The Med-Design Corporation, a leader in the design and development of safety needle products for medical use, announced that it entered into a contract with Sultan Chemists (Englewood, NJ) under which Sultan will serve as the exclusive distributor of Med-Design's Safety Dental Injector. Sultan, a leader in the field of infection control and oral therapeutics, will market the Safety Dental Injector directly to dentists and distribute the product through established dental products distributors.
The agreement sets a minimum goal of 18 million units to be sold by Sultan during the first 40 months following the initial delivery of the product by Med-Design to guarantee exclusivity. Maintenance of exclusivity in the event the goal is not met is subject to conditions set forth in the agreement. In addition, from the fourth through the tenth year following the initial delivery of the product by Med-Design, Sultan has agreed to purchase a minimum of six million units a year. The agreement requires pre-clinical evaluations be completed to the satisfaction of Med-Design and Sultan prior to launch. The first of the pre-clinical evaluations has been completed by a major university's dental school, and results are expected to be published shortly. The agreement also obligates Sultan to expend funds for the marketing and promotion of the product. As part of a previously announced agreement, Owens-Illinois will manufacture the product for Med-Design using equipment designed and owned by Med-Design. The equipment to be purchased by Med-Design is designed to have a manufacturing capacity in excess of 22 million units per year. Additional lines will be purchased by Med-Design to the extent required by market conditions.
"Sultan estimates the market for Safety Dental Injectors to be in excess of 75 million units annually," said Michael Simpson, Chief Operating Officer of Med-Design, "so we are confident that we have an excellent opportunity to build a highly profitable business in this area. In addition, Sultan's focus on infection control and oral therapeutics is a perfect match for our product, and their marketing expertise in this field gives us confidence that this product will be successful."
Med-Design intends to submit a request for a 510(k) clearance from the Food and Drug Administration in June, with approval expected in late summer. If the regulatory approval is obtained at that time, Sultan may be able to ship product to customers by the end of 2002.
