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Demetra, ForCast Orthopedics, Solenic Medical, and Zimmer Biomet made progress in response to the challenge of Periprosthetic Joint Infection (PJI) this past year.
Commentary in Zimmer Biomet’s release underlined the gravity of PJI’s impact.
Implant-associated bacterial infection or Periprosthetic Joint Infection (PJI) remains one of the most common causes of revision and a challenging complication of total joint arthroplasty (TJA). PJI is estimated to occur in 1-2% of primary TJA procedures and can have serious consequences. In fact, the mortality rate associated with PJI approaches the 5-year mortality observed in breast cancer (11%) and far exceeds that of prostate cancer (1%).
We highlight the technologies that companies are commercializing to prevent or eliminate infection.
Demetra Completes Asset Purchase from Next Science
Demetra, a provider of bone cements, spacers and biomaterials for orthopedic applications and orthopedic infection control, completed a strategic asset purchase from Next Science, developer of technologies designed to reduce the impact of infections in human health.
The addition of these technologies allows Demetra to expand its portfolio of infection management solutions. Osartis, a Demetra company, will take ownership of these assets globally. (Other companies under the Demetra umbrella include Tecres, GetSet Surgical, OrthoFundamentals/Demetra Spine, and OsteoRemedies.)
ForCast Orthopedics Enters Agreement for Antibiotic Infusion Therapy
ForCast Orthopedics and KORU Medical Systems will leverage KORU’s FreedomEDGE infusion system as part of ForCast’s technology platform targeting the treatment of PJI.
KORU Medical develops, manufactures, and commercializes patient-centric, large-volume subcutaneous infusion solutions designed to improve quality of life for patients around the world. The company’s FreedomEDGE pump will provide the infusion technology to support ForCast’s proprietary delivery system for PJI treatment, known as WIIS (Wearable Intra-Articular Infusion System), in anticipation of initiating a clinical trial in 2026.
ForCast’s lead program, FC001, has received both Orphan Drug Designation and Qualified Infectious Disease Program (QIDP) designation from FDA, which enables eligibility for Fast-Track Designation and Priority Review.
In November, FDA granted QIDP Designation for FC002, a second pipeline program for the treatment of PJI. FC002 combines ForCast’s WIIS delivery platform with tobramycin to enable targeted treatment of gram-negative PJI cases.
Successful Use of Solenic Medical Technology via Compassionate Use
Solenic Medical announced the successful, FDA-authorized compassionate use of its investigational Alternating Magnetic Field (AMF) technology. The non-invasive AMF treatment was delivered as an adjunct to surgery in a patient with a serious medical condition involving a PJI.
No device-related adverse events have been reported to date, and ongoing patient monitoring has indicated that the treatment has progressed positively. This case follows the completion of enrollment in Solenic’s human feasibility safety study with collected patient follow-up ranging from six weeks to three months. Again, no device-related adverse events have been reported to date from that study.
FDA’s authorization was specific to this single patient and is not indicative of broader approval or availability. The Solenic AMF technology (Sola2 AMF Knee System) is an investigational device and has not received FDA marketing authorization for commercial use.
Solenic’s AMF technology has been designated a Breakthrough Device by FDA and has the potential to completely replace the two-step revision surgical procedure, which is the current standard of care for chronic infections on medical implants.
Solenic will leverage the unique properties of AMF generated from non-invasive technology to neutralize biofilm on the surface of medical implants. The treatment addresses this major complication of knee and hip replacements, as well as in trauma-related implants such as plates and rods.
Zimmer Biomet Gains PMDA Approval of Iodine-Treated Total Hip Replacement
In September, Japan’s Pharmaceutical and Medical Devices Agency authorized approval for the iTaperloc Complete and iG7 Hip System, the world’s first approved orthopedic implants with Iodine Technology that inhibits bacterial adhesion on the implant surface.
In October, the company announced that FDA granted the iodine-treated total hip system a Breakthrough Device Designation.
iTaperloc and iG7 combine the clinical heritage of the Taperloc Complete Hip and the efficiency and performance of the G7 Acetabular System with Iodine Technology. Iodine is a biocompatible, essential body nutrient that does not cause antibiotic resistance and is commonly used in medicine as an antiseptic. Iodine Technology applies iodine to the implant’s surface during the manufacturing process to inhibit biofilm formation. Iodine’s mechanism differs from antibiotics, so it doesn’t contribute to resistance.
Professor Hiroyuki Tsuchiya, Director at Yokohama Sakae Kyosai Hospital and Emeritus Professor of Orthopedic Surgery at Kanazawa University, developed the technology. He noted that “By integrating a controlled-release iodine layer through advanced anodization and electrophoresis, we created an implant that inhibits bacterial adhesion and biofilm formation during the postoperative period. This innovation combines simplicity and sophistication to help address the issue of PJI after total joint replacement.”
Demetra, ForCast Orthopedics, Solenic Medical, and Zimmer Biomet made progress in response to the challenge of Periprosthetic Joint Infection (PJI) this past year.
Commentary in Zimmer Biomet’s release underlined the gravity of PJI’s impact.
Implant-associated bacterial infection or Periprosthetic Joint Infection (PJI) remains one of the most...
Demetra, ForCast Orthopedics, Solenic Medical, and Zimmer Biomet made progress in response to the challenge of Periprosthetic Joint Infection (PJI) this past year.
Commentary in Zimmer Biomet’s release underlined the gravity of PJI’s impact.
Implant-associated bacterial infection or Periprosthetic Joint Infection (PJI) remains one of the most common causes of revision and a challenging complication of total joint arthroplasty (TJA). PJI is estimated to occur in 1-2% of primary TJA procedures and can have serious consequences. In fact, the mortality rate associated with PJI approaches the 5-year mortality observed in breast cancer (11%) and far exceeds that of prostate cancer (1%).
We highlight the technologies that companies are commercializing to prevent or eliminate infection.
Demetra Completes Asset Purchase from Next Science
Demetra, a provider of bone cements, spacers and biomaterials for orthopedic applications and orthopedic infection control, completed a strategic asset purchase from Next Science, developer of technologies designed to reduce the impact of infections in human health.
The addition of these technologies allows Demetra to expand its portfolio of infection management solutions. Osartis, a Demetra company, will take ownership of these assets globally. (Other companies under the Demetra umbrella include Tecres, GetSet Surgical, OrthoFundamentals/Demetra Spine, and OsteoRemedies.)
ForCast Orthopedics Enters Agreement for Antibiotic Infusion Therapy
ForCast Orthopedics and KORU Medical Systems will leverage KORU’s FreedomEDGE infusion system as part of ForCast’s technology platform targeting the treatment of PJI.
KORU Medical develops, manufactures, and commercializes patient-centric, large-volume subcutaneous infusion solutions designed to improve quality of life for patients around the world. The company’s FreedomEDGE pump will provide the infusion technology to support ForCast’s proprietary delivery system for PJI treatment, known as WIIS (Wearable Intra-Articular Infusion System), in anticipation of initiating a clinical trial in 2026.
ForCast’s lead program, FC001, has received both Orphan Drug Designation and Qualified Infectious Disease Program (QIDP) designation from FDA, which enables eligibility for Fast-Track Designation and Priority Review.
In November, FDA granted QIDP Designation for FC002, a second pipeline program for the treatment of PJI. FC002 combines ForCast’s WIIS delivery platform with tobramycin to enable targeted treatment of gram-negative PJI cases.
Successful Use of Solenic Medical Technology via Compassionate Use
Solenic Medical announced the successful, FDA-authorized compassionate use of its investigational Alternating Magnetic Field (AMF) technology. The non-invasive AMF treatment was delivered as an adjunct to surgery in a patient with a serious medical condition involving a PJI.
No device-related adverse events have been reported to date, and ongoing patient monitoring has indicated that the treatment has progressed positively. This case follows the completion of enrollment in Solenic’s human feasibility safety study with collected patient follow-up ranging from six weeks to three months. Again, no device-related adverse events have been reported to date from that study.
FDA’s authorization was specific to this single patient and is not indicative of broader approval or availability. The Solenic AMF technology (Sola2 AMF Knee System) is an investigational device and has not received FDA marketing authorization for commercial use.
Solenic’s AMF technology has been designated a Breakthrough Device by FDA and has the potential to completely replace the two-step revision surgical procedure, which is the current standard of care for chronic infections on medical implants.
Solenic will leverage the unique properties of AMF generated from non-invasive technology to neutralize biofilm on the surface of medical implants. The treatment addresses this major complication of knee and hip replacements, as well as in trauma-related implants such as plates and rods.
Zimmer Biomet Gains PMDA Approval of Iodine-Treated Total Hip Replacement
In September, Japan’s Pharmaceutical and Medical Devices Agency authorized approval for the iTaperloc Complete and iG7 Hip System, the world’s first approved orthopedic implants with Iodine Technology that inhibits bacterial adhesion on the implant surface.
In October, the company announced that FDA granted the iodine-treated total hip system a Breakthrough Device Designation.
iTaperloc and iG7 combine the clinical heritage of the Taperloc Complete Hip and the efficiency and performance of the G7 Acetabular System with Iodine Technology. Iodine is a biocompatible, essential body nutrient that does not cause antibiotic resistance and is commonly used in medicine as an antiseptic. Iodine Technology applies iodine to the implant’s surface during the manufacturing process to inhibit biofilm formation. Iodine’s mechanism differs from antibiotics, so it doesn’t contribute to resistance.
Professor Hiroyuki Tsuchiya, Director at Yokohama Sakae Kyosai Hospital and Emeritus Professor of Orthopedic Surgery at Kanazawa University, developed the technology. He noted that “By integrating a controlled-release iodine layer through advanced anodization and electrophoresis, we created an implant that inhibits bacterial adhesion and biofilm formation during the postoperative period. This innovation combines simplicity and sophistication to help address the issue of PJI after total joint replacement.”
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
