Microlyte® SURGICAL Associated with Positive Outcomes in Prospective Clinical Case Series in Patients at Risk for Surgical Site Infection

Madison, WI, October 4, 2021 – Imbed Biosciences, Inc. (Imbed), a privately held biotech company emerging as a leader in advanced wound care, announced today the results of a prospective clinical evaluation of its next-generation wound Matrix, Microlyte® SURGICAL, in diabetic patients undergoing foot and ankle surgery who would ordinarily be at risk of a surgical site infection.  Results will be published in the October issue of WOUNDS, a widely read, peer-reviewed journal in wound care and research.

The study was conducted by Ryan Chatelain, DPM, Associate Professor with the Department of Surgery in the Quillen College of Medicine at East Tennessee State University in Johnson City, TN.  Twenty-two diabetic patients with neuropathy, infection, open wounds, history of recurrent infection, nonhealing wounds, and or peripheral vascular disease, were included, and all were at-risk for surgical site infection (SSI) due to the sequelae of diabetes.  Surgical procedures included amputation, removal of exostosis, midfoot bone removal, Achilles’ tendon repair, bunionectomy, or an elevating osteotomy with primary closure of the wound.

The overall SSI rate for the diabetic patient is 13%, and the study’s primary objective was to decrease this rate to 6.5% by prophylactic treatment with Microlyte® Matrix SURGICAL just deep to the incision, followed by placement of a non-adherent dressing over the suture line. Patients were assessed on day 3 or 5 for SSI incidence, with subsequent routine follow-up appointments until complete wound healing was achieved. The per-protocol patient population (20/22) had a 0% SSI rate with healing times typical to the procedure (between 10 and 34 days). Two patients were not included in the analysis due to non-compliance. “The findings of this preliminary study are exciting!  Microlyte, a fusion of technology and innovation, seems to offer a much-needed layer of protection for at-risk surgical groups,” said Dr. Chatelain.

Strategies to prevent SSIs have been a national concern since 2002 when the CDC initiated the Surgical Infection Prevention (SIP) Project, which includes use of an antimicrobial prophylactic agent with discontinuation 24 to 48 hours after surgery.  Similarly, the Centers for Medicare and Medicaid Services (CMS) has implemented several initiatives that reward or penalize hospitals depending on low or high SSI rates, respectively.  “Microlyte® SURGICAL is an economical and user-friendly antimicrobial bioresorbable wound matrix that, as this study suggests, is a promising tool in the fight against SSIs” said Michael J. Schurr, MD a co-founder of Imbed and Chair of General Surgery at Mountain Area Health Education Center (MAHEC) in Asheville, NC. Dr. Schurr was not involved in the reported clinical evaluation. “Microlyte® SURGICAL contains 50 to 100 times less silver than traditional silver approaches, and yet maintains therapeutic efficacy. This effectiveness results from the ultrathin form factor of the bioresorbable matrix that contours to underlying wound surface and provides intimate contact of silver ions with microbes.”

These results come on the heels of a previously published clinical trial that demonstrated a related antimicrobial product designed for smaller chronic wounds, Microlyte® Matrix, was effective at jump-starting stagnant or deteriorating chronic wounds of various etiologies. “Our goal after publishing results on chronic wounds was to evaluate this antimicrobial matrix in the management of surgical wounds in at-risk patients” says Ankit Agarwal, PhD, co-founder and CEO of Imbed. “I am happy that we were able to accomplish this goal with the invaluable help of Dr. Ryan Chatelain and his patients; these results energize our commitment in educating clinicians across the world about the benefits of this next-generation wound matrix for improving outcomes in advanced wound and surgical care.”  Imbed plans to continue conducting clinical studies in surgical procedures that have high SSI rates, such as ventral hernia repairs, Caesarean section, and colorectal surgeries.

The results are reported in: Chatelain R. “The efficacy of a novel silver-containing bioresorbable microfilm matrix in at-risk surgical wounds: a clinical case series.” Wounds. 2021; 33(10): 245–252. doi:10.25270/wnds/2021.245252

The online version of the article may be found at https://www.hmpgloballearningnetwork.com/site/wounds/case-series/efficacy-novel-silver-containing-bioresorbable-microfilm-matrix-risk

About Imbed Biosciences, Inc.

Imbed Biosciences Inc. is a privately held biotech company registered with the FDA as a medical device manufacturer with an ISO 13485 certified quality management system. The company has a portfolio of products in development based on its patented Microlyte® Matrix technology for tissue engineering to combat local pain and infections in complex wounds such as burns, chronic ulcers, surgical wounds, epidermolysis bullosa, and colorectal surgeries. Research programs at Imbed are partly funded by SBIR grants from National Institutes of Health (NIH).