Gloved hands attaching a syringe to the single-use Rigeneracons RS device

Technology

From auricular cartilage to an injectable micrograft suspension.

Mytocel MSK® is built on Rigenera® technology and the AMT® (Autologous Micrografting Technology) platform.

What is in the suspension

Cells, pericytes and matrix from the patient’s own cartilage.

Characterisation studies describe a heterogeneous suspension of cartilage-derived cells (chondrocytes and progenitor cells), pericytes and extracellular-matrix components from the donor tissue.¹

Labelled histology section of auricular cartilage showing perichondrium, elastic cartilage and chondrocytes — Auricular cartilage: perichondrium, elastic cartilage and chondrocytes. Histology as reproduced in the manufacturer’s brochure, after Junqueira

Chondrocytes and progenitor cells: Cartilage-derived cells from the donor tissue, as described in the characterisation studies.¹
Pericytes: Carried from the donor tissue alongside the cartilage-derived cells, as described in the characterisation studies.¹
Extracellular-matrix components: Matrix components from the donor tissue, collected in the same heterogeneous suspension as the cells.¹

Cutaway of the single-use cartridge holding the patient’s cartilage sample, beside a key to the micrograft composition: progenitor cells, chondrocytes, pericytes, extracellular-matrix components and genetic material — The patient’s own tissue in the single-use cartridge, and what the disaggregated micrograft suspension contains. Manufacturer’s illustration

Processing

Mechanical, not biological.

Mechanical disaggregation only: no laboratory expansion, no enzymatic digestion, no culture step.

Micrografts are collected through a calibrated 80 µm filter, the size range associated with viable progenitor-rich fractions in the characterisation work.¹

Unlike cultured chondrocyte implantation, there is no laboratory expansion and no second procedure.

Gloved hands drawing the prepared suspension from the single-use cartridge with a syringe — The prepared suspension is drawn from the cartridge. Manufacturer’s protocol photography

A description of the processes, not a comparison of outcomes.
	Mytocel MSK	Cultured chondrocyte implantation
Laboratory culture	None	Laboratory expansion
Number of procedures	One session	Two procedures
Tissue source	Patient’s own auricular cartilage	Patient’s own cartilage, expanded in a laboratory

System components

Rigeneracons RS and the N4SA processing unit.

The Mytocel MSK processing unit, a single-use cartridge and its stand on a sterile drape — The system: processing unit, single-use cartridge and stand. Manufacturer’s protocol photography

Diagram of the three elements of the Rigenera technology: the single-use Rigeneracons, the transmitter and the electromechanical rotator — The three elements of the technology, as drawn in the manufacturer’s protocol

The single-use device carries the sample and its calibrated grid; the transmitter couples it to the processing unit; the unit’s electromechanical rotator drives the disaggregation cycle. No reagents and no culture step.

Class IIaSingle use

Rigeneracons RS

Disaggregation device

Rigeneracons® RS: sterile, single-use Class IIa medical device, designed to mechanically disaggregate the auricular cartilage sample and collect the micrograft suspension through the calibrated 80 µm filter.

Class IReusable

Rigenera N4SA

Processing unit

Rigenera® N4SA: Class I motor-driven processing unit. The reusable unit provides the calibrated rotational impulse for the documented processing cycle.

Storage. Store at room temperature in a dry, ventilated place.

Regulatory status

Rigeneracons® RS: sterile, single-use Class IIa medical device. Rigenera® N4SA: Class I motor-driven processing unit. CE marked; accepted on the Great Britain market under current transitional arrangements. Registered with the MHRA.

Where the evidence sits

Mechanistic rationale, pre-clinical models, small clinical series.

Nine publications and two preliminary reports: a three-year follow-up series (n = 8), two prospective ten-patient studies to 6 and 12 months, preliminary clinical reports, pre-clinical models and mechanistic characterisation. No randomised controlled trial has been published.²³⁴

Read every study

A gloved hand holding the round disaggregation grid of the single-use device. — The disaggregation grid of the single-use device

Diagram: joint trauma or overuse drives chondrocytes to release IL-1 and TNF-alpha, increasing MMP production, collagen destruction and synovial irritation — Osteoarthritis pathogenesis as summarised in the manufacturer’s brochure, after Burrage et al. 2006: cytokine-driven MMP production degrades the cartilage matrix

Diagram of the manufacturer’s proposed mechanism: cells in the suspension releasing soluble factors that counter TNF-alpha and IL-1 signalling and MMP production — The manufacturer’s proposed mechanism, as drawn in its brochure. A rationale, not clinical evidence

References

1.Viganò M, Tessaro I, Trovato L, et al. Rationale and pre-clinical evidence for autologous cartilage micrografts in cartilage repair. 2018. View source
2.Marcarelli M, Zappia M, Rissolio L, et al. Cartilage micrografts as a novel non-invasive and non-arthroscopic autograft procedure for knee chondropathy: three-year follow-up. J Clin Med. 2021;10(2):322. View source
3.Tsoukas D, Muntean I, Simos C, Sabido-Vera R. Prospective observational study of a non-arthroscopic autologous cartilage micrografting technology for knee osteoarthritis. Bioengineering. 2023;10(11):1294. View source
4.Helito CP, Pessei V, Zaniboni C, Muntean I, et al. Efficacy of autologous micrografting technology in managing osteoarthritis pain: a pilot study. Bioengineering. 2024;11(11):1119. View source

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