A company that makes medical products from donated human tissue says its injection for chronic low back pain did clearly better than a fake procedure in a randomized trial. Vivex Biologics announced that results from the study, called ASCEND, have been published in the Journal of Clinical Medicine, and that the trial met its main goal1.
The product, VIA Disc NP, is an off-the-shelf tissue graft made from the inside of spinal discs taken from donors. It is meant to top up discs in the lower back that have worn down2. The company says 60% of people who got it had a meaningful drop in back pain six months later, compared with 1.6% of people who got the fake procedure1.
What happened
ASCEND enrolled 121 people at five sites in Australia. All had long-lasting low back pain thought to come from a worn disc, a condition doctors call discogenic pain1. According to the trial’s public registry entry, participants had had symptoms for more than six months, had not improved after at least three months of standard non-surgical care, and were split evenly by chance between the real injection and a sham, or fake, procedure3.
The trial was “double-blind”: neither the patients nor the people measuring their results were told who got which3. That design helps separate the effect of the injection from the effect of simply having a procedure and expecting to feel better.
The main goal was the share of people whose back pain score fell by at least 30% from the start, measured six months after the procedure1. A 30% drop is a common threshold for a change that patients notice in daily life, which researchers call a “minimal clinically important difference”1.
The evidence so far
These are the figures in Vivex’s announcement1:
- Pain at six months: 60% of treated people reached at least a 30% drop in back pain, against 1.6% in the sham group.
- Pain at three months: 53% against 5%. The company says this works out to treating about 2 people for one extra person to get meaningful relief.
- Day-to-day function: On a standard questionnaire about how back pain limits daily life, 53% of treated people improved meaningfully at three months against 32% in the sham group, and 60% against 31% at six months.
- Feeling acceptable: 48% of treated people reached a level of back pain they considered acceptable at six months.
- People who switched: Sham patients who later got the real injection improved in a similar way, with 56% reaching meaningful pain relief three months after treatment.
The trial’s principal investigator, Paul Verrills, said in the company’s announcement:
In my 25 years treating back pain, I’ve rarely seen a controlled trial produce a therapeutic effect of this magnitude.
He also described treatment-related side effects as “infrequent”1. Safety was a second main goal of the trial, measured as the share of people with treatment-related side effects at 12 weeks3.
What it does not show yet
Several details matter when reading these numbers.
The cleanest comparison is at three months. Under the trial rules, people in the sham group who had not improved by at least 30% at three months could switch to the real injection1. Fifty-five sham patients did so, and as planned in advance, their three-month scores were carried forward and counted as their six-month result1. So the 53% versus 5% figure at three months is the one measured while everyone was still blinded, as the company itself notes1. The six-month sham figure partly reflects earlier measurements rather than a fresh six-month check.
The fake procedure still helped some people. Pain relief in the sham group was small, but on the function questionnaire about a third of sham patients improved meaningfully1. That gap is smaller than the gap for pain.
The switch group was not blinded. Sham patients who crossed over knew they were getting the real injection, so their 56% response rate is open-label (unblinded) data1.
Safety numbers are not in the announcement. The press release does not give the count or type of side effects in ASCEND1. Biohack has not seen the full journal paper, so the figures here are those the company chose to report.
Long-term results are pending. The registry says all participants are followed to one year, with an optional extension to two years for the treated group3. Vivex says it expects to publish 12-month results “in the near term”1.
The company calls ASCEND “pivotal,” a word usually used for a trial meant to support approval. The registry entry describes it as a phase I/II trial, which typically means an earlier stage of testing3. The sources do not say how regulators will view the results.
Who is behind it
Vivex Biologics, based in Miami, sponsored the trial3 and announced the results1. Its executive chairman, John McCallum, said the trial “closes that gap with the kind of rigorous, blinded evidence physicians and payers expect”1. Co-president Rey Pascual called it “a defining moment for Vivex”1. The announcement does not describe any financial ties between the company and the trial’s investigators1.
The trial started in October 2024 and finished collecting its main results in February 2026, according to the registry, which listed no posted results at the time it was last captured3.
How it fits the field
Vivex says low back pain is the leading cause of disability worldwide and that worn discs account for at least 40% of chronic cases1. It describes current choices as conservative care that often fails, long-term opioid use or surgery, and presents its injection as a minimally invasive option done under light sedation as an outpatient1.
The procedure itself is short. A clinic that offers it describes mixing the donor tissue with saline (salt water) and delivering it into the worn disc through a thin needle, guided by live X-ray imaging2.
ASCEND is not Vivex’s first study of disc tissue grafts. An earlier US trial, called VAST, enrolled 218 people at 13 sites starting in 2017 and compared a donor tissue graft with a saline injection and with standard care4. Initial results were published in the International Journal of Spine Surgery in 20205, though the trial’s registry status is listed as unknown and no results were posted there4. The company also cites smaller studies without a comparison group: a six-site US pilot in which 64% of people assessed at two years had at least halved their back pain, and a study of 21 people of Medicare age in which 82% had meaningful relief at six months1. It also reports a pooled safety analysis with a serious side-effect rate attributed to the product of 0.26%1. Studies without a comparison group cannot tell how much improvement comes from the treatment itself, which is why the sham-controlled ASCEND result matters most to the company’s case.
Vivex also runs a patient registry that collects data from people treated with the product in regular care, without extra treatment; it is listed as not recruiting6.
What to watch next
- The full journal paper’s side-effect data and details on who did and did not respond.
- The promised 12-month results, and two-year follow-up after that13.
- Whether independent groups, not funded by Vivex, test the injection against a sham procedure.
- Any regulatory or insurance decisions, which the company’s statements point toward but the sources do not describe.
Biohack reports what was measured and by whom. This article is news, not medical advice.
