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 hires Sean Kane, area VP-Southeast 

Sean Kane

Sean Kane

Innovasis is pleased to announce the hiring of Sean Kane as Area Vice President – Southeast. Sean brings over 20 years of medical device and spine experience to Innovasis. He served previously as the Vice President of Sales for SafeWire where he built a successful distribution network and led the company to an acquisition by Stryker Corporation. Prior to SafeWire, Sean spent 12 years at DePuy Spine as Territory and Regional Manager leading his area from $600K to over $4M during his tenure. Sean earned his MBA from the Tulane University Freeman School of Business and has a Bachelor of Science in Biology from Loyola University. He resides in New Orleans and enjoys coaching baseball and softball, fishing and hunting, and raising his children Katherine (12), and twins Ryan and Lindsay (10).

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.

SA ALIF - Ax™

SA ALIF - Ax™

Innovasis is getting excited to launch our new SA ALIF.  We will be the first company to launch a Stand-Alone ALIF with Invibio® PEEK-OPTIMA® HA Enhanced.  The implant will be available at the end of Q1*.  Here are some facts about our new SA ALIF:

The Innovasis Ax Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach.

The implant is radiolucent allowing straightforward assessment of the fusion process, while two tantalum spheres enable implant visualization during the surgical procedure.  The HA PEEK body is joined to a 6 Al 4V ELI titanium faceplate that interfaces with the inserter and holds the fixation screws.

The device is offered in an array of sizes:  three footprints, six height options and four lordosis options.   The implants have a tapered leading edge which aids in implant insertion due to limited anatomical space. They feature a slightly convex profile to match the anatomy and anti-migration surface to ensure implant stability during the fusion process. The large graft cavity provides increased volume for autograft loading.

*Pending FDA clearance.

Does PEEK/HA Enhance Bone Formation Compared to PEEK in a Sheep Cervical Fusion Model?

Does PEEK/HA Enhance Bone Formation Compared to PEEK in a Sheep Cervical Fusion Model?

  • Polyetheretherketone (PEEK) has a wide range of clinical applications but does not directly bond to bone. Bulk incorporation of osteoconductive materials including hydroxyapatite (HA) into the PEEK matrix is a potential solution to address the formation of a fibrous tissue layer between PEEK and bone and has not been tested.
  • Using in vivo ovine animal models, we asked: (1) Does PEEK-HA improve cortical and cancellous bone ongrowth compared with PEEK? (2) Does PEEK-HA improve bone ongrowth and fusion outcome in a more challenging functional ovine cervical fusion model?
  • The in vivo responses of PEEK-HA Enhanced and PEEK-OPTIMA® Natural were evaluated for bone ongrowth in the form of dowels implanted in the cancellous and cortical bone of adult sheep and examined at 4 and 12 weeks as well as interbody cervical fusion at 6, 12, and 26 weeks. The bone-implant interface was evaluated with radiographic and histologic endpoints for a qualitative assessment of direct bone contact of an intervening fibrous tissue later. Gamma-irradiated cortical allograft cages were evaluated as well.
  • Incorporating HA into the PEEK matrix resulted in more direct bone apposition as opposed to the fibrous tissue interface with PEEK alone in the bone ongrowth as well as interbody cervical fusions. No adverse reactions were found at the implant–bone interface for either material. Radiography and histology revealed resorption and fracture of the allograft devices in vivo.
  • Incorporating HA into PEEK provides a more favorable environment than PEEK alone for bone ongrowth. Cervical fusion was improved with PEEK-HA compared with PEEK alone as well as allograft bone interbody devices.

Read the complete study here: http://link.springer.com/article/10.1007/s11999-016-4994-x

Px HA™ Now available!

Px HA™ Now available!

 

 
Innovasis is excited to announce that its newest product is now available to use..... the Px HA interbody device.

The Px HA system is for Posterior Lumbar Interbody Fusion (PLIF).  The implants are made from Invibio® PEEK-OPTIMA® HA Enhanced, which is integrated with an osteoconductive hydroxyapatite (HA).  

The implant is radiolucent allowing straightforward assessment of the fusion process, while three tantalum spheres enable implant visualization during the surgical procedure.  

The device is available in multiple size options to facilitate a more precise anatomical fit.  It has a tapered leading edge which aids in implant insertion due to limited anatomical space, and features a slightly convex profile to match the anatomy and anti-migration teeth to ensure implant
stability during the fusion process. The large graft cavity provides increased volume for autograft loading.

The system features a unique inserter design which helps prevent cross threading and minimizes implant breakage.

Invibio® PEEK-OPTIMA® HA Enhanced provides the accepted high performance characteristics of PEEK-OPTIMA Natural, the leading spinal interbody device material, plus Hydroxyapatite (HA) to enhance bone apposition.  This combination is a potential solution for medical applications where early bone on-growth is required, such as spinal interbody fusion.

Invibio® PEEK-OPTIMA® HA Enhanced polymer is the latest development in high performance materials for interbody fusion devices.  Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, is fully integrated, not coated, into the PEEK-OPTIMA matrix, making it available on all surfaces of a finished device.  Building on PEEK-OPTIMA, the leading PEEK-based biomaterial with over 15 years of clinical history, the benefits include, modulus similar to bone, reduced stress shielding and artifact-free imaging.

Innovasis adds a new Executive Team

Innovasis has gone through many personnel changes over the past few months.  They are excited to announce their new executive team!  Mike English has been promoted to the position of Executive Vice president, while Victor Harmon has changed his role to VP of Sales-West.  Ryan Werner has recently returned to Innovasis as their Business Development Director.  Brian Dukate has filled the role of VP of Sales-East after spending the last 6 years at Blackstone/Orthofix.  Russ Whetton has been promoted to Marketing Director after spending the last 3 years as the PNW territory manager, Jason Eakins has also accepted the role of Manager of Sales and professional education.  With these new leadership changes Innovasis is looking forward to its continued growth as a company.