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November 28, 2017 OrthoSpineNews

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has now performed the first surgeries in the United States and is able to offer all interbody products for Cervical, ALIF, TLIF and PLIF procedures.

EIT Cellular Titanium® is a 3D printed porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimize cell proliferation and bone ingrowth.

The first surgeons to implant this novel cage technology were:

  • Matthew Gornet, orthopaedic spine surgeon at St. Louis Spine and Orthopedic Surgery Center
  • Gurvinder Deol, orthopaedic spine surgeon at Wake Orthopaedics
  • Faheem Sandhu, orthopaedic spine surgeon at Georgetown University
  • Brandon Scott, orthopaedic spine surgeon at Saint Francis Medical Center

Since that time, EIT has experienced incredible adoption throughout the country and has exceeded initial case volume projections by 250%.

As to why these cages have been so appealing to U.S. surgeons, the initial surgeons have said the following:

Matthew Gornet, MD, a fellowship-trained spine surgeon from Johns Hopkins Hospital as well as author of several published book chapters and research papers said, “I am excited to use this new technology to enhance the outcomes of my patients.”

Dr. Gurvinder S. Deol, MD, is a board certified (FAAOS), fellowship-trained Orthopedic Spine Surgeon for Wake Orthopaedics in Raleigh, NC said “The large surface of cellular porous structure combined with encouraging data from over 15,000 implants throughout Europe and many international markets make a lot of sense to me.”

Faheem Sandhu MD, PhD, is director of spine surgery at MedStar Georgetown University Hospital and professor of neurological surgery at Georgetown University Medical Center said, “I’m very excited about porous titanium cages and the possibility for improving fusion rates while reducing the need for biologic agents.”

Brandon Scott, MD. at Saint Francis Healthcare System is a Neurosurgeon in Cape Girardeau, Missouri. said, “The adaptation of the design of the cervical cage to the cervical anatomy is very nice and allows me to have a perfect fit of the implant with high primary stability.”

“We are thrilled to be working with these thought-leading surgeons since our initial product launch at NASS. The market response and adoption exceeds our expectations by far,” said Guntmar Eisen, cofounder and CEO of EIT.
________

About EIT

EIT is the first medical device manufacturer to exclusively focus on implants for spinal alignment, that are designed according to latest published science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014 by Hans Eekhof and Guntmar Eisen.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 10.000 EIT cases have been performed in over 15 markets globally.


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November 28, 2017 OrthoSpineNews
Schlieren (Zurich), Switzerland, November 28, 2017

Kuros announced today that its Chief Medical Officer, Dr. Virginia Jamieson, has reached retirement age and will retire from full-time employment with effect as of May 31, 2018. Her succession will be announced in due course.

Dr. Joost de Bruijn, appointed CEO of Kuros Biosciences commented: “I would like to thank Dr. Jamieson for her many contributions and years of service as the Chief Medical Officer of Kuros. She successful designed and delivered clinical studies for the Neuroseal and PTH programs KUR-111, KUR-112 and KUR-113. Dr. Jamison will continue to drive clinical development and be actively engaged in identifying her successor.”


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November 28, 2017 OrthoSpineNews

NESS ZIONA, IsraelNov. 28, 2017 /PRNewswire/ — CollPlant (TASE: CLPT, OTC: CQPTY) – a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products (recombinant human, “rhCollagen”), announced that it has signed an agreement with a distributor in Greece and Cyprus. Under the terms of the agreement, the distributor undertook to make the first order for the product when signing the agreement, in an amount that is not material to the Company. The distributor is a Greek company operating in the field of medical devices, and the agreement is exclusive for a period of three years, with an option for an extension.

Yehiel Tal, CEO of CollPlant: “The agreement is the continuation of the implementation of our penetration strategy of the product into Europe and to increase of sales. This is the fifth distributor that has come on board to distribute the product, while in parallel we are continuing to receive positive feedback from treatments carried out in Europe, reflected in rapid recovery of chronic wounds.”

Vergenix®FG is based on the Company’s collagen technology, and is designed to treat chronic hard-to-heal wounds such as diabetic ulcers, pressure sores, surgical cuts and trauma wounds. The product is injected directly into the wound, filling it and contributing to the healing process until full wound closure, without any side effects.

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics, 3D Bio-printing of tissue and organs, and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary rhCollagen, among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix®STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; and Vergenix®FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds. CollPlant’s business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Contact at CollPlant:

Contact at Rx Communications Group, LLC:

Eran Rotem

Paula Schwartz (for US Investors)

Deputy CEO & Chief Financial Officer

Managing Director

Tel: +972-73-2325600/612

Tel: +1-917-322-2216

Email: Eran@collplant.com

Email: pschwartz@rxir.com

SOURCE CollPlant


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November 28, 2017 OrthoSpineNews

November 28, 2017

NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ Adaptive Spine Intelligence™ (ASI) technology, announced today the Company has acquired three patents from Dr. Paul McAfee, of University of Maryland St. Joseph’s Medical Center. These patents cover the methodology used to measure and plan interbody devices used in spinal surgery.

The three patents acquired from Dr. McAfee protect the associated intellectual property around a novel technique for physiologically selecting interbody device height based on patient anatomy to further enhance Medicrea’s UNiD™ ASI platform.

Dr. McAfee stated, “Medicrea is uniquely positioned to benefit from this intellectual property to enhance their industry-leading surgical planning service. Surgeons understand that the effective use of interbody devices plays an important role in determining outcomes for spinal patients and spend significant time intra-operatively testing for the ‘best-fitting’ interbody device based on a limited range of dimensions provided by legacy manufacturers. However, this current technique often leads to compromise between two available interbody dimensions and lacks scientific rationale. Knowing the level of inventory required to deliver a range meeting patient needs in every case is cost-prohibitive for even the largest legacy manufacturers. There is a clear demand for the reliable planning tools and services available with UNiD™ ASI.”

Medicrea’s systems-based approach to spine with engineering services and in-house 3D-Printing capabilities makes the Company uniquely able to deeply collaborate with surgeons to create interbody device solutions that are adapted to their clinical and mechanical preferences, as demonstrated by the recent FDA clearance of the Company’s IB3D™ offering of 3D-printed Titanium interbody devices with AdapTEK™, surgeon-adaptive technology for unparalleled control of the implant design and dimensions provided.

Denys Sournac, President and Chief Executive Officer, stated, “We are focused on fully integrating the important work done by Dr. McAfee into our proprietary UNiD™ HUB surgical planning software. Combining data-driven planning techniques with the ability to deliver personalized implants will significantly reduce the inventory required for each case while ensuring the optimal implant is provided for the patient at each level operated. Acquiring new planning methodologies, as we have done with Dr. McAfee, will allow Medicrea to further provide healthcare shareholders with scientific evidence supporting the surgical strategy and promoting a cost-effective care continuum in line with our Adaptive Spine Intelligence™ technology.”

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 150,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea 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 175 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, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com


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November 28, 2017 OrthoSpineNews

Orangeburg, NY, Nov. 27, 2017 (GLOBE NEWSWIRE) — Novastep, Inc., and its affiliates (“Novastep” or the “Company”), a global medical technologies company specializing in the foot and ankle, has announced an expansion of their cleanSTART® Delivery Platform with the launch of their airlockGO® product line.

The airlockGO® system combines Novastep’s UDI-compliant sterile packed, single-use instruments kits and implants into a ready-to-use holder. Each airlockGO® box is designed to address a given pathology of the foot and ankle by assembling all-inclusive, self-contained procedure-specific configurations of implants and instruments into a single container. It eliminates the hassle of onsite sterilization. A single airlockGO®  box replaces the need for sterilization trays which undergo costly, timely and sometimes inexact sterilization cycles.

“AirlockGO benefits all parties involved because each unit has everything you need for a given surgery in a single container that is about the size of a shoe box.”  said Vadim Gurevich, President and CEO of Novastep Inc., adding that “The entire premise behind AirlockGO is to enhance OR efficiency, reduce costs and improve inventory management.”

Operating room efficiency and cost reduction are prime areas of focus for Novastep. The company works directly with hospitals and surgery centers to reduce healthcare costs and improve process flows.  Novastep’s cleanSTART® deployment technology and airlockGO® product offerings allow a systematized, logistics platform that substantially reduces inventory and sterile field volumes, while minimizing lost or damaged instrument delays and lifecycle expenses.

Mark Prissel, DPM at Orthopedic Foot & Ankle Center of Columbus, OH, emphasized that “airlockGO is designed to benefit the patient, surgeon, and facility providing a streamlined case-specific approach to high quality single use instruments and implant technology for foot and ankle surgery, while remaining cost conscious.”  Prissel further explained that “The result is the same outstanding experience I am accustomed to with the traditional Airlock platform, but with improved efficiency.”

About Novastep
Novastep is a global medical device company specializing in the design, development and commercialization of advanced technologies that treat conditions affecting the foot and ankle. The Company is focused on optimizing clinical efficiencies, inventory management and healthcare economics by transforming the way foot and ankle products are deployed and utilized in the surgical environment. Novastep has allied itself with a strategic network of key international opinion leaders to deliver breakthrough technologies, innovative services and compelling medical education programs to the foot and ankle community. Novastep’s portfolio, services and distribution platforms are uniquely positioned to address foot and ankle trauma, deformity corrections and Charcot fracture management.

For further information concerning this announcement and/or Novastep, Inc., send all inquiries to info@novasteportho.com or call 877.287.0795.

Related Links

For general information:  novastep-us.com


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November 27, 2017 OrthoSpineNews

November 21, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today the alpha launch of the SIMPACT TRI-FIN Sacroiliac Joint Fixation Screw System.

“I am excited to add SIMPACT TRI-FIN to our growing portfolio of MIS Procedural Solutions, as well as providing surgeons an additional surgical option for sacroiliac joint fixation. SIMPACT TRI-FIN is unique in that it offers helical cutting flutes designed for faster and easier insertion, as well as a design that allows the screw to harvest local bone while being implanted across the SI joint,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine.

The SIMPACT TRI-FIN system was designed with an anti-rotational sleeve to inhibit component back out, and a screw thread design which affords the surgeon the ability to compress and stabilize the SI joint.

SIMPACT TRI-FIN also continues the use of Life Spine’s OSSEO-LOC technology. OSSEO-LOC is a proprietary surface treatment that creates a unique osteophylic surface architecture for potential bone on-growth.1 The unique surface architecture promotes mineralization of implant, while negating potential challenges associated with surface treated implants.2

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

1Feighan, J.E., Goldberg, V.M., Davy, D., Parr, J.A., Stevenson, S.
“The Influence of Surface Blasting on the Incorporation of Titanium-Alloy Implants in a Rabbit Intramedullary Model.” The Journal of Bone and Joint Surgery 77.9 (1995): 1380-96. Web.

2K.Kieswetter, Z. Schwartz, T. W. Hummert, D. L. Cochran, J. Simpson and B. D. Boyan
“Surface roughness modulates the local production of growth factors by osteoblast-like MG-62 cells” The Journal of Biomedical Materials Research (1996): Web.

Contacts

Life Spine
Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117


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November 27, 2017 OrthoSpineNews

WARSAW, Ind., Nov. 27, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today that it is a Platinum sponsor of the 14th Annual International Pediatric Orthopaedic Symposium (IPOS), taking place November 28 to December 2, 2017 in Orlando, Florida.  The IPOS meeting, presented by the Pediatric Orthopaedic Society of North America (POSNA) and the American Academy of Orthopaedic Surgeons (AAOS), brings together hundreds of pediatric orthopedic surgeons from around the world.

As part of OrthoPediatrics’ commitment to leading innovation in pediatric orthopedics and fostering clinical education, the company is actively engaged in all aspects of the meeting.  This includes sponsoring a pre-course meeting on “The Surgical Treatment of Hip Dysplasia in Older Children and Adolescents.”  The Company will also host four interactive workshops, highlighting new technology and surgical techniques in Trauma, Deformity Correction, Sports Medicine/Soft Tissue Repair and Scoliosis care.

Mark Throdahl, President and CEO of OrthoPediatrics, said, “OrthoPediatrics’ goal is to advance the field of pediatric orthopedics with the broadest and most innovative product line in our industry.  Our surgical systems, coupled with our focus on clinical education, are at the very core of our business.  We are excited for our continued partnership with organizations like POSNA and look forward to returning to the IPOS meeting for another successful year.”

OrthoPediatrics will be highlighting its products at booth #104 at the IPOS meeting.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is the only diversified orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market. OrthoPediatrics is dedicated to the cause of improving the lives of children with orthopedic conditions. OrthoPediatrics currently markets 22 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contact
The Ruth Group
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com


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November 27, 2017 OrthoSpineNews

El Dorado Hills, CA, November 21st, 2017 Consensus Orthopedics Inc. introduced TracPatch™ at MEDICA 2017 to a phenomenal response. TracPatch asserted itself as the leading wearable device for total joint patient monitoring. Partnering with Wearable Technologies AG at MEDICA in Dusseldorf, Germany, TracPatch™ stole the show as a new revolutionary wearable device empowering at-home patient recovery and remote monitoring for effective managed care.

Dr. John Mariani, a distinguished Orthopedic Surgeon at Reconstructive Orthopedics, says “The international reach of MEDICA and Wearable Technologies AG was extraordinary. Their pavilion at MEDICA provided the ideal platform to showcase TracPatch. Being able to speak closely with health care professionals, leading research centers, and recognized international suppliers reflected the need and desire for TracPatch, a truly innovative product in MedTech.”

Introduced to the international stage at MEDICA, TracPatch passively and continuously tracks a user’s daily activities, including exercise compliance, range of motion, and daily goals, while maintaining the critical connection between the healthcare provider and patient. Through data collection and monitoring, TracPatch™ ensures patients will receive effective care based on their individual needs.

“As a first-time attendee and exhibitor at MEDICA 2017, we were thrilled and humbled by the response TracPatch received. MEDICA provided TracPatch an exceptional introduction to the global healthcare industry. We were able to connect with key decision makers and leaders in the MedTech space and overall I would say MEDICA was a huge hit,” said Michael Droege, Vice President of Global Business Development at Consensus.

The introduction of TracPatch by Consensus Orthopedics at MEDICA in Dusseldorf, Germany is the beginning of an international expansion that will revolutionize the way data is used in orthopedics. Learn more at tracpatch.com

About Consensus® Orthopedics, Inc. 
Consensus Orthopedics was founded in 1992 as a medical device consulting company located in California. In 1996, Consensus Orthopedics acquired US Medical Products becoming a global manufacturer of reliable large joint orthopedic devices. Since 1996, Consensus Orthopedics has been providing the orthopedic industry with exceptional hip and knee joint replacement devices. Its signature knee system, the Consensus Knee System, has over 20 years of reliable and reproducible results. With a deep understanding of the orthopedic industry, Consensus launched its innovative TracPatch Technology division focusing on orthopedic wearable technology, which combines Consensus Orthopedics 25 years of orthopedic experience with innovative Big Data capabilities. TracPatch is a revolutionary new device empowering at-home patient recovery and remote monitoring for effective managed care. With a focus on evidence based medicine, Consensus Orthopedics is changing patient care and the future of orthopedics. Learn more at http://www.consensusortho.com.


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November 27, 2017 OrthoSpineNews

ROCKVILLE, Md.Nov. 22, 2017 /PRNewswire/ — According to Europe Market Report for Spinal Motion Preservation Devices 2017 – MedCore by iData Research, Inc., procedural growth, favorable reimbursement policies, and its use as an alternative to spinal fusion are driving the European cervical artificial disc market. Growth rates will be maintained due to increased adoption rates and patient education. The total artificial disc market represents a growing share of the overall motion preservation device market which includes cervical and lumbar artificial discs as well as dynamic posterior stabilization and interspinous process decompression devices.

Growth of the motion preservation market has been attributed to the continued expansion of the artificial disc market. Growth of the artificial disc market will be further fueled by cervical artificial discs (CADs) due to their simpler approach, favorable clinical results and lower average selling prices (ASPs), along with a favorable reimbursement environment.

“The CAD market grew driven by the more recent emergence of the technology, in addition to the available literature supporting the procedure,” explains Jeffrey Wong, Strategic Analyst Manager at iData Research. “The artificial disc market will continue to exhibit growth due to newer CAD devices, which will increase the prevalence and popularity of artificial discs in the market.”

Spinal Kinetics and DePuy Synthes currently lead the European market for cervical and lumbar artificial discs. DePuy Synthes’ presence is supported by brand recognition and loyalty towards their ProDisc®-L and ProDisc®-C lines of products. However, DePuy Synthes’ position will continue to be challenged with the recent emergence of numerous new products and competitors. Spinal Kinetics continues to make gains in the European market with the M6®-C and M6®-L artificial discs. These devices were the first to replicate the anatomic and biomechanical attributes of a natural intervertebral disc.

Additional competitors include Medtronic, Zimmer Biomet, Paradigm Spine, Globus Medical, Cousin Biotech, Ulrich Medical and SpineVision.

Total Unit Sales, Average Selling Prices, Market Value and Growth Trends are segmented in terms of:

  • Total Motion Preservation Device Market
  • Artificial Disc Market
    • Cervical Artificial Disc Market
    • Lumbar Artificial Disc Market
  • Dynamic Stabilization Market
    • Dynamic Posterior Stabilization Device Market
    • Interspinous Process Decompression Device Market

All above analyzed for each of 10 regions in Europe (GermanyFrance, UK, ItalySpain, Benelux, Scandinavia, AustriaSwitzerlandPortugal).

More information about the report is available at
https://www.marketresearch.com/iData-Research-Inc-v3689/Europe-Spinal-Motion-Preservation-Devices-11005898/

About iData Research
iData Research is an international market research and consulting firm, dedicated to providing the best in business intelligence for the medical device industry. Our research empowers our clients by providing them with the necessary tools to achieve their goals and do it right the first time. iData covers research in: Spinal Implants and VCF, Spinal MIS, Orthopedic Trauma, Large & Small Joints, Wound Management, Orthopedic Soft Tissue, Orthopedic Biomaterials, Orthopedic Soft Tissue Reinforcement and Regeneration, Dental Operatory Equipment, Dental Material, Dental Lasers, Dental Prosthetics, Dental CAD/CAM, Dental Bone Graft Substitutes, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Ophthalmics, Vascular Access, Laparoscopy, Urology, Gynecology, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Anesthesiology, Orthopedics and more.

We have built a reputation and earned our clients’ trust based on consistent and uniquely intelligent research that allows our customers to make confident decisions and impact their businesses. A combination of market expertise and over a decade of experience has resulted in a deep understanding of the medical device industry that has inspired innovation and propelled our clients to success.

Related Reports:
Europe Market Overview for Spinal Implants and VCF 2017 – MedView
Europe Market Report for Cervical Fixation 2017 – MedCore
Europe Market Report for Thoracolumbar Fixation 2017 – MedCore
Europe Market Report for Spinal Interbody Devices 2017 – MedCore
Europe Market Report for Spinal Motion Preservation Devices 2017 – MedCore
Europe Market Report for Spinal Vertebral Compression Fracture 2017 – MedCore
Europe Market Report for Spinal Electrical Stimulation Devices 2017 – MedCore
Europe Market Report for Spinal Surgery Instrumentation 2017 – MedCore

About MarketResearch.com
MarketResearch.com is the leading provider of global market intelligence products and services. With research reports from more than 720 top consulting and advisory firms, MarketResearch.com offers instant online access to the world’s most extensive database of expert insights on global industries, companies, products, and trends. Moreover, MarketResearch.com’s Research Specialists have in-depth knowledge of the publishers and the various types of reports in their respective industries and are ready to provide research assistance.

Press Contact:
Corinne Gangloff
+1 440.684.9600
cgangloff@marketresearch.com

SOURCE MarketResearch.com

Related Links

http://www.marketresearch.com


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November 27, 2017 OrthoSpineNews

November 22, 2017

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 device design and manufacturing with UNiD™ Adaptive Spine Intelligence™ (ASI) technology, announced today the Company has received Food and Drug Administration (FDA) clearance for its IB3D™ range of 3D-printed Titanium interbody devices and the introduction of AdapTEK™, its surgeon-adaptive technology.

AdapTEK™ allows a surgeon to create a range of interbody devices to their individual specifications that are then produced by Medicrea with complete in-house additive manufacturing capabilities and total control of the internal process without any of the limitations associated with subcontracting external suppliers. The technology leverages a surgeon’s clinical insight to design implants with a range of different footprints, lordotic angles, heights, lateral windows and endplate surface structure, including the proprietary HexaLOCK™ structure designed to enhance bone-implant interaction during the fusion process.

Denys Sournac, President and Chief Executive Officer, stated, “With the FDA clearance of our 3D-printed Titanium interbodies, we are able to approach a large segment of the spine market, where we were not previously present, with an adaptive range of implants delivered according to the clinical preferences and practices of individual spine surgeons. Our AdapTEK™ technology draws on the Company’s core competency to develop full-service solutions for spine surgery and aligns with the cage planning function of our proprietary UNiD™ HUB surgery planning software. This initial FDA clearance will support future strategic IB3D™ FDA clearances, which we will use to enhance our patient-specific UNiD™ ASI platform with the view of combining advanced cage planning capabilities with additive manufacturing to generate personalized interbody devices based on scientific data and precise MRI measurements at each level to select the right implant from thousands of available options.”

Medicrea’s scientific expertise is now complemented by its knowledge of the additive manufacturing process with the most technical aspects, notably the product master file, fully controlled and managed by the company’s engineers, unlike competitors in the field. This key differentiation allows the Company to respond quickly and effectively to surgeons while closely controlling inventory levels. AdapTEK™ demonstrates Medicrea’s ability to distinguish itself from traditional implant providers by providing a broad range of data-driven solutions and services generated by Adaptive Spine Intelligence™ to improve the outcomes and efficiencies in spine surgery.

About Medicrea (www.medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 150,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea 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 175 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, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com