biodesigns Awarded $1M Phase II SBIR DARPA Contract

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biodesigns of Westlake Village, CA receives DARPA contract for the delivery of a socket diagnostic tool innovation for the fitting of advanced prosthetic arm systems.

Fred Downs using the DEKA "Luke Arm" and HiFi Interface.

I have seen how our current HiFi System is already transforming amputees' lives and we look forward to further advancements for our military and ultimately widespread use of this technology.

biodesigns, inc., Southern California, was awarded a $999,822 firm-fixed-price Phase II Small Business Innovation Research (SBIR) Defense Advanced Research Projects Agency (DARPA) contract for the delivery of a socket diagnostic tool for the manufacture and fitment of custom sockets for upper-limb prostheses.

Randall Alley, CEO and Chief Prosthetist for biodesigns, was a primary interface (socket) consultant for DEKA on their “Luke Arm," as part of DARPA's Revolutionizing Prosthetics Program (RP2007), but this is biodesigns’ first DARPA contract.

DARPA’s call for the socket diagnostic tool innovation is a result of the challenges prosthetists face when designing the socket and suspension systems that hold prostheses on upper-limb amputees. Variations among individuals introduce unique complexities that factor into fitting the socket, including muscle bundles, neuromas, bone spurs, skin conditions such as scars from burns and sores from infections and shear at the interfacial boundary.

As a result, the process of fitting sockets is currently a labor-intensive, manual approach. Current fitting techniques often yield sockets that are uncomfortable, unstable, or impede full range of motion, resulting in compromised device performance or election by the amputee to not use the prosthesis altogether.

To address these challenges, DARPA sought the development of innovative diagnostic tools to improve socket fittings and socket performance thus enabling prosthetists to more successfully and systematically deploy advanced upper extremity prosthetics, such as those developed by the DARPA RP programs. The HiFi Interface™ and HiFi Imager™ System, created by Alley, is the platform technology for this contract and was also used in DEKA's “Luke Arm” studies.

Intimate Connection to the Bone:
The HiFi Interface with patented and patents-pending OsseoSynchronization™ technology is designed to replicate the stability achieved through direct connection to the bone that osseointegration surgery – the direct skeletal attachment of a prosthetic limb – provides. The HiFi is Alley’s non-invasive biomechanically-based socket solution that captures and controls the residual bone through an alternating compression and release design. “By displacing the soft tissue so there is less of a buffer between the bone and the interface wall in the compression zones, there is less unwanted motion of the bone. This reduced bone motion results in a much more dynamically responsive prosthesis that feels lighter, offers much greater stability and security, wastes less energy, and with the incredible proprioception it provides, patients also report feeling connected to their prosthesis,” Alley said.

A key to the success of Alley’s interface is his patented casting/scanning Imager which allows for the proper amount of compression in key areas but also allows patients the ability to provide feedback and help dictate their fit. “We are excited and honored to be able to move forward with DARPA,” Alley said. “I have seen how our current HiFi system is already transforming amputees’ lives and we look forward to further advancements for our military and ultimately widespread use of this technology.”

Note: See a rare glimpse of the DEKA “Luke Arm" (as part of DARPA’s Revolutionizing Prosthetics Program) with Alley’s X-Frame and HiFi Interface at http://www.youtube.com/biodesignsvideos

About biodesigns inc.
Southern California-based biodesigns, inc. is a technology-driven prosthetics company specializing in the most advanced patient care, research and product development for individuals who have experienced upper and lower limb loss. The company’s approach utilizes innovative clinical techniques and the most biomechanically advanced prosthetic interface systems available, including the High-Fidelity Interface and Imager System. biodesigns works with upper and lower limb wearers of all ages and activity levels, but also provides interface/socket trainings and licensing to other prosthetists as well as consulting services in and outside the field of prosthetics. For more information visit http://www.facebook.com/biodesigns, http://www.youtube.com/biodesignsvideos and http://www.JoinHiFi.com

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Julie Alley
biodesigns, inc
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