Advanced Prenatal Therapeutics, Inc. (APT) announced today that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device Designation for APT’s Targeted Apheresis Column for Preeclampsia (TAC-PE).
| LAGUNA HILLS, Calif., April 17, 2019 /PRNewswire/ -- Advanced Prenatal Therapeutics, Inc. (APT) announced today that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device Designation for APT’s Targeted Apheresis Column for Preeclampsia (TAC-PE). The Designation enables APT to work collaboratively with the FDA to expedite development and regulatory timelines while maintaining a high level of compliance to standards for premarket approval. APT’s novel device specifically removes disease-causing factors from the mother’s blood. It is intended to treat preeclampsia, a leading cause of prematurity and maternal/fetal death, and holds potential to substantially reduce mortality, incidence or severity of preterm birth, and the use of neonatal intensive care. “We were navigating virtually uncharted waters in 2005 when we first proposed that preeclampsia could be treated using an apheresis column to remove pathogenic factors such as sFlt-1,” said Dr. James Smith, President/CEO of APT. “Now that we are preparing for initial clinical studies, we are very pleased that the Breakthrough Designation will help provide a clear and efficient pathway to market.” The FDA grants Breakthrough Device Designation to devices that provide more effective treatment of life-threatening or irreversibly debilitating diseases. Devices must also represent a breakthrough technology, treat a disease where no approved alternatives exist, offer significant advantages over existing approved alternatives, or otherwise be in the best interest of patients. Participation in the Breakthrough Devices Program gives APT access to prioritized review of regulatory submissions like the investigational device exemption (IDE) and pre-market approval application (PMA). Additional benefits include interactive and timely communication with a designated FDA team, efficient and flexible clinical study design, and expedited review/inspection of manufacturing sites. About Advanced Prenatal Therapeutics, Inc. This press release may contain forward-looking statements that involve risks and uncertainties associated with product development and other business operations. APT’s devices are not currently approved by the FDA or other regulatory agency. There can be no assurance that these forward-looking statements will prove to be accurate, and they should not be regarded as a representation that the objectives and plans will be achieved. Contact
SOURCE Advanced Prenatal Therapeutics |
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