GammaPod Stereotactic Radiotherapy System for Breast Cancer Receives CE Mark

COLUMBIA, Md., April 25, 2019 /PRNewswire/ -- Xcision Medical Systems, LLC announced that the GammaPod stereotactic radiotherapy system has received CE marking, paving the way for new sales in Europe and offering patients the latest option in noninvasive breast cancer treatment.

"We are excited to bring GammaPod to the European market, where the need for more efficient, precise breast cancer radiotherapy treatments is increasing," said Cedric Yu, DSc, Xcision founder and chief executive officer.  "CE marking represents an important milestone that allows Xcision to access one of the world's most important markets."

With GammaPod, patients can receive partial breast radiation in conjunction with breast conserving treatment in five sessions or less.  Patients receiving whole breast irradiation with a tumor bed "boost" may be eligible to reduce the boost from several treatments to one. 

Members of the GammaPod Consortium plan to activate clinical trials later this year investigating the use of preoperative radiosurgery delivered in one to three treatments for patients with localized disease.  Researchers intend to investigate the efficacy of preoperative radiation and identify the population of patients who may be able to receive radiation alone to destroy the tumor, thereby obviating the need for surgery.

As technology continues to become more targeted, oncologists are actively considering the safety and benefits of treatment de-escalation, or reducing the volume of therapy to which patients are exposed.

"The ability of GammaPod to noninvasively deliver conformal radiation doses to only the affected area of the breast with the precision of stereotactic radiotherapy could certainly de-escalate care and reduce the burden of today's protracted treatments on patients," Yu said.

Stereotactic radiotherapy treatments differ from conventional techniques in that they deliver higher doses of more focused radiation in fewer treatments.  GammaPod uses a first-of-its-kind breast cup immobilization system to minimize motion and provide high levels of accuracy for treatment planning and delivery.

According to the International Agency for Research on Cancer, breast cancer is the most commonly diagnosed cancer in European women with an estimated incidence of more than 522,000 in 2018.  Europe accounts for 25% of newly diagnosed cases worldwide each year.

Azienda Universitaria Integrata di Udine (ASUIUD) in Italy announced last year that it would acquire GammaPod following CE marking.

"We selected GammaPod because of its practice-changing potential," said Marco Trovò, MD, head of the Radiotherapy Department at ASUIUD.  "In Italy and throughout Europe, our field is moving to treat early stage breast cancer patients with shorter courses of radiation.  The GammaPod is completely noninvasive and could potentially allow our patients to receive a full course of treatment in only one to five fractions."

Xcision is represented in Europe by Tema Sinergie S.p.A. in Italy and OncoMed Solutions LLC in Switzerland, Germany and Austria.  The company's innovative technology will be on display at the ESTRO 38 meeting in Milan, Italy from April 26 – 30 at booth 2975.

About Xcision Medical Systems
Xcision Medical Systems, LLC is a medical technology company developing advanced stereotactic radiotherapy solutions with the potential to dramatically raise the quality of treatments and improve the lives of patients and their loved ones. The company's solutions are designed to extend the benefits of radiation oncology to more patients and enable noninvasive treatments that allow patients to return to living fuller lives more quickly and less painfully after receiving a cancer diagnosis.

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Xcision Medical Systems
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SOURCE Xcision Medical Systems, LLC