- Application filed with IP Australia would expand patent estate to immunotherapy
- Creates new opportunities in the growing field of immunotherapy and reinforces a position in oncology
PolarityTE(TM) Regenerates Full-Thickness Hair-Bearing Skin in Burns & Wounds Using Revolutionary Platform Technology
First ever known successful regeneration of full-thickness skin and hair; Company poised to initiate human trial in the third quarter of 2017; Management to host conference call Thursday, June 8th at 4:30pm ET
SALT LAKE CITY, UT, 06/08/17 — PolarityTE™, Inc. (NASDAQ: COOL) today announced pre-clinical results demonstrating that the Company’s lead product, SkinTE™, regenerated full-thickness, organized skin and hair follicles in third degree burn wounds. The findings represent the first known successful regeneration of skin and hair in full-thickness swine wound models, the standard animal model for human skin. The Company expects to initiate a human clinical trial evaluating the autologous homologous SkinTE™ construct in the third quarter of 2017. [Read more…]
FDA Draft Guidance On “Minimal Manipulation Of HCT/Ps”
In September 2016, the FDA hosted a public hearing to review draft guidances pertaining to the FDA regulation of stem cells. It addressed the regulation of human cell and tissue-based products (HCT/Ps), defined by the FDA in § 1271.3(d) as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.”
FDA Draft Guidance for HCT/Ps
In this article:
- FDA Regulations on Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
- FDA Guidance Documents
- FDA Draft for Manipulating HCT/Ps
- Additional FDA Guidelines for Medicine with HCT/Ps
Since that time, we have not heard from the FDA about how they have integrated the public feedback. [Read more…]
Top 10 Differentiators for Axiogenesis within the Global iPSC Marketplace
Groundbreaking experimentation in 2006 by Shinya Yamanaka (Kyoto University, Japan) led to the introduction of induced pluripotent stem cells (iPSCs). These are adult cells that are isolated and then reprogrammed into embryonic-like stem cells through the expression of a specific set of embryonic genes. Yamanaka’s discovery, which earned him the Nobel prize in 2012, enabled the use of human cells in stem cell science, bypassing the use of embryonic stem cells (ESCs). Without the ethical problems associated with ESCs, a large and diverse market for human iPSC research tools has emerged.
Founded in 2001 and headquartered in Cologne, Germany, Axiogenesis initially focused on generating mouse embryonic stem cell derived cells and assays. After Yamanaka’s groundbreaking iPSC technology became available, Axiogenesis was the first European company to license and adopt Yamanaka’s iPSC technology in 2010. [Read more…]
Power of Strategic Alliances within the Cord Blood Banking Industry
A growing phenomenon within the cord blood industry is the use of strategic alliances. This is not surprising, because it is valuable for cord blood banks to establish collaborative relationships with doctors, hospitals, birthing centers, insurance companies, government entities, medical researchers, public and private donors, and more. However, the terms and scope of key strategic alliances within the cord blood industry are often kept quiet. Other times, the partnerships are well-known within a specific region, but not publicized on a global basis.
For this reason, five key alliances that substantially impact the cord blood industry are explored below. [Read more…]
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