CHICAGO--(BUSINESS WIRE)--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.
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.”
Dr. Schwartzberg is chairwoman of the Cancer Committee at Rose Medical Center (Denver, Colorado.) and a member of Novian Health’s Scientific Advisory Board.
Novilase is a laser-based device for destroying tumors. This minimally invasive alternative to conventional surgery provides a patient with a safe tumor treatment alternative while preserving the patient’s options for additional procedures or adjunctive therapies. This outpatient procedure does not require general anesthetic or a hospital stay. Multiple tumors can be treated during a single visit. Therapy outcomes may be assessed using a variety of currently available imaging technologies and other methods. Therapy consists of physician placement of two small gauge needles into the tumor site after local anesthetic, followed by initiation of the computer-controlled Novilase system. Treatment times vary from 15-30 minutes.
About Novian Health
Novian Health Inc., located in Chicago, is a privately held company with proprietary technology for the treatment of tumors using Interstitial Laser Therapy (ILT). Developed as an alternative to surgery, the company’s technology uses parametrically controlled heating for the ablation of tumors. Treatment of breast tumors is the first application of the technology although Novilase has the potential to treat tumors elsewhere in the body.
For more information, call (312) 266-7200 or access www.novianhealth.com.