Blue Arbor Technologies Receives FDA Breakthrough Device Designation and TAP Enrollment for the RESTORE™ Neuromuscular Interface System
April 24 2024 - 9:06AM
Business Wire
The innovative interface system is designed to
seamlessly connect a patient’s nervous system and their upper limb
prothesis to restore naturalistic hand and arm function.
Blue Arbor Technologies Inc., a company developing novel
neuromuscular interfaces and next-generation robotic prosthetic
control systems for people with limb loss, announced that the U.S.
Food and Drug Administration (FDA) has granted Breakthrough Device
Designation to the RESTORE™ Neuromuscular Interface System for
people with upper limb loss. The system has also been accepted into
the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP)
Pilot. The RESTORE System is designed to seamlessly integrate the
peripheral nervous system with commercially available robotic
prosthetics to restore naturalistic hand and arm function in
patients with upper limb loss. The platform may enable patients to
move their upper limb prosthetic devices with unprecedented
dexterity, speed, and reliability.
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“For decades, researchers and physicians have been trying to
solve the problem of limited connectivity between patients and
their protheses, so that they can function intuitively just like
human limbs,” said Aviram Giladi, M.D., research director at The
Curtis National Hand Center in Baltimore, MD., and a pioneer in
limb reconstruction. "Early studies show the RESTORE Neuromuscular
Interface System has the potential to be transformative for people
with prosthetic upper limbs, providing hope for more controlled,
seamless, and natural functioning. It could be like they’re getting
a hand back.”
Unlike current interface technologies that are dependent on
surface skin electrodes, the RESTORE System is designed to provide
a direct connection to the patient’s residual muscles and
peripheral nerves to deliver reliable, voluntary movement control
signals. This direct connection provides unparalleled control of
currently available advanced robotic prostheses. In addition, the
RESTORE System is designed to allow for simultaneous and
independent movement of finger, wrist, and elbow joints. This level
of capability far exceeds what is possible with surface skin
electrodes. Furthermore, the RESTORE System has been shown to
consistently capture motor signals for over five years in early
feasibility human trials.1
Approximately one in 200 Americans is living with limb loss2 and
it is projected that this number could double by 2050.3 Upper limb
loss affects an estimated 595,000 people in the United States, with
another 65,000 additional people sustaining limb loss each year.4 A
2022 study found that despite recent advancements in technology,
more than 44% of people with upper limb loss abandoned their
prostheses, citing problems with discomfort, heaviness, and
functionality.5
“Blue Arbor Technologies is dedicated to developing solutions
that address the unmet need for improved robotic prosthetic control
options for people with limb loss so they can more easily integrate
a prothesis in their daily lives and return to normality,” said
Paul Cederna, M.D., president of Blue Arbor Technologies. “The
Breakthrough Designation and TAP enrollment is a valuable step in
the pathway to FDA market clearance. We look forward to working
closely with the agency to make the RESTORE System available to
people with upper limb loss to hopefully increase prosthesis
adoption and use.”
The FDA Breakthrough Devices Program expedites the development,
assessment, and review process for medical devices that provide
more effective treatment options for patients with life-threatening
or irreversibly debilitating diseases or conditions. It is designed
to ensure that patients and healthcare providers have more timely
access to these novel, new medical devices. The TAP Pilot is
intended to help streamline collaboration between the FDA and
medical device sponsors to accelerate the development and path to
commercialization of innovative devices in the breakthrough
program.
About the RESTORE Neuromuscular Interface System
The RESTORE System is an investigational neuroprosthetic
interface designed to detect voluntary nerve and muscle control
signals to facilitate naturalistic function of upper limb
prosthetics. The system consists of: 1) Implantable intramuscular
electrodes; 2) A sensing unit that filters, conditions, and
processes patient-generated electromyographic (EMG) signals and
wirelessly transmits these signals to a socket-mounted receiver; 3)
A socket-mounted receiver that decodes these signals into movement
commands for the prosthesis; and 4) A software package that
controls the entire system. It is designed to be compatible with
any commercially available robotic upper extremity prothesis. The
system can be implanted at the time of an amputation or at the time
of any upper limb reconstructive operation for the treatment of
neuroma pain and phantom limb pain or for revising the shape of a
residual limb.
For more information about the RESTORE System and Blue Arbor
Technologies please visit https://bluearbortech.com.
About Blue Arbor Technologies
Blue Arbor Technologies is a medical device company devoted to
the development of next-generation robotic control systems for
people with limb loss so they can intuitively, accurately, and
reliably control a prosthetic device with unparalleled degrees of
freedom. The Restore™ System is a neuromuscular interface system
that provides a direct connection between the patient’s peripheral
nervous system and their robotic upper extremity prosthetic limb.
Blue Arbor Technologies is a privately held company located in
Grass Lake, Michigan. For more information, please visit
https://bluearbortech.com and connect on LinkedIn, Instagram,
YouTube, and Facebook.
1 Tian, Y., et al Merging Humans and Neuroprosthetics through
Regenerative Peripheral Nerve Interfaces. Semin Plast Surg. 2024
Feb 6;38(1):10-18. DOI: https://pubmed.ncbi.nlm.nih.gov/38495064/ 2
Adams Patricia F., et al, Current Estimates from the National
Health Interview Survey. Vital and Health Statistics 1996; 1999:
10.(200) 3 Ziegler-Graham K, et al. Estimating the prevalence of
limb loss in the United States: 2005 to 2050. Arch Phys Med
Rehabil. 2008 Mar;89(3):422-9.
DOI:https://pubmed.ncbi.nlm.nih.gov/18295618/ 4 Ziegler-Graham K,
et al. Estimating the prevalence of limb loss in the United States:
2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9.
DOI:https://pubmed.ncbi.nlm.nih.gov/18295618/ 5 S Salminge, et al.
Current rates of prosthetic usage in upper-limb amputees - have
innovations had an impact on device acceptance? Disabil Rehabil.
2022 Jul;44(14):3708-3713.
DOI:https://pubmed.ncbi.nlm.nih.gov/33377803/
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