pH Market
The BCSI pH sensor market is approximately 10 million platelet storage bags manufactured worldwide each year. The market is approximately 25,000 BCSI pH1000 instruments to hospitals and blood banks worldwide. At retail prices, the sensors represent a $60-$80 million annual market opportunity, and the instruments a $150-$160 million market opportunity.
Platelets for Transfusion - pH1000 System
The collection, storage, distribution, and transfusion of human platelets are a $3 billion worldwide market opportunity within the $17 billion blood products industry. U.S. prices for an apheresis unit range from $500 to $700, whereas RD unit fees are $50-60 per unit or roughly $300-350 per transfusion. Though platelets represent only 15% of the value of all blood components, they are a critical resource for any patient with a bleeding problem. Note that the average value of a transfusable platelet unit (~$600/unit) is 2-4 times that of packed red cells ($150-$300/unit). Platelets, unlike red blood cells and plasma, require room temperature (20º to 24º C) storage to preserve function and survival. The trade-off is a higher metabolic rate (leading to more rapid platelet degradation) and an environment more conducive to bacterial growth whenever a unit is contaminated (dramatically increasing the risk to the patient receiving the transfusion). Because of this and the fragile nature of platelets, the storage time or shelf life is limited to 5 to 7 days. Differences in RD platelet manufacturing between U.S. and European blood agencies have led to a maximum five-day shelf life in the U.S., but a seven-day shelf life in Europe when combined with bacterial testing. Nonetheless, platelet storage times remain short, losses due to outdating approach 20%, and the entire blood industry continues to seek ways to improve the quality of transfused platelets.
Why is pH Important?
The BCSI pH1000 System is an easy to use, non-invasive method to obtain sequential pH measurements over time without consuming platelets or risking contamination, that can delineate trends associated with platelet deterioration and may facilitate the detection of bacteria. pH determinations can be performed non-invasively and multiple times throughout the production, storage and transport conditions up till prior to transfusion. No sample is removed. The pH1000 System is simple to use and should be easily adopted by blood collection and hospital personnel with minimal training. By using pH as a proxy for platelet health, BCSI offers a more detailed snapshot of platelet quality than found with other products on the market. With such ease-of-use and non-invasive, non-sample consuming methods, BCSI offers the transfusion service market the opportunity to test and use every unit. The current practice is to test and discard 1% (or 4 per month) and use the 99% of the untested inventory as recommended under FDA and EU guidelines.
Global Marketing and Sales Plans – pH1000 System
Europe
BCSI received CE Mark approval for the pH1000 System in May 2007, with its first clinical use in Q1 of 2008. Sanquin is using the System in The Netherlands for roughly 20% of their platelet supply and BCSI intends to capture an increasing market share in the Netherlands and EU.
BCSI has launched the pH1000 System in Europe by concentrating a direct sales effort on a small number of large blood banks. The Company initially focused on generating data to show the need in the marketplace for a system to quickly, easily, and non-invasively measure platelet pH. However, BCSI’s strategy has always been to use the existing marketing, sales, and distribution capabilities of one or more of the manufacturers of blood collection sets and the related hardware. Consequently, BCSI has a distribution option agreement with CaridianBCT (formerly GambroBCT), the largest U.S. Company in our field and one of a handful of multinational firms in this business. BCSI is in discussions with several other similar companies. The financial projections presented in this plan may depend on the details of these agreements.
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U.S. Product Launch
BCSI is working with U.S. FDA to determine the approval process for the existing CaridianBCT storage bag with the BCSI pH sensor in it. BCSI seeks to work with all the major blood bag manufacturers to have the pH sensor incorporated into their platelet storage bags.
Department of Defense Appropriation and Armed Forces Sales
Although U.S. sales of the pH1000 for clinical use require FDA approval, a number of organizations such as the American Red Cross plan to evaluate the System. Blood Cell Storage, Inc. has been included in the Fiscal Year 2010 Defense Appropriations bill that has been approved by the. Congress and signed by the President, to develop a system that allows use of multiple bags to measure each bag several times.
This funding would help the Armed Forces to develop the capability to ensure the efficacy of platelets in large samples. This project would help reduce battlefield deaths caused by transfusing ineffective platelets, and reflects on the importance of the civilian use of the product to ensure that safety, health, and quality of the civilian blood supply.
Rest of World Product Launch
Our forecasts have not incorporated the rest of the world, although distributors have approached the Company from the Middle East, Asia and Latin America. There is a growing and recognized concern by the Japanese Red Cross of the effectiveness of platelet transfusions because of aging platelets that lose efficacy. pH is recognized as a measure of quality and hence platelet performance and successful transfusions.
