Phase II Amount
$4,149,083
Embody, Inc has pioneered a breakthrough, scalable, additive biomanufacturing approach of hybrid electrospinning and pneumatospinning to engineer a collagen-based construct designed to promote new, aligned tendon-like tissue growth at the tendon implant site. This means the TAPESTRY implant helps the patients body to grow the correct new cells which eventually infiltrate and replace the implant entirely. The result is complete healing by the patients own cellsno implant remains. Unlike traditional materials in competitor products, TAPESTRYs bioengineering creates an implant which mimics the cellular structure of the patients native tissue. Under this Phase II effort, Embody, Inc. will perform R&D/RDTE to advance the performance envelope of TAPESTRY by developing, prototyping, and testing arthroscopic instrumentation necessary for minimally invasive repair of the gluteus medius tendon using the TAPESTRY implant. The mission impact of this effort will enable surgeons to perform state-of-the art tendon and ligament repairs that reduce recovery time and re-injury rate.
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Each year over 800,000 active duty service members suffer a musculoskeletal injury leading to 2.2 million medical visits, 25 million lost duty days, and $3.7 billion in healthcare costs. Ligament and tendon injuries are some of the most debilitating of these injuries as they most often require surgical repair which leads to additional costs, lost duty days, and in many cases long-term sequelae failing to return the service member to full duty. Occurring in an estimated 3,000 USAF and other U.S. warfighters annually1, anterior cruciate ligament (ACL) tears are highly debilitating, expensive to treat, and have a long recovery time. More than 50% of service members with ACL injury have their activity limited or are unable to return to duty following surgery2. Persistent pain and stiffness of the knee3 and a 20% failure of the ACL again within 2 years are also reported in patients4. Return to full duty following ACL reconstruction in active-duty soldiers is lower than may be expected, with on average 267 lost days of duty, and a dramatic reduction in years of service5. Embody, Inc. seeks to return the militarys most important resource-- its people-- to full duty through the effective repair and regeneration of the ACL offering a distinct and uncontested military advantage over its adversaries. MICROBRACETM ACL repair implants are engineered with an ultimate tensile strength and modulus that is comparable to native ACL strength. The collagen graft is designed to be bio-integrated with the patients ACL allowing for return to normal biomechanical functionality. 1. Bottoni et. al. Anterior Cruciate Ligament Reconstructions in Active-Duty Military Patients. https://doi.org/10.1053/j.otsm.2005.10.008(link is external) 2. Antosh et. al. Return to Military Duty After Anterior Cruciate Ligament Reconstruction. https://doi.org/10.1093/milmed/usx007(link is external) 3. Wasserstein et al, 2015. 4. Kaeding et al, 2010 5. Sheean, et al, JAAOS, 2021