MyoCath II
We are seeking to determine whether MyoCath II will increase the bioretention of the cells injected in the heart and disperse the cells more efficiently throughout the scar tissue. More Info >
Expanding Opportunities
Although MyoCath and MyoCath II have been designed for use with MyoCell, we believe that there are a number of other clinical therapies to treat heart disease currently in development by other companies...More Info >
Myocath/Myocath II
We believe MyoCath has the potential to be approved for commercial use with MyoCell and warrants testing for other commercial applications as well. MyoCath is a disposable endoventricular catheter used for the delivery of biologic solutions to a targeted treatment site within the myocardium, the inner wall of the heart. MyoCath provides for multiple injections to a pre-determined needle insertion depth with a single core needle of 25 gauge diameter that can be advanced and retracted from the tip of the catheter. MyoCath is intended for use with commercially available Becton-Dickinson 1 milliliter and 3 milliliter syringes. Although we hope to prove that MyoCell can be administered with a variety of different catheters, MyoCath has been specifically designed to be used for the delivery of MyoCell and has been used as the delivery mechanism in the majority of our clinical trials to date.
We are developing MyoCath II, a second generation catheter. MyoCath provides a modified injection needle which has a closed tip and side holes that result in multidirectional cell injection rather than injection solely from the tip of the needle. We are seeking to determine whether MyoCath II will increase the bioretention of the cells injected in the heart and disperse the cells more efficiently throughout the scar tissue. We commenced animal studies of MyoCath II in the third quarter of 2007. Tricardia, LLC has granted us a sublicenseable license to certain patents and patent applications covering the modified injection needle we intend to use as part of MyoCath II, which license is exclusive with respect to products developed under these patents for the delivery of therapeutic compositions to the heart.
It is our hope that MyoCath and/or MyoCath II will prove to be more cost effective than, and as safe and effective as, other catheters at delivering MyoCell. Although MyoCath and MyoCath II have been designed for use with MyoCell, we believe that there are a number of other clinical therapies to treat heart disease currently in development by other companies that could be delivered via MyoCath and/or MyoCath II including, gene, protein, cytokine and growth factor therapies. Three clinical trials have been initiated by biopharmaceutical companies and other institutions utilizing MyoCath to deliver growth factors in an effort to increase blood supply to a damaged heart.
Candidate |
Proposed Use or Indication |
Status/Phase |
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|---|---|---|---|---|
| MyoCath | Disposable endoventricular catheter used for the delivery of biological solutions to the myocardium. | Used in European Phase II clinical trials of MyoCell; used in Phase I clinical trials of MyoCell | ||
| Comments: Anticipate seeking certification to apply the CE Mark for commercial sale and distribution within the European Union in 2008 provided we enter into a long term manufacturing contract with an entity that satisfies the requirements of the International Standards Organization. | ||||
| MyoCath II | Second generation disposable endoventricular catheter modified to provide multidirectional cell injection and used for the delivery of biologic solutions to the myocardium. | Preclinical | ||
| Comments: Laboratory studies currently being conducted; commenced animal studies in the third quarter of 2007. | ||||