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Scopis Introduces the First Mixed-Reality Surgical Holographic Navigation Platform Integrating Microsoft HoloLens

Posted On May 5, 2017 By OrthoSpineNews In Spine /  

May 05, 2017

CAMBRIDGE, Mass. & BERLIN–(BUSINESS WIRE)–Scopis, a company specializing in surgical navigation and medical augmented and mixed reality technologies, announced today the launch of its newest development, the Holographic Navigation Platform for use in surgery. Scopis developed this platform to offer greater precision and speed to surgeons, and better outcomes to patients undergoing open and minimally-invasive spinal procedures. The added innovation of incorporating Microsoft HoloLens into the Scopis Navigation Platform lets surgeons plan the positioning and alignment of pedicle screws during multiple vertebrae fixation surgeries, for example.

To use the Scopis Holographic Navigation Platform during such an operation, the surgeon wears Microsoft HoloLens glasses, which communicate wirelessly with the Scopis system. The planned positioning of the pedicle screws is projected onto the surgeon’s field of view and overlaid exactly onto the patient, creating the mixed reality experience. This allows the surgeon to find the screws’ planned positions faster and to align surgical instruments interactively with the holographic visualization.

“Scopis’ holographic solution has the potential to make spine surgery more effective, safe, and precise,” said Professor Christian Woiciechowsky, Chief of the Spinal Surgery Clinic at Vivantes Humboldt Hospital in Berlin. “Integrating mixed-reality tools into surgery is a huge technological advancement toward enhancing a surgeon’s vision and may provide greater benefits to patients.”

Scopis’ technology improves the accuracy of mixed reality overlay using additional 3-D position tracking. The Scopis holographic platform revolutionizes surgical workflows by enabling surgeons to use gestures to place virtual monitors into their visual field near the patient, so their eyes remain on the operative field. A video demonstrating the platform’s technological advantages is featured on Scopis’ YouTube channel: https://www.youtube.com/user/ScopisMedical/

Scopis’ technology could also benefit patients and medical professionals by reducing the radiation exposure from fluoroscopy devices that are currently used to determine the optimal position for screw placement during surgery, as well as improve surgical outcomes through more precise alignment and shorter surgery times.

“Scopis’ Holographic Navigation Platform is a universal solution that offers specific advantages for spinal surgeries and can also be applied in the many other areas where the highest levels of precision and speed are critical. In neurosurgery, for example, brain tumors could be located faster and with higher accuracy,” said Bartosz Kosmecki, CEO and Founder of Scopis. “The development of this holographic platform further highlights Scopis’ leading role in medical mixed and augmented reality.”

About Scopis

Scopis is a leader in medical augmented reality (AR), mixed reality, and hybrid navigation, creating innovative solutions for the healthcare market, including technology for surgical education, and planning and navigation systems for otorhinolaryngology (ENT), craniomaxillofacial (CMF), neuro- and spine surgery, and bronchoscopy. In over 50 countries worldwide, surgeons have performed more than 10,000 surgeries with the aid of Scopis’ products and have benefitted from the highly-advanced image guidance and visualization capabilities of Scopis’ technology.

Scopis is known as one of the top vendors and innovators for surgical navigation systems and has business operations in Germany and the United States. www.scopis.com

For Visual and Multimedia Representations of Scopis’ Products:

http://holographic.scopis.com

http://www.scopis.com

https://www.youtube.com/user/ScopisMedical/

Regional availability. Not all Scopis products are available for sale in the United States.

Contacts

Scopis:
Bartosz Kosmecki
CEO & Founder
(+1) (512) 578-9127
pr@scopis.com
or
Media Contact:
MacDougall Biomedical Communications
Joanne Tudorica or Gretchen Schweitzer
+49 89 2424 3494 or +49 176 210 37191
jtudorica@macbiocom.com
For Commercial and Surgical Inquiries:
Scopis Inc.
inquiries@scopis.com

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Ready, steady, go: Tightened EU medical device regulations are here

Posted On May 5, 2017 By OrthoSpineNews In Regulatory /  

by , Medical Plastics News – May 5, 2017

The European Commission has published the in vitro diagnostic medical device Regulation (IVDR) and the medical device Regulation (MDR).

The next step is a transition period of three years for medical devices and five years for in-vitro devices (IVD)s meaning that the new rules will fully apply at the end of May 2020 for medical devices and at the end of May 2022 for IVDs.

“The medical technology industry welcomes the fact that the transition and implementation period has finally come” said Serge Bernasconi, CEO of MedTech Europe. “Now we open a new chapter – the industry is ready to collaborate with all actors to ensure a timely and smooth transition to the new regulations.”, he added.

Going forward, implementation of the regulations is a top priority for the industry and MedTech Europe. With the publication of the regulations, a new and intensive phase of work begins for regulators and stakeholders. Many pieces of secondary legislation and guidelines will need to be developed in order to be able to implement the regulations on time.

It is important that notified bodies are designated early in the transition period and have the capacity to manage the assessment of over 500,000 medical technologies to the updated requirements within the set timeframe.

 

READ THE REST HERE

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Orthofix International Reports First Quarter 2017 Financial Results

Posted On May 5, 2017 By OrthoSpineNews In Financial /  

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX) today reported its financial results for the first quarter ended March 31, 2017. Net sales were $102.7 million, loss per share from continuing operations was ($0.13) and adjusted earnings per share from continuing operations was $0.27.

“We are very pleased with the top-line results for the first quarter 2017 and the momentum we achieved in each of our businesses,” said Brad Mason, President and Chief Executive Officer. “The solid execution of our commercial strategies is delivering results as demonstrated by another strong quarter in our BioStim business and an earlier than expected return to growth in both Biologics and Spine Fixation. Although each strategic business unit has its own commercial strategy, our overriding corporate focus is on expanding distribution in underserved markets, improving engagement of our legacy distributors and providing our salesforce with a robust stream of new products. Our bottom-line results reflect the investments we are making in these key strategies, which are proving effective in driving our top line growth.”

Financial Results Overview

The following table provides net sales by strategic business unit (“SBU”):

Three Months Ended March 31,
(Unaudited, U.S. Dollars, in thousands) 2017 2016 Change

Constant
Currency
Change
BioStim $ 44,539 $ 41,044 8.5 % 8.5 %
Biologics 14,987 14,094 6.3 % 6.3 %
Extremity Fixation 23,945 24,709 (3.1 %) (1.0 %)
Spine Fixation 19,267 18,832 2.3 % 2.3 %
Net sales $ 102,738 $ 98,679 4.1 % 4.6 %

Gross profit increased $3.6 million to $80.2 million. Gross margin increased slightly to 78.0% compared to 77.6% in the prior year period, which was in line with our expectations. Net margin (gross profit less sales and marketing expenses) was $31.6 million compared to $31.7 million in the prior year period. The decrease in net margin was primarily due to higher sales and marketing expenses, driven by a higher mix of sales from new distributors in our Biologics and Spine Fixation SBUs, who typically receive higher commission rates in their first year.

Net loss from continuing operations was ($2.3) million, or ($0.13) per share, compared to net income of $4.6 million, or $0.24 per share in the prior year period. The net loss for the quarter was impacted by strategic investments in the quarter of $7.1 million, including a pre-tax impairment of $5.6 million on our eNeura investment. Adjusted net income from continuing operations was $4.9 million, or $0.27 per share, compared to adjusted net income of $5.2 million, or $0.28 per share in the prior year period.

EBITDA was $6.6 million, compared to $13.8 million in the prior year period. Adjusted EBITDA was $15.7 million or 15.3% of net sales for the first quarter, compared to $15.5 million or 15.7% of net sales in the prior year period.

Liquidity

As of March 31, 2017, cash and cash equivalents were $41.7 million compared to $39.6 million as of December 31, 2016. As of March 31, 2017, we had no outstanding indebtedness and borrowing capacity of $125 million. Cash flow from operations decreased $1.2 million to $3.5 million, while free cash flow increased $1.3 million to ($0.4) million.

2017 Outlook

For the year ending December 31, 2017, the Company expects the following results, assuming exchange rates are the same as those currently prevailing.

Previous 2017 Outlook Current 2017 Outlook
(Unaudited, U.S. Dollars, in millions, except per share data) Low High Low High
Net sales $ 407.0 $ 411.0 $ 411.0

1

 $ 415.0

1
Net income from continuing operations $ 24.4 $ 29.3 $ 20.6

2

 $ 23.7

2
Adjusted EBITDA $ 76.0 $ 79.0 $ 76.0

3

 $ 79.0

3
EPS from continuing operations $ 1.33 $ 1.59 $ 1.12

4

 $ 1.29

4
Adjusted EPS from continuing operations $ 1.48 $ 1.58 $ 1.48

5

 $ 1.58

5
1 Represents a year-over-year increase of 0.3% to 1.3% on a reported basis
2 Represents a year-over-year increase of 489.1% to 577.7%
3 Represents a year-over-year decrease of 0.4% to 4.2%
4 Represents a year-over-year increase of 489.5% to 578.9%
5 Represents a year-over-year increase of 1.4% to 8.2%

Conference Call

Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company’s financial results for the first quarter of 2017. Interested parties may access the conference call by dialing (888) 364-3109 in the U.S. and (719) 457-2631 outside the U.S., and referencing the conference ID 9028875. A replay of the call will be available for two weeks by dialing (888) 203-1112 in the U.S. and (719) 457-0820 outside the U.S., and entering the conference ID 9028875. A webcast of the conference call may be accessed by going to the Company’s website at www.orthofix.com, by clicking on the Investors link and then the Events and Presentations page.

About Orthofix

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the Company’s sales representatives and distributors. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children, and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (“the Exchange Act”), and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. These forward-looking statements are not guarantees of our future performance and involve risks, uncertainties, estimates and assumptions that are difficult to predict. Therefore, our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to further update any such statement, or the risk factors described in Part I, Item 1A under the heading Risk Factors in our Form 10-K for the year ended December 31, 2016, to reflect new information, the occurrence of future events or circumstances or otherwise.

ORTHOFIX INTERNATIONAL N.V.
Consolidated Statements of Operations
Three Months Ended
March 31,
(Unaudited, U.S. Dollars, in thousands, except share and per share data) 2017 2016
Net sales $ 102,738 $ 98,679
Cost of sales 22,581 22,137
Gross profit 80,157 76,542
Sales and marketing 48,532 44,822
General and administrative 18,282 17,005
Research and development 7,424 7,640
Operating income 5,919 7,075
Interest income (expense), net 45 (38 )
Other income (expense), net (4,348 ) 1,833
Income before income taxes 1,616 8,870
Income tax expense (3,924 ) (4,294 )
Net income (loss) from continuing operations (2,308 ) 4,576
Discontinued operations
Loss from discontinued operations (527 ) (990 )
Income tax benefit 181 254
Net loss from discontinued operations (346 ) (736 )
Net income (loss) $ (2,654 ) $ 3,840
Net income (loss) per common share—basic
Net income (loss) from continuing operations $ (0.13 ) $ 0.25
Net loss from discontinued operations (0.02 ) (0.04 )
Net income (loss) per common share—basic $ (0.15 ) $ 0.21
Net income (loss) per common share—diluted
Net income (loss) from continuing operations $ (0.13 ) $ 0.24
Net loss from discontinued operations (0.02 ) (0.04 )
Net income (loss) per common share—diluted $ (0.15 ) $ 0.20
Weighted average number of common shares:
Basic 17,979,675 18,477,881
Diluted 17,979,675 18,758,751
ORTHOFIX INTERNATIONAL N.V.
Consolidated Balance Sheets
(U.S. Dollars, in thousands except share data) March 31,

2017

 December 31,

2016
(unaudited)
Assets
Current assets
Cash and cash equivalents $ 41,652 $ 39,572
Restricted cash — 14,369
Accounts receivable, net of allowances of $8,394 and $8,396, respectively 59,443 57,848
Inventories 66,271 63,346
Prepaid expenses and other current assets 19,478 19,238
Total current assets 186,844 194,373
Property, plant and equipment, net 47,962 48,916
Patents and other intangible assets, net 8,530 7,461
Goodwill 53,565 53,565
Deferred income taxes 41,431 47,325
Other long-term assets 16,413 20,463
Total assets $ 354,745 $ 372,103
Liabilities and shareholders’ equity
Current liabilities
Accounts payable $ 16,555 $ 14,353
Other current liabilities 46,316 69,088
Total current liabilities 62,871 83,441
Other long-term liabilities 24,740 25,185
Total liabilities 87,611 108,626
Contingencies
Shareholders’ equity
Common shares $0.10 par value; 50,000,000 shares authorized; 18,042,834 and

17,828,155 issued and outstanding as of March 31, 2017 and December 31,

2016, respectively

 1,804 1,783
Additional paid-in capital 208,686 204,095
Retained earnings 61,525 64,179
Accumulated other comprehensive loss (4,881 ) (6,580 )
Total shareholders’ equity 267,134 263,477
Total liabilities and shareholders’ equity $ 354,745 $ 372,103

ORTHOFIX INTERNATIONAL N.V.
Non-GAAP Financial Measures

The following tables present reconciliations of net income (loss) from continuing operations, earnings per share from continuing operations, gross profit, and net cash from operating activities, in each case calculated in accordance with U.S. generally accepted accounting principles (“GAAP”), to, as applicable, non-GAAP financial measures, referred to as “EBITDA,” “Adjusted EBITDA,” “Adjusted net income from continuing operations,” “Adjusted earnings per share from continuing operations,” “Net margin” and “Free cash flow” that exclude items specified in the tables. A more detailed explanation of the items excluded from these non-GAAP financial measures, as well as why management believes the non-GAAP financial measures are useful to them, is included following the reconciliations.

EBITDA and Adjusted EBITDA
Three Months Ended

March 31,
(Unaudited, U.S. Dollars, in thousands) 2017 2016
Net income (loss) from continuing operations $ (2,308 ) $ 4,576
Interest expense (income), net (45 ) 38
Income tax expense 3,924 4,294
Depreciation and amortization 5,075 4,873
EBITDA $ 6,646 $ 13,781
Share-based compensation 2,816 2,099
Foreign exchange impact (1,013 ) (1,815 )
Strategic investments 7,100 198
SEC / FCPA matters and related costs 141 245
Infrastructure investments — 962
Legal judgments/settlements 227 —
International restructuring (239 ) —
Adjusted EBITDA $ 15,678 $ 15,470
As a % of net sales 15.3 % 15.7 %

Adjusted Net Income from Continuing Operations
Three Months Ended

March 31,
(Unaudited, U.S. Dollars, in thousands) 2017 2016
Net income (loss) from continuing operations $ (2,308 ) $ 4,576
Foreign exchange impact (1,013 ) (1,815 )
Strategic investments 7,100 198
SEC / FCPA matters and related costs 141 245
Infrastructure investments — 962
Legal judgments/settlements 227 —
International restructuring (239 ) —
Long-term income tax rate adjustment 948 1,079
Adjusted net income from continuing operations $ 4,856 $ 5,245

Adjusted Earnings per Share from Continuing Operations
Three Months Ended

March 31,
(Unaudited, per diluted share) 2017 2016
EPS from continuing operations $ (0.13 ) $ 0.24
Foreign exchange impact (0.06 ) (0.10 )
Strategic investments 0.39 0.01
SEC / FCPA matters and related costs 0.01 0.01
Infrastructure investments — 0.05
Legal judgments/settlements 0.01 —
International restructuring (0.01 ) —
Long-term income tax rate adjustment 0.06 0.07
Adjusted EPS from continuing operations $ 0.27 $ 0.28
Weighted average number of diluted common shares 18,235,660 18,758,751

Net Margin
Three Months Ended

March 31,
(Unaudited, U.S. Dollars, in thousands) 2017 2016
Gross profit $ 80,157 $ 76,542
Sales and marketing (48,532 ) (44,822 )
Net margin $ 31,625 $ 31,720
BioStim $ 17,133 $ 16,408
Biologics 6,171 6,104
Extremity Fixation 6,412 7,175
Spine Fixation 2,007 2,335
Corporate (98 ) (302 )
Net margin $ 31,625 $ 31,720

Free Cash Flow
Three Months Ended

March 31,
(Unaudited, U.S. Dollars, in thousands) 2017 2016
Net cash from operating activities $ 3,470 $ 4,646
Capital expenditures (3,905 ) (6,399 )
Free cash flow $ (435 ) $ (1,753 )

2017 Outlook
Previous 2017 Outlook Current 2017 Outlook
(Unaudited, U.S. Dollars, in millions) Low High Low High
Net income from continuing operations $ 24.4 $ 29.3 $ 20.6 $ 23.7
Interest expense, net 0.1 0.2 0.1 0.2
Income tax expense 16.2 15.7 13.6 14.3
Depreciation and amortization 20.0 20.0 20.0 20.0
EBITDA $ 60.7 $ 65.2 $ 54.3 $ 58.2
Share-based compensation 11.8 11.8 11.8 11.8
Foreign exchange impact — — (1.0 ) (1.0 )
Strategic investments 1.2 0.7 8.6 8.1
SEC / FCPA matters and related costs 1.3 0.8 1.3 1.0
International restructuring 1.0 0.5 0.8 0.7
Legal judgments/settlements — — 0.2 0.2
Adjusted EBITDA $ 76.0 $ 79.0 $ 76.0 $ 79.0
Previous 2017 Outlook Current 2017 Outlook
(Unaudited, per diluted share) Low High Low High
EPS from continuing operations $ 1.33 $ 1.59 $ 1.12 $ 1.29
Foreign exchange impact — — (0.05 ) (0.05 )
Strategic investments 0.06 0.04 0.46 0.44
SEC / FCPA matters and related costs 0.07 0.04 0.07 0.05
International restructuring 0.05 0.03 0.04 0.04
Legal judgments/settlements — — 0.01 0.01
Long-term income tax rate adjustment (0.03 ) (0.12 ) (0.17 ) (0.20 )
Adjusted EPS from continuing operations $ 1.48 $ 1.58 $ 1.48 $ 1.58
Weighted average number of diluted common shares 18,400,000 18,400,000 18,400,000 18,400,000

Constant Currency

Constant currency is a non-GAAP measure, which is calculated by using foreign currency rates from the comparable, prior-year period, to present net sales at comparable rates. Constant currency can be presented for numerous GAAP measures, but is most commonly used by management to analyze net sales without the impact of changes in foreign currency rates.

EBITDA

EBITDA is a non-GAAP financial measure, which is calculated by adding interest income (expense), net; income tax expense; and depreciation and amortization to net income (loss) from continuing operations. EBITDA provides management with additional insight to its results of operations.

Adjusted EBITDA, Adjusted Net Income from Continuing Operations and Adjusted Earnings per Share from Continuing Operations

These non-GAAP financial measures provide management with additional insight to its results of operations and are calculated using the following adjustments:

  • Share-based compensation – costs related to our share-based compensation plans, which include stock options, restricted stock awards, performance-based restricted stock awards, market-based restricted stock awards and our stock purchase plan
  • Foreign exchange impact – gains and losses related to foreign currency transactions; guidance presented does not include the impact of any future foreign exchange fluctuations
  • Strategic investments – costs related to our strategic investments, including our investment in eNeura, Inc.
  • SEC / FCPA matters and related costs – legal and other professional fees associated with the SEC Investigation, Securities Class Action Complaint and Brazil subsidiary compliance review
  • Infrastructure investments – costs associated with our multi-year process and systems improvement effort, “Bluecore,” which was completed in 2016
  • Legal judgments/settlements – adverse or favorable legal judgments or negotiated legal settlements
  • International restructuring – costs related to a planned restructuring, primarily consisting of severance charges and the write-down of certain assets
  • Long-term income tax rate adjustment – reflects management’s expectation of a long-term normalized effective tax rate of 38%, which is based on current tax law and current expected income; actual tax expense will ultimately be based on GAAP performance and may differ from the 38% effective tax rate due to a variety of factors, including the jurisdictions in which profits are determined to be earned and taxed, the resolutions of issues arising from tax audits with various tax authorities, and the ability to realize deferred tax assets

Net Margin

Net margin is a non-GAAP financial measure, which is calculated by subtracting sales and marketing from gross profit. Net margin is the primary metric used by our Chief Operating Decision Maker in managing our business.

Free Cash Flow

Free cash flow is a non-GAAP financial measure, which is calculated by subtracting capital expenditures from cash flow from operating activities. Free cash flow is an important indicator of how much cash is generated or used by our normal business operations, including capital expenditures. Management uses free cash flow as a measure of progress on its capital efficiency and cash flow initiatives.

Usefulness and Limitations of Non-GAAP Financial Measures

Management uses non-GAAP measures to evaluate performance period-over-period, to analyze the underlying trends in our business, to assess performance relative to competitors and to establish operational goals and forecasts that are used in allocating resources. Management uses these non-GAAP measures as the basis for assessing the ability of the underlying operations to generate cash. In addition, management uses these non-GAAP measures to further its understanding of the performance of our business units.

Material Limitations Associated with the Use of Non-GAAP Financial Measures

The non-GAAP measures used in this press release may have limitations as analytical tools, and should not be considered in isolation or as a replacement for GAAP financial measures. Some of the limitations associated with the use of these non-GAAP financial measures are that they exclude items that reflect an economic cost and can have a material effect on cash flows. Similarly, certain non-cash expenses, such as equity compensation, do not directly impact cash flows, but are part of total compensation costs accounted for under GAAP.

Compensation for Limitations Associated with Use of Non-GAAP Financial Measures

We compensate for the limitations of our non-GAAP financial measures by relying upon GAAP results to gain a complete picture of our performance. The GAAP results provide the ability to understand our performance based on a defined set of criteria. The non-GAAP measures reflect the underlying operating results of our businesses, which we believe is an important measure of our overall performance. We provide a detailed reconciliation of the non-GAAP financial measures to our most directly comparable GAAP measures, and encourage investors to review this reconciliation.

Usefulness of Non-GAAP Financial Measures to Investors

We believe that providing non-GAAP financial measures that exclude certain items provides investors with greater transparency to the information used by senior management in its financial and operational decision-making. Management believes it is important to provide investors with the same non-GAAP metrics it uses to supplement information regarding the performance and underlying trends of our business operations in order to facilitate comparisons to its historical operating results and internally evaluate the effectiveness of our operating strategies. Disclosure of these non-GAAP financial measures also facilitates comparisons of our underlying operating performance with other companies in the industry that also supplement their GAAP results with non-GAAP financial measures.

Contacts

Orthofix International N.V.
Mark Quick, 214-937-2924
markquick@orthofix.com

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SeaSpine Reports First Quarter 2017 Financial Results

Posted On May 5, 2017 By OrthoSpineNews In Financial /  

CARLSBAD, Calif., May 04, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today financial results for the first quarter ended March 31, 2017.

First Quarter 2017 Financial Highlights and Recent Accomplishments

  • Revenue of $31.9 million, an increase of 1.6% year-over-year
  • U.S. revenue of $28.6 million, an increase of 0.2% year-over-year
    • U.S. orthobiologics revenue of $15.1 million
    • U.S. spinal hardware revenue of $13.5 million
  • International revenue of $3.3 million, an increase of 15.0% year-over-year
  • Initial launch of the reusable Rapid Graft Delivery System, which is designed to provide surgeons a cost-effective and controlled method to predictably deliver a broad range of orthobiologic grafts efficiently to the disc space
  • Initial launch of the Daytona Small Stature Pediatric Deformity System, a minimal profile version of our existing Daytona system that provides both a clinical and cosmetic benefit for pediatric patients

“Our first quarter performance reflects early traction with our strengthening distributor base and our expanding and updated product portfolio,” said Keith Valentine, President and Chief Executive Officer. “We are continuing to invest in key objectives aimed at top line performance while simultaneously reducing our net cash spend to extend our liquidity horizon.”

First Quarter 2017 Financial Results
Revenue for the first quarter of 2017 totaled $31.9 million, a 1.6% increase compared to the same period of the prior year. Total revenue in the U.S. was $28.6 million, a 0.2% increase compared to same period of the prior year.

Orthobiologics revenue totaled $17.1 million, a 2.8% increase compared to the first quarter of 2016. The increase in orthobiologics revenue was driven by an increase in both U.S. and international sales, primarily due to the addition of new distributors in both markets. Spinal hardware revenue totaled $14.8 million, a 0.2% increase compared to the first quarter of 2016. The increase in spinal hardware revenue was driven by the recent addition of a new distributor in Latin America.

Gross margin for the first quarter of 2017 was 58.7%, compared to 54.5% for the same period in 2016.  The increase in gross margin was primarily driven by a $1.7 million provision for excess orthobiologics raw material inventory recorded in the first quarter of 2016. This was somewhat offset by a $0.2 million increase in the first quarter of 2017 in non-cash amortization of technology intangible assets from the NLT acquisition and by lower gross margins associated with international sales, which were slightly higher as a percentage of total revenue compared to the same period of the prior year.

Operating expenses for the first quarter of 2017 totaled $27.8 million, compared to $29.4 million for the same period of the prior year.  The $1.6 million decrease in operating expenses was driven by lower selling, general and administrative and intangible amortization expenses.

Net loss for the first quarter of 2017 was $9.1 million, compared to a net loss of $12.0 million for the first quarter of 2016.

Cash and cash equivalents at March 31, 2017 were $12.7 million and the Company had $3.9 million of outstanding borrowings against its $30 million credit facility.

2017 Financial Outlook
Consistent with prior guidance, SeaSpine expects full-year 2017 revenue to be in the range of $129 to $133 million, reflecting growth of 0% to 3% over full-year 2016 revenue.

Webcast and Conference Call Information
The Company’s management team will host a conference call beginning today at 1:30pm PT/4:30pm ET to discuss the financial results and recent business developments. Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 2407268. To listen to the webcast, please visit the investor relations section of the SeaSpine website at www.seaspine.com.

About SeaSpine
SeaSpine is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal hardware solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal hardware portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive, complex, deformity and degenerative procedures. We believe expertise in both orthobiologic sciences and spinal hardware product development helps SeaSpine to offer its surgeon customers a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: revenue expectations for full-year 2017; and the Company’s ability to drive top-line performance and revenue growth while simultaneously reducing net cash spend.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use our existing products and to adopt our newly launched products; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; disruption to our existing distribution network as new distributors are added and the inability of new distributors to generate growth, or even offset lost business; the risk that our products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing, including in ongoing and future studies, the outcomes of which inherently are uncertain; the lack of clinical validation of products in “alpha release” and the fact they may require substantial additional development activities, which could introduce unexpected expense and delay; the risk of supply shortages, including as a result of our dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; third-party payors’ willingness to continue to provide, for our existing products, and to initiate, for our newly launched products, appropriate coverage, coding and reimbursement and uncertainty resulting from healthcare reform, both in the U.S. and abroad; unexpected expense, including as a result of developing and launching new and next generation products and product line extensions; our ability to sustain current operations and to continue to invest in product development, sales and marketing initiatives at levels sufficient to drive future revenue growth in light of cost-reduction initiatives first implemented in 2016 and that continue to impact current operations; our ability to obtain funding on a timely basis on acceptable terms, or at all, to execute our business strategy; general economic and business conditions in the markets in which we do business, both in the U.S. and abroad; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended March 31,
2017 2016
Total revenue, net $ 31,894 $ 31,399
Cost of goods sold 13,172 14,283
Gross profit 18,722 17,116
Operating expenses:
Selling, general and administrative 23,970 25,374
Research and development 3,050 2,753
Intangible amortization 792 1,281
Total operating expenses 27,812 29,408
Operating loss (9,090 ) (12,292 )
Other income (expense), net (13 ) 258
Loss before income taxes (9,103 ) (12,034 )
Benefit for income taxes — (27 )
Net loss $ (9,103 ) $ (12,007 )
Net loss per share, basic and diluted $ (0.79 ) $ (1.08 )
Weighted average shares used to compute basic and diluted net loss per share 11,586 11,167
SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET DATA
(In thousands)
March 31, 2017 December 31, 2016
Cash and cash equivalents $ 12,726 $ 14,566
Trade accounts receivable, net of allowances of $480 and $483 19,388 20,982
Inventories 42,993 45,299
Total current liabilities 22,064 24,418
Short-term debt 67 445
Long-term borrowings under credit facility 3,914 3,835
Total stockholders’ equity 106,654 110,977 
Investor Relations Contact
Lynn Pieper Lewis
(415) 937-5402
ir@seaspine.com
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MiMedx EpiFix® Receives Coverage From Kaiser Permanente

Posted On May 5, 2017 By OrthoSpineNews In Biologics /  

MARIETTA, Ga., May 4, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the Company’s EpiFix® product has received coverage from insurer Kaiser Permanente, effective April 1, 2017.

Founded in 1945 and headquartered in Oakland, California, Kaiser Permanente is one of the nation’s largest not-for-profit health plans. With this coverage decision, the Kaiser 7.4 million commercial members now have coverage for EpiFix. Kaiser’s medical policy, “Wound Care Treatments,” now includes EpiFix for up to eight applications in 12 weeks when there is evidence of wound healing. Kaiser considers EpiFix medically necessary for treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). EpiFix is the first and only placental-based product covered by Kaiser for the treatment of DFUs and VLUs.

Parker H. “Pete” Petit, Chairman and CEO said, “We are pleased to have received coverage from Kaiser and to add them to our list of insurers providing access to our dehydrated Human Amnion/Chorion Membrane (dHACM) allografts for their covered members. Kaiser joins the broad list of insurers providing coverage, which list already includes major national health plans such as Aetna, Cigna, Anthem and virtually all of the other Blue Cross/Blue Shield health plans, plus a vast number of regional insurers. With the addition of Kaiser, over 317 million commercial covered lives and Medicare/Medicaid beneficiaries now have reimbursement access to EpiFix.”

Bill Taylor, President and COO, commented, “Our evidence-based publications demonstrating the clinical efficacy and cost effectiveness of our allografts have been instrumental in gaining coverage for our allografts from both the commercial payers such as Kaiser, as well as the federal and state payers. Our Compendium, now totaling 46 peer-reviewed published studies including completed Randomized Control Trials (RCTs), scientific studies and significant case studies, is unmatched in our industry, and it is the catalyst for our success in gaining awards of coverage. We are very gratified that so many commercial health plan members and federal and state beneficiaries have access to the positive clinical outcomes that our allografts produce.”

About MiMedx

MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 800,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, the Company’s belief that evidence-based publications demonstrating the clinical efficacy and cost effectiveness of its allografts have been instrumental in gaining coverage for the allografts from both commercial payers and federal and state payers. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that future evidence-based publications may not be as impactful in gaining reimbursement coverage, reimbursement is always subject to change and may therefore impact cost effectiveness of care, access to coverage may not translate into broader use of the Company’s products, individual results from using the Company’s products may vary, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2016 and its most recent 10-Q filing.  By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

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VTI has Partnered with Medikon to Distribute Its InterFuse® Products in Turkey

Posted On May 5, 2017 By OrthoSpineNews In Spine, Top Stories /  

(PRWEB) MAY 04, 2017

VTI – Vertebral Technologies, Inc. a MIS spinal implant medical device company based in Minneapolis, MN, has partnered with the Turkish Medical Distribution company Medikon to distribute its InterFuse® product line in Turkey. Medikon will serve as an extension to VTI to meet the growing demand of high quality spinal fusion products in Turkey.

“We are excited to start working with Medikon, the company has been serving the Turkish spine surgeon community since 1995 with highly differentiated products and I’m convinced they will do an excellent job selling the InterFuse® product line,” says VTI’s Vice President of International Sales Ben Wasscher.

Sinan Kazmaci Managing Director of Medikon stated, “At Medikon we are excited to be working with the InterFuse® modular cage. When we presented the product to our most important surgeons, there was a great deal of enthusiasm and excitement for the product. Surgeons thought that the modular approach to achieve a large footprint through a small access channel was a great idea and many of them are keen to start with InterFuse®, especially for their more challenging patients.”

ABOUT MEDIKON
Medikon Ltd. Was founded in 1995, and is active in the field of spinal surgery, neurosurgery and orthopedic surgery products. Medikon is the foremost distributor of unique spinal products manufactured by some of the world’s leading companies. The company employs close to 100 people operates with 7 branches and 15 dealers all over Turkey including Ankara and İstanbul. Learn more about Medikon here: http://www.medikon.net/

ABOUT VTI’S INTERFUSE® SPINAL FUSION SYSTEM
VTI’s InterFuse® System is an intra-operative assembly technology, which allows surgeons to implant a large footprint device through a minimally invasive approach. The shape of each device is biomechanically optimized to match the contours of the endplate and the unique anatomical shape and size of each patient’s disc space. Learn more about VTI’s InterFuse product here: http://www.vti-spine.com/product/interfuse/

ABOUT VTI – VERTEBRAL TECHNOLOGIES, INC.
VTI – Vertebral Technologies, Inc. is a privately held company based in Minneapolis, MN, USA. VTI is dedicated to the design, development, manufacturing and marketing of medical devices to address painful conditions of the spine through less-invasive surgical approaches. VTI’s products utilize its unique modular-assembly technology to deliver solutions optimized for both surgeons and their patients. VTI sells its InterFuse® modular interbody fusion devices worldwide. Learn more about VTI here: http://www.vti-spine.com/

For more information, visit: http://www.vti-spine.com or contact Brian Thron at marketing(at)vti-spine(dot)com or + 1.877.912.5401.

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Anika Reports First Quarter 2017 Financial Results

Posted On May 5, 2017 By OrthoSpineNews In Financial /  

BEDFORD, Mass., May 03, 2017 (GLOBE NEWSWIRE) — Anika Therapeutics, Inc. (NASDAQ:ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the first quarter ended March 31, 2017, along with business progress in the periods.

“We made important progress executing our long-term growth strategy in the first quarter of 2017,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “We finalized the clinical study design for an additional Phase III clinical trial of CINGAL, and we commenced planning and site initiation activities for the trial in the quarter. MONOVISC continued its strong momentum with revenue growth of 24% year-over-year for the quarter, and we achieved a significant milestone in our global expansion with the launch of ORTHOVISC-T in Europe.”

First Quarter Financial Results

  • Total revenue for the first quarter of 2017 increased 5% to $23.4 million, compared to $22.3 million for the first quarter of 2016.
  • Worldwide Orthobiologics revenue grew 3% year-over-year in the first quarter of 2017. MONOVISC revenue increased 24% year-over-year in the first quarter of 2017, and it was the main revenue growth driver in the period.
  • International Orthobiologics revenue increased 12% for the first quarter of 2017, due primarily to the global expansion of MONOVISC, as well as the growth of CINGAL in Europe and Canada. Domestically, ORTHOVISC and MONOVISC continue to maintain a combined market leading position.
  • Total operating expenses for the first quarter of 2017 were $15.4 million, compared to $11.6 million for the first quarter of 2016. The increase in total operating expenses was due primarily to higher research and development spending required to advance the Company’s product pipeline, expanded operational efforts, and increased professional service fees.
  • Net income for the first quarter of 2017 was $5.5 million, or $0.37 per diluted share, compared to $6.9 million, or $0.45 per diluted share, for the first quarter of 2016. The decline in net income was due primarily to the planned increase in operating expenses previously discussed.

Recent Business Highlights
The Company made key commercial, operational, pipeline, and financial advancements, including:

  • Finalizing the clinical study design for an additional Phase III clinical trial of CINGAL, and commencing site initiation activities for the trial. The trial is a randomized, double-blind, active comparator controlled, multi-center study of CINGAL to demonstrate that CINGAL provides symptomatic relief of osteoarthritis of the knee in patients who have not responded to conservative treatment.
  • Launching ORTHOVISC-T in Europe to relieve pain and restore function in tendons affected by chronic lateral epicondylosis.
  • Advancing its product pipeline with continued progress on enrolling patients in the FastTRACK Phase III HYALOFAST Study for cartilage repair, as well as the Phase III MONOVISC study for the treatment of osteoarthritis pain in the hip.
  • Progressing the consolidation of the Company’s global manufacturing operations at Anika’s Bedford, Massachusetts corporate headquarters.
  • Completing the build-out of the Company’s new European headquarters and training center in Padova, Italy.

Conference Call Information
Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights tomorrow, Thursday, May 4th at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the “Investor Relations” section of Anika’s website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika’s website approximately two hours after the completion of the event.

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ:ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements
The statements made in this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

 

Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
     
    For the Three Months Ended March 31,
2017 2016
Product revenue $ 23,381 $ 22,278
Licensing, milestone and contract revenue 5 5
Total revenue 23,386 22,283
Operating expenses:
Cost of product revenue 6,083 5,425
Research & development 4,230 2,159
Selling, general & administrative 5,067 3,990
Total operating expenses 15,380 11,574
Income from operations 8,006 10,709
Interest income, net 58 72
Income before income taxes 8,064 10,781
Provision for income taxes 2,571 3,886
Net income $ 5,493 $ 6,895
Basic net income per share:
Net income $ 0.38 $ 0.46
Basic weighted average common shares outstanding 14,576 14,875
Diluted net income per share:
Net income $ 0.37 $ 0.45
Diluted weighted average common shares outstanding 15,043 15,307
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
(unaudited)
 
    March 31,    December 31, 
ASSETS   2017 2016
Current assets:
Cash and cash equivalents $ 119,368 $ 104,261
Investments 19,250 20,500
Accounts receivable, net of reserves of $196 and $194 at March 31,
2017 and December 31, 2016, respectively		 21,079 27,598
Inventories 16,180 15,983
Prepaid expenses and other current assets 1,173 2,098
Total current assets 177,050 170,440
Property and equipment, net 51,593 52,296
Long-term deposits and other 1,234 69
Intangible assets, net 10,162 10,227
Goodwill 7,328 7,214
Total assets $ 247,367 $ 240,246
LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities:  
Accounts payable $ 6,050 $ 2,303
Accrued expenses and other current liabilities 4,167 6,496
Total current liabilities 10,217 8,799
Other long-term liabilities 400 2,126
Deferred tax liability 6,722 6,548
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $.01 par value; 1,250 shares authorized, no shares
issued and outstanding at December 31, 2016 and December 31,
2015, respectively		 – –
Common stock, $.01 par value; 60,000 and 30,000 shares
authorized, 14,655 and 14,627 shares issued and outstanding at
March 31, 2017 and December 31, 2016, respectively		 146 146
Additional paid-in-capital 63,719 61,735
Accumulated other comprehensive loss (7,025 ) (7,317 )
Retained earnings 173,188 168,209
Total stockholders’ equity 230,028 222,773
Total liabilities and stockholders’ equity $ 247,367 $ 240,246

 

Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data 
             
 
Revenue by Product Line and Product Gross Margin
(in thousands, except percentages)
(unaudited)
  For the Three Months Ended March 31, 
Product Line:  2017 %   2016 %
Orthobiologics $ 20,227 87 % $ 19,587 88 %
Surgical 1,296 5 % 1,318 6 %
Dermal 425 2 % 381 2 %
Other 1,433 6 % 992 4 %
Product Revenue $ 23,381 100 % $ 22,278 100 %
Product Gross Profit $ 17,298 $ 16,853
Product Gross Margin 74% 76%
             
Product Revenue by Geographic Region
(in thousands, except percentages)
(unaudited)
             
  For the Three Months Ended March 31, 
  2017 % 2016 %
Geographic Region:     
United States $ 18,930 81 % $ 18,011 81 %
Europe 2,829 12 % 2,565 11 %
Other 1,622 7 % 1,702 8 %
Product Revenue $ 23,381 100 % $ 22,278 100 %

CONTACT:
Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D., President and CEO
Sylvia Cheung, CFO
Tel:  781-457-9000

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InVivo Therapeutics Provides Clinical Update and Reports 2017 First Quarter Financial Results

Posted On May 4, 2017 By OrthoSpineNews In Financial /  

May 04, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today provided a clinical update, an update on patients in the INSPIRE study of the Neuro-Spinal Scaffold™, and reported financial results for the quarter ended March 31, 2017.

“The AIS grade improvement rate observed thus far in the INSPIRE study compares favorably to the natural history of spinal cord injury”

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Clinical/Regulatory Update

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “In the first quarter, we continued to make significant progress at InVivo and with the INSPIRE study. By early April, we had enrolled four new patients into the INSPIRE study, with three patients enrolled within 30 days of each other. We also announced four new clinical sites for the INSPIRE study.

In addition to progress with INSPIRE enrollment and sites, we achieved several regulatory milestones. Health Canada approved the company’s Investigational Testing Authorization application to commence a clinical study of the Neuro-Spinal Scaffold in patients with acute, complete (AIS A) cervical (C5-T1) spinal cord injuries (SCIs), and we announced the opening of our first site for the cervical study, Toronto Western Hospital. We also announced the Medicines Healthcare Products Regulatory Agency (MHRA) approval of the company’s Clinical Trial Authorization Application to commence the INSPIRE study in the United Kingdom. Finally, we submitted the first module of our Humanitarian Device Exemption (HDE) application to the FDA.

Looking forward, we anticipate completing enrollment in the INSPIRE study in the third quarter and filing an HDE application for marketing approval of the Neuro-Spinal Scaffold in early 2018.”

INSPIRE Patient Updates

There are currently 14 INSPIRE patients in follow-up, and eight have reached the six-month primary endpoint. Of these eight patients, five had an AIS grade improvement (compared to baseline) and three did not have an AIS grade improvement at 6 months post-injury (a 62.5% conversion rate at 6 months). The INSPIRE AIS improvement rate remains considerably higher than rates observed in a range of SCI natural history databases.

InVivo announced in January 2017 that a patient enrolled into INSPIRE in December 2016 had improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury at the one-month evaluation. At a recent follow-up visit (the first since January), the patient was assessed to have reverted back to a complete AIS A spinal cord injury.

Separately, in March 2017 InVivo announced that a patient enrolled in January 2017 had improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury at the two-month evaluation. At the recent three-month follow-up evaluation, the patient was assessed to have reverted back to a complete AIS A spinal cord injury.

There are previously published examples of patients with baseline AIS A spinal cord injury that are assessed to have an AIS grade improvement followed by a return to complete AIS A status within the first year after injury. In a 2009 article, 12.5% (2/16) of baseline AIS A spinal cord injury patients (cervical and thoracic) who experienced an AIS grade improvement were later assessed to return to complete AIS A status within the first year after injury. Of those two patients, one patient improved back to an incomplete AIS grade within the same year.*

“The AIS grade improvement rate observed thus far in the INSPIRE study compares favorably to the natural history of spinal cord injury,” CEO and Chairman Mark Perrin said. “We look forward to monitoring these patients’ progress as they reach the primary endpoint at six months post-injury and as we work towards completing enrollment of INSPIRE.”

Financial Results

For the three-month period ended March 31, 2017, the Company reported a net loss of approximately $6.4 million, or $0.20 per diluted share, compared to a net loss of $6.6 million, or $0.24 per diluted share, for the three-month period ended March 31, 2016. The results for the three-month period ended March 31, 2017 were unfavorably impacted by increases in operating expenses of $816,000 in research and development and $286,000 in general and administrative, partially offset by a non-cash gain on the derivative warrant liability of $241,000 reflecting changes in the fair market value of the derivative warrant liability. The results for the three-month period ended March 31, 2016 were unfavorably impacted by a non-cash loss on the derivative warrant liability of $1.0 million. Excluding the impact of the derivative warrant liability, adjusted net loss for the three-month period ended March 31, 2017 was $6.6 million, or $0.21 per diluted share, compared to adjusted net loss of $5.6 million, or $0.20 per diluted share, for the three-month period ended March 31, 2016.

The Company ended the quarter with $26.8 million of cash, cash equivalents, and marketable securities.

Adjusted net loss and adjusted net loss per share are non-GAAP financial measures that exclude the impact of the derivative warrant liability. A reconciliation of these measures to the comparable GAAP measure is included with the tables contained in this release. The Company believes a presentation of these non-GAAP measures provides useful information to investors to better understand the Company’s operations, on a period-to-period comparable basis, with financial amounts both including and excluding the identified items.

* Spiess et al. Conversion in ASIA Impairment Scale during the First Year after Traumatic Spinal Cord Injury. Journal of Neurotrauma 26: 2027-2036 (November 2009).

About The INSPIRE Study

The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. The FDA has recommended that InVivo include a control arm in the study as part of a Study Design Consideration. We are in discussions with the FDA on this recommendation, and we continue to believe that our current study design is sufficient to demonstrate safety and probable benefit in support of an HDE application for marketing approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110.

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, refer to https://clinicaltrials.gov/ct2/show/study/NCT03105882.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold and the progress of the clinical program. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to complete The INSPIRE Study, submit an HDE application, and receive regulatory approval for the Neuro-Spinal Scaffold, the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended March 31, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

InVivo Therapeutics Holdings Corp.
Consolidated Balance Sheets
Unaudited
As of

March 31, 2017

 December 31, 2016
ASSETS:
Current assets:
Cash and cash equivalents 14,440 21,464
Restricted cash 361 361
Short-term marketable securities 11,649 11,577
Prepaid expenses and other current assets 940 451
Total current assets 27,390 33,853
Long-term marketable securities 751 —
Property, equipment and leasehold improvements, net 395 510
Other assets 415 421
Total assets 28,951 34,784
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities:
Accounts payable 1,038 1,011
Loan payable, current portion 430 423
Derivative warrant liability 1,073 1,314
Deferred rent, current portion 147 141
Accrued expenses 1,421 1,959
Total current liabilities 4,109 4,848
Loan payable, net of current portion 742 852
Deferred rent, net of current portion 95 135
Other liabilities 36 —
Total liabilities 4,982 5,835
Stockholders’ equity:
Common stock, $0.00001 par value, authorized 100,000,000 shares; issued and

outstanding 32,123,392 shares at March 31, 2017; issued and outstanding 32,044,087

shares at December 31, 2016

1

1
Accumulated other comprehensive loss (2) —
Additional paid-in capital 187,523 185,955
Accumulated deficit (163,553) (157,007)
Total stockholders’ equity 23,969 28,949
Total liabilities and stockholders’ equity 28,951 34,784
InVivo Therapeutics Holdings Corp.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Three Months Ended March 31,
2017 2016
Operating expenses:
Research and development 3,384 2,568
General and administrative 3,285 2,999
Total operating expenses 6,669 5,567
Operating loss (6,669) (5,567)
Other income (expense):
Interest income 57 54
Interest expense (20) (63)
Derivatives gain (loss) 241 (1,047)
Other income (expense), net 278 (1,056)
Net loss (6,391) (6,623)
Net loss per share, basic and diluted (0.20) (0.24)
Weighted average number of
common shares outstanding, basic and diluted 32,080,141 28,171,606
Other comprehensive loss:
Net loss (6,391) (6,623)
Other comprehensive loss:
Unrealized loss on marketable securities (2) —
Comprehensive loss (6,393) (6,623)
Reconciliation of GAAP to non-GAAP measures
InVivo Therapeutics Holdings Corp.
(In thousands, except share and per share data)
Three Months Ended
March 31,
2017 2016
Reported GAAP net loss (6,391) (6,623)
Derivatives (gain) loss (241) 1,047
Adjusted net loss (6,632) (5,576)
Reported GAAP net loss per diluted share (0.20) (0.24)
Derivative (gain) loss per diluted share (0.01) 0.04
Adjusted net loss per diluted share (0.21) (0.20)

Contacts

InVivo Therapeutics Holdings Corp.
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

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Stricter Medical Device Regulations Will Improve Patient Outcomes, Says Infiniti Research

Posted On May 4, 2017 By OrthoSpineNews In Regulatory /  

LONDON–(BUSINESS WIRE)–Regulations for medical and diagnostic devices are changing in tune with advances in technology, new and innovative medical treatments, and the need for more effective diagnostic practices. Infiniti Research expects the market for medical devices to experience positive growth in the coming years as new rules and regulations eliminate counterfeit and dangerous products, increasing consumers’ trust and allowing established and reputable vendors to flourish.

Market Insights

New European Union regulations on medical devices will help to modernize public health and increase patient safety and outcomes. First proposed in 2012, the new rules (titled “the EU Medical Devices Regulation and In-Vitro Medical Devices Regulation”) came into effect in early April of this year following trilogue negotiations between the European Parliament, European Council, and European Commission. They will fully apply after a transitional period of three years for medical devices and five years for in-vitro diagnostic devices.

These regulations are replacing and modernizing three directives pertaining to in-vitro diagnostic products and medical devices with an aim to ensure both patient safety and product innovation. Both of the new regulations will improve the quality and safety of medical devices, increase market safety and monitoring, and will make important information about vendors and medical device products more easily available for patients to access. They now allow for random inspections of producers’ facilities after devices have been placed on the market, require clinical evidence of medical device safety to be provided by manufacturers, introduce an “implant card” for patients that will enable healthcare practitioners to track and monitor which product has been implanted, and have been expanded to cover aesthetic products—such as coloured contacts—that have the potential to harm consumers.

How Can Infiniti Research Help?

As technological standards and regulations for the healthcare industry and medical devices continue to change, it can be difficult for vendors to anticipate demand and prepare for new challenges. Market intelligence can be extremely beneficial in allowing vendors to understand how new laws will affect their business, strategize to overcome major obstacles and challenges, and to identify key competitors. It also enables them to adhere to region-specific regulations in each country they do business in, ensuring the safety of their customers.

Infiniti Research was recently approached by a global manufacturer and supplier of medical devices to assess the market landscape for radiography systems in the US. The insights provided by Infiniti’s analysts helped the client to gain a comprehensive understanding of the distribution structure for floor mounted radiography systems, as well as the growth strategies followed by market leaders.

Request a brochure and see how you can benefit from Infiniti’s services.

Looking for additional research on medical devices and healthcare? Request a free proposal

About Infiniti Research

Established in 2003, Infiniti Research is a leading market intelligence company providing smart solutions to address your business challenges. Infiniti Research studies markets in more than 100 countries to help analyze competitive activity, see beyond market disruptions, and develop intelligent business strategies. With 13 years of experience and offices across three continents, Infiniti Research has been instrumental in providing a complete range of competitive intelligence, strategy, and research services for over 550 companies across the globe.

Contacts

Infiniti Research
Jesse Maida
Media & Marketing Executive
US: +1 630 333 9501
UK: +44 208 123 1770
www.infinitiresearch.com
Contact Us

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K2M to Highlight Balance ACS™ Platform & Three-Dimensional Total Body Balance™ at EPOSNA 2017

Posted On May 4, 2017 By OrthoSpineNews In Spine /  

LEESBURG, Va., May 03, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it will showcase the Balance ACS™ (or BACS™) platform at the 2017 combined meeting of The European Paediatric Orthopaedic Society and The Pediatric Orthopaedic Society of North America (EPOSNA) from May 3–6 in Barcelona, Spain, at Stand #13. The Company will also host a clinical symposium in 3D spinal solutions on May 4 in Sala H3.

“K2M is excited to participate in this year’s EPOSNA, a keynote meeting encompassing the latest science, education, and advocacy to improve surgical care in children across Europe and North America with spinal deformities,” said K2M President and CEO, Eric Major. “We look forward to further introducing Balance ACS—a comprehensive platform of products, services, and research—to surgeons across Europe and North America. With BACS, our goal is to help surgeons holistically manage the entire patient experience over the full episodic care continuum, and ultimately, achieve Total Body Balance for spine patients.”

Balance ACS provides solutions to balance the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success. During the meeting, K2M will demo the BACS System services offering—which includes BACS Preauthorization, BACS Surgical Planner, BACS Anatomical Models, and BACS Data Management—and the BACS app, a convenient portal for surgeons to access the BACS System.

K2M will also host an interactive clinical symposium entitled: “Techniques to Optimize Spinal Balance” facilitated by Dennis P. Devito, MD, an orthopaedic surgeon and director of the Spine Program at Children’s Healthcare of Atlanta. The session will begin at 12:45 p.m. on May 4 in Sala H3.

For more information about Balance ACS and K2M, visit www.BACS.com and www.K2M.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques, and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in our industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems;  our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due to sales of additional shares by our pre-IPO owners or otherwise; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com 

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com
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