A breakthrough innovation for childbirth

Currently available methods to assist childbirth – forceps, vacuum extraction and C-section - are known to have risks which can lead to unnecessary pain, trauma, and short and long-term complications.^1-^2,7 The OdonAssist™ is designed as a new, gentle^4-6 alternative for assisted vaginal birth that is safe for mothers and newborns.^3-5

Maternal and newborn health are significant areas of focus for governments and health agencies, and key areas of unmet need for innovation in medical technology.

Explore the statistics to see why innovation in assisted childbirth is overdue.

Healthy beginnings, hopeful futures.

2.3 million

children died in the first month of life in both 2022 and 2023, with approximately 1 million of these deaths occurring in just the first 24 hours.^8,24

1.9 million

babies are stillborn every year.  Most of these deaths are preventable.⁹

260,000 women

died in 2023 from complications of pregnancy and childbirth. Most of these deaths were preventable.¹⁰

In comparison with caesarean section, assisted vaginal birth is associated with a reduced risk of maternal haemorrhage,¹⁵ intrapartum stillbirth,¹⁶ admission to intensive care for newborns,¹⁵ abnormal placentation¹⁷ and stillbirth in subsequent pregnancies.¹⁸

Prolonged/complicated labour occurs in 10-15% of all births¹⁴ — often leading to a caesarean section (C-section) — and is a common cause of stillbirth and maternal death.¹⁶

Approximately 24% of newborn mortality¹¹ and 46% of stillbirths¹² occur during the process of childbirth.

Approximately 10 million women each year incur pregnancy-related complications.¹³

“When we reduce unnecessary caesarean sections, we also reduce unnecessary risks to women and their babies. We also reduce unnecessary costs for hospitals and health systems.”¹⁹

—WHO Department of Reproductive
Health and Research

It’s time for a new way to deliver newborns

2025

1950s

“Modern” vacuum extraction device invented²²

~1850

Vacuum assisted  extraction introduced²¹

1600s

Invention of obstetric forceps in early 17th century^20,22

1500s

Various reports of caesarean section procedures performed²⁰

Meet OdonAssist^TM

References

1-Cleveland Clinic. Vacuum extraction delivery. https://my.clevelandclinic.org/health/treatments/22305-vacuum-extraction-delivery. Accessed 11 Apr 2025. 

2-Cleveland Clinic. Forceps delivery. https://my.clevelandclinic.org/health/treatments/23260-forceps-delivery. Accessed 11 Apr 2025. 

3-Hotton et al. Outcomes of the novel Odon Device in indicated operative vaginal birth. Am J Obstet Gynecol. 2021;224:607.e1-607.e17.

4-Hotton et al. The OdonAssist™ inflatable device for assisted vaginal birth – the ASSIST II study (UK). Am J Obstet Gynecol. Vol. 230, Issue 3, S932 – S946.e3. 

5-Mottet et al. Safety and efficacy of the OdonAssist™ inflatable device for assisted vaginal birth: the Besancon ASSIST study. Am J Obstet Gynecol. Vol. 230, Issue 3, S947 – S958. NB. Efficacy rates reported in the ASSIST II study and subsequent Besançon ASSIST study, conducted in 104 women each, were 66.3% and 88.5% respectively 

6-Hotton et al. Women's experiences of the Odon Device to assist vaginal birth and participation in intrapartum research: a qualitative study in a maternity unit in the Southwest of England. BMJ Open. 2021;11:e057023.

7-Cleveland Clinic. C-Section. https://my.clevelandclinic.org/health/treatments/7246-cesarean-birth-c-section. Accessed 11 Apr 2025. 

8-Unicef. Neonatal Mortality. https://data.unicef.org/topic/child-survival/neonatal-mortality/. Published Mar 2025. Accessed 21 Aug 2025.  

9-(UNIGME) UNIG for CME. Never Forgotten: the situation of stillbirth around the globe. Report of the United Nations inter-agency group for child mortality estimation, 2022. Available: https://childmortality.org/wp-content/uploads/2023/03/UN-IGME-Stillbirth-Report-2022.pdf. Accessed 17 Apr 2023. 

10-WHO. Maternal mortality. https://www.who.int/news-room/fact-sheets/detail/maternal-mortality. Published 7 Apr 2025. Accessed 11 Jul 2025. 

11-UNIG for CME. Levels & trends in child mortality: report 2019, estimates developed by the United Nations inter-agency group for child mortality estimation [online], 2019. Available:https://data.unicef.org/resources/levels-and-trends-in-child-mortality-2019. Accessed 25 Apr 2023.

12-UNIG for CME. Standing Up for Stillbirth: Current estimates and key interventions, United Nations Children’s Fund, New York, 2025 https://childmortality.org/wp-content/uploads/2025/03/UNIGME-Stillbirth-Report-2024.pdf. Accessed 11 Apr 2025.

13-UNICEF. The State of the World’s Children 2009: Maternal and newborn health. New York: UNICEF; 2009.

14-Maaløe N, Kujabi ML, Nathan NO, Skovdal M, Dmello BS, Wray S, van den Akker T, Housseine N. Inconsistent definitions of labour progress and over-medicalisation cause unnecessary harm during birth. BMJ. 2023 Dec 6;383:e0765. doi: 10.1136/bmj-2023-076515. PMID: 38084433; PMCID: PMC10726361.15

15-Murphy DJ, Liebling RE, Verity L, Swingler R, Patel R. Early maternal and neonatal morbidity associated with operative delivery in second stage of labour: a cohort study. Lancet. 2001 Oct 13;358(9289):1203-7. doi: 10.1016/S0140-6736(01)06341-3. PMID: 11675055.

16-Nolens et al. Use of assisted vaginal birth to reduce unnecessary caesarean sections and improve maternal and perinatal outcomes. https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(19)30043-9/fulltext. Lancet Glob Health2019;7:e408-e409.

17-Clark EA, Silver RM. Long-term maternal morbidity associated with repeat cesarean delivery.Am J Obstet Gynecol. 2011 Dec;205(6 Suppl):S2-10. doi:10.1016/j.ajog.2011.09.028. Epub 2011 Oct 6. PMID: 22114995.

18-Moraitis AA, Oliver-Williams C, Wood AM, Fleming M, Pell JP, Smith G. Previous caesarean delivery and the risk of unexplained stillbirth: retrospective cohort study and meta-analysis.BJOG. 2015 Oct;122(11):1467-74. doi:10.1111/1471-0528.13461. Epub 2015 May 29. PMID: 26033155.

19-WHO. New WHO guidance on non-clinical interventions specifically designed to reduce unnecessary caesarean sections. https://www.who.int/news/item/11-10-2018-new-who-guidance-on-non-clinical-interventions-specifically-designed-to-reduce-unnecessary-caesarean-sections. Published 11 October 2018. Accessed 31 March 2023.

20-Sewell JE. Cesarean Section – A Brief History. Located in US National Library of Medicine. https://www.nlm.nih.gov/exhibition/cesarean/part1.html. Updated 26 July 2013. Accessed 6 April 2023.

21-Blackstone F, Katukuri V. Will vacuum delivery go the way of vaginal breech delivery? Contemp Ob Gyn.2019 Jul 10; Vol 64 No 07.

22-Baskett TF. Operative vaginal delivery – an historical perspective. Best Pract Res Clin Obstet Gynaecol.2019 Apr;56:3-10.

23-RCOG Congress in Oman, October 2024--questionnaire data on file.

24-WHO. Newborn Mortality. https://www.who.int/news-room/fact-sheets/detail/newborn-mortality. Published 14 Mar 2024. Accessed 11 Apr 2025.

25-OB/GYN meeting in Italy, November 2024--questionnaire data on file.