Platform

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Proprietary best-in-class manufacturing platform for Mesenchymal Stem Cells

 

StemMedical’s core manufacturing competencies are focused on producing and expanding very high quantities of potent and affordable MSCs.

StemMedical can produce and harvest 12-16 billion ASCs from 100 ml of adipose tissue over 2 weeks using a scalable 3D cell culturing process instead of a manual non-scalable 2D cell process over several more weeks (as is currently industry standard).

Production takes place at our production facility outside Copenhagen. To expand capacity, blueprints have been made for a 2,500 sqm manufacturing site, designed for Good Manufacturing Practices (GMP) readiness, and with a planned capacity of over 7.000 batches per year. Work is currently in preparatory stage.

The StemMedical platform has several potential applications

— The StemMedical mesenchymal stem cell platform has potential applicability across a broad range of indications
— The platform is already applied and launched in a commercial pilot in cosmetic surgery
— The next launch areas will be in reconstructive surgery followed by osteoarthritis of the knee
— StemMedical is seeing external interest in wound healing and skin burns, opening up the possibility of future launches in these indications
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StemMedical has overcome the 3 key challenges preventing effective stem cell-based therapies from reaching patients

Manufacturing

Produce enough cells at positive margin

(most struggle with producing enough cells even for trials)

Cell Therapy Space:

<0.1 billion MSCs per patient

StemMedical:

>12 billion MSCs per patient.

Clinical evidence

Demonstrate medical effect

(despite numerous trials, strong clinical results are in short order)

Cell Therapy Space:

Just 18 published results out of +1100 trials1

StemMedical:

Doubling of fat graft retention breakthrough published in Lancet.

1) As of 2020, and mainly in cardiology, osteoarthritis and neurology

Regulatory

Obtain regulatory clearance

(very few cell therapies approved)                               

Cell Therapy Space:

One MSC-based therapy approved in EU2,3,4 and zero in US2

StemMedical:

Several European countries has given regulatory clearance

 2) As of May 2023 3) Alofisel (Takeda) 4 ~25 MSC-based therapy approved outside US/EU jurisdiction as of May 2022, typically just in single countries
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