Spine

Spineology Inc. Announces New Board Members

December 04, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., the innovator in anatomy-conserving spine surgery, announced today the appointment of two new members to its Board of Directors, Bob Paulson and Phil Soran.

Mr. Soran is a successful serial entrepreneur who has founded several technology companies and was inducted into the Minnesota Business Hall of Fame in 2016. He was co-founder, President, and CEO of XIOtech Corp., which sold to Seagate Technology for $360 million in 2000. Later, he served as President and CEO of Compellent Technologies, which went public in 2007 and was subsequently acquired by Dell Inc. for $960 million. Most recently, he co-founded Flipgrid, an educational technology company, which was purchased by Microsoft in June. He currently serves on the boards of Piper Jaffray, SPS Commerce, and Foodsby.

“Spineology is an exciting company with a great market opportunity. I look forward to finding ways to add value to this strong team,” commented Mr. Soran.

Mr. Paulson has a long history of leadership in the medical device arena, having most recently served as President and CEO of NxThera, Inc., a company focused on treating prostate conditions, leading and evolving the company from concept to commercialization, culminating with the acquisition of NxThera by Boston Scientific earlier this year for up to $406 million. Prior to NxThera, Mr. Paulson was President and CEO of Restore Medical, an innovator in the treatment of snoring and sleep apnea, leading the company through a successful Initial Public Offering (IPO) and subsequent sale to Medtronic Inc. He currently serves as a board member for Veran Medical Technologies and Sun BioPharma.

“I am delighted to have the opportunity to join the Spineology board as the company continues to expand the adoption and utilization of its pioneering, anatomy-conserving technology to improve the lives of patients suffering from degenerative spinal conditions,” said Mr. Paulson.

“Bob and Phil are both accomplished business leaders and experienced board members, and we feel fortunate to have them join our Board of Directors,” said John Booth, Spineology’s Chief Executive Officer. “We think they’ll add great value to the board and we look forward to leveraging their unique skill sets as we continue to scale the business.”

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

Mainstay Medical to Showcase ReActiv8 and Key Clinical Data at the 13th German Spine Congress of the DWG

December 03, 2018

DUBLIN–(BUSINESS WIRE)–Regulatory News:

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and Euronext Dublin: MSTY.IE), a medical device company focused on commercializing ReActiv8®, an implantable restorative neurostimulation system designed to treat an underlying cause of disabling Chronic Low Back Pain, today announces that it will participate in the 13th German Spine Congress of the Deutsche Wirbelsäulengesellschaft (DWG), taking place in Wiesbaden from December 6-8. DWG will be the first medical meeting at which pivotal clinical data from the Company’s ReActiv8-B clinical study will be discussed.

A distinguished faculty of physicians, each of whom has deep experience with Reactiv8, will present the clinical data and the scientific background of the therapy, and describe commercial treatment of patients in Germany:

  • Dr. Jörg Franke, Chief, Department of Orthopedics, Klinikum Magdeburg, will chair the symposium where the results from the ReActiv8-B study will be presented, and also provide his experience with ReActiv8 in Germany;
  • Dr. Chris Gilligan, Chief, Division of Pain Medicine, Department of Anaesthesiology, Perioperative and Pain Medicine Brigham & Women’s Hospital, Assistant Professor of Anaesthesia, Harvard Medical and Principal investigator of the study, will present the pivotal clinical data from the ReActiv8-B study;
  • Dr. Jan Schilling, Chief of Spine and Neurosurgery, Tabea Hospital in Hamburg, will introduce the scientific background and the underlying physiological mechanisms of this new restorative treatment for chronic low back pain; and
  • Dr. Ardeshir Ardeshiri, Chief of Spine Surgery at Klinikum Itzehoe, will present his “real world” experience with ReActiv8 in Germany via his initial series of patient outcomes.

“As Germany is our first commercial market for ReActiv8, I am excited to be unveiling the data from our ReActiv8-B clinical study to the scientific community at the German Spine Congress,” said Jason Hannon, Chief Executive Officer of Mainstay. “We believe the long-term clinical results demonstrated in the study are compelling, particularly that we are seeing more than 60% of the study patients reporting greater than 50% pain relief at one year. We look forward to discussing the results with the attending physicians, and we plan to leverage the study results in continuing to drive our commercial business in Germany and more broadly in Europe.”

“The data from the ReActiv8-B clinical study through one year, and the favourable safety profile demonstrate that ReActiv8 is a viable restorative treatment option for patients with chronic low back pain,” said Dr. Franke. “ReActiv8 has the potential to provide long-term pain relief to this patient population, which suffers from a lack of available treatment alternatives.”

The ReActiv8 B clinical study is an international, multi-center, prospective, randomized, active-controlled, blinded trial with one-way cross-over, conducted under an Investigational Device Exemption (IDE) from the U.S. Food & Drug Administration (FDA). A total of 204 patients were implanted with ReActiv8 at leading study centers in the U.S., Europe and Australia and randomized 1:1 to therapy or control 14 days after implant. The initial results from this clinical study were announced by Mainstay on November 19, 2018.

“The results from this study confirm the results we have seen in our own experience with chronic mechanical low back pain patients with ReActiv8,” said Dr. Schilling. “There is an urgent need for new, effective therapies to treat long-term, mechanical low back pain, and the data from the studies demonstrate that ReActiv8 can provide sustained pain reduction over time.”

Mainstay will hold a ReActiv8-B symposium at which the physician faculty will make their presentations. The symposium will take place on Friday, December 7 from 13:00 – 14:30 in Studio 1.2 A & B at the Rhein Main Congress Center. Seating is limited. Pre-registration is available through www.reactiv8-B.de.

The Company will also have a booth at the DWG Congress, location number 26, and Mainstay leadership and the symposium faculty will be available for further discussions throughout the conference.

About Mainstay

Mainstay is a medical device company focused on commercializing an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands, and is listed on the regulated market of Euronext Paris (MSTY.PA) and the ESM of Euronext Dublin (MSTY.IE).

About the ReActiv8-B Study

The ReActiv8-B Study is an international, multi-center, prospective, randomized, sham-controlled, blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE). In summary, this means that eligible patients had baseline data collected and then following verification that the enrollment criteria were met, ReActiv8 was implanted. At the 14-day post implant follow up visit, half the patients were randomized to receive appropriately programmed stimulation (the treatment arm), and half were randomized to receive sham stimulation/low stimulation (the control arm). Information about the study can be found at https://clinicaltrials.gov/ct2/show/study/NCT02577354.

About Chronic Low Back Pain

One of the recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition, and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstay-medical.com

CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

Forward looking statements

This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should”, “will”, or “explore” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the data from the ReActiv8-B clinical study, the Company’s plans in relation to that data, and the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory applications and approvals, reimbursement arrangements, costs of sales and market penetration and other commercial performance.

By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance, and the actual results of the Company’s operations, and the development of its main product, the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of its main product and the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, the successful launch and commercialization of ReActiv8, the outcome of the ReActiv8-B Clinical Study, the outcome of the Company’s interactions with the FDA on a PMA application for ReActiv8, general economic and business conditions, global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, the time required to commence and complete clinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in its business strategy, and political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

Contacts

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Jessica Hodgson, Nicholas Brown
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com

FTI Consulting (for Ireland):
Jonathan Neilan
Tel: +353 1 765 0886
Email: jonathan.neilan@fticonsulting.com

NewCap (for France)
Julie Coulot
Tel: +33 1 44 71 20 40
Email: jcoulot@newcap.fr

AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne
Tel : +49 2102 1485368
Email : abo@andreasbohne.com
Wilhelm Kötting
Tel: +49 69 75913293
Email: wkotting@gmail.com

Investor Relations:

Jackson hospital first in nation to get next-gen spinal surgery technology

Nov 28, 2018 / By Taylor DesOrmeau

JACKSON, MI – It looks like a tablet but instead of connecting to headphones, the wires protruding from this new device at Henry Ford Allegiance Health connects to stickers – which are attached to the arms and legs of patients undergoing surgery.

The new device is called a Sentio generation 2 neuromonitoring system and Jackson’s hospital is the first in the nation to use it.

The minimally-invasive technology can offer patients a faster recovery, less blood loss and a shorter hospital stay, according to a HFAH press release. Surgeons began using it in Jackson in October.

“While we’re placing our instrumentation, we’re able to better assess that we’re in the correct place,” said Dr. Amritraj Loganathan, a neurosurgeon at HFAH.

The Sentio is primarily used during spine surgeries to decompress nerves. Accelerometers in the stickers can detect subtle muscle twitches – which are then shown on the screen. This shows which nerves are firing and what they’re specific functions are, Loganathan said.

What excites Loganathan is the hospital’s plan to lead studies, in expectation of finding ways to expand the tool’s usage. Loganathan believes it could help surgeons assess how healthy a nerve is.

Right now, they must rely on a patient’s pain assessment to determine if the nerve was successfully decompressed during surgery.

 

READ THE REST HERE

 

Photo: Courtesy of Henry Ford Allegiance Health

FloSpine announces the commercial launch of its CANAVERAL®Minimally Invasive Pedicle Screw System

BOCA RATON, FL — FloSpine, a medical device company that designs, develops and manufactures spinal implants and instruments for the surgical treatment of spinal disorders, announced today the commercial launch of its CANAVERAL®Minimally Invasive Pedicle Screw System.

The Canaveral Minimally Invasive Screw (MIS) System is a thoracolumbar posterior stabilization system featuring extended modular screw heads. This allows the surgeon to select the various modular screw head options to a wide range of screw offerings. This includes the option of 30mm reduction and a selection of closed or open style headbodys. The CANAVERAL® MIS system is an extensive and customizable solution for all surgical cases.

Two surgery’s using the FloSpine CANAVERAL®  MIS Pedicle Screw System were performed by Texas Back Institute surgeons Dr. Richard Guyer, MD and Dr. Jack Zigler, MD at the Presbyterian Plano Center for Diagnostics & Surgery in Plano TX. Both surgeons were impressed with the instruments and the various implant options available.

“I was very impressed by the ease of insertion, and also gratified to see how many of our recommendations that were used in the progressive refinement of the system” said Jack Zigler, MD, Orthopedic Spine Surgeon at Texas Back Institute and Co-Director of the Center for Disc Replacement.

Richard Guyer, M.D.  the Co-founder of the Texas Back Institute and Director of their Spine Fellowship Program said “FloSpine a great job engineering a very slick, surgeon-friendly system. It is also a scrub tech friendly system and they felt it was one of the easiest systems to put together” Dr. Guyer is also Co-Director for the Center for Disc Replacement at Texas Back Institute.

“The CANAVERAL®  Minimally Invasive System also reduces the number of implants that need to be present in the operating room and thereby reduces unnecessary clutter in the surgical area.

_____________________________________________

About FloSpine
FloSpine, LLC is a privately held US medical device company offering products for addressing complex deformity spine problems, minimally invasive spine surgery and thoracolumbar degenerative conditions. For more information please visit FloSpine at http://www.flospine.com

About Texas Back Institute

Texas Back Institute is one of the largest multidisciplinary spine centers in the world. Using the latest technology and medical advances, Texas Back Institute is dedicated to helping patients get back to life. For more information please visit Texas Back Institute at  https://www.texasback.com

 

UK firm sold spinal implants that disintegrated

26 Nov 2018 / 

A UK company’s spinal implants that allegedly moved and eroded in patients, and which are at the centre of legal action, have highlighted potential weaknesses in the way in which some medical devices enter the market, an investigation has revealed.

Documents seen by the Guardian show the plastic discs were approved for sale by the British Standards Institution (BSI) after tests on 30 people over six months.

A customised version was also implanted in nine baboons, according to a paper by members of the company’s own scientific advisory board.

The devices, made by the now-defunct Ranier Technology, which was based in Cambridge, are the focus of legal action brought by prosecutors in Germany against a doctor who implanted them, allegedly without first obtaining fully informed patient consent.

Many of the patients who received them are undergoing surgery to have them removed, with doctors finding some had completely disintegrated, according to an investigation coordinated by the International Consortium of Investigative Journalists, involving the Guardian and BBC’s Panorama.

Ranier Technology was granted CE (Conformité Européenne) safety marks for two implants, Cadisc-L and Cadisc-C. The devices were certified by the BSI in 2010 and 2011 respectively, and once approved were marketed to hospitals across Europe.

The firm gained millions of pounds in backing from investors impressed by its work in developing artificial spinal discs, which it said would bring relief and a normal quality of life to patients suffering degenerative disc disease.

Instead, about half of the patients given the Cadisc-L implants have had to undergo further surgery after the discs apparently disintegrated or moved in their backs, the Implant Files investigation has discovered.

The implants were seemingly beset by problems from the start, according to scientific analysis. The documents seen by the Guardian show that in trials on baboons using a custom-sized version of Cadisc-L the discs had all been put in the wrong place.

A 2009 review of some of the animals noted that “overall six months is a relatively short time to follow an implant up”, but even after that time there appeared “to be worrying changes between the implant and the bone in all but one subject”.

Details of the tests on humans have not been published, but it is known they only ran for six months before the CE mark application, even though the implants were aimed at young patients.

Viseon, Inc. Announces First US Clinical Use of the Voyant System for Minimally Invasive Spine Surgery Access, Illumination and Visualization

November 27, 2018

IRVINE, Calif.–(BUSINESS WIRE)–Viseon, Inc. today announced the first U.S. clinical human use of the Voyant System for Minimally Invasive Spine Surgery access, illumination and visualization. The case was performed by Neurosurgeon John J. Knightly, MD of the Atlantic NeuroSurgical Specialists in Morristown, New Jersey. The Voyant System is composed of a sterile single-use, disposable retractor device with integrated state-of-the-art visualization technology. The system utilizes a reusable controller enabling digital intraoperative manipulation of the surgical site image, which is displayed on operating room HD flat-panel display monitors. The sterile device also allows the surgeon to adjust intraoperative depth of focus.

Dr. John J. Knightly, Vice Chair of Neurosciences and Medical Director of the NeuroSpine Program at Overlook Medical Center’s Atlantic Neuroscience Institute in Summit, NJ, stated, “The Viseon technology has the potential to significantly change how I perform minimally invasive spinal surgery procedures. The technology represents a compelling alternative for using a surgical microscope, with sufficient anatomical distinction and depth perception to safely perform these cases, in an easy to use, disposable system.”

Viseon President and CEO Jeffrey Valko stated, “We are grateful that Dr. Knightly has pioneered our first U.S. human case, demonstrating the procedural transition from surgical microscopes. Further, he confirmed the ergonomic and efficiency advantages of this innovative system.”

Viseon previously announced FDA 510k clearance of the Voyant System in October 2018 and is currently available in the U.S. on a limited basis.

About Viseon, Inc.

Viseon has developed a platform technology that has multiple opportunities for technological expansion, including wireless, neuro-monitoring and navigation, fluorescence, sensor integration and complementary robotic applications. The company has demonstrated clinical utility in posterior lumbar decompression and interbody fusion procedures and is expanding into lumbar lateral access and anterior cervical decompression fusion applications. The privately held medical device company is located in Irvine, California, founded in 2017, and recently completed an oversubscribed follow-on financing in October 2018.

For further information, please visit www.viseon-spine.com.

Contacts

Viseon, Inc.
Jeffrey J. Valko, (949) 662-3959

Astura Medical Receives FDA 510(k) Clearance For OLYMPIC MIS Posterior Spinal Fixation System

CARLSBAD, CA – November 26, 2018 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Olympic Minimally Invasive Surgery (MIS) Posterior Spinal Fixation System.

The Olympic MIS system delivers a new level of intraoperative flexibility and efficiency by allowing surgeons to customize to their preferred workflow through the utilization of either a traditional jamshidi/guide wire technique, awl-tap wireless technique, or single-step wireless technique for the placement of MIS pedicle screws. The system features an extensive offering of pedicle screw options, including iliac fixation, in either an extended tab (no assembly) or tower/screw (single step assembly) option. Designed to address even the most complex pathologies, Olympic MIS provides the versatility to accommodate multiple rod diameters in either titanium or cobalt chrome in pre-bent lordotic, straight, or pre-bent kyphotic options. The instrumentation further supports a streamlined and reproducible procedural sequence by providing up to 50mm of reduction, along with multiple options for compression or distraction, including the ability to span multiple levels simultaneously.

“With the increasing rates of MIS adoption and further complexity of pathologies being treated, it was paramount that we addressed the wide range of techniques that surgeons are currently utilizing,” said Joel Gambrell, President and CEO of Astura. “I’m proud of the system that our team of engineers and surgeon designers developed. Olympic MIS once again accomplishes our goal of continuing to bring technology to the market that further enhances the ability of our surgeon partners to provide the best in patient care.”

The full commercial release for Olympic MIS in December represents the fourth differentiated technology delivered to the market by the company in 2018.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

For more information, please visit www.asturamedical.com or find us on LinkedIn.

Media Contact:

Steve Haayen

Astura Medical

858.472.8825 steve@asturamedical.com

Vertiflex® Announces Publication of Data Analysis Showing 85% Reduction in Patients Using Opioids After Treatment With Superion® Indirect Decompression System

November 20, 2018

CARLSBAD, Calif.–(BUSINESS WIRE)–Vertiflex® Inc., a leading innovator of advanced, minimally invasive interventions for spinal stenosis, announced additional results from a randomized, controlled trial of its Superion® Indirect Decompression System in patients with lumbar spinal stenosis (LSS). The results, published in the Journal of Pain Research (https://www.dovepress.com/articles.php?article_id=42435), showed an 85 percent decrease in the proportion of patients who were using opioids five years after being treated with interspinous process decompression (IPD) using the Superion device. The study was conducted under an Investigational Device Exemption with the U.S. Food and Drug Administration (FDA).

Superion received Premarket Approval (PMA) from the FDA in 2015 for the treatment of LSS, a common degenerative condition where the spinal cord narrows, compressing nerves that travel through the lower back into the legs. LSS causes significant pain, disability, functional impairment and diminished quality of life. It is the most common indication for spine surgery in older adults. In the United States, LSS affects more than 14 million patients.

“These findings demonstrate that treatment with IPD, a minimally-invasive treatment option for LSS, can provide effective pain relief while markedly decreasing the need for prescription opioid medications,” said Pierce D. Nunley, M.D., lead author of the publication and Director of the Spine Institute of Louisiana.

Study Design and Results

The trial estimated the type, dosage and duration of opioid medications through five years of post-operative follow-up after IPD with the Superion device. Data were obtained from the Superion treatment arm of a randomized, controlled, noninferiority trial. The prevalence of patients using opiates was determined at baseline, 6 weeks, and at 3, 6, 12, 18, 24, 36, 48 and 60 months. The primary analysis included all 190 randomized patients receiving the Superion device.

At baseline, nearly 50 percent (94 of 190) of patients were using opioid medications. Results of the data analysis showed a marked year-over-year decrease in the proportion of patients taking opioid medication to manage LSS symptoms after Superion implantation. After five years, there was an 85 percent decrease in the proportion of patients using opioids.

“We are pleased by these published results demonstrating that use of the Superion device provides effective relief from back and leg pain in patients with LSS without the need for continuing opioid therapy. These results extend previous research showing that Superion results in long-term sustained clinical improvement in patients with LSS,” said Earl Fender, President and CEO of Vertiflex. “Finding non-opioid approaches to treating pain is critical, and we are pleased to share these published findings and discuss their implications with the clinical community.”

“With growing concerns over prescription opioid overuse and misuse, which can lead to addiction, any effective strategies that can decrease or even eliminate the need for opioid therapy in patients with LSS are welcome,” said Tim Deer, M.D., an author on the publication and President and CEO, The Spine and Nerve Center of the Virginias.

In the United States, the opioid epidemic was responsible for more than 42,000 deaths in 2016, or 116 people a day.1 About 40 percent of all opioid overdose deaths involve a prescription opioid.2

About Superion

Superion is an indirect decompression device for the treatment of moderate LSS. Superion prevents compression of the nerves and vasculature in the spine while walking and standing, when symptoms most commonly manifest, and does not require the removal of any bone or tissue to implant. Superion received approval from the FDA through a Premarket Approval process based on the largest, most extensive body of device clinical evidence related to LSS.

About Vertiflex®, Inc.

Vertiflex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in Carlsbad, California, Vertiflex has developed a proprietary, minimally invasive technology for performing indirect decompressions of the lumbar spine. The procedure fills a gap in the stenosis treatment continuum. To date, Vertiflex has compiled the largest, most rigorous body of device clinical evidence related to lumbar spinal stenosis. For more information, visit www.vertiflex.com.

References

1. HHS: https://www.hhs.gov/opioids/about-the-epidemic/index.html

2. CDC: http://www.cdc.gov/drugoverdose/data/index.html

Contacts

Vertiflex®, Inc.
Kathryn Larson, Sr. Director, Strategic Marketing
klarson@vertiflex.com
+1.442.325.5941

MEDICREA® Achieves 3,000 Surgery Milestone with UNiD ASI™ and Patient Specific Implants

November 20, 2018

LYON, France & NEW YORK–(BUSINESS WIRE)–The MEDICREA® Group (Euronext Growth Paris: FR0004178572-ALMED ; OTCQX Best Market – MRNTY & MRNTF), pioneering the digital transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD ASI™ (Adaptive Spine Intelligence) proprietary software platform, services and technologies, announced today that the 3,000th surgery utilizing MEDICREA®’s patient-specific UNiD ASI™ technology has been successfully completed.

Five years after its initial launch, over 3,000 patients worldwide have benefited from UNiD ASI™, the 100% proprietary, pre-operative planning technologies and services associated with patient-specific spinal realignment rods. This technology has seen a strong acceleration in adoption rate in 2018 especially in the USA (+62% cases in the USA since January 1st, 2018). MEDICREA® just recorded its highest monthly number of UNiD® surgeries with 121 surgeries performed in October 2018.

“Planning a case is a crucial step in any spine surgery. The slightest change at the base of the spine impacts the top of the spine greatly. Therefore, if the base is not fixed properly, the patient has a higher risk of proximal junctional kyphosis (PJK). With MEDICREA®’s proprietary UNiD ASI™ platform, I can plan my case pre-operatively. The Artificial Intelligence embedded within the platform allows me to visualize the compensatory mechanisms above and below the instrumented spine that will most likely occur based on my surgical plan. I can work hand-in-hand with the UNiD Lab™ biomedical engineers who create several surgical plans and identify the one that would give my patient the best outcome” said Christopher Kleck, MD, Department of Orthopedics, University of Colorado SOM, Aurora, CO.

Christopher Kleck, MD, recently co-authored the article titled: “Pelvic Incidence Changes Between Flexion and Extension”. Recent evidence suggests that Pelvic Incidence (PI) changes with age, ethnicity, and body mass index and can be modified following spinal procedures. However, the mechanism of PI changes is still not well understood. “This new study suggests that this mechanism is even more complex than previously thought and reinforces the need for UNiD ASI™ technology” adds C. Kleck, MD.

MEDICREA®’s proprietary UNiD ASI™ technology is a comprehensive suite of services designed to help surgeons improve their patient’s outcomes. By leveraging artificial intelligence and the latest clinical research, the UNiD LAB™ Engineer provides the surgeon with insights previously not possible within their clinic. UNiD ASI™’s unique blend of software and services delivers these insights within the normal pace of a surgeon’s clinic day without slowing them down. This empowering technology allows surgeons to have more impactful patient interactions with visual surgical plans based on technology fueled by 3,000 past cases.

Dr Christopher Ames, MD, Director of spinal tumor and spinal deformity surgery at UCSF Medical Center, CA, said “I fully integrated the UNiD ASI™ technology within my practice workflow. Before I even see the patient, I can look at the images and the measurements taken by the UNiD LAB™ biomechanical engineers. For instance, in a patient who has sagittal imbalance and pelvic retroversion I can tell that I am going to need a PSO. I can directly communicate with an engineer to let them know. Within minutes, they will simulate different plans incorporating my feedback. I can review the pre-op measurements sent back to me and decide on the patient’s final operative plan. From there, I can meet the patient, explain the procedure and schedule the surgery. Instead of adding more time, my clinic became much more efficient.”

Denys Sournac, Chief Executive Officer of MEDICREA®, stated, “Spine surgery is one of the more complex procedures in healthcare because of the high number of different parameters to take into consideration. It is impossible for the human brain to compute all of them for one single patient. MEDICREA® has dedicated the past 8 years to creating and strengthening a platform based on Artificial Intelligence with the goal to assist surgeons in building precise surgical planning in order to help them improve their patient’s outcomes.”

Denys Sournac adds: “Today we are celebrating the 3,000th surgery with the UNiD ASI™ technology, including patient-specific implants. This milestone embodies the power of our platform and the depth of our clinical database collected following rigorous and centralized processes. Clinical data from which our algorithms are designed and continuously refined are extremely homogeneous and exceptionally rich.”

“The spine industry is starting its digital revolution, and we are proud to be leading the way” concluded Denys Sournac.

Click here to reach the article: Pelvic Incidence Changes Between Flexion and Extension

Click here to reach the video: UCSF Clinical Application: Live Pre-Op Planning with Adaptative Spine Intelligence

About MEDICREA® (www.medicrea.com)

Through the lens of predictive medicine, MEDICREA® leverages its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data. The Company is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, MEDICREA® is a Small and Medium sized Enterprise (SME) with 210 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D- printed titanium patient-specific implants.

For further information, please visit: medicrea.com.

Connect with MEDICREA®

FACEBOOK INSTAGRAM TWITTER WEBSITE YOUTUBE

MEDICREA® is listed on

EURONEXT Growth Paris

ISIN: FR 0004178572

Ticker: ALMED

LEI: 969500BR1CPTYMTJBA37

MEDICREA® is traded on

OTCQX Best Market

Tickers: MRNTY & MRNTF

Contacts

MEDICREA®
Denys SOURNAC
Founder, Chairman and CEO
dsournac@medicrea.com
Fabrice KILFIGER
Chief Financial Officer
fkilfiger@medircrea.com
Tel: +33 (0)4 72 01 87 87

RTI Surgical® Announces HealthPartners’® Positive Coverage Decision for Minimally Invasive Sacroiliac Joint Fusion Surgery

November 19, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, announced HealthPartners, the largest consumer governed nonprofit health care organization in the United States, issued a positive coverage decision for minimally invasive sacroiliac (SI) joint fusion surgery, effective November 1, 2018. This decision expands access to RTI’s SImmetry System for HealthPartners members considering treatment for SI joint pain or dysfunction. The SImmetry System is a minimally invasive surgical solution that uses proprietary decortication technology, bone graft and threaded fixation to facilitate bone fusion, providing an opportunity for long-term pain relief.

It has been reported that up to 30 percent of all chronic low back pain, the second most common cause of disability in American adults, is due to SI joint dysfunction. SI joint fusion surgery using the SImmetry System is designed to stabilize the dysfunctional SI joint by fusing the sacrum and the pelvic bone together.

“As a surgeon in the HealthPartners network who has experience using the SImmetry System, this positive coverage decision is a win for patients suffering from SI joint dysfunction,” said Edward Santos, M.D., a spine surgeon specializing in neck, back, cervical, thoracic and lumbar spinal disorders, and minimally invasive surgery at Summit Orthopedics in Minneapolis. “The SImmetry System is a minimally invasive surgical solution that promotes SI joint fusion through decortication, with a growing body of clinical evidence showing improvements in pain, disability and opioid use for SI joint patients.”

“RTI is encouraged by HealthPartners’ decision, which expands access to the SImmetry System for patients with SI joint pain or dysfunction,” said Camille Farhat, President and CEO, RTI Surgical. “The SImmetry System is supported by a growing body of evidence suggesting long-term pain relief for these patients. We are committed to advancing clinical data for the SImmetry System to aid in further payor decisions.”

Clinical Data Supporting the SImmetry System

The ongoing EVoluSIon Clinical Study is evaluating the impact of SImmetry on SI joint fusion and pain reduction in 250 patients across 23 sites. An early analysis of the first 50 patients published in December 2017 showed a 54 percent reduction in SI joint pain at six months, as well as a 55 percent reduction in opioid use.A separate CT fusion study on the SImmetry System demonstrated a 73 percent reduction in average pain over 24 months.iiClinical outcomes from 100 patients presented at the International Society for the Advancement of Spine Surgery (ISASS) 2018 Annual Meeting showed the SImmetry System provided a 56 percent reduction in patient-reported pain, and a statistically significant reduction in the use of opioids and other pain medications at six months.iii

For more information on the policy, visit the HealthPartners website.

About RTI Surgical, Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic and trauma procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com. Connect with us on LinkedIn and Twitter.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements, gaining market share and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

i Araghi A et al. Pain and Opioid use Outcomes Following Minimally Invasive Sacroiliac Joint Fusion with Decortication and Bone Grafting: The Evolusion Clinical Trial. Open Orthop J. 2017;11:1440-1448.
ii Cross W et al. Minimally Invasive Sacroiliac Joint Fusion: 2-Year Radiographic and Clinical Outcomes with a Principles-Based SIJ Fusion System. Open Orthop J. 2018 Jan 17;12:7-16.
iii Araghi A et al. Minimally invasive Sacroiliac Surgery with Decortication and Threaded Implants: Analysis of the EVoluSIon Study. Presented at ISASS 2018.

Contacts

Media Contact

Molly Poarch, +1 224 287 2661
mpoarch@rtix.com

Investor Contact

Nathan Elwell, +1 847 530 0249
nelwell@lincolnchurchilladvisors.com