PregnanTech

Every year, 15 million babies world-wide are born preterm before 37 weeks of pregnancy. Prevalence is 5 to 12 percent of all deliveries in developed countries and up to 18 percent in developing countries. In the US, more than 10% of all babies are born preterm. These newborns come to the world before their organs have matured and are immediately taken to Neonatal Intensive Care Units (NICUs), where they are connected to masks and tubes intended to support them with oxygen, fluid and medications and to monitors that follow their vital signs.

Life in the NICU is difficult both for the newborns and their families, who are constantly at their side. Parents are filled with anxiety and uncertainty regarding their beloved newborn, not knowing whether they will live or die, or recover to health. Parents are forced to cope with additional difficulties such as purchase of special medical equipment, loss of workdays and additional expenditures.

In many cases, preterm babies that survive the struggle of the first months of life will require medical supervision and follow-up for many years. They may suffer various complications with severe disabilities including respiratory impairment, feeding disorders, neurological disabilities, vision disorders, hearing impairment, developmental delay and cerebral palsy.

The Need

The medical world has made progress in the care of preterm infants with the application of advances including incubators, medications and innovative treatment methods. However, the best option is still, without a doubt, the prevention or delay of preterm birth. Every additional week in the uterus is crucial for the development of the fetus. One week can mean the difference between a baby that grows in a healthy and normal manner and one that may suffer from health difficulties for the rest of his or her life.

The existing solutions for prevention and delay of spontaneous preterm birth, including medications, hormones or surgical interventions, do not provide effective results. This is why the rate of preterm births worldwide has not changed for decades. There is a critical need for an effective solution. Health care systems are willing to pay for a new and successful technology that will delay or prevent preterm birth, improve newborn health and reduce costs.

LIONESS was developed in the recognition that for the prevention of spontaneous preterm birth, it is necessary to decrease the load on the inner edge of the cervix (the internal os).  Decreasing the load and pressure reduces hormonal signaling, the biochemical cascade (interleukins, prostaglandins, oxytocin, etc.) and the changes in cervical tissue (collagen, proteoglycans, elastin, water, etc.) that lead to softening of the cervix and preterm birth.

The Solution

PregnanTech’s innovative technology is a smartly structured silicone ring put in place by the physician, during a simple outpatient procedure that takes only a few moments. It is placed high around the uterine cervix, in a non-surgical manner, yet at the site of the best existing surgical solution.

The special structure of LIONESS allows the device to remain in place, keep the cervix elongated and avoid dilatation despite contractions. The LIONESS ring reduces the load on the cervix, thereby preventing the biomechanical cascade leading to preterm birth.

Existing treatments

There are a few treatments for delaying preterm birth, yet all are unsatisfactory. This is why the rate of preterm births has not changed in decades.

These include hormones (progesterone) and medications called tocolytics that have many side effects and are intended to reduce frequency of contractions.

Another existing approach, cervical cerclage, is a suture placed around the cervix. This is a solution suitable only in cases of women with a history of late miscarriages or preterm birth due to cervical insufficiency. Applying a cerclage is a surgical procedure necessitating anesthesia and it carries the risk of injury to the cervix if contractions begin.

The cost to health care systems for the cerclage surgical procedure and for some of the latest tocolytic medications can reach thousands of dollars per patient.

Pessaries are treatments originally developed for vaginal and uterine prolapse. In 2012, a medical publication suggested that the Arabin pessary might reduce the rate of preterm birth. However, numerous subsequent multicenter studies have shown it to be ineffective. The Arabin is not approved for use and sale in the United States, its efficacy is debatable, and it is not recommended for use to prevent preterm birth.

Advantages of LIONESS 

LIONESS has significant advantages over the other existing solutions with regard to efficacy, safety and ease of placement.

Efficacy:

• Inserted non-surgically in the vagina, high around the uterine cervix at the location of the existing surgical solutions
• Reduces pressure and load on the cervix and prevents shortening and dilatation
• Remains in place despite pressure and contractions
• Is specifically designed to overcome the biomechanical cascade leading to preterm birth

 Safety:

• Does not cause cervix tissue injury
• Can be easily removed
• Self-releasing mechanism in case the patient enters active labor

Ease of placement:

• Simple and fast procedure (process of a few minutes)
• Can be inserted in an Ob/Gyn clinic
• Quick and easy removal when reaching term