PALO ALTO, Calif., June 22, 2004 (PRIMEZONE) -- Human BioSystems, (OTCBB:HBSC) a biomedical company conducting research to extend the shelf life of blood platelets and donor organs, announced today it filed a patent application on April 22, 2004 under the title, "IMPROVED METHODS AND SOLUTIONS FOR STORING DONOR ORGANS."
Provisional applications were filed last year, in April 2003. In a story published on April 24, 2003, the company announced that it had made a potential breakthrough in its quest to extend the shelf life of kidneys and other human donor organs beyond the capacity of current technology.
"This is a significantly important step for Human BioSystems (HBS) because we strongly feel these patent applications are a major step toward protecting our intellectual property and represents a major leap forward in the science of preserving donor organs for much longer periods of time than is currently possible," Harry Masuda, HBS President and CEO said. "Not only has our medical team, headed by noted transplant surgeon and researcher Dr. Luis Toledo discovered a way to store organs for longer periods with more safety, we have discovered completely new formulations that appear to defy the traditional laws of nature. Our goal is that these discoveries will give medical technicians more time to optimally match donor organs to recipients so that anti-rejection drugs and related complications can be reduced or eliminated."
"Donor organs, such as kidneys, are stored at close to the freezing point of water, but never below it, otherwise the organs will be damaged by the expanding ice as water freezes. We believe that we have overcome this problem by using the methods described in our latest patent application," said Dr. Luis Toledo, HBS Chief Medical Officer.
In a series of tests conducted by Dr. Fernando Lopez, HBS Research Manager, under the supervision of Dr. Luis Toledo, it was demonstrated that by using the HBS proprietary solution and procedures as described in the patent application, rat kidneys were stored at minus 20 degrees Centigrade; well below the freezing point of water, later warmed to room temperature, then transplanted back into the animals where the kidneys exhibited signs of functionality. "Organs stored under such conditions will normally freeze and become rigid with ice crystals, damaging tissues beyond repair," Dr. Toledo noted. "The HBS Solution, cooled to minus 20 degrees Centigrade however, remained completely aqueous (watery) with no signs of crystallization (freezing) in the organ."
"Another similar test using a rat's kidney was conducted at minus 80 degrees Centigrade, a much colder temperature than the previous test conditions. Everything is solidly frozen at these temperatures, even organs stored using the HBS solution," according to Dr. Toledo. "Organs stored at such low temperatures using conventional storage methods would be destroyed by the expanding ice; however the HBS solution provided protection, with the result that most cells within the kidney remained intact."
Within the two HBS patent applications are three distinct technologies for various preservation applications: 1.) HBS Solution #1- a viable substitute for commonly used preservation solutions such as the UW Solution or Viaspan manufactured by Dupont; HBS has created, what it describes as a superior alternative. The preservation temperature range for this solution is between 0 degrees and 6 degrees C and the maximum limit for preserving kidneys is 36 hours. In the HBS comparative studies at the company's Research Center in Michigan, it was observed that the HBS Solution preserved kidneys with less cell damage at 36 hours than other solutions on the market. This technology provides a longer storage period with a more viable opportunity for rejection-free transplantation.
2.) HBS Solution #2- an advanced formulation for preserving kidneys and other donor organs for longer periods than is currently available. At a temperature of -20 degrees C, after 48 hours of preservation, a functioning rat kidney was successfully transplanted. HBS Solution #2 does not freeze a t-20 degrees C and provides longer storage periods, which in turn create opportunities for finding more acceptable recipient matches with less chance of rejection.
3.) HBS Solution #3- a cryopreservation formula that freezes organs in temperatures of -80 degrees C and lower. Unlike standard water-based solutions which expand and freeze in crystallized formations, HBS Solution does not expand in sub-zero temperatures and freezes in smooth globular patterns. These unique features allow the organ to be indefinitely preserved and protected from cellular damage. In HBS experiments, a rat kidney was frozen at -80 degrees then transplanted displaying full functionality.
Dr. Toledo stated that further studies will be conducted employing a full range of organs.
Human BioSystems is headquartered in Palo Alto, California.
Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, results from future research and testing, failure to obtain regulatory approval for the Company's products, if required, failure to develop a product based on the technology we have acquired, failure of any such products to compete effectively with existing products, failure to develop a cost effective commercial manufacturing method, the ability of the Company to fund additional studies and product development and other factors discussed in filings made by the Company with the Securities and Exchange Commission.