SpineUniverse Technology Highlights Calmare® Therapy, Premia Spine, SI-BONE, and Spinal Elements

Calmare® Therapy Reboots the Brain’s Perception of Pain

It is not uncommon for someone living with chronic neuropathic pain to travel many treatment roadways and then—often with great hesitation—decide to take a totally unfamiliar route. That’s Sharlene’s story. Her pain journey started in the 1980s soon after an oil-based myelogram and was diagnosed with adhesive arachnoiditis in 2006. In Sharlene’s case, it was her family who strongly urged her to take a detour and try a relatively unknown, FDA-cleared (510k), noninvasive pain treatment called Calmare® Therapy (scrambler therapy).

Sharlene came to know about Calmare Therapy through Facebook. “It’s funny, about 5 or 6 years ago, I saw Dr. Michael Cooney’s page. At the time, he was interested in developing a clinical trial using Calmare therapy to treat patients with arachnoiditis,” she said. Although the trial didn’t start, Sharlene’s conversations with Dr. Cooney continued and in early 2021, she met with him and started Calmare.

Michael J. Cooney, DC, is Clinical Director of Calmare NJ USA based in Rutherford, NJ and one of 7 Calmare Certified providers in the United States. He said, “Sharlene came in and after 2 weeks [10 treatments] she was pain free. I also recently completed treatment of another patient with arachnoiditis who had been in pain for about 3 years. Now his pain level is between zero and one. Of course, Calmare Therapy is not for everyone,” he said.

What is Calmare Therapy and Why Is it Called “Scrambler Therapy”?
“Calmare technology utilizes an innovative brain-centered approach to manage chronic neuropathic pain,” said William Lipford, Product Sales Director for Calmare Therapeutics. “The Calmare system’s transcutaneous process intentionally sends synthetically created no pain proprietary algorithms through unmyelinated C-fibers to the brain where chronic neuropathic pain is initially perceived,” Lipford said.

Calmare Therapy, FDA approved pain therapy medical device treats chronic neuropathy and oncologic painCalmare® Therapy is an FDA approved pain therapy medical device for the noninvasive treatment of chronic neuropathic and oncologic pain. Image © Used with permission.

When Calmare’s treatment-based process is successfully administered, the brain’s perception of the initial pain-based impulse is reset to not being pain-based, and typically lasts several months up to a year. However, Calmare is not a curative-based process, as there is no known cure for chronic neuropathic pain. Therefore, “refresh treatment sessions” are necessary (also called booster treatments) to reestablish the “pain free” response. Typically, the need for booster treatments decreases over time in most patients. There are no known adverse side effects.

Five independently controlled channels on the faceplate of the Calmare device enables the practitioner to individually control Calmare’s proprietary electrical stimuli through a specific dermatome that is part of the neural pathway between the spine and brain. Typically, 10 scrambler therapy sessions, each lasting about 35 minutes, are performed once daily over a period of two weeks. Regarding the number of treatment sessions, Cooney commented, “If the patient is not experiencing a positive response by the fourth treatment, therapy is discontinued because it’s not likely to be effective.”

Calmare Therapy device faceplate shows 5 independently controlled channelsCalmare® Therapy's device faceplate demonstrates the 5 independently controlled channels. Image © Used with permission.

Lipford explained the scrambler therapy terminology is used to describe Calmare’s delivery pattern of randomized sequences of propriety algorithms transmitted through skin. Electrode patches are positioned over select dermatomal skin areas to deliver 16 randomized algorithm sequences over 4-phased time sectors per treatment session. The therapy is a unique analgesic—not an anesthetic-based process—that temporarily reboots the patient’s pain-based impulses to be perceived as “no pain” by the brain.

Calmare Therapy Not a Secret—Many Top Tier Medical Providers
During Calmare’s US business launch, the company started out by selecting military medical facilities and major hospital groups to conduct research. Military facilities included Walter Reed National Military Medical Center, Mike O’Callaghan Military Medical Center (Nellis Air Force Base), and Hunter Holmes McGuire VA Medical Center (Army). Lead clinical trial investigators from Mayo Clinic, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and other research-based medical centers have published Calmare research. Calmare Therapy continues to be provided by these military and private medical institutions.

Dr. Cooney integrated Calmare Therapy into his pain practice 11 years ago and has used it to treat well over a thousand patients with a 75% success rate. Initially, he was skeptical about Calmare but eventually agreed to try the device. “After about 2 months of using the device, I saw its potential to help alleviate pain and also help patients to discontinue use of potentially addictive pain medications,” he said.

Lipford’s professional medical background and career in medical devices provided him opportunities to see the realities of health care from all angles. In fact, he intentionally sought out Calmare because of its innovative approach to treating chronic neuropathic pain. “My perspective of pain management is shaped by experience—that is, the patient experience and that of the practitioner. Calmare is noninvasive and non-chemical, with no known side effects. Long-term, it’s not only cost effective but life-effective and can help restore quality of life in select patients. Simply put, that’s what every person with chronic neuropathic pain wants and frankly, deserves,” stated Lipford.

Getting back to Sharlene. Her story has a happy ending. To see Sharlene’s story, watch this short video.

Calmare® Therapeutics Publications.

Calmare® Therapeutics Clinical Trials.


TOPS™ Spinal Arthroplasty System’s Innovative Backstory and Update with Ron Sacher, CEO of Premia Spine

Premia Spine announced its TOPS™ Spinal Arthroplasty System received the US Food and Drug Administration’s (FDA) Breakthrough Device Designation on March 31, 2021. This technology is a first-of-a-kind surgical treatment for lumbar spinal stenosis and up to a Grade 1 spondylolisthesis.

TOPS is the first and only facet joint replacement device system for the lumbar spine and specifically designed to preserve mobility, maintain stability, and provide durability after spinal decompression. In earlier clinical studies, TOPS was proven to deliver immediate and sustained pain relief and improved quality of life. Currently, a smaller version of the TOPS System is being studied in a multicenter clinical trial under an Investigational Device Exemption (IDE) from the FDA.

TOPS™ Spinal Arthroplasty SystemTOPS™ Spinal Arthroplasty System is limited by Federal (or United States) law to investigational use only. Image used with permission © Premia Spine.

SpineUniverse spoke with Ron Sacher, Chief Executive Officer of Premia Spine, about the company’s backstory, the TOPS clinical trial, benefits of the Breakthrough Device Designation, and his thoughts about device reimbursement and approval process.

Tell us about the TOPS history and how this unique device technology evolved.
Impliant, Inc. was the early developer of TOPS. In 2003, innovations in the spine market were focused on lumbar disc replacements, which were starting to gather steam. We noted a significant number of patients treated with fusion were actually contraindicated for lumbar disc replacement because they had spinal stenosis and/or spondylolisthesis, which are antithetical to degenerative disc disease. Disc replacement wouldn’t make sense for them.

Our team’s background in hip and knee arthroplasty led us to come up with an arthroplasty solution for the lumbar facet joints, as we understood that there was a direct relationship between arthritis of the facet joint, spinal stenosis, and spondylolisthesis. We started working with thought leaders and surgeons around the world who helped us better understand the physiology and anatomy of the lumbar spine, the interplay of the discs and facet joints, and the relationship between the anterior and posterior columns.

In those days, most dynamic posterior devices were designed as products that looked very much like a traditional screw-and-rod system, such as Dynesys® or other pedicle screw-based systems with springs or plastic rods that resembled a fusion system. Our approach was to replicate the function of the facet joint—a very complex joint responsible for flexion, extension, rotation, bending, and sagittal translation. We needed to come up with a holistic joint replacement device that could serve as an alternative to the facet joints. The development and early clinical trials took place between 2003 and 2005, and in 2006 an investigational device exemption (IDE) allowed TOPS to be studied in a US clinical trial. I continued to run the company until 2007 when I returned to the cardiovascular space.

Why is March 31, 2021 a pivotal date for TOPS?
In late 2010, I was contacted by insiders who informed me of Impliant’s financial distress. Close to $70 million dollars had been invested in the TOPS device. Investor support of the technology, which had been strong for a long time, was adversely impacted by the financial crisis and they were shutting down the company. So, I bought the assets in March 2011—which is 10 years to the day when the Breakthrough Device designation was announced on March 31, 2021.

When I reinitiated the program a decade ago, I reassembled members of the original development team, and we redesigned the TOPS device to be smaller, with a simplified surgical technique. About a year later, we were back in the European market working primarily in Germany.

Next came a conversation with the FDA about what it would take to resume the US trial. During the first phase, no new patients would be enrolled. Rather, we circled back to the original IDE sites to perform follow-up. A good number of TOPS patients from the original study participated, and we were able to demonstrate that they were doing well. It was apparent to the FDA that the original IDE study was stopped for financial reasons and not because the device didn’t perform well.

How has the Breakthrough Device Designation benefitted Premia Spine’s clinical trial?
We came back to the FDA with our new protocol for a US clinical trial on the current TOPS device. The new clinical trial started in late 2017 and is ongoing. The Breakthrough Device designation put us on a more personalized regulatory pathway.

Basically, the Agency has identified the potential need for our device and is working closely with us to expedite and tailor the regulatory process to our testing and clinical program. The Breakthrough status helps accelerate the regulatory process when compared to the traditional premarket approval process.

Another win win, in my mind, is that the FDA granted us approval to expand the number of sites beyond the original clinical trial. This allows us to remain focused on the right indications and allows more surgeons to be involved earlier in the TOPS program, during the research stage instead of waiting for commercialization.

Sometimes a product does well in a clinical trial and is less impressive when released into the market. Part of the problem is the learning curve. In our case, by having many sites we have proportionately more early cases. In other words, a large proportion of our IDE procedures are actually the first, second and third cases across our sites, thus making it possible to see the impact of a potential learning curve in our clinical outcomes.

TOPS and One-Year Clinical Study Results
“Both lumbar spinal stenosis and spondylolisthesis are fairly common conditions often treated with decompression and stabilization via rigid fixation. As a result, motion at the index level is lost, leading to stress transmission to the adjacent segments. The TOPS device allows surgeons to perform a standard decompression—but instead of fusion using an interbody device and pedicle screws for rigid fixation—TOPS replaces the facet joints and preserves motion at the operative level,” explains Domagoj Coric, MD, the clinical study’s Principal Investigator overseeing 40 study locations. Dr. Coric is Chief of the Department of Neurosurgery at Carolinas Medical Center and Neurosurgeon at Carolina NeuroSurgery & Spine Associates in Charlotte, NC.

At the April 2021 annual (virtual) meeting of the Lumbar Spine Research Society, Paul Arnold, MD, presented interim data from the ongoing multicenter, prospective, randomized US FDA-IDE clinical trial.1,2 Dr. Arnold is Professor of Neurosurgery at Carle Illinois College of Medicine and Chair of the Department of Neurosurgery at Carle Foundation Hospital in Urbana, IL.

“The TOPS system is a robust, pedicle screw-based biomechanical device intended to replace the facets and posterior elements following aggressive decompression. Currently, there are no FDA-approved devices for posterior arthroplasty with facet replacement,” said Dr. Arnold. “A total of 70 patients were available for 12-month follow-up and both groups (TOPS=52; TLIF=18) have shown good outcomes with statistically significant improvement in ODI and VAS (back and leg), and low re-operation rates,”2 Dr. Arnold stated.

“In this study, all patients have up to a Grade 1 spondylolisthesis with moderate to severe spinal stenosis at a single level. There are 49 inclusion and exclusion criteria, creating a very homogenous patient population.1 With motion preservation technology we want to see whether maintaining mobility at the index level protects adjacent levels over the long-term. We plan to follow patients for 5 years or longer,” Sacher said.

From your perspective as CEO, what are your thoughts about the device approval process?
These types of breakthrough devices take a tremendous amount of effort and capital—both human capital and financial capital. There are no shortcuts to Agency approval of devices such as these. There is a long research and development process, which includes bench testing and product refinements. Thereafter, there is an extended clinical trial period—with feasibility and pilot studies. It is followed by years of collecting and analyzing data, and ensuring you have sufficient and convincing data to demonstrate to the FDA that the device is safe and effective for introduction into the US market under an Investigational Device Exemption (IDE). Thereafter, the pivotal clinical trial process presents its own set of challenges, including the management of patient enrollment and follow-up during the IDE. It is time consuming, complicated, and costly.

In my mind, about a decade ago, the goal posts moved in the wrong direction, making it increasingly more difficult for companies to innovate and bring groundbreaking technologies to market in a timely and cost-effective manner. It adversely impacted innovation back then, and today we see fewer PMA studies than in the past.

So, it’s refreshing to see that the FDA recognized this situation and is attempting to move innovative products into the US market faster through the Breakthrough Program. We are now seeing devices approved in the US before they are approved overseas. I’m hopeful that the industry will experience shortened time to market and less costly development cycles while patients benefit from faster accessibility to innovative devices.

A critical next step is CMS’s determination on May 15, 2021 whether to grant a fast track to coverage for Breakthrough devices. I believe their reimbursement decision will influence whether companies will invest in the expensive development of new technologies. Reimbursement is a central component of the entire package needed to promote breakthrough products and reward companies for taking the high road, conducting large clinical trials, and making big investments in the right activities that will ultimately bring more reliable products to the market.

The TOPS System is limited by Federal (or United States) law to investigational use only.

Dr. Coric has stock options in Premia Spine. Dr. Arnold has no disclosures.

1. A pivotal study of the Premia Spine TOPS™ System. ClinicalTrials.gov identifier: NCT03012776. https://clinicaltrials.gov/ct2/show/NCT03012776. Updated September 16, 2020. Accessed April 30, 2021.

2. Steinmetz M, Arnold P, Coric D, Ahmad N. Facet replacement versus standard TLIF for degenerative lumbar spondylolisthesis: One-year results from an FDA-IDE randomized trial. Paper 39. Lumbar Spine Research Society 14th Annual (Virtual) Meeting. Presented April 10, 2021.


SI-BONE® SImulator™ Surgeon Training System

Shortly before COVID changed our world, the SI-BONE® SImulator Surgeon Training System was introduced. Each portable, radiation-free, haptics-based computer simulator trains surgeons and healthcare providers on two SI-BONE procedures: iFuse Implant System® and iFuse Bedrock™, as well as SI joint injections, in multiple anatomic pelvic variations. In May 2021, the recently released iFuse TORQ™ will be fully integrated into the SImulator and available for training opportunities for trauma surgeons.

SI-BONE® SImulator™ Surgeon Training SystemSI-BONE® SImulator™ Surgeon Training System. Image used with permission. © SI-BONE, Inc.

To learn more about the company’s advanced training technology, we spoke with Carlton Reckling, MD, Chief Medical Officer and Vice President, Medical Affairs for SI-BONE, Inc.

What prompted development of the SImulator?
I’ve been working on the development of the SImulator for over 5 years to improve surgeon training. The impetus of the project was to improve the surgeon experience by creating an image-based training simulator that provides excellent imaging every single time. While cadavers are often an integral part of surgical training, they are not ideal. They are usually older, vary in size and typically have osteoporosis or arthritis that can impede imaging.

In addition, the male pelvis and sacrum, where our implants are placed, has different characteristics than the female pelvis—a different shape. Also, about 30 to 40% of the population has a dysmorphic sacrum. Dysmorphic can mean 6 vertebrae instead of 4 or 5, or a variant causing one side of the sacrum to be longer or shorter than the opposite side. The SImulator allows us to integrate sacral dysmorphism into the training blanks so the surgeon can train on a dysmorphic sacrum, which could never be done in a cadaver lab.

  • The training blanks are prepared using three-dimensional (3D) printing technology to recreate actual patient data from CT scans. Each model ensures the surgeon is training with actual anatomy—not imaging that is enhanced, or smaller or larger.

Another drawback to cadaveric training is it's very difficult to assess where the implants are placed because you can’t obtain a CT scan in a cadaver lab. Our SImulator provides the surgeon a virtual CT scan after implant placement and provides valuable feedback important to the learning process. A surgeon can refine his surgical technique by inserting another blank into the SImulator and then repeat that step. Also, the SImulator allows the surgeon to perform the procedure on 3 different anatomies—male, female, and dysmorphic.

Your timing of the SImulator couldn’t have been better. Tell us about its use.
SI-BONE had been beta testing the SImulator with great success and proceeded to purchase 5 units that were delivered in late 2019. We now have a total of 25 SImulators. The timing in 2020 was fortuitous because surgeons couldn’t travel. Although travel has opened up, we’ve found many surgeons are backlogged and don’t want to take a weekend to travel because they are trying to catch up on surgical cases.

SI-BONE has a dedicated team of SImulator training managers and the entire SImulator system is completely portable, easy to carry, setup and ready for training within 20 minutes. Since the SImulator is portable, the training can come directly to an individual surgeon, a group practice or maybe an academic program. It’s all very flexible and the need for a lab facility or equipment—such as a cadaver or C-arm isn’t necessary. Sometimes we have a local surgeon present the lecture or use Zoom to bring the surgeon/speaker to a remote training location.

Is there a sensory component to the technology?
The SImulator provides sensory feedback through our regular instruments that attach to sensors. The sensors tell the computer where the instruments are in relationship to the anatomic blank—the model. Three-D printing allows us to print male, female, and dysmorphic models. The 3D model is easily replaced under the lifelike artificial skin and soft tissue. The “feel” I’ve personally experienced is very lifelike. When you insert the instruments or implants, it feels like you are in bone, when you drill it feels like you are drilling through bone.

How is the SImulator advantageous to surgeons who experience procedural delays?
The SImulator enables us to retrain a surgeon who completed cadaveric or other training and then, for whatever reason, their first case is delayed—sometimes 3 or 6 months. It can take time to navigate value analysis committee, get the device on the hospital’s formulary and to identify an appropriate patient. The SImulator provides that surgeon an advantage. They simply contact their SI-BONE representative and say, “Can you bring in the SImulator? I want to go through the procedure one more time before my first case.” No doubt, that surgeon would be quite reluctant to take time to travel to a training, such as a cadaver course out of town before they treat their first patient.


Together, Orbit™ + Luna® XD Improve Surgical Efficiency and Workflow

In March 2021, Spinal Elements® announced the relaunch and first clinical use of its Luna® XD MIS Expandable Interbody Device and Orbit™ Articulating Discectomy System acquired only a few months ago from the former Benvenue Medical, Inc.1 “Luna and Orbit are a good fit alongside our existing technologies in the expandable interbody space within our umbrella of minimally invasive surgical solutions and a complement to our MIS Ultra™ platform of products,” stated Jason Blain, President and Chief Executive Officer of Spinal Elements, Inc.

Orbit’s discectomy system is designed for the minimally invasive posterior surgical space. The instrument can rotate and pivot with up to 75-degrees of articulation to efficiently remove high-volumes of disc tissue. Straight, up-biting, and curved pituitary rongeurs are supplemented by special instruments to prepare endplates and create a large fusion bed.

Orbit™ Articulating Discectomy SystemOrbit™ Articulating Discectomy System. © Image courtesy of Spinal Elements®.

“Orbit is a best-in-class system that allows me to provide a safe and more thorough discectomy while Luna XD’s multiexpandable profile and footprint provides a large area for bone grafting and controlled restoration of disc height and lordosis, contributing to the consistency and positive clinical outcomes of my TLIF procedures,”1 stated Richard G. Fessler, MD, PhD, Professor, Department of Neurosurgery at Rush Medical College in Chicago, IL.

Luna XD is a multidimensional and expandable lumbar interbody fusion device comparable in size to an ALIF-size footprint delivered through a minimally invasive posterior approach. Luna XD is indicated in adults with symptomatic degenerative disc disease who may also have up to a Grade 1 spondylolisthesis or retrolisthesis at one or two contiguous levels (L2-S1). Potential benefits include anterior column stabilization and restoration of sagittal balance. Luna XD is the, “Best MIS TLIF cage on the market, and the only one I will use,”2 stated Jeffrey D. Coe, MD, Orthopedic Spine Surgeon at the Silicon Valley Spine Institute in Los Gatos, CA.

Luna® XD MIS Expandable Interbody DeviceLuna® XD MIS Expandable Interbody Device. © Image courtesy of Spinal Elements®.

Summary: Two-Year Single-Center Study Outcomes Meaningful
A retrospective single-center study of 50 consecutive patients demonstrated two-year safety and efficacy of the Luna 3D (forerunner of Luna XD) multidimensional, expandable lumbar interbody fusion device. Patients were treated with a minimally invasive transforaminal lumbar interbody fusion (TLIF) using Luna 3D.3

The study authors commented, “The capacity to deliver a multiexpandable interbody cage with a large footprint through a narrow surgical cannula represents a significant advancement in spinal surgery technology and fills an unmet clinical need.”3 Also, “The geometry of this multiexpandable cage allows for a large volume of contiguous bone graft to be placed postexpansion, which optimizes the local environment to encourage vertebral body fusion,”3 the authors stated.

The minimum clinically important differences relative to baseline for each patient-reported outcome was significant. (All results p<0.001)3

  • Mean Oswestry Disability Index (ODI) score decreased by 61%
  • Back pain severity decreased by 67%
  • Leg pain severity decreased by 80%

Radiographic measurements comparing baseline to two-years were equally compelling. (All results p<0.001)3

  • Anterior disc height increased from 7.6 mm to 15.5 mm
  • Posterior disc height increased from 2.9 mm to 10.1 mm
  • Average disc height increased from 5.6 mm to 13.3 mm
  • Foraminal height increased from 12.2 mm to 20.2 mm
  • Segmental lordosis increased from 6.2 degrees to 14.0 degrees

While there was one case of nonunion, the two-year fusion rate was 98%.

Expansion into the ASC Market
“The way Luna XD and Orbit are delivered to the surgeon’s facility or hospital are very friendly to the ambulatory surgical center environment. We see the trend and desire to push more procedures into the ASC setting and these technologies really help us to enable that,” said Jason Blain.

1. Spinal Elements® Announces Relaunch of Luna® XD and Orbit® Systems. March 3, 2021. Accessed April 30, 2021. https://www.spinalelements.com/MM-310-0012.pdf

2. Benvenue Medical, Inc. The next innovation in MIS lumbar fusion has a big footprint. 2020. ML3430.J. Accessed April 30, 2021. https://benvenuemedical.com/products/lunaxd-mis-expandable-interbody-device/

3. Kucharzyk DW, Miller LE. Two-year clinical and radiographic results with a multidimensional, expandable interbody implant in minimally invasive lumbar spine surgery. Cureus. 2020;12(2):e7070. DOI: 10.7759/cureus.7070. Accessed April 30, 2021. https://www.cureus.com/articles/28140-two-year-clinical-and-radiographic-results-with-a-multidimensional-expandable-interbody-implant-in-minimally-invasive-lumbar-spine-surgery

Spinal Elements® Announces the Acquisition of Benvenue Medical Assets. December 16, 2020. Accessed April 30, 2021. https://www.spinalelements.com/MM-420-0001.pdf

Coe JD, Zucherman JF, Kucharzyk DW, Poelstra KA, Miller LE, Kunwar S. Multiexpandable cage for minimally invasive posterior lumbar interbody fusion. Med Devices (Auckl). 2016;28(9):341-347. DOI: 10.2147/MDER.S112523. eCollection 2016. Accessed April 30, 2021. https://pubmed.ncbi.nlm.nih.gov/27729817/

Mica MC, Voronov LI, Carandang G, Havey RM, Wojewnik B, Patwardhan AG. Biomechanics of an expandable lumbar interbody fusion cage deployed through transforaminal approach. IJSS. 2017;11(4):24. Accessed April 30, 2021. https://www.ijssurgery.com/content/11/4/24

Updated on: 05/07/21
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