Molli Surgical Inc. has won the FDA’s nod for its wire-free localization technology for breast cancer surgery. The company said the Molli system helps radiologists tag cancerous lesions quickly and precisely, facilitating surgical excision and eliminating a source of anxiety associated with breast tumor removal.

Improving the patient experience while also increasing efficiencies for the care team is what Mollie Surgical’s mission is all about.

Traditionally, breast cancer patients require a preoperative procedure to implant a wire and radiological seeds to mark a nonpalpable lesion. Not only is the experience unpleasant for the woman, but it also requires coordination between the radiology and surgery departments as the woman can’t leave the hospital until the wire and tumor are removed. Having fasted all night, patients may then wait hours with a wire protruding from their breast before the primary surgery occurs.

With Molli, radiologists use a 3.2 mm solid magnet – about the size of a grain of rice – to mark the tumor to be removed. When the magnetic seed is implanted, a special wand detects the presence of the marker and its distance from the want. A tablet communicates with the wand and gives a real-time readout, enabling the surgeon to accurately pinpoint the tumor and remove it from the breast.

The approved indication for the device is soft tissue, meaning it can be used anywhere in the body, not just the breast – though that is the first application. Toronto-based Molli Surgical launched its technology May 1 at the American Society for Breast Surgeons’ virtual annual meeting.

“This year alone, more than 2 million women around the globe will receive the devastating news that they have breast cancer,” said Fazila Seker, Molli Surgical’s CEO. “Our mission is to make their journey smoother and support them along the way.

Pinpoints tiny lesions

The magnetic marker is designed to pick out even the smallest nonpalpable lesions.

“To give you context, 40% of tumors measure 10 mm or less,” Ananth Ravi, Molli’s co-founder and chief scientist and clinical officer, told BioWorld. “We wanted to be lockstep with the progression of [imaging] technology” to detect smaller and smaller, nonpalpable tumors “with excellent therapeutic as well as cosmetic effects.”

Molli’s was inspired by patient feedback at Sunnybrook Health Sciences Centre in Toronto about their breast surgery experience and a couple of breast surgeons looking for an alternative to wire localization. The magnet can be implanted anytime within 30 days of the patient’s scheduled breast surgery.

The solution spares women the costs and risks of radiation exposure and increases workplace efficiencies. “Decoupling your radiological implant from your surgical date allows not only the patient autonomy over her life and schedule, but you also allow the care teams autonomy,” Ravi said.

While Molli is currently being tested and used only in breast cancer surgery, the company sees an opportunity across general surgery applications.

Competition

There are other companies working in this space, including Aliso Veijo, Calif.-based, Cianna Medical Inc. with its Savi Scout surgical guidance system technology. The company was acquired by South Jordan, Utah-based Merit Medical Systems Inc. in 2018.

Cambridge, U.K.-based Endomagnetics Ltd. (Endomag) has developed the Magtrace and Sentimag magnetic localization systems for magnetic detection to identify specific lymph nodes for surgical removal. The system includes a magnetic sensing probe and base unit designed to detect small amounts of Magtrace, the tracer drug that is injected into breast tissue.

Another competitor, Concord, Mass.-based Health Beacons Inc., has developed the Localizer radiofrequency identification breast localization system, a wireless, marker-based approach to localizing lesions for surgery. The device is designed to avoid a separate procedure on the day of surgery. The RFID tag is implanted at the site of the tumor days or weeks prior to surgery. The hand-held RFID reader, called the Tagfinder, is then used to locate the tag and the tumor for surgical removal.

Broad potential

“We’re not a breast surgery company. We’re not an oncology company,” Seker told BioWorld, underscoring the system’s soft tissue indication. “How can we leverage the core technology, which is about finding things, so that you don’t need to go and use more complex imaging technologies that may be more costly and require unnecessary trips to the hospitals for the patient and unnecessary resources” for the hospital?”

The ultimate vision is to help hospitals and doctors provide real patient-centered care, she said. To that end, the company intends to partner with hospitals and physicians to understand where they believe there is a need for finding things in the body, and then learn more about the patient experience that accompanies those procedures. “Our task is really going to be figuring out where we should be putting our energy to make the greatest impact,” Seker said.

“Molli is a really simple finding technology, and that’s where I think our first opportunities will be following breast.”

For now, the company is focused on North America. Its sales team has been actively building relationships with prospective customers across the U.S. for several months, in preparation for Molli’s launch. Health Canada approval is pending.