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BAIBYS™ Fertility company presentation

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BAIBYS™ Fertility company presentation

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One-Liner
BAIBYS™ develops an AI and robotics-based COMPLETELY AUTONOMOUS system for sperm selection for IVF, which will improve success rates, reduce birth defects, and raise clinics’ throughput.

The problem
According to the WHO guidelines, in a healthy man, 96% of the sperm cells are abnormal. Natural fertilization overcomes this problem by having millions of sperm cells compete on one egg through various selection processes such that only the best one wins. However, in IVF today, the injected sperm cells are selected arbitrarily. Thus, the natural sperm selection process is bypassed, leading to fewer successful pregnancies and more birth defects. A manual selection at high magnification was proposed, showing higher success rates and reduced birth defects (NEJM, 2001). Nevertheless, this manual procedure was not widely adopted since it was lengthy (3h vs. a few minutes), subjective and inconsistent, required extensive training, and was therefore expensive.

BAIBYS’ solution
BAIBYS’ system performs the same selection process, based on the same well-accepted criteria, COMPLETELY AUTONOMOUSLY, in a fraction of the time and cost of the current manual process. The user needs only to place a cartridge with the sperm sample into the console and press a button, and the system will autonomously identify the optimal cells and will robotically transfer them to a separate droplet in the cartridge. Eliminating the drawbacks of the manual process by making it fast, objective, consistent, without trained personnel, and affordable, would allow its use in every IVF cycle, improving success rates, and reducing birth defects, while raising the clinics’ throughput and reputation.

Impact
The system shall revolutionize the IVF process by reducing the financial and emotional crisis involved with it by saving failed IVF treatments, reducing the economic burden on health systems, raising IVF clinics throughput, making IVF more accessible globally, and most importantly, reducing birth defects and helping more families in having healthy babies.

Market
The global IVF market is estimated at $41B by 2026 and growing at >10% CAGR. With 5M IVF treatments in the world forecasted for 2026, at >$200 disposable cartridge cost, plus consoles and service sales, BAIBYS’ Total Addressable Market exceeds $1B.

Progress
After a seed round of $2M in Q1/2021 (mostly from angels who are international experts in andrology and fertility clinic owners) and completing a working prototype, we closed an additional $2M investment by an Israeli VC to lead a $3-4M round. The use of proceeds is to develop the product, conduct clinical trials, and get regulatory clearances. Our seed round investors participated in this round as well.

One-Liner
BAIBYS™ develops an AI and robotics-based COMPLETELY AUTONOMOUS system for sperm selection for IVF, which will improve success rates, reduce birth defects, and raise clinics’ throughput.

The problem
According to the WHO guidelines, in a healthy man, 96% of the sperm cells are abnormal. Natural fertilization overcomes this problem by having millions of sperm cells compete on one egg through various selection processes such that only the best one wins. However, in IVF today, the injected sperm cells are selected arbitrarily. Thus, the natural sperm selection process is bypassed, leading to fewer successful pregnancies and more birth defects. A manual selection at high magnification was proposed, showing higher success rates and reduced birth defects (NEJM, 2001). Nevertheless, this manual procedure was not widely adopted since it was lengthy (3h vs. a few minutes), subjective and inconsistent, required extensive training, and was therefore expensive.

BAIBYS’ solution
BAIBYS’ system performs the same selection process, based on the same well-accepted criteria, COMPLETELY AUTONOMOUSLY, in a fraction of the time and cost of the current manual process. The user needs only to place a cartridge with the sperm sample into the console and press a button, and the system will autonomously identify the optimal cells and will robotically transfer them to a separate droplet in the cartridge. Eliminating the drawbacks of the manual process by making it fast, objective, consistent, without trained personnel, and affordable, would allow its use in every IVF cycle, improving success rates, and reducing birth defects, while raising the clinics’ throughput and reputation.

Impact
The system shall revolutionize the IVF process by reducing the financial and emotional crisis involved with it by saving failed IVF treatments, reducing the economic burden on health systems, raising IVF clinics throughput, making IVF more accessible globally, and most importantly, reducing birth defects and helping more families in having healthy babies.

Market
The global IVF market is estimated at $41B by 2026 and growing at >10% CAGR. With 5M IVF treatments in the world forecasted for 2026, at >$200 disposable cartridge cost, plus consoles and service sales, BAIBYS’ Total Addressable Market exceeds $1B.

Progress
After a seed round of $2M in Q1/2021 (mostly from angels who are international experts in andrology and fertility clinic owners) and completing a working prototype, we closed an additional $2M investment by an Israeli VC to lead a $3-4M round. The use of proceeds is to develop the product, conduct clinical trials, and get regulatory clearances. Our seed round investors participated in this round as well.

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BAIBYS™ Fertility company presentation

  1. 1. IMPROVING IVF SUCCESS January 2023 AI and robotics-based autonomous sperm selection for IVF Company Presentation
  2. 2. Vision To harness cutting-edge technologies to allow more people to have healthy BAIBYS™. Mission To leverage artificial intelligence, big data, micro-robotics, and automation to improve male fertility by revolutionizing Assisted Reproductive Technology (ART). Vision & Mission 2
  3. 3. AI-based autonomous robotic system for selecting optimal sperm cells for IVF 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. One-Liner 3
  4. 4. Fertility Crisis
  5. 5. Global Fertility Crisis Around Us 5
  6. 6. Male Fertility Drops Dramatically 6 Sperm count Decreased by 50% in 50 years and dropping Sperm morphology The criterion for “normal morphology” was changed since it became difficult to find “normal” based on the former definition – Before 2010 – Definition of “normal sperm” was “>14% of cells have normal morphology” (WHO 4th Edition) After 2010 – Definition of “normal sperm” changed to “>4% of cells have normal morphology” (WHO 5th Edition)  Male infertility accounts for ~50% of infertility cases 100 70 45 0 20 40 60 80 100 120 1940 1950 1960 1970 1980 1990 2000 2010 M/ml Year Sperm Count
  7. 7. Women Give Birth Later 7 IVF success declines with age In 2016, the U.S. tipping point More women gave birth in their 30’s than their 20’s. 29% 23% 15% 9% 3%2% 0% 5% 10% 15% 20% 25% 30% 35% 34 36 38 40 42 44 Success Woman Age IVF Success
  8. 8. Male Infertility is Hot in Academic Conferences 8 * European Society of Human Reproduction & Embryology 2022
  9. 9. IVF is Booming 9 Today 1 in 8 couples, In the future 1 in 5 * womenschronicle.com.au/2022/02/23/sperm-analysis-system- market-set-to-witness-explosive-growth-by-2029-qinghua-tongfang- hamilton-thorne-inc-stormoff/
  10. 10. IVF’s High Personal Toll 10 Enormous financial burden Emotional roller-coaster Prolonged and tedious process of several years
  11. 11. IVF Evolvement
  12. 12. Higher birth defects Moderate success rate The Challenge 12 In ~80% of current IVF – Random sperm cell is injected into the egg (ICSI) to ensure penetration Normal birth defects Higher success rate Classic IVF Sperm cells compete to fertilize the egg – Natural selection Normal birth defects Low success rate Sperm Selection at High Magnification – Detailed evaluation of sperm cell morphology and motility
  13. 13. Manual Sperm Selection at High Magnification 13 13 Trained embryologist manually selects a single sperm cell out of millions using a special microscope with high magnification (×6,100).
  14. 14. Why is High Magnification Critical? 14 At standard magnification no morphological details can be shown At high magnification morphological defects are clearly shown Higher IVF success rate & lower birth defects 14 Examining sperm cells at high magnification shows morphological defects, which correlate with low success rate and birth defects
  15. 15. Why is Morphology Important? 15 15 WHO Guidelines 6th Edition “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”.
  16. 16. Benefits of Sperm Selection 16 Higher fertilization rate Sperm quality is a critical factor for embryo development to blastocyst stage Higher pregnancy and birth rates Decrease birth defects The sperm cell delivers a novel epigenetic signature to the egg (Miller et al 2010)
  17. 17. Results According to Injected Sperm 17 Good blastocyst Embryo cells mass penetrates the blastocell cavity Many placenta cells surround the blastocyst Distinguished differentiation between them Bad blastocyst Little to no embryo cells mass Few placenta cells, most of them atretic Inner Cell Mass (ICM) = Embryo cells Trophectoderm (TE) = Placenta cells Good sperm cell Symmetric Proportional No morphology defects Bad sperm cell Asymmetric Non-proportional Has morphological defects (vacuoles)
  18. 18. Limitations of Current Technology 18 Manual solution is limited Not widely adopted Time consuming ~3h Subjective & inconsistent Requires extensive training Expensive
  19. 19. BAIBYS’ Solution
  20. 20. BAIBYS™ Solution 20 AI-based autonomous robotic sperm selection platform Fast Objective, consistent, & more accurate Fully automated Affordable The smart future of IVF
  21. 21. How Does It Work? AI Classification 21 AI classifies sperm cells morphology at high magnification • Proprietary algorithm processes the video stream of “live” sperm in real time • Autonomously classifies sperm cells based on their morphology & motility at high- magnification (×6,100) • The algorithm controls the motorized X-Y stage in real time to maintain the selected sperm cell in the middle of the field of view to allow reviewing the cell from all sides Watch the video at www.youtube.com/watch?v=cRwpi_0r4Tg
  22. 22. How Does It Work? Robotic Selection 22 Robotic platform scans sperm and extract optimal cells autonomously • Sub-micrometer motorized X-Y stage • Intelligent Scanning Technology (IST) • Controlled micro-manipulator • Automated isolation of the selected sperm • Controlled pump extracts cells • Fully autonomous from A to Z Watch the video at youtube.com/watch?v=VwDQRZflKjo
  23. 23. We found a significant differential DNA methylation and expression of many genes in sperm with poor and good morphology. Cassuto et al, 2021 Conclusions: 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… Itoi et al, 2021 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. Kruger et al, 1987 What does Science Say?(1) 23 “ “ “ “ “ 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. Dieamant et al, 2021 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. You et al, 2021
  24. 24. 24 What does Science Say?(2) * Itoi et al, 2021, page 6
  25. 25. Business Model 25 Reoccurring revenue from disposable components Capital Disposables * For illustration only
  26. 26. Product Benefits 26 Cost saving, fast, fully autonomous, objective, and accurate • Complete solution – BAIBYS™ system is a complete and integrated solution • Time saving – Fully autonomous procedure at high magnification in minutes • Low cost – Reduced costs by saving long work of a highly qualified embryologists • Increasing lab throughput – By shortening procedure overall time • Fully autonomous – Objective technique, independent of human limitation such as subjective interpretation, fatigue, and distraction • State-of-the-art technology – AI and robotic based revolutionary product • Latest development – The newest high-tech tool for IVF centers that routinely perform ICSI • Achieves the ultimate goal – Higher pregnancy rates while reducing major birth defects
  27. 27. Clinical & Regulatory Validity 27 Essential clinical data already published (refer to baibys.com/resources) Regulatory safe and recognizable – FDA 510k Shorter time-to-market
  28. 28. Total Addressable Market 28 By 2026, the IVF market is expected to reach $41B By 2026, BAIBYS’ TAM > $1B/yr Annual growth rate (CAGR) > 10% In 2019 2.5M cycles/yr Fierce Healthcare 2022 Reproductive Biomedicine Online 2019 Grand View Research 2018 5M cycles × $200
  29. 29. Automated spermatozoa candidate identification • Stage – National • Priority – January 16th, 2020 Intellectual Property 29 Process for selecting spermatozoa in particular view of a MAP • Stage – Granted (France) • Priority – January 30th, 2020
  30. 30. BAIBYS™ Team 30 Prof. Shlomo Mashiach Chairman of Advisory Board Among global IVF founders Published more than 500 articles Awarded many Israeli & international prizes Itay Itzhaky Chairman of the Board 2x exits for $270M 30+ years as CEO in medical device industry Dr. Nino Guy Cassuto Co-Founder & Chief Medical Officer IVF KOL & expert in male fertility Owner of global IVF clinics network Gal Golov Co-Founder & Co-CEO Electro-optical engineer 20+ years experience in R&D & business roles Dr. Yaron Silberman CEO PhD in AI, MBA 25+ years in BioMed business roles Recent position – CEO of a 40-employee company Betty Meiri-Farber Clinical Director Senior embryologist, MSc 25+ years experience in managing int’l IVF clinics Nahum Budin Sr. VP R&D 30+ years of R&D incl. 14 years in Israeli intelligence R&D Last position equivalent of a Colonel Managed teams of 100+ employees
  31. 31. Scientific Advisory Board 31 Prof. Shlomo Mashiach Chairman of the SAB Dr. Nino Guy Cassuto Chief Medical Officer Prof. Martha Dirnfeld Dr. Djedik Diakite Dr. Stephane Eimer Dr. Eric Konyaole Dr. Fernando Sánchez Martín Dr. Pascual Sánchez Martín Prof. Adrian Shulman Dr. Athanase Sodjiedo
  32. 32. Achievements 32 Working prototype completed Israel Innovation Authority grant Selected for IBM’s Hadassah Accelerator (5 out of >100 candidates) Accepted to NVIDIA Inception Program for AI-based Start ups International Patent (PCT) submitted Semi-finalist StartUp+ competition (20 out of 200 start-ups)
  33. 33. BAIBYS™ Value Proposition 33 Feasible technology Based on already-proven technological components Working prototype completed Simple, fast, objective, affordable solution Increase clinic throughput & revenue Increased birth rate & decreased birth defects AI where it matters In normal sperm, 96% of sperm cells are abnormal While AI in IVF commonly used to select embryo, if the sperm used for fertilization is abnormal, likelihood for good embryos is low Substantial & fast growing market Exp. $41B in 2026 CAGR>10% Company de-risked $2M Seed raised from clinic owners (target customers) $2M Round A raised from Israeli VC Profound clinical & regulatory validation Prominent KOLs & experienced team
  34. 34. Thank You +972-77-332-0302 info@baibys.com www.baibys.com

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