E&C Medical now called PeriGen
E&C Medical Intelligence (Princeton, New Jersey) reported its new name: PeriGen. Currently contracted in 36 hospitals nationwide, the PeriGen OB risk reduction solution has supported more than 285,000 births with demonstrated financial benefits for clients realized within 18 months.
PeriGen's name change reflects the company's evolution into a technology-enabled, professional services company, building on the combined strengths of proprietary technology and advanced clinical risk reduction services provided by its physicians, nurses and midwives.
Center for Wound Healing opens 35th facility
The Center for Wound Healing (CWFH; Tarrytown, New York) reported the opening of its 35th facility, The Center for Wound Healing at University Medical Center (UMCP) at Princeton in New Jersey. The 1,724 square foot center, which was designed, built and financed by CFWH, contains two wound treatment rooms and two hyperbaric oxygen chambers, which will be used by CFWH staff and Princeton HealthCare System physicians to heal chronic wounds, such as those caused by diabetes, the effects of radiation, complications from surgery, lymphedema, vascular disease and trauma.
The Center for Wound Healing manages wound care treatment centers that offer hyperbaric oxygen therapy (HBO) as well as traditional wound care treatment modalities.
Northfield Labs gets FDA response on BLA
Northfield Laboratories (Evanston, Illinois) said that it has received a complete response letter from the FDA pertaining to the company's Biologic License Application (BLA) for its investigational product, PolyHeme, indicated for the treatment of life-threatening hemoglobin levels when blood transfusion is indicated and red blood cells may not be available.
The letter says that FDA has completed its review of the company's BLA and finds "that the information and data submitted are inadequate for final approval action." Specifically, FDA stated that the Company's pivotal study "... did not meet the pre-specified primary efficacy endpoint," and that "based on the totality of the data in the application, FDA has determined that the data submitted do not support the proposed indication."
Northfield Laboratories is developing a hemoglobin-based oxygen-carrying red blood cell substitute, PolyHeme.