MyStem

from Pier Ivona
Company Name: MyStem Limited
Product Categories:
  • Medical
Opportunities:
  • Distributor
  • Reseller
  • Sales Agent
Target Markets:
  • Worldwide
  • Africa
  • Asia Pasific
  • Central America
  • Eastern Europe
  • Middle East
  • North America
  • South America
  • Western Europe
  • Canada
  • China
  • France
  • Japan
  • South Africa
  • United Kingdom

The Product

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.

The difference 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 G-force. Non-centrifuged 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). 

The Opportunity

MyStem is looking for a distributor or even more a suitable strategic partner

Distributor:

·         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:

·         be willing to add MyStem to its product portfolio (as distributor, private label, OEM or licensing)

·         will sign a co-operation contract with binding turnover (or similar economic advantage)

Options

·         might 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, veterinary medicine.

Further use can be OA knee/hip/small joints, tendonopathy, bone growth enhancement, burns, chronic ulcers, skin rejuvenation, hair regrowth.

The Company

MyStem 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 clinical 
applications. 
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. 

 

We 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.