Camber Spine Announces 510(k) Approval Of ENZA™-A Titanium ALIF

WAYNE, Pa.June 4, 2018 /PRNewswire/ — Camber Spine today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ENZA™-A Titanium Anterior Lumbar Interbody Fusion (ALIF) system, a unique, minimally invasive interbody fusion device providing integrated fixation.

Daniel Pontecorvo, CEO, said, “ENZA™-A leverages two of Camber Spine’s highly innovative platform technologies. The vast interest and success of our first generation ENZA™ (PEEK) with Duo Presa™ (Two Grips) anchor technology and our line of SPIRA™ products with Surface By Design™, inspired us to combine their defining attributes to create this next generation ENZA™-A Titanium ALIF.”

ENZA™-A Titanium ALIF is an interbody fusion device consisting of a 3D printed titanium body with a roughened surface that encourages bone growth onto the cranial and caudal surfaces of the device. The upper and lower faces are deliberately designed with pores that average 500 microns in diameter, the optimal environment for bone to grow and fully incorporate the implant with the vertebral bodies. The ENZA™-A Titanium ALIF has multiple openings to allow a large volume of autogenous bone graft to be easily packed into the implant to further facilitate fusion. Similar to the original ENZA™, this device features two sharpened anchor plates that are housed within the 3D-printed body until they are deployed into the adjacent vertebrae to provide fixation.

According to Seth Anderson, Executive Vice President of New Business Development and Surgeon Relations, “ENZA™-A Titanium ALIF was designed with the surgeon, O.R. staff, and safety in mind. Surgery time is reduced by the single, inline instrumentation used to insert the device, deploy the anchor plates, and lock it in place. Patient safety is increased by minimizing the size of the incision and retraction required for implantation of the device. With ergonomic instrumentation, this system is easy to use and makes implantation more streamlined. The ENZA™-A is the second device in the Camber Spine ENZA™-line of implants. This interbody, coupled with additional product launches expected later this year in the cervical and lateral markets, will continue to grow Camber Spine’s presence as a market leader and innovator in minimally invasive spine surgery technology advancements.”

The Camber Spine ENZA™-A Titanium ALIF is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. It is intended to be used with additional FDA-cleared supplementary fixation systems. These implants may be implanted via a laparoscopic or an open anterior approach.

About Camber Spine

WHERE OTHERS SEE PROBLEMS, WE SEE OPPORTUNITIES. TRANSFORMING SURGEON FRUSTRATIONS INTO INNOVATIONS.

Camber Spine, LLP, is a fast-growing musculoskeletal implant company founded in 2010 bringing innovative, best-in-class products to the market, providing surgeons and their patients with better treatment options. The company is committed to delivering surgeon inspired new technologies to the spine market. Camber is an ISO 13485 certified medical device company. Camber Spine Technologies, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine. For further information please visit www.cambermedtech.com. For inquiries about ENZA™-A Titanium ALIF or distribution opportunities please call 484.427.7060.

All of Camber Spine Technologies’ products are proudly MADE IN THE USA.

SOURCE Camber Spine

Pivotal Clinical Trial Demonstrates Superiority of Anular Closure Compared to Standard Lumbar Discectomy

BOSTONMay 23, 2018 /PRNewswire/ — Intrinsic Therapeutics, Inc., a medical device company focusing on spinal disc therapies, today announced the publication of two-year results from a landmark, randomized, superiority clinical trial. The trial investigated the Barricaid Anular Closure Device (ACD) in comparison to today’s gold standard of discectomy without anular closure, for patients at higher risk of recurrent lumbar disc herniation.

The clinical trial included 554 randomized patients. Its purpose was to determine whether a microdiscectomy with a bone-anchored anular closure device resulted in lower reherniation and reoperation rates and increased overall patient clinical success, when compared to traditional lumbar discectomy without defect closure.

The two-year results that have now been published in The Spine Journal demonstrate that the use of a bone-anchored ACD following discectomy is superior to treating these high-risk patients with discectomy alone. The group treated with Barricaid had significantly lower rates of reherniation (12% vs. 25%, P <0.001), reoperations to address recurrent herniation (5% vs. 13%, P=0.001), and index-level reoperations (9% vs. 16%, P =0.01).

“In order to fully comprehend the benefit of treating these patients with an implant, it is important to realize that patients who are reoperated generally do not reach the same pain and functional improvement of patients who did not have additional surgery. The odds of not returning to work were nearly three times higher after a revision surgery. Barricaid cuts the rate of reoperations in half at 2 years, preventing chronic disability and improving quality of life,” explains Dr. Matthew McGirt, Adjunct Research Associate Professor at the University of North Carolina, who was not involved in the study.

In addition, the rates of serious adverse events related to either the implant and/or procedure was 7% in the Barricaid group and 17% in the control group (P=0.001), indicating that use of the Barricaid lowers the incidence of hospital readmissions.

“These study results shine a spotlight on the fact that if we add a device to a procedure that doesn’t otherwise have one, the treatment cohort experiences fewer related hospital readmissions, with a 40% reduction at two years. According to current follow-up data of up to five years this differential is maintained,” says Professor Claudius Thomé, Head of Neurosurgery at the University of Innsbruck, Austria, and one of the principal investigators of this trial. “Moreover, if a reoperation needs to be considered in a patient later on, the same revision strategies are possible with this implant as after microdiscectomy alone.”

About herniation and lumbar discectomy

The human intervertebral disc consists of an outer fibrous ring, the anulus fibrosus, which in case of herniation allows the inner gel-like center, nucleus pulposus, to come out through a defect in the anulus. Sciatica, characterized as radiating pain in the leg, is often caused by a herniated disc compressing the nerve. The estimated annual incidence of sciatica in Western countries is 5 cases per 1,000 adults. As it mostly affects a relatively young, active patient population, the economic consequences resulting from disability and absenteeism from work are significant. Surgery for a herniated disc is often only considered when conservative treatment options have failed.

Within the discectomy population, patients with large defects in their anulus following lumbar discectomy are at high risk of symptomatic recurrence and reoperation. According to literature, 30-40% of all discectomy patients fall into this group. With almost 500,000 discectomies performed annually in the United States alone, this poses a significant problem not only for the patients affected, but for society as a whole.

About Intrinsic Therapeutics

Intrinsic Therapeutics is a medical device company focused on delivering a safe treatment to improve efficacy in patients who are at a disproportionately high risk of requiring repeat surgeries due to reherniation following lumbar discectomy surgery. Intrinsic Therapeutics currently markets and sells the Barricaid in EuropeAustraliaMexico, the Middle East and selected countries in other regions around the world. In the United States, Intrinsic Therapeutics is seeking regulatory approval of the Barricaid Anular Closure device. See www.barricaid.com for more information.

Barricaid is a registered trademark of Intrinsic Therapeutics, Inc.

CONTACT:
Cary Hagan
President and CEO
617-784-4147
clinical@in-thera.com

SOURCE Intrinsic Therapeutics, Inc.

Related Links

http://www.barricaid.com

Safe Orthopaedics Acquires a Direct Sales Force in the United Kingdom

June 01, 2018

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (FR0012452746 – SAFOR) (Paris:SAFOR), a company specialising in the design and marketing of single-use implants and instruments facilitating the minimally invasive treatment of spinal fracture conditions, is today announcing a deal to acquire the sales force of UK company Qspine, which specialises in distributing medical equipment for spinal surgery.

Since 2014, Qspine has distributed Safe Orthopaedics in the UK. The UK is Europe’s second largest market for spinal fusion surgery, worth an estimated €105 million, including €12 million for spinal fracture conditions alone.

“With the confidence resulting from our growing market share in France and initial positive signs in Germany, we are extending our direct distribution network in Europe by acquiring the sales force of our long-standing UK distributor. This sales force consists of four experienced salespeople and has delivered solid adoption of our technology with limited resources. We will gradually increase commercial resources and marketing efforts in the UK, and we intend to realise the full potential of our technology in the UK market with the medium-term aim of matching our current market share in France. These sales will contribute to the growth of the group as of the second semester of 2018,” said Pierre Dumouchel, CEO and co-founder of Safe Orthopaedics. “By selling our SteriSpine technologies directly to hospitals, we will improve our overall gross margin while also becoming more competitive and more flexible in terms of our selling prices. We are also very interested in promoting Qspine’s single-use illuminated retractor technology, which will be an excellent fit with our range.”

Qspine’s SURE retractor has recently obtained the CE mark and is now commercially available. The SURE system consists of a single-use, sterile radiolucent retractor, offering surgeons a genuine alternative – in both technical and economic terms – to traditional reusable products, while also offering a novel integrated illumination option. Safe Orthopaedics become the sole distributor of the SURE system in France, and will promote it in the UK.

“I believe this collaboration will benefit both companies. It will allow Safe Orthopaedics to quicken the pace in the UK market and gain quick access to accounts by using the unique SURE retractor. I look forward to working closely with Safe Orthopaedics to allow more surgeons to experience the many benefits that SteriSpine and SURE can deliver,” added Alan Lawson, CEO of Qspine.

Forthcoming financial events:

  • General Shareholders’ Meeting, Thursday June 28, 2018
  • Second-quarter 2018 revenues: July 10, 2018 (after the market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that offers the safest technologies to treat spinal fracture. Delivered sterile, all implants and respective disposable instrumentation are available to the surgeon at any time, any place. These technologies enable minimally invasive approaches, reducing risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpine™ Kits are CE marked and FDA cleared. The company is based at Eragny-Sur-Oise (France), and has 37 employees.

For more information, visit: www.SafeOrtho.com

About the SURE retractor

For more information, visit: www.suresystem.com

Contacts

Safe Orthopaedics
François-Henri Reynaud, +33 (0)1 34 21 50 00
CFO
investors@safeorthopaedics.com
or
Investor Relations
NewCap
Julien Perez / Valentine Brouchot
+33 (0)1 44 71 94 94
SafeOrtho@newcap.eu
or
Press Relations
Ulysse Communication
Bruno Arabian, 06 87 88 47 26
barabian@ulysse-communication.com
or
Nicolas Daniels, 06 63 66 59 22
ndaniels@ulysse-communication.com

Vericel Corporation Prices $65 Million Public Offering of Common Stock

CAMBRIDGE, Mass., May 31, 2018 (GLOBE NEWSWIRE) —

Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, today announced the pricing of its previously announced underwritten public offering of 5,000,000 shares of its common stock, at a price to the public of $13.00 per share.  The gross proceeds to Vericel from this offering are expected to be $65 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Vericel.  Vericel has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock on the same terms and conditions.  The offering is expected to close on or about June 5, 2018, subject to customary closing conditions.  Vericel anticipates using the proceeds from the offering for general corporate purposes as well as to expand Vericel’s business by in-licensing or acquiring, as the case may be, product candidates, technologies, other assets, commercial products or businesses which would be complementary to Vericel’s existing commercial franchises or its advanced cell therapy platform; however, Vericelhas no current commitments or obligations to do so.

Leerink Partners is acting as the lead bookrunner for the offering.  BTIG, LLC is also acting as a bookrunner.  Ladenburg Thalmann is acting as co-manager.

The offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed with the Securities Exchange Commission (SEC) on June 29, 2015 and declared effective by the SEC on July 15, 2015.  The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement.  A preliminary prospectus supplement and accompanying prospectus related to the offering has been filed with the SEC.  A final prospectus supplement for the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov.  Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained by contacting Leerink Partners LLC, c/o Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by email at syndicate@leerink.com, or by phone at (800) 808-7525, ext. 6132 or by contacting BTIG, LLC at 825 Third Avenue, 6th Floor, New York, NY, 10022, or by telephone at (212) 593-7555 or by e-mail at equitycapitalmarkets@btig.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

About Vericel Corporation
Vericel is a leader in advanced cell therapies for the sports medicine and severe burn care markets.  The company markets two cell therapy products in the United States.  MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area.

Epicel® and MACI® are registered trademarks of Vericel Corporation. © 2018 Vericel Corporation. All rights reserved.

Cautionary Statement on Forward-Looking Statements
This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, the public offering of Vericel’s common stock and expected use of proceeds from such offering. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ, including, the satisfaction of customary closing conditions related to the proposed public offering, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vericel’s Annual Report on Form 10-K for the year ended December 31, 2017 and Vericel’s Quarterly Report on Form 10-Q for the quarter ended March 30, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov, and in the preliminary prospectus supplement related to the proposed offering filed with the SEC. In addition to the risks described above, other unknown or unpredictable factors also could affect Vericel’s results. There can be no assurance that the actual results or developments anticipated by Vericel will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on Vericel. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.Except as required by applicable law, Vericel does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Vcel-fin

CONTACT:

Chad Rubin
Solebury Trout
crubin@troutgroup.com
+1 (646) 378-2947

Lee Stern
Solebury Trout
lstern@troutgroup.com
+1 (646) 378-2922

Primary Logo

Source: Vericel Corporation

Spineology Rampart One™ Standard ALIF Interbody Fusion System Gains FDA Clearance for Stand-Alone Use

June 04, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., announces FDA clearance of its Rampart One™ Standard ALIF device allowing it to be used with or without supplemental fixation.

“Following the success of our beta launch, this stand-alone clearance will provide additional momentum as we prepare for the full market release of the Rampart One ALIF Interbody Fusion System,” said John Booth, CEO of Spineology.

The Rampart One ALIF Interbody Fusion System is another anatomy-conserving technology from Spineology. The system includes both standard and oblique interbody devices, each with integrated fixation screws and is designed to minimize vascular retraction and exposure to maximize safety. Additionally, Rampart One is manufactured from Invibio® PEEK-OPTIMA® HA Enhanced material to support bone on-growth.

“Minimal retraction and minimal exposure are very important for the anterior approach. The Rampart One instruments work collinear with the access, providing surgeons the ability to keep the incision to a minimum,” said Dr. Jeremy Shore of Boston, Massachusetts. “Additionally, divergent fixation screw angles and midline screw placement keep vascular retraction to a minimum.”

“Advanced biomaterials are showing great promise in enhancing patient outcomes. It’s very exciting to have access to an implant like Rampart One which is constructed from PEEK-OPTIMA HA Enhanced”, said Dr. Clifford Tribus of Madison, Wisconsin.

PEEK-OPTIMA HA Enhanced provides improved osteoconductive surfaces for bone on-growth while preserving the traditional benefits of PEEK-OPTIMA Natural including a modulus of elasticity similar to that of human bone, reduced stress shielding and artifact-free imaging.

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

Medicrea Receives World’s First and Only FDA-Clearance to Market Patient-Specific Cages

May 31, 2018

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea® Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered spinal device design with UNiD ASI™ (Adaptive Spine Intelligence) technology, announced today that it has obtained the first and only 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market patient-specific spinal cages through the extension of its UNiD™ technology to select from its IB3D™ range of 3D-printed titanium interbody devices.

With this world-first clearance, Medicrea is able to digitally plan, manufacture in-house and supply a 3D-printed device in the United States that has been optimized to follow each patient’s unique spinal anatomy using the Company’s proprietary AI-driven UNiD technology.

The current treatment method involves a time-consuming process where surgeons implant a cage from a limited range of standard dimensions during the surgery. This traditional technique represents a significant share of the operating time where the surgeon must test between the available sizes to find the implant that is most suitable for the patient but remains a compromise as it will not be optimized for that patient’s anatomy or that surgeon’s plan.

With UNiD IB3D™, the implant-selection stage disappears, reducing the operating time, and the patient benefits from an implant that is perfectly adapted to their anatomy and to the parameters defined during preoperative planning.

The approval marks further evidence that Medicrea has established its expertise as a leader in patient-specific technology for the Spine as the first company to develop and receive FDA clearance for a patient-specific spinal implant in November of 2014 with the UNiD™ Rod.

Subsequently, the Company has expanded its UNiD ASI™ (Adaptive Spine Intelligence) platform into a robust outcome-centered process by developing its own FDA-cleared surgical planning software (UNiD HUB™).

The UNiD ASI™ platform is powered by data, which it transforms with machine learning and predictive modelling, and is accompanied by a suite of patient-specific implants and engineering services able to transform the way spinal surgeons operate today.

Medicrea has successfully completed more than 2,400 surgeries with patient-specific implants.

By harnessing the power of an exclusive and growing clinical and radiographic data set, the Company is uniquely able to deliver further immediate and short-term cost-savings to healthcare stakeholders.

Denys Sournac, President and Chief Executive Officer, stated, “We are proud to achieve another world-first with this most recent FDA-clearance of UNiD IB3D™. It will enable Medicrea to significantly extend our reach in the U.S. market. By expanding our groundbreaking UNiD technology to cages, we are continuing to revolutionize spinal surgery. Patients have an implant that is optimized for their anatomy and pathology, surgeons are able to operate more efficiently, and hospitals are able to significantly reduce the processing cost and simplify supply chain logistics. Additionally, we are now able to increase the share of revenue generated by Medicrea implants in each patient-specific UNiD™ surgery in both degenerative and complex spinal indications where cages are frequently used – market segments that represent an estimated annual value of over $5 billion in the United States alone.”

The algorithmic generation of patient-specific cages within the UNiD HUB’s Analyzer tool is achieved using proprietary methods based on measurements around X-ray or MRI patient imaging. These methods are supported and protected by three unique patents acquired from Dr. Paul McAfee, of University of Maryland St. Joseph’s Medical Center, around a novel technique for physiologically identifying the optimized implant based on anatomical parameters.

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 185 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

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger,
Chief Financial Officer
fkilfiger@Medicrea.com
Tel: +33 (0)4 72 01 87 87

Outcomes of Oblique Lateral Lumbar Interbody Fusion (OLLIF) Surgery Positive for all Levels of Patient Obesity

Inspired Spine announced publication of a peer reviewed study comparing the surgical outcomes of its Oblique Lateral Lumbar Interbody Fusion (OLLIF) procedure with those of traditional open spine surgeries known as transforaminal lumbar interbody fusion (TLIF) and minimally invasive TLIF (MIS-TLIF) in patients with a BMI of 30 or greater. The study showed that OLLIF was the safest surgery at any BMI and significantly safer for patients with higher BMI.

“Obese patients are generally considered to be high risk for complications associated with spinal fusion surgery and this study shows that patients undergoing OLLIF may avoid the increase in complication rate,” said Hamid Abbasi, M.D., Ph.D., FACS, FAANS, Chief Medical Officer. “Our practice has substantially advanced spinal fusion surgery and we are actively working to share these advancements with surgeons who want to bring greater value to their spinal fusion patients.”

Based upon successful outcomes from more than 800 patients, Inspired Spine’s goal is to make OLLIF the global standard of care for spinal fusion surgery. Inspired Spine is hosting a three-day OLLIF training event for medical professionals, including operating room observations beginning on July 26th. To reserve a spot in the training session, call (727) 697-7463 or email AlyMunch@InspiredSpine.org.

Study Overview 
The study is a retrospective cohort evaluation of 321 patients at a single Minnesota hospital who underwent TLIF, MIS-TLIF or OLLIF for spinal conditions including, degenerative disc disease, spondylolisthesis, spondylosis, herniation, stenosis and scoliosis. Body mass index, surgery time, blood loss and hospital stay were measured across the three patient cohorts. The OLLIF cohort showed significantly reduced blood loss relative to TLIF. Surgery time increased significantly with increasing BMI for patients undergoing both TLIF and MIS-TLIF. A one-point increase in BMI increased surgery time and blood loss significantly in the TLIF cohort.

Obesity and Lower Back Pain 
The risk of lower back pain is directly related to increases in BMI. Individuals with a BMI of equal to or greater than 30 are obese; those with BMI of 40 are morbidly obese. Lower back pain may increase sedentary lifestyle, which can lead to further increases in BMI. Lumbar fusions are common surgical procedures for conditions associated with lower back pain. However, some surgeons may refrain from offering surgery to obese patients due to concerns about higher rates of complications and challenges. Surgical procedures that minimize these complications offer greater opportunity for relief for these patients.

About Inspired Spine 
Minnesota-based Inspired Spine is a total spine care provider dedicated to improving treatment value and outcomes by applying the least invasive solutions to back-pain problems. Inspired Spine Centers offer a variety of treatment options for chronic back pain sufferers – from advanced diagnostic technologies, such as open, upright MRIs, to a range of conservative non-surgical therapies, in addition to unique minimally invasive outpatient keyhole surgical techniques. The company is building a network of comprehensive care centers that offer conservative care, such as physical therapy and pain management, as well as groundbreaking minimally invasive outpatient surgeries that reduce costs and speed recovery for patients. Inspired Spine recently acquired a property consisting of three buildings totaling 120,000 square feet in Burnsville, MN where it is building its Total Spinal Health and Technology Campus. Inspired Spine has already employed this new venue to scale its global training program, enabling more surgeons to learn its techniques. For more information, visit http://inspiredspine.com/ and follow Inspired Spine on Twitter @Inspired Spine.

Xoran and Fiagon Collaborate in the Neuro and Spine Markets

ANN ARBOR, Mich.May 31, 2018 /PRNewswire/ — Xoran Technologies and Fiagon AG Medical Technologies have agreed to expand their existing relationship and to collaborate in the Neuro and Spine markets.

As technology-driven companies, Xoran — a leader in compact, point-of-care CT scanners, and Fiagon — a leader in easy-to-use, electromagnetic surgical navigation systems, have leveraged their agility in delivering timely innovative products that are responsive to the specialized needs of their physician customers.

At the American Association of Neurological Surgeons (AANS) meeting in New Orleans last month, Xoran introduced xCAT IQ, a truly portable compact CT scanner for the Neurosurgical suite and the ICU. Feedback from Neurosurgeons has been positive — they shared their excitement about the image quality and maneuverability of xCAT IQ, and they were particularly impressed with its ability to display CBCT images in all multi-planar projections with highly precise geometric accuracy.

The Fiagon Brain Navigation System presents a complementary match with Xoran’s xCAT IQ — it is a uniquely small, plug-and-play surgical navigation system, meticulously designed with the neurosurgeon in mind. In line with the Fiagon company philosophy, the Fiagon Brain Navigation System packs the power of navigation into a small system that optimizes workflow, thereby saving valuable OR time.

The Xoran-Fiagon Collaboration

Xoran and Fiagon have a history of successful collaboration. Last year, the companies cooperated on a research project aimed at improving surgical workflow. The seamless and automatic registration procedure described in the white paper “Optimization of Intraoperative CT with Automatically-Registered Surgical Navigation” demonstrated that using a low-dose imaging technique and an automated registration method make it possible to provide high-quality intraoperative images with submillimeter IGS accuracy at the skull base, all in just under two minutes. Contact info@xorantech.com to obtain a copy of the white paper.

Moving toward Neuro and Spine

With the announcement of the world’s most compact and maneuverable iCT (intraoperative CT) designed for neurosurgeons — xCAT IQ, Xoran is poised to expand its collaboration with Fiagon — with products that improve workflow and accuracy in the neurosurgical suite and ICU.

“As Xoran is developing various neuro-specific features that are tailored to help surgery be more efficient and effective, it makes sense for us to work with Fiagon and other top companies on new projects and products in Neuro — Cranial and Spine,” stated Xoran CEO Misha Rakic. “Xoran has a long-standing record of successful grants from the National Institute of Health (NIH), and we are looking to further our collaboration with companies who make unique products that improve patient care.”

Fiagon had similar thoughts. “Indeed, as Fiagon expands into Neuro worldwide as well as Spine, working together just makes sense as both of our companies are passionate about point-of-care solutions designed specifically for the surgeon,” explained Fiagon’s CEO Dr. Kai Desinger.

With several active collaborative projects on the horizon, Xoran and Fiagon aim to help Neuro and Spine surgeons in both the OR and the ICU improve patient care.

Trust ENT innovation leaders — Xoran and Fiagon — to take physicians further in Neuro and Spine.

© 2018 Xoran Technologies LLC

CONTACT

Paul Dykstra, Marketing & Communications Manager
800-70-XORAN
info@xorantech.com

SOURCE Xoran Technologies

Related Links

https://xorantech.com