An Israeli-developed technology that delivers antibiotics directly to severe infection sites helped eight out of 10 diabetic patients who had been considered candidates for foot amputation avoid the procedure in a clinical pilot at Jerusalem’s Shaare Zedek Medical Center.
The technology, developed by Israeli biotech company GentaGel, uses a biodegradable polymer to release antibiotics gradually at the site of an infection for up to 60 days, according to information provided by the company.
The small clinical pilot included 10 patients suffering from severe infected diabetic foot ulcers and bone infections who were candidates for either amputation or removal of infected bone. Eight recovered from their infections without requiring amputation, while wound closure and bone regrowth were observed in those eight patients.
The findings are preliminary, and the company is now advancing additional studies in Israel and the United States while pursuing a regulatory pathway with the US Food and Drug Administration.
Diabetic foot infections can be particularly difficult to treat and, in severe cases, can lead to repeated surgery, long hospital stays, and amputation.
GentaGel delivers antibiotics directly to infected areas
Traditional antibiotic treatments are generally administered orally or intravenously, meaning the medication circulates throughout the body while only part of it reaches the infection at the concentration required for treatment.
GentaGel’s approach is designed to deliver the antibiotic directly into the infected area.
Its biodegradable polymer remains at the treatment site and gradually releases the medication, allowing doctors to maintain a high local concentration of antibiotics for an extended period while reducing exposure elsewhere in the body. The technology can release medication for up to 60 days.
The company said the approach could potentially be used for diabetic foot infections, orthopedic infections, chronic wounds, and other localized internal infections.
‘Real potential’ to treat infected bone
The pilot was conducted through a collaboration between GentaGel and Shaare Zedek Medical Center through Madait, the hospital’s innovation arm.
Dr. Mati Nof, director of the Foot and Ankle Surgery Unit at Shaare Zedek and the study’s principal investigator, said the purpose of the trial was to examine whether GentaGel’s treatment could help doctors treat infected bone.
“Based on the findings from the pilot with 10 patients, I became convinced that there is real potential to heal infected bone without the need for amputation,” Nof said.
Dr. Renana Ofan, CEO of Madait, said Shaare Zedek works with start-ups on early-stage validation studies and clinical trials.
“We are proud of the companies participating in our program and pleased to see their technologies progress, and to be part of the process of advancing innovation for the benefit of patients,” she said.
The technology was invented by Prof. Avi Domb, a former chief scientist and former head of the School of Pharmacy and the Institute for Drug Research at the Hebrew University of Jerusalem.
Domb specializes in controlled drug-delivery systems. GentaGel is led by co-founder and CEO Dr. Ariel Orbach and co-founder and COO Eli Lerner.
The company said severe localized infections represent a major medical and economic burden. It estimated the direct cost of treating such infections in the US at more than $20 billion annually and said the potential markets for applications of its technology are worth tens of billions of dollars.
The results of the 10-patient pilot do not by themselves establish how effective the treatment would be across a larger patient population. GentaGel’s planned follow-up studies in Israel and the US are expected to provide additional data as the company moves toward regulatory review.