This Year's Highlights

• Implantation of Christopher Reeve as third patient in NeuRx RA/4 Diaphragm Pacing Clinical Study. Successful use of the device was demonstrated in interviews with Barbara Walters and Paula Zahn. Over 25 more patients implanted with 96% success rate.
• Successful completion of ALS pilot study with an clinical effect size more than twice what was anticipated. The pilot results have shown a projected 29 month improvement in survival for the patients.
• Pioneering efforts with Plenary Presentation and Award of Distinction (at SAGES 2006 Conference) in diaphragm pacing and the feasibility study of Natural Orifice Translumenal Endoscopic Surgery (NOTES) for the clinical application of diaphragm pacing.

Anticipated Highlights

• FDA and European Market approvals of NeuRx RA/4 Diaphragm Pacing Stimulation System in Q4'06 - Q1'07.
• Publication of ALS pilot study results in preeminent medical journal in 2007.
• FDA and European Market approvals of NeuRx RA/4 Diaphragm Conditioning System in mid-2008.

Corporate Mission

Synapse Biomedical has been formed to commercialize the Diaphragm Pacing System that has been developed over a twenty-year period at Case Western Reserve University, University Hospitals of Cleveland, and the Veterans Administration. The innovative research performed at these institutions has led to significant advances in the state of the art of electrical stimulation for the treatment of chronic respiratory insufficiency, e.g. a minimally invasive surgical technique coupled with a readily removable device. This innovation allows the technology to meet clinical needs, beyond the ability of the currently available systems, in the diaphragm conditioning in muscular dystrophies (such as ALS) and in respiratory short-term intensive care setting. Our initial clinical results also demonstrate it as a more effective option, with significantly lower risk and cost, as a long-term replacement for positive pressure mechanical ventilation for the selected clinical indications.