Luther Developing a Catheter Coating for Safety, Longer Use : Compound Could Be on Market by End of Year

Luther Medical Products of Santa Ana said Wednesday that it is developing a self-sterilizing, anti-clotting substance designed to increase the safety and useful life of intravenous catheters and other medical devices.

Dr. Edward Shanbrom, a physician who developed the polymer catheter coating compound, has joined Luther Medical as a consultant to help develop the product commercially, said Ron Luther, president of Luther Medical.

The compound could be on the market by the end of 1988, Luther said.

Shanbrom and Luther last week filed with the U.S. Patent and Trademark Office to gain patent protection for the technology. In the next few weeks, they plan to seek Food and Drug Administration approval to market the product.

“It’s the equivalent of the fountain of youth for catheters,” Luther said. A catheter is a hollow, flexible tube inserted into a vein, artery or passage to withdraw or inject fluids.

Luther said that most catheters now on the market can become infected or can cause the blood to clot, requiring periodic removal and replacement with new catheters.

Catheter sterilizing and anti-clotting products already are on the market, he said, but they address either one problem or the other, Luther said.

The compound developed by Shanbrom would be combined with a material developed by Luther to dispense the compound on a timed-release basis. The resulting product would be applied to catheters to minimize clotting, kill germs and ease insertion.

Jim McCamant, editor of the Medical Technology Stock Letter in Berkeley, said the catheter market is in need of such a product. But he cautioned that the FDA might be concerned about the safety of the sterilizing agents, which would come into contact with the bloodstream.

Luther said that the polymer’s sterilizing agents are too weak to harm the body and that Shanbrom’s research has found no side effects.

Shanbrom, 63, was formerly director of research for Hyland Lab, a subsidiary of Baxter International, a Deerfield, Ill., medical supply firm. Shanbrom has studied blood and blood treatments and holds patents on technologies designed to combat viruses such as hepatitis and AIDS in processed human blood, Luther said.

Luther said Shanbrom plans to donate his share of proceeds from the new catheter-coating substance to charities in memory of his son, David, who died in a car crash in March, 1986, at age 27.

The arrangement with Shanbrom is Luther Medical’s second joint venture this year, Luther said.

Last month, Luther signed a licensing agreement with a Johnson & Johnson subsidiary to produce and market a catheter needle enclosed in a plastic sheath to protect nurses from contact with the AIDS virus.

Luther said the Johnson & Johnson pact and the development of Shanbrom’s technology could help the company become profitable after seven years of losses.

The company reported on Wednesday a net loss of $211,854 for its fiscal 1988 second quarter, which ended Dec. 31, compared to a loss of $101,044 in the year-earlier period. Revenue for the quarter increased 262% to $391,805 from $108,291.

For the first six months of the year, Luther had a loss of $330,184, compared to a loss of $222,991 in the same period a year earlier. Six-month revenue was $1.1 million, up 484%, from $188,362.

Catheters at a Glance

WHAT THEY ARE: Hollow, flexible tubes that are inserted into a vessel such as a vein or an artery to withdraw or insert fluid. Widely used in medical and surgical treatments.

SIZE OF MARKET: About $500 million worldwide annually. Large medical supply companies, such as Johnson & Johnson, account for most of the sales.