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.”

KeraNetics™ Awarded SBIR Contract from the US Army for Use of Keratin Biomaterials for Antibiotic Drug Delivery

Winston-Salem, N.C., September 30, 2011 – KeraNetics LLC announced today that it has been awarded an SBIR Phase I contract from the US Army for development of biomaterials that enhance wound healing and have anti-microbial capabilities. “This project will utilize the advantages of keratin biomaterials to control the release of antimicrobial agents which will provide a tool for first responders and combat medics to decrease infection rates and healing times in our nation’s warfighters.” said Dr. Seth Tomblyn, Formulation Scientist and Principal Investigator for the project.

Dr. Luke Burnett, Director of Product Development and Research for the Company, said “Keratins are unique 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 bone or muscle tissue”.

Dr. Justin Saul, Associate Professor at Miami University and Co-Investigator for the project, added “I am excited to lead the effort for this work at Miami University. We have had promising results in using keratin for antimicrobial applications and this award will facilitate our efforts to translate the technology toward clinical applications.”

KeraNetics™ Awarded Phase I SBIR Contract from the Office of the Secretary of Defense

Winston-Salem, N.C., November 23, 2010 – KeraNetics LLC, a Wake Forest University School of Medicine spinout with proprietary technology for the manufacture and therapeutic application of keratin biomaterials, announced today that it has been awarded a SBIR Phase I contract from the Office of the Secretary of Defense. “KeraNetics™ is focused on conducting research in the use of keratin biomaterials for nerve and bone regeneration, hemostasis, resuscitation fluids, wound and burn healing and cell culture applications” said Luke Burnett PhD, the Director of Product Development and Research at KeraNetics™ 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 for bone and muscle regeneration that could provide solutions for the complex injuries experienced by our nation’s warfighters.”

“Keratins are unique 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 bone or muscle tissue”. Dr. Burnett added that “our talented team of scientists and clinical collaborators at Wake Forest University School of Medicine such as Dr. Justin Saul who is leading this effort at Wake Forest, 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.”

Keratin Resuscitation Fluid Technology Awarded SBIR Grant from the National Institutes of Health

Winston-Salem, NC, May 13, 2010 – KeraNetics LLC, a Wake Forest University Health Sciences spinout with proprietary technology for the manufacture and therapeutic application of keratin biomaterials, announced today that the Company, in partnership with the Department of Orthopedic Surgery at Wake Forest University Health Sciences, has received a grant from the National Heart, Lung and Blood Institute of the National Institutes of Health. KeraNetics™ resuscitation fluid technology has been shown in initial preclinical studies to stabilize animals as much as 40 % blood loss. The grant will allow KeraNetics™ to further develop this technology through a focused program of further preclinical research and lay the groundwork for human clinical trials and commercialization.

“Trauma is the leading cause of death for people in the US under the age of 45. If the work proposed in the grant is successful, this new keratin resuscitation fluid could be tested in larger animals with the ultimate goal of being used by first responders and hospitals to save many victims of trauma-related hemorrhage and shock,” said Luke Burnett PhD, the Director of Product Development and Research at KeraNetics™ and the Principal Investigator for the project.

The research proposed in the grant will be conducted by scientists from KeraNetics™ under the direction of Dr. Burnett and scientists from the Department of Orthopaedic Surgery under the direction of Dr. Michael Callahan. “KeraNetics™ is fortunate to be involved with such a quality team of scientists from Waker Forest University Health Sciences. The results of our preclinical studies thus far are very encouraging and the fact that we were awarded a very competitive grant from the NIH shows how promising this technology is” said Dr. Burnett.

Keratin Nerve Regeneration Technology Awarded $2.2M Grant from the Department of Defense

Winston-Salem, N.C., April 30, 2010 – KeraNetics LLC, a Wake Forest University Health Sciences spinout with proprietary technology for the manufacture and therapeutic application of keratin biomaterials, announced today that the Department of Orthopaedic Surgery of Wake Forest University Health Sciences in partnership with KeraNetics™ has been awarded a $2.2M grant from the Department of Defense’s Office of Congressionally Directed Medical Research Programs. The grant is for a multicenter clinical trial for a KeraNetics™ technology used in peripheral nerve regeneration.

“This is the first clinical trial of its kind for a nerve conduit filler that has been shown to promote regeneration of severed nerves in animals”, said Luke Burnett PhD the Director of Product Development and Research at KeraNetics. Dr. Burnett added that “This grant was one of only 5 clinical trials selected from hundreds of qualified proposals through a rigorous peer review process. The fact that our team’s proposal was selected highlights the potential value this product will have for wounded soldiers and the strong research and clinical translation focus that the Department of Orthopaedic Surgery has in areas of trauma and regenerative medicine.”

The Principal Investigator of the trial, Dr. Zhongyu Li, is a renowned Orthopaedic Surgeon and will oversee the study to be conducted at Baptist Medical Center in Winston-Salem NC and University of Virginia Health System in Charlottesville VA.

KeraNetics™ Awarded SBIR Grant from the Office of the Secretary of Defense

Winston-Salem, N.C., February 17, 2010 – KeraNetics LLC, a Wake Forest University Health Sciences spinout with proprietary technology for the manufacture and therapeutic application of keratin biomaterials, announced today that it has been awarded a SBIR Phase I grant from the Office of the Secretary of Defense. “KeraNetics™ is committed to commercializing keratin biomaterials for use in nerve and bone regeneration, hemostasis, resuscitation fluid, wound healing and cell culture applications” said Luke Burnett PhD, the Director of Product Development and Research at KeraNetics™ and the Principal Investigator for the project. “This grant will begin to look at new solutions for cranio-facial reconstruction that are needed for our nation’s warfighters.”

“Keratins are unique because they have broad biocompatibility and can be formulated into a wide variety of materials that can potentially be used to repair or replace tissues found in the face and jaw”. Dr. Burnett added that “our talented team of scientists and clinical collaborators at Wake Forest 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.”