Orthobio Partners Orthobio Partners Orthobiologics Implementation
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The Treatments

Four treatments — and the choice is yours.

The orthobiologic procedures a practice can offer all share one principle: they use the patient's own biology, prepared and delivered at the point of care. A program can offer any combination — you choose the mix that fits your patients and your clinic.

Part of the roadmapHow to Add Orthobiologics to Your Practice
What they are

PRP, prolotherapy, BMAC & mFAT.

Plain-English explanations of each — what it is, how it's prepared, and where it's typically used.

PRP

Platelet-rich plasma

A small blood draw is spun in a centrifuge to concentrate the patient's own platelets, then injected to support healing in tendons, ligaments, and joints.

Typically used forTendinopathies, mild-to-moderate osteoarthritis, and ligament or soft-tissue injuries.
Prolo

Prolotherapy

A series of targeted injections that prompt the body's own repair response in worn or lax ligaments and tendons — no donor material, just the patient's own healing.

Typically used forJoint laxity, chronic ligament and tendon pain, and instability that hasn't responded to conservative care.
BMAC

Bone marrow aspirate concentrate

Cells are drawn from the patient's own bone marrow and concentrated, then injected to support repair in joints and soft tissue where more regenerative capacity is needed.

Typically used forMore advanced joint degeneration and cases that call for a higher-potency autologous option.
mFAT

Microfragmented adipose tissue

A small amount of the patient's own fat is harvested, gently microfragmented and rinsed — no enzymes — then injected as a living scaffold rich in regenerative cells. Most often paired with BMAC.

Typically used forAdvanced joint degeneration and larger defects — frequently combined with BMAC as a higher-potency autologous option.

All four are on the table — it's your practice's call. A program can offer any combination; you choose the mix that fits your patients, your clinical comfort, and your clinic. We build the capability — which treatments you run is always your decision.

What they have in common

Autologous, at the point of care.

However you mix them, these treatments share the traits that make orthobiologics such an attractive service line to own.

The patient's own biology
Each treatment is autologous — prepared from the patient's own blood or marrow, with no donor material.
Delivered at the point of care
Drawn, processed, and injected in a single visit — no outside lab, no shipping, no waiting.
Collected at the point of care
A cash-pay service line with no payer lag — revenue is collected almost entirely at the visit.

For general education only. Orthobiologic treatments are clinical decisions made between a physician and patient; indications, suitability, and outcomes vary by individual. Nothing here is medical advice.

The regulatory picture

Minimally manipulated, autologous — outside the 351 pathway.

Because these treatments use the patient's own tissue — drawn, prepared by simple concentration or microfragmentation, and returned in the same visit — they generally sit within the FDA's framework for minimally manipulated autologous products. Products that meet the criteria are regulated under Section 361 of the Public Health Service Act rather than the far more demanding Section 351 biologics-licensing pathway — so a qualifying program typically operates without a biologics license or an IND.

Minimal manipulation21 CFR 1271.10
Processing doesn't alter the tissue's relevant biological characteristics. Concentrating platelets or bone marrow by centrifugation generally stays within this bound.
Homologous use21 CFR 1271.10
The product performs the same basic function in the patient as it did in the body — supporting the repair and cushioning of musculoskeletal tissue.
Autologous, same procedure21 CFR 1271.15(b)
Tissue is removed from and returned to the same patient in a single procedure — the "same surgical procedure" exception the FDA draws for point-of-care autologous use.

This is a general overview, not legal or regulatory advice. Whether a given procedure qualifies turns on how the tissue is handled, the clinical indication, and current FDA guidance. We help practices build to these standards — but each practice should confirm its own position with qualified regulatory counsel.

The first step

Decide which treatments fit your practice.

A short discovery call — no obligation. We'll talk through which of these make sense for your patients, and what it would take to offer them.

Book a discovery call