Human Biosystems Announces Pre-IND Meeting with FDA

Strategic Insights -

Human Biosystems, a developer of preservation platforms for organs and other biomaterials, has announced that a pre-IND (Investigational New Drug) application meeting with the FDA has been scheduled for early October. The meeting, which is a prelude to a formal application, will discuss Human Biosystems' plan to conduct human infusion tests using its patented platelet preservation system. The company's technology aims to extend the shelf life of platelets, making them fresher and of higher quality, and reducing the need for platelet transfusions.

Key Takeaways:

  • Human Biosystems has scheduled a pre-IND meeting with the FDA to discuss its plan for human infusion tests using its patented platelet preservation system.
  • The planned studies will involve a number of human subjects who will be infused with platelets stored in the cold using the HBS process and compared to platelets prepared using the current storage method.
  • The HBS platelets will be stored at refrigerated temperatures for several days prior to infusion, potentially allowing for longer shelf life and fresher platelets.
  • Dr. David Lucas, Director of Platelet Development for HBS, stated that studies have shown that standard blood platelets stored in the cold for 24 hours or longer are not functional and are quickly eliminated from the blood after infusion.
  • Human BioSystems is a developer of preservation platforms for organs and other biomaterials, with a mission to commercialize its technologies.
  • The company has made significant progress in its nine-year history and has a goal to demonstrate that cold stored platelets using HBS technology can maintain functionality after storage for more than 24 hours, which has never been demonstrated before.

Statistics:

  • The stock price of Human Biosystems (OTCBB: HBSC) closed at 14 cents per share the day before the announcement was made.
  • The company's stock recent price increases are: BMY +3.9% on 27.4 million shares traded, CMVT +8.1% on 11.3 million shares traded, and SGP +0.9% on 9.3 million shares traded.

Sources:

  • Human Biosystems (OTCBB: HBSC) press release
  • Stock Market Alerts LLC
  • Comtex News Network, Inc.
  • Wall Street Enews
  • Stock Market Alerts LLC.