It took less than 9 months for InPress Technologies to fund and successfully conclude a 1st-in-human trial of its disposable device for treating postpartum hemorrhage, co-founder & CEO Jessie Becker said last week.
Mountain View, Calif.-based InPress said the 10-patient trial, held in Jakarta at 3 medical centers, showed that the device helped stop hemorrhaging within 2 minutes and achieved full control of bleeding in about 2 hours.
By contrast, competing devices or treatments take 10 to 24 hours to accomplish the same thing, InPress said.
"In less than nine months, we funded and completed our first human study with encouraging results. This initial clinical validation is a major accomplishment, and puts us 1 step closer to making our proprietary device part of the standard procedure for childbirth around the world," Becker said in prepared remarks.
The single-use device is inserted into the uterus after childbirth to produce an immediate, vacuum-induced tamponade effect, working with the body to encourage a natural response to postpartum hemorrhaging. InPress pitches it as a way to reduce deaths stemming from the condition, boost the standard of care and lower healthcare costs.
InPress said it plans an investigational clinical trial of its device in late 2015 once it wins the FDA’s approval.