CMS Confirms Coverage of Kerecis Fish-Skin Products by Medicare
November 14, 2024
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Kerecis produces tissue-based, skin-substitute products from intact fish skin for use in surgery and for treating wounds. Compared to other tissue-transplant products, the Kerecis® fish skin grafts are cost-effective, offer improved clinical performance and pose no disease transfer risk to humans 1-3. Being fish skin, no cultural constraints on usage4 exist.
Kerecis is actively engaged in expanding the use of the Kerecis fish skin across multiple clinical indications through several product development programs, that include, but are not limited to; fish skin for use in dura repair, breast reconstruction and hernia repair.
Products mentioned below are under development and not yet regulatory approved.
Globally millions of operations are performed annually for dura repair, breast reconstruction and hernia repair. Often synthetic mesh products provide reinforcement in such operations. The patented Kerecis fish skin provides strong repair hold, is rapidly revascularized and gradually replaced by the patient’s own tissue, decreasing postoperative complications due to rejection of synthetic mesh.
Kerecis Dura is our R&D code name for our dura repair product. The firm, but sufficiently stretchable fish skin scaffold acts as a framework that the patient’s own cells can repopulate and revascularize, allowing progressive integration of the implant by the newly formed fibrous, connective tissue. There is minimal risk of inflammation and, when fully absorbed, Kerecis Dura leaves no foreign body in-situ.
Kerecis Pectus is our R&D code name for our surgical sling for breast reconstruction. The firm, but sufficiently stretchable Kerecis Pectus sling acts as a framework that the patient’s own cells can repopulate and revascularize, allowing progressive integration of the implant by the newly formed fibrous, connective tissue. There is minimal risk of inflammation and, when fully absorbed, Kerecis Pectus leaves no foreign body in-situ. Kerecis Pectus supports the gel breast implant and maintains the breast’s aesthetics, including the inframammary fold, ptosis, and projection.
Kerecis Hernia is our R&D code name for our abdominal wall reconstruction material that is revascularized and provides strong repair-hold promise for patients with challenging hernias. Hernia surgery may be followed by complications, including rejection of prosthetic mesh that is used in the repair. Major complications currently associated with mesh repair include foreign body reaction, infection, pain, fistula formation, migration, shrinkage, and recurrence. Kerecis Hernia will offer improved clinical outcomes compared to current products on the market.
1. Winters C, Kirsner RS, Margolis DJ, Lantis JC. Cost Effectiveness of Fish Skin Grafts Versus Standard of Care on Wound Healing of Chronic Diabetic Foot Ulcers: A Retrospective Comparative Cohort Study. Wounds. 2020;32(10):283-290.
2. Seth, N., Chopra, D., & Lev-Tov, H. (2022). Fish Skin Grafts with Omega-3 for Treatment of Chronic Wounds: Exploring the Role of Omega-3 Fatty Acids in Wound Healing and A Review of Clinical Healing Outcomes. Surgical Technology International, 40: 38-46. doi: 10.52198/22.sti.40.wh1494
3. Baldursson BT, Kjartansson H, Konrádsdóttir F, Gudnason P, Sigurjonsson GF, Lund SH. Healing rate and autoimmune safety of full-thickness wounds treated with fish skin acellular dermal matrix versus porcine small-intestine submucosa: a noninferiority study. Int J Low Extrem Wounds. 2015;14(1):37-43. doi:10.1177/1534734615573661
4. Easterbrook C, Maddern G. Porcine and bovine surgical products: Jewish, Muslim, and Hindu perspectives. Arch Surg. 2008;143(4):366-370. doi:10.1001/archsurg.143.4.366
Last updated January 2023
KM-23-0018
The information presented is intended to demonstrate the Kerecis product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Kerecis product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Kerecis representative if you have questions about the availability of Kerecis products in your area.
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