Colospan (formerly Cologuard), which is developing a sleeve for protecting against intestinal leakage after a colectomy, has announced the completion of a $7.7 million financing round led by the Triventures fund. Previous investors in the company, including Docor (controlled by the Van Leer incubator, where Colospan started); Amit Technion, founded by the late Alfred Mann; and Clal Biotechnology Industries Ltd. (TASE: CBI) investment fund Anatomy, which invests in medical equipment, also took part in the round.
Colospan has developed a product that protects the intestine after a colectomy and sealing of the intestine, which are performed in cases of severe intestinal inflammatory disease and cancer of the bowel or rectum. In places where the intestine has been sealed, leakage requiring prolonged hospitalization or repeat surgery on already weak patients is liable to occur. In severe cases, the inflammations are liable to cause the death of the patient. Today, in order to prevent leakage in advance, some doctors choose to divert the contents of the intestine outside the body through a stoma (an opening in the stomach wall and a collection bag) until it is clear that the stomach has healed well, and the results of digestion can be channeled through it. The stoma, however, makes the patient's life very difficult, and another operation is needed in order to close it. The patients are not fit for another operation for several months, and are therefore left with the stoma for a long time.
Colospan founder and CEO Boaz Assaf explains, "No one knows exactly why leakage occurs. It is probably related to the characteristics of the disease and the patient, not the quality of the surgeon's work or the quality of the connecting devices. If the disease is more severe, the tension of the tissues is greater, or the patient is more overweight - all these factors are highly correlated with leakage, but the truth is that it is impossible to predict the event in advance."
Colospan's product is a silicon sleeve that constitutes a pipeline inside the intestinal pipeline. The contents of the intestine pass through it, so that they do not leak, even if there is a hole in the intestine. After 10 days, an X-ray can be taken to see whether or not the intestine has healed. If it has, the sleeve can be removed non-invasively, without surgery.
According to Assaf, the company's first trial on 60 patients found that the solution prevents life-threatening leakage and makes it possible to cut down on the use of stomas. "The trial was aimed first of all at checking the safety of the product, and showing that it remained in place, and is not discharged by the intestine. The trial was not large enough to show effectiveness at a significant level, but we saw that while the doctors were anxious at the beginning of the trial, and still used a stoma together with the trial of our product, as they gained more experience with our product, their use of a stoma went down." Leakage was observed in 5% of the cases in the trial, compared with the 10-12% described in the literature.
Assaf founded the company after working in marketing and sales in this segment in his previous position at Johnson & Johnson, which made him familiar with the patients' needs. He hooked up with engineer Eyal Teichman, and they developed the product together. "All of the companies in the segment are looking at this market and developing products, from better sealing pins to biological glue, such as Israeli company LifeBond. Our product can be used in combination with these products. As for direct competition, a number of startups are developing products similar to ours, but they are at earlier stages."
The company has CE certification for marketing its products in Europe, and is planning a limited launch in Europe during 2018 for the purpose of proving marketing feasibility. At the same time, the product will enter a trial with 100 patients in order to obtain approval from the US Food and Drug Administration (FDA) on the k de novo track for new products for which there is not much concern about their being hazardous to patients. Triventures cofounder and managing partner Michal Geva says, "Colospan has realized that in order to bring a new medical device to market, the needs of all the parties have to be taken into account: patients, the parties footing the bill, services providers, and doctors. The company is developing a serious solution for the sector."
Published by Globes [online], Israel Business News - www.globes-online.com - on September 27, 2017
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