Human BioSystems, Inc. (OTCBB: HBSC)
10 day adverage 243,635 .211x.22
The Company: Human BioSystems, Inc. (3/16/06) Float: 31.1m
Sector: Healthcare S/I: 75.3m
Industry: Medical Instruments & Supplies
www.humanbiosystems.com
Human BioSystems, Inc. (OTCBB: HBSC) is a biomedical company that has developed and is now preparing to commercialize its proprietary technology to extend the shelf life of blood platelets, the congealing component of blood. The company is also commencing a comprehensive research program to increase the shelf life and quality of donor organs including hearts, kidneys, livers and lungs, and has recently filed two provisional patents covering its preservation solution and process.
BLOOD PLATELET PRESERVATION
Why is this technology important? Cancer patients who undergo chemotherapy treatment cause damage to the platelet structure of the blood and its ability to
produce platelets for a period of time. The result is a longer period of recovery from this treatment. HBS’s proprietary technology will have the ability to provide longer shelf life for platelets allowing doctors to have available a larger, and healthier platelet inventory to help these patients to recover.
• Blood platelets are cellular blood components essential to the clotting process and critical in the treatment of cancer, organ transplantation and burns. Because platelets are highly susceptible to bacterial contamination and rapid loss of effectiveness, they currently have a United States Food and Drug Administration (FDA) mandated five-day shelf life. As a result, an estimated $700 million in blood platelets must be discarded without being used every year in the United States, Europe and Japan. This represents a significant financial loss to blood centers and hospitals. Longer preservation times will allow blood centers and hospitals to recover up to 90% or more of lost revenues.
• Human BioSystems is testing a preservation technology that stores platelets at refrigerated temperatures a few degrees above the freezing point of water. This technology uniquely allows storage of platelets in the cold without activation, making them likely to survive longer after a blood transfusion. The system consists of a solution that protects the platelets during cooling and storage and a proprietary device that quickly chills platelets to the final refrigeration temperature with minimal damage.
• The company’s goal is to prolong the shelf life of blood platelets from the FDA’s five-day standard period to 10-14 days or longer. This would be a significant medical breakthrough that should increase the global availability of precious living biological materials needed to save human lives and hundreds of millions of dollars a year in medical costs.
ORGAN PRESERVATION
Why is this technology important?
• In the U.S. alone, more than 73,000-patients were on transplant waiting lists in 2001. Currently donor organs can only be preserved for extremely brief periods ranging from four to 36 hours, depending on the organ. The company believes its technology could extend the shelf life of organs from a few hours to days while maintaining the viability; quality and safety of organs vital to patients on transplant waiting lists.
• Patients receiving donor organs preserved by the company’s preservation technology may benefit from decreased requirements for anti-rejection drugs. Current donor organ decisions must be made rapidly due to short shelf life,
recipients often receive organs that are not an ideal match. By extending organ preservation time, transplant recipients can expect optimized transplant success since more time is available for organs to be more suitably matched and thereby lessening the immune response. It is not uncommon for transplant patients to pay up to $20,000 a year in anti-rejection drugs for the rest of their lives. This can represent billions of dollars in costs to insurance companies and governments that fund medical costs.
Human BioSystems recently announced it has achieved several major technical breakthroughs in the field of organ preservation. Rat kidneys were refrigerated and stored at temperatures as low as minus 196 degrees Centigrade then retransplanted after warming, exhibiting a good perfusion index and producing urine, signs of organ functionality. The experiments were conducted using an HBS proprietary solution that only begins to freeze after reaching temperatures of minus 20 degrees Centigrade, at which temperature other solutions and organs are normally frozen in the solid state. Other beneficial aspects of the solution’s characteristics are that it appears to freeze in globular patterns rather than sharp-edged crystals, which can damage cells, and it does not appear to expand as does water. These features serve to protect the organ from abnormal pressures during the freezing process and keep it intact.
THE OUTLOOK
Working with two independent blood centers, the company simplified and improved its platelet storage technology and is now commencing human infusion studies. Pending scheduling and approval steps, HBS anticipates completion of tests within the next several months Upon successful conclusion of the pre-clinical pilot tests, the company will request a meeting with FDA to outline clinical trials involving at least two Independent blood centers. The company anticipates having such a meeting by the end of 2005 and initiating clinical trials
such a meeting by the end of 2005 and initiating clinical trials shortly thereafter. Human BioSystems plans to license both its platelet and organ preservation technology to one or more strategic alliance partners that have the capability to manufacture and distribute the company’s proprietary solution to blood centers worldwide. Initial revenue from licensing is expected in 2006. The company estimates a multi-billion dollar market demand for its platelet and organ preservation system coupled with the post-transplant technology, once fully developed and commercialized.
HBS is looking for additional products that are close to commercialization to add to its pipeline.
THE TECHNOLOGY
Human BioSystems’ proprietary preservation systems for initial products consist of non-toxic liquid solutions, proprietary protocols and solutions. These systems do not employ toxic preservatives or special cryogenic techniques or complex equipment. The platelet system is designed to utilize and complement standard platelet collection and processing activities. Collected platelets are processed using Human BioSystems’ proprietary preservation solution and intended to be packaged in FDA approved plastic storage bags. Instead of being stored in a rocking device at room temperature, as is current industry practice,
the storage bags are cooled according to HBS protocol. The platelets are cooled to four degrees C and placed into standard blood refrigeration units for storage. The Company intends to show through human infusion studies that this process exhibits improvements in viability and longevity of the blood platelets when compared to standard platelets stored at room temperature. The Company also intends to demonstrate that HBS stored platelets exhibit minimal bacteria growth during the storage period when compared to current standards of platelet storage. The company’s organ storage solution at refrigerated temperatures appears to be better than currently used solutions and is
uniquely adaptable to use in sub-zero storage up to minus 80 degrees centigrade and lower. If further tests confirm the subzero results and FDA approval is granted, this could optimize donor/recipient matching and provide long-term storage of organs versus hours of storage under current methods available. The company has applied for patents covering the technologies and the processes outlined above. The company believes its technologies are readily applicable for preserving blood platelets and donor organs.
MANAGEMENT TEAM
Harry Masuda, - CEO - Former president of high tech company Piiceon, Inc. and founder of HK Microwave. He successfully negotiated acquisitions for both companies.
David Winter, M.D., President – Previously President, GenPharm Intl., Sangstat, Human Organ Sciences and others. He was also the NASA Director of Life Sciences, where he directed all medical, biological, and biomedical –engineering for the U.S. space program. Dr. Winter led the development, registration and approval of cyclosporine and six other major components.
Paul Okimoto, Board Chairman, EVP and co-founder, Previously president of Sanhill Systems. Expertise with high tech products in biological and biomedical fields.
Luis Toledo, M.D., Ph.D., Chief Medical Officer. Internationally recognized authority on organ transplantation and preservation. Authored numerous books
.
DISCLAIMER
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, those discussed in filings made by the Company with the Securities and Exchange Commission.
