Stamford Health Names New Chair Of Orthopedic Surgery Department

By John Haffey – March 21, 2017

STAMFORD, Conn. — Dr. Charles “Chip” Cornell has been named chair of the newly created Department of Orthopedic Surgery at Stamford Health, effective March 1. As department chair, Cornell will be responsible for the direction of all orthopedic services, including subspecialty divisions and HSS Orthopedics at Stamford Health.

The hospital’s new collaboration with Hospital for Special Surgery was announced last month.

“We are proud to have someone of Dr. Cornell’s recognized leadership and surgical expertise join Stamford Health as we expand orthopedic services,” said Dr. Sharon Kiely, senior vice president of Medical Affairs and chief medical officer at Stamford Health. “This follows the announcement of our collaboration with Hospital for Special Surgery and complements our vision of further developing leading specialty services in orthopedics.”

Throughout his career, Cornell has studied the outcome of total knee replacement as treatment for osteoarthritis of the knee. His current research interests include investigating novel approaches to pain management following total knee replacement surgery as well as analysis of the benefit of implementing Clinical Pathways for total knee replacement. He is also collaborating on a study investigating the effect of pre-operative synovitis in patients with osteoarthritis of the knee and its effect on range of motion and stiffness following this procedure.

Cornell is professor of Clinical Orthopedic Surgery at Weill Cornell Medical College and an attending orthopedic surgeon at Hospital for Special Surgery. He served as clinical director of orthopedics for HSS beginning in 2006, and holds the Dr. Richard Laskin, chair in Orthopedic Surgery since 2011. Cornell has been active in the Resident and Medical School program throughout his career and recognized for his dedication to education, receiving the Philip Wilson Teaching Award three times.

To learn more about the new HSS Orthopedics at Stamford Health, click here.

SpineGuard Reports Full-Year 2016 Financial Results

March 23, 2017


SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices designed to make spine surgery safer, reported today its full-year 2016 financial results as approved by the Board of Directors on March 23, 2017.

€ thousands – IFRS Audited Dec 31, 2016 Dec 31, 2015
Revenue 7 463 6 346
Gross margin 6 354 5 365
Gross margin (% of revenue) 85,1 % 84,5 %
Sales, distribution & marketing 6 643 6 514
Administrative costs 2 049 1 968
Research & Development 1 295 857
Operating profit / (loss) -3 633 -3 974
Financial Result -545 96
Net profit / (loss) -4 178 -3 878

Pierre Jérôme, CEO and co-founder of SpineGuard, said: “2016 saw SpineGuard’s sales momentum continue and showed the great potential of our DSG™ technology platform. Our commercial organization keeps delivering double-digit growth via our PediGuard family of smart drilling probes, which we expanded with the successful launch of the PediGuard Threaded. At the same time, our R&D investments for the integration of the DSG technology into implantable devices such as pedicle screws has begun to bear fruit with first surgeries in Europe and FDA clearance early in 2017. The US is a key market for SpineGuard where we keep growing significantly year after year. Our focus on operating expenses also allowed the company to improve its operating result. We will continue to pursue this path as one of our corporate objectives for 2017.”

Operating income improves by 9%

In 2016, SpineGuard reported full-year revenue of €7,463k compared with €6,346k for 2015, an 18% increase both on reported basis and cc. 8,603 PediGuard units were sold compared with 7,449 in 2015, including 4,948 in the United States.

The gross margin improved by nearly €1M and 60 bps at 85.1% compared with the prior year of 84.5%, and remains strong. The improvement year-on-year is the result of a combined stability of average selling prices and more favorable country mix with an improved performance on manufacturing cost despite headwinds on currency vs. prior year.

Operating costs increased by €648k (+7%); mainly due to R&D expenses related to the clearance of both PediGuard Threaded and the DSG™ screw (€438k).

With the combination of an improved gross margin and the control of operating expenses, the operating result improved by +€340 k (or +9%) vs. prior year.

The Company reported a net loss of €4,178k for the full-year 2016 compared with a loss of €3,878k for the full-year 2015, impacted by the increase of financial costs related to lower Fx gains of €114k and an increase of interest on loans by €439k.

Working capital was €955k compared with €-65k for the full-year 2015. The increase is mainly due to the building of the inventory of the new products prior to their commercial launch (PediGuard Threaded and DSG modules for the screw), the anticipation of purchases with our Singapore-based manufacturing partner and the Fx Euro/dollar unfavorable impact on the manufacturing cost.

At December 31, 2016, cash and cash equivalents were €1,804k compared with €3,229k at December 31, 2015. The Company has the possibility under certain conditions to draw a €1.5M tranche of debt with IPF Partners.

2016: Excellent sales momentum and strategic objectives achieved

Sales; marketing and regulatory:

2016 was a year of significant breakthroughs in the United States:

  • Contracts with important hospital systems were either signed or consolidated;
  • A partnership agreement with OrthoPediatrics for the exclusive commercialization of PediGuard® in pediatric hospitals was signed;
  • A commercial agreement with Spartan, which is dedicated to veteran and military institutions;
  • The expansion to 36 spine teaching institutions using DSG-enabled devices in their curriculum;
  • A number of non-stocking distributors growing from 77 to 80;
  • The sales team was reinforced with the hiring of a Sr. Sales Manager for the South region and by repositioning a product specialist in the Northeast region;
  • FDA clearance of the PediGuard Threaded was received in June 2016, with a product launch in October 2016 at the North American Spine Society (NASS) congress.

In the rest of the world, the Company focused on procuring extensive training and marketing support to the network of distributors making significant progress in various markets:

  • PediGuard now used in 50% of the French spine teaching institutions (CHU);
  • more than 800 PediGuard units sold in Saudi Arabia through a tender;
  • over 70 surgeons participated to the PediGuard Threaded workshop at EuroSpine congress in Berlin in October 2016.


Eleven surgeons presented their experience with PediGuard in international scientific conventions and five new clinical studies were initiated:

  • 2 prospective mono-centric studies for the use of PediGuard in minimally invasive surgery in France and United Arab Emirates;
  • 1 retrospective mono-centric study for the PediGuard use in so-called bi-cortical techniques in the US;
  • 1 prospective randomized and mono-centric study comparing PediGuard to navigation in the US;
  • 1 study on specimen about the use of the DSG™ screw with Zavation in the US.

2017 perspectives:

After the FDA clearance in the US early 2017 for the DSG™ screw, SpineGuard intends to:

  • Foster adoption of the DSG™ technology through sustained efforts towards surgeons, distributors, teaching institutions and industrial partners;
  • Sign new deals to expand the commercial penetration of the DSG™-enabled screws;
  • Enlarge the scope of the DSG™ platform to other applications such as Bone Quality Measurement (BQM), combination with robotic, licensing agreements for non-spine (trauma, maxillo facial);
  • Continue to grow sales and improve its operating result.

Next financial press release: First Quarter 2017 revenue, on April 6, 2017.

About SpineGuard®

Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 50,000 surgical procedures have been performed worldwide with DSG enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit

For further information, visit


The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.


Pierre Jérôme
Chief Executive Officer
Tel: +33 (0)1 45 18 45 19
Manuel Lanfossi
Chief Financial Officer
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
Ronald Trahan, APR, Ronald Trahan Associates Inc.
+1-508-359-4005, x108

Centrexion Therapeutics to Present Data on CNTX-4975 from the Treatment of Knee Osteoarthritis Pain at IX SIMPAR-ISURA

March 23, 2017

BOSTON–(BUSINESS WIRE)–Centrexion Therapeutics, a company focused on advancing the treatment of chronic pain with one of the largest exclusively pain-focused pipelines of non-opioid therapies in active development, today announced it will present 12-week data from TRIUMPH, a Phase 2b clinical trial of CNTX-4975 for the treatment of moderate to severe knee pain associated with osteoarthritis, at the IX SIMPAR-ISURA (Study in Multidisciplinary Pain Research – International Symposium of Ultrasound for Regional Anesthesia and Pain Medicine) meeting taking place March 29 – April 1, 2017 in Florence, Italy.

Full abstracts are available online at Details of the poster presentation are listed below. Additional data from the TRIUMPH study will be presented at medical meetings later this year.

Abstract Title (#41): CNTX-4975 Administration in Subjects With Knee Pain Associated With Osteoarthritis: 12-Week Results of a Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study
Poster Viewing: Noon CET, March 30 – 4:00 p.m. CET, April 1, 2017
Poster Discussion: 4:00 – 4:30 p.m. CET, March 31, 2017
Location: Florence Congress Palace

About CNTX-4975

CNTX-4975 is based on Centrexion’s proprietary STRATI® technology (Synthetic TRans cApsaicin ulTra-pure Injection), a highly potent, ultrapure, synthetic form of trans-capsaicin (a medicine traditionally derived from the chili plant). CNTX-4975 is designed to be injected directly into the site of pain to provide rapid onset, large reduction and long duration of relief from moderate to severe pain without affecting touch sensibility or position sense.

CNTX-4975 works by selectively targeting the capsaicin receptor (TRPV1) to rapidly inactivate only the local pain fibers transmitting signals to the brain. With a short half-life, STRATI® is cleared from the body within 24 hours. This approach provides pain relief that can last for months until the ends of the local pain fibers regenerate, while maintaining normal sensation, such as touch, pressure and position, and without the risks of toxicities of NSAIDs and injected corticosteroids or the side effects, including abuse and addiction, associated with opioid treatments.

About Centrexion Therapeutics

Centrexion Therapeutics, Corp. is focused on advancing the treatment of chronic moderate to severe pain with one of the largest exclusively pain-focused pipelines of non-opioid, non-addictive therapies in active development. Centrexion Therapeutics recognizes the needs of over a quarter of a billion people living with chronic pain worldwide, and aims to develop new, safer and more effective therapies that overcome the limitations and challenges associated with current pain treatments. Founded by world-renowned leaders in drug development and well-funded by key investors, Centrexion Therapeutics is building a pain treatment powerhouse to address the substantial and growing global chronic pain epidemic. Centrexion Therapeutics has recently relocated from Baltimore, Md. to Boston, Mass.

For more information about Centrexion, visit


Pure Communications, Inc.
Julie Normart, +1-415-946-1087

Proposed US FDA User Fee Increase would Impact Smaller Medical Device Firms the Most

March 20, 2017 by


  • The Trump Administration has proposed user fee increases for drug, medical device and other FDA registrants in 2018.
  • Few specifics on the proposed increases make it difficult to determine exactly how medical device firms would be impacted.
  • Smaller manufacturers make up the vast majority of the US medical device industry, and would be most substantially affected by higher FDA fees.

US Food and Drug Administration user fee increases in the Trump Administration’s proposed 2018 federal budget would disproportionately impact smaller medical device companies, as these firms make up the majority of the US medical device industry.

President Trump’s recently released budget blueprint for 2018 would adjust FDA user fees for 2018 to more than $2 billion, “approximately $1 billion over the 2017 annualized…level, and replaces the need for new budget authority to cover pre-market review costs.” These increases would be offset by administrative initiatives to boost regulatory efficiencies and speed up market authorization timeframes, according to the text of the proposed budget.



Bergen County, New Jersey, Doctor Charged With Taking Bribes

Dept. Of Justice U.S. Attorney’s Office, District of New Jersey – March 8, 2017

NEWARK, N.J. – A family doctor practicing in Bergen County, New Jersey, was charged today with accepting bribes in exchange for test referrals as part of a long-running and elaborate scheme operated by Biodiagnostic Laboratory Services LLC (BLS), of Parsippany, New Jersey, its president and numerous associates, U.S. Attorney Paul J. Fishman announced.

Bernard Greenspan, 78, of Saddlebrook, New Jersey, was indicted by a federal grand jury in Newark. The 10-count indictment charges Greenspan with one count of conspiring to commit violations of the Anti-Kickback Statute, the Federal Travel Act and wire fraud; three substantive violations of the Anti-Kickback Statute; three substantive violations of the Federal Travel Act; and three substantive violations of wire fraud. Greenspan will be arraigned at a later date.

“The charges contained in the indictment allege an extremely lucrative pattern of soliciting and accepting illegal payments for referrals to a specific testing lab,” said U.S. Attorney Fishman. “This indictment is part of our continued commitment to prosecute those physicians who sought to enrich themselves through their involvement in the BLS bribery scheme.”

“The FBI, in conjunction with our law enforcement partners, the U.S. Department of Health and Human Services’ Office of Inspector General, the Internal Revenue Service, and the U.S. Postal Inspection Service, will continue to investigate allegations of fraud and kickback schemes that undermine the integrity of our health care system,” stated Acting Special Agent in Charge Andrew Campi. “We urge anyone aware of this type of illegal activity to contact the FBI.”

“This indictment is another reminder that kickbacks in connection with federal health care programs are illegal and unacceptable,” said Scott J. Lampert, Special Agent in Charge, Office of Inspector General, U.S. Department of Health and Human Services. “Taking such payments subverts the notion that patients should come before profits.”



Medtronic Announces Pricing of $2 Billion of Senior Notes

DUBLIN – March 21, 2017 – Medtronic plc (MDT) announced today that its wholly-owned subsidiary, Medtronic Global Holdings S.C.A. (“Medtronic Luxco”), has priced an offering of $1,000,000,000 principal amount of 1.700 percent senior notes due 2019 and $850,000,000 principal amount of 3.350 percent senior notes due 2027 (collectively, the “notes”). All of Medtronic Luxco`s obligations under the notes will be fully and unconditionally guaranteed by Medtronic plc and Medtronic, Inc., a wholly-owned indirect subsidiary of Medtronic Luxco, on a senior unsecured basis.

Medtronic also announced today that, concurrently with the offering by Medtronic Luxco, Medtronic, Inc. has priced an offering of $150,000,000 in principal amount of its 4.625 percent Senior Notes due 2045 (the “reopening notes”). The reopening notes will be a further issuance of, and will form a single series with, the $4,000,000,000 principal amount of Medtronic, Inc.`s currently outstanding 4.625 percent Senior Notes due 2045, and will be fully and unconditionally guaranteed by Medtronic Luxco and Medtronic plc on a senior unsecured basis. The offerings of the notes and the reopening notes are each being conducted pursuant to an effective registration statement under the Securities Act of 1933, as amended (the “Securities Act”).

The net proceeds of the offerings will be used for general corporate purposes. The offerings are expected to close on March 28, 2017, subject to customary closing conditions.

The joint book-running managers for the offerings are Citigroup Global Markets Inc., Goldman, Sachs & Co., Morgan Stanley & Co. LLC and Wells Fargo Securities, LLC. The co-managers for the offerings are BNP Paribas Securities Corp., Deutsche Bank Securities Inc., HSBC Securities (USA) Inc. and Mizuho Securities USA Inc.

The offerings of the notes and the reopening notes may be made only by means of a prospectus and prospectus supplement. You may get these documents for free by visiting EDGAR on the Securities and Exchange Commission (“SEC”) website at Alternatively, copies of the prospectus and prospectus supplement for each offering may be obtained from 20 On Hatch, Lower Hatch Street Dublin 2, Ireland, or by contacting Citigroup Global Markets Inc., toll-free at +1-800-831-9146, Goldman, Sachs & Co., toll-free at +1-866-471-2526 or Morgan Stanley & Co. LLC, toll-free at +1-866-718-1649.

About Medtronic
Medtronic plc, headquartered in Dublin, Ireland, is among the world`s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Forward-Looking Statements
This press release may be deemed to contain forward-looking statements regarding future events and the company`s future results that are subject to the safe harbor created under Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act and the Securities Exchange Act of 1934. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including but without limitation, statements relating to the offerings of the notes and the reopening notes and the use of proceeds therefrom, and the expected closing date of the offering of the notes and the reopening notes.

You should pay particular attention to the important risk factors and cautionary statements referenced in the “Risk Factors” section of the prospectuses related to the offerings referenced above, as well as the risk factors and cautionary statements described in Medtronic plc`s filings with the SEC, including the risk factors contained in each of Medtronic plc`s most recent Quarterly Reports on Form 10-Q and Annual Report on Form 10-K. Medtronic plc does not undertake to update its forward-looking statements.

Fernando Vivanco
Public Relations

Ryan Weispfenning
Investor Relations

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medtronic plc via GlobeNewswire

Global Spine Biologics Market Expected to Reach $2,214 Million by 2022 – Allied Market Research

PORTLAND, Oregon and PUNE, India, March 22, 2017 /PRNewswire/ —

Global spine biologics market was valued at $1,644 million in 2015, and is projected to reach $2,214 million by 2022, growing at a CAGR of 4.3% during the forecast period 2014-2022, according to a new report published by Allied Market Research.

Spine biologics are used during spine fusion surgery for the treatment of spinal deformities such as trauma, tumors, degenerative disc disease, and spinal cord injuries by stimulating bone growth formation through inflammatory stage, repair stage, and remodeling stage. Therefore, surge in the number of spinal fusion surgeries have fueled the adoption of biologics.

Get access to detailed report at:

The market is driven by factors such as increase in geriatric population and advantages of biologics such as minimal postoperative time, faster recovery, and ability to activate cellular growth. However, unfavorable reimbursement scenario, higher cost of bone grafts, and ethical issues related to bone grafting procedures hamper the market growth.

The bone graft substitutes segment generated the highest revenue in the global market, accounting for more than half of the total spine biologics market. In addition, the cell-based matrices segment is projected to grow rapidly, registering a CAGR of 5.9% during the forecast period.

According to Deepa Tatkare, Senior Analyst, Healthcare Research, Allied Market Research, “The emergence of biologic materials is one of the recent developments of spine fusion surgery. Earlier, autografts were considered as the ideal primary bone graft. However, allograft evolved as a better treatment option, owing to various associated complications such as pain, infection, and weakened bone. Thus, the use of biologics in spine surgeries is expected to witness higher demand in the future because of the constant development of new products.


  • The demineralized bone matrix segment is expected to grow at a CAGR of 3.4%, owing to its ability to stimulate bone formation.
  • Synthetic bone grafts segment accounted for more than half of the global bone graft substitutes market in 2015.
  • North America contributed two-thirds share of the global spine biologics market in 2015.
  • France and Germany jointly accounted for more than one-third share of the European spine biologics market in 2015.
  • Japan is the major shareholder in the Asia-Pacific spine biologics market, accounting for more than one-third share in 2015.

North America is expected to maintain its dominance throughout the forecast period. However, Asia-Pacific region is projected to grow rapidly during the forecast period, registering a CAGR of 5.3%. Improving healthcare infrastructure and increase in expenditures in the emerging markets, such as India and China, to cater to the unmet medical needs in these countries have bolstered the market growth.

The key players in the spine biologics market are focused on expanding their business operations in the fast-growing economies with new product launches as the preferred strategy. The major companies profiled in the report include Alphatec Holdings, Inc., Depuy Synthes (Johnson & Johnson), Exactech, Inc., Globus Medical, Inc., Medtronic plc, NuVasive, Inc., Orthofix International N.V., RTI Surgical, Inc., SeaSpine, and Zimmer Biomet Holdings, Inc.

Read more about this research into the Medical Devices market:

About Us:

Allied Market Research (AMR) is a full-service market research and business-consulting wing of Allied Analytics LLP based in Portland, Oregon. Allied Market Research provides global enterprises as well as medium and small businesses with unmatched quality of “Market Research Reports” and “Business Intelligence Solutions”. AMR has a targeted view to provide business insights and consulting to assist its clients to make strategic business decisions and achieve sustainable growth in their respective market domain.

We are in professional corporate relations with various companies and this helps us in digging out market data that helps us generate accurate research data tables and confirms utmost accuracy in our market forecasting. Each and every data presented in the reports published by us is extracted through primary interviews with top officials from leading companies of domain concerned. Our secondary data procurement methodology includes deep online and offline research and discussion with knowledgeable professionals and analysts in the industry.

Rahul Thakur
5933 NE Win Sivers Drive
#205, Portland, OR 97220
United States
Direct: +1-503-894-6022
Toll Free: +1 (800) 792-5285 (U.S. & Canada)
Fax: +1 (855) 550-5975



SOURCE Allied Market Research

2016: A Historic Year for VEXIM

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News:

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces its consolidated annual results (IFRS1) as of December 31st, 20162.

« Our 2016 results represent a historic turning point for VEXIM. VEXIM has reached profitability and generated a positive cash flow over the second half of 2016. These excellent results validate our profitable growth strategy. This trend should continue during 2017, as we expect sales growth of 30% to 35%, and full-year profitability. We expect to launch SpineJack® in the United States – the largest market for vertebral fractures – in 2018, further generating strong sales growth. We will decide and announce our business strategy for the US, aimed at capturing market share and building shareholder value, later this year. These achievements demonstrate that VEXIM is on the right track to become a global leader in the market of spine trauma », said Vincent Gardès, CEO of VEXIM.

Strong sales increase, solid gross margin on sales and positive net income in the second half of 2016

For the first time, and in order to comply with international standards, VEXIM issues its consolidated financial statements, in accordance with International Financial Reporting Standards (IFRS). Appendixes, on page 9 of this press release, include the conversion tables from French accounting standards to IFRS for the consolidated income statements of the financial years 2015 and 2016.

IFRS consolidated statement
(in millions of Euros)

As of December 31st Variation First Half Second Half
2016 2015 2016 2016
Revenue 18.5 13.9 33% 8.6 9.9
Gross margin 13.4 9.9 35% 6.3 7.1
Gross margin (% of sales) 72.2% 71.5% 73.8% 70.9%
Operating expenses -16.5 -14.7 12% -9.2 -7.4
Operating loss -3.2 -4.8 -33% -2.9 -0.3
Income tax & finance costs, net 0.5 0.1 0.4
Profit / (loss) for the period -2.7 -4.8 -44% -2.8 0.1

2016 highlights

  • New sales record in the 4th quarter, at €5.2 million;
  • Finalized patient enrollment for the international clinical trial intended to support our 510(k) submission to the FDA – announced on February 21st, 2017;
  • Initiated a medico-economic study comparing the SpineJack® to conservative orthopedic management (bracing) on 100 patients with a 1 and 2-year follow-up;
  • Secured long-term cash position, thanks to a successful private placement of €10.4 million in January 2016;
  • Strengthened our management team with the appointments of François Cathelineau as VP Operations, Sébastien Lemoine as VP International Sales & Market Development, followed by the appointment of Russell Powers as VP & General Manager of the US activities, in January 2017.

€18.5 million in sales: VEXIM continues to expand at a steady pace (+33%)

VEXIM’s sales for 2016 have reached €18.5 million, an increase of 33% compared to 2015. This significant growth underlines the effectiveness of the direct sales strategy implemented by the company for SpineJack® in Europe, as well as the broader adoption of the technology.

The gross margin on sales (“gross margin”) also increased by 35% compared to 2015, reaching €13.4 million (€6.3 million in the first half of 2016), representing 72.2% of sales.

The gross margin maintained itself at a high percentage due to growing sales in Europe and competitive pricing, with the support of our direct-sales strategy. The 70.9% gross margin on sales in the second half of 2016 is explained by growing sales performance in countries with indirect distribution.

Impact of gross margin and cost control: strongly reducing annual losses and generating net profit in the second half of 2016

The second half of 2016 marked a historic turning point for VEXIM, which proved its ability to achieve profitable growth and financial discipline.

Operating expenses only increased by 12% in 2016, up to €16.5 million, while sales grew 33% over the same period. Such control of operating costs contributed to further decrease the operating losses, from €4.8 million loss in 2015 to €3.2 million loss to in 2016. The net loss recorded in 2016, which includes income tax and finance costs of €0.5 million, is €2.7 million compared to €4.8 million in 2015.

For the first time since its creation in 2006, VEXIM recorded a net profit of €0.1 million in the second half of 2016. This major step is the result of the strategy followed over the past two years by VEXIM, with the aim of self-financing:

  • Gained market shares in France and abroad, to drive further revenue growth;
  • Used its technological advance to support competitive pricing and a high gross margin;
  • Drew on productivity gains and effective cost control to maintain the beneficiary’s capacity and generate cash.

Positive cash flows in the second half of the year (+€0.3 million)

As of December 31st, 2016, the Group’s cash position stood at €9.8 million (vs. €9.4 million as of June 30th, 2016), boosted by a free cash flow of €0.3 million in the second half of the year. The current cash position and future cash flows should allow VEXIM to self-finance, in line with its ambitions. VEXIM plans to generate a positive free cash flow from operations over the full year in 2017.

2017 objectives: Perspectives for a strong and profitable growth

Despite an increasingly demanding “baseline” VEXIM aims to keep achieving significant sales growth in 2017, combined with full-year profitability:

  • Expected strong sales growth of +30% to +35%;
  • Achieve profitability on a full-year basis;
  • FDA 510(k) filing in the United States during the last quarter, for an expected market launch in the first half of 2018;
  • Continue to expand abroad with new partnerships in Brazil, Australia and South Korea;
  • Keep on innovating in the treatment of vertebral fractures, by developing new products to extend the current portfolio.

To support VEXIM’s accelerated development, the Board of Directors has approved a “technical”3 project to transfer VEXIM’s listing from Alternext to the regulated market of Euronext Paris.

Financial reporting schedule:
1st quarter sales: April 19th, 20174

About VEXIM, the innovative back microsurgery specialist

Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital5, and from OSEO public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 66 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on NYSE Alternext Paris since May 3rd 2012. For further information, please visit

SpineJack®6, an innovative implant for treating Vertebral Compression Fractures

The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

Code ISIN : FR0011072602
Code mnémonique : ALVXM

1 The results have been audited and approved by the Board of Directors of Vexim on March 21st, 2017.
2 Consolidated financial statements presented in Appendix.
3 Transfer of listing with no capital raising.
4 Indicative date, subject to changes.
5 Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit and
6 This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.


IFRS consolidated financial statements

Consolidated income statements

In thousands of Euros Year ended December 31,
2015 2016
Revenue 13 888 18 504
Cost of sales (3 956) (5 143)
Gross profit 9 932 13 361
Selling and marketing expenses (8 470) (8 744)
Operations expenses (2 839) (3 041)
General and administrative expenses (3 916) (5 165)
Other gains / (losses), net 465 426
Operating loss (4 828) (3 163)
Finance income / (loss), net 2 (28)
Loss before income tax (4 826) (3 191)
Income tax expense (43) 468
Loss for the year (4 869) (2 723)
Attributable to:
Equity holders of the Company (4 869) (2 723)
Earnings per share attributable to the equity holders of the Company
Basic earnings per share (0,77) (0,36)
Diluted earnings per share (0,77) (0,36)

Consolidated balance sheet – assets

As at December 31,
In thousands of Euros 2014 2015 2016
Intangible assets 765 1 029 2 229
Property and equipment 733 935 1 382
Other receivables 231 218 171
Deferred tax assets 522
Non-current assets 1 730 2 182 4 304
Inventories 2 344 3 650 3 675
Trade receivables 2 560 3 606 4 670
Other receivables 1 336 1 829 2 255
Cash and cash equivalents 10 115 4 208 9 765
Current assets 16 355 13 293 20 365
Total assets 18 085 15 474 24 669

Consolidated balance sheet (equity and liabilities)

As at December 31,
In thousands of Euros 2014 2015 2016
Ordinary shares 634 635 762
Share premium 51 027 51 185 61 109
Other reserves (10) 423 1 204
Retained earnings (37 788) (42 658) (45 383)
Equity attributable to equity holders of the Company 13 863 9 585 17 693
Non-controlling interests
Total equity 13 863 9 585 17 693
Repayable advances 867 712 427
Retirement benefit obligations 113 148 111
Non-current liabilities 981 860 538
Repayable advances 106 210 314
Trade payables 1 385 2 586 2 365
Other payables 1 750 2 159 3 541
Provisions for other liabilities and charges 73 218
Current liabilities 3 241 5 029 6 438
Total liabilities 4 222 5 889 6 976
Total equity and liabilities 18 085 15 474 24 669

Consolidated cash-flow statement

In thousands of Euros 6-month period ended
2015 2016 June 30, 2016 December 31, 2016
Net income / (loss) (4 869) (2 723) (2 806) 83
Adjustments for:
Depreciation of tangible assets and amortization of intangible assets 168 289 136 153
Impairment of receivables (12) 74 83 (9)
Impairment of inventories (64) 121 20 101
Share-based payments 438 698 277 421
Change in retirement benefit obligation 35 55 27 28
Variation in provisions for risks 73 145 167 (22)
Income tax 43 (468) 35 (503)
Cash generated by / (used) in operations before changes in working capital (4 188) (1 809) (2 061) 252
Changes in working capital
Inventories (1 242) (147) (12) (135)
Trade receivables (1 033) (1 139) (693) (446)
Other receivables (492) (380) (436) 56
Trade payables 1 201 (221) (518) 297
Other payables 510 1 369 158 1 211
Cash generated by / (used) in changes in working capital (1 056) (518) (1 501) 983
Net cash generated by / (used) in operating activities (5 244) (2 327) (3 562) 1 235
Cash flows from investing activities
Purchases of tangible assets (384) (763) (595) (168)
Purchases of intangible assets (286) (1 164) (443) (721)
Disposal of assets 16
Net cash used in investing activities (654) (1 928) (1 038) (890)
Cash flows from financing activities
Proceeds from issuance of ordinary shares 158 10 472 10 453 19
Direct costs paid related to share issuance (421) (421)
Repayable advance (106) (210) (210)
Treasury shares (83) (55) (55)
Net cash generated by / (used) in financing activities (31) 9 786 9 822 (36)
Net increase / (decrease) in cash and cash equivalents (5 929) 5 531 5 222 309
Cash and cash equivalents at beginning of the year/ period 10 115 4 208 4 208 9 419
Effect of exchange rate fluctuations 22 26 (12) 38
Cash, cash equivalents at end of the year/ period 4 208 9 765 9 419 9 765

Conversion tables from French accounting standards to IFRS

In thousand Euros 2015
French GAAP
under IAS / IFRS


R&D projects


Others 2015
(1) (2) (3) (4)
Revenue 13 888 13 888
Cost of sales (3 956) (21) (3 977)
Gross profit 9 932 (21) 9 911
Selling and marketing expenses (8 316) (154) (8 470)
Operations expenses (2 788) (32) (18) (2 839)
General and administrative expenses (3 659) (252) (20) 21 (3 909)
Other gains / (losses), net 480 480
Operating loss (4 351) (438) (18) (20) (4 828)
Finance income / (loss), net 2 2
Loss before income tax (4 349) (438) (18) (20) (4 826)
Income tax expense (43) (43)
Loss for the year (4 392) (438) (18) (20) (4 869)
Attributable to:
Equity holders of the Company (4 392) (438) (18) (20) (4 869)
In thousand Euros

French GAAP
under IAS / IFRS


R&D projects




(1) (2) (3) (4)
Revenue 18 504 18 504
Cost of sales (5 099) (44) (5 143)
Gross profit 13 405 (44) 13 361
Selling and marketing expenses (8 452) (293) (8 744)
Operations expenses (2 985) (56) (3 041)
General and administrative expenses (4 768) (349) (91) 44 (5 165)
Other gains / (losses), net 426 426
Operating loss (2 374) (698) (91) (3 163)
Finance income / (loss), net (28) (28)
Loss before income tax (2 402) (698) (91) (3 191)
Income tax expense 468 468
Loss for the year (1 934) (698) (91) (2 723)
Attributable to:
Equity holders of the Company (1 934) (698) (91) (2 723)
In thousand Euros First half 2016
French GAAP
under IAS / IFRS


R&D projects



First half 2016

(1) (2) (3) (4)
Revenue 8 564 8 564
Cost of sales (2 226) (21) (2 246)
Gross profit 6 338 (21) 6 318
Selling and marketing expenses (4 787) (140) (4 927)
Operations expenses (1 604) (15) (1 619)
General and administrative expenses (2 772) (122) 21 (2 873)
Other gains / (losses), net 249 249
Operating loss (2 574) (277) (2 851)
Finance income / (loss), net 82 82
Loss before income tax (2 493) (277) (2 770)
Income tax expense (36) (36)
Loss for the year (2 529) (277) (2 806)
Attributable to:
Equity holders of the Company (2 529) (277) (2 806)

(1) Share-based payments valued in accordance with IFRS 2 and relative to BSA and BSPCE plans. Expense allocated to each department based on the employees’ affiliation.

(2) Restatement of year 2015, regarding a project which, activated according to the French accounting standards in the previous years, does not meet all 6 criteria of IAS 38.57, namely of how the intangible fixed asset will generate probable future economic benefits.

(3) Recalculated pension liabilities as of December 31st, 2015, to reveal actuarial gains pursuant to IAS 19.

(4) Reclassifications: depreciation on production equipment, namely mould manufacturing initially recorded under “General and administration costs”, which have been reclassified under “Cost of goods sold”.


Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
Tel.: +33 5 61 48 48 38
Caroline Carmagnol / Wendy Rigal
Tel.: +33 1 44 54 36 66
Tel.: +33 6 48 82 18 94

HSS: Shortened KOOS is Valid

Elizabeth Hofheinz, M.P.H., M.Ed. • Wed, March 22nd, 2017

It’s a no-brainer…anyone would prefer to answer 7 survey questions as opposed to 42. Hurray for the researchers from Hospital for Special Surgery (HSS) in New York, who have confirmed that a seven-question patient survey on pain, function and quality of life is a valid and efficient tool for assessing patient outcomes following revision total knee replacement (TKR).

According to the March 14, 2017 news release, “The previous commonly used knee replacement survey was 42 questions often leaving physicians with partial, unusable information. The shorter survey, known as KOOS JR. (Knee Injury and Osteoarthritis Outcome Score), and its hip replacement counterpart, HOOS JR., have already been adopted for Medicare’s primary total joint replacement bundled payment program. HSS’ research presented at AAOS now provides peer-reviewed data that confirms KOOS JR. is a valid outcomes measure for knee replacement surgery.”

“At HSS, we are continually improving how we measure outcomes and KOOS JR. is a direct result of these efforts,” said Alexander McLawhorn, M.D., M.B.A., an orthopedic surgeon at HSS. “We saw a need for a shorter, more patient friendly survey in an area where outcomes data are essential to improving quality of care. In fact, knee replacement revisions, which are more complex than primary knee surgery, are under-studied in this regard.”



Dr. Price Brakes Bundled Payments Expansion

Walter Eisner • Tue, March 21st, 2017

Our orthopedic surgeon and Health and Human Services Secretary, Tom Price, M.D., has said he is no fan of bundled payments.

After just taking office in February, he’s already putting on the brakes to the payment model with the March 20, 2017 announcement that the expansion of hip and knee replacement bundled payment programs (Comprehensive Care for Joint Replacement – CJR) from the Centers for Medicare and Medicaid Services’ (CMS) Innovation Center will be delayed.

Last fall, then Congressman Price, said in a letter to the Obama administration that CMS had overstepped its authority, upsetting the balance between the executive and legislative branches and failing to engage stakeholders when creating the programs. He also wrote, “these mandatory models overhaul major payment systems, commandeer clinical decisionmaking and dramatically alter the delivery of care.”

According to a March 20 notice in the Federal Register, the CJR program was scheduled to expand on the 20th, but those expansions will now be delayed until May 20, 2017 to “allow time for additional review, to ensure that the agency has adequate time to undertake notice and comment [on] rulemaking to modify the policy if policy modifications are warranted,” and to make sure its participants understand the rules and how to comply with them.