February 20, 2020

Calcaneus Fracture Perioperative Complication Rates Proven Lower with Application of Clarix® Cryopreserved Umbilical Cord (cUC)

Retrospective cohort study results show wound complications, re-operation and infection rates up to 70 percent lower when CLARIX is applied during open reduction and internal fixation of calcaneus fractures

Miami, FL – February 20, 2020 – Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today the results from a single-center, retrospective case-controlled series authored by Christopher M. Stewart, MD. The study, titled “The Use of Cryopreserved Umbilical Cord in Open Reduction and Internal Fixation of Calcaneus Fractures,” was published in the SunKrist Journal of Trauma, Emergency Medicine and Acute Care.  Analysis found that the overall complication rate in a controlled group of 20 consecutive patients was 35 percent, compared to a complication rate of 10 percent in the cUC group of patients when Clarix® was used as an adjunct to help decrease wound complications, re-operations, and infection rates.

Calcaneus (heel bone) fractures most often occur as a result of a traumatic event such as falling from a height, like a ladder, or being in an automobile accident where the heel is crushed against the floorboard. According to Joseph Ralph Cass, MD, FAAOS, and the American Academy of Orthopedic Surgeons, calcaneus fractures account for approximately 2 percent of all adult fractures.1  Although surgery to repair a calcaneus fracture can restore the normal shape of the bone, the procedure is sometimes associated with wound healing problems, infection or nerve damage.

Study results clearly showed lower complication rates in the cUC group of patients when Clarix was used. In the group of 19 patients who received Clarix, two patients required wound care postoperatively and two required readmission and re-operation for wound complications and infection. Conversely, in the group of 20 patients who did not receive Clarix, seven patients required wound care postoperatively and six patients required readmission, with all six requiring re-operation for wound complications and infection.

“We are extremely encouraged by the results of this retrospective cohort study,” said Herbert Slade, MD, Chief Medical Officer at TissueTech. “The costs associated with wound complications, re-operations and surgical site infection after open reduction and internal fixation of calcaneal fractures can be significant.  Finding that Clarix Cryopreserved Umbilical Cord applied directly to the bone and hardware during surgery can reduce overall complications associated with this surgery. This is very promising for trauma surgeons and their patients. We look forward to being able to show the benefit of Amniox products for this and similar surgeries in larger studies powered for significance.”

About Amniox Medical, Inc.

Amniox Medical, Inc., a TissueTech, Inc. company, is a leader in the clinical application of human birth tissue-based products (amniotic membrane & umbilical cord) processed using TissueTech’s proprietary CryoTek® cryopreservation technology. Established in 2011, Amniox serves an unmet need for better surgical and therapeutic outcomes for chronic and complex wounds, orthopedics, sports medicine, spine, urology, gynecology, plastics, and general surgery. Connect with Amniox on our Website, Facebook, LinkedIn and Twitter.

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and BioTissue, Inc., is a scientific and market leader in the field of regenerative medicine. TissueTech manufactures a broad range of ocular, surgical, wound care, and soft tissue products that are marketed under these subsidiaries. Since the company’s inception, clinicians have performed more than 500,000 human implants of the company’s products and published more than 360 peer-reviewed studies supporting its platform technology. TissueTech is committed to an unwavering culture of integrity that places our patients’ safety and clinical outcomes above all else. Learn more at https://biotissue.com/. 

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