Innovasis Announces FDA 510(k) Clearance of LxHA™ Lateral Interbody Fusion Device

Company grows lateral spine portfolio with HA Enhanced PEEK interbody 

 SALT LAKE CITY, June 25, 2019 –Innovasis, Inc. an integrated research, development and manufacturing spinal device company, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of its LxHA™ Lateral Interbody Fusion Device.

The LxHA™ lateral interbody is comprised of PEEK OPTIMA® HA Enhanced*, providing osteoconductive properties that may improve fusion**. The company anticipates full commercialization later in Q3 2019.

“We are thrilled to be able to expand our market leading footprint in the HA PEEK market. The LxHA™ addition will allow surgeons to use this technology in the lateral market giving them access to the same great outcomes we have seen with our other HA PEEK products,” said Mike Wheelock, Vice President of Sales. “The LxHA™ interbody combined with our new next generation retractor system launched later in 2019 will provide the next disruptive clinically beneficial technology to the market.”

The LxHA™ interbody features a bullet shape nose for ease of insertion, a large central graft window for maximum graft packing capabilities, and pyramid shaped teeth that resist migration. These implants are used to facilitate fusion in the lumbar spine and are placed using a lateral approach. This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the implant device is intended to be packed with autograft.

About Innovasis, Inc.
Innovasis is a groundbreaking company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery.

Innovasis Media Contact
Hayley Hendrix, 801-261-2236
hhendrix@innovasis.com

 

*PEEK OPTIMA® is a registered trademark of Invibio Ltd.
**Study evaluated the in vivo response to PEEK-OPTIMA Natural, PEEK-OPTIMA HA Enhanced and allograft in a cervical spine fusion model in sheep. Data on file at Invibio. This has not been correlated with human clinical experience.

Innovasis HA PEEK Data Registry Reaches Significant Enrollment of 150 Patients

Innovasis HA PEEK Data Registry Hits 150 Patients  

 SALT LAKE CITY, May 13, 2019 – The Innovasis, Inc. HA PEEK Data Registry has reached significant enrollment of 150 patients from multiple participating surgeons since the registry was launched in late 2018. This milestone solidifies Innovasis’ commitment to the research and clinical data of their HA Enhanced PEEK technology.  

The HA PEEK Data Registry is a multicenter, observational, quality-assessment repository to track patient outcomes treated with HA PEEK. It allows surgeons to collect outcomes and fusion rates in a secure HIPAA-compliant database that can be accessed on a real-time basis. Currently 8 centers are participating in the registry with the intention to add more throughout the year.

“The HA PEEK Data Registry allows me to track my patients and trust my results,” said Dr. Timothy Bassett. “Innovasis’ HA PEEK interbodies provide a quick and more permanent resolution in pain for my patients and the registry is a user-friendly tool to show those results and improvements.”

The data collected in the HA PEEK Data Registry serves as an archive of clinical data on HA PEEK Interbody Fusion Devices. Innovasis offers a complete portfolio of interbody devices compromised of 80% PEEK and 20% integrated hydroxyapatite, providing osteoconductive properties that may improve fusion. For more information on the HA PEEK Data Registry and Innovasis products visit innovasis.com.

 

About Innovasis, Inc.

Innovasis is a groundbreaking company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery.

Innovasis Media Contact

Hayley Hendrix, 801-261-2236

hhendrix@innovasis.com

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Innovasis Hosts 8th Annual Spine Symposium

Innovasis hosts over 40 of surgeons at their 8th Annual Spine Symposium in Deer Valley, Utah.  

 SALT LAKE CITY, April 16, 2019 – Innovasis, Inc., successfully hosted their 8th Annual Spine Symposium at the Montage, Deer Valley in late February. Over 40 surgeon attendees participated in the symposium and joined in panel discussions.

This year’s symposium focused on a wide range of topics including: Patient Safety and Quality of Care, Anterior and Lateral Approaches to the Spine, Management of the Cervical Spine, Minimally Invasive Approaches, and Healthcare Economics. The sessions were moderated by chair’s Dr. Sigurd Berven and Dr. James Schwender and a highlight from Scott Becker.

“The content and location make the Innovasis course at the Montage one of the top learning programs on the spine calendar. This course brings together experts across the continuum of care for spinal disorders to discuss important issues in the management of spinal disorders, to learn from one another, and to work toward development of an evidence-based approach to appropriate spine care,” said Dr. Sigurd Berven, Symposium Co-Chair. “This comprehensive spine course offers a expert diverse faculty that continues to outperform. This is amongst the best courses in terms of up to date concepts and techniques of spinal care. I would highly recommend attending this course or in unbiased comprehensive review of the latest techniques,” said Dr. James Schwender, Symposium Co-Chair.

Innovasis would like to thank our Symposium chairman, faculty, and panel participants who made this year’s agenda and meeting a success. Video footage and presentations from the 8th Annual Spine Symposium can be accessed at https://www.innovasis.com/2019-symposium-presentations.

About Innovasis, Inc.
Innovasis is a groundbreaking company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery.

Innovasis Enters Partnership with Stability Biologics

Innovasis expands their footprint in the biologics market with Stability Biologics®

SALT LAKE CITY, November 19, 2018 – Innovasis, Inc., a fully integrated research, development and manufacturing spinal device company, today announced their expansion into the biologics market by signing a private-label agreement with Stability Biologics, LLC.  Stability Biologics®, headquartered in Nashville, Tennessee with a state-of-the-art AATB accredited and FDA registered tissue processing and distribution center in San Antonio, Texas will provide Innovasis with an expansive line of private labeled bone allograft tissue products including its flagship product Physio®.    

Physio® is a next generation physiologic bone tissue allograft manufactured through Stability’s proprietary patent-pending process and is comprised of 100% donated human tissue, with no added extrinsic carrier. The microstructure of Physio® retains growth factors, osteogenic proteins and CaP minerals while providing excellent handling characteristics.

“We are excited to begin a strategic partnership with Stability Biologics® which will provide Innovasis’ customers with a robust biologics platform to complement our instrumentation portfolio,” said David Oka, Director of Business Development and Clinical Affairs. “We anticipate Physio’s differentiated osteogenic microstructure will provide a potent ecosystem when used with our PEEK-OPTIMA HA Enhanced interbody platform.”

“The potential for working with a company like Innovasis is very exciting,” said Brian Martin, Chief Executive Officer of Stability Biologics®. “We foresee the opportunity of a truly synergistic partnership with our respective companies given our innovative allograft tissue products combined with Innovasis’ revolutionary product  offerings allowing us both to increase our respective customer base.”

Innovasis is excited to expand their footprint in the biologics market and anticipates commercialization of their private labeled product lines by December 2018.

About Innovasis, Inc.

Innovasis is a groundbreaking company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery.

 

About Stability Biologics®

Stability Biologics® is a leading provider of high quality proprietary and competitive allograft tissue products to physicians, hospitals and ambulatory surgery centers both domestically and internationally. Stability Biologics® provides a full line of human allograft tissue products available for distribution in the surgical fields of spine, orthopedics and wound care.

  

Innovasis Media Contact

Hayley Hendrix, 801-261-2236

hhendrix@innovasis.com

 

Stability Biologics® Media Contact

Brian Martin, 615-921-5551

bmartin@stabilitybio.com

Innovasis Announces Launch of TxHA™

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Innovasis receives 510K clearance and completes first surgery case with the TxHA TLIF interbody fusion device

SALT LAKE CITY, September 6, 2018 – Innovasis is pleased to announce the commercial launch of TxHA, ™ a TLIF interbody fusion device offering PEEK Optima HA Enhanced polymer.

 

Designed for use in spinal fusion procedures, the TxHA interbody device contains osteoconductive hydroxyapatite (HA) fully integrated into the polymer and exposed on all surfaces of the implant. This product follows the successful launch of Px HA (PLIF interbody) and Ax (Stand-alone ALIF) last year.

 

The first surgery was completed by Dr. Lavelle in Syracuse, NY. “The case went extremely well! The interbody and instrumentation is well designed and allowed for an easy and straightforward implantation. With this material technology you can expect better fusion rates.” said Dr. Lavelle. “HA PEEK is the future of PEEK interbodies.”

 

The Innovasis TxHA™ Transforaminal Lumbar IBF System is an intervertebral fusion

device for use in patients with degenerative disc disease (DDD) at one or two contiguous

levels of the lumbar spine (L2-S1). The implant is used to facilitate fusion in the lumbar spine and placed via a transforaminal approach. The TxHA implant also features a tapered leading edge to ease insertion, a convex profile to match anatomy, tantalum markers for improved visualization, and pyramidal teeth for migration resistance.

Innovasis Provides Business Update

Innovasis provided a business update related to recent organizational milestones.

Leadership Team Expansion

Innovasis is pleased to announce the recent expansion of their leadership team. Mike Wheelock was hired as Vice President of Sales and David Oka as Director of Business Development and Clinical Affairs.

“The addition of experienced industry veterans like David and Mike ensures Innovasis continues developing world-class distribution and supports our commitment to collect compelling clinical evidence for our evolving HA PEEK enhanced interbody platform,” said Innovasis President Mike English. “We are excited and honored to have them join our rapidly expanding team.”

Headquarters Groundbreaking

With continued company growth, Innovasis is excited to announce the groundbreaking of new headquarters in Salt Lake City, Utah. The 50,000 sq. ft. facility will include a two-station cadaver lab, in house manufacturing, and corporate offices.  

“This move will allow us to train our surgeon and distribution partners in an extraordinary setting, expand our manufacturing capabilities, and create operational efficiencies crucial to remain competitive in this market,” commented English.

36th Humanitarian Trip Completed

Innovasis completed their 36th humanitarian trip to Lima, Peru. This is the second humanitarian trip the company has completed in 2018. “Our humanitarian mission the past six years includes a total of 60 surgeon participants and over 200 spine and cranial cases completed. We are grateful for the expert staff, surgeons, and nurses that make it possible for Innovasis to continue improving patient healthcare in Peru,” said English.

Innovasis adds new Area Vice President

Ron Eckels AVP, North West

Ron Eckels AVP, North West

Ron has held numerous roles within sales, marketing and education. He started his career with DePuy Spine (now DePuy Synthes) in 1999. He has worked for NuVasive, Alphatec and most recently Medicrea.  Ron holds a BS Degree from Towson University in Baltimore, Maryland and an MBA from Pepperdine University Graziadio School of Business and Management in Malibu, California.  Ron and his wife Colleen have two young boys with a third on the way. They live in south Denver. When not working Ron enjoys working out, golf and coaching his boys’ soccer teams.

Please join us in welcoming Ron to the Innovasis family!

34th Humanitarian trip completed!

We have just finished our 34th Humanitarian trip to Peru! We had a successful trip due to our amazing staff, specifically the surgeons and nurses who took time out of their busy schedules to make this happen.  These trips have and can change lives, please take some time if you haven't and visit our humanitarian page to learn more.  

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Innovasis receives 510k for first Stand-Alone ALIF System made from PEEK-OPTIMA® HA Enhanced polymer

Ax Stand Alone ALIF

Ax Stand Alone ALIF

Innovasis, Inc. is the first company to receive US FDA 510(k) clearance for a Stand-Alone ALIF* System made from PEEK-OPTIMA® HA Enhanced polymer from Invibio®.  Designed for use in spinal-fusion procedures, the implantable Ax™ Stand-Alone ALIF System implants contain osteoconductive hydroxyapatite (HA) fully integrated into the matrix of the polymer and exposed on all surfaces of the body of the implant, including within the inner walls of the graft chamber.

This is the second PEEK-OPTIMA HA Enhanced device marketed by the company.  At the end of Q416 the company launched a PxHA a PLIF device made from the same material.

The Innovasis Ax Stand-Alone ALIF System is an intervertebral fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). The implant is used to facilitate fusion in the lumbar spine and is inserted using an anterior lumbar interbody fusion (ALIF) procedure.

The Ax Stand-Alone ALIF implant also features a tapered leading edge, which aids in implant insertion within limited anatomical space. It also features a slightly convex profile to match the anatomy of the spine and provide a stable anti-migration surface during the fusion process. The large graft cavity provides increased volume for autograft loading.

Innovasis welcomes Jim Kwan, new VP of Operations

Innovasis would like to announce the hiring of James E. Kwan as the new Vice President - Operations. Jim most recently served as the owner and principal consultant for OPM Consulting, LLC.

Jim has over 30 years of experience managing global manufacturing and supply chain operations and has served in operational and technical leadership roles at SeaSpine Orthopedics, Integra Lifesciences, Edwards Lifesciences, Tornier Orthopedics, St. Jude Medical, SciMed Life Systems and Honeywell Defense Systems.

Jim received his Bachelor of Science in Mechanical Engineering from South Dakota School of Mines & Technology, and his Master of Business Administration in Operations/Manufacturing Systems from the University of St. Thomas.

Jim is a certified Project Management Professional, Agile Scrum Master and Lean/Six-Sigma Green Belt.  He is an active member of APICS, ASQ, PMI and Orthoworld.  Jim lives in Park City, UT with his wife and son and enjoys outdoor activities and spending time with family!

Innovasis announces an organizational change in support of our continued corporate expansion.

Mike English, President

Mike English, President

Innovasis is pleased to announce the promotion of Mike English to President.

Mike joined the company in 2014 and most recently served as the Executive Vice President.  He brings over 20 years of executive leadership experience in medical device and spine including Johnson & Johnson and NuVasive. Innovasis posted significant growth in 2016 while introducing the Excella-MIS system and the PX HA PLIF cage to the market. They are positioned to launch several new products in 2017 and plan to continue building their executive team.

“I’m honored to have the opportunity to lead this extraordinary team. Our positive cash position and strong revenue growth will allow us to continue investing in innovation and talent, “ said English.

Innovasis creates growth and value through product innovation and strategic acquisition.  It continues to expand it medical mission work through the International Ortho Neuro Foundation in South America and other nations in need. Innovasis is a  manufacturer of spine and cranial implants based in Salt Lake City, UT.

Innovasis Spine Symposium 2017

Innovasis Spine Symposium 2017

Innovasis just finished their 6th annual Spine Symposium held in Deer Valley.  This year's Symposium focused on spine care from childhood to old age.  Deformity discussions included; challenges in the treatments of deformities in the growing child, transitioning from adolescent to adult deformity and when to operate on the adolescent or wait to adulthood.  Also, included in the deformity discussions were how to correct adult degenerative scoliosis.  Other topics included were: Spinal balance, correction of the rotational deformity, adult degen, complications, cervical arthroplasty and many, many case discussions.

We want to thank our amazing faculty and everyone that presented a case or was involved in some capacity, a special thanks goes out to our chairman Dr. Alan Moskowitz, MD from the Kansas Orthopedic Center, for putting together the wonderful agenda and speaker base.  Here is some of the feedback we are hearing about this meeting:

  • "Great meeting. Excellent venue."
  • "Excellent meeting with great growth each year."
  • "Experience was great!"
  • "Great meeting. Good for surgeon education and fun for the family."
  • "Really first class meeting and hotel."

 

Innovasis meeting space.

Innovasis meeting space.