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CartiHeal’s Agili-C™ Implant Promotes the Regenerative Capacity of Articular Cartilage Defects in Human Cadaveric Ex-vivo Model

CartiHeal’s Agili-C™ Implant Promotes the Regenerative Capacity of Articular Cartilage Defects in Human Cadaveric Ex-vivo Model

KFAR SABA, IsraelNovember 7, 2018 /PRNewswire/ —

CartiHeal, developer of Agili-C™, a proprietary implant for the treatment of joint surface lesions, announced today the publication of a study demonstrating that the Agili-C™ implant promotes the regenerative capacity of articular cartilage defects in human cadaveric ex-vivo model. The study, published in KSSTA Journal – Knee Surgery, Sports Traumatology, Arthroscopy (01 November 2018, PP 1-12), was conducted at Rush University in Chicago by Prof. Susan Chubinskaya.

     (Logo: https://mma.prnewswire.com/media/451231/CartiHeal_Logo.jpg )

The goal of the study was to investigate the ex-vivo Mechanism Of Action of the Agili-C™ implant in the repair of full-thickness cartilage defects. In particular, it was intended to validate whether the Agili-C™ implant has the potential to stimulate cartilage in-growth through chondrocyte migration into the 3D interconnected porous structure of the scaffold, along with maintaining their viability and phenotype and the deposition of hyaline cartilage matrix.

In the study, human articular cartilage cadaveric knee and ankle specimens were collected within 24 hours from death from 14 donors, male and female. To model a chondral defect, donut-shaped cartilage explants were prepared from each tissue specimen. Cartilage explants with or without the Agili-C™ implant inside were cultured for 60 days.

The results of the study confirmed the ability of chondrocytes to migrate outside of the cadaveric cartilage explant tissue and into the porous structure of the Agili-C™ scaffold and fill its entire volume with newly formed extracellular matrix (ECM) enriched in hyaline cartilage components, such as collagen type II and aggrecan, and lacking collagen type I.

In addition, the study demonstrated the formation of a layer populated by progenitor-like cells on the articular surface of the implant. These cells were able to produce a thin layer that covered the surface of the newly formed extracellular matrix, similar to a lamina.

In the absence of a scaffold, chondrocytes did not migrate far from the tissue with probably some degree of hypertrophy.

In conclusion, the analysis of samples taken from knee and ankle joints of human donors confirmed that the Agili-C™ implant induces deposition of new extracellular matrix with similar characteristics to the native hyaline cartilage inside the entire volume of the scaffold.

About CartiHeal 

CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

In the United States, the Agili-C™ implant is not available for sale – it is an investigational device limited for use in the IDE study.  

Contact:
info@cartiheal.com
http://www.cartiheal.com  

SOURCE CartiHeal, PRNewswire, Nov 7, 2018 – http://www.prnewswire.co.uk/news-releases/cartiheals-agili-c-implant-promotes-the-regenerative-capacity-of-articular-cartilage-defects-in-human-699910941.html

Andrew joins the team bringing a wealth of Orthopaedic knowledge with over 20 years in the health and medical sector with the last ten years focused on Sales and Marketing in Spine, Trauma, Limb and joint reconstruction including extremities and large joints.

Innovasive™ Granted FDA Clearance for DualX™ Expanding Interbody Spinal Device

Innovasive™ Granted FDA Clearance for DualX™ Expanding Interbody Spinal Device

The DualX device expands in both width and height providing a stable foundation for spinal fusion.

Innovasive, a privately-held spinal device company, focuses on developing and commercializing minimally-invasive, innovative spinal technologies. Today, Innovasive announced that they have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market their DualX technology, a titanium, dual expanding, interbody device for spinal fusion procedures in the lumbar spine.

“DualX is a unique expandable interbody that expands in two independent directions,” explained Andy Choi, Chief Executive Officer, Innovasive, Inc. “First, it expands laterally to provide a wide base for stability and spinal support. DualX then expands vertically with lordosis to aide in the restoration of sagittal alignment of the lumbar spine.”

The DualX technology is comprised of a family of titanium expandable interbody devices designed to be used in transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF) and lateral lumbar interbody fusion (LLIF) spinal procedures. The product portfolio contains varying footprints, heights and degrees of lordosis with post-expansion bone grafting to provide a customized anatomical fit for a clinically successful fusion environment.

“The ability of DualX to provide expansion in two planes is essential for achieving a successful surgical outcome. DualX accomplishes the goals of creating a biomechanically stable environment for spinal fusion, as well as supporting normal sagittal and coronal alignment; both of which are essential factors for restoring optimal spinal balance. These critical factors will help spine surgeons achieve the primary goals of performing surgeries that lead to successful, minimally invasive spinal fusion procedures.” said, Jeffrey Roh, MD, MBA, MSc, Director of Minimally Invasive Spine Surgery at the Swedish Neuroscience Institute in Seattle, WA.

“We are excited to receive FDA clearance and look forward to a successful product launch in the near future,” said Mr. Choi. DualX will be available for implantation in spinal fusion procedures before the end of this year.

About Innovasive 
Innovasive, Inc. is a privately-held spinal device company located in Mission Viejo, CA. The Company focuses on developing and commercializing innovative, minimally-invasive technologies for spine surgery. Innovasive is a portfolio company of IntuitiveX, a life science innovation incubator.

SOURCE: Oct 31, 2018 – https://www.prweb.com/releases/innovasive_granted_fda_clearance_for_dualx_expanding_interbody_spinal_device/prweb15878221.htm

Andrew joins the team bringing a wealth of Orthopaedic knowledge with over 20 years in the health and medical sector with the last ten years focused on Sales and Marketing in Spine, Trauma, Limb and joint reconstruction including extremities and large joints.

Pedicle Screw System Market – Global Forecast to 2023: Rising Geriatric Population, Technological Advancements & Growing Preference for Minimally Invasive Surgeries

Pedicle Screw System Market – Global Forecast to 2023: Rising Geriatric Population, Technological Advancements & Growing Preference for Minimally Invasive Surgeries

DUBLINOct. 17, 2018 /PRNewswire/ —

The “Pedicle Screw System Market by Product Type (Monoaxial & Polyaxial Pedicle Screw), Surgery (Open, Minimal Invasive), Indication (Spinal Deformities, Spinal Trauma), Application (Thoracolumbar, Cervical Fusion) – Global Forecast to 2023” report has been added to ResearchAndMarkets.com’s offering.

The global pedicle screw systems market is expected to reach USD 724.23 million by 2023 from USD 538.64 million in 2018, at a CAGR of 6.1%. 

The major factors driving the growth of this market are the increasing incidence of spinal cord injuries, the growing preference for minimally invasive surgeries, and a rising geriatric population.



By product type, the pedicle screw systems market is segmented into monoaxial, polyaxial, and other pedicle screw systems. In 2018, the polyaxial pedicle screw systems segment is estimated to command the largest share of the pedicle screw systems market. The large share of this segment can be attributed to the increasing incidences and prevalence of spinal cord injuries.



On the basis of surgery type, the pedicle screw systems market has been segmented into open surgery and minimally invasive surgery. The open surgery segment is expected to account for the largest share of the pedicle screw systems market in 2018. The large share of this segment can be attributed to the rising geriatric population and increasing incidence of spinal deformities.



Based on indication, the pedicle screw systems market has been segmented into spinal degeneration, spinal trauma, spine deformities, and other indications. In 2018, the spinal degeneration segment is projected to account for the largest share of the pedicle screw systems market. The increasing incidence of degenerative spinal disorders is the major driving factor for this market.



By application, the market is categorized into thoracolumbar fusion and cervical fusion. In 2018, thoracolumbar fusion is expected to command the largest share of this market. The increasing incidences of lumbar degenerative disc diseases and the launch of new products are key factors driving the growth of the thoracolumbar fusion segment.



The market is dominated by North America, followed by EuropeNorth America will continue to dominate the market during the forecast period. The rising geriatric population and increasing incidence of spinal disorders in this region are the major factors supporting the growth of the pedicle screw systems market in North America.



Stringent regulatory frameworks and time-consuming product approval processes may hinder the growth of the pedicle screw systems market to a certain extent.



The major players in the pedicle screw systems market include Globus Medical (US), DePuy Synthes (US), Zimmer Biomet (US), B. Braun (US), Stryker (US), and Medtronic (Ireland).

Key Topics Covered: 

1 Introduction



2 Research Methodology



3 Executive Summary



4 Premium Insights

4.1 Pedicle Screw Systems Market Overview

4.2 Asia Pacific: Pedicle Screw Systems Market, By Product Type (2018)

4.3 Pedicle Screw Systems Market, By Region (2018)

4.4 Geographical Snapshot of the Pedicle Screw Systems Market



5 Market Overview

5.1 Introduction

5.2 Market Dynamics

5.2.1 Drivers

5.2.1.1 Increasing Incidence of Spinal Injuries

5.2.1.2 Rising Geriatric Population

5.2.1.3 Technological Advancements

5.2.1.4 Growing Preference for Minimally Invasive Surgeries

5.2.2 Opportunities

5.2.2.1 Emerging Economies Present Significant Growth Opportunities

5.2.3 Challenges

5.2.3.1 Stringent Regulatory Framework and Time-Consuming Approval Process

5.2.3.2 Product Failures and Recalls



6 Pedicle Screw Systems Market, By Product Type

6.1 Introduction

6.2 Polyaxial Pedicle Screw Systems

6.3 Monoaxial Pedicle Screw Systems

6.4 Other Pedicle Screw Systems



7 Pedicle Screw Systems Market, By Surgery Type

7.1 Introduction

7.2 Open Surgery

7.3 Minimally Invasive Surgery



8 Pedicle Screw Systems Market, By Indication

8.1 Introduction

8.2 Spinal Degeneration

8.3 Spinal Trauma

8.4 Spinal Deformities

8.5 Other Indications



9 Pedicle Screw Systems Market, By Application

9.1 Introduction

9.1.1 Thoracolumbar Fusion

9.1.2 Cervical Fusion



10 Pedicle Screw System Market, By Region

10.1 Introduction

10.2 North America

10.2.1 US

10.2.2 Canada

10.3 Europe

10.4 Asia Pacific

10.4.1 China

10.4.2 India

10.4.3 Japan

10.4.4 Rest of Asia Pacific

10.5 Rest of the World



11 Competitive Landscape

11.1 Overview

11.2 Market Ranking Analysis, 2017

11.3 Competitive Scenario

11.3.1 Product Launches and Approvals

11.3.2 Acquisitions

11.3.3 Expansions



12 Company Profiles

  • Alphatec Spine, Inc. (A Subsidiary of Alphatec Holdings, Inc.)
  • B. Braun Melsungen AG
  • Depuy Synthes (A Subsidiary of Johnson & Johnson)
  • Globus Medical, Inc.
  • KM Group Holdings, Inc.
  • Medtronic PLC
  • Orthofix International N.V.
  • RTI Surgical, Inc.
  • Stryker Corporation
  • Zimmer Biomet Holdings, Inc.

For more information about this report visit https://www.researchandmarkets.com/research/krbcqv/pedicle_screw?w=5

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SOURCE: PR Newswire, Oct 17, 2018 – https://www.prnewswire.com/news-releases/pedicle-screw-system-market—global-forecast-to-2023-rising-geriatric-population-technological-advancements–growing-preference-for-minimally-invasive-surgeries-300732882.html

Andrew joins the team bringing a wealth of Orthopaedic knowledge with over 20 years in the health and medical sector with the last ten years focused on Sales and Marketing in Spine, Trauma, Limb and joint reconstruction including extremities and large joints.

Innovation in Orthopaedics

Innovation in Orthopaedics

Although there is a continued rise of the giant companies in Medical Devices it seems that the truly innovative and clinical breakthrough products that can really change the face of orthopaedics are mostly coming from SME’s and start-up design manufacturers via distributors and agents.

Sure there are good developments lets say “tweaks” of existing accepted products to ensure ongoing custom, but lets face it game-changing isn’t just a new coating or shape of an implant but something that perhaps replaces the implant or a completely new material, or even prevents the need for the implant, the implant could even communicate with the patient, the surgeon and the company representative via the Internet of things!

The big guys are all about tweaking and are not fully focused on delivering true innovation. In fact, they are likely to snap up and absorb any exciting and innovative company looking like having any chance of finding the next amazing clinical solution!

This focus from the big guys is not surprising as the customer is increasingly driving commoditisation of Orthopaedic implants with buying groups and procurement driving predominately cost-driven decisions.

So….. how are new ideas and interesting products getting to market?

Look one thing I will say is that Humans are amazing creatures, where there is a challenge they adapt to survive. Nothing displays this better than the Agents and Distributors around the world. In most situations, these individuals are highly motivated professionals with a fantastic depth of knowledge of their subject. Often having previous high-level roles in industry and fantastic understanding of their field, customers and their patients’ needs.

These professionals not being tied to a particular company can actually spend the time to match their customers with the best products as well as the most innovative and cutting-edge clinical solutions, whilst maintaining and delivering great relationships.

So whats the message?

The realities of the economics of the big guys will remain but if SME’s, Manufacturers, Distributors, Agents and Surgeons can continue to work together there is hope that the amazing ideas will break through.

We have made it our mission to know and understand Distributors, Agents and Orthopaedics at Ortho Consulting Group, get in touch today to discuss how we can help develop your business globally.

Contact:

Andrew Dubowski
Head of International Business Development
andrewdubowski@orthocg.com

 

Andrew joins the team bringing a wealth of Orthopaedic knowledge with over 20 years in the health and medical sector with the last ten years focused on Sales and Marketing in Spine, Trauma, Limb and joint reconstruction including extremities and large joints.