Webcast Spectranetics at JPMorgan Global Healthcare Conference (Live)
01/10/13 at 10:30 a.m. PT
Spectranetics develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system. The Company’s products are sold in over 40 countries and are used to treat arterial blockages in the heart and legs as well as the removal of pacemaker and defibrillator leads.
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Spectranetics Presentation on January 10th, 2013, 10:30 AM Pacific Time.
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RE: Current Clinical Trials
During the second quarter of 2011, the FDA granted approval for an investigational device exemption (“IDE”) related to a multi-center, randomized trial to treat in-stent restenosis (“ISR”) in the legs under the study name EXCITE ISR. The study compares laser ablation using our Turbo-Tandem® and Turbo Elite® laser ablation devices followed by adjunctive balloon angioplasty with balloon angioplasty alone. The first enrollment in the study occurred in June 2011. As of November 2, 2012, 31 sites are approved to enroll in the study and 111 patients have been enrolled.
We have recently initiated discussions with the FDA to explore achievement of an ISR indication prior to full enrollment of the EXCITE ISR study. This may involve use of the PATENT registry, which is discussed below, in combination with patients enrolled in the EXCITE ISR study. Discussions with the FDA are ongoing; however, there is no assurance that the ISR indication will be achieved without full enrollment of the EXCITE ISR study.
In February 2012, we announced six month interim results from the Photo Ablation Using the Turbo-Booster® and Excimer Laser for In-Stent Restenosis Treatment, or PATENT, registry. A total of 90 patients were included by December 2011 at five centers in Germany. Seventy-eight patients have been followed through six months. Interim results presented at the Leipzig Interventional Course 2012 in Leipzig, Germany indicate 76% freedom from TLR at six months.
In the interim results of the PATENT registry, the success rate, defined as achievement of ≤ 30% final residual restenosis, was 98.8%, and Cumulative Major Adverse Events (“MAEs”) were 2.2% from procedure through 30 days following the procedure. The study population included patients with PAD ranging from intermittent claudication to critical limb ischemia (Rutherford class 2-5). Lesions ranged from 1cm to 25cm with average total lesion length of 12.5cm, and 93% were in the superficial femoral artery (“SFA”). The PATENT registry follow up was completed in June 2012, and we will collaborate with the physician investigators to publish complete registry results, which we expect will occur in early 2013.
The PATENT registry serves as a feasibility study for the EXCITE ISR trial. Although we believe the interim PATENT registry results are favorable, these results may not predict the results of the EXCITE ISR trial. Moreover, because there is no control group in a registry, registry results are not as reliable as the results of a controlled clinical trial.
We are supporting a physician-sponsored pilot study evaluating the use of laser ablation followed by a paclitaxel-coated angioplasty balloon (“PTX PTA”) compared with the use of PTX PTA alone in the treatment of in-stent lesions in above-the-knee arteries. This pilot study, Photoablation Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in Instent Femoro-popliteal Obstructions, or PHOTOPAC, is not intended to be used to gain an indication in the U.S. for the use of PTX PTA with laser, but to determine whether the use of laser with PTX PTA provides a benefit over PTX PTA alone and to provide data for potential future studies. The planned enrollment for the PHOTOPAC trial is 50 patients, who will be followed at one, six and 12 months after the procedure. Our support of the PHOTOPAC trial is in the form of an unrestricted research grant. The pilot study is being conducted at up to four sites in Germany. As of November 2, 2012, two sites are approved to enroll in the study and 28 patients have been enrolled.
Research, development and other technology. Research, development and other technology expenses of $4.2 million for the three months ended September 30, 2012 decreased $0.5 million, or 12%, compared with the three months ended September 30, 2011. We expect these expenses to increase as a percentage of revenue in the fourth quarter of 2012 and into 2013, as we increase headcount and otherwise expand our overall product development activities. Product development costs decreased by nearly $0.6 million compared with the third quarter of 2011 due to a temporary decrease in project activity, as project teams transitioned from completed projects to new products.
Clinical studies costs increased by approximately $0.4 million compared with the third quarter of 2011 primarily due to costs related to the EXCITE ISR trial.
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Presentation on January 10th, 2013, 10:30 AM Pacific Time.
A recording of this presentation will be posted
for on-demand playback after editing.
Please check back later."
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