Latest business developments compiled from March 01 — 31, 2016.
Latest business developments in the field of stem cell research and
regenerative medicine compiled from publicly available information and
press releases from non-academic institutions from March 01 — 31 2016, scheduled to be published in Volume 11 Issue 5 of Regenerative Medicine.
ACell (IN, USA; www.acell.com) has received additional FDA clearance for its MicroMatrix® device, which describes the concurrent use of MicroMatrix in conjunction with CytalTM Wound Matrix or Cytal Burn Matrix devices. MicroMatrix–the micronized particulate form of ACell’s patented Urinary Bladder Matrix (UBM) technology–facilitates coverage of the wound bed, especially in irregular wounds. Cytal Wound Matrix (1-Layer, 2-Layer, 3-Layer and 6-Layer) and Cytal Burn Matrix are sheet forms of UBM and provide a robust scaffold for cell infiltration and host tissue deposition. This latest FDA clearance also provides for the modification of the MicroMatrix Instructions for Use to include the option for hydration of the device in sterile saline prior to application, in order to facilitate ease of use and adherence to the wound bed. MicroMatrix and Cytal Matrix devices are intended for use in various wound management applications. ACell also manufactures a distinct line of surgical products, based upon the same UBM technology.
PixarBio (MA, USA; www.pixarbio.com) has filed an application with the US FDA Office of Orphan Products Development, for orphan drug status of their NeuroRelease SCI (NR-SCI) a novel drug candidate for the treatment of Spinal Cord Injury (SCI). NR-SCI is a patent protected injectable self-assembling minimally invasive neuroscaffold for delivery of drugs, biologics and cells.