FDA clears Halt 2000GI Electrosurgical System for soft tissue ablation

Halt Medical, Inc., today announced that the U.S. Food and Drug Administration (FDA) has cleared the Halt 2000GI™ Electrosurgical System for soft tissue ablation using radiofrequency energy.  "This clearance to market is a major milestone for our customers, employees and investors," said Russ DeLonzor, President and Chief Operating Officer. 

Radiofrequency Ablation (RFA) with the Halt System is a very precise, minimally invasive procedure where a slender probe is inserted into the target tumor under ultrasound guidance.  Once in position, the system delivers a specified amount of energy to the tissue.  The heat generated in the process destroys the tumor, allowing it to be absorbed by the body.  RFA therapy is rapidly becoming the treatment of choice among surgeons seeking minimally invasive solutions for relieving debilitating symptoms caused by a variety of diseases such as tumors of the liver, breast, prostate, bone, and kidneys.   

"The Halt System offers broad advantages over surgery to doctors, their patients, and the healthcare system," according to Gordon Epstein, MD, Chief Technology Officer.  "With traditional surgical interventions, layers of healthy tissue are cut through to gain access to the tumor.  This leads to complications, significant pain, and long recovery times.  With RFA, patients typically go home the same day and are back to work much sooner.  The direct and indirect savings to the healthcare system as we replace radical surgery with minimally invasive procedures like Halt RFA will be in the billions of dollars."   

Halt Medical was founded in 2005 by Jeffrey M. Cohen, Dr. Bruce B. Lee, and Ed Calesa with the goal of developing an RFA system optimized for the treatment of symptomatic uterine fibroids.  The Halt Fibroid System was recently approved for use in Europe, and is currently being studied for this indication in the U.S.  "Receiving clearance by the FDA to market our general use ablation system represents a significant step towards our goal of extending the benefits of RFA to the treatment of uterine fibroids in the U.S.," said Mr. Cohen. 

Information about the Halt Fibroid Study and a list of clinical sites in the U.S. may be found at www.clinicaltrials.gov, study number NCT00874029.