WHERE ARE THEY NOW?
Thubrikar Aortic Valve, Inc.
A medical device development company
Monday, February 9, 2015
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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About
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Since TAVI's last presentation to PCCI in November 2013 the company has made great strides :
- Implanted Optimum Transcatheter Aortic Valve (TAV) in two diseased human cadaver hearts; valve position and holding power were excellent
- Completed testing in 15 sheep and one pig for up to five months; complete superiority was demonstrated compared to the only approved TAV for which published animal data is available.
- Received notices of allowance from US and Canadian patent trademark offices for Optimum TAV's patent.
- Raised about $700K from individuals, Delaware Crossing Investor Group and Lehigh Valley Angel Investors.
Now they're back to tell you all about it and to receive additional help and advice so that this positive development can be sustained.
Transcatheter Aortic Valve Implantation (TAVI) continues to replace open-heart surgery in an increasing number of Aortic Stenosis patients who are eligible for the surgery, and has become the standard of care for patients at high-risk of surgery or surgery-ineligible. The FDA approved its second and third TAVI devices in 2014, and is expected to approve TAVI for intermediate-risk patients within 1 year.
The global market for TAVI devices is already estimated to be $2B, projected to reach $3B by 2019, and exceed $5B thereafter. It’s been over 4 years since the last acquisition of a TAV company. Because this field is new and still evolving, strategic investors await human data from a true next-generation TAV, like Thubrikar's valve, which can treat even lower-risk patients, who require a more durable and better performing valve.
Thubrikar Aortic Valve, Inc.(the Company) has developed a valve - the “Optimum TAV” - which recently surpassed 540 Million cycles, simulating about 15 years in vivo, in an ongoing durability test. The Company has also developed a delivery catheter that is comparable in diameter to most approved devices. In addition, it recently executed a license agreement with a Brazilian heart valve company to manufacture and commercialize the Optimum TAVI system in South America; it is expected that their human data will be received in 2015 and royalties thereafter.
Since its founding in October 2010, the Company has completed nearly all its preclinical studies with just $1.6M - about 25% of the amount spent by most predecessors that reached this stage - primarily due to Dr. Thubrikar’s unique knowledge of the aortic valve, and partly due to reduced costs for second movers.
The Company now seeks $1.3M for a First-In-Human (FIH) study toward the CE Mark, but is considering additional fundraising to become the first TAV company to perform its first-ever human study in the U.S.
Learn more about Thubrikar Aortic Valve, Inc. at www.tavi.us.
3 Major Issues
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- What more could be done to attract investors?
- Superiority of any heart valve can only be proven with long-term patient data. What must be done to make this more obvious to potential investors?
- If the Company is not acquired, what is the best approach to set up manufacturing in Pennsylvania?
Program:
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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - Samir Wadke, Executive Director of Business Development, will deliver the Company's "Elevator" Pitch to the Group
8:20 - Panel will address three major issues crucial to helping the Company reach the next level.
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
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