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Global Regenerative Trade

GOB joint venture with MBSI

Lutry, Switzerland (October 10, 2016)

Global OrthoBiologic Inc. (GOB), a leader in regenerative medicine currently doing business in 30 countries, announces a strategic Joint Venture with MBSI Medical Biobank Swiss Institute Group, a leader in stem cells and regenerative medicine.  This partnership will create a strong alliance between GOB and its global distribution network and its applied research centers based in Slovenia.

MBSI brings,through its companies,more than 19 years of expertise in stem cell technologies and has developed a variety of therapies mainly in orthopedics.

About Medical Biobank Swiss Institute- MBSI

MBSI Medical Biobank Swiss Institute SA is a Swiss holding company, formed in 2013. MBSI has acquired three companies, Educell, CELL/TRY and Biobanka. The seat of the company is in Lutry (Canton of Vaud). Biobanka was established in 2008 and its main activity is collecting, processing, storing and distributing:

  • Human cord blood,
  • Cord tissue,
  • Cells from fat,
  • Mesenchymal Stem Cells – MSC from bone marrow and cord tissue,
  • Hematopoietic Stem Cells –HSC from bone marrow, and peripheral blood
  • Dental Pulp Stem Cells DPSC.

These stems cells have great potential of regeneration and therapeutic use. Currently, Biobanka products and services are sold mainly in Slovenia but new markets in Europe and South-East Europe are currently being addressed. Biobanka is approved by the Slovenian Agency for Drugs and Medical Devices for the cryopreservation of a broad spectrum of tissues and cells.

Educell Ltd is a company focusing on development of cell therapy products and is a registered Cell and tissue establishment. The origins of Educell Ltd date back to July 1997, when the company was founded with the goal of introducing cell therapy and tissue engineering to human medicine. The company is preparing cell therapy products for treatment of articular cartilage, vesicoureteral reflux, regeneration of bone tissue and treatment of immunological disorders, which are all being used at University Medical Centre Ljubljana and other clinical institutions in Slovenia. More than 300 patients with damaged knee cartilage have been treated with Educell’s products CHONDROARTTM, which is based on patient’s autologous chondrocytes or mesenchymal stem cells. R&D department focuses on development of innovative cell therapy products for clinical applications for regeneration of cartilage, bone, intervertebral disc, soft tissues and immune diseases such as GvHD and Crohn’s disease. R&D department is also developing medical devices that enable stem cell isolation and application in the surgical theatre. Educell has developed a new kit that separates fat from stem cells and could be applied during the same surgery. Along with the development of novel products, the existing products are subjected to continuous improvements. Various patent applications under PCT have been filed for innovative products. Educell collaborates with several research institutes and clinics. Educell has been participating in several national, as well as European projects: it participated as a scientific coordinator in the EU project FP5 and FP6. In addition to expertise in:

  • Cultivation of primary cells and biobanking,
  • Tissue engineering technologies,
  • And QA and QC methods related to preparation of cell products for medical use,

Educell R&D utilizes several state of the art technologies and analytic methods e.g. quantitative RT-PCR and immunohistochemistry.

CELL/TRY is a spin-off of Educell and is offering functional tests for preclinical research of medical devices and drugs. This company is dedicated to development of testing procedures, based on human primary cells. Cell/Try is also testing biomaterials which are also used in stem cell therapies. This company acts as a scientific and technical support to Educell.

Dr. Jean-Luc Centeleghe (MBSI President), “This Joint- Venture should reinforce MBSI by offering specific products to GOB. Moreover our scientific team, with more than 19 years of activity in stem cells should bring GOB a strong asset and develop proprietary products in order to provide GOB a bench to market opportunity.MBSI should act as the applied Research Centre of GOB and our scientific team should integrate the GOB Center of Excellence.”

Dr. Miomir Knezevic (MBSI Scientific Officer), “Collaboration with GOB is an opportunity to globalize regenerative medicine technologies carefully developed and clinically tested to a broader market. Stem cells and cell therapies are the future of regenerative medicine and great opportunity for all of us.”

Randy Beimel (GOB President). “The joint venture with MBSI gives GOB a proven scientific team to complete our vision of offering the best medical devices and protocols for regenerative medicine in the world today. It’s all about the science! MBSI will independently verify which medical devices are the best, develop new cutting edge innovative devices which GOB will globally distribute, and bring proven medical devices & protocols from around the world to Europe, recreate under EU law and introduce to the European market.”

Kalervo Pesso (GOB Managing Partner Europe) The Global Academy consists of physicians from around the globe that depends on the GOB Physician and Scientific Advisory board to provide the latest most advanced treatments using regenerative medicine. The scope of expertise ranges from Orthopedic, Chronic Wound Care, Spinal Cord Injuries, Neurological disorders and aesthetic medicine. The Joint Venture with MBSI gives GOB a scientific team led by Dr. Miomir Knezevic, a pioneer in cell therapy and tissue engineering with 25 years experience the ability to successfully support the Global Academy & The GOB Centers of Excellence around the globe.

About Global OrthoBiologic (GOB) Global OrthoBiologic, based in Miami Florida, invests, identifies, develops and markets ground-breaking medical technologies related to Regenerative Medicine in the global market. Global OrthoBiologic is a privately-held medical technologies company specializing in therapies that significantly enhance the body’s natural healing ability. The company has developed extensive experience in the most advanced medical device industries. In the past several years, the emphasis has been focused exclusively on Regenerative Medicine and stem cell technologies, products, and therapies. The technologies for stem cells are cutting edge, safe, clean and do not use any additives, enzymes, or require culturing or growing of cells. Global OrthoBiologic consults with medical technology companies that are startups and/or companies looking to expand and grow their business. Global OrthoBiologic has built a comprehensive network of experts in Europe, South America, Middle East, Asia, and Australia. The company partners with recognized medical facilities worldwide for evidence-based clinical medicine. Global OrthoBiologic has additional sales offices in Sofia, Bulgaria and Dubai, UAE, as well as a distribution center in Amsterdam, Netherlands.

Vivostat Logo

THE VIVOSTAT® SYSTEM

The uniqueness of the Vivostat® system is a novel patented biotechnological process that enables reliable and reproducible preparation of autologous Fibrin Sealant or Platelet Rich Fibrin (PRF®) without using cryoprecipitation and without the need for a separate thrombin component.

THE FULLY AUTOMATED VIVOSTAT® SYSTEM CONSISTS OF THREE COMPONENTS:

  • The Processor Unit is a non-sterile, reusable, fully automated device that controls the biochemical process.
  • The Processor Unit is used to process the patient’s blood and prepare the Vivostat® Fibrin Sealant or Vivostat PRF® solution.
Vivostat Processor Product
  • The Processor Unit is operated by a single button and a display keeps the nurse informed of the remaining process time and status at all times. No specific installation is required and the large wheelbase makes moving it easy.
  • The Processor Unit can be located in any room or corridor in the operating department. It is most often placed centrally between the operating theatres. This way one Processor Unit can supply a number of operating theatres.
  • In approx.  25 min a concentrated fibrin sealant or PRF® solution is prepared from the patient’s whole blood.
  • The Applicator Unit is a non-sterile, reusable, fully automated device that controls the delivery of the Vivostat® Fibrin Sealant or Vivostat PRF®.
Vivostat Processor Product
  • The large display and integrated microprocessor automatically primes the Spraypen® and informs the surgeon of the remaining volume of fibrin sealant/PRF® throughout the entire process.
  • Different spray modes can be selected depending on the actual procedure or area to be covered. Like the Processor Unit it has a large wheelbase and can easily be moved if required.
  • The disposable set comprises of two parts: A Preparation Kit used to prepare the fibrin sealant or PRF® solution before surgery, and an Application Kit used to activate and apply the fibrin sealant/PRF® solution.

 

  • Preparation Kit
    The Preparation Kit contains the specially designed Preparation Unit – a sterile disposable device in which the patient’s blood is collected, the biochemical process carried out, and the fibrin sealant or PRF® solution harvested.

 

  • The Application Kit
    The Application Kit contains the Spraypen®1 and all other items required to prepare the system for the delivery of the fibrin sealant or PRF® solution. The Spraypen® is a sterile, disposable, hand held device which delivers the fibrin sealant or PRF® solution to the tissue. The revolutionary and patented design offers the surgeon unparalleled freedom in controlling the application unlike any other product on the market today.

 

1Besides the Spraypen®, the Vivostat® system offers different types of applicators, e.g. the Endoscopic Applicator. For a full list of application devices click here

1-2-3 Spray

Three easy steps to prepare Vivostat® Fibrin Sealant or Vivostat PRF®

1. Draw blood from the Patient

Fibrin Prep With Blood Inside

At the time of surgery or up to 24 hours before1, citrate (supplied with the kit) is added to the Preparation Unit. 120 ml of the patient’s own blood is then drawn into the same unit.

2. Process the patient’s blood

Vivostat Processor 800

The Preparation Unit is placed in the Processor Unit. At the touch of a button the process starts; after approx. 25 minutes, an autologous fibrin or PRF® solution is ready for use. No thrombin or bovine components are added to the blood at any time.

3. Load the Applicator Unit and spray

Vivostat Display Applicator

The Fibrin or PRF® solution is easily loaded into the Applicator Unit and applied to the surgical site using one of the unique application devices (e.g. the Spraypen). 1This depends on the type of kit being used. Always consult the “Instructions for Use” supplied with the kit to determine the correct preparation.

The following video illustrates how to prepare and apply autologous fibrin sealant.

Presentation DVD from Vivostat A/S on Vimeo.