SurGenTec® Announces FDA Clearance for Neurostimulation with ALARAtm Access Needle Kit

SurGenTec, a privately held spine and orthopedic technology company, announced today it has received FDA clearance for a neurostimulation indication for their ALARA Neuro Access Needle Kit. The ALARA system is used for targeting and assisting in cannulating a pedicle. Targeting needles are generally the first instrument used to perforate the pedicle wall before advancing a guidewire, tap or pedicle screw.

"We are thrilled to announce the addition of the neurostimulation indication for our ALARA Neuro Needle Kit," said Travis Greenhalgh, Founder and Chief Executive Officer of SurGenTec, "This enhancement to our system provides yet another level of safety in pedicle screw fixation and has the potential to decrease the risk of nerve injury for the patient during this intricate procedure."

Developed and marketed by SurGenTec, the ALARA Neuro needle has an insulated depth stop that allows surgeons to choose the needle depth desired before advancing into the pedicle. Once the ALARA needle is in the pedicle it can be electrically stimulated to determine the proximity to the peripheral nerve root. By adding the neurostimulation capability, the surgeon can now determine a safe trajectory with the needle before advancing a tap or pedicle screw. This extra safety check provides surgeons with another barrier to help avoid nerve injury. SurGenTec offers various configurations of the ALARA needle that can be used with or without neurostimulation.

Upcoming Conference Participation

The company will have a commercial exhibit at the upcoming North American Spine Society (NASS) meeting in Chicago, IL September 25-28, 2019. Exhibit #2107.

In addition to the above mentioned ALARA Access Needle Kit, the Company's GraftGun® Universal Graft Delivery System will be showcased including the recently launched pre-filled MIS cartridge options containing ViBone® viable bone matrix. This novel bone matrix was developed by Aziyo® Biologics as a next generation bone graft. Pre-filled MIS cartridges are designed to reduce thawing time, avoid cross contamination and improve delivery performance.

About SurGenTec

SurGenTec is a privately owned medical device company based out of Boca Raton, FL that strives to bring the next level of technology to the spine and orthopedic industry. SurGenTec develops and manufactures innovative products with patient and surgeon safety in mind. For more information, visit SurGenTec.com

About Aziyo Biologics

Aziyo Biologics is a fully integrated, commercially oriented regenerative medicine company. Since its founding in 2015 the Company has expanded through acquisitions and strategic partnerships, creating a high growth commercial entity. Its proprietary products are used in orthopedic, cardiovascular and other medical specialties. For more information, visit Aziyo.com