Novian Health begins laser therapy clinical trial for breast cancer

Chicago, IL--Laser therapy developer Novian Health has begun a multicenter clinical trial on its Novilase interstitial laser therapy (ILT) for ablating (destroying) malignant breast tumors. The first facility to participate in the trial is Rose Breast Center (Denver, CO), under the direction of Barbara Schwartzberg, MD.

Novilase ILT is an image-guided, minimally invasive alternative for lumpectomy that ablates small breast tumors. The clinical trial is the first stage of a two-stage study as part of an FDA premarket approval (PMA) process. The trial follows a single-center feasibility study on the technology for treatment of malignant breast tumors, and plans to soon begin a similar clinical trial in Europe are in the works.

The company previously received FDA 510(k) clearance for treating breast fibroadenomas, and currently offers the technology at Rose and other breast centers around the country that are participating in its ABLATE registry.

The study will evaluate the rate of complete tumor ablation of breast cancers that are up to 2 cm. It will also examine the correlation of the pathology of postablation lumpectomy specimens with magnetic resonance imaging (MRI), mammography, and ultrasound in detecting any residual tumor.

The technology 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. It 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.


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