We are a medical device company focused on the design, development and marketing of products for spine disorders. We are developing an innovative, minimally invasive implant for spinal fusion surgeries, which we plan to package and sell with an array of complementary products if it is cleared orapproved for marketing. We are committed to continuously innovating, improving, and expanding our product line to accommodate any and all surgeons, methods, and areas of spinal surgery on a global scale.
Our core technology and product candidate is our “one-size-fits-all” expandable and adjustable cage implants that have the potential to improve the safety, quality and efficiency of spinal fusion surgeries (our “Sagittae Expandable Cage”). In June 2018, we submitted a 510(k) to the United States Food and Drug Administration (“FDA”) for our Sagittae Expandable Cage. We expect to receive clearance to market the Sagittae Expandable Cage during the second half of 2018. No assurances can be made that the Sagittae Expandable Cage will be cleared by the FDA during the stated timeframe or ever. If it is cleared for marketing, we plan to complement the Sagittae Expandable Cage with: (1) a lateral access system, designed to help surgeons operate, which we have branded as our “SpineEX Scorpio Retractor” (the “Scorpio Retractor”); (2) certain disposable accessories that complement the Scorpio Retractor, including a dilator and Kirschner wire, or K-wire (the “Disposable Accessories”), which we plan to sell with the Scorpio Retractor; and (3) the Herculaes™Sterilization Container (the “Herculaes Sterilization Container”) which is designed to protect surgical instruments during cleaning, packing, sterilization, transportation and storage, with the goal of reducing wear and tear of instruments. We intend to market and sell our products as a total solution to surgeons in spinal fusion surgeries, and initially plan to sell this package in the U.S. We plan to manufacture the Sagittae Expandable Cage, but will rely on our existing supply and manufacturing arrangements for the manufacture and production of the Scorpio Retractor, the Disposable Accessories and the Herculaes Sterilization Container. The Herculaes Sterilization Container is currently approved for sale in China, but we will need to obtain FDA approval or clearance before we are allowed to market and sell the Herculaes Sterilization Container in the US. We are able to sell the Scorpio Retractor and the Disposable Accessories in the US, but do not plan to do so until we have approval to sell our other intended products. To date, we have not generated any revenues from our current products and product candidates.
In a survey conducted in 2009, the Mayo Clinic found ‘back problems’ to be the third most common complaint among patients seeking healthcare in a defined U.S. population. With an average of 600,000 spinal surgeries performed in the U.S. and over 2.5 million performed globally each year, the need for improved interbody fusion cages (“implants”) and a more efficient and effective spine surgical process has become increasingly more critical. The current implants available on the market come in a variety of sizes and shapes, often totaling upwards of 120 implants and tools required for one procedure, and these traditional implants are not time or cost efficient. The trend toward minimally invasive spinal surgeries calls for better navigation and positioning tools to facilitate the accuracy and efficiency of surgeries. We believe that we can solve most of these challenges by creating a lineup of implants and accessories that simplify and ensure the efficiency and effectiveness of surgeries and shorten recovery time, so the patient can return to a more active and pain-free life.
1. Sagittae Expandable Cage
2. Scorpio Retractor
3. Disposable Accessories
4. Herculaes Sterilization Container ----
Our business was incorporated in Delaware on March 9, 2017. Our principal executive offices are located at 4046 Clipper Court, Fremont, CA 94538. Our telephone number is 510-573-6165. Our website is www.SpineEXinc.com.展开