GT Medical Technologies Inc. revealed that it has raised $16 million in a series B financing round led by MVM Partners, which was joined by existing investors Medtech Venture Partners and Bluestone Venture Partners.

Funds will support the expanded commercialization of Gammatile Therapy, a surgically targeted radiation therapy (STaRT) that is intended to help patients with brain tumors.

“Despite advances in care and improvements in outcomes for many other forms of cancer, brain cancer treatment options and outcomes have remained tragically static, with only one-third of patients living beyond five years. Gammatile Therapy provides patients and their clinicians with a needed new treatment modality,” said Kyle Dempsey, partner at MVM Partners. “Consistent with our investment goals, Gammatile Therapy has the potential to improve outcomes, decrease total health care costs, and improve patient satisfaction relative to the current standard of care. We are thrilled to partner with the business and to help ensure more patients and clinicians have access to this innovative technology.”

Gammatile therapy is placed directly at the site of the tumor following excision and targets residual tumor cells before they can replicate. The therapy features a bioresorbable, conformable, 3D-collagen tile and uniform radiation source and is indicated for the treatment of all types of recurrent brain tumors.

The company initially nabbed U.S. FDA clearance for Gammatile Therapy in July 2018 for recurrent brain tumors. The agency expanded that clearance earlier this year to newly diagnosed malignant brain tumors. As a result, many top centers focused on brain tumor treatment have adopted the therapy, said Matt Likens, president and CEO of Tempe, Ariz.-based GT Medical Technologies.

Matt Likens, president and CEO of GT Medical Technologies

“We are excited that this funding will support our efforts to further expand access to STaRT, allowing even more patients to benefit from this targeted treatment,” he noted.

Likens told BioWorld that the extended indication has been received positively. “Now, virtually any patient who presents with a brain tumor – whether it’s newly diagnosed or recurrent disease – is eligible for Gammatile.” He noted that it has been used in a handful in newly diagnosed patients, and the company is looking to obtain more data to encourage use in these individuals.

“From a commercial standpoint, we are investing more now in our field organization, which is a two-tiered approach with some of our own direct sales representatives. We’re [also] utilizing a network of 15 different distributor organizations or agents that also have a variety of technologies that focus on neurosurgery.” That will help get in front of a host of stakeholders to drive broader adoption of Gammatile.

The company also has seen some early returns related to investment made in direct-to-patient marketing. “We find that there are so many advantages for the use of Gammatile for the patient,” to include that it is done in the last five minutes of the tumor recession procedure. Without Gammatile, patients must wait two to three weeks for wound healing before adjuvant radiation therapy can begin from external sources.

“We call it the one-and-done treatment,” as it is the only radiation that is necessary, he explained. It precludes the need for repeated trips for follow-up external beam radiation at a clinic or hospital – “as many as 30 follow-up procedures in order to do the same thing that Gammatile is doing.” With the rise of COVID-19, such repeated trips put patients at risk. Gammatile, by contrast, starts working immediately, as it is placed at the end of surgery.

Clinical work

The expanded commercialization activities that will come with the funding is just one piece of the puzzle. “I think just as important is the investment we’ll be making in clinical studies,” Likens told BioWorld. He noted that even though the technology has a nod from the FDA, the company is conducting three different studies.

To start, the company recently revealed that the first patients were enrolled last week in its registry trial, which will further validate the safety and efficacy of Gammatile Therapy in patients with metastatic brain tumors, gliomas and meningiomas from up to 50 treatment centers across the U.S. Likens said the company expects a couple of more institutions to enroll before the end of the year.

Data from the study will be used to benchmark clinical outcomes for Gammatile Therapy and allow for comparisons to existing standard-of-care treatments for patients with brain tumors.

In addition to the registry trial, two other studies evaluating Gammatile Therapy in patients with brain metastases were reported in August. Those studies, which are led by The University of Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center, are expected to begin enrollment in the fourth quarter.

Looking ahead, the company is hoping to gain regulatory clearance for Gammatile internationally. “We would hope that within about 12 to 18 months, we would be submitting for our CE mark,” he said. “Simultaneously, we have launched a program to gain registration in the MDSAP program.” That would cover Brazil, Canada, Japan and Australia. All this ex-U.S. activity is expected to bear fruit some time in 2022.

Likens also told BioWorld that his company has intellectual property beyond use in the brain, also known as extracranial applications. “We see the need for this in a number of other tumors in other parts of the anatomy where residual tumor cells continue to be an issue and are likely to cause recurrences.” Areas of interest are the spine and head & neck outside the brain.