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Monday, December 13, 2010
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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ZSX Medical
Early-stage medical device company
About
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ZSX Medical is developing an alternative to sutures to close the uterus in cesarean delivery
3 Major Issues
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Finance: Given the *total* amount of money we need to reach FDA
clearance, are we best served by seeking the money as proposed ($1.35MM,
then $6MM), or should we look for a single raise of $7.5MM? Or two
raises differently divided?
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Regulatory: There is a lot of uncertainty regarding FDA and FDA's
responsiveness going forward, suggesting that earlier correspondence
will mitigate risk. On the other hand, once we commit to a path with
FDA, it becomes more difficult to change the product. How early should
we engage with FDA about our regulatory strategy, and in what way should
we engage them?
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Strategic partnership: There may be opportunities to partner with a
large device company at a range of developmental time points, from late
pre-clinical to late clinical. What factors should we consider as we
decide when to partner, and to what extent should we focus our strategy
on partnering at our *ideal* partnering time point versus planning for a
variety of potential partnership time points?
Program:
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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - , 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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