FDA 510(k) Cleared — BK251268

Three minutes from fat to the future of your clinic.

The Synova WAVE replaces slow, costly enzymatic methods with shockwave-powered adipose stem cell separation — delivering higher viability, higher yield, and a dramatically better experience for your patients and your bottom line.

3:00 minutes
Synova WAVE
91.2%Median viability
122K+Cells per cc
0Enzymes required
FDA 510(k) Cleared
Peer-Reviewed Research
Patented Shockwave Technology
Closed Sterile System
Every hour your old method runs,
you're losing cells, time, and revenue.
The Old Way

✕ Enzymatic Digestion Takes Hours

Traditional collagenase methods require 1–4 hours, tying up lab resources, delaying procedures, and forcing patients into a second visit. That's a second scheduling slot, a second no-show risk, and revenue left on the table.

✕ FDA Regulatory Risk

Enzymatic processing is classified as "more than minimal manipulation" — placing your clinic in a regulatory gray area. The FDA issued enforcement actions against 40+ clinics in 2024–2025. Don't be next.

✕ Lower Cell Viability

Harsh enzymatic breakdown damages delicate stem cells. Leading competitors show median viability as low as 84%, with high batch-to-batch variability that undermines treatment consistency.

✕ Complex, Expensive Workflows

Enzymes are costly consumables. Protocols require trained lab techs, incubators, and careful temperature management — a 5-person, multi-room operation that crushes your margins.

The Synova WAVE

✓ 3-Minute Processing

From lipoaspirate to injectable regenerative cells in under 3 minutes. Harvest, process, and inject in a single patient visit. No second appointment. No drop-off. Full revenue captured in one shot.

✓ FDA 510(k) Cleared

The WAVE uses proprietary shockwave technology — no enzymes, no chemical additives. Classified as minimal manipulation, giving you full regulatory confidence and protecting your license.

✓ 91.2% Median Cell Viability

Gentle shockwave separation preserves cell integrity. Independent testing: 91.2% median viability vs. 84.2% for the leading competitor, with a standard deviation of just 2.6%.

✓ Dead-Simple, 2-Person Operation

A tabletop device. A closed sterile syringe. Press start. No enzymes to buy, no incubation to monitor, no specialized lab staff. One nurse and one physician — that's your entire team.

Performance that speaks for itself.
Validated through peer-reviewed research and independent lab analysis.
91.2%
Median cell viability
122K+
Avg. viable cells per cc
3 min
Total processing time
0
Enzymes or additives
The FDA draws a clear line between your cells
and someone else's.
Under U.S. federal regulation (21 CFR Part 1271), autologous stem cell procedures — where a patient's own cells are harvested, processed, and re-injected — receive a fundamentally different regulatory treatment than allogeneic (donor) products. The Synova WAVE is built to keep you on the right side of that line.
Autologous — Your Patient's Own Cells

The FDA's preferred pathway for point-of-care clinics

  • Qualifies for Section 361 HCT/P classification when minimally manipulated and used homologously — no premarket FDA approval required
  • Exempt from the "no systemic effect" criterion that restricts donor tissue — autologous cells can serve systemic metabolic functions
  • Zero risk of disease transmission between individuals — no donor screening panels for HIV, Hepatitis B/C, HTLV, CMV, or EBV required
  • Zero risk of immune rejection — the patient's body recognizes its own cells, enabling safer, more predictable outcomes
  • Same-day harvest-to-injection workflow is fully compatible with minimal manipulation requirements when using non-enzymatic processing
  • Growing clinical evidence base with 4,700+ registered stem cell trials globally, adipose-derived MSCs leading as the dominant cell source
Allogeneic — Donor Cells

Higher regulatory burden, higher risk, higher cost

  • Most donor stem cell products are classified as Section 351 biologics — requiring full IND applications, clinical trials, and Biologics License Applications (BLA)
  • Cannot serve systemic metabolic functions unless from a first- or second-degree blood relative — severely limiting clinical applications
  • Requires extensive donor screening and testing: HIV-1/2, HBV, HCV, HTLV-1/2, CMV, EBV, and other communicable disease agents
  • Carries inherent risk of immune rejection and disease transmission, requiring immunosuppression protocols in some cases
  • The FDA and FTC issued joint enforcement actions against 40+ clinics in 2024–2025 for unsubstantiated claims around donor-based stem cell products
  • No expanded allogeneic MSC product is FDA-approved for routine clinical use — access remains limited to controlled research settings

Why this matters for your clinic: The Synova WAVE's enzyme-free, closed-system processing keeps your adipose stem cell procedures firmly within the FDA's minimal manipulation framework. You're using the patient's own cells, processed mechanically in under 3 minutes, and re-injected in the same visit. That's the cleanest regulatory position in regenerative medicine — and it's the pathway the FDA has explicitly designed for point-of-care applications.

The WAVE doesn't just improve outcomes.
It transforms your P&L.

Here's the math that matters: the WAVE collapses a multi-visit, multi-staff, multi-hour procedure into a single same-day workflow. That compression is where all the money is.

$5K–$10K+
Revenue per stem cell procedure
Adipose stem cell treatments command premium pricing your longevity patients are already conditioned to pay
4–6×
More procedures per day, per physician
3-minute processing vs. 3-hour enzymatic methods means the bottleneck disappears
$24K–$60K
Potential daily revenue per location
At $6K–$10K avg. per procedure × 4–6 patients/day
1–2
Patients/day with enzymatic processing
3-hour lab cycle + specialized staff
4–6
Patients/day with the Synova WAVE
3-minute cycle + 2-person team

💰 Same-Day = Full Revenue Capture

When patients have to come back for a second visit, you lose them. Scheduling friction, life getting in the way, second thoughts — every multi-visit protocol leaks revenue. The WAVE makes it one appointment: harvest, process, inject, done. Your patient walks out treated. You captured the full $5K–$10K+ in a single session. No follow-up call. No re-booking. No drop-off.

Patients Want Same-Day — And They'll Pay For It

Your longevity clientele — the ones already spending $2K on IV drips and $15K on comprehensive panels — don't want to come back next week. They want results now. "We harvest your own stem cells and inject them today, in the same visit" is a message that sells itself. It feels cutting-edge. It feels premium. And because it's the patient's own cells with zero chemical manipulation, you can market it honestly as the safest option available.

📈 The Upsell Architecture Writes Itself

Stem cell therapy doesn't replace your existing menu — it sits at the top. A patient comes in for a joint consultation. You offer PRP at $1,200. Exosomes at $2,500. And now, autologous adipose stem cell injection at $7K–$10K+. Bundle it into a Platinum Regenerative Package with your existing IV therapies and diagnostic panels and you're looking at $12K–$15K per patient visit. The WAVE gives you a new top tier without adding operational complexity.

🔻 Slash Operational Overhead

Enzymatic processing requires a trained lab tech ($60K–$80K/year), an incubator, enzyme inventory with cold-chain storage, and careful temperature management. The WAVE eliminates all of that. One tabletop device. Sterile single-use disposables. Your existing nurse loads the syringe, presses start, and hands the physician a ready-to-inject cell concentrate 3 minutes later. That's a 5-person, multi-room workflow compressed down to 2 people, 1 room.

🏥 Scale Without Complexity

When you're running one clinic, you can personally oversee quality. When you're running five or ten, you need a process that produces the same result every time, regardless of who operates it. The WAVE's 2.6% standard deviation means your Houston clinic and your Scottsdale clinic deliver identical cell quality. That's how you build a brand around outcomes — not just marketing.

🛡️ A Compliance Moat Around Your Business

FDA 510(k) clearance + enzyme-free processing + autologous cells = the cleanest regulatory position in regenerative medicine. While competitors operate in gray areas and risk enforcement actions, you're fully compliant. That's not just risk management — it's a competitive advantage. Patients trust FDA-cleared. Insurance partnerships require it. Investors demand it.

The treatment ladder your patients want to climb.
$1.2K
PRP Injection
Standard offering
$2.5K
Exosome Therapy
Mid-tier upgrade
$7–10K
Stem Cell Injection
Powered by Synova WAVE
$12–15K
Platinum Package
Stem cells + IV + diagnostics
Whether you own the clinic or treat the patient,
the WAVE changes your game.
💰

Premium Revenue, Single Visit

$5K–$10K+ per procedure, captured in one appointment. No second visit scheduling. No patient drop-off. Same-day harvest, process, inject — full revenue in one shot.

📈

Capture a $5B+ Market

The SVF market is projected to exceed $5 billion by 2034, growing 12%+ annually. Clinics adopting point-of-care processing now will lead this wave — not chase it.

⚙️

Slash Operational Costs

No enzymes. No lab techs. No incubators. One tabletop device with single-use disposables. Your operational overhead for stem cell procedures drops by 60–80%.

🛡️

Regulatory Peace of Mind

FDA 510(k) clearance + autologous cells + enzyme-free processing = the cleanest compliance position in regenerative medicine. Protect your license, your reputation, and your business.

🏥

Attract Top Physicians

Doctors want cutting-edge tools. Offering the WAVE signals your clinic is serious about regenerative medicine — making it easier to recruit and retain top clinical talent.

Marketing That Writes Itself

"3-minute, enzyme-free, FDA-cleared, same-day stem cell treatment using your own cells." In a crowded market, that's a differentiation message your competitors can't match.

🔬

Higher Viability, Better Outcomes

91.2% median viability with 2.6% standard deviation means healthier, more potent regenerative cells — giving your patients the best possible chance at recovery.

⏱️

True Same-Day Treatment

Harvest, process, inject — all within a single visit. No second appointments. No waiting for lab results. Your patients leave the same day, treatment complete.

🧬

Autologous Cell Safety

Patient's own cells, minimally manipulated, in a closed sterile system. Zero disease transmission risk. Zero immune rejection risk. The gold standard in patient safety.

📋

Broad Clinical Applications

Orthopedic joint repair, sports injuries, chronic wound healing, cosmetic fat grafting — adipose-derived stem cells have demonstrated regenerative potential across specialties.

🎯

Consistent, Reproducible Results

Shockwave processing eliminates enzymatic variability. Lower standard deviation means predictable cell counts and reliable treatment protocols across every patient.

📚

Peer-Reviewed Validation

The SAVE (Shock-Assisted Viable Extraction) method is validated in published research, giving you confidence in the science behind every procedure you perform.

Four steps. Three minutes. One visit.
1

Harvest

Standard mini-liposuction to collect adipose tissue. 15–20 minutes, local anesthesia.

2

Load

Transfer lipoaspirate into the sterile, single-use syringe. Insert into the WAVE.

3

Process

Press start. Shockwave impulses separate regenerative cells in ~3 minutes.

4

Inject

Concentrated cell pellet is ready. Inject directly into the treatment site. Same visit.

See how the WAVE compares to conventional methods.
FeatureSynova WAVEEnzymatic (Collagenase)Other Mechanical
Processing Time~3 minutes1–4 hours15–45 minutes
Median Cell Viability91.2%75–85%70–80%
Enzymes RequiredNoneYes (collagenase)None
FDA Compliance510(k) ClearedRegulatory gray areaVaries
Avg. Viable Cells / cc122,000+Varies widelyLower yields
Sterile Closed SystemYesNo (open processing)Varies
Staff RequiredNurse + PhysicianLab tech + Physician + Support2–3 staff
Same-Day TreatmentYes — single visitOften requires 2nd visitPossible but slower
Patient ExperiencePremium, fast, modernLong wait, clinical feelModerate
Regenerative medicine isn't coming. It's here.

The clinics adopting point-of-care adipose stem cell processing today are positioning themselves at the forefront of a multi-billion-dollar market shift. Early movers capture outsized value.

Position Your Clinic Now →
$5B+
Projected SVF market size by 2034
  • Adipose-derived MSCs are the dominant cell source in stem cell therapy, with orthopedics, aesthetics, and wound healing as the leading applications.
  • Over 4,700 stem cell clinical trials registered globally — the evidence base is accelerating faster than ever.
  • Autologous therapy holds the largest market share, driven by lower rejection risk and growing patient demand for minimally invasive treatments.
  • North America leads with 46% of the global SVF market. Point-of-care devices are the fastest-growing product segment.
Ready to bring the WAVE to your clinic?

Request a demo, get pricing, or talk to our clinical team about how the Synova WAVE fits into your practice and your P&L. No pressure — just the facts you need to make the right call.

Or call us directly: 1 (833) SYNOVA-1