In a crowded minimally invasive surgery (MIS) lumbar spine surgery market, with literally dozens of expandable cages that enter the body through a small incision and then expand in situ, one company—no hyperbole—stands alone because, unlike all the other available devices, its patient conforming, patient-specific device enters the body through a space the size of a soda straw.
The company is Spineology Inc. The device is OptiMesh®. Spineology’s IDE Trial for OptiMesh began in 2013 and was cleared in 2020 and has been used in more than 50,000 cases, but most spine surgeons are not fully aware of how it works, the data from its IDE trial or how it conforms to each patient’s unique anatomy.
New Category of MIS Spine Surgery
MIS spine surgery is an anatomy-conserving strategy that, with such advanced tools as navigation and robotic-assist devices, is available to every spine surgeon and, increasingly, every spine surgery venue from the large downtown hospital to the strip mall surgery center.
For suppliers, instruments and implants evolved to support anatomy-conserving MIS surgery. Today’s dominant implant design is an expandable metal cage.
And then there’s Spineology’s OptiMesh.
It is so unique; it stands in a category all its own: a patient-conforming, patient-specific, expanding in 3-dimensions, versatile lumbar spine implant that can be placed with an open procedure or through an ultra-MIS approach. One implant is this versatile.
A category of One.
50,000 Cases, 20 Clinical Studies and an IDE Study
OptiMesh, which was cleared for commercialization through the FDA’s De Novo pathway, came to market on the basis of data from the SCOUT (Spineology Clinical Outcomes Trial) Investigational Device Exemption (IDE) trial. That data was first presented at the Society for Minimally Invasive Spine Surgery Annual Meeting in November 2019.
Patients who received Spineology’s Optimesh device in the IDE study reported substantial pain relief and improved functionality at 6-, 12-, and 24-months post-op.
The trial also documented 98% fusion rates at 24 months and approximately 92% “Excellent” or “Good” patient satisfaction scores at 6-, 12- and 24-months post-op: no serious, device-related, adverse events.
One of the IDE investigators, Dr. Stephane Lavoie of Deland, Florida, said in a statement at the time:
“OptiLIF® is the least invasive lumbar fusion procedure. The unique OptiMesh implant can be inserted through a one-centimeter incision and then expanded to restore anatomy, which provides neural decompression and optimally conforms to a patient’s endplates. As a result, patients recover quickly, and the impact to procedure efficiency is significant. OptiLIF will have a major impact on the standard of care related to low back and leg pain.”
Over 50,000 patients have been treated with OptiMesh and 20 additional clinical studies have reported excellent patient outcomes, better procedure efficiencies and, most importantly, patient conforming, precise and anatomy conserving treatment.
The NEW Spineology
Spineology’s was ahead of its time, and its focus has always been on a mesh, not metal, or plastic implant. While the market today is dominated by expanding or motion preserving metal lumbar implants, the mesh approach is the only MIS product that is patient conforming and specific while also preserving anatomy.
Founded by Dr. Stephen Kuslich in 1997, Spineology recently hired an entirely new senior executive team, led by Brian Snider, formerly with NuVasive, Inc. and then Alphatec Spine.
Orthopedics This Week had the opportunity to speak with both CEO Brian Snider and Executive Vice President of Marketing Amanda Bloom.
Snider explained why he joined Spineology and the value he found in both the company and its patient-conforming technology. “After Alphatec, I was looking for something [that] was differentiated, addressed an unmet clinical need, and supported with strong data. Once I started due diligence, I realized Spineology was really onto something. They could truly be the future of spine surgery. I went to a number of surgeons who’d used OptiMesh and they said simply, ‘my patients do better with OptiMesh.’”
For Bloom, the company was also a surprise and a revelation. “As a marketer, I realized very quickly that the OptiMesh implant is such an advanced, unique technology, truly one-of-a-kind, and never really had a voice.”
“For me, Spineology represents the opportunity to bring a clearly underappreciated technology to a wider audience of surgeons and their patients. That made rebranding Spineology one of the first things on my list when I joined.”
Why didn’t Spineology position this technology in this manner earlier? Like, say, 20 years ago? According to Bloom, the original FDA clearance did not allow the company to articulate its value proposition, or train surgeons on this unique approach to interbody fusion.
“I have to give the team here a ton of credit, they took the hard road. I remember the first time I saw the technology was in 2008 and I thought this was really compelling technology, but it lacked a clear regulatory path forward. The years the team dedicated to the development of the technology, completing the IDE trial, and obtaining the De Novo grant, paved the way for us now,” Snider said.
The ONLY Conforming, Patient-Specific Expandable Implant in the World
“OptiMesh stands in a unique category of its own. It is the only patient conforming expandable implant on the market. There’s been such a rush of development around expandable implant technology over the last 10 years, and it really took the market by storm. There are unmet needs in static implants and the hope was that an expandable implant would change that.”
But, Bloom added, “Mechanically expanding implants did meet the full needs of spine surgery. And Spineology’s OptiMesh solution was here the whole time. People just didn’t know it.”
Rebranding Spineology and OptiMesh
“We are proud of our history. We’re proud of the path we took. But this isn’t the Spineology of yesteryear. We have the only clinically validated interbody fusion technology with IDE clearance,” said Snider.
“That means we stand alone in this category. We will redefine what this technology can do. It’s simple: OptiMesh conforms to you. It conforms to a patient’s anatomical requirements. It conforms to the surgeon’s procedural needs.”
“Regardless of whether a surgeon performs open procedures, or endoscopic procedures, this one implant can help surgeons achieve the goals of surgery and provide better outcomes for their patients.”
“Dr. Kuslich developed an implant that fits through a 6.6 mm portal, expands to the size of an ALIF [anterior lumbar interbody fusion] footprint and conforms to the anatomy.”
Snider explained additional features of the OptiMesh Implant: Nearly the entire implant is comprised of biologics, and it has powerful expansion capabilities to restore disc height, achieve alignment goals and promote robust fusion—all of this with a patient-conforming implant size of an ALIF implant that is designed to avoid the point loading that you see with mechanically expandable implants
Snider added, there are a multitude of ways surgeons can utilize OptiMesh.
- Traditional open procedure, everything from complex deformity or an open TLIF [transforaminal lumbar interbody fusion].
- TLIF approach, whether it’s tubular or a Wiltse approach.
- Ultra MIS (OptiLif) approach where the surgeon uses fluoroscopy to go through Kambin’s triangle.
- Endoscopic (OptiLif Endo), the OptiMesh implant is the only implant that will fit through an endoscope.
“Many surgeons don’t know much about Spineology,” Bloom said. “This is our opportunity to reframe the story with accuracy, with fact, with value propositions that compel, and to make a difference for surgeons and their practices.”
The rebrand of the organization, which will include a new brand identity and product positioning with corresponding assets was introduced the 2024 North American Spine Society’s annual meeting on September 25. “Our logo, website, collateral, educational material and booth had a completely different look at NASS,” Bloom said.
“Additionally, had a talk at NASS, in the Red Theater, by Dr. Timothy Wang from Rush University. He’s shared how and why OptiMesh is a core focus in his practice. We’ve revamped our medical education program and are approaching training via a concierge approach,” she said.
“Just like OptiMesh conforms to you, our education programs do the same. We bring the training to the surgeons. We believe this technology is so important to patients and the surgeons who treat them, our goal is to expand access to it.”
You’ve Tried the Rest, Now Check Out OptiMesh
Sometimes in life and business, it takes a fresh set of eyes to see what is right in front of you.
Looking at OptiMesh within the context of MIS lumbar spine surgery, reveals its value to spine surgeons and their patients.
Compared to the 40 or 50 expandable cages in the market today, OptiMesh’s ability to enter through a space the size of a soda straw, then expand in three dimensions to fully cover each endplate and provide 45 pounds of support using an allograft filler does, in fact, make it truly one of a kind.
To learn more, here is the link to Spineology’s website: www.spineology.com.
