Aziyo Biologics Inc., a fully integrated regenerative medicine company, has announced positive results from PERFORM, a prospective, post-market study conducted in patients undergoing femoral arterial reconstruction using the company’s biologic extracellular matrix (ECM) scaffold. There were no device-related adverse events or infections and primary patency was maintained in 97.6 percent of procedures.
 
Patients undergoing femoral arterial reconstruction with patch angioplasty closure were eligible for the study, and a total of 43 patients were enrolled at three U.S. centers. To date, there have been no device-related adverse events and no instances of patch infection. Primary patency as determined from duplex imaging was maintained in 97.6 percent of procedures at an average of seven months follow-up. Patients are being followed for 12 months post endarterectomy.
 
“This preliminary analysis of Aziyo’s biologic ECM for femoral arterial reconstruction demonstrates the product’s safety and efficacy in peripheral vascular reconstruction,” said Joshua D. Adams, M.D., principal investigator and vascular and endovascular surgeon at Carilion Clinic Vascular and Endovascular Surgery, and previously the Medical University of South Carolina. “Evidence also supports the antimicrobial properties of ECM, rendering it more resistant to infection than standard prosthetic material. Continued patient follow-up in the study will be important to further understand the long-term effectiveness of this unique biomaterial.”
 
“We sincerely appreciate the efforts of the surgeons and patients who are participating in the study,” commented Michelle LeRoux Williams, Ph.D., chief scientific officer of Aziyo Biologics. “The preliminary data from PERFORM are encouraging. We believe this biologic ECM scaffold is an important solution for vascular repair as part of a surgeon’s regenerative medicine toolkit.”
 
PERFORM is a prospective, post-market, multi-center study evaluating the use of Aziyo’s biologic ECM scaffold in patients undergoing femoral arterial reconstruction. To be eligible for the study, patients must be indicated for femoral arterial reconstruction with patch angioplasty closure using ECM. Patient follow-up includes duplex imaging and assessment of adverse events through four to six weeks, six months and 12 months following endarterectomy.
 
Aziyo’s biologic extracellular matrix for vascular repair is constructed from a multi-laminate sheet of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) derived from porcine small intestinal submucosa (SIS). Once implanted, evidence shows that over time the ECM transforms into vascularized tissue. The Extracellular Matrix for Vascular Repair has been implanted in more than 30,000 procedures. The Extracellular Matrix for Vascular Repair is a U.S. Food and Drug Administration 510(k)-cleared medical device, intended for use as a patch material for the repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral and tibial blood vessels.
 
Porcine SIS is a decellularized matrix that serves as a bioscaffold to allow vascular ingrowth from adjacent tissues to deliver progenitor cells and nutrients to the matrix, which then differentiate into tissue-specific cells and structures. The ECM is gradually replaced as the patient’s own cells restore the diseased or damaged site. During repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where damaged or injured tissue would normally be expected. Since 1999, an estimated two million patients worldwide have received SIS ECM implants.
 
Aziyo Biologics Inc. was formed by HighCape Partners, Deerfield Management Co. and KeraLink International with the mission of restoring health and mobility to the greatest number of patients. Aziyo’s vision is to impact healthcare through innovation of new solutions realizing the commercial potential of regenerative medicine.