News – Page 66 – Selby Spine

CARLSBAD, CA – June 4, 2018 – Astura Medical, a high growth, innovative spine technology company, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ALTA ACDF Interbody Spacers and HALF DOME Lumbar Interbody Spacers in PEEK-OPTIMA^ä HA Enhanced from Invibio Biomaterial Solutions.

Combining the clinically proven strength and versatility of PEEK-OPTIMA with Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, PEEK-OPTIMA HA Enhanced provides an innovative biomaterial for interbody fusion devices. HA is fully integrated, not coated, into the PEEK-OPTIMA matrix, ensuring it is present on all surfaces and throughout the implant.

“As surgeons continue to explore different surface technology options, we are excited about the addition of HA PEEK to our suite of interbody solutions,” said Thomas Purcell, Vice President of Astura Medical. “It once again reinforces Astura’s commitment to providing our surgeon partners with differentiated technology to enhance their ability to provide the best in patient care.”

ALTA and HALF DOME HA PEEK are now commercially available in multiple footprint, height, and lordotic options for ACDF, PLIF, and TLIF procedures. In addition to the launch of their HA PEEK lineup, Astura will be introducing its MIS Percutaneous Screw System and Expandable Posterior Lumbar Interbody Cages later this year.

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

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SUWANEE, GA, June 04, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is excited to announce that Shri Parikh has joined SANUWAVE Health effective May 31, 2018 as President of our Healthcare division. Shri most recently joins us from Molnlycke Health Care where he held the title of Vice President, Sales and Marketing. Prior to Molnlycke, Shri was the Director of National Accounts at Stryker, a leading medical technology company with products and services in Orthopaedics, Medical and Surgical Equipment, and Neurotechnology and Spine.

Shri began his career in sales at Bristol-Myers Squibb and held various roles with increasing sales, marketing and corporate accounts responsibility at Guidant and St. Jude Medical before joining Stryker.

“We are thrilled that Shri chose to join the SANUWAVE family. His leadership, ethics and commercialization expertise will further spearhead the design of a carefully thought out go-to market strategy among other growth management initiatives as we continue to develop partnerships around the globe,” said Chief Executive Officer, Kevin Richardson who further stated, “We enthusiastically look forward to returning more value to our shareholders under Shri’s direction.”

President, Shri Parikh also commented, stating, “I am honored to join the SANUWAVE team and excited about our future. SANUWAVE’s unparalleled innovative technology and clinical evidence has far reaching implications benefiting patients suffering from diabetic foot ulcers and beyond. I look forward to working with the talented team at SANUWAVE to deliver sustainable capabilities and scale to support our global growth and commercialization plans, while taking all the necessary steps to enhance value for all shareholders.”

Shri was born and raised in Charlotte, NC. He holds a Bachelor of Arts degree in Medical Ethics and Economics from Davison College, a Master of Business Administration from Jacksonville University and an Advanced Management Program degree from the University of Chicago.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating System for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE® technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is US FDA cleared for the treatment of Diabetic Foot Ulcers. The dermaPACE® System is also CE Marked throughout Europe and has license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® System, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron®, Evotron® and orthoPACE® Systems in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

Contact: 

Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com

SANUWAVE Health, Inc.
Kevin Richardson II
Chairman of the Board
978-922-2447
investorrelations@sanuwave.com

WARSAW, Ind., June 04, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today the first surgery utilizing OrthoPediatrics’ newly launched rigid intramedullary nailing system, the Pediatric Nailing Platform|FEMUR (“PNP | FEMUR”), was performed on May 23, 2018 by Dr. Eric Gordon in St. Louis. Dr. Gordon, the original designer of OrthoPediatrics’ PediNail, served as a designing surgeon for the PNP|FEMUR system along with an internationally represented surgeon design team. The innovative system features two distinct child and adolescent implant offerings optimized for pediatric-specific anatomy and accompanied by an entire suite of new/enhanced high precision instrumentation. Capable of addressing trauma and deformity corrections alike, the first surgery performed with the new system represents the culmination of 18 months of development as the Company enters the next step in the evolution of its Intramedullary Nailing franchise.

The surgery performed was bilateral rotational osteotomies for excessive femoral anteversion, a procedure intended to correct a femur rotated too far forward, in a 13 year-old female. Each femur saw a 40-degree rotational correction achieved utilizing a 9mm Intramedullary Child Nail. After the case, Dr. Gordon stated, “The system’s innovative and pediatric-specific design allowed us to achieve superior results as the components fit smoothly together with ease. This is a substantial improvement in the ease of insertion and the anatomic fit, leading to an improved anatomic correction. I am excited to offer my patients a better outcome and experience with this fantastic new system.”

Joe Hauser, Vice President of Trauma & Deformity Correction at OrthoPediatrics, commented, “We are incredibly pleased with the outcome of the first surgery and grateful for the opportunity to help this young patient. I’m especially thankful for the designing surgeons and engineers involved with this project and for their efforts in developing a system that treats a wider range of children and pathologies. This platform represents the next evolution of innovation from OrthoPediatrics, and I look forward to many more success stories.”

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

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

BOSTON, May 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 Europe, Australia, Mexico, 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.

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

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.

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

Source: Vericel Corporation

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

rea-medicrea-5a4276cf1b952a23a2381b1b66a95324546377b474c62e264272afb9a3c02711-A-1-1.jpg

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

BURNSVILLE, MINN. (PRWEB) MAY 31, 2018

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.

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Current Issues in Spine

Astura Medical Receives FDA 510(k) Clearance For Cervical and Lumbar HA PEEK Interbody Systems

SANUWAVE Hires Shri Parikh as President for Global Healthcare Division

OrthoPediatrics Corp. Announces First Surgery Performed with Pediatric Nailing Platform | FEMUR

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

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