Breast tumors, both cancerous and non-cancerous, are one of the most serious health problems facing women today. Early detection is the most powerful tool in combating this problem. Coupled with early detection is the early treatment of tumors or “lumps” found in the breast.
Novilase Breast Therapy is a minimally invasive procedure that uses laser ablation to destroy tumors as an alternative to surgery. The outpatient procedure does not require general anesthesia or a hospital stay. During the procedure a physician will use ultrasound or x-ray image-guidance to insert two small probes into and beside the tumor. One delivers laser energy and the second monitors temperature at the edge of the desired ablation zone. Novilase treatment times can range from 15 to 30 minutes.
Multiple clinical trials have evaluated Novilase for the focal destruction of malignant breast tumors. Novian Health is pursuing a CE Mark based on this data and planning a confirmatory trial to seek U.S. FDA approval. Evaluation of other indications has also begun.
Novian Health has received U.S. FDA 510(k) clearance for the treatment of fibroadenomas (≤2 cm), or benign breast tumors, and ablation of soft tissue. Novian launched a post-marketing surveillance study called ABLATE (American Breast Laser Ablation Therapy Evaluation) to collect information on the treatment of benign breast tumors for the purpose of obtaining additional data in support of a reimbursement code in the U.S. More than 100 patients have been treated at centers across the United States.
Incidentally, fibroadenomas are the most common type of solid breast tumor affecting 10% of all women. Whether discovered through a self-breast examination or routine mammogram, many women request surgical excision of the fibroadenoma after consultation with their physician. Now, Novilase is another treatment option for them.
One of the multicenter international clinical trials remains open in France. This trial is evaluating Novilase Breast Therapy as a treatment option for early stage breast cancer.
For more information visit: www.novilase.com
CLINICAL TRIALS & REGISTRIES
BR-002: “A Multicenter “Ablate and Resect” Study of Novilase® Interstitial LaserTherapy for the Ablation of Small Breast Cancers”
Completed enrollment and treatment of 61 women in the United States and United Kingdom with early-stage breast cancer.
Sites included Columbia University Medical Center, Bristol Breast Centre, Walter Reed National Military Medical Center, Rose Breast Center and the Breast Center of Souther Arizona among others.
Clinical data presented at the 2015 San Antonio Breast Conference. Publication in process.
LASERBREAST1: “Local Treatment by Thermic Destruction of Primitive Breast Cancer”
Enrolling 30 women in France with early-stage breast cancer. Multicenter trial is led by investigators at the world-renown cancer centre Institut Gustave-Roussy.
ABLATE: American Breast Laser Ablation Therapy Evaluation (patient registry for FDA 510(k) cleared device) (Identifier: NCT00807924)
Enrolling up to 200 women in the United States with benign breast tumors.
Patents, trade secrets and other intellectual property rights protect Novilase Interstitial Laser Therapy. Novian Health owns and controls all of the rights in the intellectual property. The patents include 13 issued U.S. patents, shown below, 85 European patents, 12 International patents (including 2 U.S., 56 European and 5 other international multi-version Design Registration patents). In addition, multiple filings have been made that are pending.
Novian Health continues to improve the Novilase device and procedures, filing patents on the improvements and ancillary products.