Novel 3-D Marker Is ‘Game Changer’ for Post-Surgical Radiation Therapy

When most of the business news is about big companies, it’s easy to forgeGreen glove with BZt that there’s still room for a little guy with a great idea. Medical device maker Focal Therapeutics is clearly one of the latter, as a new scientific presentation underlines. The presentation was given at the 2014 Breast Cancer Coordinated Care (BC3) conference, held in February in Washington D.C.

Focal Therapeutics developed the BioZorb™ three-dimensional surgical marker, to help identify the surgical excision site following soft tissue removal, such as breast lumpectomy cavities.  The marker makes it possible for physicians to visualize the surgical region post-surgery. This helps to improve clinical precision for post-operative treatments and follow-up.

To understand the difference this makes, consider a woman who has just had a lumpectomy and now needs post-surgical radiation to prevent her cancer from returning. Once this 3D marker is placed by her surgeon, her radiation oncologist can locate the exact site more precisely, clinicians can better target the radiation (thereby decreasing the volume of tissue that receives radiation minimizing radiation exposure to nearby healthy areas such as the heart and lungs.

The presentation showed BioZorb as an alternative to traditional tissue landmarks such as seroma and clips as well as post-operative density changes seen on CT scans done for treatment planning. The results were dramatic. The device enabled physicians to achieve a greater-than-50% percent reduction in planned treatment volume, according to poster co-author Robert R. Kuske, Jr., M.D. Dr. Kuske is an internationally known radiation oncologist who uses BioZorb in his medical practice at Arizona Breast Cancer Specialists.

What’s more, there appeared to be no downside to using the BioZorb marker. Patients tolerated placement of the device without complications, and cosmetic outcomes were excellent.

With traditional methods, treatment planners have to do a certain amount of guesswork and treat a bigger area because the borders of the area needing treatment aren’t obvious. That can mean a higher radiation dose, more risk to healthy tissue and organs, and negative impacts on the patient’s appearance.

Co-author Linda Smith, M.D. of Comprehensive Breast Care in Albuquerque, N.M. said “It was a revelation to see the surgical edges so clearly with the BioZorb device in place.” Read more about the presentation here.

Dr. Gail Lebovic

Dr. Gail Lebovic

BioZorb’s inventors appear to be true visionaries, because there’s no other device like theirs in the medical marketplace. Unlike other markers, BioZorb defines the treatment area in three dimensions. Its unique open spiral is made of a bioabsorbable material, which means the patient’s body absorbs it slowly over time. That makes surgical removal after completion of therapy unnecessary.

Dowling & Dennis has worked with Focal Therapeutics’ George Hermann, president and CEO, Gail Lebovic, M.A., M.D., FACS, the company’s chief medical officer, as they have created several innovative devices in breasthealth. From all appearances, BioZorb is extending their career-long hot streak.

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