EBR Systems (EBR: $1.12) is developing the world's first wireless pacing system for the left ventricle of the heart. The company recently announced positive clinical results from its pivotal US study which opens the path for FDA registration of the device.

Results
The study recruited 183 patients with primary endpoints and targets. The first was on efficacy, with a 9.3% improvement targeted in heart function (as measured by a reduction in left ventricular end systolic volume), with a 16.4% mean reduction achieved.

On the measure of safety, the target was at least 70% of patients not experiencing complications, with the outcome reaching 80.9% in this study.

CEO John McCutcheon said that this is the most significant milestone in the company's history. The level of complications compares favourably to data published on other cardiac synchronisation therapies (CRT), noting that the complications were higher earlier in the study.

Regulatory Submission
EBR expects to file the device for FDA approval in the first quarter of next year, concluding this study due to the positive results. The company highlighted that it had significant dialogue with the regulator, which included the acceptance of a single arm pivotal study and with Breakthrough Device Designation having been granted.

The FDA submission will include improvements to the device's transmitter. McCutcheon said there is nothing controversial with the data with the company now having passed the binary results risk, with timing being the main risk for the company.

EBR will now have access to an additional US$20 million in debt funding from Runway Capital Growth having passed this clinical trial milestone.

The EBR WISE system will allow for the first time a completely wireless CRT approach to both sides of the heart while being complementary to other leadless technologies. The company estimates the US market size for its product at US$2.5 billion.

EBR Systems finished the March quarter with $84 million in cash and is capitalised at $303 million.

Bioshares recommendation: Speculative Buy Class A