Galmed Pharmaceuticals’ wholly owned subsidiary Colospan has completed a feasibility study evaluating a new intraoperative platform for the assessment of colon tissue quality.
The first-in-human, proof-of-concept clinical trial enrolled 32 patients undergoing elective colorectal cancer surgery at three hospitals in Israel.
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The study successfully demonstrated the technical feasibility of quantitatively measuring colon tissue compliance ex vivo, with measurements completed in all patients and no recorded failures or procedure-related technical problems.
This development is intended to support the creation of a new intraoperative device aimed at giving surgeons objective, quantitative information on colon tissue quality during surgical procedures.
The technology is designed to deliver real-time data on the mechanical properties of colon tissue.
The information could contribute to surgical planning by assisting in the identification of tissue characteristics relevant to the formation of a colorectal anastomosis.
Colospan also indicated such measurements might help to identify patients at greater risk of developing Low Anterior Resection Syndrome (LARS).
Galmed Pharmaceuticals president and CEO Allen Baharaff said: “The acquisition of Colospan was driven by our conviction that the company represents far more than a single-product opportunity. We recognised an innovation platform with deep scientific expertise, a differentiated technology portfolio and the ability to develop multiple solutions addressing significant unmet needs in colorectal surgery.
“The data we are publishing today support our belief that Colospan’s engineering concepts have the potential to transition effectively into real-world clinical use. We believe that the data give Colospan a strong foundation for the continued development of the platform and support our plans to advance toward future clinical trials and regulatory submissions.”
Colospan’s lead product, CG-100, is a device aimed at protecting colorectal anastomoses.
CG-100 has received FDA breakthrough device designation and CE mark, and is available for investigational use in the US under an FDA-approved IDE, but is not commercially approved in the country.
