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Global Regenerative Group & Kanfit3D Enter Into Distribution Partnership

Pleased to announce a new distribution partnership between Global Regenerative Group, a
company which has developed extensive experience in the most advanced medical device industries,
and Kanfit3D.
Boca Raton, FL, September 05, 2019 –(PR.com)– Kanfit3D offers the quick and cost-effective
production of high-quality patient-specific implants and disposable surgical instruments. It delivers
tailor-made, flexible solutions for the medical industry, including orthopaedic applications. Global
Regenerative Group will be the distributor of Kanfit3D products in the USA, Eastern Europe, Russia and
the Balkans.
According to Zachy Shtamler, Co-Founder and COO of Kanfit3D, “For our company, partnering with
Global Regenerative Group for distribution of our products means business development, growth in the
world of medical technology, and most importantly, greater customer access to us in the US, Eastern
Europe, Russia and the Balkans. Global Regenerative Group are a company that has proven itself in the
field of Regenerative Medicine and we will work together to reach new heights in meeting patient needs.
At Kanfit3D, we believe that engineering and technology can be used even more effectively in the
healthcare arena to benefit individual patients.”
“Our principal is to satisfy the customer by providing our best services. This partnership will surely help
us enhance and enrich our business and also provide newer services. The Global Regenerative Group
strives daily to improve both the quality and variety of the products and services that we provide. Our
support of Kanfit3D is another example of our commitment to help improve the quality of performance in
the products we service,” states Mihail Blagoev, Vice President of Global Regenerative Group.
Kanfit3D offers the latest in hybrid manufacturing using EOS M 290 – the leading system for tool-free
direct manufacturing in titanium (Ti-64) metal. Kanfit3D utilizes the latest manufacturing technologies to
achieve precision and accuracy in order to meet the top-most international standards.
Orthopaedic and spinal surgeons will benefit from immediate access to point-of-care, patient-specific 3D
printing in hospitals via an on-site 3D printing laboratory, as well as support from medical 3D printing
company.
The automated, patient-specific printing platform will reportedly allow clinicians to dedicate more time to
focus on patient care, while providing customized models for use in pre-operative planning and in
achieving patient consent.
For the design and production of patient-specific medical devices, Kanfit3D uses only EU certified
biocompatible materials and state-of-the-art design and manufacturing technologies. Using Computer
Aided Design (CAD) software, 3D computer models of the required object are created. These are
uploaded into the metal printer. Using the models as building instructions, the printer adds a metal
powder layer by layer, each time fusing the layer into solid metal with a high-power laser. In this way,

complete 3D objects or, in our case products, are constructed by the printer.
Global Regenerative Group was established to share groundbreaking medical technologies for use in
therapies that significantly enhance the body’s natural healing ability. During the last decade the company
has developed extensive experience in the most advanced medical device industries. In the past several
years, the company’s emphasis has been focused exclusively on Regenerative Medicine, such as stem cell
technologies, products, and therapies.
The company provides business development for medical device companies with an emphasis on
Regenerative Medicine technologies and works extensively with clinics, hospitals and medical facilities
that are engaged in Regenerative Therapy.
Global Regenerative Group has built a comprehensive network of experts in Europe, South America,
Middle East, Asia and Australia. The company also organizes and facilitates scientific conferences and
workshops to lecture about the latest developments, innovations, and breakthroughs.

Global Regenerative Group
Mihail Blagoev
Vice President
Email: blagoev@globalregenerative.group
Cell: +1 305 988 8996

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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.