Patients sue B. Braun alleging defect in replacement knees

Posted On November 8, 2017 By OrthoSpineNews In Regulatory, Top Stories /

By Peter Hall of The Morning Call / November 7, 2017

Medical device maker B. Braun concealed from regulators problems with its line of ceramic-coated artificial knees and promoted the products to surgeons despite knowing they were prone to fail, a lawsuit filed in a California court alleges.

The Bethlehem-based company’s Aesculap Implant Systems subsidiary marketed the “advanced surface” ceramic coated knees as superior to standard bare metal implants, claiming they would last longer, the lawsuit says. But the ceramic joints were defective, the suit alleges, because they didn’t adhere properly to cement used to bond them with the patients’ bones.

As a result, the 25 knee replacement patients who are suing B. Braun and Aesculap in a California court were or will be required to undergo additional surgeries to correct problems with the joints or implant different devices, the suit says.

A spokesman for B. Braun, a German company with U.S. headquarters in Bethlehem, did not respond to messages Tuesday.

The lawsuit was filed last month in Los Angeles Superior Court by attorneys Christopher K. Johnston of Guaynabo, Puerto Rico, and Anthony Buzbee of Houston on behalf of the patients, who are from Louisiana, Florida and 10 other states.

According to the lawsuit, Aesculap sought and received permission from the U.S. Food and Drug Administration to sell its advanced surface replacement knees by demonstrating that the devices were as safe and effective as devices that had already been approved. The process is less rigorous than the FDA’s standard medical device approval process, the suit says.

READ THE REST HERE

Misonix Reports First Quarter Fiscal Year 2018 Financial Results

Posted On November 8, 2017 By OrthoSpineNews In Financial /

FARMINGDALE, N.Y., Nov. 7, 2017 /PRNewswire/ — Misonix, Inc. (Nasdaq: MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today financial results for the first quarter of fiscal year 2018, ended September 30, 2017.

Financial Highlights for the First Quarter:

Revenue for the first quarter of fiscal year 2018 was $7.3 million, an increase of 18% compared with $6.2 million in the previous year’s first quarter.
Consumables sales in the United States increased 25% to $4.1 million in the first quarter of the new fiscal year compared to $3.3 million in the comparable quarter of fiscal 2017.
The gross profit percentage for the quarter was 70.1% primarily from a strong mix of higher margin consumables, compared to 69.0% in last year’s first quarter.
For the first quarter of fiscal year 2018, the Company reported a net loss of $(1.2) million, or $(0.14) per diluted share, compared to a net loss of $(0.5) million, or $(0.07) per diluted share, in the first quarter of fiscal year 2017.
At September 30, 2017, the Company maintained cash of $10.5 million with no long-term debt.

Stavros Vizirgianakis, President and Chief Executive Officer of Misonix, said, “Sales orders continued to be strong in the first quarter of fiscal year 2018, with double-digit revenue growth, picking up where we left off in fiscal 2017. Total revenue increased 18% in the first quarter of the new year primarily attributable to a 25% increase in domestic consumables sales. A significant contribution to the increase in domestic sales was made by the addition of new clinical sales specialists to support the sales activities of our distribution channel. The channel, coupled with our team of 28 clinical sales specialists, was successful in driving a 35% increase in BoneScalpel revenue in the U.S. over the prior year. We are making steady progress with the surgical community, and the hospitals where they practice, to further embed our technology in their respective surgical suites.”

“At the recent 32^nd Annual Meeting of the North American Spine Society,” Mr. Vizirgianakis continued, “Dr. Wade Jensenof the Center for Neurosciences, Orthopaedics & Spine (“CNOS”) presented data showing a significant reduction in the use of bone grafting material when the Misonix BoneScalpel is employed compared to the use of standard power drill instruments. An estimated $1.9 billion is spent annually on bone graft substitutes. This is valuable data as we are able to show that our products contribute significant value to the overall healthcare system by reducing costs in spinal fusion procedures.”

The Company also recently entered into its most significant license, royalty and manufacturing agreement with Hunan Xing Hang Rui Kang Bio-Technologies Co., Ltd., a Chinese corporation, where Misonix will receive at least $11 million in revenue and royalties over the next four years, and further strengthen its balance sheet.

Conference Call
The Company has scheduled a conference call for Tuesday, November 7, 2017, at 4:30 pm ET to review the results.

Interested parties can access the conference call by dialing (844) 861-5497 or (412) 317-6579 or can listen via a live Internet webcast, which is available in the Investor Relations section of the Company’s website at www.misonix.com.

A teleconference replay of the call will be available for three days at (877) 344-7529 or (412) 317-0088, confirmation # 10113569. A webcast replay will be available in the Investor Relations section of the Company’s website at www.misonix.com for 30 days.

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2017, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Financial Tables to Follow

MISONIX INC. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
	For the three months ended
	September 30,
	2017	2016

Net sales	$ 7,280,723	$ 6,171,625
Cost of goods sold	2,177,355	1,912,007
Gross profit	5,103,368	4,259,618

Operating expenses:
Selling expenses	3,570,713	3,325,687
General and administrative expenses	2,573,131	1,931,821
Research and development expenses	901,274	492,084
Total operating expenses	7,045,118	5,749,592
Loss from operations	(1,941,750)	(1,489,974)

Other income (expense):
Interest income	13	19
Royalty income and license fees	452,971	944,068
Other	(4,458)	(1,996)
Total other income	448,526	942,091

Loss from operations before income taxes	(1,493,224)	(547,883)

Income tax benefit	(281,000)	(26,000)
Net loss	$ (1,212,224)	$ (521,883)

Net loss per share – Basic	$ (0.14)	$ (0.07)

Net loss per share – Diluted	$ (0.14)	$ (0.07)

Weighted average shares – Basic	8,958,405	7,809,385
Weighted average shares – Diluted	8,958,405	7,809,385

MISONIX INC. and Subsidiaries
Consolidated Balance Sheets

	September 30,	June 30,
	2017	2017
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$ 10,528,041	$ 11,557,071
Accounts receivable, less allowance for doubtful accounts of $96,868 and $96,868, respectively	4,153,511	5,133,389
Inventories, net	5,206,025	4,992,434
Prepaid expenses and other current assets	504,653	918,899
Total current assets	20,392,230	22,601,793

Property, plant and equipment, net of accumulated amortization and depreciation of $8,134,134 and $7,794,580, respectively	3,842,419	3,730,203
Patents, net of accumulated amortization of $1,025,930 and $995,568, respectively	715,177	719,136
Goodwill	1,701,094	1,701,094
Intangible and other assets	280,684	282,876
Deferred income tax	5,524,422	4,334,547
Total assets	$ 32,456,026	$ 33,369,649

Liabilities and shareholders’ equity
Current liabilities:
Accounts payable	$ 2,106,506	$ 1,861,228
Accrued expenses and other current liabilities	1,815,527	3,346,138
Total current liabilities	3,922,033	5,207,366

Deferred lease liability	7,016	9,354
Deferred income	8,989	13,087
Total liabilities	3,938,038	5,229,807

Commitments and contingencies

Shareholders’ equity:
Common stock, $.01 par value-shares authorized 20,000,000; 9,365,666 and 9,357,166 shares issued and outstanding in each period, respectively	93,657	93,572
Additional paid-in capital	37,490,220	36,808,810
Accumulated deficit	(9,065,889)	(8,762,540)
Total shareholders’ equity	28,517,988	28,139,842
Total liabilities and shareholders’ equity	$ 32,456,026	$ 33,369,649

Corporate Contact	Investor Contact
Joe Dwyer	Joe Diaz
Misonix, Inc.	Lytham Partners
631-927-9113	602-889-9700
jdwyer@misonix.com	mson@lythampartners.com

SOURCE Misonix, Inc.

SPINEWAY: Joseph Brigneaud nominated to Spineway’s Board of Directors

Posted On November 8, 2017 By OrthoSpineNews In Spine /

Ecully, 7 November 2017

The Board of Directors of Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), has co-opted Mr. Joseph Brigneaud as an independent Board member.

Joseph Brigneaud, a partner at MAELO Capital – a private-equity investment firm, has over 15 years’ experience in supporting and financing companies. Having opened and headed Euronext’s regional office in Lyon for three years, he has considerable expertise in listed SMEs and mid-cap companies.

As from 23 October 2017, the composition of Spineway’s Board of Directors is as follows:

Stéphane Le Roux, Chairman of the Board – Chairman and CEO of Spineway.

Philippe Laurito, Board member – Managing Director of Spineway, President of Spineway USA, Inc.
Bérangère Boggio, Independent Board member – Director of Legal Affairs and HR at MEDAC since 2013 after seven years with the MYLAN pharmaceutical group.
Joseph Brigneaud, Independent Board member.

Stéphane Le Roux, Chairman and CEO of Spineway, said, “We are thrilled to welcome Joseph Brigneaud as a member of our Board of Directors. His perfect understanding of the stock markets and his expertise in growing SMEs will help us increase our development and successfully pursue our geographic expansion.”

SPINEWAY IS ELIGIBLE FOR THE PEA-PME

SPINEWAY will be attending the SFAF Mid-Caps conference on 14 November 2017

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 turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), received the OSEO Excellence award as well as the Deloitte Fast 50 award in 2011. Rhône Alpes INPI Patent Innovation Award (2013) – Talent INPI award (2015).
ISIN code: FR0011398874 – Euronext Growth

This press release is entered into in both English and French languages. In case of discrepancies, French language shall prevail.

Contacts:

Investor Relations
David Siegrist – Finance Director
+33 (0)4 72 77 01 52
finance.dsg@spineway.com

Financial Communication
Jérôme Gacoin / Solène Kennis
+33 (0)1 75 77 54 68
skennis@aelium.fr

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/cba803a0-08bf-446d-b4fd-a2179bf35d7

AlloSource Announces Bob Lay As Chief Operating Officer

Posted On November 7, 2017 By OrthoSpineNews In Biologics, Top Stories /

CENTENNIAL, Colo., Nov. 7, 2017 /PRNewswire-USNewswire/ — AlloSource, one of the nation’s largest providers of cartilage, bone, skin, soft-tissue and cellular allografts for use in surgical procedures and wound care to advance patient healing, today announced the appointment of Bob Lay as Chief Operating Officer.

With over 20 years of experience in both finance and operations, Bob has a broad-based understanding of how each department within an organization impacts another. He has an extensive background working with businesses and medical device companies to conduct operational audits, improve processes and systems, and balance the needs of many departments to drive company growth and success.

“The Chief Operating Officer role at AlloSource is critical to creating the cellular and tissue products surgeons need to help restore mobility in more patients,” said Thomas Cycyota, AlloSource President and Chief Executive Officer. “Bob’s background, as well as his open-minded approach to driving improvements, will help us identify new opportunities to advance the work we do.”

In addition to his role as Chief Operating Officer, Bob also served AlloSource as the Director of Cost Accounting and Vice President, Operations. Prior to his time at AlloSource, he held leadership roles at both startups and large companies. Bob received his Bachelor’s and Master’s degrees in Accounting from the University of Denver.

“I am honored to lead the dedicated and passionate Operations team at AlloSource,” said Lay. “AlloSource’s commitment to donors and patients inspires me every day, and I look forward to contributing to the organization’s continued growth.”

About AlloSource
AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource’s products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world’s largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help patients heal from severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country’s most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website, allograftpossibilities.org.

Media Contact
Megan Duggan
AlloSource
720. 382. 2766
mduggan@allosource.org

SOURCE AlloSource

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

Posted On November 7, 2017 By OrthoSpineNews In Financial /

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

Posted On November 6, 2017 By OrthoSpineNews In Regulatory, Spine /

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

Posted On November 6, 2017 By OrthoSpineNews In Financial, Top Stories /

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

Posted On November 6, 2017 By OrthoSpineNews In Financial, Top Stories /

NOVEMBER 3, 2017/ BY FINK DENSFORD

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

Posted On November 6, 2017 By OrthoSpineNews In Biologics /

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

Posted On November 6, 2017 By OrthoSpineNews In Financial /

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

Author: OrthoSpineNews

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Contacts

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

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

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

SANUWAVE Announces Exhibition at Wounds Canada 2017 Fall Conference

CONTACT INFORMATION

Smith & Nephew Third Quarter 2017 Trading Report