Smith & Nephew Announce European Launch of Handheld Imaging Technology a New Era of Evidence-Based Decision Making in Wound Care

Posted On December 11, 2017 By OrthoSpineNews In Extremities /

December 11, 2017

LONDON–(BUSINESS WIRE)–Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, today announces the European launch of MolecuLight i:X^TM, the easy to use, handheld imaging device that instantly measures wound surface area and visualises the presence and distribution of potentially harmful bacteria in wounds.^2,3

Currently wound assessments are made with the naked eye which can lack the accuracy required to most effectively guide clinical decision making.⁴ Using fluorescence, MolecuLight i:X quickly, safely, and easily visualises potentially harmful bacteria^1,2,3in wounds which may otherwise lack signs or symptoms of infection. It enhances a clinician’s ability to choose the right therapy, at the right time for their patient^1,2and can help to guide wound sampling and debridement,^1,5,6 monitor wound progression,^2,3 improve patient engagement^4,5and simplify wound documentation.¹

Clinical data from wound assessments demonstrates that incorporating the MolecuLight i:X into standard care facilitated more objective medical decision making and led to up to 9 times faster wound healing¹ and 54% more accurate swabbing.⁷

“The MolecuLight i:X enables healthcare professionals to see what they have never been able to see before“ said Paolo Di Vincenzo, Smith & Nephew’s Senior Vice President Global Marketing, Wound. “We are proud to partner with MolecuLight Inc. and bring this innovative technology to our customers. It strongly complements our range of advanced wound care products and we believe is set to start a revolution in wound care clinical practice.”

“For the first time clinicians can accurately sample a wound in situ to determine if bacteria are present as well as more effectively debride a wound under fluorescence visualisation. These are fundamental areas of everyday wound care that have remained suboptimal for too long, until now,” says Dr. Ralph DaCosta, Founder, Chief Scientific Officer and Director, MolecuLight Inc.

An estimated 2 million people are living with a chronic wound across Europe and an estimated 16% of all chronic wounds remain unresolved after a year or longer.^9,10,11 Ensuring wounds are appropriately diagnosed and treated is a priority for healthcare providers across Europe, reducing cost and improving outcomes for patients.

“Not only has the MolecuLight i:X transformed my department’s clinical decision making in terms of targeting sampling and debridement and improving antimicrobial stewardship, but the benefit to patients has also been exciting to see,” says Rosemary Hill*, Canadian Wound Ostomy Continence Nurse Clinician, Lions Gate Hospital, Vancouver. “By being able to engage patients in their wound healing progress, and by showing them the real-time images, we can reduce anxiety, and provide reassurance regarding the diminishing burden of bacteria.”

The MolecuLight i:X Imaging Device is approved by Health Canada (Medical License #95784) and has CE Marking (Certificate # G1160292355002) for sale in the European Union. The MolecuLight i:X Imaging Device is not available in the US.

Full press pack is available at: http://www.smith-nephew.com/news-and-media/media-releases/news/european-launch-of-handheld-imaging-technology-heralds-new-era-of-evidence-based-decision-making

About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. 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 2016 were almost $4.7 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).
For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

To learn more about what we do to help reduce wound infection, please visit www.closertozero.com

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.

About MolecuLight Inc.
MolecuLight Inc. is a privately owned, Canadian medical imaging company delivering real-time fluorescence image-guidance solutions that provide clinicians with new information about wound bacterial burden and wound surface area to assist clinicians in making improved diagnostic and treatment decisions.

The MolecuLight i:X is manufactured by MolecuLight® Inc.
MaRS Centre, South Tower 101 College St., Suite 200 Toronto, ON M5G 1L7 Canada
T +1 647.362.4684 F +1 647.362.4730
www.moleculight.com

® Registered trademark acknowledged

[tm] All trademarks acknowledged
MolecuLight i:X and Look to Heal are registered trademarks of MolecuLight Inc in Canada, the US and the UK. MolecuLight DarkDrape is a registered trademark of MolecuLight® Inc in Canada. Other jurisdictions pending

The MolecuLight i:X is distributed by Smith & Nephew
Wound Management
Smith & Nephew Medical Ltd, 101 Hessle Road, Hull HU3 2BN, UK
T +44 (0) 1482 225181 F +44 (0) 1482 328326
www.smith-nephew.com
All Trademarks acknowledged
©October 2017 Smith & Nephew
AWM-AWD-11878

References:

1. DaCosta RS et al. Point-of-care autofluorescence imaging for real-time sampling and treatment guidance of bioburden in chronic wounds: first-in-human results. PLoS One. 2015 Mar 19;10(3).

2. MolecuLight Inc. PN 1189 MolecuLight i:X User Manual. 2016.

3. MolecuLight Inc. Case Study 0051 Track Wound Size and Bacterial Presence with the MolecuLight i:X. 2016.

4. Hoeflok J et al. Pilot clinical evaluation of surgical site infections with a novel handheld fluorescence imaging device. Proceedings of the Annual Military Health System Research Symposium (MHSRS); 2014 Aug 18- 21; Fort Lauderdale, FL.

5. Raizman R. Point-of-care fluorescence imaging device guides care and patient education in obese patients with surgical site infections. Presented at: CAWC 2016. Proceedings of the Annual Canadian Association of Wound Care Conference (CAWC); 2016 Nov 3-6, Niagara Falls, ON.

6. Raizman R. Fluorescence imaging positively predicts bacterial presence and guides wound cleaning and patient education in a series of pilonidal sinus patients. Proceedings of the Annual Wounds UK Conference; 2016 Nov 14-16; Harrogate, UK.

7. Ottolino-Perry K et al. Improved detection of wound bacteria using fluorescence image guided wound sampling in diabetic foot ulcers. Int Wound J. 2017 Feb 28. doi: 10.1111/iwj.12717.

8. Posnett J et al. J. Wound Care (April 2009), The Resource Impact of Wounds on Health-care Providers in Europe, vol.18 (4).

9. Lindholm C and Searle R. Wound management for the 21st century: combining effectiveness and efficiency. Int Wound J. 2016 Jul;13 Suppl 2:5-15.

10. Siddiqui AR and Bernstein JM. Chronic wound infection: facts and controversies. Clin Dermatol. 2010;28:519–26.

11. Vowden P. Hard-to-heal wounds made easy. Wounds International, Schofield Healthcare Media Ltd: Norwich, UK, 2011;2. URL: http:// www.woundsinternational.com.

* Rosemary Hill is a paid consultant of Smith & Nephew or MolecuLight Inc.

Contacts

Media Enquiries
Rachel Cunningham
Rachel@roadcommunications.co.uk
+4420 8995 5832
or
Fabienne Merlet
Fabienne@roadcommunications.co.uk
+4420 8995 5832
or
Dave Snyder
Smith & Nephew
+1 (978) 749-1440

WishBone Medical Inc. Names Jean-Pierre Capdevielle as Chief Strategy Officer and Board Member

Posted On December 6, 2017 By OrthoSpineNews In Extremities, Top Stories /

Warsaw, Indiana, December 6, 2017 – WishBone Medical, Inc., a new pediatric orthopedic company in Warsaw, Indiana, announced that Jean-Pierre “JP” Capdevielle has taken on the role of Chief Strategy Officer. Mr. Capdevielle has also been elected unanimously by the Board of Directors to serve as a Director for WishBone Medical, Inc. As CSO, he will work closely with the Chairman of the Board and CEO, Nick Deeter to grow WishBone Medical’s strategic initiatives.

Mr. Capdevielle is a seasoned executive with over 37 years of international experience and has a successful track record of helping startup companies. His knowledge of the orthopedic industry has lead him to the top of major International Medical Device Companies like, Smith & Nephew and Sofamor Danek/Medtronic to name a few. Mr. Capdevielle has lead multiple teams to the successful launches of sophisticated and innovative devices and systems throughout his years of experience.

Jean-Pierre Capdevielle has an extensive professional resume. In 1979 Mr. Capdevielle founded his first company Medical Hospital Products Ltd in Malta, upon leaving in 1982 he had a team of over 240 employees. In 1988 Mr. Capdevielle joined Smith & Nephew to become their Senior Director of Continental Europe and Managing director of French, German and Spanish Operations. Upon joining Smith & Nephew, Mr. Capdevielle lead to a sales growth of 35% a year from 1989-1992 and contributed in the successful introduction of the GENESIS Modular Knee system across EU.

Upon his resignation from Smith & Nephew in 1993, Mr. Capdevielle joined and worked directly with Ron Pickard, CEO and Chairman of Sofamor Danek. At Sofamor Danek Mr. Capdevielle helped bring in revenue of up to $350 million. From 1993-2006 Mr. Capdevielle was a part of many successful business ventures before starting his current business in 2006: Isortho & ICS Consulting Group. Just within the past 4 years, Mr. Capdevielle has contributed to the success of over 22 companies.

WishBone Medical was founded by Nick Deeter, a leader in Pediatric Orthopedics. WishBone is a pediatric orthopedic company focused on the unmet needs of children suffering from orthopedic issues. WishBone’s commitment is to provide anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits with an emphasis to minimize disease, prevent infection, reduce overall costs for our customers and to achieve the best outcomes for children who are still growing, because kids are not just little adults.

“JP brings an incredible amount of medical device industry experience to our team,” says Nick Deeter, Chairman of the Board and CEO of WishBone Medical. “We are very glad to have him at WishBone Medical to serve as our Chief Strategy Officer and newly elected Board Member. We are eager for him to work with the WishBone Medical Team as we take the company into a successful second year of operations.”

Mr. Capdevielle received his M.B.A in International Marketing and Finance programs from Hautes Etudes Commerciales Jouy-en-Josas in 1974 and in 1992 completed the Marketing Executive Program from Columbia University in New York. Mr. Capdevielle currently resides in France and is fluent in over 3 languages. He served in the Military from 1974-1976. Mr. Capdevielle is married with two children and enjoys playing/watching rugby and golf in his free time.

To learn more about WishBone Medical, visit www.WishBoneMedical.com.

About WishBone Medical, Inc.

WishBone Medical, Inc. is a privately held pediatric orthopedic company offering anatomically-appropriate innovative implants and instrument solutions to pediatric patients and surgeons worldwide.

For further information, visit www.wishbonemedical.com or call Allison McSherry, General Manager at (574)306-4006

In2Bones Announces FDA Clearance of the CoLink® View “See-Through” Plating System

Posted On December 6, 2017 By OrthoSpineNews In Extremities, Regulatory, Top Stories /

December 05, 2017

MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global, Inc. today announced that its In2Bones USA, LLC subsidiary has received U.S. Food and Drug Administration (FDA) clearance for an addition to its CoLink^®Forefoot Bone Plating System used to stabilize bones during the post-surgical healing process. The addition will be marketed under the CoLink View brand name.

CoLink View Bone Plates incorporate a unique combination of titanium metal and a high-performance polymer called polyether ether ketone (PEEK). The CoLink View Plates include an X-ray transparent PEEK hub that allows the surgeon to literally watch the patient’s bone heal. This cannot be done with traditional metal plates because metal absorbs X-rays and blocks the image below. The “see-through” hub is unique to this new In2Bones plating system, and one of many device innovations designed by the company.

In addition to X-ray transparency, PEEK has a benefit of being less stiff than metal and more similar to the elasticity of bone. Bones need mechanical stress (elasticity) during the healing process. Stiffer, all metal implants may eliminate the positive elasticity and slow healing.

The CoLink View is the sixth In2Bones PEEK-related implant system that has received FDA clearance; others are expected to be cleared in 2018.

In August 2016, In2Bones USA, LLC and In2Bones, SAS, Lyon, France, merged to form In2Bones Global, Inc, a Delaware Corporation headquartered in Memphis. Since the merger and in addition to the aforementioned product, the company has launched several innovative products including the NeoView^® PEEK Distal Radius Plate, the NeoSpan^® SuperElastic Compression Staple, the Reference Toe System^®, AlloAid^® PIP, AlloAid^® Nail, the 5MS^® fifth metatarsal fracture repair system, the CoLag^® Screw System, an ankle fusion plate system and the PitStop™ PEEK subtalar implant.

For more information about In2Bones Global, Inc. extremity products in the U.S. and France, please visit www.i2b-USA.com or www.In2Bones.com.

About In2Bones USA, LLC

Located in Memphis, Tennessee, In2Bones USA, LLC is a designer, manufacturer and distributor of medical devices for the treatment of disorders and injuries of the upper (hand, wrist, elbow) and lower (foot and ankle) extremities. For more information, visit www.i2b-USA.com.

About In2Bones, SAS

Located in Lyon, France, In2Bones, SAS is a specialty orthopaedic company that develops and distributes upper and lower extremity products to enable surgeons to alleviate pain and restore motion for their patients. For more information, visit www.In2Bones.com.

Safe-Harbor Statement:

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management’s current view of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “will,” and other similar terms. The company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties impacting the business, including increased competition, technical obsolescence, regulatory issues, general economic conditions and other risks.

Contacts

Element-R Partners
Susan Duensing, CBC
847.639.8300
susan@rurelevant.com

Scientists Race To Regrow Lost Knee Cartilage

Posted On November 30, 2017 By OrthoSpineNews In Extremities /

Nov. 27, 2017 – By Kathleen Doheny/WebMD Health News

Bad knees sideline athletes and mere mortals alike.About 14 million Americans have osteoarthritis of the knees severe enough to cause pain and inflammation, according to the Arthritis Foundation, and more people are getting the condition — also known as OA — as they age.

As the knee’s natural cushioning — the cartilage — wanes, inflammation and pain rise, and people can’t get around as well.

Building knee cartilage has been a dream of researchers, and now several methods are under study. None has yet shown it can prevent or cure osteoarthritis, and all are in early phases, caution the scientists who presented their findings at the recent annual meeting of the American College of Rheumatology in San Diego, CA.

Stopping Excess Bone Breakdown

A treatment known as MIV-711 targets an enzyme called cathepsin K that is thought to play a role in the destruction of cartilage and the breakdown of too much bone.

In adults, bones are constantly being broken down and built up or replaced to maintain a healthy skeleton. “This [treatment] stops the increased breakdown of bone that happens in OA,” says researcher Philip Conaghan, MD, a professor of musculoskeletal medicine at the University of Leeds in Great Britain. “It inhibits the cathepsin K.” The bone changes happen before the cartilage loss does, he says.

In the study, researchers assigned 244 men and women who have knee arthritis to get one of two oral doses of the treatment or a placebo pill for up to 28 days. The participants’ average age was 62, and many were overweight or obese.

The researchers did MRIs at the beginning of the study and at week 26 to find changes around the bone, which reflect cartilage change. They found 65% less bone disease progression in the treated groups, regardless of dose, Conaghan says.

But they found no less pain. “It did not help symptoms,” he says.

READ THE REST HERE

Novastep adds airlockGO® to its cleanSTART® Delivery Platform

Posted On November 28, 2017 By OrthoSpineNews In Extremities, Top Stories /

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

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

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

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

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

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

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

Related Links

For general information: novastep-us.com

OrthoPediatrics Corp. to Highlight its Products at the 14th Annual International Pediatric Orthopaedic Symposium

Posted On November 27, 2017 By OrthoSpineNews In Extremities, Spine, Sports Medicine /

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

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

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

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

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

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

MEDICA 2017 Proves to Propel TracPatch Wearable Technology into the Global Medical Arena

Posted On November 27, 2017 By OrthoSpineNews In Extremities, Top Stories /

SACRAMENTO, CA (PRWEB) NOVEMBER 22, 2017

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

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

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

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

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

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

EOS imaging to Present at the 29th Annual Piper Jaffray Healthcare Conference

Posted On November 20, 2017 By OrthoSpineNews In Extremities, Spine /

November 20, 2017

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – SME), the pioneer of 2D/3D orthopedic medical imaging, today announced that Marie Meynadier, Chief Executive Officer, is scheduled to present at the 29^th Annual Piper Jaffray Healthcare Conference in New York, NY.


Event:			29^th Annual Piper Jaffray Healthcare Conference
Date:			Wednesday, November 29, 2017
Time:			10:30 am ET / 4:30 pm CET

Investors attending the conference who would like to schedule a one-on-one meeting with EOS imaging management may do so by contacting their Piper Jaffray representative, or Emma Poalillo of The Ruth Group at epoalillo@theruthgroup.com.

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging service dedicated to osteo-articular pathologies and orthopaedics, as well as the associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan, China and the European Union (EC). It posted revenues of €30.8 million in 2016 and employed 132 people at December 2016, including an R&D team of 43 engineers. The group is based in Paris and has five subsidiaries: in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

EOS imaging has been selected to integrate the EnterNext © PEA – SME 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
CFO
Pierre Schwich, +33 (0)1 55 25 61 24
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent, +33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
The Ruth Group (US)
Press relations
Joanna Zimmerman, 646-536-7006
jzimmerman@theruthgroup.com

Bioengineered Robotic Hand With Its Own Nervous System Will Sense Touch

Posted On November 16, 2017 By OrthoSpineNews In Extremities /

Credit: Florida Atlantic University

BOCA RATON, Fla., Nov. 15, 2017 /PRNewswire-USNewswire/ — The sense of touch is often taken for granted. For someone without a limb or hand, losing that sense of touch can be devastating. While highly sophisticated prostheses with complex moving fingers and joints are available to mimic almost every hand motion, they remain frustratingly difficult and unnatural for the user. This is largely because they lack the tactile experience that guides every movement. This void in sensation results in limited use or abandonment of these very expensive artificial devices. So why not make a prosthesis that can actually “feel” its environment?

That is exactly what an interdisciplinary team of scientists from Florida Atlantic University and the University of Utah School of Medicine aims to do. They are developing a first-of-its-kind bioengineered robotic hand that will grow and adapt to its environment. This “living” robot will have its own peripheral nervous system directly linking robotic sensors and actuators. FAU’s College of Engineering and Computer Science is leading the multidisciplinary team that has received a four-year, $1.3 million grant from the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health for a project titled “Virtual Neuroprosthesis: Restoring Autonomy to People Suffering from Neurotrauma.”

With expertise in robotics, bioengineering, behavioral science, nerve regeneration, electrophysiology, microfluidic devices, and orthopedic surgery, the research team is creating a living pathway from the robot’s touch sensation to the user’s brain to help amputees control the robotic hand. A neuroprosthesis platform will enable them to explore how neurons and behavior can work together to regenerate the sensation of touch in an artificial limb.

At the core of this project is a cutting-edge robotic hand and arm developed in the BioRobotics Laboratory in FAU’s College of Engineering and Computer Science. Just like human fingertips, the robotic hand is equipped with numerous sensory receptors that respond to changes in the environment. Controlled by a human, it can sense pressure changes, interpret the information it is receiving and interact with various objects. It adjusts its grip based on an object’s weight or fragility. But the real challenge is figuring out how to send that information back to the brain using living residual neural pathways to replace those that have been damaged or destroyed by trauma.

“When the peripheral nerve is cut or damaged, it uses the rich electrical activity that tactile receptors create to restore itself. We want to examine how the fingertip sensors can help damaged or severed nerves regenerate,” said Erik Engeberg, Ph.D., principal investigator, an associate professor in FAU’s Department of Ocean and Mechanical Engineering, and director of FAU’s BioRobotics Laboratory. “To accomplish this, we are going to directly connect these living nerves in vitro and then electrically stimulate them on a daily basis with sensors from the robotic hand to see how the nerves grow and regenerate while the hand is operated by limb-absent people.”

For the study, the neurons will not be kept in conventional petri dishes. Instead, they will be placed in biocompatible microfluidic chambers that provide a nurturing environment mimicking the basic function of living cells. Sarah E. Du, Ph.D., co-principal investigator, an assistant professor in FAU’s Department of Ocean and Mechanical Engineering, and an expert in the emerging field of microfluidics, has developed these tiny customized artificial chambers with embedded micro-electrodes. The research team will be able to stimulate the neurons with electrical impulses from the robot’s hand to help regrowth after injury. They will morphologically and electrically measure in real-time how much neural tissue has been restored.

Jianning Wei, Ph.D., co-principal investigator, an associate professor of biomedical science in FAU’s Charles E. Schmidt College of Medicine, and an expert in neural damage and regeneration, will prepare the neurons in vitro, observe them grow and see how they fare and regenerate in the aftermath of injury. This “virtual” method will give the research team multiple opportunities to test and retest the nerves without any harm to subjects.

Using an electroencephalogram (EEG) to detect electrical activity in the brain, Emmanuelle Tognoli, Ph.D., co-principal investigator, associate research professor in FAU’s Center for Complex Systems and Brain Sciences in the Charles E. Schmidt College of Science, and an expert in electrophysiology and neural, behavioral, and cognitive sciences, will examine how the tactile information from the robotic sensors is passed onto the brain to distinguish scenarios with successful or unsuccessful functional restoration of the sense of touch. Her objective: to understand how behavior helps nerve regeneration and how this nerve regeneration helps the behavior.

Once the nerve impulses from the robot’s tactile sensors have gone through the microfluidic chamber, they are sent back to the human user manipulating the robotic hand. This is done with a special device that converts the signals coming from the microfluidic chambers into a controllable pressure at a cuff placed on the remaining portion of the amputated person’s arm. Users will know if they are squeezing the object too hard or if they are losing their grip.

Engeberg also is working with Douglas T. Hutchinson, M.D., co-principal investigator and a professor in the Department of Orthopedics at the University of Utah School of Medicine, who specializes in hand and orthopedic surgery. They are developing a set of tasks and behavioral neural indicators of performance that will ultimately reveal how to promote a healthy sensation of touch in amputees and limb-absent people using robotic devices. The research team also is seeking a post-doctoral researcher with multi-disciplinary experience to work on this breakthrough project.

“This National Institutes of Health grant will help our interdisciplinary team of scientists address an important challenge that impacts millions of people worldwide,” said Stella Batalama, Ph.D., dean and professor of FAU’s College of Engineering and Computer Science. “By providing a better understanding of how to repair nerve injuries and trauma we will be able to help patients recover motor functionality after an amputation. This research also has broad applications for people who suffer from other forms of neurotrauma such as stroke and spinal cord injuries.”

The early stages of this project were supported by FAU’s Institute for Sensing and Embedded Network Systems (I-SENSE). Researchers also are working in collaboration with I-SENSE and FAU’s Brain Institute, two of the University’s research pillars, focused on institutional strengths.

About FAU’s College of Engineering and Computer Science:

Florida Atlantic University’s College of Engineering and Computer Science is committed to providing accessible and responsive programs of education and research recognized nationally for their high quality. Course offerings are presented on-campus, off-campus, and through distance learning in bioengineering, civil engineering, computer engineering, computer science, electrical engineering, environmental engineering, geomatics engineering, mechanical engineering and ocean engineering. For more information about the college, please visit eng.fau.edu.

About Florida Atlantic University: Florida Atlantic University, established in 1961, officially opened its doors in 1964 as the fifth public university in Florida. Today, the University, with an annual economic impact of $6.3 billion, serves more than 30,000 undergraduate and graduate students at sites throughout its six-county service region in southeast Florida. FAU’s world-class teaching and research faculty serves students through 10 colleges: the Dorothy F. Schmidt College of Arts and Letters, the College of Business, the College for Design and Social Inquiry, the College of Education, the College of Engineering and Computer Science, the Graduate College, the Harriet L. Wilkes Honors College, the Charles E. Schmidt College of Medicine, the Christine E. Lynn College of Nursing and the Charles E. Schmidt College of Science. FAU is ranked as a High Research Activity institution by the Carnegie Foundation for the Advancement of Teaching. The University is placing special focus on the rapid development of critical areas that form the basis of its strategic plan: Healthy aging, biotech, coastal and marine issues, neuroscience, regenerative medicine, informatics, lifespan and the environment. These areas provide opportunities for faculty and students to build upon FAU’s existing strengths in research and scholarship. For more information, visit fau.edu.

Media Contact:
Gisele Galoustian
Media Relations Director, Research
ggaloust@fau.edu
Phone: 561-297-2676

This news release was issued on behalf of Newswise(TM). For more information, visit http://www.newswise.com.

SOURCE Florida Atlantic University

IntraFuse Receives FDA 510(k) Clearance for FlexThread™ Fibula Pin System

Posted On November 14, 2017 By OrthoSpineNews In Extremities, Regulatory, Top Stories /

LOGAN, Utah, November 1, 2017 – IntraFuse, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for its FlexThread™ Fibula Pin System.

The IntraFuse FlexThread™ Fibula Pin System provides percutaneous fixation of distal fibula fractures, primarily Danis-Weber B type fractures, or trans-syndesmotic fractures. The simple and elegant design is easy to insert and cost competitive with today’s standard-of-care internal fixation hardware. Incorporating IntraFuse’s proprietary FlexThread™ technology, the distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod. Upon insertion of the implant into the fibula, the rigid rod portion of the implant spans and supports the fracture and the flexible screw portion bends as needed to thread into the intramedullary canal. With internal screw fixation on one side of the fracture and cross screw fixation through the rod on the other side of the fracture, proper bone alignment and length can be maintained during the healing period. Additionally, the FlexThread™ Fibula Pin is compatible with either screw or flexible fixation of the syndesmosis joint as needed.

To accommodate the anatomic size range of fibulas, the FlexThread™ Fibula Pin is available in three different screw diameters, each with two length options. Using routine intramedullary and screw fixation techniques, bone preparation is a simple, three step sequence: place guide wire, ream, tap. Optional fracture site compression is achieved concurrent with insertion of the implant, and delivery of cross fixation screws is facilitated by a guide that connects directly to the implant inserter.

The FlexThread™ Fibula Pin provides anatomic, intramedullary fixation that may have potential clinical advantages over fibula plating systems, including: reduced risk of hardware related pain, reduced rate of hardware removal, less risk of wound complications, infection and other morbidities due to a less invasive procedure, and less disruption of the periosteum which facilitates faster healing.

“Intramedullary fixation is the standard-of-care today for most fractures of the large, long bones of the body due to superior clinical outcomes versus plating systems, yet plating systems are still the standard-of-care for the smaller, long bones of the extremities,” states Wade Fallin, CEO of IntraFuse. Fallin continues, “FlexThread™ is a platform technology that can address the unique requirements for intramedullary fixation of small bone fractures where off-axis entry into the bone canal is required, or where the bone is curved. Now cleared for both clavicle and fibula fractures, the FlexThread™ technology is in further development for additional indications.”

IntraFuse is a development stage medical device company incubated and operated by Surgical Frontiers. Inquiries regarding distribution and commercialization partnerships are welcome.

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use. Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Wade Fallin

CEO

wade@surgicalfrontiers.com

www.surgicalfrontiers.com

800-230-3710