SpineGuard Reports Six-Month 2016 Financial Results

September 14, 2016

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–SpineGuard (FR0011464452 – ALSGD), an innovative company that designs, develops, and markets disposable medical devices intended to make spine surgery safer, announced today financial results for the half year ending June 30, 2016, as approved by the Board of Directors on September 13, 2016.

Pierre Jérôme, CEO of SpineGuard, said: “We are very pleased with these results for the first half of 2016. The combination of sustained strong growth in sales with good operating cost control allowed us to invest further in the deployment of our Dynamic Surgical Guidance platform. At the same time, we improved our operating results. In a market constantly seeking innovation and better clinical outcomes, SpineGuard continues to demonstrate the great medico-economic value of its DSG™ technology, unique in its ability to enable surgeons to make spine surgeries safer.”

€ thousands – IFRS H1 2016 H1 2015
Revenue 3,633 2,970
Gross margin 3,105 2,557
Gross margin (% of revenue) 85,5% 86,1%
Sales, distribution, marketing -3,477 -3,098
Administrative costs -1,076 -1,146
Research & Development -764 -646
Operating profit / (loss) -2 ,212 -2,332
Pre-tax profit / (loss) -2,472 -2,180
Net profit / (loss) -2,472 -2,180

NB : unaudited

Sales growth and reduced operating loss

For H1 2016, the Company reported revenue of €3,633k, up 22% (cc) compared with H1 2015.

Revenue in the United States increased 26% (26% cc) to €2,866k in the first half of 2016, compared with €2,274k in the first half of 2015. In the rest of the world, revenue increased 10% during the first half of 2016 to €767k compared with €696k in the first half of 2015.

4,351 PediGuard units were sold in the first half of 2016 compared with 3,716 in the first half of 2015, including 2,441 in the United States, representing 56% of total units sold.

Gross margin of 85.5% at June 30, 2016, compared with the prior year of 86.1% and remains solid. The change mainly reflects the lower ASP with the US stocking distributors but this is offset by the absence of sales commissions. Excluding stock distributors, ASP remained flat in the US while ASP was down 4% OUS due to a different country mix compared to the same period of 2015.

Operating expenses were €5,318k compared with €4,890k for H1 2015, an increase of €428k compared with June 30, 2015. This increase is due to the agents’ commissions proportioned to sales, to the hires made in sales R&D, to the gathering of the scientific advisory board in the first half of 2016 and to the accrual of variable compensation in line with the performance of the company.

Working capital requirements were €728k compared with € -65k at December 31, 2015. This continues to illustrate the relatively low operating cash needs of the Company and the efficient management of its financial resources. It should also be noted that the Company; i) sourced several raw materials and finished products in order to cover manufacturing requirements for the entire product line, and ii) is impacted by longer payment terms agreed upon for the Saudi tender that are secured by letters of credit, of which €105k was paid on July 25, as anticipated.

At June 30, 2016, cash and cash equivalents were €3,257k compared with €3,229k at December 31, 2015, and is explained as follows:

  • The operating cash flow of €(2,732)k compared with the same period last year of €(1,943)k.
  • The payment of interests to IPF Partners of €145k and to Bpifrance of €22k.
  • The on-going repayment of the BPI Innovation loan, of €63k.
  • The second draw of the IPF Partners bonds for a gross amount of €1,500k.
  • The Innovation loan received from Bpifrance for a gross amount of €1,500k.

The Company also has access to the following financing:
a) Tranche C of the loan with IPF Partners for an amount of 1,500 K€ by December 31, 2016 with the condition of attaining a 12-month rolling revenue threshold;
b) An equity line (Paceo) in place since 2014 for a maximum number of 265,000 shares.

The Company’s workforce count is 28 at H1 2016, compared with 26 at the end of December 2015.

Recent events and outlook:

The half-year revenue for 2016 is encouraging and follows the excellent performance of 2015. PediGuard® Threaded, which was launched in May at the international SpineWeek congress and cleared by the US FDA mid-June, has started to contribute to revenue growth, confirming the excellent feedback received by the surgeons who performed the first cases.

The commercial launch of the PediGuard® Threaded in the USA will occur at the NASS (North American Spine Society) annual conference at the end of October in Boston. Prior to NASS, the DSG™ screw will be presented in a symposium at the European congress for spine surgery (Eurospine), and its US-FDA clearance is progressing well with the company planning to file the 510k in the third quarter of 2016.

Next financial press release: 2016 third quarter revenue, October 12, 2016.

SpineGuard will participate at the Large & Midcap Event 2016 on October 5 and 6 in Paris.

SpineGuard will participate at Actionaria on November 18 and 19 in Paris.

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 47,000 surgical procedures have been performed worldwide with PediGuard. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. In 2015, SpineGuard started to expand the applications of DSG into pedicle screws through partnerships with innovative surgical companies in France and the US. SpineGuard has offices in San Francisco and Paris.

For further information, visit www.spineguard.com.

Disclaimer

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.

Contacts

SpineGuard
Pierre Jérôme, +33 (0)1 45 18 45 19
Chief Executive Officer
p.jerome@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent, +33 (0)1 44 71 94 94
spineguard@newcap.fr
or
US
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

Orthopaedic Surgeons to Use HipGrid Drone at the ICJR 2016 5th Annual Direct Anterior Approach Hip Course

SALT LAKE CITY, Sept. 14, 2016 /PRNewswire/ — This September 22-24, the International Congress for Joint Reconstruction (ICJR) will hold its 5th Annual Direct Anterior Hip Course for orthopaedic surgeons in Houston, TX. OrthoGrid Systems, Inc.’s (Salt Lake City, UT) will be in attendance at the meeting for the fourth year in a row.

OrthoGrid’s presence at the meeting has grown over the past four years. Richard Boddington, OrthoGrid CEO says, “We thank ICJR for the opportunity to showcase the efficacy of our HipGrid technology for direct anterior total hip arthroplasty. We’re thrilled to offer orthopaedic surgeons a simple, elegant solution to ease the learning curve of an already challenging procedure.”

OrthoGrid’s mix of innovative culture, emphasis on research and development, and technological advances provides a high level of ease, efficiency, and accuracy to orthopaedic surgical procedures such as total hip replacement (THR). “We look forward to meeting the surgeons attending this year’s ICJR Direct Anterior Hip Course and making their learning experience even more valuable with HipGrid,” says Mr. Boddington.

Direct anterior total hip arthroplasty (THA) has been gaining in popularity amongst surgeons and patients, as it is less invasive than standard, posterior approach total hip arthroplasty. With HipGrid, surgeons can quickly and effectively assess anatomic alignment and implant positioning in real time in the operating room using fluoroscopy and make necessary adjustments to optimize the surgical outcomes.

HipGrid’s effectiveness has been demonstrated in peer-reviewed and ongoing direct anterior THA clinical studies, which show improved acetabular cup angle, leg length, and hip offset outcomes and decreased mean surgical time with HipGrid compared to without.

“We have a unique product that marries seamlessly with the other tools required to successfully implement a direct anterior approach program, and we look forward to making it available to as many surgeons as possible who are interested in improving and standardizing their fluoroscopic technique without breaking the bank,” says Edouard Saget, OrthoGrid president.

To learn more about OrthoGrid and HipGrid Drone technology, visit OrthoGrid.com.

About OrthoGrid Systems, Inc.

OrthoGrid Systems, Inc. is a privately owned medical device company based in Salt Lake City, Utah.  Its focus is inventing more accurate and cost-effective ways to assist in proper positioning of implants and restoration of leg length when performing total hip replacement (THR). OrthoGrid supplies a growing portfolio of patented and patent-pending technologies related to intraoperative alignment using radiopaque grid patterns for orthopedic total joint arthroplasty and trauma.  Please visit company website for more information: www.OrthoGrid.com.

OrthoGrid® Systems, Inc.
Media Contact: Tonya Trest, VP of Sales and Marketing
Email
Phone: 801-703-5866
Source: OrthoGrid Systems, Inc.

SOURCE OrthoGrid Systems, Inc.

Related Links

http://www.orthogrid.com

IMPLANET: Successful First Surgical Procedures with the New Jazz Lock® Implant

September 14, 2016

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

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces the successful results of the first surgical procedures using the Jazz Lock®.

Having obtained CE marking and 510K clearance, Jazz Lock has been used in select hospitals in France, Italy and the United States. Initial positive results in over 25 cases strengthen Implanet’s intention to carry out the wide-scale international launch of Jazz Lock by the end of the year.

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 activity in a spine market estimated to be worth over $200 million worldwide1. 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.

Doctor Vincent Cunin, Deputy Chief of Service in the Spine Surgery department at Hospices Civils de Lyon (HCL), says: “As a spine surgeon, I have been using band implants for the last four years to correct spine deformities, with excellent post-operative clinical results. Jazz Lock’s arrival as part of the Implanet band range is a major breakthrough. This new implant’s ease of use during the first surgical procedures in Lyon, as well as the very encouraging initial post-operative clinical results, validate our choice. We will now follow these patients to confirm the long term results. In my opinion, Jazz Lock will quickly become an indispensable spine implant to surgeons across the globe.

Ludovic Lastennet, CEO of Implanet, adds: “As announced following the regulatory clearance, Jazz Lock® is the first component of an innovative range of band products designed for degenerative spine disorders that will rapidly be launched in accordance with our business plan. The positive results obtained in the first surgical procedures illustrate this implant’s potential for patients and surgeons alike. Jazz Lock® further expands the breadth of our product offering, with its launch is scheduled for upcoming major spine congresses: Eurospine in Berlin in early October and NASS in Boston (USA) in late October.

Next financial press release: results for the 1st half of 2016, on September 22, 2016, after market.

Upcoming congresses and conferences:

  • SRS in Prague, September 21 to 24, 2016
  • ICCC in São Paulo, September 30 to October 1, 2016
  • EUROSPINE in Berlin, October 6 to 8, 2016
  • NASS in Boston, October 26 to 28, 2016
  • SOFCOT in Paris, November 8 to 11, 2016

Reminder of recent press releases:

  • Green light for a new implant: Jazz Lock®, April 2016
  • Q1 2016 revenues: Strong increase in U.S. JAZZ sales: +106%, April 2016
  • Launch of the new Jazz Claw® implant, May 2016
  • Q2 2016 record revenue of €2.1 million with Spine sales growing by +68%, July 2016

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 2015 sales of €6.7 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 Compartment C of the Euronext™ regulated market in Paris.

1 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
Florent Alba
Tel. : +33 (0)1 44 71 94 94
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

Stryker announces definitive agreement to acquire the assets of Instratek

MAHWAH, N.J., USA, Sept. 14, 2016 /PRNewswire/ — Stryker announced today a definitive agreement to acquire the assets of Restore Surgical LLC, d/b/a Instratek.

Founded in 1991, Instratek is a privately held business headquartered in Houston, Texas. Instratek offers a portfolio of staple and hammertoe implants and minimally invasive soft tissue recession instrumentation for foot, ankle and upper extremity procedures.

“This acquisition supports our commitment to growth in extremities with products that complement our existing portfolio, strengthen our leadership in the forefoot segment and provide immediate access into minimally invasive soft tissue recession procedures,” said David Floyd, Group President, Orthopaedics.

The transaction is expected to close in the fourth quarter of 2016 and is subject to customary closing conditions.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

Media contact
Jeanine Guilfoyle
Stryker Orthopaedics
201-831-6277
jeanine.guilfoyle@stryker.com

Logo – http://photos.prnewswire.com/prnh/20140106/PH40722LOGO

SOURCE Stryker

Related Links

http://www.stryker.com

Got knee pain? X-rays: the first, and best screening tool in diagnosing knee pain among middle-aged patients

A study in the Journal of the American Academy of Orthopaedic Surgeons investigates
ROSEMONT, Ill. (September 9, 2016)—Knee pain is common among Americans age 40 and up. Nearly 1 in 17 people visit doctors’ offices each year for knee pain or injuries from osteoarthritis—a progressive “wear and tear” disease of the joints. Those odds increase as the U.S. population continues to age and becomes even more overweight. While a magnetic resonance imaging (MRI) is one tool that can help doctors diagnose torn knee ligaments and cartilage and other problems, plain X-rays are the best first line screening tools for knee pain.

According to a study in the September issue of the Journal of American Academy of Orthopaedic Surgeons (JAAOS), a simple X-ray is frequently the best diagnostic tool, reducing both time and cost.

Whether a patient will need surgery for knee problems depends on how much arthritis he or she has. “If an X-ray shows that a person has significant arthritis, the MRI findings—like a meniscus tear—are less important because the amount of arthritis often dictates the treatment. Therefore, patients should always get a standing X-ray before getting an MRI to screen for knee pain in patients older than 40,” says Muyibat Adelani, MD, an orthopaedic surgeon with Washington University’s Department of Orthopedics and lead author of this study.

The study looked at 100 MRIs of knees from patients age 40 and up and found that:

  • The most common diagnoses are osteoarthritis (39 percent), and meniscal tears (29 percent)—the tearing of the wedge-shaped pieces of cartilage in the knee joint;
  • Nearly 1 of 4 MRIs was taken prior to the patient’s first having obtained a weight-bearing X-ray; and,
  • Only half of those MRIs obtained prior to meeting with an orthopaedic surgeon actually contributed to a patient’s diagnosis and treatment for osteoarthritis.

“Patients should always get weight-bearing X-rays before getting an MRI because MRIs are not always needed to diagnose knee problems,” says Dr. Adelani. In cases where arthritis is suspected, weight-bearing X-rays often are more than enough for orthopaedists to complete the diagnosis and treatment plan. An appropriately timed consultation with an orthopaedic surgeon can be more cost effective than first obtaining MRI scans.

More information about the AAOS
Follow the AAOS on Facebook, Twitter, and #JAAOS

Disclosures: From the Department of Orthopedics, Washington University, St. Louis, Mo. (Dr. Adelani, Dr. Brophy, Dr. Halstead, Dr. Smith, and Dr. Wright) and St. Louis Center for Cartilage Restoration and Repair, St. Louis (Dr. Mall).

Dr. Mall or an immediate family member is a member of a speakers’ bureau or has made paid presentations on behalf of Arthrex. Dr. Brophy or an immediate family member has stock or stock options held in Ostesys, and serves as a board member, owner, officer, or committee member of The American Orthopaedic Association, the American Orthopaedic Society for Sports Medicine, and the Orthopaedic Research Society. Dr. Halstead or an immediate family member serves as a board member, owner, officer, or committee member of the American Medical Society for Sports Medicine. Dr. Smith or an immediate family member is a member of a speakers’ bureau or has made paid presentations on behalf of Arthrex. Dr. Wright or an immediate family member has received research or institutional support from the National Institutes of Health (NIAMS and NICHD) and serves as a board member, owner, officer, or committee member of the American Board of Orthopaedic Surgery, The American Orthopaedic Association, and the American Orthopaedic Society for Sports Medicine. Neither Dr. Adelani nor any immediate family member has received anything of value from or has stock or stock options held in a commercial company or institution related directly or indirectly to the subject of this article.

Contact(s):
Sheryl Cash
phone: 847-384-4032
Kayee Ip
phone: 847-384-4035

 

 

Acelity Announces Pricing of $1,750 Million of 9.625% Second Lien Senior Secured Notes

September 13, 2016

SAN ANTONIO–(BUSINESS WIRE)–Acelity L.P. Inc. (“Acelity”), a global advanced wound care and regenerative medicine company, announced today the pricing of the private offering by its wholly-owned subsidiaries, Kinetic Concepts, Inc. (“KCI”) and KCI USA, Inc. (together with KCI, the “Issuers”), of $1,750.0 million in aggregate principal amount of 9.625% second lien senior secured notes due 2021 (the “Notes”).

The Issuers intend to use the gross proceeds from the Notes offering, together with proceeds of a $100.0 million equity contribution by Acelity’s sponsors (the “Equity Contribution”) and cash on hand (including borrowings under the Issuers’ revolving credit facility), to redeem $1,750.0 million in aggregate principal amount of their outstanding 10.5% second lien senior secured notes due 2018 and to pay the fees and expenses related to such offering, redemption, the Equity Contribution and other financing transactions. The consummation of the Notes offering is conditioned upon the substantially concurrent consummation of the Equity Contribution.

The Notes offering is expected to close on September 20, 2016, subject to customary closing conditions.

The offering of the Notes will be made in a private transaction in reliance upon an exemption from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), only to “qualified institutional buyers” in accordance with Rule 144A under the Securities Act and to non-U.S. persons outside the United States in accordance with Regulation S under the Securities Act.

This press release does not and will not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The Notes and the related note guarantees have not and will not be registered under the Securities Act or any state securities laws, and may not be offered or sold in the United States to, or for the benefit of, U.S. persons except pursuant to an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws.

Forward-Looking Statements

Certain statements included in this press release may be considered “forward-looking statements”, which are based on information available to Acelity on the date of this release. Words such as “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “seek,” “foreseeable,” the negative versions of these words and/or similar terms and phrases are used to identify these forward looking statements. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties. Acelity cannot assure you that future developments affecting Acelity will be those that have been anticipated. Actual results may differ materially from these expectations due to changes in global, regional or local economic, business, competitive, market regulatory and other factors, many of which are beyond Acelity’s control, as well as other risks described from time to time under “Risk Factors” in Acelity’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q (available at www.sec.gov). Any forward-looking statement speaks only as of the date of this press release. Factors or events that could cause Acelity’s actual results to differ may emerge from time to time, and it is not possible to predict all of them. Acelity may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the forward-looking statements. Acelity’s forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions Acelity may make. Acelity undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Contacts

Acelity L.P. Inc.
Corporate Communications:
Cheston Turbyfill, +1-210-515-7757
cheston.turbyfill@acelity.com
or
Investor Relations:
Caleb Moore, +1-210-255-6433
caleb.moore@acelity.com

VEXIM Signs a Distribution Agreement with Creatori Health and Expands Its Market to South Africa

September 13, 2016

TOULOUSE, France–(BUSINESS WIRE)

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / PEA‐PME), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces the signing of a distribution agreement with Creatori Health for the distribution of its portfolio in South Africa.

The South African market, with its 53 million inhabitants, is a promising Spine trauma market with a potential of 20.000 vertebral fractures. This could lead to a market of €40 million, according to our estimates.

VEXIM’s portfolio already gained reimbursement from one of the leading medical health insurance in South Africa, which will benefit to the Creatori Health commercial team.

Creatori Health is a well-known medical device company established in South Africa since 2004 by the current MD, Dr. Jaco Van Der Walt. Supplying leading edge technology has been a core focus of the Company, and after 9 successful years namely in the Neurosurgery field, the company decided to expand its focus to Spine and Neurosurgery in 2014, streamlining the product portfolio to ensure the best possible servicing to their clients. SpineJack® is a natural extension of its current business and a great strategic fit.

“Creatori Health is looking forward to providing the South African medical industry with SpineJack® – a clinically sound device that is not only unique, but will definitely add value as a treatment option to both patients and surgeons. With the support of VEXIM, and the granted reimbursement from a leading funder for medical insurance, we feel positive about the contribution SpineJack® will bring to the medical industry in South Africa”, said Dr WJ Van Der Walt, CEO of Creatori Health.

“Thanks to our preparation activities in this market, and based on the strong clinical literature supporting SpineJack®, reimbursement has already been granted by one leading health insurer. That will for sure benefit to Creatori Health and allow for a fast penetration of the market”, said Vincent Gardès, CEO of VEXIM.

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 Capital1 and from BPI 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 62 employees, including its own sales teams in Europe and a network of international distributors.

VEXIM has been listed on Alternext Paris since May 2012. For further information, please visit www.vexim.com

SpineJack® 2, a revolutionary implant for treating Vertebral Fractures

The revolutionary aspect of the SpineJack® lies in its ability 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, enabling 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 fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spinal surgery and worldwide patent protection through to 2029.

MasterflowTM 2, a high-performance orthopedic cement delivery system

The MasterflowTM is an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure for treating vertebral compression fractures. The device provides a better control of the injection of biomaterials into the spine. A complement of the SpineJack®, the MasterflowTM stands out for being both easy to use and precise, particularly in its ability to stop the cement delivery instantly without inertia. The MasterflowTM contributes to reducing pain in patients. Its first sales were recorded in the U.S. in February 2015, and the system has also received the CE marking in February 2015, a mandatory conformity mark for products marketed in Europe.

Name : VEXIM
ISIN code : FR0011072602
Ticker : ALVXM

1 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 www.truffle.fr and www.fcpi.fr.

2 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.

Contacts

VEXIM
Vincent Gardès, Tél. : +33 5 61 48 48 38
CEO
investisseur@vexim.com
or
PRESS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tél. : +33 1 44 54 36 66
Tél. : +33 6 48 82 18 94
vexim@alizerp.com

New Motion Preserving Wrist Implant hits 1 year Milestone

FRANKLIN, Mass., Sept. 12, 2016 /PRNewswire/ — In May of 2015 the new motion preserving WristMotion™ hemiarthroplasty implant from Arthrosurface, Inc. (www.arthrosurface.com) was launched. The following month, the first patients were treated by the three co-developing surgeons, Dr. Randall Culp, Dr. Joseph Sherrill and Dr. Insok Yi. The WristMotion™ implant system is designed to intraoperatively map the curvature of the patients’ wrist joint and resurface the arthritic bone with a congruent and robust articular surface implant. To date more than 100 procedures have been performed across the US with new surgeons treating more patients every month. The product was launched at the ASSH Hand Meeting in September of 2015 to an overwhelmingly positive response.

There are a variety of conditions that lead to pain and arthritis in the hand joint, many of which are caused by previous trauma or chronic overuse. Historically, when patients developed arthritis in their wrist, several procedures were performed: a PRC (Proximal Row Carpectomy), a 4 corner fusion (4CF) or a joint replacement with implants. The implants either replaced one side (hemi) or both sides of the joint (Total). In the PRC procedure, the arthritic bones in the middle of the hand were removed and a new articulation formed between the remaining bones. In the 4 corner fusion procedure, the arthritic bones were left intact but immobilized so they no longer move against each other. The idea was that once the bones fused together, the pain would go away. Total replacements were performed more commonly than hemi’s and they involved significant bone resection. The WristMotion™ system consists of an anatomic implant to resurface the arthritic capitate bone. The implant creates a new articulating surface and is designed to preserve more bone than other implants, thereby providing patients with an alternative to other treatments.

Dr. Randy Culp said, “The bones in the hand are very uniquely shaped and contribute to the overall mobility of the hand. Whether we fuse or remove the bones for a PRC, we are making a compromise. Now that we can use an implant to reshape the bones to match each other, we have another way to preserve motion.” Follow-up on early patients has shown that the implants are stable, patients are able to return to their previous activities with pain-free motion and many have returned to sports such as golf.

Previously, surgeons promoted fusions or PRC’s over joint replacements. That thinking is starting to change. As Dr. Joseph Sherrill commented, “In spite of initial successful outcomes following PRC or four corner fusions, there is a significant failure rate over time due to progressive radio carpal arthritis. The WristMotion™ implant is an excellent treatment option for these patients who may be considering fusion but would prefer to maintain wrist motion.”

The WristMotion™ system is based on the same time tested principles of other Arthrosurface joint restoration systems. Match the implant to the patient and restore joint congruency using instrumentation that is reproducible and intuitive. “When I saw how well the knee and shoulder patients of my partners functioned when they used Arthrosurface, I thought that we needed something like that for the wrist. As hand surgeons we operate in a small space so instruments and implants need to be streamlined and small. The WristMotion™ system is extremely intuitive and reproducible which makes the procedure reliable and quick,” said Dr. In Sok Yi.

Steven Ek, CEO, Arthrosurface commented, “We are very excited about expanding our joint preserving technology into the hand and wrist. By adding new products to our extremity portfolio, surgeons have more options to treat disabling arthritis with unique and motion preserving solutions. For Arthrosurface, the extremity product line is a key to driver for our growth.”

About Arthrosurface

Arthrosurface, Inc. is a leader in the design and distribution of orthopedic devices for joint preservation, restoration and resurfacing. The HemiCAP® system is a unique, less invasive technology that can be used to treat a wide variety of joint conditions caused by trauma, injury and disease. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world.

Logo –  http://photos.prnewswire.com/prnh/20131118/NE19554LOGO

SOURCE Arthrosurface, Inc.

Related Links

http://arthrosurface.com

Surface Solutions Group to Showcase Medical Device Coating Solutions at MD&M Minneapolis

September 13, 2016

CHICAGO–(BUSINESS WIRE)–Surface Solutions Group, LLC, (SSG) an industry leading automated applicator of coating technologies for the medical device industry, announced today that it will be exhibiting its FluoroBond®-PT process and other coating solutions in Booth #1832 at the Medical Design & Manufacturing Conference & Expo (MD&M) in Minneapolis on September 21-22, 2016.

MD&M Expo attendees are invited to meet with SSG’s team and learn more about FluoroBond®-PT, a revolutionary process that solves PTFE (polytetrafluoroethylene) adhesion problems of PFOA-free (Perfluorooctanoic Acid) coatings in the medical device industry.

“The medical device industry has been experiencing PFOA-free PTFE delamination, primarily on stainless steel guide wires and similar products. The PFOA-free coatings are sensitive to saline, which degrades the hydrophobicity of PTFE, making them vulnerable to electro/chemical attack,” said George Osterhout, President of SSG. “FluoroBond®-PT solves those problems.”

FluoroBond®-PT is a unique environmentally friendly treatment process developed by SSG for stainless steel, nitinol, and other metals that solves the PTFE coating delamination issues experienced in catheterization labs, operating rooms, and doctor’s offices. SSG’s FluoroBond®-PT is used to hyper clean the substrate, and remove free iron and iron oxides from the surface of the substrate, without removing material or changing the dimension of the substrate’s surface. “There has been no delamination in the field on guide wires that were coated with SSG’s unique FluoroBond®-PT process,” stated Osterhout.

About Surface Solutions Group

Surface Solutions Group is dedicated to developing innovative coating solutions for the medical device industry. With over 50 years of coating industry experience, SSG’s coating technologies, extensive automation and state of the art facility provides its customers with consistently applied coatings on medical devices that follow stringent quality processes, and meet its customers’ demanding performance requirements. Its customers include some of the largest names in the medical device industry. To learn more about SSG’s capabilities, visit www.surfacesolutionsgroup.com or call 773-427-2084.

Contacts

Surface Solutions Group, LLC
Mike Osterhout
773-427-2084 x 169
mike@surfacesolutionsgroup.com
or
Custom Direct, Inc.
Patty Martucci
630-529-1936 x 224
martucci@customdirect.com

EOS imaging Announces New Sale into Carolinas HealthCare System

September 13, 2016

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, today announced the sale of an EOS system to the Carolinas HealthCare System. The system will be located at a dedicated imaging center in Carolina HealthCare’s Morehead Medical Plaza campus in Charlotte, NC. It will be available for pediatric and adult patients in the Carolinas HealthCare System, including those served at the Levine Children’s Hospital, which is also located in the Morehead Medical Plaza. The Levine Children’s Hospital was named a Best Children’s Hospital by U.S. News & World Report in orthopedics1.

Carolinas HealthCare System is one of the leading healthcare organizations in the Southeast and one of the most comprehensive systems in the country. The organization includes more than 900 care locations and 7,500 beds throughout North and South Carolina.

Marie Meynadier, CEO of EOS imaging, said, “We are pleased that the unique benefits of the EOS system and services will soon be available to patients in the North and South Carolina area. Adoption by such a prestigious group further validates our technology. In addition, this sale marks the entry into another large hospital network in the U.S., which further expands patient access to the EOS technology and provides incremental growth potential within the hospital network.”

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 orthopedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States, Japan, China, and the European Union. The Group posted 2015 revenues of €21.8 million and employs 122 people. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

1 http://www.carolinashealthcare.org/about-us

Contacts

EOS imaging
Anne Renevot
CFO
+33 (0)1 55 25 61 24
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Valentine Brouchot
+33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
The Ruth Group (US)
Press relations / Joanna Zimmerman
646-536-7006
jzimmerman@theruthgroup.com