RTek Medical Systems Receives FDA Approval to Market New Cancer-Treatment System
November 08, 2000
RTek Medical Systems LLC, a privately held, Pittsford-based company created last year to commercialize a new prostate cancer treatment system developed by researchers at the University of Rochester Medical Center, has been granted approval from the U.S. Food and Drug Administration to begin marketing its new product.
The system, named PIPER, for Prostate Implant Planning Engine for Radiotherapy, was developed to improve a common prostate cancer procedure called brachytherapy, in which tiny radioactive "seeds" the size of rice are surgically implanted into the prostate. The seeds deliver low levels of radiation that destroy nearby cancer cells over a period of several weeks. Brachytherapy is an increasingly popular procedure for treating the nearly 200,000 men in the U.S. who are diagnosed with cancer of the prostate each year.
The success of brachytherapy hinges on the placement of the radioactive seeds at precise locations within the prostate, an organ about the size of a walnut that is located between the rectum and bladder and contributes fluids to semen. Arranged properly, the seeds will kill all of the nearby cancer cells without harming the healthy tissue surrounding the prostate. RTek's PIPER product is a computerized planning system that helps clinicians determine how many seeds will be necessary, and exactly where each seed should be placed within the prostate, in order to eradicate the cancer. The recommended treatment plan guides the surgeon, who inserts several dozen seeds into the prostate during a one- or two-hour surgical procedure.
Physicians commonly use computer programs to help them decide how to place the seeds. RTek's new system is revolutionary because of its speed and optimization capabilities. Based on an ultrasound scan of a patient's prostate and other organs, the PIPER System automatically compiles a computer-optimized radiation treatment plan in less than two minutes. The system's speed and precision make it possible for radiation planning to be done right in the operating room immediately before surgery, instead of several weeks beforehand as is now standard. "That's a tremendous advantage," says surgeon Edward Messing, M.D., chair of the Department of Urology, who has performed scores of brachytherapy procedures at Strong Memorial Hospital.
"The prostate you see in the operating room is never the same one you saw three weeks previously in your office," says Messing. "Hormone therapy before surgery can shrink the prostate, for instance, and even anesthesia can change the positioning of the pelvis the day of surgery. This oftentimes makes deviations from the now-dated plan necessary during surgery." RTek's PIPER System uses sophisticated optimization algorithms to make the planning process faster and more precise. With a radiation treatment plan compiled just minutes before the operation, the plan is more likely to match what physicians actually confront in the operating room. The PIPER System also aids the surgeon during the procedure, by providing interactive seed location and dose feedback so that actual seed placements can be adjusted to match the optimized plan. "The market for brachytherapy products is growing at a rate of approximately 20% per year," says RTek CEO, Bob Jackson, Ph.D. "We're pleased to be able to offer this exciting technology and are confident it will be a commercial success."
PIPER was developed by medical physicist Yan Yu, Ph.D., associate professor of radiation oncology at the University of Rochester Medical Center, based on more than five years of basic research that has been funded by a variety of sources, including the National Cancer Institute and the Whitaker Foundation. The PIPER system was patented by the University and licensed to RTek.
RTek was formed in September 1999 as a joint venture of the University of Rochester and Real Time Enterprises, Inc. of Pittsford, NY, a medical software engineering company. Real Time Enterprises developed the commercial software for the PIPER System and helped prepare the regulatory submissions. RTek Medical Systems is part of an accelerated effort by the University to commercialize technology developed in its laboratories. "There are many exciting technologies being developed in the Medical Center and across the entire University," says Jay Stein, M.D., senior vice president and vice provost for Health Affairs at the University, and CEO of the Medical Center and Strong Health. "This is one of the first of an ongoing series of technologies we plan to commercialize."