CARLSBAD, Calif., Oct. 18, 2022 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the full commercial launch of the 7D FLASH™ Navigation System Percutaneous Spine Module. The release of the Percutaneous Module represents a new application and increased functionality for its 7D FLASH Navigation System, which now allows SeaSpine to further penetrate the minimally invasive spine surgery market, which SeaSpine estimates at approximately $4 billion worldwide.
“The addition of the Percutaneous Module to the FLASH Navigation System has brought versatility to my OR,” stated Dr. Douglas Orndorff of Spine Colorado. “Whether I am performing mini-open procedures, large revision surgeries, or MIS fusions, I can do them all with one system that optimizes my workflows depending on my approach. I’m also excited about the future launch of the Lumbar Facet Fusion system that will work seamlessly with the Percutaneous Module, enabling an integrated procedural solution for my patients.”
The 7D FLASH Navigation System uses visible light to create a three-dimensional image for surgical navigation in just seconds, which is expected to result in shorter and more efficient spinal procedures. It is the only marketed image-guidance system that utilizes novel and proprietary camera-based technology, coupled with machine-vision algorithms, to eliminate the long-standing frustrations with legacy surgical navigation platforms. The speed, accuracy, and efficiency of machine-vision technology is intended to provide significant economic value, lower radiation for staff and patients in open procedures, and harnesses the true potential of image-guided navigation – providing a truly unique offering for both open and minimally invasive spine procedures. 
“Our Percutaneous Module has expanded the clinical functionality of the FLASH Navigation System by providing surgeons with a fully integrated procedural solution for minimally invasive surgery,” said Dr. Beau Standish, President of Enabling Technologies at SeaSpine. “This new application addresses a large and important part of the spine navigation market and should help drive adoption of our FLASH Navigation System among surgeons, hospitals and ambulatory surgery centers.”
About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development, and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine’s complete procedural solutions feature its market-leading FLASH™ Navigation, a system designed to improve accuracy of screw placement and provide a cost-effective, rapid, radiation-free solution to surgical navigation, and a comprehensive portfolio of spinal implants and orthobiologics to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to facilitate spinal fusion in degenerative, minimally invasive surgery (MIS), and complex spinal deformity procedures on the lumbar, thoracic and cervical spine. With product development expertise in advanced optics, software, orthobiologic sciences and spinal implants, SeaSpine can offer its surgeon customers a complete solution to meet their patients’ evolving clinical needs. SeaSpine currently markets its products in the United States and in approximately 30 countries worldwide.
Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the future launch of the Company’s Lumbar Facet Fusion system and its ability to work with the Percutaneous Module; the expectation that the 7D FLASH Navigation System will result in shorter and more efficient spinal procedures; the ability of the 7D FLASH Navigation System to eliminate the long-standing frustrations with legacy surgical navigation platforms and to provide significant economic value and harnesses the true potential of image-guided navigation in surgical procedures; and the ability of the 7D Percutaneous Spine Module to help drive adoption of the FLASH Navigation System among surgeons, hospitals and ambulatory surgery centers. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the ability of the 7D FLASH Navigation System to perform as designed and intended and to meet the needs of surgeons and patients; risks inherent in the use of novel imaging techniques, including advanced optical technologies and machine vision-based registration algorithms; unexpected delays in the support and/or launch of the 7D Percutaneous Spine Module or other next generation or new applications of the 7D FLASH Navigation System, including the fact that newly launched products may require substantial additional development activities, which could introduce further delays, or as a result of obtaining regulatory clearances; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.
Investor Relations Contact
Greg Chodaczek
610-368-6505
ir@seaspine.com
Wow! That is not good for the entire industry. Why do you think they went bust?
Wow! That is not good for the entire industry. Why do you think they went bust?
The strategy of building a Direct Sales force was misguided. They burned through money too fast and the sales were too light to offset the burn. If your company lacks true innovation, you can’t be successful selling through a direct sales model. As frustrating as selling through distributors is, at least your sales costs are fixed. This was a sad case of copying the Kyphon sales model without a “kyphon-like” product to support it.
Their CEO is a very talented guy, who unfortunately lacked the necessary experience in spine to avoid the $75MM mistake.
The strategy of building a Direct Sales force was misguided. They burned through money too fast and the sales were too light to offset the burn. If your company lacks true innovation, you can’t be successful selling through a direct sales model. As frustrating as selling through distributors is, at least your sales costs are fixed. This was a sad case of copying the Kyphon sales model without a “kyphon-like” product to support it.
Their CEO is a very talented guy, who unfortunately lacked the necessary experience in spine to avoid the $75MM mistake.
I agree that this is an isolated incident, and not indicative of the spine industry as a whole. The spine industry will continue to grow (though perhaps not at their current double digit growth levels), and there will continue to be room for innovators in the spine implant space. That said, companies like IST, that only have “me too” products and limited or no Intellectual Property coverage for their devices, will continue to be squeezed out of the market. This bodes poorly for the vast majority of small “me too” pedicle screw companies (there are currently over 250 different pedicle screw systems, I believe) that have been presenting at the SAS and NASS meetings over the past few years…
I agree that this is an isolated incident, and not indicative of the spine industry as a whole. The spine industry will continue to grow (though perhaps not at their current double digit growth levels), and there will continue to be room for innovators in the spine implant space. That said, companies like IST, that only have “me too” products and limited or no Intellectual Property coverage for their devices, will continue to be squeezed out of the market. This bodes poorly for the vast majority of small “me too” pedicle screw companies (there are currently over 250 different pedicle screw systems, I believe) that have been presenting at the SAS and NASS meetings over the past few years…
As I stated, during the Wall Street heyday investors were throwing money at companies with no rhyme or reason. At best, IST had a “me too” product portfolio that was conceived in vitro in Plano, Texas. The expectations for the Axient DSS were hopeful at best. Based on the current market conditions and questions from the FDA on DSS, where was this company going? Look at what has happened with Applied Spine, Raymedica and Disc Motion Technology. Who will be next? Maybe this will be an antidote for the “Entrepreneurial Fever” that has become so pervasive within our industry? Just because someone has the wherewithal to sell a company or raise capital doesn’t qualify them to run a company, yet, there are many of those people in our profession. All of us can sit back and play Monday morning quarterback. Why hasn’t anyone questioned the Board of Directors, the Surgeons involved, and the Investors on who was monitoring the actions of the Executive Management Team if there were so many signs? Having launched products over the last ten years, building forecasts and revenue models I can only ask; What were they doing with this money?
As I stated, during the Wall Street heyday investors were throwing money at companies with no rhyme or reason. At best, IST had a “me too” product portfolio that was conceived in vitro in Plano, Texas. The expectations for the Axient DSS were hopeful at best. Based on the current market conditions and questions from the FDA on DSS, where was this company going? Look at what has happened with Applied Spine, Raymedica and Disc Motion Technology. Who will be next? Maybe this will be an antidote for the “Entrepreneurial Fever” that has become so pervasive within our industry? Just because someone has the wherewithal to sell a company or raise capital doesn’t qualify them to run a company, yet, there are many of those people in our profession. All of us can sit back and play Monday morning quarterback. Why hasn’t anyone questioned the Board of Directors, the Surgeons involved, and the Investors on who was monitoring the actions of the Executive Management Team if there were so many signs? Having launched products over the last ten years, building forecasts and revenue models I can only ask; What were they doing with this money?
As I stated, during the Wall Street heyday investors were throwing money at companies with no rhyme or reason. At best, IST had a “me too” product portfolio that was conceived in vitro in Plano, Texas. The expectations for the Axient DSS were hopeful at best. Based on the current market conditions and questions from the FDA on DSS, where was this company going? Look at what has happened with Applied Spine, Raymedica and Disc Motion Technology. Who will be next? Maybe this will be an antidote for the “Entrepreneurial Fever” that has become so pervasive within our industry? Just because someone has the wherewithal to sell a company or raise capital doesn't qualify them to run a company, yet, there are many of those people in our profession. All of us can sit back and play Monday morning quarterback. Why hasn't anyone questioned the Board of Directors, the Surgeons involved, and the Investors on who was monitoring the actions of the Executive Management Team if there were so many signs? Having launched products over the last ten years, building forecasts and revenue models I can only ask; What were they doing with this money?
As I stated, during the Wall Street heyday investors were throwing money at companies with no rhyme or reason. At best, IST had a “me too” product portfolio that was conceived in vitro in Plano, Texas. The expectations for the Axient DSS were hopeful at best. Based on the current market conditions and questions from the FDA on DSS, where was this company going? Look at what has happened with Applied Spine, Raymedica and Disc Motion Technology. Who will be next? Maybe this will be an antidote for the “Entrepreneurial Fever” that has become so pervasive within our industry? Just because someone has the wherewithal to sell a company or raise capital doesn't qualify them to run a company, yet, there are many of those people in our profession. All of us can sit back and play Monday morning quarterback. Why hasn't anyone questioned the Board of Directors, the Surgeons involved, and the Investors on who was monitoring the actions of the Executive Management Team if there were so many signs? Having launched products over the last ten years, building forecasts and revenue models I can only ask; What were they doing with this money?