David_Castleman-123-1.jpg

CoreLink Names David Castleman Vice President of Research and Development

Posted On April 25, 2018 By OrthoSpineNews In Spine /  

April 25, 2018

ST. LOUIS–(BUSINESS WIRE)–CoreLink, LLC, a fast growing, vertically integrated designer and manufacturer of spinal implant systems, announced today the recent appointment of David Castleman to the newly created position of Vice President of Research and Development.

“CoreLink draws on nearly half a century of surgical device manufacturing expertise. When combined with our robust internal capabilities, we are now well positioned to develop a wide array of new products to advance the state of spine care,” said Jay Bartling, founder and CEO of CoreLink, LLC. “We are excited to create this new position and believe David to be the perfect candidate for it. His engineering insight and product development rigor will help focus and leverage our capabilities in pursuit of our commitment to empower our surgeons’ performance and help improve their patients’ lives.”

Under the product development leadership of Mr. Castleman, CoreLink expects to launch multiple new implant systems in 2017 including a full direct lateral platform of products, Foundation™ 3D ALIF*, M3™ Stand-alone ALIF*, and Foundation Corpectomy*, all of which will feature the patent pending Mimetic Metal™ and StrutSure™ 3D printed titanium technologies. (*Not currently available for sale in the United States)

“I am pleased to join such a young and nimble yet broadly capable company,” said Castleman. “The vertical integration of CoreLink’s manufacturing provides significant advantages with regard to product development. The more intimate working relationship between engineering and manufacturing not only enhances its speed to market, but also facilitates better quality control and product improvement. We are going to make some great stuff.”

David adds more than 25 years of orthopedic device experience including 14 years in the spine industry. He gained expertise in international business development, marketing, and product development in positions with Smith & Nephew, Medtronic, and Zimmer Biomet, respectively. David received his Master of Business Administration from the University of Memphis and a Bachelor of Science degree in Mechanical Engineering from the University of Tennessee.

For more information, visit: www.corelinksurgical.com

About CoreLink

CoreLink, LLC internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems. CoreLink leverages this expertise through collaboration and a dedication to empowering surgeons with the highest quality and most effective instruments and implants possible. That is how CoreLink came to be known as The Source.

Be a part of something at The Source.

Contacts

CoreLink, LLC
Matthew Linhardt, 888-349-7808
m.linhardt@corelinksurgical.com

Read More
slider4_876x300.jpg

EOS imaging Announces New EOS® System Installations in Two U.S. Private Orthopedic Practices

Posted On April 25, 2018 By OrthoSpineNews In Extremities, Spine /  

April 25, 2018

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – PME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced that University Orthopedics in Providence, Rhode Island, and the Hey Clinic for Scoliosis and Spine Surgery in Raleigh, NC, have installed the EOS® system for low-dose, 2D and 3D imaging of patients. Both practices are part of the U.S. private practice sector, which amounts to 73 percent of all orthopedic practices in the country.

University Orthopedics is a multiple facility private practice in Rhode Island for patients with orthopedic related conditions and injuries. University Orthopedics directs many clinical research efforts intended to innovate new orthopedic surgery techniques, new surgical implant devices that improve the success of various procedures, and new ways to prevent orthopedic injury.

“We believe in using advanced technology to provide the safest and best healthcare possible” said Dr. Alan Daniels, Adult Spine Deformity Orthopedic Surgeon and Partner at University Orthopedics. “EOS® provides extremely high-quality full-body images for pediatric and adult patients at lower radiation doses than traditional x-rays, increasing patient safety. The EOS® images allow us to carefully assess the entire skeleton, so we can provide optimal individualized patient-specific care.”

Weber Shill, CEO of University Orthopedics, added: “I saw the clinical and educational benefits of the EOS® system immediately and was enthusiastic about getting behind a project that our surgeons were so motivated about and I knew our patients would appreciate. Like any healthcare organization today, we have to be cognizant about our capital expenditures, and EOS imaging custom finance program for the private sector facilitated our acquisition.”

For more than 13 years, the Hey Clinic has served patients with spinal conditions from North Carolina and beyond through a full array of treatment options. The clinic, recently relocated to a new facility on the Duke Raleigh Hospital campus, is committed to personalized attention, generous appointment times and a strong emphasis on patient education and engagement.

“When we decided to update our imaging options, we thoroughly researched available technologies and determined that the EOS® system would best serve our patients with its high image quality for diagnostics, low radiation to decrease cancer risk and 3D modeling capabilities for treatment planning,” commented Dr. Lloyd Hey, Orthopedic Surgeon and Founder of the Hey Clinic. “In addition, EOS® will help us facilitate educating patients and families about their condition and treatment choices. We are excited to work with EOS imaging to improve patient care.”

“We are encouraged to see a growing number of private practices adopting the EOS® system” said Marie Meynadier, Chief Executive Officer of EOS imaging. “Our technology has received strong recognition from academic and non-academic hospitals, both clinically and in terms of operational value. Private practices play an important role in orthopedic care, and we will do our best to support them in providing our low dose, 2D/3D solutions to a growing number of patients.”

About EOS imaging
EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopaedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 31 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 250 installed EOS® platforms representing around one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017.

For more information, please visit www.eos-imaging.com.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Contacts

EOS imaging
Marie Meynadier
CEO
Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
Press Relations (US)
Joanna Zimmerman
The Ruth Group
Ph: 646-536-7006
jzimmerman@theruthgroup.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
The Ruth Group
Ph: 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com

Read More
3D-Printing-image800-1a-1.jpg

CollPlant Opens a New rhCollagen Production Facility

Posted On April 25, 2018 By OrthoSpineNews In Biologics /  

NESS ZIONA, Israel, April 23, 2018 /PRNewswire/ —

CollPlant (NASDAQ: CLGN) (TASE:CLGN), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products today announced the opening of a new rhCollagen production facility in Rehovot, Israel.

This 6,000 square foot cGMP facility was designed for purification of rhCollagen and formulation of end-products, including BioInks for 3D bioprinting and its proprietary tissue repair products. The facility includes clean rooms, logistic support areas, and dedicated production equipment to support the company’s production demand for the next few years.

Yehiel Tal, CEO of CollPlant commented: “The new facility will enable operational flexibility and cost reduction for the rhCollagen and end products. Consequently, we believe the new facility will enhance our competitiveness and profitability. Additionally, we expect this facility to serve for process development of new production technologies.”

The first production runs have been successfully completed, and validation is expected to take place during the second quarter of 2018.

About CollPlant

CollPlant is a regenerative medicine company focused on 3D bioprinting of tissues and organs, and on developing and commercializing tissue repair products for orthobiologics, and advanced wound care markets. Our products are based on our rhCollagen (recombinant human collagen) that is produced with CollPlant’s proprietary plant based genetic engineering technology.

Our products address indications for diverse fields of organ and tissue repair, and are ushering in a new era in regenerative medicine. Our flagship rhCollagen BioInk product line is ideal for 3D bioprinting of tissues and organs, and our unique Vergenix line of rhCollagen products includes a soft tissue repair matrix for treating tendinopathy and a wound repair matrix to promote a rapid optimal healing of acute and chronic wounds.

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

Safe Harbor Statements

This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant’s objectives plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that Collplant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant’s actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company’s history of significant losses and its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the Company’s expectations regarding the timing and cost of commencing clinical trials with respect to tissues and organs which are based on its rhCollagen based Bioink, VergenixSTR, and VergenixFG; the Company’s ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based BioInk, VergenixSTR, and VergenixFG including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company’s rhCollagen based BioInk, VergenixSTR, and VergenixFG; the Company’s ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company’s ability to establish and maintain strategic partnerships and other corporate collaborations; the Company’s reliance on third parties to conduct some or all aspects of its product manufacturing; the scope of protection we are able to establish and maintain for intellectual property rights and the Company’s ability to operate its business without infringing the intellectual property rights of others; the overall global economic environment; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates; projected capital expenditures and liquidity; changes in the Company’s strategy; and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting Collplant is contained under the heading “Risk Factors” included in CollPlant’s most recent annual report on Form 20-F filed with the SEC, and in other filings that Collplant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant’s current views with respect to future events, and Collplant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact at CollPlant:   
Eran Rotem
Deputy CEO and CFO
Tel: + 972-73-2325600/612
Email: Eran@collplant.com

IR Contact 
Amato and Partners, LLC
90 Park Avenue, 17th Floor
New York, NY 10016
admin@amatoandpartners.com

SOURCE CollPlant

Read More
navio-li.jpg

First European robotics-assisted total knee replacement performed with Smith & Nephew’s NAVIO™ Surgical System

Posted On April 25, 2018 By OrthoSpineNews In Recon, Top Stories /  

24 April 2018

Smith & Nephew (NYSE:SNN; LSE:SN), the global medical technology business, announces that Spire Bushey Hospital in the UK, has completed Europe’s first robotics-assisted total knee replacement procedure using the NAVIO◊ Surgical System.

Consultant Orthopaedic Surgeon Mr Richard Carrington, MBBS, FRCS (Orth), performed the first surgery using the Smith & Nephew JOURNEY◊ II Total Knee System.

The Smith & Nephew NAVIO Surgical System is a next generation handheld robotics platform designed to aid surgeons with component positioning, ligament balancing and bone preparation – key factors that may drive implant survivorship.1,2  NAVIO is designed to help the surgeon with surgical planning and balancing of the joint to the patient’s specific needs. The handheld instrumentation uses multiple control modes to help the surgeon accurately prepare the bone for implantation.

The small footprint of NAVIO allows for easy set up and portability. Furthermore, NAVIO does not require a preoperative image, such as a CT scan. This allows patients to receive the benefits of robotics-assistance without the extra steps, costs, and radiation associated with additional preoperative imaging.3

“We are proud to support Spire Bushey in being the first hospital in Europe to bring patients the benefits of a robotic-assisted total knee procedure using the NAVIO Surgical System,” said Massimiliano Colella, President Europe and Canada, Smith & Nephew. “It is an important innovation as 80% of all knee replacement surgeries globally are total knees4, and it is exciting that Spire’s patients can now benefit from the improvements in accuracy that robotics is designed to deliver.”

Enquiries

Media

Dave Snyder
+1 (978) 749-1440
Smith & Nephew plc

References

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to supporting healthcare professionals in their daily efforts to improve the lives of their patients. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has more than 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

For more information about Smith & Nephew, please visit our corporate website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com

About Spire Bushey Hospital

Working with leading consultants in their field, we have become the private hospital of choice for knee replacements in London and our region. Across both 2016 and 2017*, more knee replacements were carried out at Spire Bushey than any other private London hospital.  Our team of expert physiotherapists provide comprehensive pre-habilitation programmes to help strengthen the limb before surgery to improve recovery. They use the onsite gym and hydrotherapy pool to support patient rehabilitation following surgery.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

◊ Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.

 

Read More
LMASfixcrop2-e1509138763115.png

NuVasive Sponsors AANS 2018, Hosts Workshops And Presentations On Latest Innovations

Posted On April 24, 2018 By OrthoSpineNews In Spine, Top Stories /  

SAN DIEGO, April 24, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company is a sponsor of the American Association of Neurological Surgeons (AANS) Annual Scientific meeting being held April 28-May 2, 2018, in New Orleans, at the Earnest N. Morial Convention Center. NuVasive will host a hands-on workshop featuring the latest advances in Lateral Single-Position surgery, technology to reduce OR radiation and developments in 3D-printed implants.

The NuVasive Industry Lunch and Learn Workshop, Single-Position Lateral Surgery Solutions to Treat L4-S1, Featuring Advanced 3D-Printed Implants and LessRay® Radiation Emission Reduction Technology, by Kaveh Khajavi, M.D., Robert Issacs, M.D. and Juan Uribe, M.D., will take place on Monday, April 30 from 1:10-1:55 p.m. in Room 272-273. For more information, visit the AANS Program Schedule.

“The interactive workshop provides a forum to discover our commitment to Safer, Faster and Smarter surgery through Surgical Intelligence as well as our leadership position in Lateral Single-Position surgery and how it fits in with our industry-leading lateral procedural solutions,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “Lateral Single-Position benefits include reducing the number of times a patient has to be repositioned for greater OR efficiency. Attendees will hear directly from early adopters of the technology and also learn what NuVasive is doing to incorporate advanced materials into its surgical implants and how Surgical Intelligence includes proactively combatting radiation exposure in the OR with LessRay technology.”

Additionally, AANS attendees can visit NuVasive Booth #529 to experience the latest innovative spine solutions and systems firsthand from the NuVasive team of experts and meet NFL great and NuVasive spokesperson Archie Manning. The College Hall of Fame and former NFL Pro Bowl quarterback will discuss his firsthand experience with the life-changing NuVasive XLIF® procedure at the Lunch and Learn and in the booth on Monday, April 30. Manning continues to proudly share his personal story of how the XLIF spine procedure changed his life by restoring height and stability to the collapsed disc space on the left side of his lumbar spine. XLIF is the leading lateral spine procedure, supported by over 10 years of clinical evidence.

Individual NuVasive booth stations will focus on a variety of spine solutions, including Lateral Single-Position Surgery, Surgical Intelligence, Advanced Materials Science™, Cervicothoracic and TLIF.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

Read More

Ortho Sales Partners Announces the Appointment of Chris Stewart as Senior Vice President and General Manager of Hospital Strategy

Posted On April 24, 2018 By OrthoSpineNews In Recon, Spine, Top Stories /  

Ortho Sales Partners, the global leader in commercialization services for the orthopedic industry, is pleased to announce the addition of Chris Stewart to the companies executive team. Mr. Stewart is a very well regarded leader and innovator that brings an in-depth knowledge of the supplier, hospital and physician relationship. In addition to having a cross functional leadership role, Mr. Stewart will lead the organization and its clients in strategies related to hospital access and supply chain value analysis illustration as well as enhancing Ortho Sales Partners software and logistics platforms developed to optimize supply chain delivery and clinician user experience.

Prior to joining Ortho Sales Partners, Mr. Stewart was the Assistant Vice President and Business Unit Leader of Medical Device Management for HealthTrust. Mr. Stewart managed consulting services for hospital IDN memberships comprised of approximately 1,600 acute and 2,000 ASC facilities. He oversaw a team of orthopedic, spine, osteobiologic and cardiovascular specialists who worked with hospital clients to actively manage their clinically sensitive implant service lines. Using data as an asset, his team developed strategic roadmaps to help hospitals and physicians achieve financial and clinical alignment, so they could plan, not just react, to financial pressures and complex market changes.

Mr. Stewart holds a bachelor’s degree in economics and business administration from the University of Tennessee, Knoxville. He has presented at numerous healthcare forums on topics that include physician engagement, clinical best practice, alternative service models for the OR, strategic alliance of GPOs, shifting reimbursement models, new technologies, changing population demographics and the future of supply chain delivery.

About his new role, Mr. Stewart said: “I am excited to be joining this team of accomplished industry thought leaders who share the same vision and passion for enhancing value within this ever-changing healthcare environment”

Kevin McGann, CEO of Ortho Sales Partners, said: “We are very pleased to announce the addition of Chris Stewart to our team at Ortho Sales Partners.  Chris is a well-respected healthcare executive, who has tremendous knowledge of the hospital networks, ambulatory surgery centers and group purchasing organizations.  His experience in creating value added programs, and the utilization of data to direct purchasing behaviors is a tremendous asset to manufacturers, healthcare providers and physicians across the entire industry”

_____________

About Ortho Sales Partners

Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations and produced results that have profoundly impacted each client’s business.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis from industry stalwarts from some of the highest growth companies.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US. (http://www.orthosalespartners.com).

 

Additional Product Platforms

Surg.io (http://www.surg.io)

OrthoEx (http://www.orthoex.com)

The De Angelis Group (http://www.orthospinesearch.com)

Read More
mcra_logo-123-1.jpg

MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA

Posted On April 24, 2018 By OrthoSpineNews In Regulatory /  

WASHINGTON, April 24, 2018 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the medical device industry, is pleased to announce that it delivered an informational presentation on April 16th about United States Medical Device Regulations to twenty-two members of the Center for Medical Device Evaluation of the China Food and Drug Administration (CFDA) in Beijing, China.

The session aimed to collaboratively explore U.S. device regulations and offer high-level knowledge about the FDA review process. MCRA attended along with its partner, China Med Device, LLC, a Chinese market focused integrated advisory firm. MCRA was represented by Mr. Justin Eggleton, Senior Director of Regulatory Affairs. Mr. Eggleton shared a comprehensive overview of the regulatory processes for introducing medical device technologies to the U.S. market, insights on key regulatory topics, and case studies within the neuro-musculoskeletal industry. An interactive Q&A session provided an opportunity for Chinese officials to explore the many complexities and nuances of the various regulatory pathways.

Justin Eggleton said, “MCRA is honored to be invited by the CFDA to discuss the medical device regulation process in the U.S. This discussion allowed MCRA and the CFDA to gain a deeper understanding of the challenges faced when trying to maintain an active and healthy regulatory system able to keep pace with innovation. Further, as a firm that provides integrated support for companies entering international markets, it is crucial for opportunities such as these to ensure we have direct access and knowledge of the current regulatory environment. China is the 2nd largest medical device market with double digit growth now.” MCRA general manager David Lown commented “the mutual communication and dialogues will enhance the understanding of both countries regulatory challenges and facilitate the adoption of innovation more efficiently and effectively towards the international standards in the neuromuscular sector.”

For more information on MCRA, please visit www.mcra.com 

About MCRA
Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves nearly 500 clients globally. MCRA has a demonstrated history of driving success in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.

Contact
David W. Lown
General Manager, MCRA, LLC
Phone: 212.583.0250 ext. 2111
Email: dlown@mcra.com

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

Related Links

http://www.mcra.com

Read More
1-2-1.jpg

Organogenesis Showcases New Product Offerings and Research at SAWC Spring 2018

Posted On April 24, 2018 By OrthoSpineNews In Biologics /  

CANTON, Mass. and CHARLOTTE, N.C., April 24, 2018 /PRNewswire/ — The latest advanced wound care research and product offerings from Organogenesis Inc. – including the recently-launched PuraPly® Antimicrobial 1.6 cm small size – will be showcased during the nation’s largest interdisciplinary wound care forum, the Symposium on Advanced Wound Care Spring | Wound Healing Society (SAWC Spring | WHS) meeting, held April 25-29 in Charlotte, NC.

Organogenesis Inc., a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the advanced wound care, surgical and sports medicine markets, will feature its full suite of advanced wound care and surgical biologic product offerings at exhibit booth #419.

Scientific presentations will feature several products within the Organogenesis portfolio, and exhibit booth attendees will have the chance to learn more about the company’s comprehensive wound care portfolio designed to empower personalized healing for a wide variety of wound types across the wound care continuum.

Organogenesis is also a proud sponsor of the Thursday, April 26 Lunch Symposium, “Understanding the Latest Evidence: A Fresh Look at the Use of Skin Substitutes Across the Wound Care Continuum,” featuring speakers Daniel Kapp, MD; George Koullias, MD; and Katie C. Mowry, PhD.

POSTER AND ORAL PRESENTATIONS OF INTEREST INCLUDE:

Assessment of Composition and Specificity of Extracellular Matrix and Growth Factor Targets Within Dehydrated Amnion/Chorion Grafts
John P. McQuilling, PhD; Katie C. Mowry, PhD

Human Amnion/Chorion Grafts Alter the Gene Expression Profile of Cells Associated with the Wound Microenvironment In Vitro (POSTER AND ORAL PRESENTATION)
John P. McQuilling, PhD; MaryRose Kammer, MS; Katie C. Mowry, PhD

The Use of Indocyanine Green Fluorescent Angiography (LUNA) to Follow Improvements in Wound Healing After Application of a Fresh Amniotic Membrane
Thomas E. Serena, MD, FACS, MAPWCA, FACHM; Bryan Donor, DO; Keyer Patel, DO; Laura Serena, LPN; Judith A. Fulton, PhD

Fresh Amniotic Membrane: Uncovering the Mechanism of Action
Judith A. Fulton, PhD; Thomas E. Serena, MD, FACS, MAPWCA, FACHM

Use of Amniotic Suspension Allograft and a Dehydrated Amnion Chorion Graft to Treat Non-Healing Venous Leg Ulcers (POSTER AND ORAL PRESENTATION)
Windy Cole, DPM, FACFAS

Use of a Purified Native Collagen Matrix Plus Polyhexamethylene Biguanide (PHMB) Antimicrobial in the Management of Chronic Wounds
Woods, Gorenstein et al.

Use of a Purified Collagen Matrix Plus Polyhexamethylene Biguanide Antimicrobial in the Management of Non- Healing Pressure Ulcers
Oropallo et al.

Preliminary Evaluation of Purified Native Collagen Matrix with Polyhexamethylene Biguanide Reducing Methicillin Resistant Staphylococcus Aureus Infections and Altering Cytokine Profile Using a Porcine Deep Dermal Wound Model
Solis et al.

About Organogenesis Inc.
Organogenesis Inc. is a leading regenerative medicine company offering a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Organogenesis’s comprehensive portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com.

Contact:
Angelyn Lowe
(781) 830-2353
alowe@organo.com

SOURCE Organogenesis Inc.

Related Links

http://organogenesis.com

Read More
unnamed-1.jpg

TransEnterix Schedules First Quarter 2018 Financial and Operating Results Conference Call for May 8, 2018

Posted On April 24, 2018 By OrthoSpineNews In Financial /  

April 24, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC) announced today that it plans to release first quarter 2018 financial and operating results after the market closes on Tuesday, May 8, 2018. Todd M. Pope, President and Chief Executive Officer, and Joseph P. Slattery, Executive Vice President and Chief Financial Officer will host a conference call to discuss these results starting at 4:30 pm Eastern Time the same day. The call will be concurrently webcast.

To listen to the conference call on your telephone, please dial 844-804-5261 for domestic callers and 612-979-9885 for international callers, and reference conference ID 4854118 approximately ten minutes prior to the start time. To access the live audio webcast or archived recording, use the following link http://ir.transenterix.com/events.cfm. The replay will be available on the Company’s website.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance™ Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1 443-213-0501
invest@transenterix.com
or
Media Contact:
Joanna Rice, + 1 951-751-1858
joanna@greymattermarketing.com

Read More
6b961b64-08c1-4ee8-a772-c86aa27cfc96-original.jpeg

Samumed’s Osteoarthritis and Tendinopathy Research Selected for Multiple Presentations at the 2018 Osteoarthritis Research Society Int’l World Congress

Posted On April 23, 2018 By OrthoSpineNews In Extremities /  

SAN DIEGO, April 23, 2018 (GLOBE NEWSWIRE) — Samumed, LLC, a leader in Wnt research and development, today announced it will present its most recent clinical and preclinical data on the company’s investigational Wnt pathway inhibitors for the treatment of osteoarthritis (SM04690) and tendinopathy (SM04755) at the 2018 Osteoarthritis Research Society International World Congress, to be held April 26-29, 2018 in Liverpool, U.K.

“We are honored to present our work on the first potential disease modifying treatment in osteoarthritis and our first-in-class topical tendinopathy treatment at the OARSI congress. Our encouraging findings continue to drive our innovative research in Wnt pathway modulation for potential therapeutic options currently lacking in the clinical space,” said Dr. Yusuf Yazici, Samumed’s Chief Medical Officer.

Oral Presentation Details:

Abstract Title Date/Time Session Title
Experimental Tendinopathy Treatment with SM04755, a Topical Small Molecule Inhibitor of the Wnt Pathway – Oral Presentation #27 Friday, April 27 10:45-12:00pm BST Plenary Session 4 – Non-Cartilaginous Soft Tissues in OA: Tendons, Ligaments and Synovium

Poster Presentation Details:

Abstract Title Date/Time Session Title
SM04690, a Wnt Pathway Inhibitor: Anti-Inflammatory and Cartilage Protective Effects in Preclinical Osteoarthritis Models – Poster #98 Friday, April 27 12:30-1:00pm and 4:30-5:00pm BST

Saturday, April 28
4:15-5:00pm BST

 OA: Cartilage & Bone
Radiographic Outcomes Were Concordant with Outcome Measures in Rheumatology Osteoarthritis Research Society International (OMERACT-OARSI) Strict Response: Post-Hoc Analysis from a Phase 2 Study of a Wnt Pathway Inhibitor, SM04690, for Knee Osteoarthritis Treatment – Poster #466 Friday, April 27 12:30-1:00pm and 4:30-5:00pm BST

Saturday, April 28
4:15-5:00pm BST

 OA: Clinical Aspects & Outcomes
Joint Space Width Inclusion Criteria Can Reduce Knee Osteoarthritis Trial Heterogeneity: Post-Hoc Data from a Phase 2 Trial of Wnt Pathway Inhibitor, SM04690 – Poster #518 Friday, April 27 12:30-1:00pm and 4:30-5:00pm BST

Saturday, April 28
4:15-5:00pm BST

 Clinical Research Methods
Results from a 52-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of a Novel, Intra-Articular Wnt Pathway Inhibitor (SM04690) for the Treatment of Knee Osteoarthritis – Poster #550 Friday, April 27 12:30-1:00pm and 4:30-5:00pm BST

Saturday, April 28
4:15-5:00pm BST

 Therapy – Intraarticular

Further details can be found on the OARSI website at https://2018.oarsi.org/. A copy of the presentation materials can be accessed by visiting the Publications section of the Samumed website after the presentations conclude.

In addition, Samumed will be holding a scientific symposium at 12:15pm BST on Saturday, April 28 entitled, “Advancing Disease Modification in Knee Osteoarthritis: Clinical Implications of Wnt Pathway Inhibition.” This symposium will feature highly esteemed faculty: Dr. Timothy McAlindon, Dr. Rik Lories, Dr. Nancy E. Lane, and Dr. Yusuf Yazici.

About Osteoarthritis Research Society International
The Osteoarthritis Research Society International (OARSI) is the leading medical society for advancing the understanding, early detection, treatment and prevention of osteoarthritis (OA) through its exclusive dedication to research. OARSI’s passion and area of focus is on OA, a debilitating disease affecting more than 600 million people around the world. With more than 30 years of experience serving the OA community, OARSI provides the necessary framework, expert resources and support for its international constituents to address the challenges of OA so that the knowledge gained can ultimately be used to help improve patient care and patient outcomes.

About SM04690
SM04690 is a small molecule inhibitor of the Wnt pathway administered as an intra-articular injection, and is being developed as a potential disease modifying drug for osteoarthritis (DMOAD). Preclinical data suggested SM04690 has a dual mechanism of action with three specific effects on joint health – generating new articular cartilage, slowing down cartilage degradation, and reducing inflammation in the joint. Additional information on Samumed’s SM04690 osteoarthritis program can be found here: https://www.samumed.com/pipeline/detail.aspx?id=20

About SM04755
SM04755 is a small-molecule Wnt pathway inhibitor and is being developed as a potential topical therapeutic for tendinopathy. Preclinical data on SM04755 have been previously shown to inhibit inflammation, reduce fibrosis, and increase tenocyte differentiation (tendon repair). Additional information on Samumed’s SM04755 tendinopathy program can be found here: https://www.samumed.com/pipeline/detail.aspx?id=13

About Samumed
Samumed’s small-molecule drug platform is harnessing the innate restorative power of the Wnt pathway to reverse the course of severe and prevalent diseases. Samumed’s clinical pipeline can be found here: https://www.samumed.com/pipeline/default.aspx

Corporate Contact:
Erich Horsley
Samumed, LLC
erich@samumed.com
858-365-0200

Investor Contact:
Ashley Robinson
LifeSci Advisors
arr@lifesciadvisors.com
617-535-7742

Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt@lifescipublicrelations.com
646-627-8384

Read More