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REPORT T&R Biofab Signs Agreement for Exclusive Distribution of Orbital Patient- Specific Implants DATE : 2023.02.28 VIEW : 1774

- A biodegradable product customized to individual patients by 3D printer -

 

 

T&R Biofab (246710, CEO Won-soo Yun), a company specializing in regenerative medicine, announced that it has signed a supply agreement with Johnson & Johnson Medical Korea, for its 3D bioprinted patient-customized implant products (Product name: TnR PSI Plus, T&R PSI Plus). 

 

'T&R PSI Plus' is a patient-specific implant (PSI) for patients with fractures and injuries in the maxillofacial region. The core materials are PCL (polycaprolactone), a US FDA-approved biodegradable polymer, and Beta-TCP (beta-tricalcium phosphate), both well-documented in various clinical applications and case studies for their safety, biocompatibility, biodegradability, and in inducing new bone growth as well as other tissues, like cartilage. 

 

‘T&R PSI Plus’ is a customized implant optimized for each patient's injury site specifications, designed using the patient's derived CT data and manufactured using ultra-precise 3D bioprinting technology. The implant is designed to capture complex defects and anatomical features, reducing unnecessary manipulations in the bone during surgery and providing a better fit and comfort for the patient. Since the product launch in 2014, surgeons have attested to its benefits in improving surgical accuracy and shortening surgery time. In addition, the biodegradable nature of the implant associated to its gradual replacement by the patient’s own tissue, in other words, autologous tissue, greatly reduces the risk of long-term side effects associated with traditional implants, such as severe inflammatory responses.

 

"We are very pleased with the recognition of our technology and product quality. It is of great significance that we have signed the first supply contract of PSI" said Dr. Won-soo Yun, CEO of T&R Biofab. 

 

T&R Biofab received a Level 4 medical device license from the Ministry of Food and Drug Administration in 2014 for T&R PSI Plus, and has been a trusted provider in best hospitals in Korea. Moreover, in cooperation with leading medical institutions and authorities in US, Poland, and Ukraine, T&R Biofab recently supplied ‘T&R PSI Plus’ implants as humanitarian aid to treat injured patients from the ongoing Ukraine war, contributing to life-changing treatments on a global scale. 


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Privacy Policy

Privacy Policy

T&R Biofab Co., Ltd. (hereinafter “Company”) protects the personal information of the information supplier pursuant to Article 30 of the Personal Information Protection Act and establishes and discloses the personal information handling guideline as follows to promptly and efficiently handle the difficulties relating to such. ?

1Objective of Personal Information Handling
Company handles personal information for the following objectives. The personal information handled is not used for any purpose other than the following objectives, and in the event the objective of use changes, necessary measures, such as obtaining a separate consent pursuant to Article 18 of the Personal Information Protection Act, will be taken.
  • ① Personal identification pursuant to the use of service and confirmation of real name
  • ② Procurement of communication channel for additional survey relating to product administration and delivery of medical information relating to the products
  • ③ Handling of consumer complaints
  • ④ Product research and development and improvement
2Personal Information Handling and Retention Period
  • ① Company handles and retains personal information within the personal information retention and use period consented by the information supplier at the time of gathering the personal information or the personal information retention and use period pursuant to laws.
  • ② Each of the personal information handling and retention period is as follows.
    1. Personal identification pursuant to use and confirmation of real name: 3 years
    2. Records on consumer complaints or settlement of disputes: 5 years from the termination date of handling the dispute
    3. Cases relating to product administration and medical information relating to the products: 5 years
    4. Product research and development and improvement: Until the achievement of the objective (for product research and development and improvement, only abstract information that cannot specify an individual after 5 years have passed may be retained)
3Rights and Obligations of Information Supplier and Exercising Method
  • ① The information supplier may exercise the rights relating to personal information protection in the following sections at any time against Company.
    1. 1. Demand to access personal information
    2. 2. Demand to make correction when there is an error
    3. 3. Demand for deletion
    4. 4. Demand for suspension of handling
  • ② The exercise of rights pursuant to Clause 1 may be performed against Company through writing, email, or fax pursuant to the form in Exhibit No. 8 of the Enforcement Regulation of the Personal Information Protection Act, and Company shall take measures regarding such without delay.
  • ③ In the event that the information supplier demands for correction or removal regarding an error in the personal information, Company shall not use or provide the concerned personal information until the correction or removal is complete.
  • ④ The exercise of rights pursuant to Clause 1 may be performed through an agent that has been consigned or a legal representative of the information supplier. In this case, a power of attorney pursuant to the form in Exhibit No. 11 of the Enforcement Regulations of the Personal Information Protection Act must be submitted.??
4(Items of Personal Information Handled
Company handles the following personal information items.
  • 1. Personal identification and provision of service relating to products ?Name, address, phone number, email address, and occupation
  • 2. Other than that, the below personal information items may be automatically generated and collected in the course of using the service through the internet. IP address, cookie, MAC address, service usage records, visit history, poor usage records, etc
5Destruction of Personal Information
  • ① Company destroys the pertaining personal information without delay when the personal information is deemed to be no longer necessary, such as when the objective of handling has been achieved or the personal information retention period has lapsed.
  • ② In the event of having to preserve personal information pursuant to other laws, despite of achieving the objective of handling or the lapse of the personal information retention period consented by the information supplier, the pertaining personal information is preserved by transferring to a separate database or by using a different storage place.
  • ③ The personal information destruction procedure and method are as follows.
    1. 1. Destruction procedure
      Company selects the personal information with a cause for destruction, and destroys the personal information by obtaining the approval of the personal information protection manager of Compan
    2. 2. Destruction method
      Company destroys personal information recorded or stored in an electronic file form so that the record may not be regenerated, and destroys personal information recorded or stored in a paper document through incineration or shedding in a shredder.
6Personal Information Safety Procurement Measures
Company takes the following measures to procure safety of personal information.
  • 1. Managerial measures: Establishment and implementation of internal management plans, regular employee training, etc.
  • 2. Technical measures: Installation of security program, encryption of matters such as unique identifier, installation of access control system, and management of access authority
  • 3. Physical measures: Access control such as to the data processing room or data storage room
7Personal Information Protection Manager
  • ① Company designates a personal information protection manager as below to take responsibility by controlling the work regarding the handling of personal information and to provide relief for damages and handle complaints of the information supplier relating to the handling of personal information. ?
    1. Name : Kim, Young-phill ?
    2. Affiliation : Administration Division
    3. Contact Information : 031-431-3344, ypkim@tnrbiofab.com
  • ② The information supplier may make any inquiries to the personal information protection manager for matters regarding damage relief, complaint processing, and any matters relating to personal information protection occurring while using the service of Company. Company will respond and handle the inquiries of the information supplier without delay.
8Modification of Personal Information Handling Policy
  • ① This Personal Information Handling Policy shall be applied from Jun 01, 2017.
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Rejection of unauthorized collection of email addresses

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