TEI Biosciences, Inc. has gained FDA Investigational Device Exemption (IDE) approval to initiate a human clinical trial to gain specific claims of clinical benefits from use of SurgiMend® PRS in breast reconstruction following mastectomy for breast cancer.
The approved IDE is for a clinical trial enrolling patients who have had cancer recurrence after prior Breast Conserving Therapy, and who then undergo mastectomy with immediate two-stage implant-based breast reconstruction using SurgiMend PRS.
While Breast Conserving Therapy, which consists of a lumpectomy to remove the cancerous breast tissue as well as radiotherapy and chemotherapy, is a very effective cancer treatment, when cancer recurs the treatment of choice is mastectomy to remove the cancer and surrounding breast tissue. Many patients choose to have their breasts reconstructed using breast implants. Prior radiotherapy from Breast Conserving Therapy predisposes the patient to local breast complications after breast reconstruction, including, delayed healing, infection and contraction of the skin and tissue capsule surrounding the breast implant. Over 40% of these patients will experience moderately to severely poor cosmetic outcomes and pain/discomfort in the first few years following implant-based breast reconstruction due to this capsular contraction .
Published studies suggest that use of an Acellular Dermal Matrix (ADM) during implant-based breast reconstruction may reduce the onset and severity of capsular contracture. Recent studies by Dr. Michael Scheflan, an internationally renowned Plastic & Reconstructive Surgeon, find that SurgiMend PRS can markedly reduce the incidence of early and severe capsular contracture in patients with radiotherapy treatment. With these findings in hand, the objective of this clinical trial, conducted with FDA approval, is to show that in patients with prior radiotherapy the rate of early onset of moderate to severe capsular contracture is reduced by over 50% when SurgiMend PRS is used in two-stage tissue-expander-to-permanent breast implant immediate breast reconstruction.
“We have been working with the FDA for over 2 years and we’re very pleased to receive approval to begin enrolling patients in this first of several pivotal IDE studies, which we believe will help advance this important aspect of women’s health” said Dr. Yiannis Monovoukas, President and CEO.
TEI Biosciences is currently recruiting clinical sites at public and private hospitals, as well as private practices, and expects to initiate enrollment in the third quarter of 2013.
Source: TEI Biosciences, Inc.