Preterm Birth

Preterm birth is the largest barrier to optimal birth outcomes facing families today.

15 million

Babies born preterm each year

1.1 million

Worldwide deaths each year

#1 leading cause of death

Preterm birth complications are the leading cause of death among children under 5 years of age.

The numbers are

Climbing consistently.

Here at Galena Innovations, we plan to change the current state of preterm birth management with our revolutionary device.

On this page, you’ll learn everything you need to know about preterm birth. Let us know if you’d like to learn more about how Galena Innovations is leading the way in preventing preterm birth.

Change is Needed to Address Preterm Birth (PTB)

Survivors face lifelong complications

Families have longer and more frequent hospital visits

Preterm birth costs the U.S. $26.2B per year

The Path to

Spontaneous Preterm Birth

- Behaviors
- Demographics
- Environmental factors
- Support factors
- Maternal and fetal HPA axis
- Genetics
- Race and ethnicity
- Socioeconomics
- Maternal health
- Obstetric history
- Obstetric health
- Other

- Infection and inflammation
- Uterine, placental, or decidual bleeding
- Cervical tissue dysfunction
- Uterine overdistension
- Placentation and implantation errors
- Maternal-fetal stress response

PPROM
(Decidual and fetal membrane activation)
Cervical insufficiency
(Cervical remodeling)
Preterm labor
(Myometrial activation)
PPROM, cervical insufficiency, and preterm labor can facilitate one another or act independently

- Softening
- Funneling
- Effacement
- Dilation

Addressing the Gap in Care

The goal is to provide optimal care for those facing preterm birth

Answering one of the most prevalent problems in modern-day obstetrics

The World Health Organization (WHO) has asked for safe, feasible, and cost-effective care

To help address this growing and fatal condition

Focusing on cervical ripening

is the most logical place to begin to prevent PTB

PHYSICIANS

Physicians are looking for solutions. One physician stated:

“Nothing else really works.”

MOTHERS

Mothers are looking for answers. One mom stated:

“I would be willing to try anything to prevent preterm labor again.”

When shown the Hannah Cervical Cup, one mom said:

“Where was this on my child’s date of birth?”

introducing

The Hannah Cervical Cup

The Benefits:

Placing the cervix in a state of ripening-resistant tension
Improving the stiffness of the cervix over time
Creating pelvic floor support
Creating a barrier to infection
Creating an environment where amniotic fluid can reaccumulate
Offering a mode of medication administration
Maintaining all benefits for the length of pregnancy

How it works

THE HANNAH CERVICAL CUP is placed on the cervix by suction. The combination of the cup’s structure and suction enable the cervix—made up of collagen—to enhance its natural load-bearing qualities by creating tension. This initially elicits the collagen fibers to realign, creating cervical stiffness and enabling the internal cervical os to remain closed. Over time, the extracellular matrix becomes strengthened as the tension stimulates collagen synthesis and reorganization of collagen fibers to support the pregnancy.

- The shape of the cup’s flange offers pelvic floor support.
- The device protects pregnancy after early membrane rupture as an infection barrier and by allowing fluid to reaccumulate.
- The Hannah Cervical Cup can dispense medication through a ring that surrounds the cervix.
The Hannah Cervical Cup is applied after the 12th week of pregnancy by a physician in an out- or in-patient setting and is designed to be removed at the 37th week of pregnancy. Placement and removal take only a few minutes and can prolong pregnancy for weeks.

Galena Innovations will Philanthropically Focus on Preventing Preterm Birth in the Developing World

Our philanthropic goals:

Gain funding from outside sources. If you wish to contribute, please contact us
Collaborate with existing charities that have working infrastructures in place to educate birth attendants
Facilitate a volunteer program with mothers and birth workers in developed countries
- Ask established entities to be involved (Helping Babies Breath, Helping Babies Survive)
- Engage providers, nurses, and key opinion leaders to act as volunteers
- Engage SMFM and ACOG to assist in curriculum development for birth workers

Gain regulatory approval in specific countries
Gain cultural assimilation and acceptance of the Hannah Cervical Cup
Train birth workers on use of the Hannah Cervical Cup
Decrease the preterm birth rate in the top-ten most prevalent countries: Malawi, Comoros, Congo, Zimbabwe, Equatorial Guinea, Mozambique, Gabon, Pakistan, Indonesia, Mauritania
Service between 8.6 to 14 million women in this setting

Preterm Birth