CELN: Celsion Delivers BPH Treatment System for Development of a Non-Invasive Temperature Monitoring Device
March 4, 1999 09:00 AM
COLUMBIA, Md.--(BW HealthWire)--March 4, 1999--
-- Department of Health and Human Services Funds Project with $455,000 Grant --
Celsion Corp. CELN today announced that it delivered its patented benign prostatic hyperplasia (BPH) treatment system to MMTC, Inc. of Princeton, NJ for use in the development of a second generation system. The project is being funded by a $455,000 Small Business Innovation Research (SBIR) Phase II grant from the Department of Health and Human Services (DHHS).
Research conducted under the grant is expected to create the optimum protocol and design for a non-invasive temperature sensing device to monitor prostate temperatures. The device will be incorporated into Celsion's second generation BPH system to provide enhanced real-time prostate temperature data, a desirable feature which is absent in all other BPH thermotherapy systems on the market.
After work performed at MMTC, the system will be transported to the Montefiore Medical Center in Bronx, NY where animal tests will be performed under the DHHS research grant.
MEASURING TEMPERATURE WITH MICROWAVE RADIOMETRY
CELN Chairman and Chief Scientific Officer Dr. Augustine Cheung said, "Our goal in enhancing the BPH system is to offer a safe, effective, non-surgical treatment providing immediate relief and long-term symptom control of the urinary obstruction condition often caused by BPH, an enlargement of the prostate gland which afflicts roughly 50% of men over 55.
"The availability of a real-time, non-invasive temperature measurement device would further enhance the safety and efficacy of our BPH system by monitoring the temperature of the treated area to avoid overheating," Cheung added. "By enabling the documentation of treatment dose and efficacy data, the system should allow physicians to create a data bank in order to prescribe individually tailored treatments."
The temperature sensing device under development for inclusion in Celsion's second generation BPH system incorporates a novel measurement principle based on microwave radiometry.
Celsion's existing system offers a dual modality approach for non-surgical management and treatment of BPH, incorporating both balloon dilation and heat therapy. Preclinical studies in animals of the current first generation system indicated that this unique approach should be capable of providing immediate symptomatic relief and long-term symptom control.
BPH CLINICALS UNDERWAY AT MONTEFIORE MEDICAL CENTER
Clinical evaluations of the first generation system, which has an Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA), are underway at the Montefiore Medical Center in Bronx, NY to demonstrate clinical efficacy in humans. Once the clinicals are completed, Celsion intends to bring its BPH treatment system to market abroad and apply for FDA Premarket Approval (PMA) for commercialization in the U.S.
"Our current BPH system is positioned to notably expand the $9 billion worldwide market for BPH treatment by encouraging more men to seek treatment, especially those with moderate symptoms," stated CELN President and CEO Spencer Volk. "We expect the current clinical studies to confirm the 'walk-in be treated, walk-out with total relief' nature of our out-patient BPH system. Once the accuracy of the new temperature sensing device is verified in animals, we will include that capability in our BPH treatment system."
ABOUT CELSION
In addition to its BPH treatment system, under an FDA IDE Celsion is preparing to conduct clinicals of its breast cancer treatment system to demonstrate that focused heat alone safely and effectively ablates tumors. Celsion's research is concentrated on designing focused heat systems to treat additional cancers.
Celsion Corporation is a research and development company dedicated to commercializing medical treatment systems for cancer and BPH using focused heat delivered by patented microwave technology. Clinicals and further development of the Company's treatment systems are being conducted by leading institutions such as the Massachusetts Institute of Technology, Massachusetts General Hospital, Montefiore Medical Center, and Duke University.
Forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties, including, without limitation, possible changes in cost of materials, expense items, capital expenditures, capital structure, and other financial items; introduction of new products and possible acquisitions of assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission. |
