NEW DEVICE OFFERS MICRO-INVASIVE ALTERNATIVE TO LUMPECTOMY FOR BENIGN BREAST TUMORS
NOVIAN HealthTM Announces FDA Clearance for Patented Interstitial Laser Therapy
CHICAGO — June 26, 2007 – NOVIAN Health Inc. has developed an Interstitial Laser Therapy (ILT) device. In its initial application, the device, used to treat fibroadenomas (benign tumors) of the breast with tumor sizes up to 20 mm, was granted clearance from the U.S. Food and Drug Administration on May 2, 2007.
“We are extremely pleased to have received FDA clearance,” said Chip Appelbaum, President and CEO of NOVIAN Health. “This allows us to begin the commercialization phase of establishing and operating treatment sites, which will offer women an alternative to traditional surgery, as well as to expand our clinical development efforts in malignant tumors.” Previously known as Kelsey Inc., the company is now introducing NOVIAN Health as its new name, a reflection of the company’s mission in creating a new path in healthcare.
Lasers have been used successfully to ablate tissue in other areas of medicine, such as prostate cancer. The NOVIAN Health device applies this proven technology to treating non-malignant breast tumors. ILT is a micro-invasive technique that uses needle probes to deliver laser energy into the tumor, causing the tumor to shrink. ILT’s major advantages over the traditional lumpectomy are:
A micro-invasive surgical process – access via two small needles rather than a scalpel wound
Local anesthesia rather than general anesthesia or IV sedation
Minimal post-operative scar tissue
Reduced risk of surgical complications
Shorter preparation and quicker recovery time for patients
Does not preclude any future medical or surgical treatment options
“Thousands of women in the U.S. find breast tumors each year, and about 80 percent of all breast tumors are benign,” said Dr. Kambiz Dowlat, Professor of Surgery at Rush University Medical Center and founder of NOVIAN Health. “The traditional treatment for removing these tumors is a lumpectomy. Many women are hesitant to undergo this invasive surgery and, until now, that was really their only option. We believe that breast ILT provides women a better option to treat many tumors.”
NOVIAN Health Inc., located in Chicago, is a small, privately held company with proprietary technology for the treatment of tumors using Interstitial Laser Therapy (ILT). The company has developed, tested, and patented a micro-invasive surgical process that uses ILT (controlled heating) for the ablation of breast tumors as an alternative to the surgically invasive, traditional “lumpectomy.” ILT offers significant advantages over surgical removal including minimal scarring, quicker recovery times, and only requiring local anesthesia. NOVIAN Health recently received its first FDA 510k clearance and expects to offer its technology at centers around the country. Their plan is to launch several centers nationwide that will be associated with existing surgical practices.