Phase II year
2016
(last award dollars: 2017)
Phase II Amount
$1,478,049
Nearly 12 million wounds are treated in U.S. emergency departments every year. Skin wounds such as severe burns, large trauma wounds, or non-healing/chronic wounds that are too extensive or complex to close by natural healing are often reconstructed using autologous skin grafts. Although autologous skin grafts are currently the gold standard in complex wound repair, there are significant rates of morbidities, including excessive pain and discomfort, risk of infection, loss of grafted skin, discoloration, scarring, and loss of sensation associated with both the graft and donor sites. This approach is also limited by the availability of healthy skin and is not a viable treatment option for severe burn patients. It is thus imperative to develop alternative treatments for large, full-thickness wounds. Sharklet Technologies, Inc. (STI) proposes to pursue innovative R&D focused on improving the treatment of full-thickness wounds, consistent with the mission of several institutes within the NIH. To overcome the limitations of current dressings and reduce the need for autologous skin grafts, STI proposes to manufacture and commercialize an advanced, biodegradable woundcare device comprised of a vasoinductive matrix to promote healing of the dermis combined with a Sharklet micropatterned apical layer to enhance autologous epidermal healing via guided cell migration into the wound site. Our Phase I SBIR studies exceeded milestones, demonstrating statistically significant increases in wound healing metrics in vitro (64%, p=0.024) and in vivo in a rat model designed to recapitulate a broad range of non-healing/chronic wounds (32%, p=0.001, Day 10, target 25% (pâ¤0.05). Building on these successes, the following Phase II SBIR Aims are proposed to scale up development of the Sharkskin wound dressing: AIM I â Develop design criteria and process parameters for production of bilayered, Sharkletâ¢-patterned wound treatment devices, AIM II â Fabricate first-generation devices that meet functionality, quality, safety and efficacy requirements, AIM III â Prove that the Sharkskin wound dressing will significantly improve epidermal closure rate, epidermal barrier function and dermal revascularization in a porcine ischemic wound model compared to standard care, AIM IV â Complete investigational device exemption application and submit for FDA approval in preparation for follow-on clinical studies. Phase II results will lead to the submission of a 510(k) regulatory package for a device-level claim. The strong Phase I success and the broad-based technical, business and regulatory skills of STI's expert, multi-disciplinary team sets the stage for a successful Phase II manufacturing and validation project designed to lead to post-Phase II clinical trials in collaboration with a third-party investor or industry partner. The Phase II project will validate the efficacy of an innovative wound-healing product that uses patented Sharklet micropatterns to accelerate autologous wound healing.
Public Health Relevance Statement: PROJECT NARRATIVE The U.S. annual estimated cost of treating severe and chronic wounds is ~$25 billion. When wound healing is problematic, patches of healthy skin from other areas on the patient are often used to reconstruct the wounded area, but this grafting may lead to severe pain and discomfort at the donor sites, risk of infection, graft rejection, scarring and/or discoloration. Sharklet Technologies therefore proposes in this Phase II SBIR project to validate the efficacy and scale-up development of its micropatterned, biodegradable wound dressings that will significantly enhance healing of full-thickness wounds by directing migration of skin cells and new blood vessels into the wounded area and reducing the need for autologous skin grafting.
Project Terms: 3D Print; Accident and Emergency department; Address; Age; alternative treatment; angiogenesis; Apical; Area; Autologous; base; biomaterial compatibility; Blood Vessels; Burn injury; Businesses; Categories; cell motility; Cells; Chronic Disease; chronic wound; Cicatrix; Clinic; Clinical Research; Clinical Trials; Collaborations; commercialization; Comorbidity; Complex; cost; Data; Dermal; Dermis; design; Development; Devices; dexterity; Dimensions; efficacy testing; Epidermis; Esthesia; Europe; Exhibits; Family suidae; Forearm; Foundations; Generations; Goals; Gold; graft failure; graft healing; Graft Rejection; head/neck injury; Healed; healing; improved; In Vitro; in vivo; Incidence; industry partner; Infection; innovation; Institutes; Laceration; Lead; Legal patent; Manuals; meetings; migration; Mission; model design; Modeling; Morbidity - disease rate; Necrosis; neovascularization; Numbness; Outcome; Pain; Patients; Pattern; Phase; phase 1 study; Phase II Clinical Trials; Physiological; Population; Postoperative Period; pre-clinical; Preparation; Process; product development; Production; Pronation; Rattus; reconstruction; Regulation; repaired; research and development; research clinical testing; Risk; Safety; safety testing; scale up; Site; skills; Skin; skin barrier; skin discoloration; Skin graft; Small Business Innovation Research Grant; Staging; standard care; Sterile coverings; success; Surgical Flaps; System; Technology; Thick; Tissues; Trauma; United States National Institutes of Health; Validation; verification and validation; wound; Wound Hea
