Previous Statements by ATRC
» AtriCure's CEO Hosts Update Call on DEEP AF Feasibility Trial - Conference Call Transcript
» AtriCure's CEO Discusses Q3 2011 Results - Earnings Call Transcript
» AtriCure's CEO Discusses Q2 2011 Results - Earnings Call Transcript
» AtriCure CEO Discusses Q1 2011 Results - Earnings Call Transcript
Before we begin today, let me remind you that the company’s remarks may include forward-looking statements. These statements include, but are not limited to, those that address activities, events or developments that AtriCure expects, believes or anticipates, will or may occur in the future, such as revenue and earnings estimates, other predictions of financial performance, launches of new products and market acceptance of new products.Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond AtriCure’s control, including, but not limited to, the rate and degree of market acceptance of AtriCure’s products, governmental approvals, and other risks and uncertainties described from time-to-time in AtriCure’s SEC filings. AtriCure’s results may differ materially from those projected on today’s call, and AtriCure undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additionally, we may refer to non-GAAP financial metrics. A reconciliation of these non-GAAP measures is included in our press release, which is available on our website. I would like to remind everyone that the Food and Drug Administration, or FDA, has not approved certain AtriCure products for the treatment of atrial fibrillation or AF, or for stroke reduction. The company and others acting on its behalf may not promote these non-approved products or train doctors for the surgical treatment of AF or stroke reduction unless the product is so indicated. These restrictions do not prevent doctors from choosing to use the products for the treatment of AF or stroke reduction or prevent AtriCure from engaging in sales and marketing efforts that focus only on the general attributes of the products for the current cleared uses. AtriCure educates and trains doctors in the proper use of its products and related technologies including for the treatment of atrial fibrillation in accordance with the product specific indications.
With that, I would like to turn the call back to Dave.David J. Drachman Thank you, Julie. The AtriCure Synergy Ablation System is the first and only surgical ablation system FDA approved for the treatment of AF, and the only ablation technology approved for persistent and long-standing persistent atrial fibrillation. We believe this system’s recent FDA approval for the treatment of AF during open concomitant surgical procedures is a major milestone for cardiac surgery, and provides AtriCure with new opportunities for expansion and growth. Our highest strategic priority is accelerating U.S. growth. We plan to leverage our AF approval by providing surgeons with concrete hints of training. We also believe that a well executed concomitant AF training and market development plan is the foundation for an advanced minimally invasive thoracoscopic ablation approach, which represents a major growth opportunity. Our research suggests that in the U.S., 85,000 patients per year undergo coronary bypass and/or valve procedures with a diagnosis of preoperative AF. Of these 85,000 patients, approximately 25% are currently receiving ablation treatment. Our growth strategy is designed to improve patient outcomes, gaining market share and increase penetration above the 25% level through comprehensive training and carefully well-selected patients. Going forward, we anticipate stabilization of the macroeconomic pressures impacting hospitals and procedure volumes. We believe our technology and our clinical leadership, and powerful market development drivers, as a result we are planning for accelerated U.S. growth throughout the year and strong growth from the international markets during 2012. In preparation of our expansion and growth plans, we enhanced our executive leadership team with the addition of Andrew Lux, as our Chief Operating Officer. Andrew has held leadership positions with Medtronic’s Cardiac Surgery Division, Johnson & Johnson, and General Electric. He has a proven track record of implementing world-class manufacturing systems and developing innovative technologies, which have been widely adopted in the marketplace. Andrew has responsibility for worldwide operations as well as product research and development.
Turning to our training program, as a condition of FDA approval, we agreed to train and certify existing Synergy System users within 18 months, and to train new users prior to their purchase of the system.Read the rest of this transcript for free on seekingalpha.com