US Patients
We anticipate beginning US patient enrollment in 2021 pending IDE approval.
Patients Outside of the US
The BalancedBack Total Joint Replacement is available under clinical protocol at several sites around the world.
The Technology
Data Driven
We are a data driven team. Patients treated with BalancedBack outside of the United States have been tracked in our data registry through REDCap. A total of 89 BalancedBack Total Joint Replacement procedures have been completed at a total of 133 spinal levels in 3 clinical studies (n=7, n=12, n=70), with up to 13-year follow-up on some of the earliest cases.
BalancedBack total joint replacements have been performed from L1/L2 to L5/S1, including single-level, two-level, and three-level procedures. The device has been used in primary cases and adjacent to prior fusions as a revision strategy. The results of these pilot studies are encouraging and suggest a reasonable expectation this device could provide for more effective treatment relative to the current standard of care with a meaningful clinical improvement in function (disability), leg pain, and back pain in contrast to the current standard of care.
Patient Stories
Following is a sample of BalancedBack Total Joint Replacement patient experiences obtained from multiple OUS pilot clinical studies performed to date.
Note: This is not a complete list of patient experiences. Lumbar total joint replacement is not suitable for all patients and there are risks associated with total joint replacement. As such patient experience may differ from the samples provided.
Don H.
“Within three hours of the [BalancedBack] surgery, I was up standing.”
Travis T.
“I would say this is the best I’ve felt–five days after surgery–than I have in the last two months.”
Stephanie W.
“I would never have thought that I would feel this good, so quickly, and actually be able to ski after having back
surgery.”
Carol S.
“For six months [before BalancedBack] I ended up sleeping in a camping recliner. Walking seemed to be the only thing
that would give me semi-relief.”
Corey H.
“Over the last five or six years, I don’t remember a day that I’ve gotten out of bed and not hurt.”
Michael B.
“I had an 18 degree curvature of the spine and I realized when I looked in the mirror, I couldn’t stand straight.”
BJ B.
“BalancedBack has given me my life back.”
Ronnie B.
“When I woke up from anesthesia, I had absolutely, absolutely, no back pain whatsoever.”
Harvey F.
“I kept on working and just pushed through the pain… until about three to four years ago when [the pain] started
catching up to me.”
Manuel N.
“Now that I have come to the realization that I was the first in the world to have this done, it is a big deal to me”
Samantha C.
“I am completely 100% back to my routine from years and years ago when my back was good.”
About 3Spine
3Spine is a new kind of healthcare company that vertically integrates the development, clinical research, and delivery of novel healthcare technology. The BalancedBack Total Joint Replacement is the technology platform developed by 3Spine as an alternative to fusion for the lumbar spine.
3Spine SEZC
Cayman Enterprise City
The Strathvale House, 4th floor
90 N Church Street
George Town, Grand Cayman
Cayman Islands
1-345-232-0690
3Spine Management Co. Inc
46 Railroad Ave
Unit 204
Duxbury, MA 02332
1-781-291-8040
US Regulatory Status
CAUTION: Investigational Device. Limited by United States law to investigational use.
The BalancedBack Total Joint Replacement is not available in the United States. The information within BalancedBack.com
is not intended as a substitute for medical professional help or advice. Statements made on this site are not to be
interpreted as a guarantee.
Cayman REGULATORY STATUS
The BalancedBack Total Joint Replacement is undergoing clinical trial in the Cayman Islands in compliance with section 9
of the 2018 Health Practice Regulations.
South africa REGULATORY STATUS
The BalancedBack Total Joint Replacement is a Class D device in South Africa per Rule 8. This device is available for
investigational use only per Schedule 16 of the Department of Health Regulation No. 1515. The BalancedBack Total Joint
Replacement is for professional use only.
To learn more about Breakthrough Designation
https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
