Globus Medical (GMED) Announces First Case In Orthopedic Trauma

Posted On September 15, 2017 By OrthoSpineNews In Extremities /

9/15/2017

AUDUBON, Pa., Sept. 14, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced it completed its first orthopedic trauma surgical case. Globus Medical’s new ANTHEM™ Distal Radius Fracture System was used by Dr. Asif Ilyas, Hand Surgeon and Trauma Surgeon with The Rothman Institute at Thomas Jefferson University in Philadelphia PA, to successfully treat a distal radius fracture.

The ANTHEM™ Distal Radius Fracture System is a comprehensive fixation system designed to treat a variety of traumatic wrist fractures with anatomically contoured plates for intraoperative versatility. “This is the first orthopedic trauma surgery performed using a plating system designed, manufactured and sold by Globus Medical,” said Barclay Davis, Vice President, Orthopedic Trauma. “We are very proud to continue Globus’ reputation for innovation, speed to market, and listening to our surgeon customers, by bringing this philosophy to the orthopedic trauma market. This introduction is the culmination of a significant effort between Globus Medical’s outstanding product development team and leading orthopedic trauma surgeons. And there are many more to come.”

The innovative ANTHEM™ plate design allows a clear view of the fracture line for improved diagnosis and care. “This plate features a positioning slot and screw that allows multidirectional fine tuning of plate position to provide surgeons maximum flexibility during surgery. I am impressed by how intuitive the tray and system are and how natural the instrumentation feels. The implant was seamless in its placement and fixation,” said Dr. Asif Ilyas. “Trauma is a large, busy, and complex space. That space is ready for a company like Globus to take our current designs and technology and advance them to the next level.”

Globus Medical is planning to introduce its new orthopedic trauma product line at the Orthopaedic Trauma Association’s 33rd Annual Meeting to be held October 11-14, 2017 in Vancouver, Canada.

Indications
The ANTHEM™ Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. Small fragment and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age).

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact :
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

VEXIM: Strong First Half 2017 Results, in Line with Expectations

Posted On September 15, 2017 By OrthoSpineNews In Financial /

September 14, 2017

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

VEXIM (FR0011072602 – ALVXM / PEA‐PME) (Paris:ALVXM), a medical device company specializing in the minimally-invasive treatment of vertebral fractures, announces its consolidated results for the first half of 2017² in line with guidance³.

“Our sales performance and controlled expenses for the first half of 2017 are in line with our expectations. This trend should be reinforced in the second half of 2017 allowing us to remain confident in reaching profitability for 2017. On the U.S. development, we are excited to announce we will hold an investors meeting at the upcoming 2017 NASS Congress in Orlando where we will share information on our on-going FDA clinical trial comparing SpineJack® to balloon kyphoplasty and also the go-to-market strategy that will support the launch of SpineJack® in the U.S., subject to 510(k) clearance. These various milestones further position our company to become a global leader in the spine-trauma market,” said Vincent Gardès, VEXIM’s CEO.

+21% increase in sales, gross margin of 72.6% and significant net loss reduction

VEXIM’s sales reached €10.4 million in the first half of 2017, up 21% compared to the same period of 2016. This significant revenue growth shows the effectiveness of the direct sales strategy implemented for SpineJack® in Europe, combined with a network of specialized distributors at the international level (see press release on VEXIM’s sales in the first half of 2017⁴).

The gross profit increased 19% compared to the first half of 2016, up to €7.5 million, representing a 72.6% gross margin (as percentage of sales) vs. 73.8% on the same period last year and 72.2% for the full year 2016. Given the implementation of the direct sales strategy, VEXIM maintained a high level of gross margin, in a context of stable prices.

Compared to the 21% increase in revenue, operating expenses decreased 1%, to €9.0 million, compared with the first half of 2016. The effective control of operating expenses resulted in a saving of €1.3 million in the net operating loss, down to €1.5 million. Net loss for the period was €1.6 million.


Consolidated statement as of June 30, 2017

in € millions	First Half 2017	First Half 2016	YoY (%)
Sales	10.4	8.6	21%
Gross profit (gross margin)	7.5 (72.6%)	6.3 (73.8%)	19%
Operating expenses	9.0	9.1	-1%
Net operating income (loss)	-1.5	-2.8	-46%
Net income (loss)	-1.6	-2.8	-43%

Solid cash position at €5.7 million

As of June 30, 2017, VEXIM had €5.7 million in cash, allowing the company to secure its future development. The company’s current cash position and future cash flows should allow VEXIM to continue to grow in-line with its ambitions.

Other business achievements over the first half of 2017

Finalized recruitment of all patients for the FDA study supporting the 510(k) filing for SpineJack® in the U.S.;
Launch of a dedicated and specific product for the German market: Masterflow™ Plus;
Regulatory approval of SpineJack® in Brazil.

Full-year 2017 guidance confirmed

Given the Company’s solid results for the first half of 2017, VEXIM is on track to reach its full-year 2017 objectives:

Maintain strong revenue growth and reach 30% growth over the full year 2017;
Achieve profitability for the full year 2017 and generate operational positive cash-flows;
Further expand internationally through upcoming distribution agreements in Brazil by the end of 2017;
Share information on the on-going 510(k) clinical trial and subsequent go-to-market strategy in the U.S. at the upcoming NASS meeting in Orlando;
Continue innovating in the treatment of high energy vertebral fractures through product development projects, leveraging the SpineJack® platform;
Continue to develop and penetrate the German market;
Regarding the transfer of VEXIM shares to the regulated market of Euronext Paris, which was authorized by the Board of Directors on 21 March 2017, the company is still reviewing all necessary requirements and changes needed to pursue this project. VEXIM aims at completing this review shortly and will complete the transfer by the end of 2017 or beginning of 2018.

Financial reporting schedule:
3^rdquarter sales results: Wednesday, October 25^th, 2017⁵ (after market close)

NASS 2017: Vexim Investor & Analyst Lunch Meeting & Webcast

U.S. FDA clinical trial update and go-to-market strategy

(in English)

Wednesday, October 25^th, 2017 at 12:00 PM ET (Orlando) / 6:00 PM CEST (Paris time)

To join please contact:

For U.S.: The Ruth Group at epoalillo@theruthgroup.com or Tel : +1 646 536 7024

For EU & Intl: Alize RP at vexim@alizerp.com or Tel. : +33 1 44 54 36 66

A replay of the webcast will be available on VEXIM’s website within 48 hours at:

http://www.vexim.com/us/ (U.S. section of the website) > shareholder area

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 long-standing shareholder, Truffle Capital⁶ 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 Masterflow^TM, 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 67 employees, including its own sales teams in Europe and a network of international distributors.

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

SpineJack® ⁷, 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.

Name: VEXIM
ISIN code: FR0011072602
Ticker: ALVXM

Appendixes


Condensed consolidated interim financial statements

In thousands of Euros	Six-month period ended
	June 30, 2016	June 30, 2017

Revenue	8 564	10 365
Cost of sales	(2 246)	(2 843)

Gross profit	6 318	7 522

Selling and marketing expenses	(4 927)	(5 001)
Operational expenses	(1 619)	(1 572)
General and administrative expenses	(2 773)	(2 714)
Other gains / (losses), net	240	284

Operating loss	(2 761)	(1 481)

Finance income / (loss), net	(9)	(53)

Loss before income tax	(2 770)	(1 534)
Income tax expense	(36)	(54)

Loss for the year	(2 806)	(1 588)

Attributable to:
Equity holders of the Company	(2 806)	(1 588)
	–	–

Earnings per share attributable to the equity holders of the Company during the period

Basic earnings per share	(0,37)	(0,21)


Diluted earnings per share	(0,37)	(0,21)


Interim consolidated balance sheet – Assets

In thousands of Euros	December 31, 2016	June 30, 2017

Intangible assets	2 229	3 226
Property and equipment	1 382	1 649
Other receivables	171	226
Deferred tax assets	522	500

Non-current assets	4 304	5 601

Inventories	3 675	4 684
Trade receivables	4 670	5 508
Other receivables	2 255	2 112
Cash and cash equivalents	9 765	5 734

Current assets	20 365	18 038

Total assets	24 669	23 639


Interim consolidated balance sheet – Equity and liabilities

In thousands of Euros	December 31, 2016	June 30, 2017

Ordinary shares	762	764
Share premium	61 109	61 296
Other reserves	1 204	1 724
Retained earnings	(45 383)	(46 970)
Equity attributable to equity holders of the Company	17 693	16 813

Non-controlling interests	–	–

Total equity	17 693	16 813

Repayable advances	427	43
Retirement benefit obligations	111	125
Non-current liabilities	538	168

Repayable advances	314	400
Trade payables	2 365	3 603
Other payables	3 541	2 437
Provisions for other liabilities and charges	218	218
Current liabilities	6 438	6 658

Total liabilities	6 976	6 826

Total equity and liabilities	24 669	23 639


Interim consolidated statement of cash-flow

In thousands of Euros	Six-month period ended
	June 30, 2016	June 30, 2017

Loss for the period	(2 806)	(1 588)
Adjustments for:
Depreciation of tangible assets, amortization of intangible assets	136	162
Impairment of receivables	83	(22)
Impairment of inventories	20	7
Share-based payments	277	496
Change in retirement benefit obligation	27	14
Variation in provisions for risks	167	–
Income tax	35	54

Cash used in operations before changes in working capital	(2 061)	(877)

Changes in working capital
Inventories	(12)	(1 016)
Trade receivables	(693)	(816)
Other receivables	(436)	178
Trade payables	(518)	1 238
Other payables	158	(1 284)
Cash used in changes in working capital	(1 501)	(1 700)


Net cash used in operating activities	(3 562)	(2 577)

Cash flows from investing activities
Purchases of property and equipment	(595)	(356)
Purchases of intangible assets	(443)	(1 070)
Disposal of assets	–	–

Net cash used in investing activities	(1 038)	(1 426)

Cash flows from financing activities
Proceeds from issuance of ordinary shares, net of issuance costs	10 453	189
Direct costs paid related to capital increase	(421)	–
Repayable advance	(210)	(314)
Treasury shares	–	69

Net cash generated by / (used) in financing activities	9 822	(56)

Net increase / (decrease) in cash and cash equivalents	5 222	(4 059)

Cash and cash equivalents at beginning of the period	4 208	9 765
Effect of exchange rate fluctuations	(12)	29

Cash, cash equivalents at end of the period	9 418	5 734

¹ NASS : North American Spine Society : https://www.spine.org/
² The results, which were subject to a limited review, have been approved by the Board of Directors of VEXIM at its meeting held on September 13^th, 2017.
³ Consolidated financial statements presented in Appendix.
⁴ Press release published on July 11^th, 2017: http://us.vexim.com/press/continued-growth-adoption-spinejack-q2-2017/
⁵ indicative date, subject to change.
⁶ 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.
⁷ 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, CEO
José Da Gloria, Chief Financial Officer
Tél. : +33 5 61 48 48 38
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

SpineGuard Reports Six-Month 2017 Financial Results

Posted On September 15, 2017 By OrthoSpineNews In Financial /

September 14, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (Paris:ALSGD) (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, 2017, as approved by the Board of Directors on September 13, 2017.

Stéphane Bette, CEO of SpineGuard, said: “We are particularly gratified by the first half result for 2017 because it combines sales growth and significant improvement in our operational result. These results show our ability to capitalize on our solid foundations and optimize our operational functions with the view of reaching profitability towards the end of 2018. This six months was also very fruitful in terms of strategic alliances, with the signing of two major deals: the distribution in China with XR Medical, which opens great long term perspectives in the second largest spinal market worldwide; and, the exclusive licensing with Adin Dental Implants that illustrates the value of our technology beyond spine surgery.”


€ thousands – IFRS	H1 2017	H1 2016
Revenue	4,199	3,633
Gross margin	3,613	3,105
Gross margin (% of revenue)	86,0%	85,5%
Sales, distribution, marketing	-3,400	-3,477
Administrative costs	-1,055	-1,076
Research & Development	-684	-764
Operating profit / (loss)	-1 ,526	-2 ,212
Non recurring operating costs	-152	0
Financial result	-566	-260
Income tax	0	0
Net profit / (loss)	-2,244	-2,472

NB : unaudited

Sales growth and reduced operating loss

For H1 2017, the Company reported revenue of €4,199k, up 16% (13% cc) compared with H1 2016.

Revenue in the United States increased 19% (15% cc) to €3,397k in the first half of 2017, compared with €2,866k in the first half of 2016. In the rest of the world, revenue increased 5% during the first half of 2017 to €802k compared with €767k in the first half of 2016.

4,264 DSG units were sold in the first half of 2017 compared with 4,351 in the first half of 2016, including 2,589 in the United States, representing 61% of total units sold.

Gross margin of 86.0% at June 30, 2017 compares favorably with the prior year result of 85.5%. The change mainly reflects a stronger ASP in the USA in particular thanks to the PediGuard Threaded.

Operating expenses were €5,139k compared with €5,318k for H1 2017, a decrease of 4% compared with June 30, 2016.

Working capital requirements were €840k compared with €955k at December 31, 2016. This continues to illustrate the relatively low operating cash needs of the Company and the efficient management of its financial resources.

At June 30, 2017, cash and cash equivalents were €2,061k compared with €1,804k at December 31, 2016, and is explained as follows:

The operating cash flow of €(1,494)k compared with the same period last year of €(2,732)k.
The payment of interests to IPF Partners of €178k and to Bpifrance of €37k.
The equity funding for a net amount of €1,855k in April 2017.

The Company’s workforce count is 28 at H1 2017, flat compared to end of December 2016.

Recent events and outlook:

The appointment of Stéphane Bette, co-Founder, CTO and US General Manager, as CEO of the company effective on July 13^th; Pierre Jérôme, who has served as CEO since the company’s founding, continues to serve as Board Director of the company;
the signature of an exclusive distribution agreement with XinRong Medical Group for PediGuard® in China, the second largest spinal market worldwide;
the first licensing deal for DSG™ technology outside spine with Adin in dental implantology;
the US Patent Office granted a new patent for DSG™ technology in digital health: Bone Quality Measurement;
the 10th scientific publication on PediGuard clinical value;
the implementation of a profitability plan to reach operating breakeven by the end of 2018;
SpineGuard is actively pursuing other industry partnerships for expanded commercial applications of its proprietary digital DSG™ technology within the spinal and broader musculoskeletal sector to trigger new sources of revenue;
in the USA, SpineGuard’s primary commercial focus, the launch of the Zavation DSG™ screw is scheduled at the coming NASS (North American Spine Society) mid-October in Orlando (FL).

Next financial press release: Third quarter 2017 revenue on October 5, 2017

About SpineGuard®
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 55,000 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 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
Stéphane Bette, Tel. : +33 (0) 1 45 18 45 19
Chief Executive Officer
s.bette@spineguard.com
or
Manuel Lanfossi, Tel: +33 (0)1 45 18 45 19
Chief Financial Officer
m.lanfossi@spineguard.com
or
NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.fr

Carevature’s Dreal™ Lumbar Decompression System Shows Enhanced Foraminotomy Efficiency, With Reduced Spinal Instability and Patient Strain in Minimally Invasive Cases

Posted On September 15, 2017 By OrthoSpineNews In Spine, Top Stories /

TEL AVIV, Israel, Sept. 13, 2017 /PRNewswire/ — Carevature Medical Ltd., developer of advanced orthopedic and neurological surgery solutions, announces the preliminary clinical results of its Dreal™ spinal decompression and bone removal system. The results will be given in an oral presentation by Dr. John Peloza at the annual forum of the Society for Minimally-Invasive Spine Surgery in Las Vegas, NV (September 14-16, 2017).

Dr. Peloza’s presentation will focus on cases performed by high-profile spinal surgeons – including John Peloza, MD; Richard Guyer, MD; Nahshon Rand, MD; Michael Millgram, MD; William Beutler, MD, FACS; Walter Peppelman, DO; and Ely Ashkenazi, MD. Results have shown the Dreal™ to promote improved access to the foramen, as well as potential increase in foraminal volume, without compromising spinal stability.

Dr. Peloza, a world-renowned orthopedic surgeon, specializing in advanced minimally invasive spine technologies, has successfully employed the Dreal™ in over 60 commercial lumbar and cervical procedures at Baylor Scott and White Medical Center, Frisco, TX. “Our clinical work so far shows the Dreal™ system enables shorter and safer decompressions, preserving maximum healthy tissue and facilitating patient recovery”, says Dr. Peloza. “Dreal™ has become a valuable work tool for me, in both lumbar and cervical cases using a minimally-invasive approach.”

Dr. Larry Khoo, a renowned pioneer of minimally-invasive techniques from the Spine Clinic of Los Angeles and executive VP marketing of SMISS adds: “In procedures where avoiding fusion or preserving segmental motion are a desired goal, the Dreal™ represents the next step in minimally-invasive decompression technology. I’ve been using it to perform lumbar decompressions through a standard 18mm tube, allowing me to achieve more thorough decompression of the lateral recesses and foramina, while still preserving the functional facet complex – resulting in decreased risk of delayed instability.”

Yosi Weitzman, founder and CEO of Carevature, is equally optimistic: “We’ve set out to overcome the present-day challenges of minimally-invasive orthopedic and neurological surgery. That’s why we’re committed to expanding our technology into additional indications. We’re excited to introduce the benefits of the Dreal™ to a growing number of surgeons and medical centers, as part of our mission to improve surgical outcomes for patients, surgeons, and healthcare systems.”

ABOUT CAREVATURE

Carevature Medical Ltd., a privately-held medical device company headquartered in Rehovot, Israel, is dedicated to developing advanced orthopedic surgery solutions. Carevature is currently marketing its flagship line of products for spinal indications, Dreal™: the first and only curved device powerful enough to efficiently cut bone, and small enough for use in all sections of the spine. Over 550 patients worldwide have been treated with the Dreal™, with outstanding safety and recovery results.

www.carevature.com

Media contact:

Robert W. Cook, VP Marketing & Sales

Carevature Medical, Inc.

M: 260-417-1643

E: bob@carevature.com

SOURCE Carevature Medical Ltd.

Lima Corporate Announces 100,000 SMR Shoulder Prosthesis Implanted Worldwide

Posted On September 15, 2017 By OrthoSpineNews In Extremities, Top Stories /

San Daniele del Friuli, Udine, Italy – 14th September 2017 – Lima Corporate is pleased to announce that, in August, the SMR System reached the significant milestone of 100,000 shoulder prosthesis implanted worldwide. The SMR System is the first shoulder platform launched on the market in 2002, and it has since then encountered a huge success which has led to this important milestone.

The SMR has proven to be an effective and reliable shoulder implant appreciated by surgeons all over the world, thanks to the advantages provided by a modular solution. Together with the celebration of the 15th anniversary of the SMR System on the market and by launching the SMR Bone Graft Instruments and Lima Personalized Surgical Instruments (LPSI), Lima is positioned as the pioneer in modularity applied to shoulder replacement. The innovation and the versatility of the system are now complemented by the SMR Bone Graft Instruments and LPSI Shoulder guides combined with the preoperative planning software.

The SMR Modular Shoulder System is on the market since 2002 and has been developed with the support of several shoulder surgeons, led by Prof. Mario Randelli, from Humanitas Clinical Institute in Milan (Italy). The aim of the SMR System is to provide to surgeons a complete platform, where the modularity of the system allows intraoperative versatility and a simple conversion from anatomic to reverse, without removing the humeral stem and the Metal Back glenoid.

“SMR is the original shoulder modular platform system which is surgeon user-friendly and covers all options in shoulder arthroplasty, backed by excellent clinical results” said Mr. Peter Poon from North Shore Hospital in Auckland (New Zealand).

“I’ve been involved in the development of the SMR and I followed the evolution of the platform over the years, including the use of Trabecular Titanium for glenoid reconstruction. I strongly believe in the modular platform and the cementless use of the implant. I’ve been using the SMR since 2002 in over 600 patients with great clinical results” said Prof. Raffaele Russo from the Pellegrini Hospital in Naples (Italy).

“I started using the SMR as an alternative to the all poly cemented glenoid considering the excellent results published regarding the system. I have continued to use the SMR and subsequently, the Metal Back TT for the past five years because of the system’s versatility and ability it affords me to perform glenoid reconstructions I could not do with any other system”, said Dr. Kevin Setter from SUNY Upstate Medical University, Syracuse (US).

Luigi Ferrari, CEO of Lima Corporate, said about the milestone: “SMR System has been an important component of our growth since its launch on the market in 2002, and today we are proud to celebrate this milestone. SMR is the first shoulder platform with 15 years of clinical follow-up. We see growing excitement for it as we continue to develop innovative solutions to support our surgeon customers in their practice.”

About Lima Corporate Lima Corporate is a global medical device company providing reconstructive orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, Lima Corporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. Lima Corporate’s product range includes large joint revision and primary implants and complete extremities solutions including fixation. For additional information on the Company, please visit: www.limacorporate.com

Limacorporate S.p.a.

Nadine MAO-DESIO

Corporate Marketing & Communication Manager

Via Nazionale, 52

3038 Villanova di San Daniele

Udine – Italy

T: +39 0432 945511

E: nadine.maodesio@limacorporate.com

Medovex Corp Initiates Forward Integration-Direct Sales Ops Strategy on Heels of Initial Strong Sales Opportunity in Key German Market

Posted On September 14, 2017 By OrthoSpineNews In Spine, Top Stories /

September 14, 2017

ATLANTA, GA–(Marketwired – Sep 14, 2017) – Medovex Corp. (NASDAQ: MDVX) (“Medovex” or the “Company”), the developer of the DenerveX® System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to back pain, today announced that it has formed a direct Medovex sales operation in Germany with a direct sales force. This new sales structure which will allow it to go direct in Germany, a large key market opportunity that has seen strong initial sales interest, and offers great dedicated reimbursement.

Dennis Moon, Medovex Executive Vice President, stated, “Initial sales of the DenerveX System in Germany, our most important market outside of the U.S., have been encouraging. While we continue to go narrow and deep, in a very controlled manner, early rollout procedure results have exceeded expectations. Being able to take control of our distribution through our new direct presence is expected to gain us numerous strategic advantages, not limited to better product control, increased selling focus and greater sales force accountability.”

The Company previously recently announced it had received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for its DenerveX System allowing the Company to market the device in Australia, the first country in the Asia Pacific region. Ahead of schedule, this paves the way for entry into an important area globally, Asia Pacific. Australia is a highly regarded market by many in the global medical community for the quality of care and delivery of the latest technology for the treatment of chronic disease such as Facet Joint Pain.

The Company also announced it had received its first order for the DenerveX System from Australia. On September 17, 2017, the Company expects to conduct sales and product training with its Australia distributor with anticipated initial procedures to be conducted shortly thereafter, following receipt of first shipments of the product.

Recently, the Company also provided a 30 day post procedure update on one of the first cases using its DenerveX System. It has also now received a five week post procedure update from Dr. Chris Dare on his first patient in the UK.

The first case was conducted on July 15, 2017 and results were assessed via visual analog scale (VAS) at 30 days post procedure. According to the VAS score, the patient reported a 70% reduction in pain. The second patient was recently assessed five weeks post procedure, reporting an 80% reduction in pain. The Company continues to secure additional patient testimonials which it intends to make available to shareholders upon completion.

Videos of leading spine surgeon Dr. Vik Kapoor talking about FJS and the DenerveX Device may be viewed at the following links:

https://youtu.be/6Q7hpEsF2mg
https://youtu.be/GIgPaIenXp4

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in the United States and other countries in the EU and Rest of World affecting millions each year. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.

The DenerveX System is a highly differentiated technology. It denervates and removes capsular tissue from the Facet Joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and RF ablation treatment on the Facet Joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.

The DenerveX System consists of the DenerveX Kit which contains the DenerveX Device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet FDA cleared.

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

CONTACT INFORMATION
Medovex Corp.
Jason Assad
470-505-9905
Email Contact

Precision ADM Receives ISO 13485 Medical Device Manufacturing Certification

Posted On September 14, 2017 By OrthoSpineNews In Regulatory /

WINNIPEG, Sept. 14, 2017 /PRNewswire/ – Precision ADM Inc. is pleased to announce that it is the first Canadian metal Additive and Subtractive manufacturing services company to receive ISO 13485:2016 Quality Management System certification. This industry standard represents the comprehensive set of requirements for the design and manufacture of medical devices.

Implementing this standard enables Precision ADM to manufacture medical devices, such as Orthopaedic Implants, using the latest digital manufacturing technologies. Using these technologies, Precision ADM can lower production costs by reducing waste and decreasing time to market by simplifying – or eliminating – tooling and equipment.

Additive Manufacturing also makes it possible to produce custom, patient-specific designs and devices with complex geometries, with potential lower cost than traditional manufacturing methods. Precision ADM is currently targeting additively manufactured medical devices produced in materials such as Titanium, Cobalt-Chrome, and stainless-steel alloys.

“Achieving ISO 13485 Registration and Certification using both metal Additive and Subtractive Manufacturing methods for Medical Devices is a first for any Canadian AM services company,” said Martin Petrak, CEO. “We are proud of our team’s accomplishment in achieving this significant milestone and are excited to work under this quality system with our existing and new clients.”

Dale Kellington, General Manager, added “The design and manufacturing controls this Certification demands gives our medical device customers the confidence they need that our manufacturing output will meet their stringent requirements. Our experience in product innovation and validation testing through our parent company, the Orthopaedic Innovation Centre, gives us a unique perspective on medical device manufacturing.”

“The expertise and experience our engineers possess give us the ability to solve the complex issues facing the medical field today,” said Derek VanDenDriessche, Director of Medical Sales.

For more information on manufacturing medical devices or other Additive Manufacturing solutions, please contact Precision ADM via email at: info@precisionadm.com or visit us online at: precisionadm.com

About Precision ADM
Precision ADM Inc. is a global engineering and manufacturing solutions provider that uses Additive Manufacturing, also known as 3D Printing, as a core technology, complimented by multi-axis machining to manufacture high value components and devices for the medical, aerospace, energy, and industrial sectors. Precision ADM has created a comprehensive Advanced Digital Manufacturing™ process which includes Design Support, Engineering, Manufacturing and Finishing. Precision ADM is ISO 13485:2016 certified and headquartered in Winnipeg, Manitoba, Canada.

SOURCE Precision ADM

Ortho Sales Partners Announces the Hiring of Tim Hein as Vice President, Market Development

Posted On September 14, 2017 By OrthoSpineNews In Spine /

SCOTTSDALE, ARIZONA (PRWEB) SEPTEMBER 14, 2017

Ortho Sales Partners, a global leader in orthopedic sales commercialization services, is excited to announce the addition of Tim Hein as Vice President of Market Development, further filling out its team of orthopedic and spine industry veterans. Mr. Hein has spent his career introducing disruptive technologies to the market and has experienced great success as part of landscape changing acquisitions while at Kyphon and LDR Spine.

Mr. Hein provides yet another example of the commitment Ortho Sales Partners has made to its clients by attracting the industry’s top talent. Primary functions that Mr. Hein will lead fall in the areas of both strategic and tactical sales execution. Leveraging over 16 years of experience creating and managing high functioning, results oriented sales teams, Mr. Hein has developed processes that create predictable growth and success. A graduate of the United States Military Academy at West Point, Mr. Hein has demonstrated leadership and focus in each of his corporate roles.

Mr. Hein’s career progression is steady and has provided some of the best experiences and perspective available in the spine industry. With a career that started at JNJ, Mr. Hein was quickly promoted to Regional Sales Director at DePuy Spine. In 2006, he was recruited by Kyphon which was acquired by Medtronic for $4.2 Billion. In 2009 Mr. Hein joined LDR Spine, an early stage company with disruptive spinal technology, as a Regional Director of Sales. Mr. Hein was a key executive during his more than seven years at LDR Spine, culminating in the role as Area Vice President of Sales-West. He was retained by Zimmer Biomet after it acquired LDR Spine for $1 Billion prior to joining the sales leadership team at Ortho Sales Partners.

“I am very pleased to join Ortho Sales Partners and add to the comprehensive services offered” said Hein. “I look forward to the opportunity to work with clients in support of their success in a very dynamic market and time in our industry.”

“The addition of someone with Tim Hein’s pedigree is humbling for our team” said Josh Sandberg President, Ortho Sales Partners. “Tim will allow us to offer clients hands on focus and experience that will allow them to avoid common pitfalls of commercializing new products. His ability to consistently bring novel disruptive technologies to the market and succeed is a rare talent and we look forward to leveraging his experience to the benefit of our clients.”
_____________

About Ortho Sales Partners

Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations such as:

A surgeon with a product idea and limited financial wherewithal to properly execute a sales plan.
OUS companies looking to establish or enhance their presence in the United States.
Companies with recent FDA approval in need of a strategic sales plan validated against current market conditions.
Established companies looking for sales and marketing horsepower to properly launch a new product.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis from industry stalwarts from some of the highest growth companies.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US. (http://www.orthosalespartners.com)

image1_0_high_quality.png_full_jpegtran_q95-e1505410341929.jpg

Bodycad Announces First Use of Its Unicompartmental Knee System in Patients

Posted On September 14, 2017 By OrthoSpineNews In Recon, Top Stories /

QUEBEC CITY, Sept. 14, 2017 /PRNewswire/ — Bodycad has announced that the first personalized restoration procedures using its Unicompartmental Knee System in patients have been successfully performed.

Bodycad’s revolutionary system is designed to optimize personalized restoration of the patient’s unique anatomical features and kinematics. The system is based on proprietary 3D rendering of medical images of the patient’s anatomy, resulting in a better fit and the potential for improved clinical results and patient satisfaction.

“The personalized restoration enabled me to perform the procedure in an exact manner with minimal bone resection,” said Dr. Brian Hamlin, Co-Director of the Bone and Joint Center of Magee-Womens Hospital of University of PittsburghMedical Center, one of two orthopaedic surgeons to perform the procedure. “The reconstruction resulted in a well balanced knee with optimized tracking while avoiding overcorrection.”

Bodycad uses proprietary imaging algorithms to produce a precise 3D image of the patient’s knee. Its suite of Personalized Restoration Software enables a seamless integration of the image to implant process called the PREP (personalized restoration evaluation process). The efficient, rapid, and highly automated process is the only one of itskind in the world that is impeccably integrated between software and modern manufacturing such as 3D printing.

“I was involved throughout the production of the personalized restoration,” said Prof. Werner Siebert of Vitos Orthopedic Clinic Kassel and incoming President of the German Orthopaedic Society, who also performed the procedure. “I provided patient imaging, consulted with a Bodycad PREP Tech on the resulting rendering, and then reviewed and approved the final design. The result was an exceptional fit for the patient.”

“Everyone’s anatomy is unique and that’s why standardized implants have limitations,” says Jean Robichaud, President and Founder of Bodycad. “These recent procedures reinforce a growing body of evidence that demonstrates the benefit of personalized restorations.”

Earlier this year, the company received US and European clearance for its Unicompartmental Knee System and is working collaboratively with practitioners to offer this personalized approach to orthopaedics.

About Bodycad

Bodycad is a Quebec City-based developer and manufacturer of personalized orthopaedic restorations. They are the only company in the world to have a seamlessly integrated, purpose-built, CAD/CAM platform. Its proprietary approach offers patients a high level of conformity to their unique anatomy, with the potential for greater comfort, fit and durability that make the pursuit of orthopaedic perfection possible. Learn more at www.bodycad.com.

Contact

Andy McLeod
2035 rue du Haut-Bord
Quebec, Quebec, Canada
G1N 4R7
(418) 527.1388
info@bodycad.com

SOURCE Bodycad

Bioventus Announces First Patients Enrolled in BONES Study for EXOGEN®

Posted On September 13, 2017 By OrthoSpineNews In Biologics /

September 13, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologics, today announced the first patients have been enrolled in its BONES (Bioventus Observational Non-interventional EXOGEN Studies) clinical development program. BONES includes three observational, non-interventional, direct-to-patient studies designed to collect real world data on the use of the EXOGEN Ultrasound Bone Healing System. EXOGEN uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural bone healing process.

The BONES studies will compare the incidence of fracture nonunions in patients utilizing EXOGEN with patients from a national health insurance claims database who received standard of care alone. The studies will include long and small bones of upper and lower extremities and the unique design of BONES was discussed with FDA during its development. Its primary endpoint is defined as the ability of EXOGEN to mitigate the risk of a fracture progressing to nonunion in the presence of known risk factors.

“We are excited to build on the vast clinical experience available on this established therapy and further develop our knowledge on the real world effectiveness of EXOGEN, by assessing its value in reducing nonunions, a highly disabling complication that also carries a significant societal burden,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus. “Accomplishing this ambitious goal requires an alternative methodology to randomized controlled trials and involves epidemiologically grounded research of large patient cohorts enrolled both prospectively, and within the big data available from US health insurance claims.”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN^®Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSI, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, and EXOGEN are registered trademarks of Bioventus LLC.

EXOGEN – Summary of Indications for Use in the US

*Summary of Indications for Use: The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions* excluding skull and vertebra. In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization. There are no known contraindications for the EXOGEN device. Safety and effectiveness has not been established for individuals lacking skeletal maturity; pregnant or nursing women; patients with cardiac pacemakers; on fractures due to bone cancer; or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling, at www.exogen.com or by contacting customer service at 1-800-836-4080. *A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

Author: OrthoSpineNews

Contacts

Contacts

CONTACT INFORMATION

Contacts