Focal Therapeutics is a medical device company based in Portola Valley, Calif. that developed and markets the BioZorb tissue marker. Focal’s management team and investors include three medical device pioneers: George D. Hermann, the CEO; Gail S. Lebovic, M.D. the Chief Medical Officer; and investor Thomas J. Fogarty, M.D.
The BioZorb tissue marker is an implantable device, placed by surgeons, that uniquely delineates the surgical site of tissue removal in three dimensions. The proprietary device helps clinicians overcome challenges involved in identifying the tissue excision site for subsequent treatments (such as radiation) and/or follow-up. This approach, which is compatible with virtually all forms of radiation therapy, assists in targeting for treatment planning, patient positioning during treatment, and long-term surveillance.
Made of a bioabsorbable polymer with six embedded titanium marker clips, BioZorb is placed at the time of surgical removal of tissue – for example, during breast surgery. The only device of its type, it utilizes a unique open spiral design to permanently mark the surgery site in three dimensions.
Physician users have noted that the marker dramatically improves visualization of the treatment area for radiation planning and therapy. “This device could represent a quantum leap in the ability to mark tissue for radiation treatment after surgery,” said Christopher Glaser, M.D., F.A.C.S., a surgeon at Mitchell Memorial Cancer Center and Owensboro Health Surgical Specialists, in Owensboro, Ky.
Other breast cancer specialists have reported additional clinical advantages. One example is Dr. Robert R. Kuske, Jr., an internationally known radiation oncologist and head of Arizona Breast Cancer Specialists. “This device represents a significant advancement towards the more precise delivery of radiation treatment,” Dr. Kuske said.
The BioZorb tissue marker received 510(k) clearance from the U.S. Food and Drug Administration in February 2012.
Focal Therapeutics is ISO 13485 certified.
Clinical experience with the BioZorb marker has been presented at the following scientific meetings:
World Congress of Breast Diseases 2012; Bahia, Brazil American Society for Radiation Oncology 2012; Boston, USA European Society for Radiation Oncology 2013; Geneva, Switzerland American Society of Breast Surgeons 2013; Chicago, USA American Association of Physicists in Medicine 2013; Indianapolis, USA ASCO Breast Cancer Symposium 2013; San Francisco, USA American Society for Radiation Oncology 2013; Atlanta, USA Royal Australian and New Zealand College of Radiologists 2013; Auckland, NZ San Antonio Breast Cancer Symposium 2013; San Antonio, USA Breast Cancer Coordinated Care 2014; Washington, USA
These presentations detail BioZorb’s clinical utility, ease of use, and its acceptance by clinicians and patients alike. The authors note BioZorb’s advantages for radiation treatment planning, patient positioning during treatment, assistance with advanced methods of radiation delivery and for long-term clinical follow-up.
In the U.S. alone, the company’s BioZorb technology can benefit an estimated 900,000 women each year who face surgical intervention for breast cancer diagnosis and/or treatment. In addition to BioZorb’s clinical benefits, Focal Therapeutics anticipates significant cost savings in the delivery of breast healthcare worldwide. BioZorb addresses a potential market that exceeds $1 billion annually.
The tissue marker provides an innovative solution to a vital clinical need: how to reliably delineate a region of soft tissue excision in three dimensions. Prior to BioZorb, there was no reproducible way to 3-dimensionally delineate the surgical site of tumor removal – a clinical situation that makes post-operative radiation planning difficult. Older methods typically used for radiation planning in the breast are fraught with uncertainty, and as a result may lead to overestimation of the volume of tissue that needs to be treated in order to decrease the chances of cancer recurrence. Treatment volumes that are larger than necessary can result in excessive radiation exposure to normal breast tissue as well as nearby vital organs such as the heart and lungs. BioZorb provides the first 3-D surgical marker to clearly delineate the region of tumor excision, thereby assisting clinicians in various aspects of post-operative cancer treatment and follow-up.
BioZorb has no direct competition. As a 3-D soft tissue marker it is potentially applicable to multiple anatomic sites, and its current application in breast cancer patients demonstrates the device’s clinical utility and acceptance. Breast cancer is the most common cancer among women worldwide with more than 1 million cases per year. Some 290,000 of those cases occur in the U.S. annually, according to the American Cancer Society.