Asana Medical, Inc. Frequently Asked Questions

What is Inflammatory Bowel Disease (“IBD”)?

Inflammatory bowel disease (IBD) involves chronic inflammation of all or part of the digestive tract. IBD primarily includes Ulcerative Colitis and Crohn’s disease. Both usually involve severe diarrhea, pain, fatigue, and weight loss. IBD can be debilitating and sometimes leads to life-threatening complications. Ulcerative colitis causes long-lasting inflammation and sores (ulcers) in the innermost lining of your large intestine (colon) and rectum. Crohn’s disease causes inflammation of the lining of your digestive tract. In Crohn’s disease, inflammation often spreads deep into affected tissues. The inflammation can involve different areas of the digestive tract. Collagenous colitis and lymphocytic colitis also are considered inflammatory bowel diseases but are usually regarded separately from classic inflammatory bowel disease. (Source: Mayo Clinic Staff)

What is ECM?

“ECM” stands for Extracellular Matrix, a mature tissue engineering technology that Asana is leveraging to the gastrointestinal space. ECM is a meshwork of proteins and carbohydrates that binds cells together or divides one tissue from another. (Source: biologyreference.com) Many medical devices have been developed based on this technology, and they have proven to be safe and effective for years. Asana is developing a novel approach to using ECM in the intestines to treat IBD.

What is ExtraCellular Matrix Hydrogel (ECMH) and how does it work?

ECMH (ExtraCellular Matrix Hydrogel) is a liquid form of ECM. It consists of the Company’s unique porcine-derived, engineered tissue material that will be delivered to the diseased colon where it will build a protective barrier and act as a scaffold for natural tissue recovery to occur. This mechanism has been demonstrated in multiple applications in humans including esophageal and atrial septal defect repairs, hernia grafts, pericardial closures, and burn and wound treatments; several of these applications have been successfully marketed for more than a decade. ECMH creates an environment favorable for the body to grow new tissue in place of diseased or damaged tissue.

What solutions are currently available?

There is no cure for IBD. Current first-tier drug treatment options include aminosalicylates (5-ASA) for mild cases to systemic corticosteroids and potent immunosuppressants for moderate to severe cases. Many advanced therapies subject the patient to potentially debilitating side effects. Even so, approximately 20% to 30% of those afflicted with IBD find no relief from any drug therapy. In such instances, patients undergo major surgery to remove part of the intestines and or colon, a procedure that leads to challenging, lifelong lifestyle changes.

What other diseases can Asana’s technology be used for?

We anticipate that our technology can be used not just for IBD, but for other GI diseases such as rectal mucositis as well. Rectal Mucositis can occur when cancer patients receive radiation and/or chemotherapy in the pelvic region, leading to permanent damage to blood vessels near the rectum. This often leads to uncontrolled bleeding and pain, and there is no effective treatment for this condition.

Does IBD go away?

Patients usually go through period of remission (no disease activity) and flare (disease activity). While patients are in remission, they usually have few or no symptoms. Still, there is currently no cure for these diseases.

How many people have IBD?

More than 5 million people suffer from the two principle forms of IBD: Ulcerative Colitis (UC) and Crohn’s disease. In the United States over 1.1 million people are afflicted with IBD. Asana will initially focus its resources to develop a treatment for Ulcerative Colitis then leverage that experience to pursue Crohn’s disease. Approximately 700,000 Americans, and over 1 million Europeans, suffer from UC. According to studies conducted earlier this decade, the annual per-patient per-year treatment costs for UC ranged from $15,020 in the US to over $5,000 outside the US. Market data obtained by Asana indicated that 2012, revenues in the US and EU of pharmacological agents to treat ulcerative colitis such as 5-ASA, corticosteroids, 6MP (immunosuppressant), and biologics such as Remicade™ and Humira™ totaled approximately $4.2 billion. That same report estimates an annual 5% growth in this market; surpassing $6.8 billion by the year 2021.

How does Asana expect its technology to work?

Asana is confident that its unique engineered tissue material, ECMH, can be used to coat and protect the colon in ulcerative colitis patients, allowing the body to heal the inflamed tissue. The ECMH material would be delivered to the colon using a standard GI procedure, creating a drug-free, surgery-free therapy to facilitate and maintain disease remission.

What is University of Pittsburgh’s role?

The Company has obtained the exclusive license from the University of Pittsburgh to develop new medical applications to treat IBD. Asana is collaborating with Stephen F. Badylak MD PhD DVM, Deputy Director of The McGowan Institute for Regenerative Medicine at the University of Pittsburgh, a world-class center for work in extracellular matrix (ECM).

What is Asana Medical’s business strategy?

Asana will undertake the development of its medical device with a view toward value inflection opportunities. We have aligned with several contract service providers to support our core team—including reimbursement, quality assurance, process development, manufacturing, and testing—to expedite our development timeline. Asana will seek strategic relationships to support distribution and sales in multiple markets. Further, as part of Asana’s core mission to maximize the value of its business assets, we will actively pursue strategic partnerships as well as financing, licensing, and business opportunities.

What type of company is Asana, Inc.?

Asana is a private corporation, registered with the State of Florida.

Where is Asana Medical, Inc. located?

Asana has offices in Miami Lakes, FL.

Is Asana going public?

There are currently no plans for Asana, Inc. to become a public company.

Who is on Asana Medical’s management team?

We are a company of highly motivated innovators, doctors, engineers, entrepreneurs, and professionals that identified an opportunity to apply existing Tissue Engineering Technology in a novel application. To learn more about Asana Medical’s Management Team, Board of Directors and its Medical Advisory Board, click HERE.

Is Asana Medical, Inc. currently raising money?

Yes. Asana is raising capital through a Preferred Stock offering available to accredited investors only. For more information please contact the Company.

Has Asana conducted any animal tests?

Asana has conducted multiple animal studies in different species: dogs and rats. All studies showed very favorable results using extracellular matrix in the colon. For an overview of each study, click HERE.

Is Asana conducting any human tests?

Asana plans to initiate its first clinical trial (using ECMH to treat UC) in 2016/2017.

How can I speak with someone at Asana Medical?

You may contact us by regular mail, email, or telephone:
6135 NW 167 Street, Suite E15
Miami Lakes, FL 33015

Email: gcoombs@asanamedical.com
Tel: (844) 432-7262

For additional information on IBD, including Crohn’s disease and Ulcerative Colitis, visit the Crohn’s & Colitis Foundation of America at www.ccfa.org

Facebook Twitter LinkedIn
Asana Medical Inc.
6135 NW 167 Street, Suite E15
Miami Lakes, FL 33015
info@asanamedical.com
tel: (844) 432-7262