InPress Technologies Completes Clinical Trial of Device to Halt Postpartum Hemorrhage

InPress Technologies (InPress) has completed its first human clinical trial for a device designed to control and stop postpartum hemorrhages.

The study was conducted at three medical centers in Jakarta, Indonesia: Dr. Cipto Mangunkusumo Hospital (RSCM), RSIA Budi Kemuliaan (RSIA) and Fatmawati General Hospital (RSUP). In the study of 10 patients, hemorrhage control was initiated within two minutes of the InPress device placement and full control was reached in roughly two hours on average. Trial administrators claim the results are significant because similar devices designed to treat postpartum hemorrhages (PPH) require from 10 to 24 hours to reach full hemorrhage control.

The “First in Woman” clinical investigation began enrolling patients in July 2014, after InPress received a “Lefteroff Innovator Award” from the Fogarty Institute for Innovation (FII). Named in honor of Tracy Lefteroff, the award directly funds projects for promising new innovators working on pre-screened medical ideas.

“In less than nine months, we funded and completed our first human study with encouraging results,” said Jessie Becker, co-founder/CEO of InPress Technologies. “This initial clinical validation is a major accomplishment, and puts us one step closer to making our proprietary device part of the standard procedure for childbirth around the world.”

PPH is excessive bleeding in a mother after childbirth and the leading cause of perinatal maternal death around the world. Clinically, 80 percent of the instances of PPH are caused by failure of the uterus to contract after childbirth. Known as uterine atony, this leaves the blood vessels fully dilated and allows unobstructed bleeding. Pharmaceuticals often are used to treat PPH, but they only address its symptoms. The non-invasive InPress device is designed to solve the most common underlying cause of PPH by producing an immediate, vacuum-induced tamponade effect that results in normal postpartum uterine contractions over time.

“The InPress device works with the body to encourage the body’s natural response to PPH and does so quickly,” said Sabaratnam Arulkumaran, M.D., professor emeritus of Obstetrics and Gynecology at St. George’s University of London. “I believe it is a solution with the potential to impact how we treat PPH globally.”

Simply inserted into the uterus upon childbirth, the single-use InPress device offers the high potential to dramatically reduce the cost of healthcare as well as the risk of maternal mortality associated with PPH.

The device is not yet commercially available in the United States. InPress is planning to begin an investigational clinical trial (pending U.S. Food and Drug Administration approval) later this year.