TransEnterix Acquires Assets, Intellectual Property and Retains R&D Team from MST Medical Surgery Technologies

Posted On September 24, 2018 By OrthoSpineNews In Financial /  

September 23, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced that it has acquired substantially all of the assets of MST Medical Surgery Technologies Ltd. (“MST”), an Israel medical technology company, in a cash and stock transaction with a total consideration, further described below. MST is a leader in the field of surgical technology, having developed a software-based image analytics platform powered by advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.

“Adding innovative, novel technological capabilities to Senhance is a critical part of our long-term strategy as we work towards digitizing the interface between the surgeon and the patient,” said Todd M. Pope, President and CEO of TransEnterix. “The addition of the MST technology to our Senhance platform will increase the effectiveness of surgeons, making procedures quicker and less error-prone, leading to better outcomes for the patient.”

“We are very excited to be partnering with TransEnterix, one of the leaders in surgical robotics who is pioneering the industry with their Senhance platform,” said Motti Frimer, CEO of MST. “The Senhance is a fantastic product with incredible potential, and we have a shared vision with TransEnterix of providing digital laparoscopy to better equip surgeons with innovative technologies that enhance their abilities, providing better quality, more consistent outcomes.”

Strategic Rationale

The addition of MST’s technology, IP portfolio, and R&D team supports and accelerates TransEnterix’s vision to leverage its Senhance Surgical System to deliver digital laparoscopy, thereby increasing control in the surgical environment and reducing surgical variability.

  • Innovative Surgical Technology Portfolio: MST’s technology and software engine will help accelerate Senhance platform innovation to meaningfully advance the benefits of digital laparoscopy to patients, surgeons and operating rooms globally. Key components of MST’s technology include advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.
  • Established R&D Center: Provides immediate access to an established R&D center in Israel, with a core team of experienced engineers. In addition, the R&D center allows the Company to tap into talent from one of the world’s top technology hubs.

Transaction Structure

TransEnterix acquired from MST substantially all of its assets, which includes technology and intellectual property, and will transfer MST’s Israeli-based R&D team to a newly formed subsidiary, TransEnterix Israel, Ltd.

The transaction will be financed with a combination of cash and stock, delivered in two separate tranches. At the closing of the transaction, MST will receive approximately $5.8 million in cash and 3,150,000 shares of TransEnterix common stock. The second tranche of $6.6 million, payable in cash or stock, is to be paid within one year of closing. The timing and form of payment of the second tranche is at TransEnterix’s sole discretion.

Conference Call

TransEnterix, Inc. will host a conference call tomorrow, Monday, September 24, 2018 at 8:00 AM ET to discuss this acquisition. To listen to the conference call on your telephone, please dial (844) 804-5261 for domestic callers or (612) 979-9885 for international callers, and reference the “Acquisition of Medical Surgical Technologies Ltd” conference call, approximately ten minutes prior to the start time. To access the live audio webcast with presentation slides or archived recording, use the following link http://ir.transenterix.com/events.cfm. The presentation materials for the conference call will be available for download at 7:00 AM ET at http://ir.transenterix.com/events.cfm. The replay will be available on TransEnterix’s website for approximately 90 days after the conference call.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance™ Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward Looking Statements

This press release includes statements relating to the acquisition of the assets and R&D team of MST and the anticipated uses of such assets by TransEnterix in the future, including related to the Senhance Surgical System. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the reported transaction with MST is successfully consummated, our ability to use the acquired assets as intended, and our commercial success related to such assets. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 8, 2018 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

TransEnterix, Inc.
Investors:
Mark Klausner, 443-213-0501
transenterix@westwicke.com
or
Media:
Joanna Rice, 951-751-1858
joanna@greymattermarketing.com

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Medtronic to Acquire Mazor Robotics

Posted On September 21, 2018 By OrthoSpineNews In Financial, Robotics, Top Stories /  

DUBLIN and CAESAREA, Israel – September 20, 2018 – Medtronic plc (NYSE:MDT), a global leader in medical technology, and Mazor Robotics (NASDAQ:MZOR, TASE:MZOR.TZ), a pioneer in the field of robotic guidance systems, today announced the companies have entered into a definitive merger agreement under which Medtronic will acquire all outstanding ordinary shares of Mazor for $58.50 per American Depository Share, or $29.25 (104.80 ILS) per ordinary share, in cash, for a total of approximately $1.64 billion, or $1.34 billion net of Medtronic’s existing stake in Mazor and cash acquired. The boards of directors of both companies have unanimously approved the transaction.

Medtronic’s acquisition of Mazor strengthens Medtronic’s position as a global leader in enabling technologies for spine surgery, and drives Mazor Robotics’ vision to bring its core technology to the forefront of the global market. Mazor’s proprietary core platform technology, including the Mazor X(TM) Robotic Guidance System (Mazor X), and the Renaissance® Surgical-Guidance System (Renaissance), are transforming spinal surgery from freehand procedures to accurate, state-of-the-art, guided procedures. By combining Medtronic’s market-leading spine implants, navigation, and intra-operative imaging technology with Mazor’s robotic-assisted surgery (RAS) systems, Medtronic intends to offer a fully-integrated procedural solution for surgical planning, execution and confirmation. The companies plan to showcase this technology integration at the upcoming NASS (North American Spine Society) 2018 Annual Meeting in Los Angeles.

“We believe robotic-assisted procedures are the future of spine surgery, enhancing surgeons’ abilities to perform complex procedures with greater precision, consistency and control. Medtronic is committed to accelerating the adoption of robotic-assisted surgery and transforming spine care through procedural solutions that integrate implants, biologics and enabling technologies,” said Geoff Martha, executive vice president and president of the Restorative Therapies Group at Medtronic. “The acquisition of Mazor adds robotic-assisted guidance systems to our expanding portfolio of enabling technologies, and we intend to further cultivate Mazor’s legacy of innovation in surgical robotics with the site and team in Israel as a base for future growth.”

This transaction builds on a relationship originated in May 2016 under a multi-phased strategic and equity investment agreement between Medtronic and Mazor. In August 2017, Medtronic expanded the partnership to become the exclusive worldwide distributor of the Mazor X system, leading to the successful installation of more than 80 Mazor X systems since launch. With today’s announcement bringing the two companies together, Medtronic aims to accelerate the advancement and adoption of RAS in spine to the benefit of patients, providers, and the healthcare system more broadly.

“Today is a historic day for spine surgery and a defining event in the market’s evolution, and I want to acknowledge and thank all of those whose contribution and faith have been so critical and impactful to our success,” said Ori Hadomi, CEO of Mazor Robotics. “The Mazor team and product portfolio’s full integration into Medtronic will maximize our impact globally through Medtronic’s channels, advance our systems’ leadership position in the marketplace, and drive the realization of our vision to heal through innovation.”

Financial Highlights
The acquisition is expected to close during Medtronic’s third fiscal quarter ending January 25, 2019, subject to the satisfaction of customary closing conditions including receipt of regulatory clearances and approval by Mazor’s shareholders. The transaction is expected to be modestly dilutive to Medtronic’s fiscal 2019 adjusted earnings per share, but given the current strength of Medtronic’s business, the company expects to absorb the dilution.

Consistent with its long-term financial objectives, Medtronic projects the acquisition to generate a double-digit return on invested capital (ROIC) by year four, with an increasing contribution thereafter.

Medtronic’s financial advisors for the transaction are Perella Weinberg Partners LP and Goldman Sachs & Co. LLC, with Meitar Liquornik Geva Leshem Tal and Ropes & Gray LLP acting as legal advisors. Mazor’s financial advisor is J.P. Morgan Securities LLC, Duff & Phelps LLC, with Kirkland & Ellis LLP and Luchtenstein Levy Wiseman Law office acting as legal advisor.

About Mazor Robotics
Mazor, founded in 2001, pioneered the application of robotics technology and guidance for use during spinal procedures, and is the market segment’s leader. In 2011, the Company introduced the Renaissance system and in 2016 launched the next generation Mazor X system. To date, more than 200 Mazor systems are in clinical use on four continents and have guided the placement of more than 250,000 implants during some 40,000 procedures, enabling minimally-invasive spine surgery to become standard procedure in many hospitals. Mazor’s core technology has received more than 15 U.S. Food and Drug Administration clearances and has been the subject of more than 60 publications, leading the spine robotics market on the evidence front. Mazor is the holder of more than fifty patents worldwide.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements, including, but not limited to, statements regarding the proposed transaction between Medtronic and Mazor, the expected timetable for completing the transaction, strategic and other potential benefits of the transaction, including meeting Medtronic’s long-term financial metrics for acquisitions, Mazor’s products and product candidates, and other statements about Medtronic or Mazor managements’ future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability and timing to satisfy conditions to closing including shareholder and regulatory approvals, the impact of the announcement of the transaction on the business, and other risks and uncertainties such as those described in Medtronic’s and Mazor’s reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic and Mazor caution investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic and Mazor undertake no obligation to update or revise any of these statements except to the extent required by law.

ADDITIONAL INFORMATION

In connection with the proposed transaction, Mazor intends to mail a proxy statement to its shareholders and furnish a copy of the proxy statement with the SEC on Form 6-K. Shareholders of Mazor are urged to read the proxy statement and the other relevant material when they become available because they will contain important information about Mazor, Medtronic, the proposed transaction and related matters. Shareholders are urged to carefully read the proxy statement and other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction. The proxy statement (when available) may be obtained for free at the SEC’s website at www.sec.gov. In addition, the proxy statement will be available, without charge, at Mazor’s website at www.mazorrobotics.com.

-end-

Medtronic Contacts:
David T. Young
Public Relations
+1-774-284-2746

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Mazor Contacts:
Eran Gabay – Gelbart Kahana
Israel Public Relations
+972-54-246378

Michael Polyviou – EVC Group
U.S. Public Relations
+1-732-232-6914

 

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Providence Medical Technology Secures $25 Million In Equity Financing

Posted On September 20, 2018 By OrthoSpineNews In Financial /  

PLEASANTON, Calif., Sept. 20, 2018 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing surgical equipment and implants for cervical spine fusion surgery, today announced the closing of $25 million in new equity financing. Revelation Partners led the round with participation from the private equity investment team at BMO Global Asset Management (EMEA), MVM Life Science Partners, Medvest Capital, and Aphelion Capital. Inclusive of this new investment, Providence has raised a total of $53 million in equity financing since its 2008 inception.

The proceeds of the financing will be used to accelerate commercial expansion and clinical development of its DTRAX®line of cervical fusion instruments designed to help patients suffering from advanced cervical spine conditions.

“DTRAX is an important innovation in cervical spine treatment that addresses a large market with significant unmet clinical need,” said Zack Scott, Managing Partner of Revelation Partners. “We are pleased to back the Providence team during this pivotal stage of the Company’s growth.”

“We welcome Revelation Partners and BMO to our dedicated team of investors,” said Jeff Smith, CEO of Providence. “We are committed to improving the lives of patients suffering from cervical spine disorders. This funding enables Providence to increase our investment in clinical evidence development and bring our unique cervical fusion technology to more patients and surgeons. I am grateful for the new and continued support from our venture partners.”

Over 300,000 Americans receive cervical spine fusion annually for debilitating neck and arm pain. While many have successful results, roughly 20% of two-level anterior fusions fail.1,2 Additionally, 22% of patients are predicted to require reoperation for adjacent segment disease within ten years after surgery.3 Providence has developed a unique tissue-sparing approach to cervical fusion that is designed to address this unmet need. The company’s flagship DTRAX Spinal System was recently cleared by the FDA for use in posterior cervical fusion in patients with cervical degenerative disc disease and has been approved at over 1,800 hospitals in the United States.

About DTRAX Spinal System
The DTRAX Spinal System is a set of surgical instruments indicated for performing posterior cervical fusion in patients with cervical degenerative disc disease. The system allows surgeons to perform posterior cervical fusion using a variety of surgical techniques including a tissue-sparing technique that reduces the dissection and stripping of muscles.4

About Providence
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative surgical solutions for cervical spine surgery. The company has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market.

The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, ALLY® bone and facet screws, and ENTRUS™ Allograft Bone. All products are sterile-packaged and single-use to maximize perioperative efficiency and ensure consistent quality and performance.

For more information, please visit www.providencemt.com.

MKT-PMT-308 Rev 0

References
1. Davis RJ, et al. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6. PubMed PMID: 24010901.

2. Fraser JF, et al. Anterior approaches to fusion of the cervical spine: a meta analysis of fusion rates. J Neurosurg Spine. 2007 Apr;6(4):298-303. PubMed PMID: 17436916.

3. Lee JC, et al. Adjacent segment pathology requiring reoperation after anterior cervical arthrodesis: the influence of smoking, sex, and number of operated levels. Spine (Phila Pa 1976). 2015 May 15;40(10):E571-7. doi: 10.1097/BRS.0000000000000846. PubMed PMID: 25705959.

4. McCormack BM, et al. Novel instrumentation and technique for tissue sparing posterior cervical fusion. J Clin Neurosci. 2016 Dec;34:299-302. doi: 10.1016/j.jocn.2016.08.008. Epub 2016 Aug 31. PubMed PMID: 27590864.

SOURCE Providence Medical Technology, Inc.

Related Links

http://www.providencemt.com

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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

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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: 3rd 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

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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

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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 33rd annual 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 3rd 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

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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

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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

Related Links

http://www.lvcpartners.com

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Zimmer Biomet Announces Quarterly Dividend for Third Quarter of 2018

Posted On September 14, 2018 By OrthoSpineNews In Financial /  

WARSAW, Ind., Sept. 13, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the third quarter of 2018.

The cash dividend of $0.24 per share is payable on October 31, 2018 to stockholders of record as of the close of business on September 28, 2018. Future declarations of dividends are subject to approval of the Board of Directors and may be adjusted as business needs or market conditions change.

About the Company

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

ZBH-Fin

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmer.com

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