Genzyme Corp. said Wednesday pivotal clinical trials of HAL-F, asynthetic membrane used to prevent adhesions following surgery,were successful and will be used to support submission of apremarket approval (PMA) application with the FDA this year.
"This has the potential to be Genzyme's biggest product," saidStephen Push, vice president of corporate communications for theCambridge, Mass.-based company. "It would be our first product thathas a truly mass market. Ninety percent of the people who havesurgery get adhesions. There are 16 million surgical operations a yearworldwide."
Although Push did not release detailed results of the trials, he said thedevice "in many cases prevented adhesions altogether and for thosewho developed adhesions they were significantly reduced."
Genzyme's stock (NASDAQ:GENZ) Wednesday jumped 12 percent,or $3.37, to close at $32.25.
He said Genzyme already has filed for product approval in Europeand expects to submit a PMA to the FDA by the middle of 1995.
Adhesions occur when internal organs and tissues are damagedduring surgery and the traumatized tissues join together, rather thanremaining separate. In patients undergoing abdominal surgery, whichis where HAL-F was tested, adhesions can cause small bowelobstructions and other complications. The conventional treatmentusually involves more surgery.
The HAL-F membrane, Push said, is placed between the damagedtissues to prevent them from joining together and forming anadhesion. The membrane is made from hyaluronic acid, apolysaccharide found naturally in the body and modified to slow itsdeterioration. Because it is natural, Push added, the membrane breaksdown and does not have to be removed.
The randomized, blinded pivotal trial of HAL-F involved 183abdominal surgery patients at 11 medical centers. Half the patientsreceived the HAL-F membrane between the surgical incision and theunderlying tissue. The others were not treated with HAL-F. Numberand extent of adhesions were the primary endpoints.
Genzyme also is conducting a pivotal clinical study of HAL-F inassociation with gynecological surgery.
Push said HAL-F is one of four related HAL products. HAL-C,which also is in pivotal clinical studies, is a coating solution designedto prevent adhesions and HAL-S is a synovial fluid replacement usedin arthroscopic surgery. HAL-G is a gel, which also is aimed atpreventing adhesions. n
-- Charles Craig
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