Novilase Breast Therapy is a minimally invasive procedure that uses laser ablation to destroy tumors. Novilase laser ablation is intended to be an alternative to surgery while preserving options for additional procedures or adjuvant therapies. The outpatient procedure does not require general anesthesia or a hospital stay. Therapy consists of ultrasound or x-ray image-guided placement of two small probes (one to deliver laser energy and the second to monitor temperature at the edge of the ablation zone) by a trained physician into the tumor site after local anesthetic. Novilase treatment times can vary from 15 to 30 minutes.
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.
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. The ABLATE registry has been initiated to collect information on the treatment of benign breast tumors for the purpose of obtaining additional data in support of a CPT reimbursement code. Patients are being treated at centers around 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. Novian Health will be pursuing a CE Mark in the near future.
Two multicenter international clinical trials are currently evaluating Novilase 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”
Enrolling 60 women in the United States and United Kingdom with early-stage breast cancer. Enrollment is complete in the US and the UK.
LASERBREAST1: “Local Treatment by Thermic Destruction of Primitive Breast Cancer”
Enrolling 30 women in France with early-stage breast cancer.
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, 58 European patents, 8 International patents, and 1 U.S., 28 European and 1 other international multiversion 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. It is intended that the intellectual property rights will remain 100% owned by Novian Health.