KeraStat® Cream Cleared by FDA for Radiation Dermatitis

Winston-Salem, N.C., July 20, 2020 – KeraNetics Inc. announces today that the next product in its KeraStat® wound dressing portfolio, KeraStat® Cream, has been cleared by the US Food and Drug Administration for indications of radiation dermatitis. This product is designed to reduce the painful ulceration and skin damage that occurs during radiation therapy. The effectiveness of KeraStat® Cream is backed by human data in patients with breast cancer, that shows that KeraStat® Cream reduces the symptoms of radiation dermatitis and improves quality of life. Large animal testing has shown that KeraStat® Cream is also an appropriate countermeasure for Cutaneous Radiation Injury, a more significant skin condition that could result from an event such as nuclear terrorism. KeraNetics™ is in the process of expanding the potential uses of the product by completing an additional human study in patients with head and neck cancer, conducted by Wake Forest Baptist Health and the Wake Forest Cancer Center. This study is enrolling patients now (NCT04173247).

The initial work that led to the development of KeraStat® Cream was funded under a Biomedical Advanced Research and Development Authority (BARDA) contract HHSO100201200007C. Radiation dermatitis, a cutaneous radiation injury, is seen in 95% of patients undergoing radiation therapy to the head, neck, breast, chest wall, perineum, or vulva, and negatively affects the patients’ quality of life.

“The clearance of this product by the FDA today will help improve the lives of patients, particularly those with breast cancer who are struggling with radiation treatment,” said Dr. Luke Burnett, the CEO and Chief Science Officer at KeraNetics™. “This product is the first step in finding an evidence-based solution to radiation dermatitis and an easily deployed medical countermeasure that could be included in the Strategic National Stockpile to protect US citizens.”

For more information contact Luke Burnett, CEO and Chief Science Officer. 336-765-0621, info@keranetics.com

KeraNetics™ Begins Human Clinical Study for Radiation Dermatitis

Winston-Salem, N.C., March 21, 2018 – KeraNetics™ announces today that the next product in its KeraStat® wound dressing portfolio, KeraStat® Cream, has begun pilot human clinical trial testing. The randomized open-label study is designed to evaluate the feasibility of the use of KeraStat® Cream in women undergoing radiation therapy for breast cancer who may develop a skin condition called radiation dermatitis. The study will also look at safety, tolerability, and effectiveness of the cream in comparison to the current standard of care. The study will take place at Wake Forest Baptist Health and is being conducted under an Institutional Review Board (IRB) approved protocol.

The initial work that led to the development of the KeraStat® line for cutaneous radiation injuries was funded under a Biomedical Advanced Research and Development Authority (BARDA) contract HHSO100201200007C. Radiation dermatitis, a cutaneous radiation injury, is seen in 85% of patients undergoing radiation therapy to the head, neck, breast, chest wall, perineum, or vulva; negatively affects patients’ quality of life; and can cause treatment interruptions. “We are excited to begin this work that may, in a small way, help improve the lives of patients struggling with cancer treatments” said Dr. Luke Burnett, the Chief Science Officer at KeraNetics™.

Unfortunately, radiation exposure is a real threat in today’s world. In addition to radiation dermatitis, preclinical testing suggests that KeraStat® Cream may be an appropriate medical countermeasure for cutaneous radiation injury. The product is designed to be easily transportable and requires no healthcare training to apply. Dr. Burnett added that “we hope that this pilot study is the first step in finding both an evidence-based solution to radiation dermatitis and an easily deployed medical countermeasure that can address the issues of a national radiation emergency.”

KeraNetics™ Receives FDA Clearance for KeraStat®Gel

Winston-Salem, NC, June 2, 2017 – KeraNetics, LLC, the global leader in purified keratin medical products, announced today that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for KeraStat® Gel.  KeraStat® Gel is a hydrogel wound dressing that maintains a moist environment to support wound healing.  The prescription indications approved for use include the management of: partial thickness burns; severe sunburns; superficial injuries, cuts, abrasions, and incisions/surgical wounds; ulcers of a variety of etiologies; donor sites; and grafts.

KeraStat® Gel development was funded, in part, by the Department of Defense and Biomedical Advanced Research Development Authority.  Luke Burnett, Chief Science Officer, said “The FDA approval of KeraStat® Gel means that this treatment is now available for the catastrophic battlefield wounds our Soldiers get in combat.  This has been a multiyear effort and would not have been possible without the generous funding we have received from governmental partners at the Department of Defense and BARDA.”

Keratin Hydrogels Show Significant Promise as Muscle Void Fillers

New Rochelle, NY, April 27, 2017—The use of human hair-derived keratin biomaterials to regenerate skeletal muscle has shown promise in new research that documents significant increases in both new muscle tissue formation and muscle function among mouse models of volumetric muscle loss. Two new studies that compare muscle regeneration following treatment with keratin hydrogels, no repair, or an alternative tissue matrix are published in in Tissue Engineering, Part A, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The articles are available free on the Tissue Engineering website until May 27, 2017.

In “Cell and Growth Factor-Loaded Keratin Hydrogels for Treatment of Volumetric Muscle Loss (VML) in  Mouse Model,” Hannah Baker, PhD, Juliana Passipieri, PhD, George Christ, PhD , and coauthors from University Maryland (College Park), University of Virginia (Charlottesville), Wake Forest University and KeraNetics, LLC (Winston-Salem, NC), and Miami University (Oxford, OH) report that mice with an area of substantial muscle mass loss that were treated with keratin hydrogels and growth factors had the best recovery of muscle contraction force. Examination of the affected muscle two months after treatment showed that mice with greater recovery of muscle function also had more extensive new muscle.

In a second study, entitled “Keratin Hydrogel Enhances In Vivo Skeletal Muscle Function in a Rat Model of Volumetric Muscle Loss,” Passipieri, Baker, Christ, et al. compared the results of treating a substantial muscle injury in rats using keratin hydrogels with or without growth factors or skeletal muscle progenitor cells versus control animals treated with no repair or an alternative tissue matrix. Keratin hydrogel-treated animals recovered up to 90% of the maximum possible muscle function.

“The authors have identified a novel permissive environment for muscle development in a region of loss.” says Tissue Engineering Co-Editor-in-Chief Peter C. Johnson, MD, Principal, MedSurgPI, LLC and President and CEO, Scintellix, LLC, Raleigh, NC. “Further study to identify the optimal application of this technology and its mechanism of action is warranted.”

KeraNetics™ Awarded $1M Contract from the Department of Defense Small Business Innovation Research Program for Keratin Biomaterial System for Functional Tissue Regeneration

Winston-Salem, N.C., August 20, 2015 – KeraNetics LLC announced today that it has been awarded a $1M Department of Defense (DoD) contract under the Small Business Innovation Research (SBIR) program for final pre-clinical testing and a safety trial of KeraGenics Muscle for the treatment of volumetric muscle loss (VML). Dr. Luke Burnett, Chief Science Officer for the company and Principal Investigator for the project, said: “the goal of this project is to develop a regenerative solution for large soft tissue defects that occur after blasts from Improvised Explosive Devices. This injury is called volumetric muscle loss, or VML, and there are no good solutions currently available for our Warfighters.”

KeraNetics™ has conducted a significant amount of research in the area of muscle regeneration with funding from DoD Small Business Innovation Research. Dr. Burnett stated: “We are grateful for the generous funding from the Department of Defense that allows us to complete this work. Our preclinical studies show that this product provides the environment necessary to allow the body to regenerate muscle tissue, as opposed to scar tissue, in large muscle defects. We are excited to conduct this study as it will provide the first opportunity to assess this technology’s effects in a human study of muscle defect.”

KeraNetics™ Awarded $1.4M Contract from the Congressionally Directed Medical Research Program for Use of KeraGenics™ Bone for Military Bone Injuries

Winston-Salem, N.C., July 17, 2015 – KeraNetics LLC announced today that it has been awarded a $1.4M Congressionally Directed Medical Research Program (CDMRP) contract under the Department of Defense Joint Warfighter Medical Research Program for pre-clinical testing of KeraGenics Bone for the treatment of segmental bone defects. Dr. Luke Burnett, Chief Science Officer for the company and Principal Investigator for the project, said: “Segmental bone defects are a common injury in our Wounded Warriors and are also a clinical issue relevant to civilian trauma patients. This project will complete dosing and efficacy studies needed to support a request to FDA for an initial meeting prior to conducting a clinical trial.”

KeraNetics™ has conducted a significant amount of research in the area of bone regeneration, with funding from DoD Small Business Innovation Research and CDMRP contracts. Dr. Burnett stated: “We are grateful for the generous funding from the Department of Defense that allows us to complete this work. Our preclinical studies show that this product produces robust bone regeneration in a segmental bone defects with an improved safety profile.”

KeraNetics™ Awarded $1,000,000 SBIR Contract from the US Army for Use of KeraStat® Burn Gel and Halofuginone for Burn Scar Treatment

Winston-Salem, N.C., February 2, 2014 – KeraNetics LLC announced today that it has been awarded a $1,000,000 SBIR Phase II contract from the US Army for testing KeraStat® Burn Gel and Halofuginone for the treatment of burn scars. Dr. Luke Burnett, Chief Science Officer for the Company and Principal Investigator for the project said of the award: “Burn scars are a significant problem for our Wounded Warriors, and there are not a lot of good options for treating these injuries. One potential solution is a product KeraNetics™ has been developing called KeraStat®. With the gracious funding from the Department of Defense, and the US Army in particular, we will be able to test this product in a human clinical study of second-degree thermal burns. We are also grateful to the excellent clinical faculty at the Wake Forest Baptist Health Burn Center who are partnering with us for the study.”

Dr. Burnett added, “In addition to testing KeraStat® in a clinical trial, we will also be conducting development testing of a combination of KeraStat® and a novel drug for preventing scar contracture called halofuginone. Our preliminary data has shown that both KeraStat® and halofuginone can prevent the formation of scars after burn injury. We are fortunate to work with Applied Catheter Technologies, which is active in testing halofuginone for various medical applications.”

KeraNetics™ Awarded SBIR Contract from the Office of the Secretary of Defense for Development of Muscle-Regenerating Keratin Biomaterials

Winston-Salem, N.C., October 3, 2011 – KeraNetics LLC announced today that it has been awarded an SBIR Phase I contract from the Office of the Secretary of Defense for development of muscle-regenerating biomaterials. Dr. Elizabeth Pettit Kneller, Principal Investigator for the project and a Scientist at KeraNetics™ said, “This is an important opportunity to investigate novel keratin biomaterials for soft tissue injuries, which are a major source of injury and disability to our nation’s warriors.”

Luke Burnett PhD, Director of Product Development and Research at KeraNetics™ stated “Keratins are unique because they mimic the cell’s structural and functional characteristics and can be formulated into a wide variety of materials as therapeutic delivery systems.”

Dr. George Christ, a Co-Investigator on the project and renowned expert in the field of muscle physiology and regenerative medicine, added, “This represents an exciting opportunity to evaluate the applicability of the regenerative technology platform developed by KeraNetics™ to the treatment of skeletal muscle trauma.”

KeraNetics™ Awarded Sub-Contract on Applied Research Award from the U.S. Army in the amount of $2 million for use of keratin for Antibiotic Drug Delivery

Winston-Salem, N.C., June 16, 2012 – KeraNetics LLC announced today that it has been awarded a sub-contract on a $2 million dollar project from the U.S. Army’s Defense Medical Research and Development Program (DMRDP), part of the Congressionally Directed Medical Research Program. This contract is to develop and test keratin drug-delivery systems for a novel class of antibiotics. “Antibiotic resistance is an increasing problem for both military and civilian patients. This project will test a novel class of antibiotics that are not susceptible to drug resistance. Coupled with our keratin drug-delivery system, these compounds will prevent infections while speeding healing in wounds commonly seen on the battlefield,” said Dr. Luke Burnett, Senior Scientist and Co-Investigator for the project.

Dr. Burnett, Director of Product Development and Research for the Company, said “This project will leverage the strength of industry and government collaborations and could result in infection control products that change the Standard of Care for our Wounded Warriors. We are grateful to the U.S. Army for the opportunity to conduct this research.”

KeraNetics™ Awarded $1,000,000 Phase II SBIR Contract from the Office of the Secretary of Defense

Winston-Salem, N.C., February 8, 2012 – KeraNetics LLC, a biomaterials company with proprietary technology for the manufacture and therapeutic application of keratin biomaterials, announced today that it has been awarded a SBIR Phase II contract from the Office of the Secretary of Defense. “KeraNetics™ is focused on conducting research in the use of keratin biomaterials for drug delivery and muscle regeneration” said Seth Tomblyn PhD, Principal Scientist and the Principal Investigator for the project. “This project will utilize the advantages of keratin biomaterials to provide spatiotemporal control over the release of growth factors that are promising strategies to induce muscle regeneration in the complex injuries experienced by our nation’s warfighters.”

Dr. Luke Burnett, the Senior Scientist at KeraNetics™ stated that “keratins are unique biomaterials because they have broad biocompatibility and can be formulated into a wide variety of materials that can potentially be used as therapeutic delivery systems to aid in the repair or replacement of muscle tissue”. Dr. Burnett added that “our talented team of scientists and clinical collaborators such as Dr. George Christ at the Wake Forest Institute for Regenerative Medicine and Dr. Justin Saul at Miami University who are leading this effort, are grateful to the Department of Defense for the opportunity to work on translating this technology with the ultimate goal of improving the lives of Wounded Warriors.”