TRXC's earnings call and analyst questions provided some good insight. The last 15 minnutes of analyst questions are a good listen if you have the time.
Basically the company just updated how it is still on track to meet its timeline goals. The big piece of news was the fact that after meeting and receiving feedback from the FDA from the pre filing, the company is not required to conduct a 50 patient clinical trial to receive clearance from the FDA. If a 50 patient trial was required by the FDA, the company would have to spend hundreds of thousands of dollars and it would delay their release by 2-3 months, some analysts estimated even longer.
So that was the big piece of news. Other than that, company just updated what it's been doing recently, they have a constant flow of surgeons through their doors looking at the technology and demoing it, they are visiting hospitals pitching their value proposition.
The company is on track to submit its fda 510k filing in Q4, and receive approval in the first half of 2015. The company will concurrently file for a CE mark in Europe, and receive approval in first half of 2015. The company plans to commercialize and launch both in the EU and US in 2015 after approval. THe company has enough funds to support through commercialization ($52 million on hand now).
The company also keeps touting its newly developed advanced energy flexible ligating shears, which is a rapidly growing instrument that has always been rigid, and now TRXC developed one that is flexible, and creates no plume or smoke when sealing tissues. This is a $3B market that TRXC believes they can capture some.
Worlwide 2014 surgery congress in Canada is at the end of this month and a world renowned surgeon will be doing a live surgery with TRXC's device and it will be broadcast to all the surgeons. Getting the word out about TRXCs technology.
The company's resources will be heavily spent in the R&D section, and operational expenses for Q3 and Q4 of 2014, but these expenses will drop dramatically after they file for FDA approval in Q4. Then in Q1 of 2015 and for the following quarters, that money on R&D will drop significantly and be transferred to hiring and training a sales force, whome management believes can sell up to 10 surgibots a year.
That's all I can remember, listen to the call on TRXCs website.
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