Obstetrx Publishes Positive Results Of Pilot Study For Its Novel 'Mini-Sponge' Technology To Stop Severe Hemorrhage Following Childbirth
WILSONVILLE, Ore., Nov. 11, 2020 /PRNewswire/ -- Obstetrx, Inc., an early-stage company focused on leveraging proven technology to effectively treat postpartum hemorrhage (PPH), today announced results of a pilot study of its novel XSTAT PPH uterine tamponade device. The research findings, published in Obstetrics & Gynecology, Management of Postpartum Hemorrhage With a Mini-Sponge Tamponade Device (Nov 2020 - Volume 136 - Issue 5 - p876-881), demonstrate that XSTAT PPH can be safely, quickly and easily administered and successfully stop severe uterine bleeding within one minute, with no additional clinical intervention. PPH is a life-threatening condition that accounts for 20% of all maternal deaths globally.
"Postpartum hemorrhage often requires a series of progressively invasive and costly treatments, including blood transfusions or surgery, with increased risk to the mother," said Maria I. Rodriguez, MD, MPH, Department of Obstetrics & Gynecology, Oregon Health & Science University, and principle investigator of the study. "The XSTAT PPH showed promise as a safe, simple, and effective solution that could become a first-line treatment, reducing bleeding and transfusions, as well as lowering costs associated with the current standard of care, while achieving comparable or improved efficacy."
The pilot study was conducted at the University Teaching Hospital in Lusaka, Zambia, to evaluate safety, efficacy, and ease of use of the XSTAT PPH device. The device was successfully placed in nine patients experiencing postpartum hemorrhage after vaginal birth who failed to respond to conventional pharmacologic treatments. In all cases, bleeding was resolved within one minute. Patients did not require further surgical intervention or blood transfusions, and no device-related adverse events were reported.
The mean time to place the XSTAT PPH device was 62 seconds, markedly less time than has been documented with the current standard of care (silicone obstetric balloons). The investigators noted that this rapid placement time, even with first use, reflects an important advantage of the device, since decreasing the time from hemorrhage diagnosis to successfully controlling blood loss reduces patient morbidity and the need for blood transfusions.
"The 'mini-sponge' technology used in our uterine tamponade device was developed by RevMedx, Inc. in collaboration with the U.S. Special Forces to rapidly stop high-flow bleeding without the need for external compression or other intervention. This technology is already successfully saving the lives of soldiers on the battlefield, and we are enthusiastic about its potential to save mothers' lives during childbirth," said Andrew Barofsky, co-founder, president, and CEO, Obstetrx. "We look forward to completing the clinical development of XSTAT PPH and to establishing this novel treatment as a new standard of care that transforms the management of postpartum hemorrhage."
Obstetrx is planning to launch a pivotal trial with XSTAT PPH in the first half of 2021 in preparation for submission to the U.S. Food and Drug Administration (FDA) for 510k market clearance in 2022. The company is preparing to begin manufacturing and sales of its novel PPH device promptly following market clearance using existing FDA-registered manufacturing systems and capabilities.
About XSTAT PPH
The mini-sponge XSTAT hemorrhage-control technology is licensed from Oregon Biomedical Engineering Institute, Inc. XSTAT received FDA clearance in 2014 and CE Mark certification in Europe in 2018 to treat high-flow arterial bleeding in military and civilian prehospital trauma settings.
About Postpartum Hemorrhage
About Obstetrx, Inc.
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