There are no companies identified which currently manufacture and market products and services with similar applications as the Company.
In short, the BAFI™ product meets all regulatory and legal requirements. It is not an FDA device and does not need FDA compliance at this time. However the BAFI™ product line and services will conform to all voluntary and mandatory FDA standards. Pursuant to legal opinion, FDA is not required, and the BAFI™ product will further yield to UL safety standards.
PATENTS & TRADEMARKS
The Company was notified by the US Patents Office that the patent would issue and that the examiner had approved all 20 claims.
A patent search has revealed that there are no devices for portable oxygen gas cylinders. Attorney Donn Harms has stated his opinion that BAFI is a patentable item with millions' of user potential. The Company has retained Donn Harms to file all patents accordingly.
There are always risks inherent in the distribution and use of consumer products, including health care products, by the medical marketplace. The Company has adopted an active program to minimize its exposure to product liability lawsuits through the purchase of Product Liability Insurance with JMB Insurance Agency, Inc. in Chicago. This company has a policy underwritten by Hartford Connecticut.
Beginning with the design phase of product development, the Company has incorporated preventive measures aimed at reducing its potential exposure to liability risk. The Company's product development and manufacturing program includes high product reliability standards meant to result in high mean times between failure (MTBF). The company plans to achieve a high MTBF factor by pursuing strict quality control procedures and by holding its manufacturing partners to such high standards by written contract. By designing and manufacturing a reliable, high quality product, the Company will minimize, but not eliminate, the possibility and occurrence of defective products.
The manufacturing and marketing of the Company's products, incorporating new and unproved technology, has inherent risk. No one can be sure how each product will operate over time and under various conditions of actual use. Even if the products are successfully manufactured and marketed, the occurrence of warranty or product liability, or retraction of market acceptance due to product failure or failure of the product to meet expectations could prevent the Company from ever becoming profitable. Development of new technologies for manufacture is frequently subject to unforeseen expenses, difficulties and complications, and in some cases such development cannot be accomplished. In the opinion of management, the products and services, as designed, has many positive attributes, but such attributes must be balanced against limited field operating experience and unknown technological changes.
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