According to the CDC, breast cancer is the most commonly diagnosed type of cancer among American women, after certain types of skin cancer. For most, treatment includes radiation therapy, which often results in damage to healthy nearby tissue. In 2007, Focal Therapeutics, a Aliso Viejo, California firm, was established by James Stubbs, Ph.D., George Hermann, and Dr. Lebovic to “help surgeons, radiation oncologists, and other clinicians to clearly identify a surgical site through the use of an innovative tissue marker”. The company’s first product, BioZorb is a tissue marker that is sutured in place by the surgeon during a lumpectomy after tumor removal. It received 510(k) clearance from the U.S. Food and Drug Administration in February 2012 and went into initial clinical use later that year. It is currently used in the United States and New Zealand and has continued to receive recognition from physicians. There is no other product that three dimensionally marks the surgical site during a lumpectomy.
This year’s Breast Cancer Symposium will be hosted in San Francisco on Sept. 25-27. To recognize on-going advancements in this healthcare space, Medgadget interviewed Focal Therapeutics’ Chief Medical Officer Dr. Gail Lebovic who will be presenting very exciting recent clinical data at the Symposium. The data summarizes the clinical experience with 108 patients that have been followed for three years. In total, there will be five poster presentations regarding various aspects of the clinical experience with BioZorb.
Janelle Chang Clark, Medgadget: What user need does this product address?
Gail Lebovic, MD, CMO of Focal Therapeutics: Radiation to the site of tumor excision is a critical aspect of breast cancer treatment in order to prevent recurrence. Currently the most common method of identifying the surgical location is by visualization of tissue changes (primarily the collection of seroma fluid) that occurs within the tissues after breast surgery. These changes can be seen on CT, and many radiation oncologists use this method to delineate the volume of tissue needed for radiation therapy. However, the fluid within the surgical cavity can infiltrate and flow into areas of the breast that are distant from the actual tumor resection site resulting in ambiguity and inadvertent overestimation of the breast tissue that is targeted for radiation.1
Another problem arises where there is no visible postoperative seroma remaining on CT scan. This can occur when the surgeon closes the cavity with oncoplastic techniques or when radiation therapy is delayed for several months so that the patient can receive chemotherapy before having radiation treatments. In cases where radiation is delayed for months after the surgery, the seroma fluid may be completely absorbed leaving no visible indication of the tumor bed location. This can compromise optimal targeting for radiation treatment planning. These, and other sources of targeting ambiguity, can lead to suboptimal clinical treatment conditions such as radiation exposure to adjacent normal tissues (e.g. the heart and lung) as well as under dosing the tissue requiring radiation.2-4
BioZorb helps to provide a means of “communication” between the surgeon and radiation oncologist – identifying the tumor excision site.
Medgadget: What is the benefit to the coil shape design? If the polymer is bioabsorbable, are the titanium markers left behind in the body?
Dr. Lebovic: Permanent titanium clips are fixed to the bioabsorbable spiral portion of the marker in a fixed 3-D array and held in place during healing. The bioabsorbable component is resorbed slowly by the body, leaving the array of titanium markers in place.
Additionally, surgeons have reported that the marker provides a structure for the breast tissue that helps preserve the natural contour of the breast, thereby helping to address a common problem of unsightly and disfiguring deformities after breast conservation therapy.6-8
Medgadget: How long does the material take to absorb into the body? Does it pose any risk to the patient?
Dr. Lebovic: The marker is composed of two commonly used medically implantable materials with a long history of surgical use. The bioabsorbable component is resorbed slowly by the body over a year or more, leaving the array of titanium markers in place.
Medgadget: How long was the product in development and what were the most challenging aspects of getting it into clinical use?
Dr. Lebovic: The product was in development for several years, and the most challenging aspect was the actual design of the product. While it appears elegantly simple in design, the engineering and manufacturing challenges of achieving it’s unique shape with the embedded marker clips in a bioabsorbable was very challenging. In addition, we were interested in using materials with a proven track record in medical devices, so we feel very fortunate to have an exceptional team of engineers that were able to make that happen. Doing all of this, and creating an affordable technology that can be easily integrated into the surgeons’ existing practice patterns was a challenge, but we are very pleased to be getting the positive feedback from surgeons around the country using the product.
Medgadget: Are you able to share insight into the company’s pipeline and what will follow-up to the BioZorb?
FT: We do have some exciting other technologies in development, and hope to be able to share them some time in the next year. Right now, all of our efforts are focused on supporting our team in the field, as surgeons across the country become aware of the benefits of integrating BioZorb into their routine. Although it is an elegantly simple device, it turns out to be very useful to mark the surgical site in this novel fashion.
See the procedure here:
Link: Focal Therapeutics
1. Landis DM, Luo W, et al. Variability among breast radiation oncologists in delineation of the postsurgical lumpectomy cavity. Int J Radiat Oncol Biol Phys; 67, 1299-1308, 2007.
2. Njeh CF. Tumor delineation: The weakest link in the search for accuracy in radiotherapy. J Med Phys; 33, 136-140, 2008.
3. Benda RK, Yasuda G, et al. Breast boost: are we missing the target? Cancer; 97, 905-909, 2003.
4. Machtay M, Lanciano R, et al. Inaccuracies in using the lumpectomy scar for planning electron boosts in primary breast carcinoma. Int J Radiat Oncol Biol Phys; 30(1):43-8 , 1994.
5. Kuske RR, Cross MJ, et al. Utility of a novel 3-D marker in treatment planning for breast cancer. American Society for Radiation Oncology Annual Meeting, Atlanta, GA; 2013.
6. Cross MJ, Ross J et al. Identifying the surgical breast cavity after oncoplastic breast surgery. American Society of Clinical Oncology Breast Cancer Symposium, San Francisco, CA; 2014.
7. Glaser CC, White KS, et al. Use of absorbable three dimensional marker improves accuracy of treatment planning for post-lumpectomy radiation therapy. SIS World Congress on Breast Healthcare, Orlando, FL; 2014.
8. Kaufman CS, Hall W et al. Initial experience with a novel 3-dimensional bioabsorbable lumpectomy marker. American Society of Breast Surgeons Annual Meeting, Orlando, FL; 2015.