Additional US Patents Issued to Catalyst OrthoScience, Inc. for Its Stemless Shoulder Arthroplasty Technology

Posted On January 19, 2018 By OrthoSpineNews In Recon, Regulatory, Top Stories /  

NAPLES, Fla., Jan. 19, 2018 /PRNewswire/ — Catalyst OrthoScience, Inc. has been granted four new patents by the United States Patent and Trademark Office for technologies incorporated in the CSR™ Total Shoulder Replacement System.  The Catalyst CSR™ Total Shoulder System is a new canal-sparing, anatomic shoulder arthroplasty system that provides consistently reproducible shoulder joint restoration with an humeral implant that is smaller, more anatomically-shaped, and less invasive than traditional shoulder replacement surgery.

U.S. Patent Number

Title

Patent Issue Date

9,814,588

Glenoid Arthroplasty with Multi-directional Fixation

November 14, 2017

9,814,587

Humeral Arthroplasty

November 14, 2017

9,814,471

Glenoid Arthroplasty with Offset Reamers

November 14, 2017

9,775,716

Glenoid Arthroplasty

October 3, 2107

These patents expand the portfolio of Catalyst intellectual property related to the Company’s proprietary glenoid and humeral implant designs and instrumentation. “The granting of these patents endorses the extent of our technology and provides Catalyst with further protection for its product offerings in the shoulder replacement market,” said Bob Kaufman, CEO of Catalyst OrthoScience. “We have built a solid intellectual property portfolio and will continue to work to extend the depth and breadth of that protection.”

With core technology driven by surgeon and patient need, Catalyst has been able to draw a loyal following of orthopedic surgeons since receiving FDA clearance for the CSR™ total shoulder replacement solution last year. “Catalyst’s core technology is truly innovative, as evidenced by not only the growing patent portfolio, but also by the growing number of high caliber shoulder specialists who have embraced Catalyst as an important part of their clinical offering,” said Rod Allen, Catalyst’s Senior Vice President of Sales and Marketing.

Catalyst OrthoScience was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D. who realized, based on his own experience as a fellowship-trained shoulder specialist, that improvements were needed to make shoulder replacement surgery less invasive and to give patients a more normal feeling shoulder after surgery.  “It feels great to be granted these patents,” said Dr. Goldberg. “I’m still amazed at how much our team has accomplished in such a short timeframe, and now patients are seeing the benefit.”

About Catalyst OrthoScience Inc.

Headquartered in Naples, FL, Catalyst OrthoScience develops and markets innovative medical device solutions that make orthopedic surgery less invasive and more efficient for both surgeons and patients.

The company’s first offering is the Catalyst CSR Shoulder System. The Catalyst CSR is a single-tray total shoulder arthroplasty system containing a non-spherical humeral implant for consistent anatomic joint line restoration and specialized glenoid instrumentation for a less invasive approach that preserves the natural anatomy and removes less of the patient’s bone.

Catalyst OrthoScience’s products are marketed under a portfolio of brands including Catalyst OrthoScience® and Catalyst CSR™. For additional information on the Company, please visit  http://www.catalystortho.com.

SOURCE Catalyst OrthoScience, Inc.

Related Links

http://www.catalystortho.com

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Novel Method of Isolating Infecting Organisms after Joint Replacement

Posted On January 19, 2018 By OrthoSpineNews In Recon /  

PHILADELPHIA, Jan. 19, 2018 /PRNewswire/ — Joint replacement surgery carries the risk of developing an infection in the replaced joint, which can lead to a so-called revision or re-do of the joint replacement. However, current diagnostic practices can fail to detect bacteria in 30-50 percent of clinical cases, complicating or delaying appropriate treatment. Thomas Jefferson University researchers have found that genomic analysis using next generation sequencing (NGS), can identify infecting organisms in over 80 percent of cases of infected joint replacement that had previously escaped detection. The research was published January 17th 2018 in the Journal of Bone and Joint Surgery.

“This method can help detect pathogens that we would otherwise miss using standard approaches, namely culture,” said senior author Javad Parvizi, MD, Vice Chairman of Research and Professor of Orthopedic Surgery at the Rothman Institute at Thomas Jefferson University. “The study has revealed unexpected pathogens and let us to select more appropriate and effective treatments for patients.”

In order to test the ability to isolate infective organisms, Dr. Parvizi and colleagues prospectively enrolled patients undergoing a revision joint replacement over a 9-month period in 2016, and assessed for organisms identified using traditional method: culture, side by side with NGS.

The results showed that NGS identified organisms in 89 percent of infected cases versus 61 percent with culture. Furthermore, NGS was able to detect the pathogen in 81 percent of the cases that were negative for pathogens by the standard culture method, and which would have been missed otherwise.

One patient, whose case was described in a separate paper in Arthroplasty Today, reported to the emergency department with an infected joint replacement. Although standard culture was unable to identify the pathogen, NGS diagnostic tests resulted in an unexpected finding: The infection was caused by Streptococcus canis, an organism found in dogs. Further questioning of the patient confirmed that he had been scratched by his dog a few days prior to the joint infection. Once the pathogen was known, the patient could be switched to more effective antibiotics and recovered well.

“The fact that we can use this technology to detect organisms in culture-negative patients with an infected prosthesis may be significant, and could help us provide targeted treatment for these patients,” said co-author Karan Goswami, MD, a research fellow and PhD candidate affiliated with the Rothman Institute at Jefferson. “However, further study is required to validate our findings in larger numbers and determine the significance of NGS signal on treatment outcomes. A multicenter trial is underway to explore this question.”

The American Academy of Microbiologists (AAM) recently published a report supporting the use of NGS, stating, “…NGS has the potential to dramatically revolutionize the clinical microbiological laboratory by replacing current time-consuming techniques with a single all-inclusive diagnostic test.”

“Because of its promising role in diagnosing patients with periprosthetic joint infection, we have already begun to use the genomic test at our institution to isolate organisms in patients with suspected joint infection. NGS has provided critical information for the management of cases of periprosthetic joint infection at our institution, and we work closely with our microbiology colleagues to optimize treatment for these patients” said Dr. Parvizi.

Dr. Parvizi has ownership interest in MicroGenDX, the laboratory that provided next generation sequencing of samples in this study. No other disclosures were reported.

Article references:
M Tarabichi, et al., “Diagnosis of Periprosthetic Joint Infection: The Potential of Next-Generation Sequencing” the Journal of Bone and Joint Surgery, DOI: 10.2106/JBJS.17.00434 , 2018.

M Tarabichi, et al., “Diagnosis of Streptococcus canis periprosthetic joint infection: the utility of next-generation sequencing,” Arthroplasty Today, DOI:  10.1016/j.artd.2017.08.005 2017.

SOURCE Thomas Jefferson University Hospital

Related Links

http://www.jeffersonhealth.org

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Centric Medical™ Announces FDA 510(k) Clearance of the Cannulated Screw Internal Fixation System for Foot and Ankle Indications

Posted On January 18, 2018 By OrthoSpineNews In Extremities, Regulatory /  

January 16, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the Cannulated Screw Internal Fixation System. This clearance further expands the offering of Cannulated Screws for Centric Medical, to be used in Foot & Ankle reconstruction procedures.

“I am excited to add another cannulated screw option to our rapidly growing foot and ankle portfolio. This addition has allowed for a more robust offering for distal extremity procedures including reconstruction, joint fusion, osteotomies, fracture repair, arthrodesis and fracture fixation,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine. “The system is extremely easy to use, low profile and offers partially and fully threaded options. I am incredibly proud that Centric Medical saw five 510K clearances in 2017 and I think a full cannulated screw selection is an integral step to a complete foot and ankle portfolio.”

The Cannulated Screw Internal Fixation System is a streamlined multi-component system comprised of titanium alloy, with a wide variety of diameters and lengths. The new options, which are specifically indicated for the forefoot, come in 2.0, 2.5, and 3.0mm diameters with headed and headless designs. This system complements the previously FDA cleared range of 3.5-7.5mm diameters indicated for the midfoot and hindfoot which also offer designs with and without a head.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.centricmedical.com.

Contacts

Centric Medical
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

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Zimmer Biomet Holdings Announces Audio Webcast and Conference Call of Fourth Quarter and Full-Year 2017 Results

Posted On January 18, 2018 By OrthoSpineNews In Financial /  

WARSAW, Ind., Jan. 18, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today announced its fourth quarter and full-year sales and earnings conference call will be broadcast over the Internet on Tuesday, January 30, 2018, at 8 a.m. Eastern Time.  A news release detailing the quarterly and full-year results will be made available at 7 a.m. Eastern Time the morning of the conference call.

The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985.  For a complete listing of international toll-free and local numbers, please visit http://investor.zimmerbiomet.com.  A digital recording will be available 24 hours after the completion of the conference call, from January 31, 2018 to March 1, 2018.  To access the recording, U.S. callers should dial (888) 203-1112 and international callers should dial +1 (719) 457-0820, and enter the Access Code ID 7278985.

About the Company
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmer.com

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Smith & Nephew’s Episode of Care Assurance Program (eCAP) reduces hospital readmission by 97% following total joint replacement surgery

Posted On January 18, 2018 By OrthoSpineNews In Recon, Top Stories /  

LONDON, Jan. 18, 2018 /PRNewswire/ — Smith & Nephew (NYSE: SNN; LSE: SN), the global medical technology business, today announces results showing a 97.3% decrease in readmission rates for joint arthroplasties (TJA) conducted under its Episode of Care Assurance Program (eCAP).

Working with Provider PPI, eCAP combines Smith & Nephew’s leading hip and knee implants with its PICO™ Negative Pressure Wound Therapy and ACTICOAT™ Flex 7 Antimicrobial Barrier Dressings. These products are applied post-surgery; PICO may help protect the incision by reducing seroma and hematoma fluid collections, reducing edema and lateral tension and improving perfusion.1-5 ACTICOAT Flex 7, which contains Nanocrystalline Silver, provides an effective barrier to microbial contamination to help deter surgical site infections.6

Over the past 14 months 1,380 TJAs have been conducted under the eCAP program with only two readmissions, a readmission rate of only 0.145% as compared to published rates of 5.3% or more.7

“As healthcare systems move from fee for service to pay for value, healthcare providers are increasingly responsible for the episode of care for the patient,” said Glenn Warner, President Smith & Nephew US. “eCAP can help enable providers to reduce costly readmissions after TJA by adding class-leading wound care products to help manage surgical incisions. We are proud to support our customers with innovative programs that deliver improved care in a large-scale, real-world setting.”

Smith & Nephew worked with Provider PPI, a group purchasing organization, to implement this program at Provider PPI’s client facilities in late 2016 with positive results, and is now serving 16 facilities across the US.

“Adding PICO and ACTICOAT products from Smith & Nephew to our TJA cases has been a great win for our health system clients and their patients,” said Paul Gallagher, Vice President, Provider PPI. “I am extremely pleased to see our readmission rate drop to nearly zero. In Smith & Nephew we’ve worked with a comprehensive product solutions partner that’s willing to stand behind its product portfolio.”

References

  1. Lumb H. Bacterial barrier testing (wet-wet) of PICO™ dressing with a 7 day test duration against S. marcescens.
  2. Wilkes RP, et al. Closed incision management with negative pressure wound therapy (CIM): Biomechanics. Surg Innov 2011.
  3. Karlakki S, et al. Negative Pressure Wound Therapy for management of the surgical incision in Orthopedic surgery. A review of evidence and mechanisms for an emerging indication. Bone Joint Res 2013; 2: 276-284.
  4. Canonico S, et al. Therapeutic possibilities with portable NPWT. Initial multidisciplinary observations with the negative pressure device. Acta Vulnol 2012; 10: 57-66.
  5. Selvaggi F, et al. New advances in Negative Pressure Wound Therapy (NPWT) for surgical wounds of patients affected with Crohn’s Disease. Surg Tech Int 2014; XXIV: 83- 89.
  6. Burrell et al. Efficacy of Silver-Coated Dressing as Bacterial Barriers in a Rodent Burn Sepsis Model, WOUNDS 1999; 11(4):64-71.
  7. Unplanned Readmission After Total Joint Arthroplasty: Rates, Reasons, And Risk Factors – The Journal Of Bone & Joint Surgery – jbjs.org – Volume 95-A – Number 20 October 16, 2013.

    For detailed product information, including indications for use, contraindications, effects, precautions and warnings, please consult each product’s Instructions for Use (IFU) prior to use.

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 around 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)

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.

SOURCE Smith & Nephew

Related Links

https://www.smith-nephew.com

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Orthocell Secures New Patent for Suture-Less Repair of Soft Tissue

Posted On January 18, 2018 By OrthoSpineNews In Regulatory /  

January 17, 2018

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce it has been granted a further Australian patent for its CelGro® collagen medical device platform for soft tissue regeneration and repair applications. The patent entitled “Suture-less repair of soft tissue” provides additional important intellectual property to protect the CelGro® product platform.

Orthocell Managing Director Paul Anderson said: “This is an important addition to our current global IP portfolio. Not only does it further strengthen our IP position in regenerative medicine products and surgical techniques for soft tissue repair, but it also acts to validate CelGro® as a collagen medical device platform, for use across multiple indications including bone, tendons, peripheral nerves and aid in the repair of spinal cord injuries. This comes at a perfect time for the company as we move our products through the registration processes in the US.”

The patent has an expiry date of 12 October 2035. This is the first patent granted in the suture-less repair of tissue patent family. Further patent applications are in progress in all major jurisdictions including US, EU and Japan.

Suture-less repair of soft tissue refers to the method of repairing damaged soft tissue without the use of stitches. Suture-less repair has the potential to greatly improve the efficiency and efficacy of surgical procedures by simplifying techniques, reducing surgery time and reducing the risk of additional trauma to soft tissue through the use of sutures. Therefore, Orthocell’s patented method of suture-less repair provides surgeons with an alternative to direct suture repair of soft tissue defects within tendons, ligaments and nerves.

For example, in the US alone, over 20 million people suffer from peripheral nerve injury as a result of motor vehicle, sporting or work related incidents every year, at an annual cost of approximately US$150 billion. Many of these injuries require surgical nerve reconstruction involving the use of collagen conduits that are secured in place using sutures. To address the disadvantages of suturing, Orthocell developed the CelGro® collagen medical device platform with handling characteristics to assist surgeons in performing complex reconstructive surgical procedures and enabling the suture-less repair of soft tissue defects.

CelGro®’s nerve addressable market is estimated to be worth more than US$1.1 billion per annum, with approximately 700,000 procedures that could utilise CelGro® completed each year. Market growth is expected to be underpinned by the surgeons’ preference for quality and functional bio-absorbable membranes. The company believes CelGro® represents a breakthrough in soft tissue reconstruction and offers significant global commercial potential in its existing addressable markets of bone, tendon, nerve and cartilage as well as much wider applications in general surgical and soft tissue reconstructive applications.

About CelGro®

CelGro® is a collagen medical device platform for soft tissue regeneration and repair applications manufactured by Orthocell at its quality controlled Good Manufacturing Practices (GMP) licensed facility in WA.

Orthocell has received market authorisation (CE Mark) of CelGro® collagen scaffold medical device in the EU for dental bone and soft tissue applications. The CE Mark allows CelGro® to be sold within EU countries, validates CelGro®’s quality manufacturing and product performance, and provides a strong foundation for indication expansion and regulatory approvals.

CelGro® has been shown to improve tissue in-growth and repair in clinical studies using the collagen medical device to augment repair of the rotator cuff tendon within the shoulder, to guide bone regeneration within the jaw and to assist in the rejoining of severed, or damaged peripheral nerves. CelGro® is a customisable collagen medical device with numerous competitive advantages over existing synthetic and biologic tissue repair devices, particularly in the areas of cell compatibility, tensile strength and the promotion of quality tissue in growth and repair.

Medical scaffolds are analogous to construction scaffolds in that they provide integral support to the soft tissue whilst it undergoes repair.

Contacts

General enquiries
Orthocell Limited
Paul Anderson, +61 8 9360 2888
Managing Director
paulanderson@orthocell.com.au
or
Investor enquiries
Vesparum Capital
Joel Seah, +61 3 8582 4800
orthocell@vesparum.com
or
Media enquiries
WE Buchan
Ben Walsh, +61 411 520 012
bwalsh@buchanwe.com.au

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Biogennix Reports Record Growth for 2017; Expands Executive Management Team

Posted On January 18, 2018 By OrthoSpineNews In Biologics /  

January 17, 2018

IRVINE, Calif.–(BUSINESS WIRE)–Irvine-based Biogennix, an osteobiologics company that develops, manufactures, and distributes proprietary bone graft substitutes used for bone fusion procedures, revealed today that it achieved record growth in 2017. The company closed the year with 47% growth, the broadest increase the company has experienced in its history.

The majority of Biogennix’s growth is attributed to increases in sales of the company’s novel bone graft substitutes, Morpheus™ and osteoSPAN™, both of which are resorbable, osteoconductive scaffolds ideally suited for bone regeneration. The Morpheus product is a moldable version of osteoSPAN which combines the granules with an organic binder, providing optimal handling characteristics for surgeons.

The company also kicked off 2018 with the announcement of two key new hires: Rob Cripe, who will assume the role of Chief Marketing Officer; and Peter Gordon, who has been named Eastern Area Sales Director.

Cripe brings over 25 years of medical device industry experience, specializing in worldwide commercial execution. Having held executive responsibilities for sales, marketing, clinical and product development teams with companies such as Zimmer/Biomet, Smith and Nephew and DJO Global, Cripe has a deep understanding of successful execution strategies in multi-billion dollar, public organizations. He has also held executive roles for smaller, privately held companies in biologics, stroke therapy and orthotics and prosthetics, giving him a well-rounded perspective of the start-up environment.

Gordon comes to Biogennix after five years with LDR Spine where he was responsible for sales growth in the New England region. Working through a distributor sales force he consistently grew sales each year and was one of the top ten Regional Managers in sales growth 4 out of 5 years during his tenure. Prior to LDR Spine Peter was Director of Field Marketing for Archus Orthopedics. He also has served as Director of Spinal Arthroplasty Education and as Regional Sales Manager with DePuy Spine while based in Seattle. He also gained experience with bone graft materials and biologics with GenSci Orthobiologics where he was Eastern Regional Sales Director, growing sales from 0 to over 5 million dollars in less than three years.

“We’re pleased to report that 2017 was a benchmark year for us,” said Scott Bauccio, Biogennix’s Vice President of Sales and Business Development. “Our Morpheus and osteoSPAN bone graft products continued to exceed expectations on a national level and we believe that the products will fast become the standard of effectiveness and ease of use when it comes to bone graft substitutes in 2018. By further strengthening our executive team with top-caliber industry talent and expertise offered by Rob Cripe and Peter Gordon, we expect to continue to grow exponentially and expand upon last year’s success.”

Biogennix is a leading developer of osteobiologic products specifically designed for spine fusion and bone trauma. The company is led by a team of scientists and industry veterans committed to delivering unique products for bone regeneration. Biogennix designs, manufactures and distributes all of its products from its Irvine facilities.

Biogennix™ is a fully-integrated osteobiologic company headquartered in Irvine which develops, manufactures, and distributes proprietary bone graft substitutes used in bone fusion procedures. Learn more at biogennix.com.

Contacts

Biogennix
Paul Williams, 310-569-0023
paul@medialinecommunications.com

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IMPLANET: Successful First Surgical Procedures with the Jazz Lock® in Brazil

Posted On January 18, 2018 By OrthoSpineNews In Spine /  

January 17, 2018

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

IMPLANET (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today is announcing the successful results of the first surgeries using JAZZ Lock® in Brazil.

The first JAZZ Lock® procedures follow ANVISA clearance in November 2017. The initial surgeries in Latin America confirm Implanet’s global strategy to carry out the international launch of JAZZ Lock® initiated in 2017.

JAZZ Lock® fixation is the first component of an innovative range of band products designed for degenerative spine disorder surgery. JAZZ Lock® broadens the JAZZ technological platform, allowing Implanet to expand its reach in a spine market estimated to be worth over $200 million worldwide1 and $3.1 million in Brazil. Implanet offers surgeons a new implant with an optimized and reproducible surgical technique. Based on the polyester band platform, JAZZ Lock® simplifies the surgical procedure by replacing the locking screw and connecting rod with an innovative locking system.

Dr. Alexandre Elias, member of the Pain and Functional Neurosurgery Department at Hospital 9 de Julho in São Paulo and former Chief of the Spine Department at University UNIFESP says: “As a Neuro surgeon, I have been using Implanet’s band implants, with excellent post-operative clinical results. The arrival of JAZZ Lock® as part of the Implanet band range in Brazil is a major breakthrough. This new implant, easy to use during the first surgery in Sao Paulo, as well as the highly encouraging initial post-operative clinical results, validates our choice. We will now follow these patients to confirm the long term results. In my opinion, JAZZ Lock® will quickly become an essential spine implant to surgeons.”

Alvaro Tadeu dos Santos Jr, CEO of Importek says: “Completing with Implanet the ANVISA registration of the JAZZ Technology platform by end 2017 was our major goal. JAZZ Lock® is now part of the enhanced JAZZ Range, now available in Brazil. This will drive the deployment of the technology platform in our domestic market via our direct sales force organization.”

Ludovic Lastennet, CEO of Implanet, adds: “As announced we are executing our commercial deployment plan. Following the regulatory clearance in Europe (CE) and the US (FDA), JAZZ Lock® is now cleared for use in Brazil (ANVISA). The positive results obtained in the first surgeries in multiple regions of the world illustrate this product’s potential for patients and surgeons alike.”

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.

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

IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-801 Source: i-Data for 2010

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot
Tel. : +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau
Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen
Tel.: +1 917 385 21 60
implanet@alphabronze.net

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EOS imaging Reports Full Year 2017 Sales Up 21% to €37.1 Million

Posted On January 17, 2018 By OrthoSpineNews In Financial /  

January 17, 2018

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopaedic medical imaging, today announced its consolidated sales revenue for the fourth quarter and full year ended December 31, 2017. Sales in the last quarter amounted to €12.2 million, up 22% from the fourth quarter of 2016. Excluding the impact of the exchange rate, the fourth quarter sales across North America, Middle East Europe and Asia Pacific grew 35%.

Marie Meynadier, CEO of EOS imaging, said: “2017 was a year of execution in which we delivered sustainable top-line growth while significantly reshaping our presence in North America, the most strategic market for our Company. The important commercial investment we made there in 2017 has enabled us to set up a first-rate organization, and is already reflected in our significant growth in the fourth quarter. Our remarkable progress in the Europe-Middle East and Asia-Pacific regions, with 45% and 83% respective growth in 2017, continues to demonstrate the demand for our solutions from hospitals and health professionals worldwide. We approach 2018 very confident in our ability to accelerate our growth in all our priority markets and continue to deploy EOS as a standard of care.”

  • Sales Trend by Product Line
In millions of euros 2017 2016 Change (%)
Equipment sales 30.0 25.1 +20%
% of total sales 81% 82%
Sales of maintenance contracts 6.0 4.7 +27%
% of total sales 16% 15%
Sales of consumables and services 1.2 1.0 +15%
% of total sales 3% 3%
Total Sales 37.1 30.8 +21%
Non audited data

EOS imaging recorded annual revenue of €37.1 million, up 21% compared to the full year 2016. The Company sold 77 EOS® systems in 2017, compared to 60 in the same period last year. Revenue from equipment sales was €30.0 million, up 20% compared to 2016.

Recurring revenues grew 25% to €7.1 million. They include €6.0 million maintenance revenue and €1.2 million revenue of consumables and services. Recurring revenues in 2017 represented 19% of total sales, compared to 18% of total sales in 2016.

  • Full Year 2017 Sales by Geography: strong momentum in priority markets
In millions of euros 2017 2016 Change (%)
EMEA 16,6 11.4 +45%
North America 14.6 15.4 -5%
Asia-Pacific 5.9 3.2 +83%
Latin America 0.8 na
Total revenue 37.1 30.8 +21%
Non audited data

In 2017, EOS imaging’s sales in Europe, Middle East and Africa grew 45% to €16.6 million and accounted for 45% of the Company’s sales, compared to 37% in 2016.

Following the reorganization and strengthening of the second and third quarters, North America resumed 40% growth in the last quarter, in line with the growth observed in 2016. North America sales in USD increased by 53% in the fourth quarter. For the whole year, sales amounts to €14.6 million and represent 39% of total sales, compared with 50% in 2016.

Asia Pacific sales grew 83% to €5.9 million, notably due to the China and Australia markets.

There was no sale in Latin America, which was not a priority area of exploration. Excluding Latin America, full year revenue increased 24% and fourth quarter revenue increased 32% (35% at constant exchange rate).

  • Quarterly Sales by Product Line
In millions of euros 2017 2016
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Equipment sales 5.5 7.7 6.7 10.1

4.1

7.4

5.5

8.1
Growth versus n-1 -1 34% 4% 23% 24%

% of total revenue 77% 82% 83% 83%
Sales of maintenance contracts 1.4 1.4 1.5 1.7

1.0

1.2

0.9

1.5
Growth versus n-1 -1 41% 16% 53% 10%

% of total revenue 20% 15% 17% 14%
Sales of consumables and services 0.3 0.2 0.3 0.4

0.2

0.2

0.2

0.4
Growth versus n-1 -1 9% 3% 33% 17%

% of total revenue 4% 3% 3% 3%
Total sales 7.1 9.3 8.5 12.2

5.3

8.8

6.6

10.0
Growth versus n-1 -1 34% 6% 28% 22%

Non audited data

EOS imaging sold 26 systems and recorded revenue of €12.2 million in the fourth quarter of 2017.

  • Amendment of the Company Financing Agreement with IPF

In order to secure and accelerate sales growth in 2018, EOS imaging entered into an amendment with International Personal Finance (IPF) to modify the terms of its ongoing financing agreement. As part of the amendment, the amortization of the first three tranches is suspended from December 2017 until June 2019 and the last repayment is deferred from December 2020 to June 2022. In addition, a new tranche of €5.0 million can be subscribed by the end of June 2018 with amortization between December 2021 and December 2022 (60% bullet) under conditions comparable to those of the previous tranche and no additional warrant issuance.

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

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

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

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan and the European Union (EC). The Group posted 2017 sales of €37.1 million and employs 152 people at December 2017. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Next press release: 2017 Results and Q1 Sales, April 11, 2018 (after market close)

Contacts

EOS imaging
Pierre Schwich
CFO
Tél : +33 (0)1 55 25 61 24
investors@eos-imaging.com
or
The Ruth Group (US)
Press Relations / Joanna Zimmerman
(O) 646.536.7006
jzimmerman@theruthgroup.com

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1-3.jpg

New Robotic Spine Surgery: Get Better, Faster

Posted On January 17, 2018 By OrthoSpineNews In Robotics /  

BALTIMORE, Jan. 17, 2018 /PRNewswire/ — Surgeons at The Johns Hopkins Hospital have for the first time used a real-time, image-guided robot to insert screws into a patient’s spine, alleviating her from severe pain and improving her mobility.

“People get excited when they realize that there are new potential interventions and strategies to help them get better, faster,” says Nicholas Theodore, M.D., professor of neurosurgery at the Johns Hopkins University School of Medicine and director of the Neurosurgical Spine Center of Johns Hopkins Medicine. “We are really excited to be able to offer this to our patients.”

The first patient to go through this new procedure had a spine injury from a fall at home. She agreed to the new robotic surgery, in part, because it aims to be 100 percent accurate.

Current image-guided surgical procedures require the surgeon to look back and forth between the patient and an image, which causes imperfection of screw placement. While oftentimes these placements are “good enough,” it wasn’t good enough for Theodore, who invented the robot and maintains a financial interest in the technology.

This new robot “marries” a CT scan of the patient with the actual patient, allowing the surgeon to point to a spot on the CT scan and tell the robot to aim for that same spot. Connected to a camera, which itself reads landmarks on the patient, the robot is able to process what the camera “sees” with the CT image in real time. The biggest fear in this type of procedure is movement—what if the patient breathes or otherwise moves slightly—but this robot can sense changes in position and adjust accordingly.

After the surgery “I felt better right away. It was amazing,” said the patient in a video testimonial.

Spine surgery is used to treat conditions that include degenerative disease, spine tumors and trauma. According to a 2015 study, traffic accidents and falls are the leading cause of spinal injuries in the United Arab Emirates.

Theodore will be a featured speaker during the Pediatrics and Orthopaedics conferences at Arab Health, in Dubai, and is available for in person interviews on Sunday, January 28th.

Media contact: Alsy Acevedo rel=”nofollow”>aaceved5@jhmi.edu, +1 410-446-1750.

Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is an $8 billion integrated global health enterprise and one of the leading academic health care systems in the United States. JHM unites physicians and scientists of the Johns Hopkins University School of Medicine with the organizations, health professionals and facilities of The Johns Hopkins Hospital and Health System. JHM’s vision, “Together, we will deliver the promise of medicine,” is supported by its mission to improve the health of the community and the world by setting the standard of excellence in medical education, research and clinical care. Diverse and inclusive, JHM educates medical students, scientists, health care professionals and the public; conducts biomedical research; and provides patient-centered medicine to prevent, diagnose and treat human illness. JHM operates six academic and community hospitals, four suburban health care and surgery centers, and 40 primary and specialty care outpatient sites under the umbrella of Johns Hopkins Community Physicians. JHM extends health care into the community and globally through Johns Hopkins Home Care Group, Johns Hopkins Medicine International and Johns Hopkins HealthCare. The Johns Hopkins Hospital, opened in 1889, has been ranked #1 in the nation by U.S. News & World Report for 22 years of the survey’s 28-year history. For more information about Johns Hopkins Medicine; its research, education and clinical programs; and for the latest health, science and research news, visit www.hopkinsmedicine.org.

Photo – https://mma.prnewswire.com/media/628191/Johns_Hopkins_Medicine_Nicholas_Theodore_Surgery.jpg

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