Press Releases
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Astura Medical Receives FDA 510(k) Clearance For HALF DOME X Expandable Posterior Lumbar Interbody System
Authored: May 6, 2019
Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Half Dome X Expandable Posterior Lumbar Interbody System. The Half Dome X system delivers a new level of intraoperative flexibility and efficiency by providing infinitely adjustable expansion of height and width of the interbody spacer for a controlled restoration of disc height and optimized fit. These features, coupled with acid-etched endplates of the implant and an integrated bone …
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Astura Medical Reports 104% Annual Revenue Growth in 2018
Authored: March 25, 2019
CARLSBAD, CA – March 22, 2019 – Astura Medical, a high-growth, innovative spine technology company, today reported an annual revenue increase of 104% for the full year ending Dec. 31, 2018. “We’re proud of the successful performance by our team in 2018. To more than double our revenue for the third consecutive year further solidifies our position in the marketplace as one of the fastest growing companies in spine today,” said Joel Gambrell, Co-founder & CEO. “The increasing number of our …
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Astura Medical Perfecting the Art and Science behind Spine Technology
Authored: January 23, 2019
The US spinal implant market is currently the largest in the world, standing at $12 billion and estimated to reach $17 billion by 2021. Despite the massive growth rate, when it comes to quality medical device supply, the industry appears to have fallen short outside of the large mainstay players at the top. The increasing complexity of devices, rising cost pressures, and the murky intent of physician-owned distributorships all contribute to the widening gap in optimal product quality and performance. …
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Astura Medical Receives FDA 510(k) Clearance For OLYMPIC MIS Posterior Spinal Fixation System
Authored: November 26, 2018
Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Olympic Minimally Invasive Surgery (MIS) Posterior Spinal Fixation System. The Olympic MIS system delivers a new level of intraoperative flexibility and efficiency by allowing surgeons to customize to their preferred workflow through the utilization of either a traditional jamshidi/guide wire technique, awl-tap wireless technique, or single-step wireless technique for the placement of MIS pedicle screws. The system features an …
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Astura Medical Receives FDA 510(k) Clearance For Cervical and Lumbar HA PEEK Interbody Systems
Authored: June 4, 2018
Astura Medical, a high growth, innovative spine technology company, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ALTA ACDF Interbody Spacers and HALF DOME Lumbar Interbody Spacers in PEEK-OPTIMA™ HA Enhanced from Invibio Biomaterial Solutions. Combining the clinically proven strength and versatility of PEEK-OPTIMA with Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, PEEK-OPTIMA HA Enhanced provides an innovative biomaterial for interbody fusion devices. HA is fully integrated, not …
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Astura Medical Reports 312% Annual Revenue Growth in 2017
Authored: March 14, 2018
Astura Medical, a high-growth, innovative spine technology company, today reported an annual revenue increase of 312% for the full year ending Dec. 31, 2017. “Our market-leading growth rate in 2017 can be attributed to a number of factors, but it’s our rapidly increasing network of surgeon and distributor partners throughout the country that is the real validation on the quality of our technology and performance of our team,” said Joel Gambrell, President and CEO of Astura Medical. 2017 was highlighted …
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Astura Medical Announces Initial Cases and Full Commercial Release For BRIDALVEIL OCT Stabilization System
Authored: February 21, 2018
Astura Medical, a high growth, innovative spine technology company, announced today the completion of the initial surgeries and full commercial release for its BRIDALVEIL Occipital-Cervico-Thoracic (OCT) System. The first cases were successfully completed at multiple hospitals across the country, including at the University of Colorado Hospital by Dr. David Ou-Yang, Assistant Professor of Orthopedics. “Our practice addresses a wide range of complex conditions, so I’m always looking for the most advanced technology to meet our surgical demands,” said Dr. Ou-Yang. …
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Astura Medical Receives FDA 510(k) Clearance For BRIDALVEIL OCT Stabilization System
Authored: October 19, 2017
Astura Medical, a high growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s BRIDALVEIL Occipital-Cervico-Thoracic (OCT) System. “The FDA 510(k) clearance of our BRIDALVEIL OCT System, demonstrates the power of our innovation engine at Astura Medical and represents our best system released to date. We are excited for the opportunity to provide our rapidly expanding group of surgeon partners the most complete OCT technology offering …