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Additive Implants Announces FDA Clearance for SureMAX™-X Cervical Spacer
PRESS RELEASE UPDATED: FEB 18, 2020
PHOENIX, February 18, 2020 (Newswire.com) - Additive Implants, Inc. is pleased to announce it received regulatory clearance to market in the US its second product, the SureMAX™-X Cervical Spacer. This 3D printed titanium spacer has a unique patented* design to create uniform end plate coverage and optimize load distribution.
“Maximizing implant coverage of the endplates and providing for more uniform load distribution is important to minimizing implant subsidence. We accomplished this objective through a number of differentiated features on the spacer, including the posterior window and the eyebrow holes on the anterior surface,” said Bob Brosnahan, COO of Additive Implants.
The roughened porous and convex shaped surfaces maximize contact with the bony endplates. Large lateral windows facilitate radiographic confirmation of healing.
SureMAX™-X offers an industry-leading range of implant sizes; 7º, 10º and 14º lordotic and hyperlordotic angles with footprints of 12 x 14mm, 14 x 16mm, 15 x 18mm, and 15 x 20mm in heights of 5, 6, 7, 8, and 9mm.
Brosnahan added, “By using Euler’s Column Theory and limiting the implant’s height to 9mm, we were able to make SureMAX™-X less stiff than other titanium spacers.”
While in contrast, the SureMAX™ Cervical Spacer, Additive Implants’ first product launch, is more focused on bone implant interface and overall stability.
“We felt it was important for us as a company to offer choices of not just sizes but also design philosophies,” said Jeff Horn, VP Commercialization of Additive Implants. “We wanted surgeons to have multiple options to deliver the best surgical outcomes based on their technique preferences; whether they use Caspar pins, do bone sparing surgery or thoroughly debride the end plates.”
For more information, contact Jeff Horn at Additive Implants at 3101 East Shea Boulevard, Suite 122; Phoenix, Arizona; 85028; www.AdditiveImplant.com; (602) 418-6003.
* US Patent #10,299,938 and other patents.
SPRING 2019 ARIZONA INNOVATION CHALLENGE AWARDEES ANNOUNCED
PHOENIX, AZ (June 20, 2019) — The Arizona Commerce Authority (ACA) today announced the selection of ten awardees in the Spring 2019 Arizona Innovation Challenge (AIC), its business plan competition designed to advance innovation and technology commercialization opportunities in Arizona by helping early-stage ventures scale.
All AIC awardees will participate in Venture Ready, the ACA’s rigorous, year-long mentorship program that connects early-stage companies with other founders, senior executives and subject matter experts to further refine business plans and investor pitches. In order for the awardees to receive all of their non-dilutive funding, they will be required to successfully graduate from Venture Ready within 12 months.
“Congratulations to our Spring 2019 awardees! This group is a strong testament to the quality of entrepreneurial talent we have in Arizona,” said Sandra Watson, President & CEO of the Arizona Commerce Authority. “We look forward to helping these founders achieve their vision and scale their companies in our state.”
The ten Spring 2019 Arizona Innovation Challenge awardees are:
Additive Implants Inc., Bio & Life Sciences, Phoenix, AZ
Admiral Instruments, Advanced Manufacturing, Phoenix, AZ
AdviNOW Medical, Bio & Life Sciences, Scottsdale, AZ
BrightGuest, IT - Software, Gilbert, AZ
CATS Tonometer, LLC, Bio & Life, Sciences Tucson, AZ
Digitile, IT - Software, Phoenix, AZ
Innovative Construction Technology, IT - Software, Phoenix, AZ
LIGHTHOUSE, Bio & Life Sciences, Scottsdale, AZ
Remitter, IT - Software, Tempe, AZ
SafKan, Inc., Bio & Life Sciences, Tucson, AZ
The ACA will open applications for the next round of AIC competition in the fall of 2019. Companies located anywhere in the world may apply, as long as they plan to establish operations and commercialize their product or service in Arizona if they are selected as an awardee.
Connie Weber, (602) 845-1243, firstname.lastname@example.org
About the Arizona Commerce Authority
The Arizona Commerce Authority (ACA) is the state’s leading economic development organization with a streamlined mission to grow and strengthen Arizona’s economy. The ACA uses a three-pronged approach to advance the overall economy: attract, expand, create – attract out-of-state companies to establish operations in Arizona; work with existing companies to expand their business in Arizona and beyond; and help entrepreneurs create new Arizona businesses in targeted industries. For more information, please visit azcommerce.com and follow the ACA on Twitter @azcommerce.
PHOENIX, Arizona, March 12, 2019 – Additive Implants, Inc., a medical device company focused on using the power of additive manufacturing to address unmet surgeon needs, announces the FDA clearance of its first product, the 3D printed, titanium alloy SureMAX™ Cervical Spacer System.
“Failure to achieve sagittal alignment due to hardware design limitations still exists in ACDF procedures,” said Bob Brosnahan, COO with Additive Implants. “We’ve learned through extensive research with high volume cervical surgeons that stability at the bone-implant interface throughout the healing process may hold the key to better sagittal alignment and improved outcomes. The SureMAX™ Cervical Spacer was engineered with that stability in mind.”
The 3D printed, titanium alloy SureMAX™ Cervical Spacer offers a roughened porous surface with several unique features on the superior, inferior, and lateral aspects of the implant, designed to effectively engage bone on the vertebral endplates. These features combine to provide an ideal environment for fusion while also helping to resist rotational forces throughout the healing process.
“Surgeons look to device manufacturers for solutions to help them achieve proper sagittal alignment in their ACDF procedures, but too often limited options result in a “one size fits all” portfolio that falls short of expectations,” said Jeff Horn, VP Commercialization with Additive Implants. “We’ve achieved something special with the SureMAX™ spacer. The system offers a comprehensive suite of footprints and heights available in 7° lordotic and 14° hyperlordotic options that will provide surgeons seeking sagittal balance a solution for any patient pathology.”
Additive Implants will be launching the SureMAX™ Cervical Spacer System to the US Market at The Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves Spine Summit 2019 in Miami Beach, March 15-17, booth #410.
Independent distributors or surgeons interested in learning more about the new system should contact Additive Implants directly. (Contact Information Below)
For more information, contact Additive Implants at 3101 East Shea Boulevard, Suite 122; Phoenix, Arizona; 85028; www.AdditiveImplant.com; (602) 418-6003.