DONI

A device that supports skin and muscles between the vagina and rectum, preventing perineal tears that can have serious consequences (OASIS).

 

Obstetric anal sphincter injuries (OASIS) are caused by perineal trauma during vaginal delivery, also referred to as third- and fourth-degree perineal lacerations. OASIS is a well-known complication of childbirth with a reported incidence rate of 6%.

Third- and fourth-degree tears are traumatic, requiring surgical repair to be conducted in an operating room by a surgeon.

2/3 of women who sustain a recognized 3rd and 4th degree tear during delivery subsequently suffer from fecal incontinence, sexual dysfunction and others will require psychological therapy due to worsening in quality of life. Recovering can be hard and can last up to six months. direct costs are around $50,000 per patient.

Inventors

Michal Grosvald Yaar, Rabin Medical Center

Contact info

Avital Pritz, Director of Medical Devices and Digital Health

For further information please contact:

avital@mor-research.com

A device that supports the skin tissue, protects the perineum muscles, perineal body, and the tissue between the vagina and the rectum. The device consists of a plastic main frame, straps, a heating compartment, and fastening tape. The main frame is shaped and configured to conform to the area around the anus and vagina and forms a guide to assist the birthing of the baby. The support device exerts force to compress and stabilize the posterior vaginal wall and the perineum.

In the US alone there are 240,000 cases each year of women with 3rd and 4th degree tears.
The cost per case to the health system is $50, 000 which means that the cost to the health system is $13B per year!
The potential market in the US alone is estimated at $540M with 3M vaginal births each year. This device has the potential to protect any woman that is going through vaginal delivery from perineal tear which means that the Total Addressable Market is huge.

Initial prototype developed

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