Founded Q1 2018
Stage Business development; safety clinical study
Investors Trendlines Incubators Israel, Sheba Medical Center
CEO David Shashar, MD
Lioness is a disposable silicone device placed in the vagina and secured high around the uterine cervix. Lioness maintains its position on the cervix despite pressure and contractions, stopping cervical dilatation, keeping the cervix elongated, and delaying the “cascade” that leads to preterm birth.
The technology draws on the advantages of suturing the cervix (cerclage) and pessaries; yet, without their drawbacks. Other advantages —
PregnanTech’s preterm birth kit includes Lioness, a deployment apparatus, and a cervix grasping tool.
IP – National phase
Preterm birth is the #1 problem in obstetrics. Between 9% and 17% of all pregnant women are at risk for preterm birth. In the United States, expenses associated with preterm births surpass $25 billion annually. Unfortunately, existing solutions for prevention and delay of spontaneous preterm birth 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 that will delay or prevent preterm birth, improve newborn health and reduce costs.
PregnanTech answers this need. The Company has developed LIONESS, a novel, non-surgical and safe solution for the prevention of preterm birth.
David Shashar received his medical degree from the Hebrew University in Jerusalem and is board certified in obstetrics and gynecology. He holds an executive MBA from the Kellogg-Recanati Business School and a MSc in biomedical engineering from the Technion-Israel Institute of Technology.
Prior to leading PregnanTech, David was the medical director of multidisciplinary collaboration platforms at Sheba Medical Center, assigned to proactively align physicians and engineers from the Israeli medical industry and academia to develop cost-effective, innovative medical technological solutions to meet pressing clinical problems. He has vast experience in inventing, innovating and developing new medical technologies.
Ms. Sandach holds BSc in Chemical engineering and ME in industrial Design from the Technion Israel Institute of Technology, Haifa, Israel. Limor is a senior manager with over 20 years of experience investing in healthcare innovation and managing start-ups in medical devices. Limor served as CEO of AV Medical Technologies. During her tenure, AV completed product development, obtained CE and FDA approvals, and began generating sales in the United States. Following a successful partnership, AV was acquired by Medtronic in late 2019.
In Parallel, Limor was a partner in Access Medical Ventures (AMV), invested and served as a director in medical device start-ups. Prior to that, Limor served at management positions in healthcare VCs – 7Healthventures, Evergreen and XT – leading due diligence and portfolio development.
Nufar holds a BSc in Biology and Cognitive Science from the Hebrew University in Jerusalem and possesses over eight years of experience in the field of medical device as a Clinical Research Associate and Clinical Trials Manager. During her tenure in a leading regulatory affairs consulting company, Nufar has monitored and managed multiple clinical trials conducted worldwide, for a variety of medical device companies.
Preterm birth (defined as delivery between 24 and 37 weeks of pregnancy) is the #1 problem in obstetrics. One in 10 babies worldwide is born preterm (15 million a year). Of these, 1 million will die and 1 million will suffer substantial disabilities for the rest of their lives, including breathing or feeding disorders and neural disabilities.
Babies born prematurely pose a huge financial cost to health care systems and families. In the United States, expenses associated with preterm births surpass $26 billion. Between 9% and 17% of all pregnant women are at risk for preterm birth.
Currently available treatments such as medications, hormones, suturing the cervix (cerclage), and pessaries are unsatisfactory. Obstetricians are at a loss in treating preterm birth.
PregnanTech estimates the market potential for Lioness to be more than $2 billion annually in developed countries alone.