About Safe Implant Technology

Safe Implant Technology ApS (SIT) is a medical development company that design surface coatings for implantable medical devices. 

Any foreign or non-human material introduced into human tissue triggers a rejection response, which may either go unnoticed or in a substantial number of cases lead to excessive immune reactions impacting on the device’s biocompatibility and the host’s health. Medical-device–related immune reactions may lead to adverse reactions that may range from mere discomfort to life-threatening disease with sequelae. 

To date it is known that such adverse reaction include but are not limited to serious inflammation, fibrosis (eg, capsular contraction of breast implants), loss of tissue integrity and mobility (eg, hernia meshes), device damage (eg, rupture of breast implants and device malfunctioning (eg, insulin pumps). In rare cases, malignant tissue transformation has been reported (eg, breast-implant–associated anaplastic large-cell lymphoma, BIA-ALCL). 

Device encapsulations occur on both soft shell and hard shell medical implants, may progress unnoticed and present themselves only after years (eg, capsular contraction around breast implants and BIA-ALCL) or arise soon after implantation (eg, encapsulation of glucose measurement chips of insulin pumps, clotting of shunts or stents). 

SIT has identified inflammation perpetuating an excessive immunological reaction as the underlying common cause for these adverse reactions and has developed a theory of both preventive and prophylactic coating of the implants that preserves device integrity and function as well as well-being of the implant recipient. 

The composition of matter and the mode of action of GP5, the pioneering product, are patented and exploit well-known and effective mechanisms established for the clinical treatment of autoimmune reactions and diseases. 

In animal studies and human clinical studies of arthritis patients, the foundational product has been optimized and is ready to be used as CC7 for generic surface coating of medical devices irrespective of their surface and composition. CC7 has been shown to suppress excessive immunologic anti-host and anti-device reactions and upon activation of the surface coating establishes a permanent, non-degradable cell-free matrix layer between implant and tissue.   

SIT is currently seeking funding of the next stage of CC7 clinical development which is planned to establish a robust preclinical data foundation for clinical studies in humans, evaluating CC7 and enabling regulatory approval of CC7 under the risk-based regulatory framework established for moderate-risk devices by the U.S. Food and Drug Administration (FDA) and other regulatory authorities world-wide. 

GP5 and CC7 Highlights

  • Proprietary Surface Coating
  • SIT’s technology consists of a medical device surface coating which decreases the immune reaction against an implant post-surgery
  • The coating is a local suppressor of inflammation around the medical implant and surgical site, “hiding” the medical device from the immune system, resulting in lower re-operation rates and a reduction in patient sequelae
  • Post operative complications includes; 
  • Adhesions (tissue to tissue attachments)
  • Capsular contracture (scar tissue hardens and contract)
  • Other potentially serious long-term complications

Team & Board

Søren Luplau-Pagh

MBA

Chairman of the board, Investor relations &
Business development

Henrik Nakskov

MSc, Chemist, HD

Science, Chemistry &
Development

Stephan Braun

MD, PhD

Medical & Regulatory afairs

Morten Olesen

BSc, HA (Financial)

Research & Development

Gorm Danscher

dr.med. Professor emeritus

Member of the Board

Contact us!

Call or email us today.

Our office

Safe Implant Technology ApS
Strandvejen 301, 2.
2920 Charlottenlund
Denmark

Get in touch

+45 31 33 37 42
sit@SafeImplantTechnology.com

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