Mazor Robotics Reports Record Third Quarter 2017; Revenue More Than Doubles to $17.2 Million

November 07, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of robotic guidance systems, reported record third quarter revenue of $17.2 million. As previously announced, the Company received purchase orders for 22 systems in the 2017 third quarter, including 19 Mazor X systems.

Recent Significant Highlights

  • Entered the next phase of its strategic partnership with Medtronic assuming exclusive worldwide distribution of the Mazor X system, and Medtronic making a $40 million third tranche investment in Mazor. On November 1, Mazor and Medtronic completed the transfer of Mazor X capital sales, clinical sales and support activities to Medtronic and the absorption of 29 former Mazor employees into the Medtronic robotic sales team.
  • Received CE approval of the Mazor X system, allowing Medtronic to market the Mazor X in the European Union, as well as other countries that recognize the CE Mark.
  • Interim data from the first multi-center prospective study of spinal surgical robotics was presented at the North American Spine Society (NASS) annual meeting, demonstrating that spinal surgeries performed using Mazor Robotics’ proprietary Mazor Core™ technology have a five-fold reduction in surgical complications and a seven-fold reduction in revision surgeries, compared to freehand-based minimally invasive lumbar fusion surgeries.

“We delivered record quarterly revenue and more than doubled last year’s Q3 results,” commented Ori Hadomi, Chief Executive Officer. “Our performance demonstrates that we are executing our objectives to drive market penetration and increased utilization of our systems. We entered the next phase with Medtronic, our commercial partner, for the Mazor X system and the smooth transition ensures continued sales momentum while significantly lowering our operating costs beginning Q4 2017. In addition to the operational achievements, the recent prospective data results that were presented at NASS are a game changer for Mazor as it validates the strength of our proprietary Mazor Core ™ technology and reinforces the patient value and economic proposition of our systems.”

THIRD QUARTER 2017 FINANCIAL RESULTS ON IFRS BASIS (“GAAP”)

Revenue for the three months ended September 30, 2017 increased 126% to $17.2 million compared to $7.6 million in the year-ago third quarter. U.S. revenue increased 170% to $15.4 million compared to $5.7 million in the year-ago third quarter, as the Company recognized revenue from 17 systems (16 Mazor X and one Renaissance) compared to six systems (three Mazor X and three Renaissance) in the third quarter of 2016. International revenue was $1.8 million compared to $1.9 million in the year-ago third quarter. Recurring revenue from kits sales, services and other increased 63% to $7.0 million in the third quarter of 2017 compared to $4.3 million in the year-ago third quarter, which is primarily attributed to the higher system installed base. The Company ended the quarter with a backlog of 17 systems (15 Mazor X and two Renaissance). As of September 18, 2017, Medtronic assumed exclusive worldwide distribution of the Mazor X under the Exclusive Lead Sharing and Distribution Agreement signed between the parties. The contracted pricing with Medtronic is at a lower rate than Mazor realized through its direct sales channel.

The Company’s gross margin for the three months ended September 30, 2017 was 69.2% compared to 65.7% in the year-ago third quarter. Total operating expenses were $15.7 million compared to $10.6 million in the year-ago third quarter primarily reflecting the Company’s increased investment in sales and marketing activities. The Company’s sales and marketing expenses are now expected to decrease as Medtronic assumed commercial responsibility for the Mazor X, effective September 18, 2017. Operating loss was $3.8 million compared to an operating loss of $5.6 million in the year-ago third quarter. Net loss for the third quarter of 2017 was $3.7 million, or $0.07 per share, compared to a net loss of $5.2 million, or $0.11 per share, for the year-ago third quarter.

Cash used in operating activities during the 2017 third quarter was $2.9 million compared to $4.6 million used in operating activities in the year-ago third quarter. The lower cash use is due to the significantly higher revenue in the 2017 third quarter. As of September 30, 2017, cash, cash equivalents and investments totaled $98.8 million.

THIRD QUARTER 2017 FINANCIAL RESULTS ON NON-GAAP BASIS

The tables below include reconciliation of the Company’s GAAP results to non-GAAP results. The reconciliation relates to non-cash expenses in the amount of $2.6 million with respect to share-based payments and amortization of intangible assets recorded in the third quarter of 2017. On a non-GAAP basis, the net loss in the third quarter of 2017 was $1.0 million, or $0.02 per share, compared to $4.9 million, or $0.11 per share, for the year-ago third quarter.

NINE MONTHS ENDED SEPTEMBER 30, 2017 FINANCIAL RESULTS ON IFRS BASIS (“GAAP”)

For the nine months ended September 30, 2017, revenue increased 99% and totaled $44.4 million compared to $22.3 million for the nine months ended September 30, 2016, due to higher system sales and an increase in recurring revenue. Recurring revenue totaled $18.5 million, an increase of 50% compared to $12.3 million in the nine months ended September 30, 2016. The growth in recurring revenue is attributed to the increase in the installed base and high utilization of the Company’s robotic guidance systems, both in the U.S. and globally. Gross margin for the nine months ended September 30, 2017 was 68.0% compared with 72.3% in the nine months ended September 30, 2016. This expected decrease is attributed mainly to the higher manufacturing costs of the Mazor X compared to the Renaissance system. Net loss for the nine months ended September 30, 2017 was $12.6 million, or $0.26 per share, compared to a net loss of $14.4 million, or $0.33 per share, in the first nine months of 2016.

NINE MONTHS ENDED SEPTEMBER 30, 2017 FINANCIAL RESULTS ON NON-GAAP BASIS

On a non-GAAP basis, the net loss for the first nine months of 2017 was $7.3 million, or $0.15 per share, compared to a net loss of $12.9 million, or $0.29 per share, in the first nine months of 2016.

CONFERENCE CALL INFORMATION

The Company will host a conference call to discuss its third quarter financial results as well as recent corporate developments on November 7, 2017 at 8:30 AM EST (3:30 PM IST). Investors within the United States interested in participating are invited to call 800-298-0498. Participants in Israel can use the toll-free dial-in number 1-80-924-6042. All other international participants can use the dial-in number 719-457-2654. For all callers, refer to Conference ID 5718138.

A replay of the event will be available for two weeks following the conclusion of the call. To access the replay, callers in the United States can call 1-866-375-1919 and reference the Replay Access Code: 5718138. All international callers can dial +1 719-457-0820, using the same Replay Access Code. To access the webcast, please visit www.mazorrobotics.com and select ‘Investor Relations.’

Use of Non-GAAP Measures

In addition to disclosing financial results calculated in accordance with generally accepted accounting principles in conformity with International Financial Reporting Standards (GAAP), this press release contains Non-GAAP financial measures for gross profit, operating expenses, operating loss, net loss and basic and diluted earnings per share that exclude the effects of capitalization of development costs, non-cash expense of amortization of intangible assets and share-based payments. Management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company’s performance that enhances management’s and investors’ ability to evaluate the Company’s net income and earnings per share and to compare them to historical net income and earnings per share.

The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company’s business internally and therefore decided to make these non-GAAP adjustments available to investors.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance System enables surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding continued sales momentum and significantly lower operating costs beginning Q4 2017, the recent prospective data results presented at NASS being a game changer for the Company, the expected decrease in sales and marketing expenses, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 1, 2017 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law

Mazor Robotics Ltd.
CONSOLIDATED STATEMENT OF PROFIT OR LOSS
(in thousands, except per share data)
(UNAUDITED)
Nine month period Three month period
ended September 30, ended September 30,
2017 2016 2017 2016
Revenue $ 44,378 $ 22,336 $ 17,204 $ 7,633
Cost of revenue $ 14,180 $ 6,182 $ 5,305 $ 2,616
Gross profit $ 30,198 $ 16,154 $ 11,899 $ 5,017
Operating expenses:
Research and development, net $ 5,692 $ 4,027 $ 1,658 $ 785
Selling and marketing, net $ 32,638 $ 22,781 $ 12,429 $ 8,125
General and administrative $ 5,310 $ 4,072 $ 1,653 $ 1,660
Total operating cost and expenses $ 43,640 $ 30,880 $ 15,740 $ 10,570
Loss from operations $ (13,442) $ (14,726) $ (3,841) $ (5,553)
Financing income, net $ 631 $ 345 $ 188 $ 142
Loss before taxes on income $ (12,811) $ (14,381) $ (3,653) $ (5,411)
Income tax expense (benefit) $ (250) $ 21 $ $ (188)
Net loss $ (12,561) $ (14,402) $ (3,653) $ (5,223)
Net loss per share – Basic and diluted $ (0.26) $ (0.33) $ (0.07) $ (0.11)
Weighted average common shares outstanding – Basic and diluted 48,334 43,981 49,011 46,159
Mazor Robotics Ltd.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION AS OF
(U.S. Dollars in thousands)
September 30, December 31,
2017 2016
(Unaudited) (Audited)
Current assets
Cash and cash equivalents $ 49,028 $ 14,954
Short-term investments 44,280 37,862
Trade receivables 6,185 8,225
Other current assets 2,011 1,728
Inventory 8,382 4,715
Total current assets 109,886 67,484
Non-current assets
Long-term investments 5,471 9,017
Property and equipment, net 4,146 3,615
Intangible assets, net 2,009 2,258
Other non-current assets 989 351
Total non-current assets 12,615 15,241
Total assets $ 122,501 $ 82,725
Current liabilities
Trade payables $ 1,654 $ 5,018
Deferred revenue 3,717 4,031
Other current liabilities 10,740 8,462
Total current liabilities 16,111 17,511
Non-current liabilities
Employee benefits 448 325
Total non-current liabilities 448 325
Total liabilities 16,559 17,836
Equity
Share capital 134 124
Share premium 217,145 174,647
Amounts allocated to warrants 9,629
Capital reserve for share-based payment transactions 11,336 9,859
Foreign currency translation reserve 2,119 2,119
Accumulated loss (134,421) (121,860)
Total equity 105,942 64,889
Total liabilities and equity $ 122,501 $ 82,725
Mazor Robotics Ltd.
CONSOLIDATED CASH FLOW STATEMENTS
(U.S. Dollars in thousands)
(UNAUDITED)
Nine months ended Three months ended
September 30, September 30,
2017 2016 2017 2016
Cash flows from operating activities:
Loss for the period $ (12,561) $ (14,402) $ (3,653) $ (5,223)
Adjustments:
Depreciation and amortization $ 1,107 $ 476 $ 393 $ 180
Gain on sale of property and equipment $ $ (6) $ $ (6)
Finance income, net $ (328) $ (313) $ (209) $ (140)
Share-based expenses $ 4,975 $ 3,378 $ 2,553 $ 1,244
Income tax expense (tax benefit) $ (250) $ 21 $ $ (188)
$ 5,504 $ 3,556 $ 2,737 $ 1,090
Change in inventory $ (3,967) $ (1,288) $ (1,017) $ (557)
Change in trade and other accounts receivable $ 1,774 $ 2,076 $ 514 $ (301)
Change in prepaid lease fees $ (30) $ (18) $ (8) $ (14)
Change in trade and other accounts payable $ (940) $ 1,635 $ (1,732) $ 302
Change in employee benefits $ 123 $ 39 $ (13) $ (29)
$ (3,040) $ 2,444 $ (2,256) $ (599)
Interest received $ 432 $ 235 $ 249 $ 98
Income tax paid $ (15) $ (38) $ $ 1
$ 417 $ 197 $ 249 $ 99
Net cash used in operating activities $ (9,680) $ (8,205) $ (2,923) $ (4,633)
Cash flows from investing activities:
Proceeds from (investment in) short-term investments and deposits, net $ 1,416 $ (11,617) $ (9,019) $ (9,240)
Purchase of long-term investments $ (4,288) $ (8,906) $ (3,665) $ (7,781)
Proceeds in long-term investments $ $ 498 $ $ 498
Purchase of property and equipment $ (1,557) $ (1,735) $ (244) $ (628)
Capitalization of development costs $ $ (1,517) $ $ (920)
Net cash used in investing activities $ (4,429) $ (23,277) $ (12,928) $ (18,071)
Cash flows from financing activities:
Proceeds from issuance of ADRs, net $ 40,000 $ 31,416 $ 40,000 $ 19,521
Proceeds from exercise of share options by employees $ 8,293 $ 3,587 $ 4,574 $ 3,464
Proceeds from exercise of share options and warrants, net $ $ 481 $ $
Net cash provided by financing activities $ 48,293 $ 35,484 $ 44,574 $ 22,985
Net increase in cash and cash equivalents $ 34,184 $ 4,002 $ 28,723 $ 281
Cash and cash equivalents at the beginning of the period $ 14,954 $ 13,519 $ 20,347 $ 17,277
Effect of exchange rate differences on balances of cash and cash equivalents $ (110) $ 76 $ (42) $ 39
Cash and cash equivalents at the end of the period $ 49,028 $ 17,597 $ 49,028 $ 17,597
Supplementary cash flows information:
Purchase of property and equipment in credit $ (96) $ (68) $ (96) $ (68)
Issuance costs in credit $ (22) $ (385) $ (22) $ (385)
Capitalization of development expenses on credit $ $ (20) $ $ (20)
Classification of inventory to fixed assets $ 300 $ $ 300 $
Mazor Robotics Ltd.
RECONCILIATIONS OF GAAP TO NON-GAAP FINANCIAL MEASURES
(U.S. Dollars in thousands, except per share data)
(UNAUDITED)
Nine month period Three month period
ended September 30, ended September 30,
2017 2016 2017 2016
GAAP gross profit $ 30,198 $ 16,154 $ 11,899 $ 5,017
Amortization of intangible assets 250 85
Share-based payments 248 170 140 87
Non-GAAP gross profit $ 30,696 $ 16,324 $ 12,124 $ 5,104
GAAP gross profit as percentage of revenues 68.0% 72.3% 69.2% 65.7%
Non-GAAP gross profit as percentage of revenues 69.2% 73.1% 70.5% 66.9%
GAAP operating expenses $ 43,640 $ 30,880 $ 15,740 $ 10,570
Share-based payments:
Research and development $ 641 $ 695 $ 289 $ 348
Selling and marketing $ 2,363 $ 1,972 $ 1,512 $ 757
General and administrative $ 1,723 $ 971 $ 612 $ 482
Development costs capitalization $ $ (2,332) $ $ (1,321)
Non-GAAP operating expenses $ 38,913 $ 29,574 $ 13,327 $ 10,304
GAAP operating loss $ (13,442) $ (14,726) $ (3,841) $ (5,553)
Non-GAAP operating loss $ (8,217) $ (13,250) $ (1,203) $ (5,200)
GAAP net loss $ (12,561) $ (14,402) $ (3653) $ (5,223)
Amortization of intangible assets $ 250 $ $ 85 $
Share-based payments $ 4,975 $ 3,808 $ 2,553 $ 1,674
Development costs capitalization $ $ (2,332) $ $ (1,321)
Non-GAAP net loss $ (7,336) $ (12,926) $ (1,015) $ (4,870)
GAAP basic and diluted loss per share $ (0.26) $ (0.33) $ (0.07) $ (0.11)
Non-GAAP basic and diluted loss per share $ (0.15) $ (0.29) $ (0.02) $ (0.11)

Contacts

EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
or
Doug Sherk, 646-445-4800
dsherk@evcgroup.com

Amedica Submits 510(k) Application to FDA for Valeo C+CSC with Lumen

SALT LAKE CITY, Nov. 06, 2017 (GLOBE NEWSWIRE) — Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company that develops and manufactures silicon nitride as a platform for biomedical applications, announced that the company made a 510(k) submission to the U.S Food and Drug Administration for its  Valeo C+CSC with Lumen spinal implant.

The Valeo C+CSC with Lumen is a modified CSC (cancellous structured ceramic) that is similar to Amedica’s commercially available Valeo C and Valeo C+ CSC (cleared in Europe only) cervical implants. This device increases implant surface area and plays an active role in the spinal fusion process while maintaining the other benefits silicon nitride brings to patients and physicians.

“The Valeo C+CSC with Lumen submission is a key step in introducing our proprietary porous silicon nitride technology into the US market. We look forward to working with the FDA on this important company milestone,” said Dr. Sonny Bal, Amedica CEO

About Amedica Corporation

Amedica is focused on the development and application of spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s products are manufactured in its ISO 13485 certified manufacturing facility, and it has a partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, and OEM and private label partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on September 20, 2017, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

Contacts:
Amedica IR
801-839-3502
IR@amedica.com

OrthoPediatrics Could Win By Tapping A Massive, Underserved Market, Says Stifel

Shanthi Rexaline , Benzinga Staff Writer /November 6, 2017

Orthopediatrics Corp KIDS 4.9% is poised to achieve strong top-line growth due to its exclusive focus on the sizeable and largely underserved $2.5 billion pediatric orthopedic market, according to Stifel.

Stifel initiated coverage of Orthopediatrics with a Buy rating and a $23 price target for the shares. The valuation represents a 5.5 times enterprise value to revenue multiple, applied to Stifel’s 2019 revenue estimate for Orthopediatrics of $63.6 billion and discounted 10 percent to the end of 2018.

The pediatric orthopedic market, including trauma and deformity, complex spine and sports medicine, offers the most comprehensive and still-expanding portfolio of pediatric orthopedic implants and instruments to treat a wide array of orthopedic conditions, said analyst Rick Wise.

Capitalizing on this opportunity, Wise said the firm can deliver top-line CAGR in the solid high teens, suggesting revenues that would icrease from an estimated $45 million this year to $98.5 million in 2022. This would put Orthopediatrics above the average revenue growth among its peers.

 

READ THE REST HERE

Hologic to retain CEO MacMillan | Personnel Moves – November 3, 2017

NOVEMBER 3, 2017/ BY 

Hologic (NSDQ:HOLX) said this week its current prez and CEO Stephen MacMillan will stay on with the company, resolving rumors that he may depart it to take up the corner office at Zimmer Biomet (NYSE:ZBH).

In an SEC filing, the Marlborough, Mass.-based company’s board said it approved a special “performance-based retention equity grant” to MacMillan after he had begun to receive interest from other medical device firms.

“Mr. MacMillan has led a dramatic turnaround of Hologic since joining in December 2013. The company’s performance has increased significantly under his leadership and he personally has recruited a large number of leaders to the company. In light of his long track record of success, other larger medical device companies have expressed interest over time in retaining him to serve as chief executive officer. Mr. MacMillan recently received such an offer from a large medical device company. The independent members of the company’s board of directors considered the potential for disruption to Hologic and its business should Mr. MacMillan leave, and determined that it was in the best interests of Hologic and its stockholders to retain him as chairman, president and chief executive officer. Accordingly, the independent members of the board, after careful consideration and discussions with Mr. MacMillan and the compensation committee’s compensation consultant, awarded him a special retention equity grant, all of which is performance-based. He has formally declined the other more substantial offer, reaffirmed his full commitment to Hologic, and will remain as chairman, president and chief executive officer of Hologic,” the company wrote in an SEC filing.

 

READ THE REST HERE

SANUWAVE Announces Exhibition at Wounds Canada 2017 Fall Conference

SUWANEE, GA–(Marketwired – Nov 3, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company will exhibit at Wounds Canada 2017 Fall Conference in Mississauga, Ontario on 16 – 19 November 2017. SANUWAVE cordially invites you to our booth number 111. Wounds Canada’s fall conference is a continuing education event designed to support healthcare professionals who work with patients with wounds or who are at risk for developing wounds. SANUWAVE is using this occasion to introduce and educate on our lead wound care product, dermaPACE®.

In Canada, 2.4 million people were living with diabetes in 2008-2009, a figure that is expected to rise to close to 4 million people by 2018-2019. Ulceration of the foot is one of the major health problems with diabetes, diabetic foot ulcers in acute inpatient care is a serious chronic disease, and is a major factor in the story of wounds. Wounds Canada, formerly Canadian Association of Wound Care, estimates that the average cost of treating a chronic wound in Canada is $10K and diabetes related ulcers cost the Canadian health care system $150M annually. Early treatment intervention with dermaPACE can prevent ulcers from developing complications such as infection that could lead to amputation.

“We are very excited about growing our activities in Canada in the wound care arena,” stated Mr. Richardson, Chief Executive Officer of SANUWAVE. “Our exhibition will be the springboard to establish and then grow our market presence in Canada.”

About SANUWAVE Health, Inc. 
SANUWAVE Health, Inc. (OTCQB: SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

CONTACT INFORMATION

  • Millennium Park Capital LLC
    Christopher Wynne
    312-724-7845
    cwynne@mparkcm.com

    SANUWAVE Health, Inc.
    Andre Mouton
    Vice President International Sales and Relations
    +1-615-823-9907 (Cell)
    +1-678-569-0881 (Fax)
    Skype: andre.w.mouton
    Andre.Mouton@sanuwave.com

Smith & Nephew Third Quarter 2017 Trading Report

Smith & Nephew plc (LSE:SN, NYSE:SNN) trading report for the third quarter ended 30 September
2017.

Highlights2

Q3 revenue was $1,152 million, up 3% on both a reported and underlying basis
• Revenue growth was 1% in the Established Markets, with US up 2%
• Emerging Markets up 9%, maintaining improved performance achieved in first half of 2017
• Reconstruction revenue up 4%, with 6% growth in Knee Implants, continuing strong, market-beating
performance, and Hip Implants up 1%, returning to growth
• Advanced Wound Management revenue grew 2%, reflecting recovery in Bioactives offset by Wound
Care
• Full year outlook at the lower end of guidance range
• Review of cost base initiated to further Simplify and Improve our Operating Model

Post-quarter events
• Chief Executive Officer’s intention to retire by the end of 2018 announced
• Agreement signed to acquire Rotation Medical, Inc., the developer of a novel tissue regeneration
technology for shoulder rotator cuff repair

Commenting on Q3, Olivier Bohuon, Chief Executive Officer of Smith & Nephew, said:

“I am pleased with what we have achieved so far in 2017, where our focus on execution is delivering
improvements in performance. Of particular note is the sustained nature of the market-beating growth
from our Knee Implants franchise and the strong Emerging Markets recovery across the year. We
delivered 3% revenue growth in the quarter, in-line with guidance despite the recent natural disasters in
the Americas delaying some procedures.

“After the quarter end we announced an agreement to acquire Rotation Medical. Its pioneering
bioinductive implant is a novel tissue regeneration technology for shoulder repair that treats an unmet
clinical need and is highly complementary to our leading Sports Medicine shoulder portfolio.

“Looking ahead, our focus on accelerating the top-line is unchanged and we are also starting the next
stage in our continuing drive to improve efficiency across the Group. I am as determined as ever to keep
pushing for further success, and to leave Smith & Nephew an even better company.”

Enquiries

Investors
Ingeborg Øie +44 (0) 20 7960 2285
Smith & Nephew

Media
Charles Reynolds +44 (0) 1923 477314
Smith & Nephew

Deborah Scott / Simon Conway +44 (0) 20 3727 1000
FTI Consulting

Analyst conference call
A conference call to discuss Smith & Nephew’s third quarter results will be held today at 8.00am GMT /
4.00am EDT, details of which can be found at www.smith-nephew.com/results.

Notes

1. All numbers given are for the quarter and nine months ended 30 September 2017 unless stated otherwise.

2. Unless otherwise specified as ‘reported’ all revenue growth throughout this document is ‘underlying’ after adjusting for the effects of currency translation and including the comparative impact of acquisitions and excluding disposals. All percentages compare to the equivalent 2016 period.

Underlying revenue growth is used to compare the revenue in a given period to the comparative period on a like-for-like basis. Underlying revenue growth reconciles to reported revenue growth, the most directly comparable financial measure calculated in accordance with IFRS, by making adjustments for the effect of acquisitions and disposals and the impact of movements in exchange rates (currency impact), as described below.

The effect of acquisitions and disposals measures the impact on revenue from newly acquired material business combinations, technologies and recent material business disposals. This is calculated by comparing the current year, constant currency actual revenue (which include acquisitions and exclude disposals from the relevant date of completion) with prior year, constant currency actual revenue, adjusted to include the results of acquisitions and exclude disposals for the commensurate period in the prior year.

Currency impact measures the increase/decrease in revenue resulting from currency movements on non-US Dollar sales and is measured as the difference between: 1) the increase/decrease in current year revenue translated into US Dollars at the current year average rate and the prior year revenue translated at the prior year average rate; and 2) the increase/decrease being measured by translating current and prior year revenue into US Dollars using a constant fixed rate.

Forward calendar

The full year results will be released on 8 February 2018

 

READ THE REST HERE

Global XLIF Surgery Market Dominating Industry are NuVasive Inc., RTI Surgical Inc. and K2M,Inc.

11-6-2017 – Press release from: Data Bridge Market Research

The report delivers a detailed study with present and upcoming Opportunities to clarify the future investment in the “Global XLIF surgery market” are expected to reach USD 2,557.74 million by 2024 from USD 1,644.68 million in 2016 at a CAGR of 5.7%. The new market report contains data for historic years 2015, the base year of calculation is 2016 and the forecast period is 2017 to 2024.

Segmentation:

By Product Type (XLIF interbody cages, XLIF interbody fusion systems) By End User (hospitals, spinal surgery centers, others)

Drivers:

Click & Get Free Sample Report Visit @ databridgemarketresearch.com/request-a-sample/?dbmr=globa…

The major factors driving the growth of this market are the rising number of minimally invasive procedures, increasing number of spinal disorders and growing number of geriatric population. On the other hand, higher expenses of treatment procedures, increasing research on substitutive treatments and stringent reimbursement policies. These factors increase the demand for XLIF surgery in patient.

RISING NUMBER OF MINIMALLY INVASIVE PROCEDURES

XLIF is the latest and advanced minimally invasive method for the anterior spine which is avoiding the incision that navigates the abdomen also avoiding the cut or disrupts the muscles of the back. XLIF surgery market is growing due to increasing number of the minimally invasive surgery.

INCREASING NUMBER OF SPINAL DISORDERS

The XLIF surgery market is growing due to the growing number of the spinal disorders globally. Spinal cord damage is among the most traumatic events that occur in an individual’s life. Spinal cord injury affects friends, family, employers, community and the health care system.

Read more about the Global XLIF Surgery Market Report Visit @: databridgemarketresearch.com/reports/global-xlif-surgery-…

GROWING NUMBER OF GERIATRIC POPULATION

Another major factor contributing to the growth of the XLIF surgery market includes increasing number of the elderly population in the country. Furthermore, government support in the form of funding also drives the growth of this market.

Major Players:

• NUVASIVE INC.:
Incorporated in 1997 and headquartered at San Diego, California, United States. The company is medical device company in the global spine surgery market. It develops minimally-disruptive surgical products and procedurally-integrated solutions for spine surgery. Its wide range of products is focused on various applications of spine fusion surgery and spinal fusion process.

• RTI Surgical Inc.:
Founded in 1997 and headquartered at Alachua, Florida, U.S., RTI Surgicals, Inc., is engaged in the development and marketing of biologic, metal, and synthetic implants. The company operates through four business segments, namely, spine, sports medicine and orthopedics, surgical specialties and cardiothoracic.

Ask more details to our expert Visit @: databridgemarketresearch.com/speak-to-analyst/?dbmr=globa…

• K2M, INC.:
Founded in 2004 and headquartered at Virginia, United States. K2M is engaged in the development, design and commercialization of the spine and minimally invasive spine technologies and techniques for the treatment of the spinal pathologies. K2M operates in four product categories such as complex spine, minimally invasive, degenerative, and biologics.

Recent Development:
1. In July 2017, K2M Group Holdings, Inc. signed the agreement with Mitsubishi Corporation subsidiary Japan Medicalnext Co., Ltd. for the distribution of K2M’s innovative spinal technologies in Japan.
2. In October 2016, K2M Group Holdings, Inc. received 510(k) clearance from FDA for the expansion of the CASCADIA Lateral Interbody System, which consists of the Lamellar 3D Titanium Technology. The CASCADIA Lateral Interbody System expanded the portfolio of the company for the minimally invasive surgery products

Related Report

U.S. XLIF Surgery Market – Industry Trends and Forecast to 2024

U.S. XLIF Surgery Market by Product Type, By End-Users, By Distribution Channel, By Country (U.S.) – Industry Trends and Forecast to 2024

Read More: databridgemarketresearch.com/reports/u-s-xlif-surgery-mar…

About Data Bridge Market Research:

Data Bridge Market Research set forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process.

Contact:
Vishal Dixit
Data Bridge Market Research
Tel: +1-888-387-2818
Email: Sales@databridgemarketresearch.com
Investor: investors@databridgemarketresearch.com
Visit Blog databridgemarketresearch.com/blog/
Follow us on LinkedIn: www.linkedin.com/company/data-bridge-market-research

This release was published on openPR.

Osiris Therapeutics, Inc. Announces Resolution of SEC Investigation

COLUMBIA, Md., Nov. 02, 2017 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (OTC Pink:OSIR) (the “Company”), a leading regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, today announced the resolution of the previously disclosed investigation by the Securities and Exchange Commission (the “SEC”) into the Company’s historical accounting practices.

The Company has agreed to settle with the SEC, without admitting or denying the allegations of the SEC, by consenting to the entry of a final judgment, subject to court approval, that permanently restrains and enjoins the Company from violating certain provisions of the federal securities laws. As part of the resolution, the Company also has agreed to pay a civil penalty in the amount of $1,500,000.  This resolution, if approved by the Court, will resolve, as to the Company, the matters alleged by the SEC in the complaint.

The Company cooperated fully with the SEC during its investigation. Since the SEC’s investigation began, the Company has made numerous important changes to its internal control over financial reporting and disclosure practices, hired a new chief executive officer, chief financial officer and general counsel, and enhanced staff in its accounting and finance departments.

“We are very pleased to have reached the resolution announced today, which relates to activities that occurred during the tenure of the Company’s former management team,” said Peter Friedli, Chairman of the Board of the Company. “We have instituted broad remedial measures designed to detect and prevent the issues that led to the matter being resolved, and this resolution allows us to continue moving forward with the Company’s critical mission of making advances in the area of cellular and regenerative medicine.”

The resolution announced today relates only to the SEC.  As previously disclosed, there is an ongoing criminal investigation being conducted by the U.S. Attorney’s Office for the Southern District of New York relating to matters that were also investigated by the SEC, and the Company is cooperating fully with the investigation by the U.S. Attorney’s Office.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, is a world leader in researching, developing, and marketing regenerative medicine products that improve health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, the Company continues to advance its research and development in biotechnology by focusing on innovation in regenerative medicine — including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in wound care, orthopedics, and sports medicine, including Grafix®, Stravix®, BIO (available exclusively through Stryker), and Cartiform® (available exclusively through Arthrex). Osiris, Grafix, Stravix and Cartiform are registered trademarks of Osiris Therapeutics, Inc., and BIO4 is a registered trademark of Howmedica Osteonics Corp. Osiris makes no claims concerning functional activities of Grafix or Stravix. Although well characterized in scientific literature and studies, preservation of tissue integrity including cells may not be indicative of clinical outcome. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include statements about the Company’s expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Such forward-looking statements include, without limitation, statements regarding the Company’s ability to move forward with its business activities, the effectiveness of the Company’s remediation measures, including the effectiveness of completed and planned improvements in its internal control over financial reporting.  Forward-looking statements are subject to known and unknown risks and uncertainties and could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Several factors could cause actual results to differ materially from those expressed in or contemplated by the forward-looking statements. Such factors include, but are not limited to, the identification of additional errors in the restatement process for the 2015 quarterly and interim periods, changes or additional errors uncovered by the Company or its independent registered accounting firm, changes in the scope or focus of the accounting adjustments, the risk that additional information may arise prior to the expected filing with the SEC of the Company’s audited financial statements for 2015, 2016 and 2017 or subsequent events that would require us to make adjustments.  In addition, the Company’s independent registered accounting firm may determine that other adjustments or errors exist in previously reported 2015 interim periods or other prior periods.  Other risk factors affecting the Company are discussed in detail in the Company’s filings with the SEC, including its Form 10-K/A for 2014.  Accordingly, you should not unduly rely on these forward-looking statements. The Company undertakes no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

For additional information, please contact:

Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1834
OsirisPR@Osiris.com

 

Source: Osiris Therapeutics, Inc.

News Provided by Acquire Media

Paragon 28® Increases its Robust Ankle Fracture Offering – Gorilla® Ankle Fracture Plating System – Hook Plating System Launched

ENGLEWOOD, Colo.Nov. 2, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach and facilitate reproducible results benefitting both the surgeon and patient.

Today Paragon 28 increases its robust foot and ankle specific portfolio even further with the addition of Hook Plates to the Gorilla® Ankle Fracture Plating System.  The Gorilla® Ankle Fracture Plating System now offers surgeons 52 total plates in ten families.  The Hook Plates are offered across three families and provide surgeons eight unique options to address fractures of the tibia and fibula with a hook plate design.

Paragon 28 Gorilla® Ankle Fracture Plating System – Hook Plates

  • All plates are 1.5mm thick and have a proximal and distal taper to assist in percutaneous insertion
  • All plates have chamfered edges to minimize soft tissue irritation
  • All plates accept 2.7, 3.5, and 4.2 mm locking and non-locking polyaxial screws

Straight Fibular Hook Plates

  • Available in 5 and 6 hole configurations
  • Hooks optimized to address comminuted lateral malleolus or avulsion fragments

Anatomic Fibular Hook Plates

  • Available in 5 and 6 hole right and left side specific configurations
  • Distal screw cluster allows for an interfrag screw to be placed through the hooks to provide support and additional fixation to distal fragment of the lateral malleolus

Medial Malleolus Hook Plates

  • Available in 2 and 4 hole plate configurations
  • Intended for fixation of comminuted or small fractures of the medial malleolus that may not be conducive to lag screw fixation

Case Specific Instrumentation

  • Single and Double Hook Plate Tamps
    • May be used to assist in initial plate placement, biasing of the plate (Single Plate Tamp), and seating of hook into distal aspect of fragment
  • Hook Screw Drill Guide
    • May be used with the Anatomic Fibular Hook Plates to aid in centering a screw between the hooks and distal plate screws
    • Placement of this screw through the hooks is intended to prevent distal fragment rotation and provide additional stability to the construct

Paragon 28 is grateful for the significant contributions Dr. Christopher Zingas, MD, Dr. John Kwon, MD and Dr. Michael Houghton, MD made as the surgeon designers of this system.

Product Page:
http://www.paragon28.com/products/ankle-fracture-plating-system/

CONTACT: Jim Edson, Director of Product Management and Marketing, jedson@paragon28.com

 

SOURCE Paragon 28

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Shoulder Arthroplasty Market – Global Opportunity Analysis and Industry Forecast, 2017-2023

LONDONNov. 2, 2017 /PRNewswire/ —

Shoulder Arthroplasty Market by Procedure (Partial Shoulder Arthroplasty, Total Shoulder Arthroplasty, and Revision Shoulder Arthroplasty), Device (Shoulder Arthroplasty Resurfacing Implants, Shoulder Arthroplasty Trauma Devices, and Shoulder Arthroplasty Platform Systems), Indication (Arthritis, Fracture/Dislocation, Rotator Cuff Tear Arthropathy, Hill Sachs Defect, and Other), and End User (Hospitals & Clinics, and Outpatient Surgical Centers) – Global Opportunity Analysis and Industry Forecast, 2017-2023

Download the full report: https://www.reportbuyer.com/product/5139386

Shoulder arthroplasty or shoulder replacement is a surgical procedure, which assists in the replacement of damaged ball and socket joint located in the shoulder. This is done using a prosthesis, usually consists of polythene and metal components. Shoulder arthroplasty has become a preferred modality of surgeons for the treatment of osteoarthritis, rheumatoid arthritis, and osteonecrosis, as these procedures have yielded significant and reproducible results. Large-scale adoption of total shoulder arthroplasty procedures for the treatment of people suffering from arthritis has highly contributed to the market growth.

Increase in prevalence of shoulder arthritis and rise in geriatric population worldwide drive the growth of the global shoulder arthroplasty market. In addition, rise in awareness towards shoulder arthroplasties and advancements in the surgical techniques supplement the market growth. However, increase in risk of postoperative complications, such as neurologic injury and hematoma, hampers the market growth. Conversely, rise in investments by the key players to manufacture shoulder arthroplasty devices in the developing economies is expected to offer lucrative opportunities for the market growth. The global shoulder arthroplasty market was valued at $1,080 million in 2016, and is expected to reach $1,814 million by 2023, registering a CAGR of 7.6% from 2017 to 2023.

The shoulder arthroplasty market is segmented based on procedure, device, indication, end user, and region. On the basis of procedure, the market is divided into partial shoulder arthroplasty, total shoulder arthroplasty, and revision shoulder arthroplasty. By device, it is categorized into shoulder arthroplasty resurfacing implants, shoulder arthroplasty trauma devices, and shoulder arthroplasty platform systems. Depending on indication, it is classified into arthritis, fracture/dislocation, rotator cuff tear arthropathy, Hill Sachs defect, and other. As per end user, it is fragmented into hospitals & clinics and outpatient surgical centers. Regionally, the market is analyzed across North AmericaEuropeAsia-Pacific, and LAMEA.

The total shoulder arthroplasty (TSA) segment accounted for the highest share in the global shoulder arthroplasty market in 2016, and is anticipated to register a highest CAGR of 9.2% from 2017 to 2023. This is attributed to increase in adoption of total reverse shoulder arthroplasty.

In addition, shoulder arthroplasties are majorly performed in hospitals and clinics, and thus this segment generated the highest revenue. In the recent years, Asia-Pacific witnessed rapid growth in the shoulder arthroplasties market, owing to steady increase in the population suffering from various forms of arthritis. Moreover, increase in investments by the key players of Japan and India to develop shoulder arthroplasty devices is projected to offer lucrative opportunities for the expansion of the market.

KEY BENEFITS FOR STAKEHOLDERS
The study provides an in-depth analysis of the global shoulder arthroplasty market with the current trends and future estimations to elucidate the imminent investment pockets.
Comprehensive analysis of the factors that drive and restrict the market growth is provided.
Comprehensive quantitative analysis of the industry is provided from 2016 to 2023 to assist stakeholders to capitalize on the prevailing market opportunities.
Extensive analysis of the key segments of the industry helps to understand the trends in shoulder arthroplasty devices and procedures performed globally.
Key players and their strategies are provided to understand the competitive outlook of the industry.

KEY MARKET SEGMENTS

By Procedure
Partial Shoulder Arthroplasty
Partial Resurfacing
Hemi Resurfacing
Partial-mid Head
Stemmed Hemi
Total Shoulder Arthroplasty
Total Resurfacing
Total-mid Head
Total Conventional
Total Reverse
Revision Shoulder Arthroplasty

By Device
Shoulder Arthroplasty Resurfacing Implants
Shoulder Arthroplasty Trauma Devices
Shoulder Arthroplasty Platform Systems

By Indication
Arthritis
Osteoarthritis
Rheumatoid Arthritis
Other Inflammatory Arthritis
Fracture/Dislocation
Rotator Cuff Tear Arthropathy
Hill Sachs Defect
Other

By End User
Hospitals & Clinics
Outpatient Surgical Centers

By Region
North America
U.S.
Canada
Mexico
Europe
UK
France
Germany
Italy
Spain
Rest of Europe
Asia-Pacific
Japan
China
India
Australia
South Korea
Rest of Asia-Pacific
LAMEA
Brazil
South Africa
Turkey
Saudi Arabia
Rest of LAMEA

KEY MARKET PLAYERS
Wright Medical Group, Inc. /Tornier Inc.
Integra LifeSciences Corporation
Zimmer Biomet
Johnson & Johnson (DePuy Synthes)
Arthrex, Inc.
Smith and Nephew Plc.
Conmed Corporation
DJO Global
Evolutis
Exactech, Inc.

The other players in the value chain include (profiles not included in the report)
Implantcast GmbH
Lima Corporate
Medacta International
Kinamed Incorporated
Corin
Imascap SAS
Catalyst Orthoscience
Biotechni
Cayenne Medical
BioTek Instruments, Inc.

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Reportbuyer is a leading industry intelligence solution that provides all market research reports from top publishers
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Sarah Smith
Research Advisor at Reportbuyer.com
Email: query@reportbuyer.com
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