Yaari

Device-Based Treatment of Shoulder Dystocia

Device Based Treatment of Emergency Shoulder Dystocia Births

SHOULDER DYSTOCIA

Shoulder dystocia is an emergency birth complication in which the baby’s head has been born but one of the shoulders becomes stuck behind the mother’s pubic bone, delaying the birth of the baby’s body. The dystocia must be dealt with within 7 minutes in order to prevent serious injury or death to the baby. A series of manual maneuvers is currently used to release the baby’s shoulders.

There are an estimated 1.5 million cases of shoulder dystocia annually worldwide. Shoulder dystocia can result in maternal injury, neonatal injury, permanent disability and death and is the most common cause of obstetric brachial plexus injury (OBPI). Approximately 50,000 newborns each year worldwide are left with permanent brachial plexus injury due to shoulder dystocia.

THE YAARI EXTRACTOR

The Yaari Extractor™ is a simple mechanical solution to aid physicians in resolving shoulder dystocia births. The extractor is comprised of two control arms and a flexible engagement element. The flexible element is introduced into the birth canal and is wrapped around the fetal shoulder from behind the maternal pubic bone. Using the control arms, the physician manipulates the fetal shoulder to a position where the maternal pushing effort can deliver the shoulder.

HOW IT WORKS

The Yaari Extractor resolves shoulder dystocia by removing the anterior fetal shoulder from behind the maternal pubic bone and moving it to the oblique diameter where it is delivered safely.

The device achieves the following tasks without applying traction to the fetal head or neck:

Disengaging the anterior fetal shoulder from the maternal pubic bone.

Rotating the fetal shoulder to the oblique diameter.

Delivering the fetal shoulder from the birth canal.

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CAUTION: Investigational device. Limited by United States law to investigational use.

CLINICAL BENEFITS

Simple-to-use

Single-use mechanical tool.

Anatomically Compliant

Combines both rigid and flexible elements to best suit anatomy with no traction applied to the fetal head or brachial plexus.

Control

Direct and controlled application of limited force.

Safety

The maternal pelvis is not used as a fulcrum.

CLINICAL BENEFITS

Simple-to-use

Single-use mechanical tool.

Anatomically Compliant

Combines both rigid and flexible elements to best suit anatomy with no traction applied to the fetal head or brachial plexus.

Control

Direct and controlled application of limited force.

Safety

The maternal pelvis is not used as a fulcrum.

ABOUT

FetalEase is a privately held Israeli start-up company dedicated to commercializing the Yaari Extractor. The device was invented by Dr. Abraham Yaari, an OB/GYN with over 20 years of experience delivering babies in the US and Israel.

We are driven by our mission to prevent unnecessary injuries to mother and newborn and seek to collaborate and partner with organizations dedicated to improving outcomes of complicated births globally

LEADERSHIP

MANAGEMENT

Aaron Feldman

CEO

More than 20 years’ experience in the R&D and commercialization of medical devices. Former CEO of Rafael Medical Technologies, CardioFlow and currently co-Founder of Ark Surgical and Restore Medical.

Abraham Yaari, MD

Medical Director

Trained as an OB/GYN in the US and in Israel, followed by over 20 years of practice in those countries. Co-founder of Ark Surgical.

Cindy Domecus

Director of Clinical Affairs

Executive level Regulatory Affairs and Clinical Research professional with over 30 years of experience and expertise. Former Senior Vice President/Vice President of Regulatory Affairs and Clinical Research for Conceptus and Kyphon. Managed the FDA clearance process for Alydia Health’s Jada device.

Anne Geary Schmults

Vice President of Marketing and Sales

Senior commercial executive in the medical device industry including in the high-risk obstetrics market. Former Director of Business Development at Alydia Health and Business Development Consultant at Safe Obstetric Systems. Anne has also held sales leadership positions at Stryker, Kyphon (acquired by Medtronic), Spine Tech (acquired by Sulzer Medica), and Johnson and Johnson.

Nishant Varma - FetalEase

Nishant Varma

Director of Sales and Business Development

Founding partner of Safe Obstetric Systems. Commercialised a solution for high-risk C-sections (Fetal Pillow), scaled operations internationally, and led the company's exit to CooperSurgical (appointed as Director of Business Development). Prior experience includes Investment Banking at Barclays.

Ahava Stein

Director of Clinical Operations

Over 20 years of experience working directly with the FDA as well as with CE submissions. Ahava has managed multicenter, clinical studies, participated in numerous BIMO inspections, clinical site inspections in the US, Europe and Israel.

BOARD OF DIRECTORS

Isaac Silberman

Entrepreneur and impact investor with a business background in real-estate and private equity deals, as well as with NGOs.

Abraham Yaari, MD

Trained as an OB/GYN in the US and in Israel, followed by over 20 years of practice in those countries. Co-founder of Ark Surgical.

Ross McQuivey, MD

Senior healthcare industry leader and OB/GYN physician. Former Chief Medical Officer of Laborie and of Clinical Innovations. Currently CMO of Biote.

Aaron Feldman

More than 20 years’ experience in the R&D and commercialization of medical devices. Former CEO of Rafael Medical Technologies, CardioFlow and currently co-Founder of Ark Surgical and Restore Medical.

ADVISORS

Anne Morrissey

Strategic Advisor

Former President and CEO of Alydia Health from 2016 to 2020. Alydia Health was acquired by Organon in June 2021 for $240M. Previously, she also served as Marketing Manager at General Surgical Innovations, subsequently acquired by Tyco.

Edward Evantash, MD

Clinical Affairs

Past Medical Director and Vice President, Global Medical Affairs at Hologic and Chief Medical Officer of Alydia Health. Dr. Evantash previously served as Division Chief of Obstetrics and Gynecology at Tufts Medical Center. He received his medical degree from the University of Pennsylvania School of Medicine as a Penn Scholar.

Robert Gherman, MD

Principal Investigator

MFM specialist in Chambersburg, PA. Practices at WellSpanMaternal-Fetal Medicine and is affiliated with MedStar Franklin Square Medical Center. Researched and published extensively on the topic of shoulder dystocia and is considered a leading expert on the subject.