MIPS Project Detail:

Xcision Medical Systems, LLC.

Radiosurgery of early stage breast cancer

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Company

Xcision Medical Systems, LLC.

Columbia

Howard

County

, Maryland

Founded:

2006

Website:

https://xcision.com/

Company Description:

Xcision Medical Systems 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.

Xcision’s initial focus is on breast cancer, using stereotactic partial breast irradiation to treat patients eligible for breast-conserving therapy. The company’s first product, GammaPod™, is a new, stereotactic radiotherapy system optimized for the treatment of breast cancer in 1-5 sessions.

MIPS Project

Radiosurgery of early stage breast cancer

Project #

4804.28

|

MIPS Round

58 |

Starting Date:

Aug 2016

MIPS Project Challenge:
The broad goal of this two-phase MIPS project was to test the clinical feasibility of the GammaPod™.

Project Scope:
This project was designed to perform pre-clinical and clinical testing to gather safety and feasibility information in support of FDA submission for device approval. Preclinical testing of the GammaPod™ device involved assessment of both geometric and dosimetric accuracy. Researchers also identified and evaluated the most and least favorable candidates for treatment, and assessed patient comfort with the device. In addition, through a clinical study, they delivered radiation treatments to eligible patients and assessed the feasibility and safety of using GammaPod™ to deliver a focal dose of radiation to a target in the breast. Such clinical evidence was crucial for both gaining FDA clearance and for market adoption.

Both pre-clinical and clinical testing are crucial for the GammaPod device to gain FDA clearance and market adoption. Through the first in-human clinical testing, we verified that the GammaPod system is capable of delivering a high focal dose to a target in the breast with low doses to surrounding structures and organs such as the lung, heart, and normal breast tissue.

Cedric Xinsheng Yu, CEO, Xcision Medical Systems

Results:

In the study, researchers identified the geometric and dosimetric accuracy of the breast cup device, identified patients not suitable for GammaPod™, and confirmed patient comfort.

The research generated through this MIPS project resulted in three peer-reviewed publications in 2013 and eight patents.

In 2015, the company obtained the necessary MDE (NRC) licenses, FDA IDE approval to start clinical testing, and NRC source and device registration necessary for ultimate market launch.

Xcision has achieved revenue of $5.2 million and acquired $13.7 million in private funding. Through sales revenue and investment funding, Xcision was able to increase its number of employees from 17 to 22.

The first patient treated using the GammaPod™ occurred on 3/8/16. The IRBapproved clinical trial under the FDA IDE approval completed enrollment in August, 2017. Xcision has submitted application to the FDA for full clearance.

Faculty members at the University of Maryland, Baltimore invented a method and device for delivering stereotactic radiotherapy specifically for breast cancer. By licensing this technology from UMB and collaborating with the PI and his research team, Xcision developed a new, breast-specific stereotactic radiotherapy machine, the GammaPodTM . The GammaPod uses tens of thousands of radiation beams to focus the radiation at the tumor to kill tumor cells.