By: David Shashar
CEO
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PregnanTech

PregnanTech has developed a groundbreaking new medical device for the prevention of preterm birth. Preterm birth is the most common, catastrophic, and costly complication of pregnancy and the leading cause of infant death and illness worldwide.

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Minimum investment: $8,500
Type:Convertible  
Stage:Seed
Category:Medical Devices
•  Overfunding - Over 100%    
  • Campaign Highlights
  • Pitch
  • Team
  • Financial data
  • The Deal
  • Documents
  • Disclosures
  • Updates

Campaign Highlights

Breakthrough Medical Technology Protected by Two Patents

PregnanTech's device, called LIONESS, is designed to create a revolution in the field of obstetrics and neonatology (newborn medicine) with a novel, non-surgical and safe solution for the prevention of preterm birth. The company holds two patents that protect the product's technological innovation — the results of collaborative development by a team of expert gynecologists and engineers.

 

 

 

 

Current Company Investors

PregnanTech is funded by the Trendlines Group, which specializes in investments in start-ups in the field of medical technology, and by the Israel Innovation Authority. The company has received an additional investment from the Sheba Medical Center at Tel Hashomer, Israel.

 

 

Clinical Success and International Collaboration

PregnanTech has conducted a range of successful preclinical studies and in 2019 began a clinical safety study with the LIONESS among non-pregnant women intended for hysterectomy. Initial findings demonstrate the significant potential inherent in the device. The most influential obstetrician in Europe, Professor Kypros Nicolaides from King's College Hospital in London, has expressed his interest in leading, during 2021, a first clinical trial among pregnant women at risk of preterm birth.

 

Enormous Economic Savings for  Health Care Systems and Families

The financial burden resulting from preterm birth on health systems, hospitals and families is enormous. Approximately half of all infant hospitalization costs are attributed to treatment of preterm born infants, although these constitute only 10% of births. The cost of treating a preterm newborn is approximately 10 times that of a newborn born at term. Every additional week makes a difference. Delaying a preterm birth by as little as a week could reduce expenses by at least 25%.

 

Multidisciplinary and Experienced Team in The Fields of Medicine, Engineering and Business Development

The PregnanTech venture originated as a collaboration between engineers from Trendlines Labs and physicians from Sheba Medical Center at Tel Hashomer, Israel. The company's founders are physicians in the field of Obstetrics and Gynecology that are personally familiar with the daily suffering caused by preterm birth and the need to find an efficient solution. CEO and founder Dr. David Shashar is an obstetrician and engineer who has extensive experience in managing collaborative work between physicians, medical engineers, and business development experts from universities and Israeli industry in the process of developing new innovative medical technologies.

 

Pitch

The idea

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 loved 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 on 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 the 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 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.

 

Effectiveness:

  • 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

Team

Dr. David Shashar
CEO and Founder
Biography
Dr. Shashar graduated from the Hebrew University Medical School and completed his training in Obstetrics and Gynecology at the Sheba Medical Center at Tel Hashomer. David also holds a Master‘s Degree in medical engineering from the Technion and an MBA from Tel Aviv University. He has extensive experience in leading collaborations between physicians, engineers and business experts from the Israeli academia and industry in developing innovative technological solutions to unmet medical needs.

  • Founder
Nir Lilach
Development Manager
Biography
Nir has over 20 years of experience in leading medical projects from concept to the manufacture of a final product. Nir serves as partner at Eliachar Technologies Development, which specializes in the development of technological products for the medical sector. Nir has a degree in industrial design from IED – Istituto Europeo di Design.

Dr. Helena Grinberg-Rashi
Regulatory Manager
Biography
Helena holds a PhD in Molecular Medicine and Human Genetics and an MBA from IDC. She is a senior consultant in clinical development and global regulations for medical device companies, digital health technologies, pharma and bio technologies. Dr. Grinberg-Rashi is the owner of HGR consulting services and her rich experience is utilized for the formulating PregnanTech‘s clinical & regulatory strategy.

Steve Rhodes
Director
Biography
Mr. Rhodes is the chairman and founder of The Trendlines Group. Steve holds a BA from Harvard University and an MBA from the University of Chicago. He has extensive investment experience and serves as a director in many of Trendlines‘ portfolio companies. Mr. Rhodes has years of management experience, including in-depth understanding of financial and organizational requirements for commercial exploitation of start-up companies. He has been involved in dozens of successful negotiations with strategic partners and distributors in the medical device industry.

Professor Eyal Schiff
Medical Consultant
Biography
Professor Schiff directed the Division of Obstetrics, Gynecology and Fertility at the Sheba Medical Center at Tel Hashomer from 2002 to 2019. He is an associate professor at Tel Aviv University and an expert in high-risk pregnancy. He has published over 100 academic articles in the field. Professor Schiff was nominated one of the best Gynecologists in Israel for 5 consecutive years according to Forbes magazine.

Dr. Susan Alpert
Clinical and Regulatory Consultant
Biography
Susan has extensive experience in the field of medical regulatory affairs. She served as VP of Regulatory Affairs at Medtronic where she led the company‘s global regulatory processes. Dr. Alpert worked for the FDA for many years, six of them in assessing medical devices. Dr. Alpert is a pediatrician.

Financial data

The Deal

Documents

Disclosures

Updates

Currently there are no updates in this pitch

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