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Global Regenerative Trade

Global OrthoBiologic, Inc. announces Manufacturing Agreement with Quality Precision Technology!

Quality Precision Technology (QPT) has signed a contract manufacturing agreement with Global OrthoBiologic, Inc. (GOB). GOB and other medical device companies represent customers that are an essential part of the medical community vision, which is to manufacture cutting edge medical devices and technologies that will be successful by being used in innovative yet common, high volume medical applications.

Quality Precision Technologywill manufactureGOB products and technologies developed by the Joint Venture with “MBSI” and its own R&D subsidiary “Global LIFE”.

Randy Beimel (GOB President) Through our extensive travel and business relationships around the world, GOB has identified a huge demand for EU R&D and manufacturing to offerto non EU medical technology companies an opportunity to successfully introduce their products into the EU under the strict guidelines of European UnionLaw in order to successfully develop the market for their products through the GOB physician and distribution network.”

The analysts have forecast the global regenerative medicine market to grow at a CAGR of 20.7% during the period 2016-2020. According to the 2016 report, a key growth driver for the regenerative medicine market is the increased focus on cell therapy products. There are more than 40 approved cell therapy products in the market. Most small and large biotech companies are working on various cell types such as progenitor cells, adult and embryonic stem cells, and iPSCs. Cell therapies are our own body products (such as regenerative cells) that can turn into other types of cells within the body. For this reason, surgeons use regenerative cells to speed the healing of bodily tissues including bone, muscle, cartilage, ligament and tendon. When a patient’s own regenerative cells are used in high concentration they may help promote faster healing and better outcomes. These cells have proved their efficacy in the treatment of chronic heart failure, cancer, diabetes, bone fractures, spine fusions, soft tissue healing, and many other procedures.

Most cell-based immunotherapy trials are conducted in the US and European countries. The scope of cell therapy products is widening with around 300 companies and many institutes conducting more than 1,900 clinical trials around the world. Regulatory approval of products is likely to further boost its demand and augment market growth during the forecast period.

James Laird (QPT President) “Quality Precision Technology provides high quality machining solutions to carry out all needs in the: water distillation, hydraulics, oil, electronics, telecommunications, aerospace, and semi conductor industries. Equipped to design and produce everything from prototype components to fully assembled machines and equipment. Capable of handling small and medium batch work as well as repetitive orders to meet the exacting demands of the customer. Quality Precision Technology is excited to expand their manufacturing expertise into the cutting edge sector of medical devices for use in cell therapies. The use of cell therapies is one of the fastest growing segments in medical technologies and Quality Precision Technology, through their partnership with GOB intends to capitalize on it.”

 

About Quality Precision Technology

Established in 1983, Quality Precision Technology Ltd (QPT) has become a strategic supplier of PCB assembly’s and full turnkey solutions to a wide range of Blue Chip companies. Accredited with ISO 9001-2008 and currently engaged in receiving ISO 13485. Backed up by our own in house IPC Training School, we place quality of product and on time delivery as our priority goals whilst being price competitive at the same time. We work very closely with our customers at the design stage to make sure that all design for manufacture issues are addressed. Our customer base are involved in a wide range of activities such as Oil and Gas – Sub sea and Topside Equipment, Satellite Communications, Railway Communications, Diving and Sub sea Acoustics, IC Development and Laser Products.

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.