SeaSpine Holdings Corp. (SPNE) stock prices were down by 4.41% as of the market closing on July 7th, 2021, bringing the price per share down to USD$18.84 at the end of the trading day. After-hours trading saw the stock surge by 20.59%, bringing it up to USD$22.72.
510(k) Clearance
July 8th, 2021 saw the company announce the U.S Food and Drug Administration having granted 510(k) clearance for its 7D Percutaneous Spine Module for minimally invasive surgery, thus facilitating a new application and increased functionality for the 7D Flash Navigation System. The news followed the company’s recent acquisition of 7D surgical, with SPNE anticipating a limited release of the Percutaneous Spine Module in the third quarter of 2021.
Scope of Treatment
The 510(k) clearance will facilitate the addressing of a crucial segment of the spine navigation market, thus helping the company round out its FLASH Navigation Spine portfolio. The MIS application is expected to be a valuable enhancement for ambulatory hospitals and surgery centers.
7D FLASH Navigation System
The 7D FLASH Navigation System creates a 3-D image using visible light in a matter of seconds. These images are used in surgical navigation and are expected to result in shorter and more efficient spinal procedures. Following the announcement of the 510(k) clearance, the system is the only cleared image guidance system that makes use of the company’s proprietary and unique camera-based technology. In conjunction with machine-vision algorithms, the system is designed to eliminate critical issues with legacy surgical navigation platforms. The machine-vision technology will provide significant economic value with its unparalleled speed, accuracy, and efficiency.
Launch of Waveform L System
June 8th, 2021 saw the company announce the limited commercial launch of its 3D-printed WaveForm L Interbody System, which was designed for the lateral lumbar interbody fusion procedure. It seamlessly integrates with the entirety of the Regatta NanoMetalene lateral interbody portfolio, including the recently launched Regatta Lateral Plate. The system is designed to deliver a fully porourinterbopdy solution with a graft aperture, which is designed to accommodate a substantial amount of SPNE’s leading allograft demineralized bone matrix offerings, OsteoStrand and OsteoStrand Plus.
Future Outlook for SPNE
Armed with the FDA clearance that will facilitate and accelerate the commercialization of the company’s flagship candidate, SPNE is poised to capitalize on the opportunities afforded by the expanded scope of the development of the treatment. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.
