Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 880.73K | Year: 2014
DESCRIPTION (provided by applicant): Infection is a common and frequently very serious complication associated with medical implants. Man-made materials, including those used to fabricate ventricular assist devices (VADs), compromise the body's ability tofight infection in tw ways. First, by breaching skin with transcutaneous cannulae and drivelines, and second, by eliciting a foreign body reaction which results in scarring near the implant surface that creates an environment where bacteria can thrive outside the reach of the body's immune system. Currently available infection resistant materials typically rely on the release of antimicrobial substances. Though effective over the short-term, the released drugs can compromise normal healing and exacerbate the problem of isolating the implant surface from the body's immune defenses. Ension proposes development of an infection resistant surface designed to promote normal healing for application to the transcutaneous drivelines of ventricular assist devices. The
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.58M | Year: 2008
DESCRIPTION (provided by applicant): Many oxygenators clinically available for pediatric (and adult) extracorporeal membrane oxygenation (ECMO) utilize heparin coatings such as Carmeda BioActive Surface on device surfaces, including the microporous hollow fibers, to improve biocompatibility. Despite application of these coatings, significant inflammatory and coagulation-related complications, as well as plasma leakage, remain associated with extended ECMO support. Furthermore, application of current heparin coatings reduces permeance of the underlying hollow fiber membranes affecting their capacity to transfer oxygen and carbon dioxide. Reductions in gas exchange efficiency caused by these coatings result in greater total biomaterial surface area requirement s (a larger microporous hollow fiber surface area oxygenator) thus exacerbating the inflammatory response problem the coating is intended to mitigate, as well as leading to increased priming volumes. During Phase I of this work five ionized plasma (IP) dep osited coatings designed to overcome these limitations and to provide enhanced bioactivity and stability were prototyped and evaluated. Two Phase I coatings exceeded the criteria outlined in our Phase I proposal to adjudicate feasibility. Each demonstrated sufficient levels of active heparin and plasma resistance to mitigate complications associated with long-term use of membrane oxygenation, without unduly decreasing the gas permeance of the fibers. This demonstration of feasibility warrants a formal Phase II research and development effort with the overall objective of advancing the coating technology from proof-of-concept to a level where coating composition and deposition processes are robust and sufficiently consistent to pursue commercialization of one or both coatings. The proposed development program will address: 1) optimization of coating composition, 2) optimization of coating processes, 3) comprehensive in vitro performance assessments, 4) in vitro biocompatibility evaluations in human blood, and 5) prolonged in vivo testing in animals. Upon completion of this Phase II project we will have produced and validated a heparin-based, biocompatible coating that is gas permeable, highly bioactive, maintains its bioactivity after being sterilized and store d prior to use, and prevents or delays plasma leakage. Such a coating has significant potential to reduce inflammatory response and subsequent morbidity associated with existing blood oxygenators and other blood-contacting medical devices. Ension has targe ted pediatric blood oxygenators as the first market segment to be addressed with this improved biocompatible coating, even though it represents only a small portion of the overall market for this product, because it will permit rapid development and serve as a stepping stone for access to other applications in other market segments. Extracorporeal membrane oxygenation (ECMO) is associated with serious complications and potentially poor outcomes in pediatric patients due to changes to the blood resulting fro m blood- biomaterial interaction. PUBLIC HEALTH RELEVANCE: This Phase II project represents the main research and development effort for realization of a heparin-based biocompatible coating that is highly bioactive, cost- effective, and maintains its bioac tivity after being sterilized and stored prior to use. Such a coating has significant potential to reduce inflammatory response and subsequent morbidity resulting from use of existing blood oxygenators and other blood-contacting medical devices.
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 224.97K | Year: 2015
DESCRIPTION provided by applicant The objective of the proposed Phase I SBIR is to develop and evaluate the ability of a novel regenerative collagen matrix RCM to prevent scarring and contracture while promoting regeneration in burn wounds Scarring and contracture of burn wounds are very common and can lead to loss of tissue functionality and severely compromised tissue aesthetics Current dermal substitutes have not been significantly effective in minimizing scarring and contracture in burn wounds The standard of care includes massage pressure therapies steroids silicone dressings and additional surgeries to manage the scar and contracture burden All current therapies aim to manage scarring and contracture after healing The critical barrier to progress in the field is the lack of a wound dressing capable of intervening at the cellular level from the beginning of the healing process to prevent scarring and contracture To this end the proposed RCM incorporates enhanced architectural features and reinforced physical chemical and biological parameters to achieve a wound dressing suitable for application early in the treatment process and with the ability to prevent scarring an contracture while promoting regeneration in burn wounds Physical reinforcement will provide stress shielding to the cells that minimizes unchecked wound firboproliferation that leads to scarring and contracture This is achieved by combining two physical forms of collagens within the RCM Chemical reinforcement through crosslinking of the collagen will increase in vivo half life by making the collagen more resistant to enzymatic degradation in the wound milieu Biological reinforcement through heparin immobilization will induce regeneration because of heparinandapos s ability to sequester growth factors within the RCM and optimally present them to the cells that potentiates their effects The proposed RCMandapos s novel bi modal architecture will exhibit a random open pore scaffold to facilitate cellular migration and intercellular interaction withn the matrix and oriented micro channels to provide a micro niche topography for keratinocytes to enhance their proliferative phenotype and synthesis of the basement membrane proteins This bi modal architecture of the proposed RCM plays a vital role in providing the necessary stimuli for the wound invading cells to promote regeneration rather than scarring RCM will undergo extensive in vitro characterization to ensure that all Phase I design specifications are satisfied after sterilization In vitro feasibility assessments will include colagen denaturation temperature degradation time heparin bioactivity and pore size distribution In vivo testing will be performed using a standard swine burn model to determine initial efficacy and preliminary biocompatibility of RCM over the course of one and three months with biopsies collected at specified time points for histological wound evaluations If the proposed Phase I is successful then a Phase II SBIR proposal will be submitted with the objective to realize a commercialization path by conducting pre clinical studies aimed to determine efficacy and safety as described in the FDAandapos s andquot Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds Developing Products for Treatmentandquot PUBLIC HEALTH RELEVANCE The objective of the proposed Phase I SBIR is to develop and evaluate the ability of a novel regenerative collagen matrix RCM to prevent scarring and contracture while promoting regeneration in burn wounds Scars and contracture compromise the regeneration of the burn wound tissue to its original functionality and aesthetics The current standard of care is to largely manage scars and contractures only after healing has occurred In contrast the proposed RCM incorporates enhanced novel architectural features and reinforced physical chemical and biological parameters to prevent scarring and contracture before healing has occurred to enable optimal functional and aesthetic recovery of the wounded tissue
Ension, Inc. | Date: 2012-10-01
A variety of polymeric synthetic hernia mesh prosthesis with surface treatment on at least one tissue-facing surface to control tissue adhesion are disclosed including heparin surface treatment which provides heparin present in an amount to yield heparin bioactivity of at least one of i) an ATIII binding of at least 2 pmol/cm
Ension, Inc. | Date: 2012-01-09
A method of treating the surface of a medical device with a biomolecule comprising the steps of: providing a polyolefin substrate forming a medical device; cleaning the polyolefin substrate; exposing the polyolefin substrate to a reactive gas containing acrylic acid and to plasma energy to yield a plasma-deposited polyacrylic acid coating on the polyolefin substrate; and attaching a biomolecule, such as heparin, to the polyolefin substrate following formation of the plasma-deposited polyacrylic acid coating on the polyolefin substrate.