SBIR-STTR Award

Proposed Expansion of Phase II Contract #FA8649-20-9-9080
Award last edited on: 5/17/2023

Sponsored Program
SBIR
Awarding Agency
DOD : AF
Total Award Amount
$4,198,851
Award Phase
2
Solicitation Topic Code
AF211-CSO1
Principal Investigator
Michael Paul Francis

Company Information

Embody Inc

4112 Monarch Way Suite 409
Norfolk, VA 23508
   (757) 777-5674
   N/A
   embody-inc.com
Location: Single
Congr. District: 03
County: Norfolk city

Phase I

Contract Number: FA8649-21-P-1187
Start Date: 4/14/2021    Completed: 7/19/2021
Phase I year
2021
Phase I Amount
$49,768
Embody, Inc. has pioneered a breakthrough, scalable, additive biomanufacturing approach of hybrid electrospinning/pneumatospinning to engineer a collagen-based construct designed to promote new, highly aligned tendon-like tissue growth at the tendon implant site. This means the TAPESTRYTM helps the patient’s body to promote soft tissue healing and will be completely absorbed during the remodeling process. The result is improved healing by the patient’s own cells—no implant remains. Unlike traditional materials in competitor’s products, TAPESTRY’s bioengineering is based on the tendon it is going to be repairing and the implant will mimic the structure of the patient’s native tissue to accelerate repair. Embody, Inc.’s revolutionary bioengineered tendon analog known as TAPESTRYTM should be the Air Force’s go-to for advanced regenerative tendon repair.

Phase II

Contract Number: FA8649-22-P-0643
Start Date: 3/11/2022    Completed: 6/11/2023
Phase II year
2022
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 patient’s body to grow the correct new cells which eventually infiltrate and replace the implant entirely. The result is complete healing by the patient’s own cells—no implant remains. Unlike traditional materials in competitor products, TAPESTRY’s bioengineering creates an implant which mimics the cellular structure of the patient’s 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. ---------- 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 military’s 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 patient’s 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