Colospan Announces Extended IDE Approval for Its Intraluminal Bypass Device – An Alternative Approach to Diverting Stoma

Colospan, which develops novel solutions for colorectal surgery, announced today that the United States Food and Drug Administration (FDA) has approved a product line extension to its Intraluminal Bypass Device as part of the company’s investigational device exemption (IDE) application. The line extension offers surgeons size selection for Colospan’s flagship CG-100 product, a device designed to reduce diverting stoma rates in patients undergoing a gastrointestinal resection procedure.

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Colospan receives €8.2 million from the European Innovation Council for its novel colorectal surgery device

Colospan announced today that it has been awarded €8.2 million ($9.3 million) from the European Innovation Council (EIC) as part of EIC Accelerator program. The funding is composed of both a grant and equity. Colospan is one of only 99 innovative start-ups and SMEs that were selected to receive an allocation from EUR 627 million of European Commission funding to help bring promising technologies to the market.

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Colospan accelerates FDA pivotal trial and appoints medtech veteran, Gregory D. Casciaro, to the Board of Directors

Colospan which develops novel solutions for colorectal surgery, announced today the appointment of Gregory D. Casciaro to its board of directors.
“We are excited to welcome Greg to the Board of Directors. With four decades of medical device experience and a proven track record of successfully leading private and public companies, Greg is a true asset and will be instrumental in shaping the company’s future strategic horizon,” said Boaz Assaf, CEO and Founder of Colospan.

Throughout his career, Mr. Casciaro has served in numerous executive leadership roles in the medtech industry, most recently as the President and CEO of Cardiac Dimension and prior to that as the CEO of AccessClosure (acquired by Cardinal Health), CEO of XTENT (acquired by Biosensors International), CEO of Orquest (acquired by Johnson & Johnson) and CEO of General Surgical Innovations (acquired by U.S. Surgical, now part of Medtronic).

“Colospan’s innovative product is designed to address the unmet needs of anastamotic leaks, diverting stoma and their related complications,” Mr. Casciaro said. “I am excited to join the Board of Directors and help lead the company forward in its journey to improve the lives of patients and positively impact healthcare economics with its novel solution”

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Colospan Ltd. is opening its US headquarters in Cambridge, MA.

The Israeli startup which develops novel and proprietary solutions for colorectal surgery is putting a major focus on its US operations to support its IDE approved, multi-center randomized trial currently enrolling rectal cancer patients in 9 participating hospitals across the United States.
Colospan offers rectal cancer patients a unique alternative to the diverting stoma by providing a temporary intraluminal bypass which is designed to reduce the contact of fecal materials with the anastomotic site. This temporary diversion solution is removed without surgery in under two weeks and aims to minimize post-operative complications for a comfortable recovery.
The goal of the prospective, controlled study is to create clinical data related to the safety, performance, and risk/benefit of the CG-100 device in the intended patient population.

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Colospan is taking a big step towards commercialization

Colospan is pleased to announce that Clalit HMO has executed a purchasing code for the CG-100 intraluminal bypass device.
This step will make the CG-100 available at all of Clalit’s hospitals and help transform the lives of rectal cancer patients as well as save resources to the healthcare system.
The agreement was finalized after an extensive economic and clinical evaluation of the CG-100 device in over 75 rectal cancer patients.

Clalit Health services is the largest HMO in Israel, covering 5 million customers holding 52% market share.
Clalit owns 14 hospitals (30% of Israel’s hospital beds) with a 10 Billion $ budget.
An agreement by such a major group like Clalit is a significant validation of the CG-100’s value proposition.

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Henry Ford Hospital First in the U.S. to Test Novel CG-100 Intraluminal Device in patients undergoing colorectal anastomosis

Colospan Ltd. today announced that Detroit-based Henry Ford Hospital is the first in the U.S. to perform an investigational procedure using the CG-100™ bypass device to assess its ability to reduce the need for stoma creation in rectal cancer patients undergoing colorectal or coloanal surgery. CG-100 is a temporary protective bypass device which is being evaluated as an investigational treatment to determine whether it can reduce the need for a diverting stoma and its related complications. Henry Ford Hospital is the only site in Michigan – and just one of 12 sites nationwide – that will be enrolling colorectal cancer patients in the clinical trial.

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Colospan Announces FDA Approval of IDE for Intraluminal Bypass Device – an Alternative approach to Diverting Stoma

Colospan which develops novel solutions for colorectal surgery, announced today that the United States Food and Drug Administration (FDA) has approved the company’s investigational device exemption (IDE) application. With this IDE approval in hand, the company will launch its pivotal study for CG-100, a temporary Intraluminal Bypass Device, designed to reduce diverting stoma rates in patients undergoing gastrointestinal resection procedures.

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