CHICAGO--(BUSINESS WIRE)--Apr 12, 2012-- Novian Health, developer of Novilase(R) Breast Therapy, announced the company has begun a multicenter clinical trial on the use of Novilase(R) Interstitial Laser Therapy (ILT) for the destruction of malignant breast tumors.
The first facility to participate in the multi-center clinical trial is the renowned Rose Breast Center, in Denver, under the study direction of Barbara Schwartzberg, M.D.
Novilase ILT is an image-guided, minimally invasive alternative for lumpectomy. It is used to ablate (destroy) small breast tumors. The new clinical trial is the first stage of a two stage study as part of an FDA premarket approval (PMA) process. The trial follows a successful, single center feasibility study on Novilase ILT for treatment of malignant breast tumors. The company said it will soon begin a similar clinical trial in Europe.
Novian Health has previously received FDA 510(k) clearance for the treatment of breast fibroadenomas and currently offers Novilase at Rose and other breast centers around the country that are participating in its ABLATE registry.
This study will evaluate the rate of complete tumor ablation (destruction by laser) of breast cancers that are up to 2 centimeters.
It will also examine the correlation of the pathology of postablation lumpectomy specimens with MRI, mammography and ultrasound in detecting any residual tumor.
"The goal of this study is to evaluate whether minimally invasive laser ablation of early-stage breast cancer is as effective as a traditional surgical lumpectomy," said Dr. Barbara Schwartzberg, Chair of Cancer Services at Rose Medical Center. "With laser, this may be performed more conveniently, with less pain and with less deformity. I am proud to offer this as an option for patients at the Rose Breast Center, continuing our tradition of providing the latest technologies and treatments." "All of us at Novian Health are excited to begin this multicenter trial and to be working with the prestigious Rose Breast Center, as part of a process aimed at making this minimally-invasive therapy for breast cancer available to women," said Henry "Chip" Appelbaum, President and CEO of Novian Health.
Novilase ILT may provide women who have early-stage breast cancer with the option of an ablation procedure that could result in a lower rate of residual disease and thus fewer re-treatments, a shorter recovery time, minimal scarring or breast deformity. Novilase does not preclude any additional treatment, if necessary, such as the use of radiation therapy and/or systemic adjuvant therapy, as per standard of care.
Given the overall shift to more precise and targeted cancer treatments, many women have an increased expectation for less invasive procedures. Just as needle-core breast biopsy has provided a new alternative to surgical biopsy, Novilase ILT may be another option for women with breast cancer who are considering lumpectomy.
More than 600,000 lumpectomies are performed in the United States annually, including both malignant and benign tumors. The company estimates that approximately 50% of malignancies meet the inclusion criteria for this study. The trial is registered on www.ClinicalTrials.gov (? NCT01478438).
About Novilase Novilase is a laser-based device for destroying tumors. This minimally invasive alternative to conventional surgery provides a tumor treatment alternative while preserving the patient's options for additional procedures or adjunctive therapies. The image-guided outpatient procedure does not require general anesthetic or a hospital stay. Therapy consists of image-guided placement by trained physician of two small gauge needles into the tumor site after local anesthetic, followed by initiation of the computer-controlled Novilase system.
Treatment times vary from 15 to 30 minutes.
About Novian Health Novian Health Inc. is a privately held, medical device company with proprietary technology for the treatment of tumors using Interstitial Laser Therapy. Headquartered in Chicago the company also has a subsidiary in Evry, France. Developed as an alternative to surgery, the company's technology uses parametrically controlled heating for the ablation of tumors. Image-guided treatment of breast tumors is the first application of the technology, with the potential for Novilase to treat tumors elsewhere in the body. For more information, call (312) 266-7200 or access www.novianhealth.com.
About Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for 60 years, Rose Medical Center has earned its reputation as Denver's "Baby Hospital" while becoming a leader in comprehensive women's, surgical and endoscopy services, heart and vascular, orthopedics, total joint replacement, bariatrics, and sports, internal and aesthetic medicine.
With origins in Jewish teachings, traditions and community, Rose's founders built this hospital to "serve the need of every creed." By offering a high level of expertise and service across all disciplines, Rose has truly become a destination hospital, attracting patients from throughout Colorado and around the world. Learn more at www.rosemed.com.
CONTACT: Dowling & Dennis Public Relations Liz Dowling, 415-388-2794 Liz@DowlingDennis.net KEYWORD: UNITED STATES NORTH AMERICA ILLINOIS INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS ONCOLOGY RADIOLOGY SOURCE: Novian Health Inc.
Copyright Business Wire 2012 PUB: 04/12/2012 08:15 AM/DISC: 04/12/2012 08:15 AM http://www.businesswire.com/news/home/20120412005417/