Clinical Studies

Novilase™ is a minimally invasive laser procedure for treating breast tumors.  Novian Health is currently FDA-cleared for the treatment of fibroadenomas, a common form of benign (non-cancerous) breast tumors.  An alternative to lumpectomy surgery, Novilase™ is safe, simple, effective, and less risky than lumpectomy while providing a superior cosmetic outcome.

How Does Novilase™ Work?

Novilase™ destroys (or ablates) the tumor with heat from a laser. The procedure is performed via two small probes inserted in the skin. The treatment is delivered with precise monitoring and control by the physician and has built-in automatic safeguards. The procedure’s design ensures that only targeted tissue is destroyed – no more, no less. The ability of Novilase™ to monitor temperatures at the periphery allows precise control of the ablation parameters. After the treatment, the body’s natural healing process repairs the site by replacing ablated tissue with normal tissue.

The minimally invasive nature of the procedure provides patients with a treatment option that can be safer than a traditional lumpectomy and preserves the natural form and feel of the patient’s breast. In contrast, the traditional surgical approach of lumpectomy requires an incision, the removal of tissue and the risks of surgery, and can scar and alter the breast’s form and feel.

While Novilase™ is the first breast procedure to use laser ablation to treat fibroadenomas, laser ablation has been successfully used to treat benign prostate tumors since the early 1990s. Novilase™ also uses the same image guidance that has been trusted for more than a decade for breast biopsy.

What is a Fibroadenoma?

A fibroadenoma is the most common type of benign breast tumor. About 10 percent of all women will experience fibroadenomas during their lifetime. Most are not treated. However, some tumors are considered suspicious or bothersome.

Of the more than 1 million suspicious breast lumps detected each year in the U.S., about 80 percent are benign. Although not cancerous, fibroadenomas can cause physical discomfort and also anxiety because of the association of lumps with breast cancer. Thus, after consultation with their physicians, many women with this condition request that their fibroadenomas be removed.

What is a Lumpectomy?

Lumpectomy is a form of breast surgery in which the tumor and a margin of normal tissue around the tumor are removed from the breast.

What are The Advantages of Novilase™ vs. Lumpectomy?

Novilase™ provides multiple advantages over lumpectomy, the traditional approach to fibroadenoma removal:

• Alternative to surgery or watching and waiting. Before Novilase™, patients who wanted to avoid a lumpectomy surgery were advised to “watch and wait.” Watching and waiting causes anxiety for many women because of the chance the tumor could grow and may become cancerous. Fibroadenomas can also cause physical discomfort. 

• Less invasive. The two Novilase™ probes are inserted via two skin nicks of about 1/8 inch each, versus the 2-3-inch incision needed for a lumpectomy.

• Less infection risk. Because Novilase™ works through heating without an incision, the infection risk is extremely low. A lumpectomy incision and cavity can be more prone to infection and other complications.

• Faster recovery. A patient can resume normal activity within a few hours of the Novilase™ procedure. The recovery period for a lumpectomy can last a few days.

• No stitches and minimal scarring. When the procedure is complete, the two small nicks are covered with a small adhesive bandage. A lumpectomy incision is closed with sutures and creates a more substantial scar.

• Natural shape maintained. The “dimpling” that can occur with lumpectomy does not typically occur with Novilase™, because the procedure does not remove tissue. Thus, the breast maintains its natural shape.

Who Performs the Novilase™ Procedure?

Novilase™ is performed by physicians –   surgeons or radiologists – who are also skilled in the use of image-guided biopsy techniques.

Who is a Candidate for Novilase™ Treatment?

Novilase™ is indicated for patients who fit the following criteria:

• Females ages 15 and older

• Breast tumors detected by physical examination or by imaging techniques such as mammogram or ultrasound.  However, because the technique is dependent upon imaging for placement of the laser probe, the tumor should be well defined on a mammogram or ultrasound.

• Definitive histological (studied under a microscope) diagnosis of benignity

• Fibroadenomas that do not exceed 2.0 cm in diameter and measure at least 0.5 cm away from the skin.

• Women with single or multiple fibroadenomas.

What are The Contraindications for Novilase™ Treatment?

Novilase™ is not indicated for patients who fit the following criteria:

Pregnant or lactating women and women with uncorrectable coagulopathy (impaired blood clotting);

Tumors that cannot be clearly visualized by mammography or ultrasound;

Tumors with uncertain histology -- i.e. cystosarcoma, phylloides, atypia, or in-situ carcinoma;

Women with significant co-existing diseases that could interfere with data analysis of their breast tumor;

Women with physical or psychological disorders within the last five years that may be life-threatening.

Are There Potential Complications with Novilase™?

No major complications have been observed with Novilase™. The only potential complications observed have been minor skin scalding, and this is preventable.

Can Novilase™ be Used with Malignant Breast Tumors?

For the initial use of the technology, Novilase™ developer Novian Health sought and received FDA 510(k) clearance for the treatment of fibroadenomas of up to 2 cm. The company is planning a clinical trial to obtain FDA approval of Novilase™ for treatment of malignant breast tumors. Several publications cover Novian Health’s significant clinical experience treating malignant breast tumors as part of its previous clinical studies.