual sperm cells
2. No clinical data | |||||
🇺🇸 | 1. Motility-based only, not by morphology | ||||||
🇫🇷 | Mojo send customers semen sample test kits, fertility experts use AI to analyse and provide a detailed report on 22 biomarkers. | 1. No individual cell evaluation
2. B2C product, sent to customers to do a fertility test | |||||
Technology differentiates spermatozoa from others and thus define the individual biochemical profile of each of them, to know which are the most suitable to achieve reproductive success, without the need to alter the spermatozoa for analysis |
💬 Scientific Research and Evidence
IMSI [a method of sperm selection at high magnification] seems to be an effective tool at reducing the incidence of structural defects compared to ICSI. The incidence of birth defects was statistically different, with 2.5% (32/1280) in IMSI and 4.5% (119/2627) in ICSI. The results demonstrated that IMSI decreased the incidence of structural defects compared to ICSI – 2.2% (18/830) vs. 3.8% (78/2049) – in a statistically significant manner.
Abnormal spermatozoa generally have a lower fertilizing potential, depending on the types of anomalies, and may also have abnormal DNA. Morphological defects have been associated with increased DNA fragmentation, an increased incidence of structural chromosomal aberrations, immature chromatin and aneuploidy. Emphasis is therefore given to the form of the head, although the sperm tail (midpiece and principal piece) is also important to consider for the understanding of the male reproductive tract.
This study demonstrates the value of analyzing sperm morphology using the criteria recommended in terms of predicting fertilization and perhaps pregnancy outcome. If the morphology is not evaluated with care, a diagnosis of unexplained infertility can be made incorrectly and lead to much frustration for both the patient and the physician.
Abnormal spermatozoa generally have a lower fertilizing potential, depending on the types of anomalies, and may also have abnormal DNA. Morphological defects have been associated with increased DNA fragmentation, an increased incidence of structural chromosomal aberrations, immature chromatin and aneuploidy. Emphasis is therefore given to the form of the head, although the sperm tail (midpiece and principal piece) is also important to consider for the understanding of the male reproductive tract. Tremendous opportunities exist for machine learning to advance male fertility treatments. The fundamental challenge of sperm selection — selecting the most promising candidate from 100,000,000 gametes — presents a challenge that is uniquely well-suited to the high-throughput capabilities of machine learning algorithms paired with modern data processing capabilities.
🧲 Team
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| Name | Position | Team |
|---|---|---|
Chairman of Advisory Board | Advisory Board | |
Scientific Advisory Board | Advisory Board | |
Scientific Advisory Board | Advisory Board | |
Scientific Advisory Board | Advisory Board | |
Scientific Advisory Board | Advisory Board | |
Scientific Advisory Board | Advisory Board | |
Scientific Advisory Board | Advisory Board | |
Scientific Advisory Board | Advisory Board | |
Chairman of the Board | Advisory Board | |
Clinical Director | Leadership | |
VP of R&D | Leadership | |
Co-founderCMO | Leadership | |
Co-founderCo-CEO | Leadership | |
CEO | Leadership |
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update: 19.05.2022