A hydrogel that adheres firmly to cartilage and meniscus

November 21, 2018, Ecole Polytechnique Federale de Lausanne

EPFL researchers have developed a hydrogel – made up of nearly 90% water – that naturally adheres to soft tissue like cartilage and the meniscus. If the hydrogel carries repair cells, it could help damaged tissue to heal.

Some types of body tissue, like cartilage and meniscus, have little or no blood supply and are unable to heal if damaged. One promising approach to this problem is to inject a hydrogel loaded with repair cells or drugs into the damaged area in the hope of stimulating tissue regeneration.

However, commercial  do not stay put after being applied to the treatment area because of pressure from the body’s movements and the flow of bodily fluids. Doctors therefore use special membranes to keep the hydrogel in place, yet those membranes are attached with sutures that perforate the very tissue the hydrogel is supposed to heal.

Two EPFL  groups, led by Dominique Pioletti and Pierre-Etienne Bourban, have created a biocompatible hydrogel that naturally adheres to  like cartilage and the meniscus. Their hydrogel, which is almost 90% water, can withstand  and extensive deformation and therefore eliminates the need for a separate binding process. Their research has been published in ACS Applied Materials & Interfaces.

“Our hydrogel is ten times more adhesive than currently available bioadhesives on the market such as fibrin,” says Pioletti, head of the Laboratory of Biomechanical Orthopedics in EPFL’s School of Engineering. “And thanks to its high water content, our hydrogel is very similar in nature to the natural tissue it’s designed to heal.”



Photo Credit: Ecole Polytechnique Federale de Lausanne

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

November 20, 2018

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

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

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

Study Design and Results

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

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

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

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

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

About Superion

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

About Vertiflex®, Inc.

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


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

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


Vertiflex®, Inc.
Kathryn Larson, Sr. Director, Strategic Marketing

Clinical Launch of SurGenTec® GraftGun® System Prefilled with ViBone® a Resounding Success

November 21, 2018

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec announced today the successful completion of the initial clinical launch of its new GraftGun bone graft delivery system combined with ViBone Viable Bone Matrix prefilled tubes. This early evaluation of the combined products was focused in the Minimally Invasive Spine (MIS) surgery field.

Earlier this year, SurGenTec and Aziyo® Biologics joined forces to bring the first preloaded MIS viable bone matrix cartridges to market for use in orthopedic and spine surgery. SurGenTec is the manufacturer of the GraftGun bone graft delivery system while Aziyo is the manufacturer of ViBone, a next generation viable bone graft.

“The primary goal of our partnership with Aziyo is to provide surgeons with a high quality viable bone matrix product with shorter thaw times and no mix requirements while also eliminating the need for a cumbersome funnel-based fill process,” said Travis Greenhalgh, Chief Executive Officer of SurGenTec LLC. “We are thrilled with the feedback from the initial clinical experience of surgeons and operating room staff which has been overwhelmingly positive. Our goal is to now expand promotion and usage of the combined products into more regions within the U.S.”

Kris Parchuri, DO of Spine & Orthopedic Specialists in Tulsa, Oklahoma said, “I have been able to decrease OR time and deliver a quality bone graft for my patients. This combination makes it easy for the operating room staff and provides more control with less wasted bone graft.”

Shawn Hermenau, MD of the Desert Spine Institute in Yuma, Arizona stated, “The GraftGun MIS system with ViBone allows me to access collapsed disc spaces and confidently deliver the quantity of bone graft to actually fill the entire disc space. The prefilled ViBone cartridges definitely add to efficiency in the OR.”

The GraftGun MIS system prefilled with ViBone has now been used in a variety of procedures including spinal fusions, tibial plateau fractures, total joint revisions and Charcot joint procedures. Prefilled ViBone MIS cartridges are simply thawed for two minutes and then connected to the GraftGun for ease of use. Once ViBone is opened in the operating room, it is delivered directly to the surgical site with precision and control. This innovative approach helps reduce the risk of surgical site contamination. The surgeon may also choose a variety of tip options to access tight spaces.

About GraftGun

GraftGun is part of SurGenTec’s Graft Delivery System (GDS). It is designed to allow for quick and accurate bone graft delivery to a surgical site without the problems of a traditional funnel. Its patented, controlled release method is designed to safely dispense bone graft with enough pressure to easily fill any bone void during surgery. The GraftGun GDS includes SurGenTec’s loading device technology, which provides surgeons the freedom to choose the bone graft that best suits their needs. To learn more visit www.surgentec.com/graftgun.php

About ViBone

ViBone is a next generation viable bone matrix that was designed to perform and handle more like high quality autograft. The proprietary manufacturing process was designed to optimally protect the tissue environment with less disruption. ViBone is based on science that brings bone grafting closer to meeting the surgeon and patient’s needs and provides a better option for bone repair. To learn more visit www.aziyo.com/vibone/

About SurGenTec

SurGenTec is an ISO 13485 certified medical device manufacturer based out of Boca Raton, FL. The company develops innovative products focused on minimally invasive surgical solutions. SurGenTec was recently awarded the 2018 Spine Technology Award presented at NASS for their ALARA Access Needle. This new technology will be released in early December 2018. The company is currently working on CE marks to enter the world market. SurGenTec released their patented GraftGun bone graft delivery system in December 2017. Over the past year it has gained traction and allowed surgeons to facilitate graft delivery in some of the most difficult procedures. SurGenTec bolstered their offerings with prefilled cortical fibers and DBM putty cartridges which were released in November 2018. To learn more visit www.surgentec.com

About Aziyo Biologics

Aziyo Biologics is a fully integrated, commercially oriented regenerative medicine company. Since its founding in 2015 the Company has expanded through acquisitions and strategic partnerships, creating a high growth commercial entity. Its proprietary products are used in orthopedic, cardiovascular and other medical specialties. For learn more visit www.aziyo.com


Ricki Goldman
Phone: 561-990-7882
Email: Ricki@surgentec.com

Global Ambulatory Surgical Centers Market to Witness a CAGR of 3.5% during 2018-2024

NEW YORK, Nov. 21, 2018 (GLOBE NEWSWIRE) — The global ambulatory surgical centers (ASCs) market was valued at USD 77.1 billion in 2017 and is expected to reach USD 97.3 billion by 2024, at a CAGR of 3.5%. The growth is primarily attributed to the growing number of surgeries performed in ASCs and growing incidence of accidental cases. There are several advantages of using ambulatory surgical centers such as the personal attention, the patient receive and the lack of exposure to a wide range of infections. This is also one of the reason that ASCs market is expected to increase in coming years globally.

Ambulatory surgery centers (ASCs) are providing surgical and emergency care services on an outpatient basis. It offers improved patient care quality along with the reduction in healthcare cost. The growth of this industry is attributed to increasing prevalence of acute and chronic diseases and growing incidence of accidental cases across the globe. Patients are opting for ambulatory services owing to rising burden of treatment cost and better outcomes with higher patient satisfaction. Moreover, technological advancements in the surgical techniques have allowed increasing number of procedure performed in ASCs. Furthermore, as healthcare industry and investors look for new methods to cut costs, an ambulatory surgical center offers additional benefits as compared to hospitals. The lower rate of infections and cost effectiveness of ASCs will drive the ambulatory surgical centers market over the forecast period.

Global Ambulatory Surgical Centers Market Regional Insight

Geographically, North America held the largest market share of the global market in 2017. The growth in the region is attributed to the growing investments in ASCs by major private healthcare companies and patients adopting minimally invasive therapies. Europe held the second largest share of the global market owing to higher volume of orthopedic surgery, and high number of eyes disorders. Additionally, local governments of this region are also promoting the adoption of ASCs. Asia-Pacific is expected to be the fastest growing market due to growing number of aging population and increasing accidental cases and more chronic conditions are expected to propel the market growth in this region.

Browse full research report with TOC on “Global Ambulatory Surgical Centers Market Outlook, Trend and Opportunity Analysis, Competitive Insights, Actionable Segmentation & Forecast 2024” at: https://www.energiasmarketresearch.com/global-ambulatory-surgical-centers-market-outlook/

To purchase report: sales@energiasmarketresearch.com

Key findings from the report:

  • On the basis of specialty, the multi-specialty surgical centers segment held the share of the market in 2017. The growth is attributed to growing number of surgeries procedure performed, and people moving towards multi-specialty surgical centers due to presence of highly skilled and qualified surgeons, nurse, and staff.
    • On the basis of multi-specialty surgical centers, the orthopedic segment held the major share of the market
  • On the basis of services, the surgical services held the major share of the market in 2017, and expected to continue its dominance over the forecast period
    • Based on the ownership type, the physician only, segment held the major share of the market in 2017
  • Geographically, North America held the largest share of the global market in 2017 and the trend is likely to continue over the forecast period
  • Some of the key companies operating in the market include, Proliance Surgeons, Inc., Tenet Healthcare Corporation, Regent Surgical Health, Surgical Management Professionals, ASD Management, United Surgical Partners International, Symbion Pty Ltd., AmSurg Corp., Medical Facilities Corporation, Ambulatory Surgical Centers of America, and HCA Healthcare, Inc.

This report segments global ambulatory surgical centers market by specialty, services, location, ownership type, modality, and region.

By Specialty

  • Single Specialty Surgical Centers
    • Podiatry
    • Dental
    • Otolaryngology
    • Endoscopy
    • Gynecology
    • Ophthalmology
    • Orthopedic
    • Pain management
    • Plastic surgery
    • Other
  • Multi-Specialty Surgical Centers
    • Podiatry
    • Dental
    • Otolaryngology
    • Endoscopy
    • Gynecology
    • Ophthalmology
    • Orthopedic
    • Pain management
    • Plastic surgery
    • Other

By Services

  • Surgical services
  • Diagnostic services

By Location

  • Rural
  • Urban

By Ownership Type

  • Physician only
  • Corporate-physician
  • Hospital-physician
  • Corporate-hospital
  • Corporate only
  • Hospital only

By Modality

  • Hospital-based ambulatory surgical center
  • Freestanding ambulatory surgical center 

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

About Energias Market Research Pvt. Ltd. –

Energias Market Research launched with the objective to provide in-depth market analysis, business research solutions, and consultation that is tailored to our client’s specific needs based on our impeccable research methodology.

With a wide range of expertise from various industrial sectors and more than 50 industries that include energy, chemical and materials, information communication technology, semiconductor industries, healthcare and daily consumer goods, etc. We strive to provide our clients with a one-stop solution for all research and consulting needs.

Our comprehensive industry-specific knowledge enables us in creating high quality global research outputs. This wide-range capability differentiates us from our competitors.


Mr. Alan Andrews

Business Development Manager

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Visit: https://www.energiasmarketresearch.com/

Integra® XT Revision Total Ankle Replacement System Offers Innovative Solution to Ankle Arthroplasty Revision Surgery

PLAINSBORO, N.J., Nov. 20, 2018 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq:IART), a leading global medical technology company, today announced one of the first surgeries with the Integra® XT Revision Total Ankle Replacement System.

“Integra’s new total ankle revision system is designed to provide surgeons with stable tibial fixation through a narrow, finned tibia. I appreciate the anterior surgical approach, which is mindful of the blood supply,” said Dr. Christopher Ritter, a foot and ankle surgeon in Buffalo, New York. “I have performed several revision procedures with the XT Revision System and found that it is easy to implant and provides stable fixation. My patients are happy with their early outcomes.”

The Integra XT Revision Total Ankle Replacement System is one of the first FDA cleared devices indicated for revision ankle arthroplasty only and can be used to revise any commercially available primary total ankle replacement system. Key implant features include:

  • An augmented posterior sloped talus which addresses subsidence by rebuilding posterior talar height.
  • An anatomic design that mimics the natural kinematics of the ankle, designed to promote a more normal gait and better overall function post-operatively.

“The launch of the Integra XT Revision Total Ankle Replacement System represents Integra’s commitment to further advance ankle arthroplasty solutions,” said Robert T. Davis, Jr., corporate vice president and president, Orthopedics and Tissue Technologies. “Many of our surgeons have expressed their excitement for the XT system and our approach for ankle revision surgery. With this addition to our ankle reconstruction portfolio, Integra now offers comprehensive care for end-stage ankle arthritis patients.”

The Integra XT Revision Total Ankle Replacement System was developed in partnership with five world leading foot and ankle surgeons – Dr. Michel Bonnin, (Lyon, France), Dr. Chris Coetzee (Eagan, Minnesota), Dr. Jean Alain Colombier (Toulouse, France), Thierry Judet, PhD (Paris, France), and Dr. Mark Myerson (Baltimore, Maryland).  It is available in the U.S. through Integra’s Extremity Orthopedics sales team.

About Integra XT Revision Total Ankle Replacement System
Integra XT is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.  Components are intended for cemented use only.

About Integra
Integra LifeSciences is a global leader in regenerative technologies, neurosurgical and extremity orthopedic solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel®, Bactiseal®, Cadence®, Certas™Codman®, CUSA®, DuraGen®, DuraSeal®, ICP Express®, Integra®, MediHoney®, MicroFrance®, PriMatrix®, Salto Talaris®, SurgiMend®, TCC-EZ®, Titan™ and VersaTru™.  For the latest news and information about Integra and its brands, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2017 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

CONTACT: Integra LifeSciences Holdings Corporation

Sravan Emany
(609) 936-2488

Michael Beaulieu

Laurene Isip

Altus Capital Partners, Inc. Acquires ChoiceSpine, LP

November 20, 2018

WILTON, Conn.–(BUSINESS WIRE)–Altus Capital Partners, Inc. (“Altus”), an investment firm focused on the North American manufacturing sector, today announced it has acquired ChoiceSpine, LP, a leading designer, manufacturer, and marketer of specialized spinal implants, instrumentation and biologics for the surgical treatment of complex spine disorders. Financial terms of the transaction were not disclosed.

Based in Knoxville, TN and founded in 2006, ChoiceSpine, LP and Knox Spine, LLC (collectively, the Company) collaborates with physicians to develop new products which incorporate current medical technology with customized patient solutions. ChoiceSpine products include minimally invasive, cervical, thoracolumbar, interbody, lateral, and biologics kits and implants that increase procedural efficiency and efficacy.

“We recognize the need in the medical technology space for proven spinal products that can enhance the quality of life for spinal patients,” said Altus Co-Founder and Senior Partner Gregory L. Greenberg. “ChoiceSpine, a global medical device corporation specializing in innovative solutions for both spinal fusion hardware and biologics, demonstrates a track record of proven innovation, strong sales growth, increased distribution and the necessity of their products in the marketplace.”

Management will continue to invest in the expansion of the business. Altus Capital Partner Heidi Goldstein added, “We look forward to working with Founders Rick Henson and Marty Altshuler, who continue to invest alongside us in the Company, in further capitalizing on the depth of their design and engineering capabilities, sales growth and momentum.”

“We have built a deep bench of talent that has led the company with an increased focus on product design and engineering which benefit so many patients experiencing spinal injuries,” said Rick Henson. “We look forward to working with Altus in further developing our offerings as well as expanding into new product verticals to continue to grow the company and provide patient solutions for the treatment of spinal disorders,” added Marty Altshuler.

This is Altus’ third acquisition in less than two years and its second in the medical technology space. The firm successfully completed the tender offer for all of the outstanding shares of common stock of MGC Diagnostics Corporation (“MGC”), a global medical technology company dedicated to cardiorespiratory health solutions in December 2017, and the acquisition of Max Environmental Technologies, Inc., an integrated environmental solutions company, in February, 2017.

About ChoiceSpine

ChoiceSpine is a privately-held spinal device company located in Knoxville, TN. The company prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon-focused systems that are designed to be safe, efficient, and easy-to-use. By working closely with physicians and maintaining a service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to market.

About Altus Capital Partners

Altus Capital Partners is a private equity firm that makes control investments in middle market manufacturing businesses. We believe that our exclusive focus on manufacturing provides us with a unique understanding of the opportunities and challenges faced by companies in the sector. We utilize a patient, thoughtful investment approach and seek to partner with the management teams of our operating companies to achieve growth. With offices in Wilton, CT and Lincolnshire, IL, Altus Capital Partners has completed 18 platform investments and numerous add on acquisitions since 2003. For more information, please visit www.altuscapitalpartners.com/.


Laura Brophy
Marketcom PR

IMPLANET: CE Mark Clearance for the Jazz Cap System®, a Screw Securing Solution for Vertebral Fusion

November 20, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans), a medical technology company specializing in vertebral and knee surgery implants, is announcing the award of CE marking for the Jazz Cap System®, developed to meet the constraints of vertebral fusion indications in adults.

Jazz Cap System®, which was developed principally to facilitate the treatment of degenerative conditions in adult patients, is a proprietary solution for securing screws in poor-quality bone—a factor in 10% to 30% of vertebral fusion cases in adult patients1. Jazz Cap System® is a set of single-use sterile implants consisting of a screw and its Jazz Cap® blocker, which incorporates the patented Jazz Lock® system and a Jazz Band®.

Régis Le Couëdic, Implanet’s Head of Research and Development, commented: “As part of our ongoing innovation drive, we are working closely with surgeons to continually upgrade our Jazz® range. The Jazz Cap System® compliments our range perfectly, in line with our approach of covering all indications compatible with use of sublaminar bands. It will help meet demand from surgeons for screw securing solutions to better accommodate certain degenerative conditions. This functionality is protected by new and existing patents”.

“As promised, we have kept up our pace of innovation despite an increasingly challenging regulatory environment. The award of this new CE marking in record time is a ringing endorsement of our approach. Jazz Cap System® addresses a market worth $2.5 billion, four to five times the size of the spinal deformity market2. The proprietary Jazz Cap System® is designed for specific compatibility with a given fixation system, providing Implanet and its partners a significant competitive advantage in securing screws in poor-quality bones.” added Ludovic Lastennet, Implanet’s Chief Executive Officer.

Implanet will be attending the following scientific conferences:
BSS (British Scoliosis Society) in Belfast from November 29 to November 30, 2018, stand 9
DWG in Wiesbaden (Germany) from December 6 to December 8, 2018, stand 102

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 46 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

1 Source: 2015 Health Advances study
2 Sources i-Data 2010; D. K. Chin and al. Osteoporos Int (2007) 18:1219–1224; Company; 2015 Health Advances study


Ludovic Lastennet
Tel. : +33 (0)5 57 99 55 55

Investor Relations
Julie Coulot
Tel. : +33 (0)1 44 71 20 40

Media Relations
Nicolas Merigeau
Tel. : +33 (0)1 44 71 94 98

US-Investor Relations
Pascal Nigen
Tel.: +1 917 385 21 60

OrthoXel™ Orthopaedic Trauma Device Company Announce CE Mark Clearance Following FDA 510(k) for new Apex Femoral Nailing System

CORK, IrelandNov. 20, 2018 /PRNewswire/ — OrthoXel is a specialist orthopaedic trauma company, using innovative engineering design to evolve truly next generation fracture fixation devices. OrthoXel is delighted to announce that following United States FDA 510k and CE mark clearance for the Apex Tibial Nailing System, the new Apex Femoral Nailing System has been granted European CE Mark, following the FDA 510(k) earlier in the year.

The Apex Femoral Nailing System has the potential to be implanted by the surgeon in antegrade (at the hip) and retrograde (at the knee) as a universal nail for left and right legs, dramatically reducing hospital inventory. Like the Apex Tibial Nailing System, the Apex Femoral Nailing System has the OrthoXel patented micromotion locking to stimulate bone callus formation.

The new Apex Femoral Nailing System was showcased at the Orthopaedic Trauma Association meeting in Orlando, Florida in October and will be presented in the UK at the Orthopaedic Trauma Society annual meeting in Burton-on-Trent January 10-11th 2019.

The Apex Femoral Nailing System

The Apex Femoral Nailing System features a modern anatomic nail curvature in a universal nail that can be surgically implanted from antegrade or retrograde orientations with a dedicated instrumentation kit. The system offers a comprehensive suite of versatile multiple-trajectory locking options including patented OrthoXel™ micromotion for controlled axial movement with exceptional torsional stability to promote callus formation. Additional locking options include recon and rigid interlocking for unstable proximal femoral fractures.

The unique Apex Femoral Nail locking options provide ultimate flexibility and control for the surgeon to choose the right fixation for each patient. In addition to patented gliding micromotion, the Apex system offers an innovative locking endcap that can simultaneously lock multiple bone screws for added stability when needed

  • Proximal Micromotion: Up to two mediolateral bone screws and one recon bone screw provide torsional stability with patented controlled axial micromotion.
  • Proximal Recon Rigid Locking: Up to two mediolateral bone screws and two recon bone screws provide rigid locking, with an optional locking endcap.
  • Proximal Rigid Interlocking: Up to two mediolateral bone screws, one recon bone screw, and one interlocking bone screw provide rigid locking. The optional addition of the locking endcap simultaneously locks all four screws when needed.

Pat O’Connor Co-Founder & CEO, OrthoXel – “With this latest approval and ongoing clinical studies, OrthoXel is positioned to target the European and US markets throughout 2019 with products that we believe are a considerable advancement on predicate devices on the market. This is an exciting time for OrthoXel as we transition from R&D and proof of concept into commercialization of our unique devices.”

Charles Daly Co-Founder & Chief Technical Officer, OrthoXel – “OrthoXel is delighted to receive European CE Mark for the Apex Femoral Nailing System for the specific treatment of a wide range of femoral fractures. We now have full regulatory approval for both our tibial and femoral nailing platforms and will focus on generating clinical case studies in order to be market ready for 2019. Our incredible engineering and design team in Cork has really strived to achieve truly next generation intramedullary nails that are packed with unique features and benefits for the surgeon and patient alike.  We strongly recommend anyone that wants more detailed product information to visit our new website at www.orthoxel.com.”

About OrthoXel
Founded in 2014, and partially funded under the Enterprise Ireland, High Potential Start-Up (HPSU) fund. OrthoXel is a specialist orthopaedic trauma device company, using innovative engineering design to evolve truly next generation fracture fixation devices.

OrthoXel is committed to patient-focused fracture care, offering surgeon-designed devices and an innovative approach to clinical evaluation, from initial concept designs through to full product launch.

For more information about the technical specification and advanced locking options of the Apex Femoral and the Apex Tibial Nailing Systems visit: www.orthoxel.com/product

Press Contact:  Alanna Carty Global Marketing Manager 204965@email4pr.com, Tel: +353 (0) 86 274 1539


Related Links


Innovasis Enters Partnership with Stability Biologics

SALT LAKE CITY, November 19, 2018 – Innovasis, Inc., a fully integrated research, development and manufacturing spinal device company, today announced their expansion into the biologics market by signing a private-label agreement with Stability Biologics, LLC. Stability Biologics®, headquartered in Nashville, Tennessee with a state of-the-art AATB accredited and FDA registered tissue processing and distribution center in San Antonio, Texas will provide Innovasis with an expansive line of private labeled bone allograft tissue products including its flagship product Physio®.

Physio® is a next generation physiologic bone tissue allograft manufactured through Stability’s proprietary patent-pending process and is comprised of 100% donated human tissue, with no added extrinsic carrier. The microstructure of Physio® retains growth factors, osteogenic proteins and CaP minerals while providing excellent handling characteristics.

“We are excited to begin a strategic partnership with Stability Biologics® which will provide Innovasis’ customers with a robust biologics platform to complement our instrumentation portfolio,” said David Oka, Director of Business Development and Clinical Affairs. “We anticipate Physio’s differentiated osteogenic microstructure will provide a potent ecosystem when used with our PEEK-OPTIMA HA Enhanced interbody platform.”

“The potential for working with a company like Innovasis is very exciting,” said Brian Martin, Chief Executive Officer of Stability Biologics®. “We foresee the opportunity of a truly synergistic partnership with our respective companies given our innovative allograft tissue products combined with Innovasis’ revolutionary product offerings allowing us both to increase our respective customer base.”

Innovasis is excited to expand their footprint in the biologics market and anticipates commercialization of their private labeled product lines by December 2018.

About Innovasis, Inc.

Innovasis is a groundbreaking company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery.

About Stability Biologics®

Stability Biologics® is a leading provider of high quality proprietary and competitive allograft tissue products to physicians, hospitals and ambulatory surgery centers both domestically and internationally. Stability Biologics® provides a full line of human allograft tissue products available for distribution in the surgical fields of spine, orthopedics and wound care.

Innovasis Media Contact

Hayley Hendrix, 801-261-2236


Stability Biologics® Media Contact

Brian Martin, 615-921-5551


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

November 20, 2018

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

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

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

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

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

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

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

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

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

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

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

About MEDICREA® (www.medicrea.com)

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

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

For further information, please visit: medicrea.com.

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MEDICREA® is listed on

EURONEXT Growth Paris

ISIN: FR 0004178572

Ticker: ALMED


MEDICREA® is traded on

OTCQX Best Market

Tickers: MRNTY & MRNTF


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