BETA
Israeli medical-device company developing colorectal surgical technologies, led by the CG-100 intraluminal bypass, and a wholly owned subsidiary of Galmed Pharmaceuticals.
Colospan was incorporated in Israel in December 2010 and is led by founder and CEO Boaz Assaf. Current parent-company disclosures identify its headquarters as Kfar Saba, Israel; it also maintains a U.S. presence in Cambridge, Massachusetts. Galmed Pharmaceuticals completed its acquisition of Colospan on June 22, 2026.
CG-100 is a temporary internal bypass intended to protect a healing colorectal anastomosis and potentially avoid a diverting stoma in selected patients. Colospan reports EU MDR CE marking, Israeli authorization and commercial availability in those markets, while its parent describes an early European rollout. In the United States, CG-100 remains investigational under an IDE; Breakthrough Device designation is not marketing authorization.
The randomized pivotal trial NCT04184973 was listed as recruiting in its July 2026 registry update, with 250 planned participants and estimated completion in December 2026. A separate tissue-assessment platform reached sponsor-reported ex-vivo feasibility testing in samples from 32 surgical patients. Neither early feasibility nor projected cost savings establishes clinical superiority or guaranteed avoidance of a stoma.
FDA IDE study and company-reported Breakthrough Device designation do not authorize U.S. commercial sale. EU MDR CE marking and Israeli authorization are reported separately. [3][5][8][13][14][15]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [17][18]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Single-use silicone sheath placed during colorectal surgery to divert fecal contents internally away from a healing anastomosis. Designed for nonsurgical removal after approximately ten days, subject to clinical assessment. [3][1][8][5][7]
Marketed · regulatory scope variesCompany reports commercial availability in the EU and Israel; regional rollout is early. Investigational only in the United States.
NCT05632744: registry status completed in the 2026-07-02 update; 7 participants (actual). [21]
NCT04184973: registry status recruiting in the 2026-07-06 update; 250 participants (estimated). Study completion is estimated for 2026-12-31; this is not an FDA decision or commercial launch date. [22]
Second platform exploring quantitative mechanical assessment of colon tissue. Sponsor reported ex-vivo measurements from 32 surgical patients at three Israeli centers; this establishes technical feasibility, not clinical utility. [14]
Investigational / in developmentSponsor announced ex-vivo technical feasibility measurements from 32 patients; future device and clinical utility remain in development. [14]
Colospan became wholly owned. Final SEC-reported terms: $3.3M cash and up to $2M performance-based earnout, replacing original share consideration. [4]
Company identifies Asklepios Altona Clinic in Hamburg as its first German user; does not establish broad commercial adoption. [6]
Company announced FDA Breakthrough designation; not authorization to market in the United States. [5]
Company reported an €8.2M grant-and-equity award. Release dateline December 20 differs from December 23 website archive; use release dateline, not an assumed cash-disbursement date. [23]
47-patient prospective study reported early experience and two device-related serious adverse events; authors called for a larger randomized study. [7]
Parent SEC filing identifies incorporation in Israel in December 2010. [3]
Accessed 10/29/2026