Novian Health Receives the CE Mark Approval for its Breakthrough...

Novian Health Receives the CE Mark Approval for its Breakthrough Novilase Breast Therapy

Healthcare Tech Outlook | Wednesday, July 31, 2019

The breakthrough laser therapy technology facilitates a less invasive treatment for breast cancer patients.

FREMONT, CA: Breast tumors are considered as one of the most severe health problems faced by women today. It is the most common form of cancer in women with over 404,920 annual incidences in the EU alone. Fibroadenomas are commonly occurring solid breast tumors, and affect almost 10 percent of all women.

Breast cancer treatment is slowly moving toward minimally invasive approaches with the emergence of new technologies. The Novilase Breast Therapy is a breakthrough technology which provides a significantly less invasive option when compared to surgical biopsy. The developer of the innovative technology, Novian Health, recently announced the CE Mark approval for the product.

Novilase Breast Therapy leverages laser-induced heat for focal termination of breast tumors up to 2cms in size. The CE Mark approval will enable Novian Health to commercialize its technology in the European Union (EU) and Switzerland. It will allow breast cancer patients to choose a less invasive alternative to surgery for early-stage breast cancer and benign breast tumors.

Based in Chicago, Novian Health is a medical device company with proprietary technology for the treatment of tumors using Interstitial Laser Therapy. The company specializes in image-guided laser tumor therapy. Novian Health aims to provide women with the least invasive alternatives to surgery for cancerous and non-cancerous breast tumors. The Novilase laser procedure can be performed in a breast center equipped with ultrasound imaging guidance.

Novilase Breast Therapy is the first thermal ablation device approved for the treatment of malignant tumors. Hence, the CE Mark approval is a significant milestone for the healthcare company. It will significantly aid the women in the EU; since the solution is designed to help patients avoid the trauma and risk of breast surgery.

The innovative breast therapy technology only requires local anesthesia for the minimally invasive procedure. The Novilase approach leverages ultrasound imaging to insert two small probes into the breast and guide them to the tumor. One probe is designed to monitor the procedure by sensing the temperature change, while the other leverages heat to annihilate the tumor. The entire approach takes less than 30 minutes, and the follow-up imaging confirms the success of the procedure.

According to a recent study in the US and the UK, Novilase Breast Therapy was able to terminate over 90 percent of malignant breast tumors. The trial patient-reported enhanced health-related quality of life outcomes when compared to lumpectomy surgery. Also, no adverse events or effects were reported during the trials.

Novilase has emerged as a better option for women looking for a less traumatic and minimally invasive procedure in the treatment of malignant and benign breast tumors. Almost up to 25 percent of the women undergoing lumpectomy need additional surgeries. According to the clinical data collected by Novian Health during the trials, Novilase can significantly reduce the retreatment rate for patients, leading to faster recovery and better cosmetic results. The streamlined treatment will enable organizations to accelerate their recovery by undergoing radiation or chemotherapy sooner.

Novilase Breast Therapy has been cleared as an alternative approach to surgery for the treatment of breast tumors in the US. The US food and drug administration (FDA) approved the investigational device exemption (IDE) to conduct a confirmatory study (BR-003) and gather the necessary data to bolster the marketing application for focal destruction of malignant breast tumors.

Novian Health also obtained the ISO:13485:2016 certification for its quality management system after it demonstrated its ability to uphold the quality of its products and services, to effectively meet the customer needs, and keep up with the relevant regulatory requirements.

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