When Will Arthrosamid Be Available in the USA? FDA Status, Costs & Evidence (2026)

Quick Answer: Arthrosamid is not FDA-approved and not available in the United States as of 2026. A Phase 3 US clinical trial is currently underway. If the trial succeeds and the FDA review goes smoothly, the earliest realistic commercial availability is 2028 — and 2029 or later is more probable. There is no compassionate use program and no way to receive it from a US doctor outside of the clinical trial. For a deeper look at the regulatory timeline, see our Arthrosamid FDA timeline guide.

Why Everyone Is Talking About Arthrosamid

If you have been searching for knee pain solutions recently, you have probably noticed a name popping up more and more: Arthrosamid. Google searches for this treatment have surged in 2026, and patient forums are buzzing with questions about it.

The interest is understandable. Arthrosamid promises something that no currently available knee injection can deliver: lasting pain relief from a single shot that does not wear off in six months.

But before you get too excited, there are some important realities to understand. Here is a clear, balanced look at what Arthrosamid actually is, what the evidence shows, and what US patients need to know right now.

What Is Arthrosamid?

Arthrosamid is a polyacrylamide hydrogel injection for knee osteoarthritis, developed by Contura International, a Danish medical device company. The product is made of 2.5% cross-linked polyacrylamide and 97.5% water.

What makes it different from every knee injection currently available in the United States is its mechanism:

Traditional HA injections (Synvisc, Euflexxa, Monovisc, etc.) add temporary lubrication to your joint fluid. Your body absorbs the gel over months, so you need repeat treatments.
Arthrosamid integrates into the synovial membrane (the lining of your joint) and creates a permanent, non-biodegradable cushion. It does not break down, so one injection could potentially last years.

This is not an incremental improvement over existing treatments. It is a fundamentally different approach to managing knee osteoarthritis pain.

Why the Sudden Surge of Interest?

Several factors are driving the breakout search interest in Arthrosamid:

1. Clinical Trial Results Are Encouraging

The MIVAC trial, published in Osteoarthritis and Cartilage in 2023, showed statistically significant pain reduction at 12 months compared to saline placebo. Follow-up data at 24 months showed sustained benefit without repeat injections. The LUNA trial (199 patients) found a 17-point improvement on the WOMAC pain scale at 12 months — a clinically meaningful result. And data presented at the World Congress on Osteoarthritis in 2025 showed sustained benefit out to 5 years from a single injection.

2. The Appeal of One-and-Done Treatment

For patients who currently get HA injections every 6 months (and deal with the scheduling, copays, and occasional insurance hassles), the idea of a single injection lasting 2 to 3 years or longer is enormously appealing. That message resonates deeply with the millions of Americans managing chronic knee OA.

3. Word of Mouth From International Patients

Arthrosamid has been available in Europe and the UK for several years and received Health Canada approval in 2025. Patients who have traveled abroad for the treatment have been sharing their experiences on social media, Reddit, and patient forums. Many of these reports are positive, which fuels interest among US patients.

4. Growing Frustration With Current Options

Many knee OA patients feel stuck between treatments that wear off quickly (cortisone, HA injections) and major surgery they are not ready for (knee replacement). Arthrosamid fills a gap in the treatment spectrum that patients have been asking about for years.

What the Evidence Actually Shows

Let us separate the facts from the hype.

What We Know

MIVAC trial results are real and published in a respected peer-reviewed journal
Pain reduction was statistically significant compared to placebo at 12 months
24-month data shows sustained benefit without retreatment
5-year data presented at WCO 2025 shows long-term durability in international patients
Safety profile appears favorable with adverse events similar to other knee injections
The LUNA study confirmed a 17-point WOMAC improvement at 12 months in 199 patients
CE marking in Europe, UK approval, Australian approval, and Health Canada approval (2025) signal broad regulatory confidence outside the US

What We Do Not Know

How long relief actually lasts beyond 5 years in most patients
Whether it works for severe arthritis (most studies focused on mild to moderate)
Long-term safety of a permanent implant in the knee over 10, 20, or 30 years
How it compares head-to-head with HA injections (no direct comparison trials)
Whether the hydrogel causes issues if knee replacement is needed later
How it performs in a large, diverse US population versus smaller European studies

The Honest Assessment

Arthrosamid’s early data is genuinely promising. It is not snake oil or marketing fluff. But “promising early data” is very different from “proven treatment.” Many therapies have looked great in early trials and then failed to deliver in larger, longer studies.

The US Availability Problem

Here is the part that frustrates many American patients: Arthrosamid is not available in the United States.

Current FDA Status (2026)

Not FDA-approved for any indication in the US
Not available at any US clinic or hospital (except through clinical trials)
No compassionate use or special access program exists for Arthrosamid in the US
No HCPCS billing code exists, so insurance cannot cover it even theoretically
Contura International is conducting a Phase 3 US pivotal trial — enrollment is ongoing

It is illegal for a US physician to administer Arthrosamid outside of an approved clinical trial. Any US clinic claiming to offer Arthrosamid outside the trial is operating improperly.

When Will Arthrosamid Be Available in the USA?

Predicting FDA timelines is difficult, but here is a realistic framework based on where the US trial stands today:

Milestone	Estimated Date
Phase 3 trial enrollment complete	Mid 2026
Phase 3 primary endpoint data available	Late 2026 – Early 2027
PMA submission to FDA	2027
FDA review period (6-12+ months)	2027 – 2028
Possible FDA decision	Late 2027 – Mid 2028
Commercial availability if approved	2028 at the earliest

These are optimistic estimates. Delays are common — the FDA may request additional follow-up data, the trial results may not match international data, or approval may be denied entirely. A realistic planning assumption for US patients is that Arthrosamid will not be commercially available before 2028, and 2029 or later is entirely possible.

For a detailed breakdown of the FDA pathway, see our Arthrosamid FDA timeline and clinical trial guide.

What Should US Patients Do Right Now?

If you have knee osteoarthritis and are interested in Arthrosamid, here is practical guidance:

1. Do Not Wait for Arthrosamid to Treat Your Pain

Knee OA is a progressive condition. Untreated pain leads to reduced activity, muscle loss, weight gain, and faster joint deterioration. Effective treatments are available right now.

2. Consider Proven Treatments Today

Physical therapy remains the foundation of knee OA management
Hyaluronic acid injections are FDA-approved, Medicare-covered, and effective for 6-12 months — see our gel injection cost guide for pricing by brand
Cortisone injections provide short-term relief for flare-ups
Weight management reduces load on arthritic joints
Bracing and activity modification help manage symptoms daily

3. Be Cautious About Medical Tourism

Some patients are traveling to Europe, the UK, or Canada for Arthrosamid injections. If you consider this:

Verify the clinic’s credentials thoroughly
Understand that follow-up care will be managed by your US doctor, who may be unfamiliar with the product
Budget realistically: $3,000 to $6,000 for the injection plus travel and lodging (projected US pricing if approved would be $4,000–$7,000)
Inform your US physician so they can monitor you appropriately

4. Stay Informed

Sign up for updates on Arthrosamid FDA progress and clinical trial results. When new data is published, we will break it down in plain language.

What About Clinical Trials?

Some US patients may be able to access Arthrosamid through clinical trials. If you are interested:

Check ClinicalTrials.gov for active Arthrosamid studies
Ask your orthopedic doctor if they are aware of any enrollment opportunities
Understand that trial participation involves randomization (you may receive a placebo)
Clinical trials are free and include monitoring, but require commitment to the study protocol

Typical eligibility requirements for the US pivotal trial include confirmed knee OA (usually KL Grade 2-3), age 40 or older, failed conservative treatment, and no prior joint replacement on the study knee.

Frequently Asked Questions

When will Arthrosamid be available in the USA?

As of mid-2026, Arthrosamid is in an active Phase 3 US clinical trial. If the trial produces positive results and the FDA review proceeds without major delays, the earliest realistic commercial availability is late 2027 to mid-2028. A more conservative estimate is 2029 or later. There is no guarantee of approval — if the US trial does not meet its endpoints, availability could be delayed further or not happen at all. Do not put your current knee care on hold waiting for this timeline.

Is Arthrosamid FDA-approved?

No. As of 2026, Arthrosamid is not FDA-approved for use in the United States. It is CE-marked in Europe, approved in the UK, approved by Australia’s TGA, and received Health Canada approval in 2025 — but the US remains in the clinical trial phase. FDA approval requires the completion of a separate US pivotal trial and a Premarket Approval (PMA) review.

How much does Arthrosamid cost?

At international clinics where it is currently approved, Arthrosamid costs approximately $3,000 to $6,000 for the injection. This does not include travel, lodging, or follow-up care. It is not covered by any US insurance. If it receives FDA approval, the projected US price is $4,000 to $7,000 per injection — still not insured until Medicare and private insurers establish coverage policies. By comparison, FDA-approved gel injections (HA viscosupplementation) typically cost $500 to $1,500 with insurance or Medicare coverage. See our gel injection cost guide for a full brand-by-brand breakdown.

Is Arthrosamid better than Durolane?

Durolane is a single-injection hyaluronic acid gel shot that is FDA-approved, available in the US today, and covered by Medicare and most private insurance. Arthrosamid is not yet available in the US. The key difference is permanence: Durolane is biodegradable and wears off over 6-12 months; Arthrosamid is non-biodegradable and potentially lasts years from one injection. However, no head-to-head clinical trial has compared them directly. For US patients today, Durolane is the accessible, insured option. Arthrosamid may eventually be a longer-lasting alternative once FDA-approved. See our Arthrosamid vs. Durolane comparison and the Durolane cost guide for details.

Is Arthrosamid permanent?

The polyacrylamide hydrogel is non-biodegradable, meaning your body does not break it down. It integrates into the synovial membrane and remains in place indefinitely. This is both its advantage (long-lasting) and a concern (cannot be easily removed).

Can Arthrosamid replace knee replacement surgery?

No. Arthrosamid is a pain management treatment, not a cure for osteoarthritis. It does not regenerate cartilage or repair structural damage. Patients with severe, end-stage arthritis may still need knee replacement. Arthrosamid may help delay surgery for patients with mild to moderate disease.

Is Arthrosamid better than Synvisc or other HA injections?

It is too early to make that comparison definitively. Arthrosamid may last longer, but HA injections have 25+ years of safety data, FDA approval, and insurance coverage. No direct comparison trial exists. For a detailed breakdown, see our Arthrosamid vs. Hyaluronic Acid comparison.

Should I wait for Arthrosamid before getting knee injections?

No. Do not delay treatment for a product that is at least two years away from US availability — and approval is not guaranteed. Treat your pain now with proven options such as gel injections, physical therapy, and appropriate lifestyle changes. Getting treatment today does not prevent you from switching to Arthrosamid later if it becomes available.

The Bottom Line

Arthrosamid is a legitimate, innovative treatment that deserves the attention it is getting. The early clinical data is encouraging, and the concept of a single injection providing years of relief could genuinely change how we manage knee osteoarthritis.

But right now, in 2026, it is an emerging treatment that is not available to most American patients through normal channels. The FDA approval process will take time — realistically until 2028 or later — and that is a good thing. Patients deserve thorough vetting of any treatment that will be permanently implanted in their bodies.

In the meantime, effective treatments exist today. Talk to your doctor about your options, manage your knee OA with proven therapies, and keep an eye on Arthrosamid’s progress.

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