When a woman finds a tumor in her breast — as thousands of women in the U.S. do each year — her options are somewhat limited and almost always include surgery to remove the tumor.
“The traditional treatment for removing these tumors is a lumpectomy,” said Kambiz Dowlat, MD, professor of surgery at Rush University Medical Center (Chicago) and founder of Novian Health (Chicago), a company that has developed an Interstitial Laser Therapy (ILT) device to treat fibroadenomas — or, benign tumors — of the breast.
“Many women are hesitant to undergo [a lumpectomy] and, until now,” he said, “that was really their only option. We believe that breast ILT provides women a better option to treat many tumors.”
According to Dowlat, about 80% of all tumors are benign.
Novian reported this week receiving FDA clearance in May for its ILT device for tumors up to 20 mm in size. The clearance also was for the indication of general surgery procedures including incision, excision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissue.
Previously known as Kelsey, the company recently introduced Novian Health as its new name, selected to reflect the company’s mission: to create a new path in healthcare, it says. Novian is a small, privately held company in Chicago.
“We are extremely pleased to have received FDA clearance,” said Chip Appelbaum, president/CEO of Novian. “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.”
The ILT system works by precisely delivering laser heat to destroy the tumor, Appelbaum told Medical Device Daily in an interview via email.
“Laser probe is placed precisely in the center of a tumor, similar to a stereotactic biopsy needle, and a thermal sensing probe is placed at the periphery of the desired zone of ablation. Our probes are 14-gauge needles, smaller than a typical biopsy needle. The laser then heats the tissue, for about 15-25 minutes, and when the desired zone has been ablated the laser turns off. The probes are then removed and a band-aid is applied,” Appelbaum said.
“The entire process takes less than an hour and is conducted under local anesthetic, no general anesthetic or sedation is required. This means that an OR environment is not required, rather just a procedure room you would find in a physicians office.”
Although the company plans to initially market the device for ablation of benign breast tumors, Appelbaum told MDD that plans are underway to expand its clinical development and seek approval to use the system to treat malignant breast tumors.
He said there were no serious adverse events in clinical testing of the system.
According to the company, ILT offers several major advantages over the traditional lumpectomy, including minimal scarring, quicker recovery times, reduced risk of surgical complications, and requiring only local anesthesia.
Appelbaum said that, typically, a patient who undergoes this procedure is released within an hour and is sent home with over-the-counter analgesics. And, unlike a standard lumpectomy, the patient is able to immediately resume her normal activity, he added.
Dowlat, the inventor of the device, also introduced the stereotactic biopsy technique for diagnosing breast tumors, Appelbaum said. The Novian Health ILT System is a therapeutic outgrowth of Dowlat’s early work, he noted.
“We realized that there had been no significant new developments for the treatment of breast tumors in decades. The only choices were lumpectomy or mastectomy. There was clearly a need to provide patients with a less traumatic and minimally invasive alternative. Dr. Dowlat has worked with lasers for the ablation of tissue over the last 20 years and wished to apply his efforts to where there was a demonstrated medical need,” Appelbaum said.
A major key to the ILT System, Appelbaum said, is the ability to precisely monitor and control the process.
“The temperature sensing devices are extremely sensitive and accurate,” he said. “This allows the surgeon to precisely ablate the desired tissue, no more — no less.”