The Future of Colorectal Care
Colospan has developed CG-100, a breakthrough solution for colorectal surgery that aims to improve the clinical and financial outcomes associated with anastomotic leaks and diverting stomas
Potential alternative to diverting stoma
Eliminates the need for 2nd surgery
Colorectal Surgery Pathway
Colorectal Cancer
Colorectal cancer is one of the most prevalent and deadly forms of cancer worldwide, with over 1.9 million new cases and more than 930,000 deaths each year. Despite advances in screening and early detection, a large portion of patients are still diagnosed at stages requiring surgical intervention. As global populations age, the incidence of colorectal cancer continues to rise, creating not only a major public health concern but also a growing economic burden on healthcare systems – driving up costs for treatment, hospitalizations, and long-term patient care.
Surgical Treatment
For many patients with rectal cancer, therapy begins with chemotherapy and radiation to shrink the tumor and improve the likelihood of complete removal. Surgery then involves excising the diseased bowel segment and creating a new connection between the healthy ends, known as an anastomosis, using staples or sutures. Although the concept sounds simple, these are highly complex procedures requiring great precision to avoid serious complications. Even with minimally invasive approaches and improved perioperative care, colorectal surgery carries substantial risk. The quality of the surgical outcome directly influences long-term survival, recurrence rates, and patient quality of life.
Anastomotic Leak
One of the most serious and feared complications of colorectal cancer surgery is an anastomotic leak, which occurs when the newly joined bowel ends fail to heal properly. This can allow intestinal contents to spill into the abdominal cavity, triggering severe infection and inflammation. Anastomotic leaks affect up to 20% of patients and are associated with sepsis, the need for reoperation, prolonged hospitalization, delayed chemotherapy, increased cancer recurrence, and higher mortality rates. Preventing leak-related complications remains a critical unmet need, and innovations that reduce their incidence have the potential to transform colorectal cancer outcomes while delivering substantial economic benefits to healthcare systems.
1M patients are at high-risk of an anastomotic leak requiring protection
Diverting Stoma - Sub-Optimal Standard of Care
During colorectal surgery, a temporary stoma is often created to protect the healing site by diverting stool into an external bag.
Stoma comes at a high cost: loss of bowel control, constant pouch care, risk of leakage, visible bulging, and major impact on daily life and intimacy.
A 2nd surgery is required to remove the stoma, adding more risk, cost, and recovery time.
Stomas challenges highlight the urgent need for a better solution.
Requires second surgery for stoma reversal
Digestive waste exits through an abdominal stoma into an ostomy bag involuntarily.
Stoma remains in place for 2-12 months
Living with a stoma can impact quality of life and lead to health issues
“If we can find a secure way to avoid diverting stoma, this would truly be the holy grail of colorectal surgery”
Anthony Senagore, MD
Former president ASCRS
CG-100 - Potential Alternative to Diverting Stoma
CG-100 is a CE marked intraluminal bypass made of soft silicone, placed through the anus to protect the surgical site after colorectal surgery. It uses inflatable balloons and a securing ring to stay in place while allowing safe movement within the colon.
The device is removed non-surgically after 10 days, once the risk of leakage has reduced. Application and removal are designed to be quick, simple with no additional procedures – offering a meaningful potential advantage over traditional stomas.
CG-100 is the New Gold Standard of the Future
Deployed during primary surgery
Maintenance free, no bags, no 2nd surgery
Easy nonsurgical removal after 10 days
Potential Value for all Stakeholders
Patients
Improved Quality Of Life
Physicians
Reduced complications
Payers & Providers
Reduced costs
The CG-100 pivotal clinical study is currently enrolling participants at select medical centers.
To learn more or to explore participation opportunities
Economic Impact
By eliminating the need for stoma supplies and a stoma reversal procedure, Colospan’s CG-100 can deliver potential savings of up to $40,000 per patient.
Colospan's Breakthrough Solution Adresses The #1 Challenge in Colorectal Surgery: Anastomotic Leaks
Colospan’s CG-100, is a CE-marked (under MDR) minimally invasive alternative to diverting stoma, designed to reduce complications, simplify recovery, and improve outcomes for patients and healthcare systems alike.
With over 120 successful cases across the EU and U.S., Colospan brings vast clinical experience and is currently conducting a pivotal clinical study under an FDA Investigational Device Exemption (IDE). The company is supported by the European Innovation Council (EIC) and backed by top-tier global investors.
Colospan’s expert team includes leaders in clinical, regulatory, and commercial domains, alongside top colorectal surgeons. The company holds robust IP across the U.S., Europe, China, and Japan.
Colospan has received funding from the European Union’s EIC Accelerator program, Project # 190124297 – CG-100
News
Galmed Pharmaceuticals to Acquire Colospan to Create a GI-Focused Platform Targeting a $6 Billion Market
Asklepios Altona Clinic, First Hospital in Germany to use Novel CG-100 Intraluminal Device in patients undergoing colorectal Surgery
Colospan Receives FDA Breakthrough Device Designation for Its Intraluminal Bypass Device
Colospan Announces Extended IDE Approval for Its Intraluminal Bypass Device – An Alternative Approach to Diverting Stoma
Colospan receives €8.2 million from the European Innovation Council for its novel colorectal surgery device
Colospan accelerates FDA pivotal trial and appoints medtech veteran, Gregory D. Casciaro, to the Board of Directors
Colospan Ltd. is opening its US headquarters in Cambridge, MA.
Colospan is taking a big step towards commercialization
Henry Ford Hospital First in the U.S. to Test Novel CG-100 Intraluminal Device in patients undergoing colorectal anastomosis
Colospan Announces FDA Approval of IDE for Intraluminal Bypass Device – an Alternative approach to Diverting Stoma
Colospan Completes $7.7M Equity Financing Round – Reports Successful Results of Clinical Trial
Colospan Selected to Present its Colorectal Surgical Device at the Life Science Intelligence Summit in Silicon Valley
Colospan Completes 20th Patient Recruitment for Clinical Trial
AMIT Invests $0.5M in Colospan
Colospan Recruits $2M in its Second Funding Round
Upcoming Events
The 2025 American Society of Colon and Rectal Surgeons (ASCRS) Annual Scientific Meeting – Hall B2, Booth 917
Publications
Protection of colorectal anastomosis with an intraluminal bypass device for patients undergoing an elective anterior resection: a pilot study
Intraluminal Bypass Device for The Replacement of Diverting Stoma: Results From First Prospective Clinical Trial in 20 Patients.
