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December 2020

biodesigns Announces 11th Patent for Interface Technology, Expands Licensing Program

By Biodesigns, Press Release / Media, Socket Technology, Uncategorized

WESTLAKE VILLAGE, Calif., Dec. 19th, 2020 – Southern California-based biodesigns, inc., the leader in non-surgical human interface development and technology, is pleased to announce another patent for their innovative High-Fidelity™ (HiFiTM) Interface technology. This latest patent, Method of Manufacturing Prosthetic Socket Interface (US10,878,137), complements their interface technology patent portfolio including Methods for Bone Stabilization, (US10,123,888, US10,702,404), Methods for Use of Compression Stabilized Prosthetic Socket Interface, (US8,323,353), Method, System, and Tools for Affixing Compression Stabilized Prosthetic Socket Interface, (US8,656,918), Adaptable Socket System, Method and Kit (US9,283,093, US10,369,027, EP2914221B1, CA2,889,918), System and Method for Engaging Target with Artificial Limb Equipment (CN106913407B), and Adjustable Pod System, Method and External Member (CN104884005B).

Randall Alley, biodesigns’ CEO, Chief Prosthetist, and Head of User-Interface Technology, has discovered a revolutionary approach for attaching items, equipment, tools and technology non-surgically to the body. The core of the patented and patents-pending HiFi™ Osseostabilizing™ Human Device Interface (HDI) technology is its ability to improve worn device performance and control by syncing the interface more effectively and efficiently to skeletal motion. By surrounding the underlying bone with an alternating array of compression, users experience improved connectivity, a heightened sense of proprioception, and a higher level of device embodiment, whether wearing a prosthesis, exoskeleton, or other wearable technologies.

“When I traveled the world for nearly 15 years fitting complex prosthetic systems, I continually witnessed poor outcomes  and high rejection rates caused by the Standard of Care (SOC) sockets being provided. Patients’ biggest complaints were discomfort and feeling disconnected from their prosthesis. It was then I decided to dedicate my career to improving the human device interface by focusing more on interface biomechanics to achieve improved comfort, increased user feedback, enhanced performance, and ultimately greater device acceptance,” stated Alley. “Today, I am pleased to see the HiFi™ interface technology expand into other industries. Our goal is simple – device embodiment so we can be one step closer to seamless human-device integration.”

To make the technology more accessible to patients globally, biodesigns licenses the HiFi™ Prosthetic Interface technology to other Orthotic and Prosthetic (O&P) facilities in the U.S. and abroad, including several NHS (National Health Services) facilities who are interested in improving their outcomes for upper and lower limb prosthetic wearers. Additional programs include a license to their exoskeleton interface technology as well as a license to their recreational consumer interface products, including exolimb™ which is scheduled to launch in 2021.

About biodesigns:

Southern California-based biodesigns, inc. is a technology-driven facility specializing in the most advanced patient care, research and product development in non-surgical Human Device Interfaces. In prosthetics, it is reestablishing a connection that has been lost; with the military, it is enhancing mission-critical performance and reducing injury; and in consumer wearables it is improving the way individuals interact with tech, tools, and gear. biodesigns’ mission is to create the universal interface standard in Orthotics & Prosthetics (O&P), Exoskeletons, Orthopedics, and consumer wearables. biodesigns’ intellectual property portfolio is managed by Fish IP Law LLP, a premier intellectual property law firm.

For more information visit www.biodesigns.com

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The Importance of the Prosthetic Interface and Its Impact on Patient Management

By Lower Extremity, Socket Technology, Upper Extremity

The Interface or Socket that the Prosthetist provides has a profound impact on their patient’s ability to move forward with rehab and greatly impacts their life today and in the future. Read the recent article by Tricia West and Randall Alley. We must remember to think of our patients in the hear and now but maybe, and even more importantly, in the future.

https://www.aanlcp.org/wp-content/uploads/2020/10/Fall-2020.pdf

Captain DuVal and Alley Highlighted

By Biodesigns, HiFi, Military, Prosthetics, Upper Extremity

Exciting week end of the year as biodesigns was visited by Fox11 and ABC channel 7 regarding the innovative prosthetic work we are involved in with Captain Carey DuVal, right, below elbow amputee, and BrainRobotics.

Check out some of our coverage:

https://abc7.com/technology/veteran-tests-new-technology-with-robotics-prosthetics/8702452/ 

https://www.foxla.com/news/westlake-village-prosthetics-company-tests-state-of-the-art-bionic-arm

https://sofrep.com/news/army-captain-becomes-first-soldier-with-a-prosthetic-limb-to-complete-special-forces-selection/

https://www.washingtonpost.com/technology/2020/12/23/innovations-bionic-hand-ai/

So glad to share this story with others. We hope it provides encouragement and inspiration.

 

biodesigns First Facility in US to Test BrainRobotics’ Myoelectric Hand, Captain Carey DuVal First US Amputee

By Biodesigns, HiFi, Myoelectric, Press Release / Media, Uncategorized, Upper Extremity

https://www.foxla.com/news/westlake-village-prosthetics-company-tests-state-of-the-art-bionic-arm

WESTLAKE VILLAGE, Calif., Dec. 1, 2020 – Southern California-based biodesigns, inc., a biomechanically-focused, outcomes-driven, prosthetic clinic and human interface development company, has been engaged to test BrainRobotics’ new myoelectric prosthetic hand with select prosthesis wearers, including transradial (below elbow) amputee, US Army Captain Carey DuVal.

When determining who should test their new hand terminal device in the US, BrainRobotics searched online and connected with individuals in the O&P (orthotic and prosthetic) and adaptive community, including Adaptive CrossFit coaches. BrainRobotics noted that transradial amputee Captain Carey Duval, and other high-functioning amputees, stressed the critical importance of their interface or socket to their overall success and improved prosthesis performance. Captain Carey DuVal, under the care of Randall Alley, CEO and Chief Prosthetist at biodesigns, originally sought out Alley for his patented and patents-pending High-Fidelity™ Interface technology out of frustration with existing sockets that were holding him back from performing at an elite level.

“The High-Fidelity Interface with Osseostabilizing™ technology is a complete departure from Standard of Care Sockets. The HiFi Interface focuses on manipulating soft tissue via an alternating, circumferential array of targeted compression to capture the wearers’ underlying bone to better control and sync the interface and hence the prosthesis with skeletal motion. This provides the user with improved function, improved range of motion, enhanced stability, added proprioception, and overall improved component and prosthesis satisfaction,” stated Alley. “Carey needed a system that could keep up with him. A veritable “super-user”, he is the perfect person to test our HiFi Interface with the BrainRobotics’ hand.”

The fitting process and socket design utilized will often determine whether a component or prosthesis is ultimately accepted or rejected by the wearer. A main goal for BrainRobotics’ US marketing strategy, as they await FDA approval, is to engage users and prosthetists that have demonstrated high levels of success, to test all parts of their system, including hand function and ease of fabrication. Currently BrainRobotics is targeting an official US launch in Q1 2021.

“With the BrainRobotics’ hand I quickly noticed the grip system seemed to be more intuitive and very responsive, allowing me to switch easily and quickly between different grips,” stated Captain DuVal.

“Our initial feedback is very positive, and this with only the 2-site option being tested,” stated Alley. “I expect even more encouraging results when the 8-channel system with embedded pattern recognition becomes available for us to evaluate.”

About BrainRobotics:

The BrainRobotics’ hand design is based on research that began in 2015 in the Harvard Innovations Lab and leverages advanced BMI (brain/machine interface) technology to deliver more capability, usability, and affordability to the prosthetic industry. The initial US product launch will consist of the 2-site myoelectric version available for transradial amputees or those with congenital amelia, with a more advanced, 8-channel version to include pattern recognition and AI integrated into the arm system. While there are several prosthetic hands currently available for upper limb wearers, the goal of the BrainRobotics’ hand is to complement function with greater intuition, while making the system more affordable and accessible. BrainRobotics’ goal is to have a terminal device package, including the hand, wrist, electrodes, batteries, and charger, at a cost 30% below existing prosthetic hand solutions.

About Captain Carey DuVal:

Carey DuVal, a transradial amputee as a result of a VBIED attack during combat deployment to Afghanistan in 2014, made history as the first amputee to be selected during US Army Special Forces Assessment and Selection to attend the prestigious Special Forces Qualification Course (Q-Course). Captain DuVal credits his HiFi Interface as the game changer and reason he was able to perform at such an elite level. “I notice my body is much more symmetrical now as I don’t favor my sound side,” he said. “I’ve recently gotten back to all of my previous max lifts. The HiFi allows me to do things that no other socket in the world can do.” Capt. DuVal also participates in CrossFit and competed in the WheelWod open and qualified for the WheelWod Games. WheelWod is the adaptive version of the CrossFit Games and, like CrossFit, includes aerobics, weightlifting and gymnastic movements. Currently stationed at Fort Bragg, Capt. DuVal will be retiring within a year and he intends to put his experiences with prosthetics to help others by training as a physical rehabilitation specialist for amputees.

About Randall Alley, biodesigns:

Randall Alley is CEO, Chief Prosthetist and Head of User-Interface Technologies for biodesigns. Alley is a board-certified prosthetist and received both his prosthetic certificate and Bachelor of Science in Kinesiology from UCLA. Alley has 30 years experience fitting challenging prosthetic patients and was co-founder and former director of the world’s largest upper limb prosthetic program. It was his dissatisfaction with the numerous issues cause by the Standard of Care Prosthetic Sockets that led him to dedicate his career to improving the interface. Alley was also the Principal Investigator on two SBIR/DOD contracts, has contributed to five upper limb prosthetic and orthotic textbooks, received a Certificate of Appreciation from the US Army, the Clinical Creativity Award from the American Academy of Orthotists and Prosthetists, was the Interface Consultant on DARPA’s/DEKA’s Bionic LUKE Arm Revolutionizing Prosthetic Program, and has over 10 patents for his human attachment technologies.

For more information, visit www.brainrobotics.com

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