Thubrikar Aortic Valve, Inc.
A medical device development company
Monday, November 11, 2013
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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About
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Thubrikar Aortic Valve, Inc. (The Company) is testing its next-generation Transcatheter Aortic Valve Implantation (TAVI) device - the Optimum TAV - as a treatment option for patients with Aortic Stenosis. TAVs are replacement heart valves that were first sold in Europe in 2007, and an estimated 100,000 TAVI procedures have been performed to date globally.
TAVI is now the standard of care for surgery-ineligible patients, and continues to supplant surgical valve replacement for high-risk surgical candidates. TAVI has been commercially available in Europe since 2007 to many intermediate- and low-risk candidates. The first and only U.S. approval (for Edwards LifeSciences’ Sapien TAV) occurred in November 2011 for surgery-ineligible patients, and was expanded to high-risk patients in October 2012. Global sales were nearly $0.9 Billion in 2012, with the US comprising 28% and Germany comprising 24%.
Due to the technical limitations of current first-generation TAVs, there will be a demand for a new TAV with longer durability. The Company intends to market Optimum TAV even to younger, lower-risk patients where durability becomes critical.
Optimum TAV is a low-profile, self-expanding bioprosthesis comprised of bovine pericardial leaflets and a thin yet strong nitinol frame. It was designed after the natural aortic valve and on the research of Dr. Mano Thubrikar, author of “The Aortic Valve.” The Company has demonstrated feasibility of its device in 8 acute and chronic sheep, surpassed the ISO (and FDA) requirement for durability, and will have completed all required preclinical studies by early 2014.
3 Major Issues
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- The Company anticipates an acquisition offer(s) by a larger heart valve or stent/catheter/imaging company upon demonstrating sufficient human data, but requires additional funding to do so. Company seeks an additional $2 Million, primarily from angel networks and state organizations, to conduct First-In-Human implants toward the CE Mark. The Company would accept an additional $8 Million or more for a full clinical trial of up to 100 patients, though VC funding for early-stage medical devices has been challenging in recent years. What general approaches to obtaining capital would seem the most likely to be effective in the current environment?
- TAVs sell for approximately $30K each and have three major markets: 1) Europe, which has approved 8 TAVs since 2007, but is contemplating stricter regulatory guidelines 2) the US, which has approved only 1 TAV but already comprises the highest percentage of global sales by country and 3) Rest Of World, which includes multiple developed, but smaller markets as well as developing countries, where pricing would need to decrease. Considering that the Company requires significant funding for clinical studies, should it continue to focus on Europe, or shift to other market (s)?
- If the Company is not acquired, what is the best partnership model to pursue for marketing and distribution, and what would it need to sell the product on its own in the applicable markets?
Program:
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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - Samir D. Wadke, Director of Business Development, will deliver the Company's "Elevator"
Pitch to the Group
8:20 - A Panel will address 3 Major Issues for the Company
9:00 - Open discussion: members and guests
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 Slides
None available at this time
 Audio
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 Video
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 Webcast
None available at this time
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