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U.S. FOCUSED CLINICAL
TRIALS |
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MARVEL
(Phase
II/III Clinical Trial.)
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330
anticipated, including 110 controls.
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20
sites in the United States and Canada and up to 15 sites
in Europe anticipated.
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Designed
to be a double-blind, randomized, placebo-controlled,
multicenter trial to evaluate
the safety and efficacy of MyoCell® delivered via MyoStar®.
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MyoCell® implantation
procedure completed on first patient in October 2007; six-month
interim data anticipated in the second quarter
of 2009 and final trial results anticipated in the fourth quarter
of 2009.
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MYOHEART
(Phase
I Clinical Trial)
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20
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Five
sites in the United States
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Phase
I dose escalation study to assess safety, feasibility and
efficacy of MyoCell® delivered
via the MyoCath® catheter.
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Trial
commenced in 2003; treatment
of all 20 patients completed in October 2006; final twelve-month
data presented in January 2008.
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EUROPEAN
CLINICAL TRIALS |
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SEISMIC
(Phase
II Clinical Trial)
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40,
including 14 controls.
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Twelve
sites in the Netherlands, Germany, Belgium, Spain, Poland
and the United Kingdom.
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Phase
II European study to assess the safety and efficacy of MyoCell® therapy
delivered via MyoCath® catheter.
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Trial
commenced in November 2005; treatment of all patients completed
in July 2007; final results presented in April
2008.
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Phase
I/II Clinical Trial
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15
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Three
sites in the Netherlands, Germany and Italy.
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Phase
I/II European study to assess the safety and efficacy
of MyoCell®.
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Trial
commenced in 2002; twelve-month
follow-up completed in June 2004.
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Netherlands
Pilot Trial
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5
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One
site in the Netherlands.
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Pilot
study to assess safety and feasibility of MyoCell®.
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Trial
commenced in 2001; six-month
follow-up completed in October 2003.
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2002
Trial
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3
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One
site in the Netherlands.
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Designed
to evaluate the safety and efficacy of MyoCell® delivered
via the TransAccess catheter.
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Trial
commenced in 2002; discontinued upon Transvascular's acquisition
by Medtronic.
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OTHER
CLINICAL TRIALS |
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Partial
Reimbursement Registry Studies
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Up
to 50 anticipated in the next two years.
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Six
sites in Korea, Mexico, Switzerland, The Bahamas, Singapore
and South Africa anticipated.
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Designed
to generate additional safety and efficacy data and revenues.
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Requisite
regulatory approval to conduct trials recieved at all sites;
contracts in place with an institution in each of Mexico,
the Bahamas, Switzerland and Korea; MyoCell® implantation
procedure completed for four patients in Korea and one patient
in Mexico.
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