Ortho Regenerative Technologies Inc. Appoints Accomplished Life Science Executive, Luc Mainville, as CFO

Posted On September 20, 2018 By OrthoSpineNews In Financial /

KIRKLAND, Quebec, Sept. 19, 2018 (GLOBE NEWSWIRE) — Ortho Regenerative Technologies Inc. (“Ortho RTi” or the “Corporation”) (CSE: ORTH) today announced the appointment of Luc Mainville as Senior Vice President and Chief Financial Officer, with overall responsibility for operational finance, financial reporting, budgeting and strategic planning, as well as helping to manage the Corporation’s relationships and interactions with the investment community. Mr. Mainville succeeds Ortho RTi’s interim CFO, Benedek Simo, who will remain as Corporate Controller.

“We are delighted to have Luc join Ortho RTi at this important time in its corporate and clinical development,” said Brent Norton, President and CEO, Ortho RTi. “Being able to attract someone of Luc’s caliber to this role is a clear testament to the quality of our science and the potential market opportunity for our products under development. His significant operational experience will be a particularly valuable asset as we implement the last phase of our pre-IND program and pursue joint development initiatives with interested industry players for our lead product, Ortho-R.”

Mr. Mainville has an accomplished history of financial and operational leadership successes within the life science industry. In an executive management career that spans more than 20 years, he has led or been integrally involved in four go-public transactions, completed more than 20 public financings, and managed more than 50 licensing, merger and acquisition, and sale transactions. Mr. Mainville also serves as Senior Vice President and CFO for Valeo Pharma. His earlier experience includes senior management and financial roles at various life science companies, including Acerus Pharma, Cardiome Pharma Corp., Neopharm Labs Inc. and LAB Research Inc. Prior to launching his career in the life science industry, Mr. Mainville was a Partner at KPMG LLP. Mr. Mainville has served as Vice-Chairman of BIOTECanada and holds an MBA from McGill University.

About Ortho Regenerative technologies Inc.

Ortho RTi is an emerging Orthopaedic and Sports Medicine technology company dedicated to the development of novel therapeutic soft tissue repair technologies to dramatically improve the success rate of sports medicine surgeries. Our proprietary biopolymer has been specifically designed to increase the healing rates of sports related injuries to ligaments, tendons and cartilage. The polymer can be directly placed into the site of injury by a surgeon during a routine operative procedure without significantly extending the time of the surgery and without further intervention. Further information about Ortho RTi is available on the Company’s website at www.orthorti.com and on SEDAR at www.sedar.com.

Caution regarding forward-looking statements

This news release may contain certain forward-looking statements regarding the Corporation’s expectations for future events. Such expectations are based on certain assumptions that are founded on currently available information. If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Corporation disclaims any intention or obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.

For further Information, please contact:

Stephen Kilmer
Investor & Media Relations
647.872.4849
kilmer@orthorti.com

Green Sun Medical Celebrates Spine Technology Award, Scoliosis Brace Company Continues Helping Kids

Posted On September 20, 2018 By OrthoSpineNews In Spine /

Fort Collins, CO., 9/20/18 – Green Sun Medical LLC., a medical device company specializing in scoliosis bracing, announced that it has been selected to receive Orthopedics This Week’s Spine Technology Award during the 2018 National Association of Spine Surgeons (NASS) Meeting in Los Angeles, CA. Green Sun Medical has developed a comfortable, dynamic brace which applies continuous corrective pressure to the spine of adolescent patients with scoliosis. The brace will provide physicians and patients with real-time performance metrics utilizing a cloud-based health platform developed by Mindset Medical LLC.

Commenting on the company’s latest award, CEO Jamie Haggard said, “Winning the Spine Technology Award is the dream of every entrepreneur who works in the spine industry. Our goal is to provide a transformative scoliosis treatment experience for children. Creating a better quality of life and clinical outcome is now one step closer for adolescents who are coping with this disease.”

To meet our goal, Green Sun Medical has assembled a team of the world’s thought leaders in scoliosis treatment. The company is executing a carefully planned clinical study beginning at the National Scoliosis Center and continuing at the Shriner’s Hospital for Children in Sacramento, CA.

About Green Sun Medical:

Green Sun Medical is based in Fort Collins, CO. Founded in 2015, the company has developed a connected dynamic scoliosis brace. It has won numerous prestigious awards including; the FDA sponsored Pediatric Device Symposium, SXSW Pediatrics Device Competition and a $200,000 prize for best medtech innovation from the Medtech Innovator. www.greensunmedical.com

Attachments

Jamie Haggard
Green Sun Medical 
970-215-3291
jamie@greensunmedical.com

NuVasive To Showcase Spine Precision Surgery Leading To Smarter, More Predictable Clinical Outcomes At NASS 2018

Posted On September 20, 2018 By OrthoSpineNews In Spine /

SAN DIEGO, Sept. 20, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ :NUVA ), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced it will highlight the Company’s latest disruptive spine technology at the North American Spine Society (NASS) Annual Meeting held September 26-29, 2018 in Los Angeles, California, at the Los Angeles Convention Center.

“Now more than ever, NuVasive is expanding its portfolio with innovative launches covering spine’s leading procedures, materials and systems,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “NuVasive is fully committed to furthering its R&D investment and bringing disruptive technology to market to meet the needs of our surgeon partners to provide better and more predictable outcomes for patients.”

At the annual meeting, NuVasive will highlight its commitment in developing spine precision surgery advancements in key focus areas:

Surgical Intelligence™ is an ecosystem of integrated, modular technologies to deliver safer, faster and smarter surgery. A key part of this ecosystem is LessRay^®, a stand-alone proprietary technology that enhances low-dose, low-radiation fluoroscopy (or x-ray) images to have similar diagnostic capabilities as conventional full-dose fluoroscopy images. With the evolution of Surgical Intelligence, LessRay will integrate into the Pulse™ surgical automation platform, a first-of-its-kind integrated spine system addressing a broad range of clinical challenges, with enhanced utility and intuitive workflow. This platform introduces 2D- and 3D-navigation and smart imaging capabilities along with the Company’s leading neuromonitoring, NuvaMap^® O.R. surgical planning, radiation reduction and patient-specific rod-bending technologies. Both systems will be available for live demonstrations at the meeting.
Lateral Single-Position Solutions are intended to decrease the amount of time a patient is under anesthesia and increase operating room efficiency by reducing the need for patient repositioning. This is built on the foundation of the Company’s XLIF^® procedure and is supported by extensive clinical evidence with more than 400 peer-reviewed, XLIF-specific publications. NuVasive’s proprietary instrumentation and fixation expand the benefits of lateral surgery to more spinal levels from T6-S1, compared to traditional lateral procedures, by providing direct access to the L5-S1 level from a lateral position.
Advanced Materials Science™ (AMS) Interbody Portfolio is designed to deliver enhanced osseointegration and biomechanics through innovative implant design and superior surface, structure and imaging characteristics. The Company’s recently launched TLX^® 20 degree expandable spinal interbody implant with a first-of-its-kind oblique profile designed for transforaminal lumbar interbody fusion (TLIF) procedures will be on display, and demonstrates the Company’s commitment for further development of a full suite of expandable cage technologies. NuVasive is the only company to offer four specific materials for spinal interbodies: traditional PEEK (polyetheretherketone), propriety porous PEEK, titanium and 3D-printed porous titanium.
Intraoperative Neuromonitoring (IONM) For the first time, the NASS Annual Meeting will include an IONM symposium where surgeons can learn more about the utility, evidence and value of neuromonitoring in spine surgery, along with moderated abstract presentations. NuVasive’s clinical services division is the nation’s largest provider of outsourced IONM services, and the Company will demonstrate its neuromonitoring capabilities through its Pulse platform.

NuVasive 2018 NASS Annual Meeting Participation Details
NuVasive will showcase its innovation in Booth #2301 at the NASS Annual Meeting, as well as host several clinical workshops and participate in numerous podium presentations demonstrating the Company’s commitment to high-quality studies to advance the full application of its spinal solutions.

About NuVasive
NuVasive, Inc. (NASDAQ :NUVA ) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA^® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Implanet Publishes Its Interim 2018 Results

Posted On September 19, 2018 By OrthoSpineNews In Financial /

September 19, 2018

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

Implanet (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans; OTCQX: IMPZY) (Paris:ALIMP) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee surgery implants, has announced its interim results for the six-month period ended June 30, 2018, as approved by the Board of Directors on September 18, 2018.

Ludovic Lastennet, Implanet’s Chief Executive Officer, commented: “Through our unrelenting focus on costs containment we were able to improve our operating performance in spite of a revenue contraction in the first half of 2018. Jazz® continued to deliver healthy sales growth, particularly in France (sales up 10%) and in the US (sales up 14% at constant exchange rates). We have already begun to replicate this direct sales model by opening a branch in the United Kingdom and a subsidiary in Germany. We have also extended the Jazz® range by introducing Jazz Evo® for the adult degenerative spinal disease market. Finally, we have obtained additional funds by arranging a €5 million¹ convertible bond line. The implementation of these actions should continue in the coming months to lift our operating performance that has already begun to improve.”

In thousands of euros – IFRS*	H1 2018	H1 2017	Change (%)
Revenue	3,632	4,119	-12%
Cost of sales	-1,609	-2,014	-20%
Gross profit	2,023	2,105	-4%
Gross margin	55.7%	51.1%	+4 pts
Operating costs	-4,772	-5,189	-8%
Operating income/(loss) before non-recurring items	-2,750	-3,084	+11%
Other non-recurring operating income/(expense)	0	-456	–
Operating income/(loss)	-2,750	-3,540	+22%
Financial income/(loss)	-22	-150	+85%
Net income/(loss)	-2,772	-3,690	+25%

*Unaudited data

Jazz® revenue up 10% in France and up 14% in the United States (at constant exchange rates)

Implanet’s sales declined 12% to €3.6 million and fell 9% at constant exchange rates in the first half of 2018. Lower sales performance in the rest of the world segment was the main factor. The strong growth trajectory in Jazz® sales continued, especially in markets in which Implanet has a direct presence: +10% in France to €0.9 million and +14% (at constant exchange rates) to €1.1 million in the United States. Jazz®’s contribution to overall revenue continues to grow. It now stands at 61% of total revenue (vs. 58% in H1 2017).

Significant improvement in gross margin and operating performance

During the first half of 2018, Implanet’s gross margin improved by 4 points to 55.7% (vs. 51.1% in H1 2017). The main factor at work here was the shift in the product mix following the shutdown of the Arthroscopy business.

Implanet has kept a very tight grip on its operating costs, which continues to pay off handsomely quarter after quarter. Overhead declined 8% (or €0.4 million) over the period helping Implanet to cut its operating loss before non-recurring items by 11% and its operating loss by 22% to €2.7 million from €3.5 million in the first half of 2017.

During the first half, Implanet’s financial expenses improved significantly owing to the Company’s lower borrowing costs.

As a result of these factors, Implanet’s net loss narrowed to €2.8 million in the first half of 2018 (vs. €3.7 million in H1 2017).

Cash and cash equivalents

At June 30, 2018, Implanet held €2.0 million in cash and cash equivalents (vs. €4.0 million at December 31, 2017).

In August, Implanet also raised €0.5 million by issuing another tranche of its convertible bonds to the European Select Growth Fund. Implanet can also request the subscription of an additional 350 convertible bonds subject to certain conditions, which would enable it to raise €3.5 million to support Jazz®’s international development.

Significant advances and highlights

Business development: replication of the direct sales model in France and the United States to conquer the principal European markets

155 surgeons using Jazz® technology in France and the United States (vs. 137 at June 30, 2017)
finalization of the strategic alliance with L&K Biomed (signature of the cross-distribution agreements covering respective products in Asia and Europe)
opening of Implanet’s branch in the United Kingdom
establishment of Implanet subsidiary in Germany, the largest market in Europe, to develop a mixed sales network (direct sales staff and exclusive sales agents).

Clinical development, innovation and regulatory affairs: compelling clinical results and strong increases in the uptake of Jazz®

encouraging results from the first surgeries carried out in Brazil using Jazz Lock®
publication of the results of the clinical in the form of a prospective assessment of Jazz®² in vertebral column deformity surgery in the American Association of Neurological Surgeons’ Journal of Neurosurgery, supporting the use of the Jazz® platform as a promising alternative in the prevention of proximal junctional kyphosis
launch of Jazz Evo® dedicated to treat vertebral fusion indications in adults following CE mark and 510(K) authorization from FDA.

Next press release: 3^rd quarter 2018 revenue on October 9, 2018 before the market opens.

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 46 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com.

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

IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

Disclaimer
This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 16, 2018 under number D.18-0337 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

¹ Conditions detailed in the press released of March 8, 2018
² Clinical study by Dr. H. Francis Farhadi of the Ohio State University Medical Center (USA).

Contacts

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

SPINEWAY : Early redemption of 44 ORNANE Notes End of bond financing by ORNANE

Posted On September 19, 2018 By OrthoSpineNews In Financial /

Ecully, 19 September 2018

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), announces the early redemption of 44 notes redeemable in cash and/or convertible into new and/or existing shares (the “Notes”) and the end of the financing via issuance of Notes set up on 28 July 2017 with the YA II PN, LTD investment fund.

The diversification of Spineway’s financing methods implemented as part of its strategic plan with the issuance of bonds convertible into new or existing shares (OCEANE) representing a maximum of €14.50M, resulted in the early redemption of the 44 Notes still in YA II PN, LTD’s possession, for a total of 440 000 euros.

To this end, today Spineway redeemed 50% of the 44 Notes still in YA II PN, LTD’s possession, i.e., €220 000. The remainder shall be paid end of October/early November 2018.

The early redemption of the Notes also results in the early termination of this agreement and therefore cancels the option for Spineway to trigger the final tranche of 100 Notes.

Finally, in order to protect the bearers of the 267 379 Warrants issued pursuant to the issuance of Notes with attached Warrants, the exercise ratio for said Warrants shall be adjusted as provided in the agreement.

This early redemption allows Spineway to clarify its financing methods and limit, in part, dilution. Thanks to solid financing via the issuance of OCEANE, Spineway will be able to implement its strategic plan and reorganize its US subsidiary and reposition its offer on its global markets.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLANS FOR SMES)
Find out all about Spineway at www.spineway.com

Next communication: Half-year results for 2018 – 24 October 2018

This press release has been prepared in both English and French. In case of discrepancies, the French version shall prevail.

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

Contacts:


*Investor relations* David Siegrist – CFO Phone: +33 (0)4 72 77 01 52 finance.dsg@spineway.com		*Financial communication* Jérôme Gacoin / Solène Kennis Phone: +33 (0)1 75 77 54 68 skennis@aelium.fr

Attachment

Early redemption of 44 ORNANE Notes.pdf

rea-medicrea-5a4276cf1b952a23a2381b1b66a95324546377b474c62e264272afb9a3c02711-A-1.jpg

Medicrea Reports First Half 2018 Results

Posted On September 19, 2018 By OrthoSpineNews In Financial /

September 19, 2018

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED, PEA-PME eligible, and OTCQX: MNRTY and MNRTF), pioneering the transformation of spinal surgeries through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD™ ASI (Adaptive Spine Intelligence) technology, has today published its unaudited results for the first half of 2018, as approved by the Board of Directors on September 12, 2018.

(€ millions)	H1 2017	H1 2018
Sales	14.7	16.9
Gross margin (% of sales)	73%	68%
Operating income/(loss) before amortization and provision (EBITDA)	(1.0)	(1.6)
Operating income/(loss) after amortization and provision (EBIT)	(3.6)	(4.6)
Other non-recurring expenses	(0.2)	(0.4)
Cost of net financial debt	(1.4)	(1.1)
Income/(loss) before tax	(5.5)	(6.5)
Net income/(loss)	(5.1)	(6.5)

First Half 2018 Results

Sales for the first half of 2018 amounted to €16.9 million, marked by two quarters of record invoicing in 2018 resulting in growth of 15% in comparison with the first half of 2017 and 22% at constant exchange rates. The 50% increase in personalized UNiD ASI™ surgery in the United States, the recovery of sales in Brazil, the strengthening of market share in France and the opening of new subsidiaries (Belgium and Australia) are behind this performance.

Gross margin, down in comparison with the first half of 2017, was impacted by a number of one-off factors: the unfavorable currency effect of the dollar/euro conversion, a different mix of sales in comparison with the same period of 2017 and some exceptional inventory discrepancies. The decrease in sub-contracting expected during the second half of the year should have a favorable impact on the gross margin rate.

Operating expenses increased by €1.8 million as a result of Research & Development investments to complete the range of UNiD ASI™ products and services, and the integration of the marketing and administrative expenses of the newly-created subsidiaries.

The operating loss for the first half-year stood at €4.6 million and the loss before tax, after taking into account the cost of net financial debt, was €6.5 million.

Cash at June 30, 2018 amounted to €5.1 million, strengthened by the €3.1 million equity raise which took place beginning of July.

Outlook

Net loss for the first half of 2018 reflects the significant and necessary investments made by the Group to gain recognition for its position as a leading and strategic player in the field of personalized spine surgery.

The spinal market has entered a period of consolidation with 12 merger-acquisition transactions over the last 12 months, including two major deals announced very recently with the purchase in the United States of K2M by Stryker, and of Surgimap, a surgical planning software developer, by Globus Medical.

This trend reflects the growing interest of leading market players in planning tools solutions for the treatment of spinal pathologies. Medicrea has established itself as the worldwide leader and has set the industry standard in the segment by being the only company to date to use cutting-edge analysis tools based on artificial intelligence and predictive modeling to offer customized implants to treat each patient’s individual pathologies.

Medicrea’s UNiD ASI™ technology is therefore becoming increasingly popular with surgeons who are incorporating it into their day-to-day practice: to date, more than 2,800 patients have been operated on using personalized implants, and the number of UNiD ASI™ procedures performed in the United States has grown by 60% in relation to 2017.

“The approach we have developed is specific and tailored to each patient. It will become a standard of care and replace the traditional approach of spinal surgery, which has used commoditized implants for many years,” said Denys Sournac, Chairman and CEO of Medicrea.

Medicrea continues to consolidate its presence and visibility on the US territory

In July 2018, 4 US-based international institutional investors participated in a capital increase worth €3.1 million through the issue of ordinary shares with warrants attached (€4.8 million in the event of all the warrants being exercised).

Since August 28, 2018, Company’s securities are traded on the US OTCQX Best Market (“OTCQX”). In addition to trading on the Euronext-Growth market, this listing will give Medicrea the opportunity to increase its visibility within the US and grow its investor base.

Medicrea will be attending the 33^rdannual meeting of the North American Spine Society (“NASS”) which will be held between September 26 and 29, 2018 in Los Angeles, California. During this major conference, the Company will present the latest innovations from its proprietary UNiD ASI™ (Adaptive Spine Intelligence) patient-specific technology for personalized spine surgery to leading orthopedic surgeons.

Next publication: Sales for the 3^rd quarter of 2018: October 11, 2018, after market.

About Medicrea ( www.medicrea.com )

Through the lens of predictive medicine, Medicrea leverages its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data. The Company is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 200 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: www.medicrea.com

Connect with Medicrea
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED
LEI: 969500BR1CPTYMTJBA37

Medicrea is traded on
OTCQX Best Market
Tickers: MNRTY & MRNTF

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@medicrea.com

SpineGuard Reports Six-Month 2018 Financial Results

Posted On September 19, 2018 By OrthoSpineNews In Financial /

September 18, 2018

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

SpineGuard (FR0011464452 – ALSGD) (Paris:ALSGD), an innovative company that designs, develops, and markets disposable medical devices intended to make spine surgery safer by bringing real-time digital technology into the operating room, announced today financial results for the half year ending June 30, 2018, as approved by the Board of Directors on September 18, 2018.

Stéphane Bette, CEO of SpineGuard, said: “Our results are in line with our objectives and demonstrate that we are moving toward our operational profitability goal by year-end. Strengthened by our recent financings, we will continue to invest for our growth with a focus on the United States, the DSG smart screw as well as to prepare for the future with the digital and robotic applications of our DSG® technology.”

€ thousands – IFRS	H1 2018	H1 2017
Revenue	3,626	4,199
Gross margin	3,131	3,613
Gross margin (% of revenue)	86,3%	86,0%
Sales, distribution, marketing	-2,436	-3,400
Administrative costs	– 980	-1,055
Research & Development	-554	-684
Non recurring operating profit / (loss)	– 839	-1 ,526
Non recurring operating costs	0	-152
Operating profit / (loss)	-839	-1,678
Financial result	-229	-566
Income tax	0	0
Net profit / (loss)	-1,086	-2,244
EBITDA	-483	-1,612

NB : unaudited

Operating break even for year-end well underway

Operating loss improves by 50% at – €839K- vs. – €1,678K and EBITDA improves by 70% at – €483K at June 30, 2018 compared to – €1,612K at June 30, 2017.

Operating expenses were €3,970K compared with €5,139K for H1 2017, a decrease of €1,169K compared with June 30, 2017.

Gross margin of 86.3% at June 30, 2018 compares favorably with the prior year result of 86.0%. The change mainly reflects a stronger ASP in the USA, in particular, thanks to the PediGuard Threaded and the permanent actions on cost of goods.

For H1 2018, the Company reported revenue of €3,626K, down 5% cc (14% reported) compared with H1 2016.

Revenue in the United States decreased 1% cc (-11% reported) to €3,022K in the first half of 2018, compared with €3,397K in the first half of 2017. In the rest of the world, revenue decreased 25% during the first half of 2018 to €604K compared with €802K in the first half of 2017.

4,352 DSG units were sold in the first half of 2018 compared with 4,264 in the first half of 2017, including 2,599 in the United States, representing 61% of total units sold.

Working capital requirements were €806K compared with €706K at December 31, 2017.

At June 30, 2018, cash and cash equivalents were €861K compared with €1,190K at December 31, 2017, and is explained as follows:

The operating cash flow of €(566)K compared with the same period last year of €(1,494)K.
Equity funding using the equity line (OCAPI) for a gross amount of €1,200K throughout the period.
The payment of interests to IPF Partners of €173K and to Bpifrance of €37K.
The repayment of capital to IPF Partners of €525K.

The Company’s workforce count is 20 at H1 2018, compared to 22 at the end of December 2017.

Recent events and outlook:

In every operating room around the world, SpineGuard continues to demonstrate the value of its dynamic surgical guidance technology in market looking for innovation and safer and enhanced clinical solutions. The DSG technology platform remains unique in its ability to differentiate tissues in real time with reduced X-ray exposure for the surgical teams;
In the USA, the commercial launch started at the end of 2017. It was completed in April 2018 with an agency contract with Zavation under which SpineGuard Inc. acts as a commercial agent in certain key accounts in the country;
The distribution in China with our partner XR Medical continues to bear fruit with a 600 unit order in H1 and exciting perspectives both for the second half of 2018 and long term in the second largest market worldwide after the USA;
SpineGuard and ConfiDent ABC (Adin Group) continue to work in close partnership to accelerate the deployment of the DSG technology in dental implantology;
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 early September, SpineGuard secured €9.0m of financing consisting of: 1) the issuance of a €6.0m euro bond facility with Norgine Ventures and Harbert European Fund Advisors in substitution of IPF Partners in two tranches and; 2) a new equity line in the form of a €3.0m convertible bond facility with Nice & Green (OCAPI) over a period of 15 months. The line has zero associated warrants. SpineGuard estimates that these combined financings provide for an extended runway until August 2020.

SpineGuard delivers on its profitability plan to reach operating breakeven by the end of 2018.

Next financial press release: Third quarter 2018 revenue on October 11, 2018

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 60,000 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
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Mathilde Bohin / Pierre Laurent, Tel: +33 (0)1 44 71 94 94
spineguard@newcap.eu

Safe Orthopaedics Announces the Commercial Launch of SteriSpineTMVA, a Balloon for the Vertebral Augmentation

Posted On September 18, 2018 By OrthoSpineNews In Spine /

September 18, 2018

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

SAFE ORTHOPAEDICS (FR0012452746 – SAFOR) (Paris:SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments for back surgery, today announces its worldwide launch of its Kyphoplasty System: the SteriSpine^TM VA.

The new system adds to an already existing portfolio of sterile & single use devices and establishes Safe Orthopaedics as the only company that can offer a comprehensive portfolio of ready to use spinal fracture treatment options, which consists of a balloon and cement systems for restoring the vertebral body and a complete range of implants for stabilizing the spinal segment (Screw, rod, cross connectors…) post-fracture…

The European market for the treatment of vertebral compression fractures (VCF) via vertebral augmentation (Kyphoplasty) is estimated at €82M in 2018 and is expected to grow to over €120M in 2026¹ with a CAGR of 4.8%, in large part, because of the ageing population in Europe.

Sjors Hermans, Global sales director of Safe Orthopaedics comments: “The SteriSpine^TM VA is one of the two first systems in the market to offer a high quality, high pressure balloon of 700 PSI. Safe Orthopaedics is now the only one in the world to propose a full ready to use spinal treatment for the vertebral fracture.”

Pierre Dumouchel, CEO of Safe Orthopaedics, concludes: “Reinforcing our leadership in the fracture segment, we address a new segment representing €72M in France, Germany and the UK that will sustain our strong growth and reinforce our gross margin.”

In last July, Safe Orthopaedics announced the launch of its kyphoplasty offer in the countries where Safe Orthopaedics has a direct sales force. From September 2018, this offer is extended to all countries where the Safe Orthopaedics is present. This cement injection method, performed with a balloon, allows Safe Orthopaedics to provide a complete emergency fracture treatment package to push the penetration of its products towards the surgeons and strengthen its gross margin.

The SteriSpine^TM VA balloon is a high pressure, high quality balloon that can be inflated up to 700 PSI. The majority of the systems in the market today allow between 300 and 400 PSI. It comes in different sizes to accommodate all different kinds of patient anatomy.

¹ 2017 Millennium Research data

Next financial publication: First half 2018 results, September 28, (after market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that offers the safest technologies to treat spinal fracture. Delivered sterile, all implants and respective disposable instrumentation are available to the surgeon at any time, any place. These technologies enable minimally invasive approaches, reducing risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpine™ Kits are CE marked and FDA cleared. The company is based at Eragny-Sur-Oise (France), and has 37 employees.

For more information, visit: www.SafeOrtho.com

Contacts

Safe Orthopaedics
François-Henri Reynaud, Tel. : +33 (0)1 34 21 50 00
Chief Financial Officer
investors@safeorthopaedics.com
or
Investor relations
NewCap
Valentine Brouchot, Tél. : +33 (0)1 44 71 94 94
SafeOrtho@newcap.eu
or
Press Relations
Ulysse Communication
Bruno Arabian, +33 (0)6 87 88 47 26
barabian@ulysse-communication.com
Nicolas Daniels, +33 (0)6 63 66 59 22
ndaniels@ulysse-communication.com

NuVasive Announces UK Launch Of MAGEC® X For Early Onset Scoliosis Treatment

Posted On September 18, 2018 By OrthoSpineNews In Spine /

SAN DIEGO, Sept. 18, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the United Kingdom (U.K.) launch of MAGEC^® X, the newest product generation within the MAGEC pediatric portfolio that addresses early-onset scoliosis (EOS).

The development of MAGEC X is distinguished by the inclusion of 5.0mm diameter patient rods, delivering a 68 percent improved fatigue-strength performance over the traditional 4.5mm option.ⁱIt also incorporates several advanced rod mechanisms, most notably a robust actuator seal designed to help further contain and reduce the release of titanium wear debris. Additionally, the rod includes an anti-jam feature to simplify intraoperative and postoperative rod lengthening. Key aesthetic improvements, such as laser-marked sagittal bending lines, help to enhance surgeon workflow efficiency and ease of use.

“I am extremely impressed with the NuVasive MAGEC X 5.0mm solution and its ability to provide superior rod strength without having to sacrifice the ideal fixation size thus meeting the clinical needs of pediatric patients,” said Dr. Stewart Tucker, MBBS, FRCS, orthopedic surgeon at Great Ormond Street Hospital in London, England. “Additionally, MAGEC X substantially improves intra-op workflow with enhanced ease of use. It provides surgeons with tremendous flexibility, enabling upsizing of rods while maintaining small screw heads, giving optimal profile and soft tissue cover.”

The 5.0mm growing rod in the MAGEC X system pairs with the NuVasive Reline^® Small Stature fixation system, the first pediatric deformity fixation solution that combines rod strength with low-profile implants. Together, the two systems help minimize the occurrence of revision surgeries by adding enhanced construct strength with an optimized low-profile for EOS patients.

“Following in the footsteps of our proven MAGEC solution, MAGEC X brings several new capabilities to the MAGEC portfolio and is a testament to NuVasive’s continuing practice of innovating and delivering next-generation spinal technologies for surgeons and patients in the pediatric space,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “MAGEC X’s 5.0mm rod is truly game-changing as it supports patients with a small implant profile, but with significantly increased fatigue strength over the previous generation.”

This U.K. commercial launch of MAGEC X follows the Company’s U.S. commercial launch which occurred in July 2018. The Company will also host a MAGEC Users Meeting in Lisbon, Portugal on November 16, 2018, following the International Congress on Early Onset Scoliosis (ICEOS) Annual Meeting. This global users meeting will bring together surgeons and surgical staff from around the world to discuss challenges, shared successes, and review best practices related to the use of MAGEC as a treatment for EOS.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

ⁱData on File: TR 9604057; dynamic 4-point bending testing per ASTM F2193.

Logo – https://mma.prnewswire.com/media/454552/NuVasive_Logo.jpg

SOURCE NuVasive, Inc.

Zavation Medical Products, LLC, a LongueVue Capital Portfolio Company, Completes Investment in Pan Medical U.S. Corp.

Posted On September 18, 2018 By OrthoSpineNews In Financial /

JACKSON, Miss., Sept. 18, 2018 /PRNewswire/ — Zavation Medical Products (“Zavation”), a LongueVue Capital (“LVC”) portfolio company, is pleased to announce it has partnered with the management team of Pan Medical U.S. Corp (“PanMed” or the “Company”) to acquire the Company. This partnership broadens Zavation’s service offering by adding a full suite of minimally invasive products, including the novel CurvePlus kyphoplasty system, the simplest and most complete curved kyphoplasty system on the market. The CurvePlus system is the only FDA approved kyphoplasty system that allows for both the balloon and cement to be passed through a curved needle. This not only facilitates precise balloon placement, but limits the number of steps in the procedure and decreases overall procedure time.

Based in Jackson, MS, Zavation designs, engineers, and manufactures a portfolio of spinal hardware and biologics covering key areas including cervical, thoracolumbar, interbody fusion, and minimally invasive surgery. Founded in 2012, Zavation has experienced exceptional growth and created a national network of 150+ distributors across approximately 40 states. The Company has commercialized over 12 product families since inception, with approximately 10 additional novel products expected to launch over the next year. Zavation operates a 30,000 square foot vertically integrated facility with approximately 60 employees.

PanMed, headquartered in Tampa, FL, designs, develops, and manufactures highly complex medical products used in minimally invasive procedures, primarily in the kyphoplasty and interventional radiology markets. PanMed has built a differentiated position with its extensive expertise in highly specialized balloons, catheters, needles, and instrument kits. PanMed was founded in the United Kingdom over 30 years ago with a focus on the catheter balloon market. Recognizing the sizable opportunity in the U.S., the Company shifted its focus to the kyphoplasty and interventional radiology markets and relocated operations to the United States in 2016. PanMed sells branded products through a network of independent distributors, agents, and OEMs, while also maintaining a private label program for spinal hardware companies throughout the world. The Company is currently expanding into a 14,000 square foot facility to meet outsized demand for its novel and new CurvePlus platform.

“We are delighted to partner with Zavation, a high growth complementary hardware business with incredible customer service and a deep knowledge of the U.S. market. We have a strong relationship with the Zavation team, as PanMed has been a supplier to Zavation for over three years. We see significant value in the transaction, and, as such, have invested in the combined business,” said Dr. Max Nasralla, visionary Founder and President of PanMed, who will continue in his current role throughout the integration process and remain as a shareholder and strategic advisor to the combined entity thereafter. “With our growth trajectory, we need to ensure the ability to continue to provide exceptional customer service, which the Zavation partnership will enable us to do.”

“An important component of choosing a partner for PanMed was a cultural fit that will provide continuity to our customers, who are critical to our ongoing success,” said Jennie Budding, COO of PanMed and incoming Vice President at Zavation. “I have watched this business grow over the past 15 years, and I am delighted that our new partners will provide our team with the resources needed to successfully scale the business while never compromising our commitment to quality and to our customers, both domestically and abroad.”

Jeffrey Johnson, CEO of Zavation, added, “After years of testing a variety of different kyphoplasty balloons for our ZVPlasty system, we realized that many competitive products on the market are substantially inferior to those of PanMed. We saw an opportunity to partner with PanMed to provide a unique and proprietary curved kyphoplasty solution, and we could not be more excited about the future of our partnership. The combined business will have an industry leading product portfolio, and we are thrilled to offer PanMed’s products to our network of distributors and surgeons.”

“I am extremely excited to work with Jennie [Budding], Max [Nasralla], and the rest of the PanMed team to methodically grow PanMed for the years to come,” said Brad Risher, Senior Vice President of Interventional Spine at Zavation. “PanMed has the potential to disrupt the kyphoplasty and interventional radiology markets, and we look forward to welcoming the PanMed organization into the Zavation family.”

Baird served as exclusive financial advisor to LVC and Zavation on the transaction. Abacus Finance Group, LLC provided the senior debt financing to Zavation in support of the transaction. Zavation and LVC’s legal counsel was provided by McGuireWoods, LLP.

To learn more information about Zavation and its products, visit www.zavation.com

To learn more information about PanMed and its products, visit www.panmed.us

ABOUT LONGUEVUE CAPITAL
LongueVue Capital is a private equity firm focused on making situation-driven, value-oriented equity and debt investments in lower middle market companies (up to $150 million in annual revenue) to support buy-outs, recapitalizations, acquisitions and growth. LVC currently has approximately $500 million under management across two funds. Since its formation in 2001, LVC has made successful investments in a wide variety of industries, including healthcare, business services, transportation and logistics, energy services, and niche manufacturing. LVC is based in New Orleans with additional offices in New York and Salt Lake City. For more information, please visit www.lvcpartners.com.

SOURCE LongueVue Capital

Month: September 2018

Ortho Regenerative Technologies Inc. Appoints Accomplished Life Science Executive, Luc Mainville, as CFO

Green Sun Medical Celebrates Spine Technology Award, Scoliosis Brace Company Continues Helping Kids

NuVasive To Showcase Spine Precision Surgery Leading To Smarter, More Predictable Clinical Outcomes At NASS 2018

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Safe Orthopaedics Announces the Commercial Launch of SteriSpineTMVA, a Balloon for the Vertebral Augmentation

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