MyStem allows surgeons to obtain an autologous graft
fraction rich in regenerative components. The disposable kit works performing a
single-step intra-OR autologous tissue minimal manipulation using
a GMP-in-a-box concept. Further USP - Adult Stem cells in Tissue
Regenerative Fraction accelerates healing processes more than any other product
available. MyStem has a proprietary kit that collects and concentrates regenerative
fraction without extensive manipulation in only 10 – 15 minutes. MyStem is
simple, no centrifuge needed, quality sampling is not operator dependent, up to
1000 times more than the bone marrow MSC + Growth Factors.
between non-centrifuged and centrifuged stromal vascular fraction cells is that
centrifuged SVF cells requires a pre-filtering phase after enzymatic digestion
(see Zuk protocol) otherwise debris goes down into pellet due to centrifugaton
but microfiltrated cell fraction (MyStem) is purified from debris, RBCs (Red
Blood Cells) and further concentrated using MyStem kit components.
Shelf life of
the product is 5 years.
MyStem is a
Class IIA medical device for Autologous stromal tissue graft fractioning.
MyStem is FDA cleared and CE certified. The device was designed to and
actually comply with current EMA Regulation (i.e. Minimal Manipulation,
Intra-OR, Autologous Use).
MyStem is looking for a distributor or
even more a suitable strategic partner
· have a
regenerative medicine products portfolio
· have direct
access to the relevant market segments (see below)
· has own
sales or a reliable distribution network
· can sell
a relevant quantity within the target market
· will sign
a distribution contract with binding quantities / turnover
Manufacturer or strategic partner:
willing to add MyStem to its product portfolio (as distributor,
private label, OEM or licensing)
sign a co-operation contract with binding turnover (or similar economic
cover several markets (regional and/or target segments)
· might add
his products to the MyStem portfolio
· might be
investing in MyStem
We are open to discuss various forms from Global Distribution,
Licensing/OEM and beyond.
Target Market Segments
There has to be experience in OrthoBiologics (something like
Synthetic Bone Augmentation Grafts, Bone Paste, Bone Cement, etc.) Targets include hospitals, clinics and specialized
practitioners with a focus on surgery, orthopedics, spine, wound healing,
severe burns treatment, dentistry, aesthetic/plastic surgery, sports,
Further use can be OA knee/hip/small joints, tendonopathy, bone
growth enhancement, burns, chronic ulcers, skin rejuvenation, hair regrowth.
Limited is an EU-estabilished privately held company with his focus on
Regenerative Medicine medical devices. We are focused on Adipose tissue as preferred source of regenerative components for
Our company develops and markets a proprietary single-use medical device for Non-Enzymatic Adipose SVF cells selection and concentration in an
intra-operatively set-up (GMP-in-a-box concept). MyStem X2 is currently used from surgeons of various
specialties in several countries all over the world for treating various
diseases with a cell suspension local application.
Our vision to provide effective, evidence-based regenerative treatments to as
many patients is possible let us focus on non-surgical effective treatments
like AdMsc-Conditioned Medium protocols.
found out that the fat harvesting phase is a major obstacle to a broader usage
due to surgery downtime and procedure time (clinic check-in, examinations,
surgery time, etc) therefore a non surgical regenerative treatment will be
better accepted by both surgeons and patient.