We are confident in one thing... it is now no longer a matter of "IF" we can drive down maternal and infant mortality rates worldwide -- with this novel approach to resolving labor dystocia, it is now just a matter of "WHEN".

 

WHAT WE KNOW

• Labor dystocia (abnormally slow or protracted labor) accounts for the diagnosis or medical indication for up to 55% of primary cesarean deliveries in the United States. 

• The rising maternal morbidity and mortality rate is tied to a steady increase in cesarean sections, beginning in1970 when the cesarean section rate in the United States was at about 5%. In 1990, the c-section rate grew to about 22%, and by 2014 it began hovering at about 30%.

• Unfortunately, cesarean section rates are the highest in the southern United States where it reaches as high as 38%, with some hospitals reporting up to 50% of their deliveries as c-sections.

• Cesarean section rates are highest among Black women, as are the rates of morbidity and mortality. According to the CDC, cesarean section rate for black women in 2021 was 36.8% as opposed to white women, at 31%. And according to an 11-year analysis of more than 9 million deliveries in U.S. hospitals, presented at the ANESTHESIOLOGY® 2022 annual meeting, researchers found, "Black women have a 53% increased risk of dying in the hospital during childbirth, no matter their income level, type of insurance or other social determinants of health."

• In 2021 there were 1,174,545 cesarean deliveries representing 32% of all deliveries.

• The Department of Health and Human Services' (HHS) Healthy People 2030 initiative has set a target C-section rate of 23.6% for low-risk deliveries.

• Only four states in 2021 were able to achieve a c-section rate of less than 25%.

​

THE COST OF DOING NOTHING: HUMAN AND FINANCIAL

• Researchers in 2019 found that "cesarean delivery was associated with 2.7 times the risk of severe maternal morbidity (95% CI: 2.6, 2.7), compared to vaginal delivery, and was estimated to contribute to 37% (95% CI: 36, 38) of severe maternal morbidity cases in the population."

• Through a retrospective study conducted in 2022, researchers "estimated that the total cost of nine maternal morbidity conditions for all pregnancies and births in 2019 was $32.3 billion from conception to five years postpartum, amounting to $8,624 in societal costs per birthing person."

• There is an average of a $14,000 difference in healthcare costs incurred by a cesarean section as opposed to a vaginal delivery. If over 50% of cesarean sections are due to labor dystocia caused by fetal malpositioning, this represents an $8.22 billion dollar problem

• A study in 2023 examining trends in in-hospital severe maternal morbidity and mortality (SMM) rates found that "...maternal mortality improved between 2008 and 2021 despite increases in SMM prevalence and presence of comorbidities for the overall population." 

• In 2022, a retrospective study done by the CDC found that four in five pregnancy related deaths in the United States are preventable.

​

WHAT IS THE CURRENT STATE OF THE ART

• To date, there are no tools or mechanisms available, aside from maternal repositioning techniques, to help correct fetal lie and resolve labor dystocia.

​

WHAT WE WILL ACCOMPLISH

• FINANCIAL IMPACT: If the ErgoBirthing Fetal Rotation System resolved labor dystocia for just 10% of all labors and reduced cesarean sections by 10% nationwide, that would equal a reduction of over $1.6 billion dollars in unnecessary healthcare costs.

• HEALTH IMPACT: The ErgoBirthing Fetal Rotation System, if successful in resolving just 10% of all episodes of labor dystocia, has the potential to save hundreds of thousands of women per year from the physical, psychological and financial impacts of unplanned cesarean sections and from complications resulting from prolonged labor and surgery, including severe morbidity and even death.

​

OUR LEAN STARTUP TEAM

• Founder, CEO and Chief Product Officer: Sherah Bassard brings over 21 years of direct care experience with laboring women, and nearly 30 years in women's healthcare nursing. With intimate, hands-on knowledge of the biological mechanisms and processes of labor as well as the specific educational needs and workflow requirements particular to the childbirth clinical setting, she provides invaluable insight, practical solutions, and product design capabilities to some of maternal health's most intransigent challenges. In addition to designing products, she will be spearheading the formulation of the clinical education content and marketing strategies of the company.

• Chief Financial Officer: We will utilize the fractional CFO services offered by Eco-Tax, CPA and financial consulting company. Eco-Tax provides bookkeeping, CPA services, and a dedicated Fractional CFO to provide personalized support and business management services. 

• Chief of Business Development: TBD. We will conduct a search for a business development expert with a background in intellectual property law and deep experience in management, scaling, and fundraising for medical device companies.

• Chief of Marketing and Education: TBD. We will conduct a search for an experienced educator with an established and successful online and/or in-person perinatal education platform, connections to clinicians and deep knowledge of the world of perinatal nursing and childbirth management.

 

WHAT WE NEED TO MOVE FORWARD

OUR FINANCIAL GOAL: We are seeking to raise $750K in the pre-seed round of fundraising.

• Resources to acquire a Non-Provisional Patent

• Resources to consult with a medical device attorney to determine whether FDA De Novo Device Designation must be acquired.

• Resources to Build Our Team​

  • The Founder and CEO will work full time focusing on the development and direction of ErgoBirthing Designs, Inc.

  • Chief Legal and Business Development Officer will provide expert guidance for business formation, intellectual property and contracts.

  • A fractional or permanent Chief Financial Officer will direct the formation of a strong accounting and finance team and guide financial decision-making to ensure the financial security and prosperity of the company and its investors. 

  • A fractional or permanent Chief of Marketing and Education will establish and direct the strategies, processes, mediums and content for all public communications about our products. 

 

Resources to Begin Production 

Potential partners: STARFISH MEDICAL, CLEIO, DemeTECH

We will maintain a very lean team of executives and employees by partnering with a fully vertically integrated CMO who can assist with R&D, manufacturing, regulation, and distribution. The company we select will expertly facilitate the process of bringing the Fetal Rotation System, its accompanying software, and the full suite of our products to market, potentially in a matter of months:

• research and development

• finalizing design schematics and materials

• producing and testing prototypes

• manufacturing and packaging 

• achieving and maintaining compliance with federal law for permits and approvals

• assisting with clinical trials and publishing results

• building our software interface for collecting data

• managing distribution

• ongoing product management