Ascendx Spine, Inc. has received the ‘Spotlight’ award from SEMDA (Southeast Medical Device Association) as the best presentation at the Seventh Annual SEMDA Conference last week. As a result, Ascendx was asked to be a featured presenting company at AdvaMed 2013: The MedTech Conference, which will be held September 23-25, 2013, in Washington, D.C.
Ascendx Spine Wins Spotlight Award
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In December 2012, Ascendx received FDA 510(k) clearance for its Ascendx VCF Repair System. Previously, the company has received FDA clearance for its Ascendx Acu-Cut Vertebral Augmentation System. Both products, which are used to treat vertebral compression fractures (VCF), are also approved for marketing in Europe.
“We now have Ascendx positioned strongly for strategic partnerships and full commercial launch of our products globally, ” said Julian M. Mackenzie, President and CEO, Ascendx Spine, in the February 25, 2013 news release.
“We are grateful to SEMDA for this prestigious award, ” added Mackenzie. “Additionally, we look forward to presenting our story at AdvaMed 2013: The MedTech Conference, an international event of thousands of attendees, influential policymakers, strategic investors, CEOs, business development executives and media. This opportunity is ours as a direct result of winning the ‘Presenting Company Spotlight’ award during the 2013 SEMDA conference, and another great reason for emerging companies to participate in the SEMDA organization.”
“We have been traveling the country in pursuit of the most innovative medical technology companies, and were highly impressed with the quality of presentations at SEMDA, ” said Ray Briscuso, managing partner and producer, AdvaMed 2013: The MedTech Conference. “Because they received the Spotlight award, we’re glad Ascendx Spine will join us at our conference.”
As for future plans for strategic partnerships, Julian Mackenzie told OTW, “We intend to develop our business in such a way that will ensure the financial viability of the company and confirm the superior clinical outcomes that we demonstrated during our clinical trial. In so doing we are confident that we will attract significant interest from the strategic players in our industry. That being said we are open to consider all strategic partner enquiries. Initially we intend to launch in the U.S. (Florida) and Germany, where we plan to establish a significant presence on the ground.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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