Asana Medical, Inc.


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March 16, 2015 Issue

The Most Powerful Name In Corporate News and Information


Device-Based Treatment for Ulcerative Colitis



Marc Ramer

Founder, CEO


Asana Medical, Inc.


Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – March 16, 2015


CEOCFO: Mr. Ramer, would you tell us the concept for Asana?

Mr. Ramer: Asana Medical is an early-stage medical device company in the gastrointestinal space. Specifically, we are developing a device-based treatment for ulcerative colitis. Right now, the only therapies available to treat ulcerative colitis are inadequate and there is no good treatment option available. For example, the drugs used to treat ulcerative colitis can potentially have devastating side effects, such as lymphoma, skin cancer or tuberculosis. Even then, 20% to 30% of patients fail to respond to even those severe drugs and have no alternative but have their colons removed, which is a major and life altering surgery.


CEOCFO: How will you do that?

Mr. Ramer: We have come up with a medical device that sets up the colon to heal itself thereby eliminating the symptoms of the disease.


CEOCFO: Is that the ECMH?

Mr. Ramer: Yes, that is correct. It is ECMH (extracellular matrix hydrogel).


CEOCFO: Would you give us a description of ulcerative colitis?

Mr. Ramer: Ulcerative colitis is a disease in which the body attacks the lining of the colon, called the mucosa; once the body attacks the mucosa, it breaks down and the colon can no longer function properly. Once that happens, it manifests in a series of debilitating symptoms including symptoms like chronic bloody diarrhea, pain, tremendous urgency to use the restroom, and frequent bowel movements. I have heard of cases where UC patients go up to 24 times in a day. There is a big psychological component as well, people feel like they are chained to the bathroom. Even worse, it can lead to malnutrition because of chronic dehydration and ultimately a greatly increased risk of colon cancer.


CEOCFO: Did you set out looking for a technology to address this situation or did you come upon it and realize the potential?

Mr. Ramer: This disease is in my family and I saw a family member go through colon removal surgery. I am a biomedical engineer by training and a loving family member, and I had to find a better way. Sitting with that family member post-op, I hatched the idea that ultimately became this company but not with this specific technology. I thought, why couldn’t we somehow replace the diseased mucosa and stimulate the regrowth of healthy new mucosa? After networking through some prominent scientists, I came upon one named Dr. Stephen Badylak. Dr. Badylak is the deputy director of the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. He was sold on the concept from our very first conversation. Steve is one of the world’s foremost authorities in tissue-engineered products, which includes ECMH, and he has helped commercialize ECM-based technologies for multiple clinical applications. He immediately saw the potential of this and we have been working together collaboratively ever since.


CEOCFO: Are the people that should know of Asana aware of what you are doing?

Mr. Ramer: It is early but to the extent that is appropriate, we are getting the word out to the medical world. We have a medical advisory board that is unusually strong for a startup company like ours. These key opinion leaders see the potential in what we can do for their patients. Our first task is to develop the product and process, then get it into humans and ultimately commercialize. Right now, it is not as important to get the message out to the clinical world as it is to get it out to the investment world.


CEOCFO: What is the market potential here?

Mr. Ramer: It is substantial. Our estimate is that the market ultimately exceeds $4 billion and we hope to capture a substantial portion of that. 5.7 million people worldwide have ulcerative colitis. There are about 1.4 million in the EU and nearly 900,000 in North America. The patient population multiplied by the projected price point of ECMH (which will be competitive with the existing biologic drugs) equates to a $4 billion market opportunity.


CEOCFO: Are there competing technologies of which you are aware?

Mr. Ramer: We consider the biologic drugs our primary competition because there is no medical device, that we are aware of, that is positioned to treat ulcerative colitis. Occasionally, a colorectal surgeon or GI will put in a stent, for example, to open a colonic stricture or a narrowing, but that is just treating symptoms. We are unique in that regard. There are stem-cell-based technologies involving tissue-engineering approaches to re-grow colons, but they are only in the preliminary stages and not near commercialization.


CEOCFO: What is the IP situation for you?

Mr. Ramer: Our IP situation is strong. We have one core patent on which I am an inventor, along with two of our colleagues from the University of Pittsburgh. We are licensing from Pitt two additional patents that describe ECMH’s composition and manufacturing process.


CEOCFO: What part does the FDA play in regulating?

Mr. Ramer: It plays a substantial part. This product is going to be regulated as a device. We are confident of this based on ECM products having been regulated historically as devices.


CEOCFO: What is going on right now at Asana?

Mr. Ramer: We are doing preclinical work as part of product development right now. This includes our benchtop testing and our animal testing to develop a product that, ultimately, will be proven safe and effective in a small-scale human clinical trial. We have conducted four animal studies and we have a very important and large one starting soon. That, combined with the benchtop testing, will provide the data we need for an FDA submission.


CEOCFO: Have there been any surprises so far?

Mr. Ramer: A positive one insofar as we are a medical device startup but the caliber of people we have attracted to the table are the kinds of individuals you typically see at more established companies, people who already have established names and reputations in the field. I think that speaks to the substance of Asana and the great potential of what we are offering.


CEOCFO: What are your plans for developing the company? 

Mr. Ramer: Our daily focus has been to cultivate the necessary financial and human resources that will help us continue our rapid device development. The projected cost for us to produce human data in two years is in the neighborhood of $4-5 million dollars. Even if we could afford to self-finance operations and clinical trials, our experience has shown us that joining with the right strategic partners and investors can exponentially improve our chances for success. So we are proceeding along this path.


CEOCFO: What is the interest in ulcerative colitis today?

Mr. Ramer: Given the size of the market and the fact that there is a large unmet market need right now to address IBD, which is Irritable Bowel Disease, there is a substantial market opportunity available. Many people we speak with have a personal link to IBD so they are interested from both a business perspective and a personal one.


CEOCFO: I think it may be helpful that it is easy to understand!

Mr. Ramer: I think people identify with it because even if you have not had one of these diseases, certainly everyone at some point has had some gastric distress.


CEOCFO: What have you learned from your background as a biomedical engineer?

Mr. Ramer: I would say a sense of perspective. In my career, I have worked on everything from advanced R&D, which is the proverbial sketch on the cocktail napkin, to commercialization and post market surveillance. I have seen the full gamut of what it takes to get a product to market and follow it once in the market. Having that perspective means knowing how to leverage your resources appropriately to each stage of the product and process development effort. I have learned especially after having been CEO of Asana, that things do not happen as quickly or as smoothly as you would hope and nobody gets a smooth ride through a medical device startup. It is not about expecting a smooth ride but rather anticipating bumps in the road and knowing how to mitigate those risks and put contingency plans in place.


CEOCFO: How do people reach out to you if they want more information?

Mr. Ramer: I would say they should first check out our website to learn more about us at There is a Contact Us page on the website where they can reach out with questions. The emails and phone calls will come to me directly and I would be happy to entertain any questions.


CEOCFO: Why does Asana standout?

Mr. Ramer: Asana truly is a special medical device startup opportunity. The caliber of the individuals we have attracted, people with a record of success already, is special. Likewise, the quality and caliber of our various advisory boards is very high. We have proven that our technology works in a preliminary animal study. We have passion within the team to push this forward because this is personal to me in particular. I believe Asana is poised for success and many smart people are bullish on our prospects.


“We are a medical device startup but the caliber of people we have attracted to the table are the kinds of individuals you typically see at more established companies, people who already have established names and reputations in the field. I think that speaks to the substance of Asana and the great potential of what we are offering.”- Marc Ramer


Asana Medical, Inc.



Marc Ramer

(844) 43ASANA, ext. 103






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