Asana Medical, Inc. is a regenerative medicine company on a mission to develop a first-in-class treatment to provide relief to people who suffer from Inflammatory Bowel Disease (IBD), such as Crohn’s Disease and Ulcerative Colitis.
Asana Medical is developing a patented, non-surgical Extracellular Matrix Hydrogel (ECMH), a porcine-derived material, that forms a protective barrier, acting as a scaffold for natural tissue recovery to occur. This mechanism has been successfully shown in Asana’s animal studies demonstrating safety and efficacy for its intended use.
Anyone who suffers from IBD, the most common forms being Ulcerative Colitis and Crohn’s Disease, knows that chronic diarrhea, pain, bleeding and urgency can be crippling to one’s quality of life. Not to mention, it increases your risk for cancer and severely alters your personal and financial health.
These statistics underscore a serious need for new approach to treating IBD.
The Disease
Ulcerative Colitis and Crohn’s Disease the two major forms of IBD, share similar symptoms characterized by recurrent inflammatory episodes resulting in pain, chronic diarrhea, bleeding and urgency to use the restroom. More severe cases can include malnutrition and stunted growth in pediatric cases. IBD increases the risk for colon cancer. However, Crohn’s Disease is typically found in the distal end of the lower intestine and the proximal end of the colon but can affect the entire gastrointestinal tract while UC is limited to the colon. Another key differentiator between Crohn’s and UC is that in Crohn’s the entire thickness of the bowel wall could be affected while UC is limited to the inner lining of the bowel wall.
The current treatments for Ulcerative Colitis and Crohn’s patients are aminosalicylates (5-ASA) for mild cases, whereas systemic corticosteroids, antibiotics potent immunosuppressants and biologics are for prescribed for moderate to severe cases. These treatments have debilitating side effects, and still leave 20-30% of UC patients with the need for a colectomy – a major surgical procedure to remove the colon. Surgery rates for those diagnosed with Crohn’s disease is significantly higher.
Asana believes that their Extracellular Matrix Hydrogel will provide current and newly diagnosed patients with a superior treatment alternative that focuses on restoration and healing.
Asana Medical licensed, from the University of Pittsburgh, on a field-specific and exclusive worldwide basis a patented, tissue-engineered hydrogel with regenerative properties. The hydrogel contains ExtraCellular Matrix (ECM), a commercialized product with an excellent safety profile and efficacy history. Extracellular Matrix has been used successfully in esophageal, prolapse and general surgical repairs, hernia grafts, and burn, wound and ulcer treatments.
The ECMH is delivered, on a non-surgical basis, directly to the patient’s affected area as a liquid that gels upon reaching body temperature and adheres to the diseased tissue, forming a protective barrier that acts as a scaffold for natural tissue recovery to occur.
Testing the product
An early canine proof-of-concept study conducted at the University of Pittsburgh’s McGowan Institute for Regenerative Medicine confirmed ECM’s regenerative properties. The Institute and its director, Stephen Badylak DVM, PhD, MD, are globally-recognized for work with ECM in tissue engineering and regenerative medicine. Data found during the study validates Asana Medical’s premise that ECM creates a scaffold for natural tissue recovery and growth.
Following the canine study, a pilot rodent study was conducted with the McGowan Institute to establish the viability of a hydrogel version of ECM. That study was carried out in a widely used Ulcerative Colitis rodent model and confirmed the original findings of colon tissue regeneration.
*The arrow on the Control picture shows no improvement in 7 days, but the ECMH arrow shows regeneration of the tissue on the entire colon.*
Recently, Asana completed a comprehensive rodent study, under a Corporate Research Agreement with the McGowan Institute, to confirm data generated by the earlier pilot study. The data from this well-controlled and blinded study showed statistically significant evidence that Asana’s product, ECMH, regenerates tissue. (See above.) When the ECMH and Control Groups are compared in the picture above, it is observed that within 7 days, the top layer of the tissue treated with ECMH is regrown.
When viewing the bar graph below, the best result is to have lower scores. As observed, the ECMH with the lowest scores statistically outperformed the Control Group. This data confirms that the measurable conditions such as inflammation and ulceration are changed. In addition, tissue swelling and redness are reduced, and the size and number of open wounds are also reduced. The study validates that with the ECMH treatment, the destroyed tissue has regrown.
For more information about the rodent study, please review our abstract.
A wide array of pharmaceutical therapies have been developed and are marketed to treat the clinical symptoms of Ulcerative Colitis and Crohn’s, such as the aminosalicylates (5-ASA), corticosteroids, antibiotics, immunomodulators and biologics most of which focus on moderating or suppressing the body’s immune system to prevent inflammation. Asana’s novel approach to treating UC is focused on addressing the cause – ulceration of the tissue in addition to the clinical symptoms. Asana’s ExtraCellular Matrix Hydrogel is a porcine-derived material that promotes natural tissue recovery.
This is where Asana comes in.
Asana’s goal is to treat patients unresponsive to 5-ASA, the typical first-line medical therapy, and provide them with a superior treatment alternative that restores and promotes healthy tissue. For patients who progress further in the treatment profile, Asana’s therapy can still be used. This treatment will give patients an option that provides relief from the disease without exposure to the side effects associated with systemic pharmaceutical products while decreasing the need for major surgery which leads to harsh lifestyle changes.
Asana Medical’s revolutionary treatment has the potential to treat the principle types of Inflammatory Bowel Disease. Asana’s initial indication will target Ulcerative Coliti followed by Crohn’s disease. Asana will position its therapy to treat Ulcerative Colitis for patients that have failed first-line therapies, such as 5-ASA, or as alternative therapy to patients that cannot tolerate corticosteroids or immunosuppressants. This initial indication translates to multi-billion dollar worldwide market opportunity for Asana.
North America by the Numbers
Internationally, Ulcerative Colitis is common in the more industrialized nations in the Northern hemisphere such as Sweden, Germany, United Kingdom, and France. There are as many as 2.1 million people afflicted with UC in Europe. Recent studies indicate an increased diagnosis rates of the disease in Asia and other areas of the world where the disease rates were traditionally very low.
Multi-billion Dollar Market Opportunity
GlobalData, a reliable source for clinical market research, reported 2012 UC prevalence rate in the 10 major pharmaceutical markets worldwide at 1.861 million patients. Of this total, more than 1.54 million were treated with pharmaceuticals, generating $4.182 billion in total revenues. GlobalData forecasts that this market should exceed $6.8 billion by 2022, the same year ECMH is commercialized. Asana will price ECMH to reflect development, manufacturing, clinical, and licensing costs. Management believes, with the proper marketing and distribution infrastructure, ECMH can command market penetration rates consistent with first-in-class product category introductions and has developed a revenue model with the assistance of outside expert consultants that reflects this scenario.
As the Chief Executive Officer and Founder, Dr. Sapan is responsible for providing strategic leadership direction for Asana Medical, Inc. by working with the Board and other management to establish long-range goals, strategies, plans and policies. Dr. Sapan has more than 30 years experience as a C-level business and scientific leader, as well as varied experience in the pharmaceutical and biotechnology industries.
As the Executive Vice President of Operations, Mr. Coombs is responsible for the implementation of strategic and tactical directives. Mr. Coombs is a 26-year financial and operational veteran of pharmaceutical, medical device and biotechnology companies and is a Founder of Asana Medical, Inc.
As the Vice President of Research and Development, Dr. Winston (a consultant) is responsible for overseeing and supervising all development and innovation efforts for Asana Medical, Inc. Dr. Winston has focused his professional career spanning over 33 years in product development, manufacturing, preclinical and clinical testing, guiding vaccines, diagnostics, immunotherapeutics and smoking cessation products from inception through regulatory approval.
As the Vice President of Legal and Business Affairs, Mr. Bulman oversees all legal matters for Asana Medical, Inc. and serves as the primary legal advisor to the CEO, and the organization’s senior management team. Mr. Bulman is a business and technology attorney with more than 29 years of experience counseling early-stage ventures, including life sciences companies.
Mr. Ramphal is the Treasurer for Asana Medical, Inc. and has extensive accounting and finance experience working with early-stage companies to arrange funding, create business plans and financial models, and establish financial reporting, strategic planning and control processes. He has spent the last two decades as Managing Partner and Founder of Global Resource Partners, Inc.