FDA grants Novian Health IDE approval for Novilase ILT System to treat breast cancer

Novian Health, developer of Novilase® Breast Therapy, announced that the US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for the company to start a multi-center study of its Novilase® Interstitial Laser Therapy (ILT) System. Novian developed the ILT System for the ablation of small (up to 20 mm) malignant breast tumors. Novilase has previously received FDA 510(k) clearance for the treatment of breast fibroadenomas.

“It will be another boon for patients when this therapy can be applied to cancerous breast tumors.”

Novilase ILT uses parametrically controlled heating to ablate tumors. The procedure is performed with either ultrasound or stereotactic x-ray imaging guidance and two small 14-gauge probes. It is intended to be a minimally-invasive alternative to lumpectomy.

An IDE allows the investigational device to be used in a clinical study designed to collect safety and effectiveness data. The data is required to support a Premarket Approval (PMA) application to the FDA. The study is scheduled to begin in the fourth quarter of 2011.

Patients enrolled in the study will undergo Novilase ILT of a malignant breast tumor. Following the procedure, imaging and an excision to remove the ablated tissue will be performed no later than 28 days post-ablation. The researchers will then collect data to confirm the tumor has been destroyed and correlate the post-ablation imaging (i.e., MR, ultrasound, and x-ray) with pathology. Data collected will be used to support a future study which will treat malignant breast tumors with Novilase ILT and followed with imaging.

"I'm pleased that the company was able to secure the IDE approval despite a challenging regulatory environment," said Henry "Chip" Appelbaum, President and CEO of Novian Health.

The new multi-center study follows a single-site feasibility study on malignant tumors that was conducted at Rush University Medical Center by Kambiz Dowlat, M.D. After receiving 510(k) clearance, Novian Health launched its American Breast Laser Ablation Therapy Evaluation (ABLATE) registry. This data collection program tracks the progress of women who receive Novilase Breast Therapy.

"The potential benefit offered by Novilase has extended the treatment options for our patients in terms of non-surgical removal of non-malignant tumors," said Barbara Schwartzberg, M.D., a leading breast surgeon in Denver, Colorado. "It will be another boon for patients when this therapy can be applied to cancerous breast tumors."