SBIR-STTR Award

Open Call for Innovative Defense-Related Dual-Purpose Technologies/Solutions with a Clear Air Force Stakeholder Need
Award last edited on: 2/12/2021

Sponsored Program
SBIR
Awarding Agency
DOD : AF
Total Award Amount
$299,866
Award Phase
2
Solicitation Topic Code
AF192-001
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: FA8649-19-P-A287
Start Date: 8/2/2019    Completed: 8/2/2020
Phase I year
2019
Phase I Amount
$50,000
Along with field injuries, off duty sporting, weight training and recreational activities are commonly reported as causing anterior cruciate ligament (ACL) tears. Occurring in 3,000 Air Force and other U.S. warfighters annually, 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 surgery. A regenerative therapy which preserves native ACL tissue, immediately restores joint strength and promotes ACL healing would significantly improve the service readiness, effectiveness, performance and quality of life of Air Force service members with ACL injuries. The Embody Team has biomanufactured a collagen microfiber graft (microBrace™) that provides a direct solution to this problem. Our therapeutic will reduce surgery time by around 1hr and obviate the need for a second surgery for autologous tissue harvest (the current standard of care). Our advanced therapeutic will also enable treatment closer to the point of injury and sooner, which we postulate will further lead to improved patient outcomes. Our proposed solution will have tremendous medical impact, accelerating the return of Air Force service members, veterans and citizens back to pre-injury performance.

Phase II

Contract Number: FA86492099080
Start Date: 6/22/2020    Completed: 9/22/2022
Phase II year
2020
Phase II Amount
$249,866
Along with field injuries, off-duty sporting, weight training and other recreational activities are commonly reported as the cause of anterior cruciate ligament (ACL) tears. Occurring in an estimated 500,000 U.S. citizens and 3,000 USAF and other US warfighters annually, 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 surgery. Persistent pain and stiffness of the knee and a 20% failure of the ACL again within 2 years are also reported. The Embody team, working together with the Hospital for Special Surgery Team, is developing a breakthrough biomanufactured collagen microfiber graft that provides a direct solution to these problems. A regenerative therapy, which preserves native ACL tissue, immediately restores joint mechanical strength, and promotes ACL healing would significantly improve the current method of ACL repair. We will evaluate our regenerative graft in preclinical sheep and human cadaver testing to determine device performance, efficacy, mechanism of action, and optimal delivery. These studies are directly aimed at solving our mission need and will enable requisite studies to be performed to enable subsequent human trials for both military