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. Data from a multicenter trial in the UK and U.S. that evaluated Novilase for ablation of small breast cancers was published in Annals of Surgical Oncology (see article here). Novian Health has received a CE Mark for treatment of malignant and benign tumors of the breast in part based on this data and will conduct a confirmatory trial to seek U.S. FDA clearance for focal destruction of malignant breast tumors.
Novian Health has received FDA 510(k) clearance for the treatment of fibroadenomas, e.g., 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. (See ABLATE Registry for information on ABLATE). More than 100 patients have been treated at centers across the United States. Data has been presented at American College of Surgeons meetings.
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. Novilase provides an option for a minimally-invasive treatment.
Evaluation of other indications and a potential immunotherapeutic benefit has also begun.
For more information visit: www.novilase.com
CLINICAL TRIALS & REGISTRIES
BR-003: Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumours ≤15 mm
Up to 107 women with early-stage breast cancer (≤15 mm) will be enrolled at sites in the USA, UK, Germany, Switzerland, and Israel. Participating sites include UCSD, Walter Reed National Military Medical Center, Oxford University Hospitals NHS Trust, University of Zurich, Breast Centre Zurich, Kliniken Essen-Mitte, and St. Elisabeth-Krankenhaus in Cologne, among others. Enrollment is expected to begin in January 2023.
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 Southern Arizona among others.
Clinical data has been presented at the San Antonio, Miami, and the American Society of Breast Surgeons Conferences. Data was also published in the Annals of Surgical Oncology (Schwartzberg, B., Lewin, J., Abdelatif, O. et al. Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations. Ann Surg Oncol 25, 2958–2964 (2018). https://doi.org/10.1245/s10434-018-6623-2)
LASERBREAST1: “Local Treatment by Thermic Destruction of Primitive Breast Cancer”
Enrolled up to 30 women in France with early-stage breast cancer. Multicenter trial led by investigators at the world-renown cancer centre Institut Gustave-Roussy. Data was presented at the Paris Breast Rendez-Vous Congress.
ABLATE: American Breast Laser Ablation Therapy Evaluation (patient registry for FDA 510(k) cleared device)
Enrolled 100 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. Novilase is protected in the U.S., Europe and internationally by over 90 patents, designs and trademarks. Additional filings are made as appropriate.
Novian Health continues to improve the Novilase device and procedures, filing patents on the improvements and ancillary products.