James Donegan, Chairman and Chief Executive Officer of Med-Design, commented, "The quarter was highlighted by an increase in the sales of the Safety Seldinger Needle
by MedAmicus, who continues to close contracts with major customers.
under which MedAmicus will manufacture and distribute the Safety Seldinger Needle
into the arterial access market.
On October 15, 2001, the Company received the up-front license fee payment of $2,000,000 from MedAmicus under the terms of the agreement for the licensing of the Seldinger Needle Device into the arterial access market.
Third, MedAmicus began shipping units of its venous access Seldinger Needle Device to OEM customers.
With the recent FDA clearance of the Safety Seldinger Needle
that we had licensed to MedAmicus, the FDA has cleared four products for market launch that are royalty-bearing to Med-Design.
Second, MedAmicus announced the filing of a 510(K) application with the United States Food and Drug Administration, which received clearance on July 10, 2001, for the Safety Seldinger Needle that was licensed from and co-developed by Med-Design.
There are important factors that could cause actual results to differ materially from those expressed or implied by such forward looking statements including delays in introduction of the Safety Seldinger Needle due to manufacturing difficulties or other factors and other factors discussed in our filings with the Securities and Exchange Commission.
Our principal accomplishment was the licensing to Becton Dickinson of several patents relating to our syringe products and licensing to Med Amicus our Safety Seldinger Needle
We have licensed our Safety Seldinger Needle
to MedAmicus in an agreement that should provide an exceptional royalty from sales in a high value niche market.
Med-Design and MedAmicus have tentatively determined that the Safety Seldinger Needle
product will launch in the United States during the early summer, 2001.
Safety Seldinger Needle
Device and a New Cardiovascular Product Is
MedAmicus will market the Safety Seldinger Needle
initially to its customer base in the venous access market including pacing, port and dialysis applications, as it explores with Med-Design channels of distribution into other potential markets.