A biodegradable antibiotic-delivery device developed by Israeli biotech company GentaGel helped eight of ten diabetic patients who were candidates for foot amputation avoid the procedure in a small clinical pilot conducted at Shaare Zedek Medical Center in Jerusalem, according to information provided by the company.
Israeli biotech GentaGel reports 8 of 10 amputation-candidate diabetic patients avoided procedure in small pilot
A biodegradable antibiotic-delivery device developed by Israeli biotech company GentaGel helped eight of ten diabetic patients who were candidates for foot amputation avoid the procedure in a small clinical pilot conducted at Shaare Zedek Medical Center in Jerusalem, according to information provided by the company.
The device uses a biodegradable polymer that is placed at an infection site and gradually releases antibiotics locally for up to 60 days, according to GentaGel. Conventional antibiotic treatments administered orally or intravenously circulate throughout the body, with only part of the medication reaching the infection at the concentration required for treatment.
The pilot enrolled 10 patients with severe infected diabetic foot ulcers and bone infections who were candidates for either amputation or removal of infected bone. Eight of those patients recovered without requiring amputation; wound closure and bone regrowth were observed in the same eight patients.
The pilot was conducted through a collaboration between GentaGel and Shaare Zedek's innovation arm, Madait. GentaGel said it is now advancing additional studies in Israel and the United States and pursuing a regulatory pathway with the US Food and Drug Administration.
The underlying technology was invented by Prof. Avi Domb, described by the company as a former chief scientist and former head of the School of Pharmacy and the Institute for Drug Research at the Hebrew University of Jerusalem, who 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 it estimates the direct cost of treating severe localized infections in the United States at more than $20 billion annually and described potential markets for applications of its technology as worth tens of billions of dollars, without providing a source for either figure.
- The source does not state the specific antibiotic or antibiotics used in the GentaGel device.
- The source does not identify a control group or describe the trial's design beyond its size and patient profile.
- The source does not provide the source or methodology behind the company's estimate of more than $20 billion in annual US treatment costs.
- The source does not state the source or methodology behind the company's claim that potential markets are worth tens of billions of dollars.
- The source does not state a timeline for the planned follow-up studies in Israel and the United States.
- The source does not include any independent scientific or regulatory assessment of the pilot's findings.
Read the original at The Jerusalem Post