IRVING, TX – April 30, 2020 – 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 El Capitan Anterior Lumbar Interbody Fusion (ALIF) System.
El Capitan was designed to provide the widest array of interbody and fixation options, along with the most efficient and streamlined supporting instrumentation on the market today.
“With the increased adoption and utility of anterior column reconstruction, we aimed to provide a system that accommodates the demanding clinical needs for this procedure,” said Thomas Purcell, Co-founder and Vice President. “Our surgeon design partners and engineering team addressed the current technological gaps in efficiency while incorporating additional fixation versatility into a single system to deliver another best-in-class technology to our ever-growing portfolio of solutions.”
Expanding on the foundation of success from the company’s previous interbody spacer technologies, El Capitan provides the choice of either HA PEEK or Acid-etched Titanium interbody spacers in an extensive array of heights, widths, and lordotic options.
The system also provides the flexibility for additional plating and fixation options in an effort to tailor to the specific needs of each patient. The plating options from El Capitan allow for a Zero-Profile, Half Plate, or Full Plate that can be implanted in combination with the interbody. By providing either Anchoring Nails or Screws, which can be delivered via multiple techniques including an All-in-One option, El Capitan can accommodate the wide variance of anatomical challenges presented in anterior lumbar surgery.
El Capitan is the company’s second technology platform providing a combined interbody and fixation option to receive 510k approval within the last month. Later this year, the company is scheduled to release another combined technology for Anterior Cervical Discectomy Fusion (ACDF).
IRVING, TX – April 14, 2020 – 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 Sirion Lateral Lumbar Interbody Fusion (LLIF) System.
From initial access with the retractor to the interbody and plating options, the Sirion LLIF System delivers unprecedented intraoperative flexibility and efficiency by providing a complete procedural solution for lateral surgery driven by surgeon preference.
“Since the outset of the design process, our goal was to develop a system that could address the wide array of procedural and anatomical challenges presented in lateral surgery,” said Thomas Purcell, Co-founder and Vice President. “Once again, our surgeon design partners and engineering team have exceeded expectations to bring another best-in-class MIS platform to market.”
The Sirion retractor was developed internally to ensure the intricate design details and quality benchmarks that the company has become renowned for were achieved. This resulted in a retractor that allows for access customization by offering a 2 or 3 blade configuration, with each blade having infinite, independent distraction and toeing capability. An optional anterior blade is also offered in multiple widths, as well as various shims and bone pins to allow surgeons the ability to further tailor the access and rigidity of the retractor to the unique needs of each patient.
Building from the well-established success of previous systems within the company’s portfolio, Sirion provides interbody spacers in either HA PEEK or Acid-etched Ti in a wide range of lengths, widths, heights, and lordotic options. When additional fixation is required, lateral plating options in either a 1, 2, or 4 hole configuration are available, which can be implanted in combination with the interbody or in-situ after the interbody has been placed for maximum versatility.
The launch of Sirion represents the first platform from Astura with a combined interbody and fixation option in a single system. The company is scheduled to release additional combined technology for Anterior Lumbar Interbody Fusion (ALIF) and Anterior Cervical Discectomy Fusion (ACDF) in the coming months.
Astura Medical, a high-growth, innovative spine technology company,
today announced the relocation of its corporate headquarters from Carlsbad, California to Irving, Texas, effective November 4, 2019.
The company’s new 40,000 square foot facility will provide an expanded framework to support its current growth and future expansion. The company’s operations, including research and development, finance, accounting, marketing, sales, customer service, quality control, shipping/receiving, and professional education, including a new state-of-the-art cadaver lab and training center, will be housed in the new headquarters.
“We’re excited for the next phase of growth and development for our organization,” said President & CEO, Joel Gambrell. “Our new facility will provide the necessary infrastructure to continue to build upon our current momentum as one of the fastest growing companies in spine today. The increased operational capabilities will allow us to further improve upon our capacity to deliver best-in-class technology and continue to meet the ever-increasing demand for our technology from our surgeon, distributor, and hospital partners, both today and in the years ahead.”
Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.
The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.
Astura Medical, a high-growth, innovative spine technology company, and Academy Medical, a Service-Disabled Veteran-Owned Small Business (SDVOSB) with priority status with government purchasing agents, today announced their partnership for contracting within the Department of Defense (DoD) and VA.
Academy Medical’s goal is to provide sales channels, via contracts, to appropriate medical and surgical vendors, ultimately creating a streamlined, more efficient process for government purchasing agents. Astura Medical’s partnership with Academy Medical will help advance their penetration into the VA and DoD marketplace – resulting in better healthcare for our veterans and active military members and their families.
When looking for businesses to collaborate with in order to provide best-in-class technology to hospitals and physicians, Ryan Isham, Vice President of Med/Surg at Academy Medical, said, “It is our goal is to partner with manufacturers that can provide the solutions, currently and in the future, that can help us provide value to the government while increasing the level of care veterans, active duty military, and their families receive. Through our partnership with Astura, we will be able to further deliver on that goal.”
Astura has established itself as one of the fastest growing companies in spine today, with annual revenue growth of 312% in 2017 and 104% in 2018. The company was founded in Dec. 2014 around a disciplined, multi-phased approach to the development, manufacturing, and distribution of spinal instrumentation and implants. The company’s unique approach has led to a number of innovative technologies such as their recently commercialized solutions – Half Dome X Expandable Posterior Lumbar Interbody System and Olympic MIS Posterior Spinal Fixation System.
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 graft delivery system within the inserter, maximize bone graft volume and endplate contact. The wide array of implant options and expansive instrumentation delivers a streamlined, efficient procedural sequence that can address even the most difficult pathologies through multiple approaches.
“I’m thrilled by the effort of our engineers and surgeon design team partners, as we were able to solve the existing challenges in the expandable posterior interbody marketplace to create what we believe to be a best-in-class system,” said Thomas Purcell, Co-founder and Vice President.
Half Dome X is now commercially available in multiple footprint, height, and lordotic options for PLIF, OTLIF, and TLIF procedures. In addition to the launch of their first expandable spacer, Astura will be introducing its Cervical Corpectomy Cages and additional Deformity Solutions in the coming months.
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 surgeon, distributor, and hospital partnerships, year after year, reflects the value that our technology delivers to their patients, which is our ultimate goal.”
In addition to more than doubling revenue in 2018, the year was highlighted by a number of other achievements for Astura. The company was able obtain 510k approvals for their Olympic MIS System, Olympic Navigation Instruments, and Bridalveil OCT Navigation Instruments, as well as bringing on additional inventory and personnel to support the increased demand for the company’s technology.
“2019 is shaping up to be another banner year for our organization,” stated Mr. Gambrell. “We foresee further growth coming from our currently available procedural solutions, along with significant growth from our recently released MIS Percutaneous Screw System and additional product launches including Expandable Posterior Lumbar Interbody Cages, Cervical Corpectomy Cages, and additional Deformity Solutions in the coming months.”
Astura will be showcasing their latest technology at Booth 2304 during the American Academy of Neurological Surgeons (AANS) Annual Meeting, taking place in San Diego, April 14th-16th.
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.
In such a scenario, breaking all barriers in quality medical device development and distribution is Astura Medical, a high-growth and innovative spine technology company. Founded in 2014, Astura Medical is governed by a single aim: to bring best-in-class instrumentation and implants to independent distributors and their surgeons. As such, the company doesn’t have physician ownership and steers away from any physician-owned distributorships, while adopting best practices at every stage of developing, manufacturing, and commercial distribution of its technology.
Joel Gambrell, Co-Founder, President, and CEO of Astura Medical and an industry veteran with two decades of experience in medical device sales and distribution, says, “In my years of service I noticed how the market was burgeoning with new players, but very few companies aced the sophistication that spinal instrumentation requires. Instead, companies were spending significant time and resources to develop customized solutions to fill the voids of their systems in order to keep up with the demands of surgeons.” Given their precise engineering, high speed to market, and above all a passion for innovation, today Astura Medical is gaining significant momentum and a reputation for delivering high-quality solutions that is impressive for a startup company given the company’s short time being in the market.
Unlike other manufacturers that provide generic or standard instruments, what makes Astura Medical a cut above the rest is their attention to detail for every aspect of each device. “Leveraging our many years of experience as well as valuable surgeon input, we bring to the table instrumentation that is crafted to perfection in terms of balance, aesthetics, ergonomics, and functionality,” states Gambrell.
The company has successfully delivered numerous projects to the market, all in 15 months or less. Astura’s current portfolio includes three different material options for its interbody portfolio cages including acid-etched titanium, PEEK, and Hydroxyapatite (HA) PEEK available for ACDF’s, PLIF’s, TLIF’s, or OTLIF’s. To complement its interbody portfolio, Astura provides a maximum angle anterior cervical plating system, as well as a thoracolumbar fixation system with several pedicle screw options including three different thread pitch options in dual-lead, cortical cancellous, or full cortical. The latest addition to its solution suite is Bridalveil OCT, the most comprehensive posterior occipital-cervical-thoracic system on the market today that has empowered surgeons to treat even the most complex cases with ease.
To throw better light on Astura Medical’s unique value proposition, Gambrell gives an example of a surgeon who struggled for years to attain the right cervical plate accommodating for the varying patient anatomy in their practice. On opting for Astura Medical’s system that features a lagging capability with an easy, yet reliable and robust locking mechanism, the surgeon could complete his cases with confidence every time. As a result of their cutting-edge solutions, the company witnessed an annual revenue increase of 312 percent last year. They also attained a significant credit line from the Bank of America to which Gambrell remarked, “Just the fact that a prominent bank is partnering with us at this stage, self-explains our strong financial position and the ingenuity of our solutions.”
In the coming months, Astura will launch two more systems—an Expandable Lumbar Interbody System and Minimally Invasive Screw System. Then in 2019, the company will bring a Lateral Lumbar Interbody Fusion (LLIF), Standalone Anterior Lumbar Interbody Fusion (ALIF), and a Standalone cervical ACDF system to market. Given their strong game plan and quality solutions, there is no contending that Astura Medical brings to the market the most superior medical devices that a distributor can get.
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 extensive offering of pedicle screw options, including iliac fixation, in either an extended tab (no assembly) or tower/screw (single step assembly) option. Designed to address even the most complex pathologies, Olympic MIS provides the versatility to accommodate multiple rod diameters in either titanium or cobalt chrome in pre-bent lordotic, straight, or pre-bent kyphotic options. The instrumentation further supports a streamlined and reproducible procedural sequence by providing up to 50mm of reduction, along with multiple options for compression or distraction, including the ability to span multiple levels simultaneously.
“With the increasing rates of MIS adoption and further complexity of pathologies being treated, it was paramount that we addressed the wide range of techniques that surgeons are currently utilizing,” said Joel Gambrell, President and CEO of Astura. “I’m proud of the system that our team of engineers and surgeon designers developed. Olympic MIS once again accomplishes our goal of continuing to bring technology to the market that further enhances the ability of our surgeon partners to provide the best in patient care.”
The full commercial release for Olympic MIS in December represents the fourth differentiated technology delivered to the market by the company in 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 coated, into the PEEK-OPTIMA matrix, ensuring it is present on all surfaces and throughout the implant.
“As surgeons continue to explore different surface technology options, we are excited about the addition of HA PEEK to our suite of interbody solutions,” said Thomas Purcell, Vice President of Astura Medical. “It once again reinforces Astura’s commitment to providing our surgeon partners with differentiated technology to enhance their ability to provide the best in patient care.”
ALTA and HALF DOME HA PEEK are now commercially available in multiple footprint, height, and lordotic options for ACDF, PLIF, and TLIF procedures. In addition to the launch of their HA PEEK lineup, Astura will be introducing its MIS Percutaneous Screw System and Expandable Posterior Lumbar Interbody Cages later this year.
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 by a number of other achievements for Astura, including the 510k approval and initial release of the BRIDALVEIL Occipital-Cervico-Thoracic (OCT) System, several key personnel hires, and significantly increasing inventory to support the rising demand for the company’s product portfolio.
“As we look ahead, we anticipate further growth to come from the continued success of our Phase One suite of products and our recent full commercial release of Bridalveil OCT,” stated Mr. Gambrell. “Our current momentum combined with the scheduled launch of our MIS Platform later this year, which will include an MIS Percutaneous Screw System and Expandable Posterior Lumbar Interbody Cages, positions us well for a strong performance in 2018.”
