Breast cancer patients have long been in need of reliable therapeutic options that reduce pain and the risk of disfigurement. At the forthcoming MedTech conference of the Advanced Medical Technology Association (AdvaMed, Washington, DC), laser therapy specialist Novian Health Inc (Chicago) will showcase a novel technology for the ablation of early-stage breast tumors. The company’s CE-marked system is seeking to displace existing surgical procedures as the treatment of choice for early-stage breast tumors.
Every year, more than 275,000 women in the United States and 2 million around the world receive the dreaded diagnosis of breast cancer. The news can be overwhelming, triggering sudden and intense emotions. One participant in a study of patient responses to a breast cancer diagnosis said she felt “paralyzed and frozen with fear.”
Even as they are struggling to cope with such a life-changing diagnosis, women and their physicians must make difficult choices about what course of treatment to pursue. The first step is typically surgery. At present, for those women whose tumor is spotted while it is still small and localized have the option of removing the tumor through a breast-conserving surgical procedure called a “lumpectomy.”
About two-thirds of early-stage breast cancer patients and their doctors opt for the lumpectomy. But the procedure is far from a panacea. More than 25% of lumpectomy patients require additional surgery because their tumors were not completely removed during the initial procedure, and about 30% of lumpectomy patients end up having sufficient deformity of their breast to justify reconstructive surgery. Moreover, performing a lumpectomy requires an operating room and general anesthesia. Recovery can be painful and take several days, and the procedure leaves a scar and may change the shape of the breast.
Novian’s Novilase® Breast Therapy system is a minimally-invasive alternative to lumpectomy that offers better health-related quality-of-life outcomes, a better patient experience, quicker recovery, and may even lower overall healthcare costs. Novian’s system received the CE mark in 2019, permitting the technology to be commercialized in the European Union and Switzerland. The company now has approval to move ahead with the pivotal clinical trial needed to support FDA clearance for the intended use of focal destruction of malignant breast tumors. Novilase has previously received FDA clearance as an alternative to surgery for the treatment of benign breast tumors (fibroadenomas).
Novian’s novel technology replaces the scalpel with a tumor-destroying laser. The potentially game-changing treatment was originally devised by Kambiz Dowlat, MD, a professor of surgery at Rush University Medical Center (Chicago).
During a procedure using the Novilase system, doctors employ ultrasound imaging to guide a laser probe into the center of the patient’s tumor. They also position a temperature probe just outside the tumor. When the laser is turned on, it heats the cells in the tumor to 60°C (140°F), focally destroying the tumor. The laser automatically turns off when that target temperature is reached.
Focused application of such a high temperature kills the cancerous cells, resulting in the gradual disappearance of the dead tumor cells over the following weeks. In a key trial of the technology at top cancer hospitals in the United States and UK, researchers demonstrated that the Novilase system completely destroyed the cancer in one procedure in 98% of women with tumors smaller than 1.5 cm, and in 91% of women whose tumors were smaller than 2 cm.
Moreover, the procedure can be performed on an outpatient basis using local anesthesia. Recovery time is hours instead of days, the scar is minimal, and there is no change in breast shape. Women say the procedure feels much like a routine trip to the dentist, and report much less pain and fatigue than lumpectomy patients, along with a more positive outlook for their futures.
“It is incredibly exciting for women to be able to have their breast cancer treated without surgery,” says Margaret Chen, MD, FACS, chief of breast cancer surgery at ProHEALTH Care, New York, and a researcher in the studies of Novilase at Columbia University Medical Center.
“Novilase Breast Therapy can not only improve outcomes for breast cancer patients, but can also significantly reduce the trauma that women experience from surgery and reduce costs,” says Henry Appelbaum, president and CEO of Novian Health.
Recognizing the promise of the Novilase system, health technology accelerator MedTech Innovator (Los Angeles) recently selected Novian as one of 50 companies to participate in the organization’s four-month showcase and accelerator program. As part of that program, Novian will tell its story at AdvaMed’s annual MedTech conference, which will be held virtually this year on October 5–7.
In addition to offering a pioneering technology, says Appelbaum, Novian also presents a strong business case for potential investors. Once cleared for use in the United States, Novilase could replace about 70% of the 1.6 million lumpectomies performed each year in Europe and the United States to remove cancerous and benign tumors, creating a potential market of more than $2 billion per year.
“At Novian, we feel tremendously fortunate to be in a position to make a real difference in the lives of women who face the often-devastating diagnosis of breast cancer, while also building value for the company,” says Applebaum.
For further information visit Novian Health.