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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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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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Molecular Matrix, Inc. Receives a 510K Clearance for its Revolutionary Bone Graft Substitute Technology, Osteo-P™

Posted On January 17, 2018 By OrthoSpineNews In Regulatory /  

SACRAMENTO, CALIF. (PRWEB) JANUARY 17, 2018

Molecular Matrix, Inc (MMI) today announced the FDA clearance (510k) of Osteo-P™, a value-driven, effective musculoskeletal solution for bone regeneration.

The Osteo-P™ bone graft substitute is a non-mineralized, synthetic bone void filler made of a hyper-crosslinked carbohydrate polymer (HCCP). It is highly porous, biocompatible, biodegradable, and has shown exceptional capabilities of bone repair.

The polymer technology offers several advantages over current bone graft substitutes, including exceptional bone formation and implant resorption, real-time fusion monitoring, and the ability to hold a suture.

Based on proprietary research, Osteo-P™ is intended for the filling of bone defects created surgically or through traumatic injury. When placed or gently packed into bone voids, Osteo-P™ supports and guides the ingrowth of new bone across the graft site, after which it is resorbed and replaced by newly formed bone during the healing process.

“Osteo-P™ provides an optimal microenvironment for infiltration of bone precursors such as osteoblasts that have been known to play a key role in bone regeneration,” says Molecular Matrix founder and CEO Charles Lee, PhD. “This microenvironment includes a significant surface area that allows the flow of fluids and metabolites, leading to the formation of healthy bone.”

The product is available in large pore granules, sheets, cubes, wedges and cylinders offering greater application, flexibility, and excellent handling characteristics. Additionally, customized products are routinely manufactured for collaborative research projects and may be useful for complex anatomic defects.

“The compressibility and tensile strength of Osteo-P™ allows the scaffold to be gently packed in to fill a void.” says Kee D. Kim, MD, Professor of Neurological Surgery and Co-Director of the University of California Davis Health, Spine Center. “The degradation profile, in conjunction with host bone regeneration, results in the formation of the patient’s own healthy bone.”

Osteo-P™ is intended for single patient use only, and is provided in a one-time use, with double sterile packaging. It is not indicated for use as a structural support in load bearing applications. The technology is delivered in a ready to use sterile package, and stores at room temperature. Additionally, Osteo-P™ is not subject to degradation through hydrolysis, making shipping logistics more convenient.

“The Osteo-P™ bone void filler provides cutting edge technology for our sales channels, offering significant advantages over other bone void fillers in the market today. In addition, this technology platform ensures Molecular Matrix will continue to develop this technology for multiple other tissue regeneration initiatives and other specific clinical applications” states Jim Keefer, COO of Molecular Matrix. “We are all very excited about our future, and expect significant market penetration over the coming months and years.”

Molecular Matrix’s HCCP technology provides a broad platform for tissue engineering in the orthopedic disciplines. Its HCCP has been shown to be effective for bone regeneration, evidenced by bone precursor cell activities. The technology will bring advancements in orthopedics, spine, trauma, and dental applications with superior bone regeneration products.

About Molecular Matrix

MMI has assembled a strong management team and Board of Directors (BOD) and believes that the quality and experience of the group is a critical factor to the success of the Company. MMI’s management team and BOD have over 75 years of experience in research and development, spine and biologics, and commercialization of new technologies.

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Catalyst OrthoScience Strengthens Its Board of Directors with The Addition of Greg Rainey

Posted On January 17, 2018 By OrthoSpineNews In Extremities, Top Stories /  

NAPLES, Fla., Jan. 16, 2018 /PRNewswire/ — Catalyst OrthoScience, Inc., a cutting-edge medical device company focused on the upper extremity orthopedics market, today announced the addition of Greg Rainey to its Board of Directors.

Mr. Rainey brings over forty years of experience to the Catalyst OrthoScience Board. Mr. Rainey’s career has been in sales management and business development, serving a cross section of the healthcare industry including orthopedics, medical supplies and equipment, and biologics. Mr. Rainey is the founder and principal of CCI Performance Group, an executive consulting firm designed to deliver sustainable business solutions for both leading Fortune 500 healthcare companies and early-stage medical device ventures. Most recently, he served on the Board of Directors for RTI Surgical (RTIX), and currently sits on the Board of CAS Medical (CASM). Mr. Rainey’s experience includes Stryker Corporation where he served as Vice President of Sales for the Orthopedic Division. Prior to Stryker, Mr. Rainey held sales leadership positions Joint Medical Corporation and U.S. Surgical Corporation.  Mr. Rainey received his undergraduate degree in Biology from Loyola University.

“We are privileged to have Greg join our board at such an important time in our company’s history.  Greg’s successful track record in orthopedics is critical to us as we expand the market presence of our disruptive, stemless shoulder replacement technology. We look forward to his contributions,” said Bob Kaufman, Chairman and Chief Executive Officer of Catalyst OrthoScience.

The Catalyst CSR™ Total Shoulder System provides consistently reproducible shoulder joint restoration with a canal-sparing humeral implant that is smaller, more anatomically-shaped, and less invasive than traditional shoulder replacement

Catalyst OrthoScience was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D. saw the need to make shoulder replacement surgery less invasive and give patients a more normal feeling shoulder after surgery.

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, the Catalyst CSR™ Total Shoulder System, represents the next evolution in stemless total shoulder arthroplasty. 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, patented glenoid instrumentation for a less invasive approach that preserves the natural anatomy and removes less of the patient’s bone.  The Catalyst CSR™ System is optimal for use in both the inpatient and outpatient settings and was cleared for use by the FDA in 2016.

Catalyst OrthoScience’s products are marketed under a variety 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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Safe Orthopaedics Reports Strong Growth of 37% in Its 2017 Adjusted Revenues

Posted On January 16, 2018 By OrthoSpineNews In Financial /  

January 15, 2018

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company specialized in the design and marketing of single-use implants and instruments facilitating the minimally invasive treatment of spinal fracture conditions, is today announcing its revenues for the fourth quarter of 2017 and for the financial year ended to December 31, 2017, together with its cash position at December 31, 2017.

“In 2017, we successfully continued our commercial realignment to focus on both the fastest-growing regions, such as France and Germany, and on the most promising technologies, such as the minimally invasive treatment of spinal fractures”, said Pierre Dumouchel, Chief Executive Officer and co-founder of Safe Orthopaedics. “Our adjusted1 revenues recorded strong growth of 37%, while the steady pace of additions to our sales and marketing teams, which now account for 45% of our headcount, continues to pay off handsomely. Following on recent recruitments, we expect to maintain this strong growth momentum during 2018, as well as launching new technologies to provide even safer treatment options for vertebral fractures.”

in thousands of euros

2017
(12 months)

2016
(12 months)

 Change
France 1,582 1,182 +34%
Rest of the world (excluding United States) 1,528 1,083 +41%

Total adjusted1 revenues

 3,110 2,265 +37%
United States (discontinued operations) 0 100 n/a
Total revenues 3,110 2,365 +32%
in thousands of euros

Q4 2017
(3 months)

Q4 2016
(3 months)

 Change
France 443 327 +36%
Rest of the world (excluding United States) 336 313 +7%
Total revenues 780 640 +22%

Adjusted revenues1 in the financial year to December 31, 2017 came to €3,110 K, representing a strong increase of 37% compared to the previous year.

The robust top-line growth continued in France, with sales totaling €1,582 K versus €1,182 K in 2016. That represents an increase of 34% over the full year and of 36% in the fourth quarter of 2017. In the second half of 2017, Safe Orthopaedics hired two new sales representatives, who will have a positive impact on business in 2018.

Sales in the Rest of the world (excluding United States) continued to grow, with the top line advancing 41% to €1,527 K in 2017. High growth was mainly generated by longstanding distributors and rapid expansion in Latin America. Following very strong revenue growth in the third quarter, orders were affected by a minor catch-up effect in the fourth quarter due to a business contraction in the Middle East. As a result, Safe Orthopaedics decided together with its distributor to respond by introducing fresh commercial initiatives to revitalize sales in the region in 2018. During the fourth quarter of 2017, Safe Orthopaedics also hired a 25year experience sales manager covering export markets.

Safe Orthopaedics expanded into Germany during 2017, and the company intends to extend its French in selling its products on this territory. A team of sales Director and two sales representatives was hired to develop business in Germany. Their knowledge of the local market and their long experience in the spinal surgery sector will be valuable assets for its development. Safe Orthopaedics also attended the DWG German Spine Congress, during which the company presented its innovative product ranges and comforted its position on the German market.

Safe Orthopaedics reinforced its marketing team and implemented a European action plan. Plan will be mostly focused on boosting sales support and provide surgeons with a number of training courses to treat vertebral fractures.

Cash position

At December 31, 2017, Safe Orthopaedics had €3,725 thousands in available cash, compared with €3,664 thousands at December 31, 2016. Its cash position was strengthened by the successful completion in June 2017 of a €5.8 million rights issue. The capital it raised gave Safe Orthopaedics the requisite additional resources to bolster its French and international sales teams and to convince surgeons of the benefits of single-use instruments in each market segment.

Next report:

  • Full-year 2017 results on Monday, April 30, 2018 (before the market opening)
  • First-quarter 2018 revenues: Monday, May 14, 2018 (after the market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that offers the safest technologies to treat spinal fracture. Delivered sterile, all implants and respective disposable instrumentation are available to the surgeon at any time, any place. These technologies enable minimally invasive approaches, reducing risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpine™ Kits are CE marked and FDA cleared. The company is based at Eragny-Sur-Oise (France), and has 34 employees.
For more information, visit: www.SafeOrtho.com

1 Revenues adjusted for operations discontinued in the United States since March 1, 2016

Contacts

Contacts
Safe Orthopaedics
François-Henri Reynaud, Tél.: +33 (0)1 34 21 50 00
CFO
investors@safeorthopaedics.com
or
NewCap
Julien Perez / Valentine Brouchot
Investor Relations
or
Nicolas Merigeau, Tél.: +33 (0)1 44 71 94 94
Media Relations
SafeOrtho@newcap.eu

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SPINEWAY : 1st complex surgery performed in the USA with Spineway’s MIS implants

Posted On January 16, 2018 By OrthoSpineNews In Spine /  

Ecully, 15 January 2018

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), announces that the Texas Back Institute (TBI), a group of US hospitals specializing in neck and back pain, performed the first operation addressing scoliosis via minimally invasive surgery using the Group’s MONT-BLANC MIS implants.

This complex operation was successfully performed by Dr. Theodore Belanger at the Texas Health Presbyterian Hospital and positions Spineway as an innovative player in the treatment of scoliosis. Indeed, very few laboratories in the world offer solutions adapted to deforming conditions such as scoliosis with a minimally invasive approach.

Prior to this implant, Texas Back Institute performed a series of fifteen surgeries with Spineway’s MONT-BLANC MIS implants de Spineway on patients with degenerative conditions.

With 40 years’ experience, TBI is currently one of the biggest top-level multidisciplinary university centers in the US. With 9 medical centers and over 20 surgeons throughout the state of Texas, TBI is well-known and has cutting-edge expertise in the treatment of back conditions.

Theodore Belanger, Orthopedic Spine and Scoliosis Surgeon at TBI, said the following about this partnership: “I feel there is great promise in the innovative thinking at the core of Spineway, and I look forward to a strong working relationship between the company and the Texas Back Institute over the coming years!”

Building on this major step forward, Spineway will continue its expansion in the United States and confirms a sharp increase in its revenue for the 2017 financial year.

This press release is available in both English and French. In case of discrepancy, the French version shall prevail.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME

Find out all about Spineway at www.spineway.com

Next communication: 
2017 annual revenue – 17 January 2018, after market closes

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), received the OSEO Excellence award as well as the Deloitte Fast 50 award in 2011. Rhône Alpes INPI Patent Innovation Award (2013) – Talent INPI award (2015). 
ISIN code: FR0011398874 – Euronext Growth

Contacts:              

Investor Relations
David Siegrist – Finance Director
+33 (0)4 72 77 01 52
finance.dsg@spineway.com		 Financial Communication
Jérôme Gacoin / Solène Kennis
+33 (0)1 75 77 54 68
skennis@aelium.fr

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/8ad5a411-2b11-4b70-882a-c93aa16f26e9

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Regenexx Publishes New Research Findings That May Help Alleviate the Opioid Crisis

Posted On January 16, 2018 By OrthoSpineNews In Biologics /  

January 16, 2018

BROOMFIELD, Colo.–(BUSINESS WIRE)–A significant number of opioid deaths worldwide involve patients who become addicted to prescription narcotics due to severe low back pain. Regenexx, a physician-run medical network and pioneer in the invention of orthopedic stem cell injections, has today released new research that examines a more effective alternative for treating lower back pain to bypass the harmful effects of opioids and high dose steroids. The study, led by Regenexx founder and world-renowned leader for interventional orthopedics, Christopher J. Centeno, MD, was recently published in the 2017 Journal of Experimental Orthopedics, titled, “The Use of Lumbar Epidural Injection of Platelet Lysate for Treatment of Radicular Pain.”

Epidural steroid injections have been a mainstay of lower back treatment for decades, but the fact that they often fail to manage pain long-term has led many patients to seek relief through high dose and addictive narcotics. “Despite being the most common non-surgical procedure for sciatica and lower back pain performed in the U.S., there is limited evidence of the efficacy of epidural steroid injections (ESI),” said Christopher J. Centeno, MD, CMO of Regenexx. “Additionally, some evidence suggests that high dose use of corticosteroids may have significant side effects.”

The research’s methodology included a registry-based, case series evaluating the use of platelet lysate epidural injections for the treatment of lumbar radicular pain as an alternative to corticosteroids. Backed by MRI findings that were consistent with symptoms, 470 participants were treated with epidural injections presenting with symptoms of lumbar radicular pain (also known as sciatica). Collected outcomes included numeric pain score, functional rating index, and a modified single assessment numeric evaluation rating.

“The main advantage of platelet lysate is that it’s anabolic rather than catabolic,” said Dr. Centeno. “This means that it has growth factors that can help things heal rather than high-dose steroids that can destroy tissue by killing cells. Platelet lysate also has anti-inflammatory cytokines, like A2M, IRAP, and TIMPs.”

Following treatment with platelet lysate, patients reported significant improvements in pain and subjective improvement through their 2-year follow-up. Notably, the regenerative platelet lysate injections produced relief for longer periods than usually seen with epidural steroid injections. These findings are very encouraging to physicians who treat lower back pain, as they are now actively seeking ways to help patients without turning to narcotics.

The research team consisted of Christopher Centeno, Jason Markle, Ehren Dodson, Ian Stemper, Matter Hyzy, Christopher Williams and Michael Freeman. The full study can be found online at the Journal of Orthopedics.

About Regenexx and the Regenexx Physician Network
The Regenexx® Procedures are the nation’s most advanced non-surgical stem cell and blood platelet treatments for common joint injuries and degenerative joint conditions, such as osteoarthritis and avascular necrosis. These stem cell procedures utilize a patient’s own stem cells or blood platelets to help heal damaged tissues, tendons, ligaments, cartilage, spinal disc, or bone.

For more information on Regenexx, please visit: http://www.regenexx.com

Contacts

Regenexx
Susannah Spruill, 720-577-5409
regenexx@matternow.com

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EIT Emerging Implant Technology announces first FDA multilevel approval for their 3D printed cervical cage

Posted On January 16, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

TUTTLINGEN, GERMANY (PRWEB) JANUARY 16, 2018

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative 3D printed titanium implants for spinal applications today announced the U.S. Food and Drug Administration (FDA) clearance of the expansion of the label of their EIT Cellular Titanium® Cervical Cage to be used in multiple contiguous cervical levels (C2 to T1).

EIT Cellular Titanium® is a 3D printed porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimize cell proliferation and bone ingrowth. The anatomical design of the EIT cervical cage assists the surgical and biomechanical challenges of cervical multi-level fusion by adapted to maximized vertebral endplate contact and sagittal balance restoration.

The fusion potential of the implants is supported by EIT’s proprietary 3D process including post-printing etching procedures, allowing for unique porous structures that are impossible to manufacture with traditional manufacturing techniques. “This is another important regulatory milestone for EIT,” said Guntmar Eisen, Founder and CEO of EIT. “Only very few cervical cages are approved for multilevel use and we are poised to quickly enter the US market with the most advanced technology and state of the art FDA labeling and compliance.”

This marks the first multi-level 3D printed cervical cage to enter the US market. The EIT cervical cage is to be used with supplemental fixation and designed for use with autogenous and/or allogenic bone graft to facilitate fusion. Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), assisted EIT on the FDA strategy and submission. Justin Eggleton, Senior Director of Regulatory Affairs commented “this clearance represents continued synergy between FDA and the medical community. The expanded indications to multiple levels in the cervical spine facilitates improved surgeon collaboration and the ability to collect data that will strengthen the total product lifecycle, which ultimately benefits patients.”

The company’s plans to complete the current product portfolio with a lateral lumbar cage in Q2 and a fully printed lateral expanding cage in Q4. For more information about the EIT 3D platform, visit http://www.eit-spine.de

About EIT

EIT is the first medical device manufacturer to exclusively focus on spinal implants, that are designed according to latest science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014. Implants and Instruments are made in Germany.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 15.000 EIT cases have been performed in over 15 markets globally. EIT has started to launch its products in the US in Q4 of 2017.

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