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DJO Global Announces Financial Results for Third Quarter 2017

November 15, 2017 OrthoSpineNews

November 14, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced financial results for its public reporting subsidiary, DJO Finance LLC (“DJOFL”), for the third quarter ended September 30, 2017.

Third quarter Financial Highlights

  • Net sales grew 1.3% to $290.9 million, or 0.3% at constant currency rates.
  • Net loss attributable to DJOFL was $22.7 million compared to $22.6 million in the prior year period.
  • Adjusted EBITDA increased 5.5% to $66.8 million.

Business Transformation Progress

  • Company’s transformation remains on track to deliver 7% to 10% annual cost reduction by the end of 2018.
  • Transformation actions taken to date expected to contribute $33 million savings over the next four quarters.

“The third quarter was another period of significant progress on DJO’s overall business transformation,” said Brady Shirley, DJO’s President and Chief Executive Officer. “Nine months into our journey, we are starting to see tangible results from our team’s hard work. Throughout this year we have continued to grow our global brands and our year-to-date results show the impact of our transformation, with Adjusted EBITDA growing at over three times the rate of revenue growth—the first time in many years we have had such sustained productivity improvement. Our productivity momentum will enable us to invest for even stronger growth as we exit 2017 and begin 2018. With clear evidence that our strategy is working, we remain committed to the rigorous execution of the initiatives that are critical to improving our operations, growing our global business and improving our customer experience.”

Sales Results

DJOFL achieved net sales for the third quarter of 2017 of $290.9 million, reflecting growth of 1.3%, or 0.3% on a constant currency basis. The Company estimates that net sales were negatively impacted by approximately $3.0 million as a result of the severe hurricanes in the U.S. during the third quarter of 2017. For the third quarter 2017, domestic and international shipping days did not differ materially from the third quarter of 2016. For the nine months ending September 30, 2017, sales grew 1.8% over the comparable period in 2016 to $874.0 million, or 2.4% on a sales per day, constant currency basis. The nine months ending September 30, 2017 included one less shipping day compared to the same period in 2016.

Net sales for the Surgical Implant segment grew 14.1% in the third quarter of 2017 to $46.6 million. Sales across all three implant subcategories (knee, hip and shoulder) again grew at double digit rates compared to the prior year. For the nine months ending September 30, 2017, Surgical Implant sales grew 15.6% over the comparable period in 2016, to $146.2 million.

Net sales for DJO’s International segment were $76.9 million in the third quarter of 2017, reflecting growth of 6.9% compared to the third quarter of 2016, or 2.6% on a constant currency basis. Growth was driven by stronger sales in the Company’s direct markets, primarily France, Australia, and Scandinavia. For the nine months ending September 30, 2017, International sales grew 3.4% to $234.8 million, or 4.5% on a sales per day, constant currency basis over the comparable period in 2016.

Net sales for DJO’s Recovery Sciences segment were $39.3 million in the third quarter of 2017, a decline of 1.1% compared to the third quarter of 2016. Growth in the segment’s Chattanooga rehabilitation equipment and consumer product line were offset by a decline in Regeneration CMF product in the quarter compared to the prior year period. For the nine months ending September 30, 2017, Recovery Sciences sales grew 1.6% over the comparable period in 2016 to $116.6 million.

Net sales for DJO’s Bracing and Vascular segment were $128.0 million in the third quarter of 2017, a decline of 4.8%, compared to the third quarter of 2016, reflecting moderate weakness across the Company’s bracing and support products, as well as continued pressure in the Company’s Dr. Comfort product line. For the nine months ending September 30, 2017, Bracing and Vascular sales declined 3.6% from the comparable period in 2016 to $376.4 million.

Earnings Results

For the third quarter of 2017, DJOFL reported a net loss of $22.7 million, compared to a net loss of $22.6 million for the third quarter of 2016. As detailed in the attached financial tables, the results for the current and prior year third quarter periods and the current and prior year twelve-month periods were impacted by significant non-cash items, non-recurring items and other adjustments.

Adjusted EBITDA for the third quarter of 2017 was $66.8 million compared with Adjusted EBITDA of $63.3 million in the third quarter of 2016. For the nine months ending September 30, 2017, Adjusted EBITDA was $187.6 million compared with Adjusted EBITDA of $175.8 million in the first nine months of 2016. Including projected future savings from cost savings programs currently underway of $33.0 million as permitted under our credit agreement and the indentures governing our outstanding notes, Adjusted EBITDA for the twelve months ended September 30, 2017 was $280.1 million.

The Company defines Adjusted EBITDA as net (loss) income attributable to DJOFL plus net interest expense, income tax provision (benefit), and depreciation and amortization, further adjusted for certain non-cash items, non-recurring items and other adjustment items as permitted in calculating covenant compliance under the Company’s secured term loan and revolving credit facilities (“Senior Secured Credit Facilities”) and the indentures governing its 8.125% second lien notes and its 10.75% third lien notes. A reconciliation between net loss attributable to DJOFL and Adjusted EBITDA is included in the attached financial tables.

Net cash provided by continuing operating activities for the nine months ending September 30, 2017 was $61.7 million compared to $19.9 million for the same period of 2016. The improvement in cash flow was primarily attributable to working capital initiatives executed as part of the Company’s overall business transformation.

Conference Call Information

DJO has scheduled a conference call to discuss this announcement beginning at 4:30 pm, Eastern Time, Tuesday, November 14, 2017. Individuals interested in listening to the conference call may do so by dialing (866) 394-8509 (International callers please use (706) 643-6833), using the reservation code 22322226. A telephone replay will be available for 48 hours following the conclusion of the call by dialing (855) 859-2056 and using the above reservation code. The live conference call and replay will be available via the Internet at www.DJOglobal.com.

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation, enabling people to regain or maintain their natural motion. Its products are used by orthopaedic surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopaedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort® and Exos™. For additional information on the Company, please visit www.DJOglobal.com.

Safe Harbor Statement

This press release contains 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. Such statements relate to, among other things, the Company’s expectations for improved liquidity, estimated cost reductions associated with the execution of its business transformation plans and improved efficiencies. The words “believe,” “will,” “should,” “expect,” “target,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to the successful execution of the Company’s business transformation plans, including achievement of planned actions to improve liquidity, improvements in operational effectiveness, optimization of the Company’s procurement activities, improvements in manufacturing, distribution, sales and operations planning, and actions to improve the profitability of the mix of our product and customers. Other important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: business strategies relative to our Bracing and Vascular, Recovery Sciences, International and Surgical Implant segments; the continued growth of the markets the Company addresses and any impact on these markets from changes in global economic conditions; the impact of potential reductions in reimbursement levels and coverage by Medicare and other governmental and commercial payors; the Company’s highly leveraged financial position; the Company’s ability to successfully develop, license or acquire, and timely introduce and market new products or product enhancements; risks relating to the Company’s international operations; resources needed and risks involved in complying with government regulations and government investigations; the availability and sufficiency of insurance coverage for pending and future product liability claims; and the effects of healthcare reform, Medicare competitive bidding, managed care and buying groups on the prices of the Company’s products. These and other risk factors related to DJO are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 15, 2017. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.

DJO Finance LLC
Unaudited Condensed Consolidated Statements of Operations

(In thousands)
Three Months Ended Nine Months Ended
September September September September
30, 30, 30, 30,
2017 2016 2017 2016
Net sales $ 290,876 $ 287,040 $ 874,011 $ 858,798
Operating expenses:
Cost of sales (exclusive of amortization, see note 1) 122,325 122,533 366,779 361,090
Selling, general and administrative 122,066 114,788 391,967 358,344
Research and development 8,864 8,481 27,066 28,457
Amortization of intangible assets 15,852 18,994 50,713 57,657
269,107 264,796 836,525 805,548
Operating income 21,769 22,244 37,486 53,250
Other (expense) income:
Interest expense, net (43,691 ) (42,683 ) (129,446 ) (127,349 )
Other income (expense), net 824 (20 ) 2,008 732
(42,867 ) (42,703 ) (127,438 ) (126,617 )
Loss before income taxes (21,098 ) (20,459 ) (89,952 ) (73,367 )
Income tax provision (1,504 ) (2,166 ) (6,677 ) (11,156 )
Net loss from continuing operations (22,602 ) (22,625 ) (96,629 ) (84,523 )
Net income from discontinued operations 123 142 228 807
Net loss (22,479 ) (22,483 ) (96,401 ) (83,716 )
Net income attributable to noncontrolling interests (214 ) (99 ) (644 ) (461 )
Net loss attributable to DJO Finance LLC $ (22,693 ) $ (22,582 ) $ (97,045 ) $ (84,177 )

Note 1 — Cost of sales is exclusive of amortization of intangible assets of $6,981 and $20,942 for the three and nine months ended September 30, 2017 and $7,057 and $21,544 for the three and nine months ended September 30, 2016, respectively.
DJO Finance LLC
Unaudited Condensed Consolidated Balance Sheets

(In thousands)
September 30, December 31,
2017 2016
Assets
Current assets:
Cash and cash equivalents $ 39,018 $ 35,212
Accounts receivable, net 175,031 178,193
Inventories, net 158,928 151,557
Prepaid expenses and other current assets 24,218 23,650
Current assets of discontinued operations 511 511
Total current assets 397,706 389,123
Property and equipment, net 134,538 128,019
Goodwill 863,011 855,626
Intangible assets, net 622,460 672,134
Other assets 6,109 5,536
Total assets $ 2,023,824 $ 2,050,438
Liabilities and Deficit
Current liabilities:
Accounts payable $ 93,102 $ 63,822
Accrued interest 41,738 16,740
Current portion of debt obligations 14,593 10,550
Other current liabilities 130,941 113,265
Total current liabilities 280,374 204,377
Long-term debt obligations 2,372,850 2,392,238
Deferred tax liabilities, net 210,772 202,740
Other long-term liabilities 15,330 14,932
Total liabilities $ 2,879,326 $ 2,814,287
Commitments and contingencies
Deficit:
DJO Finance LLC membership deficit:
Member capital 841,907 844,294
Accumulated deficit (1,676,688 ) (1,579,642 )
Accumulated other comprehensive loss (22,551 ) (30,580 )
Total membership deficit (857,332 ) (765,928 )
Noncontrolling interests 1,830 2,079
Total deficit (855,502 ) (763,849 )
Total liabilities and deficit $

2,023,824

 $ 2,050,438
DJO Finance LLC
Unaudited Segment Information

(In thousands)
Three Months Ended Nine Months Ended
September September September September
30, 30, 30, 30,
2017 2016 2017 2016
Net sales:
Bracing and Vascular $ 127,971 $ 134,421 $ 376,439 $ 390,388
Recovery Sciences 39,346 39,793 116,622 114,817
Surgical Implant 46,613 40,852 146,197 126,477
International 76,946 71,974 234,753 227,116
$ 290,876 $ 287,040 $ 874,011 $ 858,798
Operating income:
Bracing and Vascular $

27,060

 $ 30,393 $

72,292

 $

79,999
Recovery Sciences 11,322 7,683 30,938 22,184
Surgical Implant 9,126 7,908 27,328 21,190
International 14,894 11,657 42,013 35,299
Expenses not allocated to segments and eliminations (40,633 ) (35,397

)

 (135,085

)

 (105,422 )
$ 21,769 $ 22,244 $ 37,486 $ 53,250

DJO Finance LLC
Adjusted EBITDA

For the Three and Nine Months Ended September 30, 2017 and 2016
(unaudited)

Our Senior Secured Credit Facilities, consisting of a $1,055.0 million term loan facility (including a $20.0 million delayed draw term loan facility) and a $150.0 million asset-based revolving credit facility, under which $55.0 million was outstanding as of September 30, 2017, and the Indentures governing our $1,015.0 million of 8.125% second lien notes and $298.5 million of 10.75% third lien notes (collectively, the “notes”) represent significant components of our capital structure. Under our Senior Secured Credit Facilities, we are required to maintain a specified senior secured first lien leverage ratio, which is determined based on our Adjusted EBITDA. If we fail to comply with the senior secured first lien leverage ratio under our Senior Secured Credit Facilities, we would be in default. Upon the occurrence of an event of default under the Senior Secured Credit Facilities, the lenders could elect to declare all amounts outstanding under the Senior Secured Credit Facilities to be immediately due and payable and terminate all commitments to extend further credit. If we were unable to repay those amounts, the lenders under the Senior Secured Credit Facilities could proceed against the collateral granted to them to secure that indebtedness. We have pledged substantially all of our assets as collateral under the Senior Secured Credit Facilities and under the notes. Any acceleration under the Senior Secured Credit Facilities would also result in a default under the Indentures governing the notes, which could lead to the note holders electing to declare the principal, premium, if any, and interest on the then outstanding notes immediately due and payable. In addition, under the Indentures governing the notes, our and our subsidiaries’ ability to engage in activities such as incurring additional indebtedness, making investments, refinancing subordinated indebtedness, paying dividends and entering into certain merger transactions is governed, in part, by our ability to satisfy tests based on Adjusted EBITDA. Our ability to meet the covenants specified in the Senior Secured Credit Facilities and the Indentures governing those notes will depend on future events, some of which are beyond our control, and we cannot assure you that we will meet those covenants.

Adjusted EBITDA is defined as net income (loss) attributable to DJOFL plus interest expense, net, income tax provision (benefit), and depreciation and amortization, further adjusted for certain non-cash items, non-recurring items and other adjustment items as permitted in calculating covenant compliance and other ratios under our Senior Secured Credit Facilities and the Indentures governing the notes. We believe that the presentation of Adjusted EBITDA is appropriate to provide additional information to investors about the calculation of, and compliance with, certain financial covenants and other ratios in our Senior Secured Credit Facilities and the Indentures governing the notes. Adjusted EBITDA is a material component of these calculations.

Adjusted EBITDA should not be considered as an alternative to net income (loss) attributable to DJOFL or other performance measures presented in accordance with accounting principles generally accepted in the United States of America (“GAAP”), or as an alternative to cash flow from operations as a measure of our liquidity. Adjusted EBITDA does not represent net income (loss) attributable to DJOFL or cash flow from operations as those terms are defined by GAAP and does not necessarily indicate whether cash flows will be sufficient to fund cash needs. In particular, the definition of Adjusted EBITDA under our Senior Secured Credit Facilities and the Indentures governing the notes allows us to add back certain non-cash, extraordinary, unusual or non-recurring charges that are deducted in calculating net income (loss) attributable to DJOFL. However, these are expenses that may recur, vary greatly and are difficult to predict. While Adjusted EBITDA and similar measures are frequently used as measures of operations and the ability to meet debt service requirements, Adjusted EBITDA is not necessarily comparable to other similarly titled captions of other companies due to the potential inconsistencies in the method of calculation.

The following table provides reconciliation between net loss attributable to DJOFL and Adjusted EBITDA (in thousands):

Twelve
Months
Three Months Ended Nine Months Ended Ended
September September September September September
30, 30, 30, 30, 30,
2017 2016 2017 2016 2017
Net loss attributable to DJO Finance LLC $ (22,693 ) $ (22,582 ) $ (97,045 ) $ (84,177 ) $ (299,172 )
Income from discontinued operations, net (123 ) (142 ) (228 ) (806 ) (560 )
Interest expense, net 43,691 42,683 129,446 127,349 172,176
Income tax provision (benefit) 1,504 2,166 6,677 11,156 (11,330 )
Depreciation and amortization 26,285 29,031 83,001 88,208 112,686
Non-cash charges (a) 1,204 338 2,312 2,941 181,770
Non-recurring and integration charges (b) 15,712 9,895 59,296 25,832 82,139
Other adjustment items (c) 1,249 1,938 4,160 5,302 9,413
66,829 63,327 187,619 175,805 247,122
Permitted pro forma adjustments applicable to the twelve month period only (d)
Future cost savings 32,967
Adjusted EBITDA $ 66,829 $ 63,327 $ 187,619 $ 175,805 $ 280,089

(a) Non-cash charges are comprised of the following:
Twelve
Months
Three Months Ended Nine Months Ended Ended
September September September September September
30, 30, 30, 30, 30,
2017 2016 2017 2016 2017
Stock compensation expense $ 483 $ 285 $ 1,329 $ 1,806 $ 2,711

Loss on disposal of fixed assets and assets held for sale, net

 721 (4 ) 983 886 1,046
Impairment of goodwill (1) — — — — 160,000
Inventory adjustments (2) — — — — 18,013
Purchase accounting adjustments (3) — 57 — 249 —
Total non-cash charges $ 1,204 $ 338 $ 2,312 $ 2,941 $ 181,770
(1) Impairment of goodwill and intangible assets for the twelve months ended September 30, 2017 consisted of goodwill impairment charges of $99.0 million and $61.0 million related to the CMF and Vascular reporting units, respectively. The impairment charge for our CMF reporting unit resulted from reductions in our projected operating results and estimated future cash flows due to disruption caused by our exit of the Empi business. The impairment charge for our Vascular reporting unit resulted from reductions in our projected operating results and estimated future cash flows due to a loss of revenue caused by disruption as we transitioned our Dr. Comfort therapeutic footwear manufacturing and distribution to a new ERP system and market pressure in the therapeutic shoe market.
(2) In the fourth quarter of fiscal 2016, current management implemented a new strategy relating to our procurement, manufacturing and liquidation philosophies in order to significantly reduce inventory levels. Historically, our strategy was to purchase inventory in large quantities to capture purchase discounts and rebates and provide an expansive mix of products for our customers. Our new strategy aims to integrate our supply chain services with customer demand through focused forecasted consumption and sales efforts, therefore limiting the range of SKUs we plan to offer. As a result of these changes, the Company recorded a charge to cost of sales and corresponding reduction in inventory of approximately $18.0 million. The E&O reserve expense in fiscal 2016 included $5.7 million related to the Company’s decision to discontinue certain SKUs mainly within the Bracing and Vascular product lines, $8.3 million related to holding inventory for shorter periods and the planned scrapping of long-dated inventory, $2.0 million related to new Surgical Implant products that changed the expected life cycle of its current product portfolio, and $2.0 million of slow moving consigned inventory within certain OfficeCare clinics for which management has decided not to strategically relocate.
(3) Purchase accounting adjustments consisted of amortization of fair market value inventory adjustments for all periods presented.

(b)

Non-recurring and integration charges are comprised of the following:
Twelve
Months
Three Months Ended Nine Months Ended Ended
September September September September September
30, 30, 30, 30, 30,
2017 2016 2017 2016 2017
Restructuring and reorganization (1) $ 11,391 $ 1,177 $ 50,441 $ 3,998 $ 64,089
Acquisition related expenses and integration (2) 879 2,873 1,457 8,855 2,952
Executive transition — 914 (49 ) 954 1,048
Litigation and regulatory costs and settlements, net (3) 3,336 4,576 6,748 11,062 12,248
Other non-recurring items — 287 — 895 —
IT automation projects 106 68 699 68 1,802
Total non-recurring and integration charges $ 15,712 $ 9,895 $ 59,296 $ 25,832 $ 82,139
(1) Consists of costs related to the Company’s business transformation projects to improve the Company’s liquidity and profitability and to improve the Company’s customer’s experiences.
(2) Consists of direct acquisition costs and integration expenses related to acquired businesses and costs related to potential acquisitions.
(3) For the twelve months ended September 30, 2017, litigation and regulatory costs consisted of $3.3 million in litigation costs related to ongoing product liability issues and $8.9 million related to other litigation and regulatory costs and settlements.

(c)

Other adjustment items are comprised of the following:
Twelve
Months
Three Months Ended Nine Months Ended Ended
September September September September September
30, 30, 30, 30, 30,
2017 2016 2017 2016 2017
Blackstone monitoring fees $ 1,750 $ 1,750 $ 5,250 $ 5,250 $ 7,000
Non-controlling interests 214 99 644 461 806
Other (1) (715 ) 89 (1,734 ) (409 ) 1,607
Total other adjustment items $ 1,249 $ 1,938 $ 4,160 $ 5,302 $ 9,413
(1) Other adjustments consist primarily of net realized and unrealized foreign currency transaction gains and losses.
(d) Permitted pro forma adjustments include future cost savings related to the exit of our Empi business and our business transformation initiative.

Contacts

DJO Global, Inc.
David Smith
SVP and Treasurer
760.734.3075
ir@djoglobal.com

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Regulatory

MedShape Announces FDA Clearance for the DynaNail® XL

November 15, 2017 OrthoSpineNews

ATLANTA, Nov. 14, 2017 /PRNewswire/ — MedShape, Inc., the industry leader in orthopaedic devices using advanced functional materials, announced today that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the DynaNail® XL TTC Fusion System. The DynaNail XL is available in 260mm and 300mm lengths, thus expanding the product’s use to patients with longer tibial anatomies or who have undergone prior failed fusion procedures using an intramedullary nail (IM) nail. The DynaNail XL will be launched in early 2018.

Indicated for tibiotalocalcaneal (TTC) fusion surgery, the DynaNail XL was developed in response to surgeon demand for an IM nail that better accommodates longer patient tibial anatomies or when tibial fractures are present. Its longer length in combination with DynaNail’s pseudoelastic NiTiNOL Element could help reduce stress risers in the bone, consequently lowering the chance for tibial fractures.1 DynaNail XL features a similar design as the original 220 mm version but also has a proximal taper for easy insertion through the tibial isthmus and an extra proximal screw hole for an optional cortical screw for additional stability.

Clinically introduced in 2012, the DynaNail is the first and only internal fusion device to harness the pseudoelastic properties of NiTiNOL to provide the compression performance of an external frame inside an IM nail design. Compression has shown to be important not only in keeping the bones in close apposition but also in providing the physiological stresses needed to promote bone healing.  Like the original 220mm version, the DynaNail XL features an internal NiTiNOL Compressive Element that maintains post-operative compression for up to 6 mm of bone resorption and settling. The DynaNail Compressive Element also allows for effective load sharing across the bone due to its axial compliance during weight-bearing.2 To date, the DynaNail has demonstrated clinical success in revision TTC surgeries and in patients with large bony defects or who are diabetic.3,4,5

The FDA clearance of the DynaNail XL closes out a year noted by several updates to the DynaNail product line. In June, the DynaFrame™ Carbon-Fiber (CF) Deployment System was launched, providing surgeons with a simple, robust method to insert the DynaNail and activate the NiTiNOL element during surgery. This was followed by the release of new instrument sets to accommodate the increased demand. Finally, with the DynaNail XL, MedShape also gained clearance to offer a new alternate surgical technique that allows for a more streamlined approach and the option for automatic dynamization once the NiTiNOL Element has fully recovered.

“The recent additions to the DynaNail portfolio demonstrate our continued commitment toward improving upon the success of the company’s flagship product,” said Kurt Jacobus, MedShape CEO. “We have been pleased with the growing adoption of this unique technology by both orthopaedic surgeons and podiatrists and anticipate continued growth with these new offerings.”

About MedShape, Inc.

MedShape, Inc. is a privately held medical device company working to develop and commercialize a portfolio of surgical solutions for foot and ankle and trauma surgeons that use its patented advanced material technologies. For more information, visit: www.medshape.com.

1Catanzariti, A. R., DPM, & Mendicino, R. W., DPM. (2009). Intramedullary Nail Fixation for Reconstruction of the Hindfoot and Ankle in Charcot Neuroarthropathy. In Surgical Reconstruction of the Diabetic Foot and Ankle (pp. 241-254). Philadelphia: Wolters Kluwer.

2Anderson RT, Pacaccio DJ, Yakacki CM, Carpenter RD. Finite element analysis of a pseudoelastic compression-generating intramedullary ankle arthrodesis nail. J Mech Beh Biomed Mat, 2016; 62: 83-92.

3Kreulen C, Lian E, Giza E. Technique for Use of Trabecular Metal Spacers in Tibiotalocalcaneal Arthrodesis with Large Bony Defects. Foot Ankle Int, 2017; 38(1): 96-106.

4Latt LD, Dupont KM, Smith KE. Revision Tibiotalocalcaneal Arthrodesis with a Pseudoelastic Intramedullary Nail – A Case Study. Foot Ankle Spec; 2017; 10(1): 75-81.

5Hsu AR, Ellington JK, Adams SB, Jr. Tibiotalocalcaneal Arthrodesis Using a NiTiNOL Intramedullary Hindfoot Nail. Foot Ankle Spec 2015; 8(5): 389-96.

DynaNail and DynaFrame are a registered trademark and trademark of MedShape, Inc, respectively.

Media Contact:
Jenn Pratt
Carabiner Communications
678.313.3438
jpratt@carabinercomms.com

Company Contact:
Kathryn Smith, Ph.D.
678.235.3304
Kathryn.smith@medshape.com

 

SOURCE MedShape, Inc.

Related Links

http://www.medshape.com

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SpineTop Stories

New England Baptist to open spine center thanks to largest donation in its history

November 14, 2017 OrthoSpineNews

11-14-2017 – By   –  Reporter, Boston Business Journal

New England Baptist Hospital will create a new spine institute, thanks to a $3 million gift from one of its board members.

Jeffrey Libert, a trustee of the hospital, recently gifted the hospital $3 million on behalf of his family to form the Libert Family Spine Institute, which will look to create a new singular door for patients suffering from back pain and find approaches and treatments beyond surgical interventions.

The donation is the largest in the hospital’s history, and is on top of $2 million Libert had already donated to the hospital for medical education and research.

“With the largest number of spine surgery patients regionally, and a significant volume of non-surgical patients, NEBH is uniquely positioned to enhance clinical care by leveraging data with predictive analytics to improve existing treatments and design better options for patients with spine disease or injury,” said Dr. Scott Tromanhauser, chief of spine surgery, chief medical quality officer and director of research administration for the hospital, in a statement. “By establishing this institute, we will be able to make a significant difference in how back pain is treated.”

 

READ THE REST HERE

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ExtremitiesRegulatoryTop Stories

IntraFuse Receives FDA 510(k) Clearance for FlexThread™ Fibula Pin System

November 14, 2017 OrthoSpineNews

LOGAN, Utah, November 1, 2017 – IntraFuse, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for its FlexThread™ Fibula Pin System.

The IntraFuse FlexThread™ Fibula Pin System provides percutaneous fixation of distal fibula fractures, primarily Danis-Weber B type fractures, or trans-syndesmotic fractures.  The simple and elegant design is easy to insert and cost competitive with today’s standard-of-care internal fixation hardware. Incorporating IntraFuse’s proprietary FlexThread™ technology, the distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod.  Upon insertion of the implant into the fibula, the rigid rod portion of the implant spans and supports the fracture and the flexible screw portion bends as needed to thread into the intramedullary canal.  With internal screw fixation on one side of the fracture and cross screw fixation through the rod on the other side of the fracture, proper bone alignment and length can be maintained during the healing period. Additionally, the FlexThread™ Fibula Pin is compatible with either screw or flexible fixation of the syndesmosis joint as needed.

To accommodate the anatomic size range of fibulas, the FlexThread™ Fibula Pin is available in three different screw diameters, each with two length options.  Using routine intramedullary and screw fixation techniques, bone preparation is a simple, three step sequence:  place guide wire, ream, tap.   Optional fracture site compression is achieved concurrent with insertion of the implant, and delivery of cross fixation screws is facilitated by a guide that connects directly to the implant inserter.

The FlexThread™ Fibula Pin provides anatomic, intramedullary fixation that may have potential clinical advantages over fibula plating systems, including: reduced risk of hardware related pain, reduced rate of hardware removal, less risk of wound complications, infection and other morbidities due to a less invasive procedure, and less disruption of the periosteum which facilitates faster healing.

“Intramedullary fixation is the standard-of-care today for most fractures of the large, long bones of the body due to superior clinical outcomes versus plating systems, yet plating systems are still the standard-of-care for the smaller, long bones of the extremities,” states Wade Fallin, CEO of IntraFuse.  Fallin continues, “FlexThread™ is a platform technology that can address the unique requirements for intramedullary fixation of small bone fractures where off-axis entry into the bone canal is required, or where the bone is curved.  Now cleared for both clavicle and fibula fractures, the FlexThread™ technology is in further development for additional indications.”

IntraFuse is a development stage medical device company incubated and operated by Surgical Frontiers.  Inquiries regarding distribution and commercialization partnerships are welcome.

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Wade Fallin

CEO

wade@surgicalfrontiers.com

www.surgicalfrontiers.com

800-230-3710

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ExtremitiesRegulatoryTop Stories

Mortise Medical Receives FDA Clearance for SyndesMetrics Syndesmosis Repair System

November 14, 2017 OrthoSpineNews

LOGAN, Utah, November 14, 2017 – Mortise Medical, a start-up medical device company focused on advanced soft tissue repair systems for ankle injuries, announces that it has recently received FDA 510(k) clearance for its innovative SyndesMetricsÔ Syndesmosis Repair System.

The Mortise Medical SyndesMetricsÔ Syndesmosis Repair System was developed to address three clinical needs for syndesmotic disruption injuries: predictable and repeatable anatomic reduction, restoration of physiological motion, and restoration of ankle stability.  Anatomic reduction is achieved using the SyndesMetricsÔ Reduction Clamp, which features: anatomic referencing clamp points; precision, surgeon controlled, calibrated clamping force; and an integrated drill guide to prepare the bone for the SyndesMetricsÔ  implant system.  Both the SyndesMetricsÔ Reduction Clamp and implant system are compatible with distal fibula plating systems.  Also, the SyndesMetricsÔ implant system features minimal hardware prominence, no suture prominence and a reversible locking mechanism for securing the high strength suture tape that connects the tibial and fibular implant components.

Based on biomechanical testing on matched pair human cadaveric ankle specimens at the University of Iowa, the SyndesMetricsÔ implant system was found to more closely reproduce normal physiological ankle motion when compared to a 4.5mm cortical screw or a suture button construct.1  Additionally, mechanical testing conducted by a third party medical device testing company demonstrated that SyndesMetricsÔ repair constructs had higher static strength and higher fatigue strength than 3.5mm cortical screw or suture button repair constructs.2

“Surgeons will find this innovative system more intuitive to use and more reproducible for positioning and tensioning the distal tibiofibular syndesmosis than anything we now have available,” states Dr. Charles L. Saltzman, Professor and Chairman of Orthopaedics at the University of Utah and immediate past President of the International Federation of Foot and Ankle Societies.

Mortise Medical is a medical device company incubated and operated by Surgical Frontiers.

1 Goetz JE, et al., Annual Meeting of the American Society of Biomechanics, 2017

2 Data on file

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Wade Fallin

CEO

wade@surgicalfrontiers.com

www.surgicalfrontiers.com

800-230-3710

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Spine

Russo Partners Teams with Medovex to Highlight Medical Technology Innovation with DenerveX System

November 14, 2017 OrthoSpineNews

NEW YORK, Nov. 13, 2017 /PRNewswire/ — Russo Partners LLC and Medovex Corp. (NASDAQ: MDVX) have teamed to call attention to the need for new treatments for chronic back pain and the Company’s innovative solution known as the DenerveX® System. Currently approved for use outside of the U.S., DenerveX is a new device designed to enable doctors to provide patients with enduring relief of back pain caused by Facet Joint Syndrome.

The Medovex public relations initiatives include an extensive video campaign featuring spine surgeons worldwide. Wilcots, an NFL broadcaster, former professional football player and leader of Russo Partners’ Sports-Health Alliance, recently interviewed doctors at the EUROSPINE 2017 annual meeting in Dublin and the North American Spine Society (NASS) conference in Orlando, where he also taped a demonstration of the DenerveX System in use in a surgical cadaver lab. Russo Partners and Medovex will integrate the content into ongoing social and traditional media initiatives this quarter as Medovex continues its country-by-country roll-out of the medical technology.

“Solomon has the natural ability to bring professionals together and craft medical stories in a natural and impactful manner,” said Patrick Kullmann, president and COO of Medovex. “We look forward to using the output of his work to increase the visibility and awareness of what we are doing at Medovex to transform how surgeons and pain management physicians treat a common source of chronic back pain. This is a meaningful change with our DenerveX system that is focused on long-term relief.”

Wilcots added, “Chronic back pain, including that caused by Facet Joint Syndrome, is common among former professional athletes. The opportunity presented by the DenerveX System is one of giving people back quality of life without reliance on prescriptive pain relief medicines. This is exciting technology about which physicians were eager to speak with me and share their perspectives on how it will change their practices and patients’ lives. We will continue with these initiatives throughout 2018.”

The DenerveX System is a non-addictive opioid drug alternative capable of restoring a patient to a more normal and active lifestyle. It was designed by medical professionals for medical professionals to enhance a patient’s quality of life. Using highly differentiated technology, the DenerveX System denervates and removes capsular tissue from the facet joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and radio frequency ablation treatment on the facet joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint. To learn more about the DenerveX System, visit http://medovex.com/us/denervex-system/.

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in countries worldwide, including the U.S. and countries in the EU. This condition affects millions of people each year, and current treatment options are generally temporary with no proven long-lasting option.

About Medovex

Medovex Corp. was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX System, is intended to provide long lasting relief from pain associated with Facet Joint Syndrome at significantly less cost over time than currently available options. To learn more about Medovex, visit www.medovex.com.

About Russo Partners’ Sports-Health Alliance

The Sports-Health Alliance is an award-winning public relations service at the intersection of health, medicine and sports. Launched by Russo Partners in 2017, this offering leverages the agency’s inside access to athletes, broadcasters and sports business leaders who have a shared passion with their clients for a disease or treatment. The Alliance was cultivated over a two-year span and involves Russo Partners’ Team Leader Solomon Wilcots. Visit https://russopartnersllc.com/services/sports-health-alliance/ for more information.

About Russo Partners

Since 1988, Russo Partners, formerly Noonan/Russo Communications, has provided public and investor relations and corporate communications services to both emerging and established healthcare and technology-centric companies worldwide. The agency’s staff is comprised of senior executives with extensive backgrounds in science, medicine, finance and communications. Visit www.russopartnersllc.com for more information.

CONTACT INFORMATION

Medovex Corp.
Jason Assad
470-505-9905
Jassad@medovex.com

GLOBAL MEDIA CONTACTS

David Schull
Russo Partners LLC
212-845-4271 (office)
858-717-2310 (mobile)
David.schull@russopartnersllc.com

Caroline Cunningham
Russo Partners LLC
212-845-4292 (office)
203-969-4308 (mobile)
Caroline.cunningham@russopartnersllc.com

SOURCE Russo Partners, LLC

Related Links

http://www.russopartnersllc.com

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SpineTop Stories

SpineGuard and XingRong Medical launch PediGuard® in China

November 14, 2017 OrthoSpineNews

November 13, 2017

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

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced today that XinRong Medical Group will officially launch the Classic PediGuard product range in China during the Chinese Orthopedic Association (COA) annual meeting being held in Zhuhai, China from November 15-18.

The COA meeting is the largest and most influential Orthopedic Surgery Society in China with 14 sub-specialties such as spine surgery. This annual meeting is widely attended by Chinese surgeons (over 21,000 attendees in 2016) and is a unique opportunity to launch the PediGuard®. Over recent years, the Chinese orthopedic market has become the second largest in the world, after the USA.

On November 16th, XinRong Medical Group will offer a PediGuard® workshop at their booth #3A11 with Prof. Chen Zhong Quing (China), Prof. Wong Hee Kit (Singapore) and Prof. Liang Yu (China) as faculty.

“We believe the COA annual meeting is the best congress with the right timing to launch the PediGuard® in China. The workshop given by XinRong Medical Group will be the opportunity for the Chinese spine surgeons who have been waiting for SpineGuard’s DSG™ technology since its clearance by CFDA, to learn more about the products from experienced key opinion leader surgeons and facilitate first use. We are delighted by the collaboration with our very dynamic partner XinRong and are looking forward to supporting our common success in China with PediGuard®” said Stéphane Bette, CEO and co-founder of SpineGuard.

“We are very excited to hold the official PediGuard® China Launch Meeting during COA supported by top key opinion leaders in spine surgery in China. PediGuard® can alert surgeons of potential pedicular or vertebral breaches and provides real-time feedback through audio and visual signals. With the introduction of this device, we could help Chinese surgeons reduce the risk of pedicle screw misplacement and dramatically improve outcomes for patients. Moreover and looking forward, SpineGuard has received the patent for its smart screw concept integrating its DSG™ sensor into the implantable pedicle screw through imbedding electronics into the screwdriver handle, opening new opportunities for further collaborations.”, added Christine Zhang, XinRong Medical Group’s CEO.

More information on the DSG™ technology and surgeons’ testimonials here.

Next financial press release: 2017 full year revenue, January 4, 2018

About SpineGuard®
Founded in 2009 in France and the USA, by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 55,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

About XinRong Medical Group
XinRong Medical Group, a leader in medical technology, is dedicated to increasing patient affordability and providing the most advanced solutions for surgeons such that they can deliver the best patient care. XinRong Medical offers innovative solutions in orthopedic surgery, neurosurgery, reconstructive surgery, and minimally invasive therapy. Established in 2000 in Jiangsu Province, China, XinRong Medical was one of the first companies in China cleared by CFDA to manufacture Orthopedic Implants. In 2014, the Company received a strategic investment from The Blackstone Group (NYSE: BX). For additional information about XinRong Medical, please refer to our website www.XRBest.Com, or contact us directly at +86-512-58100828 or info@xrmed.com.

Disclaimer
The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Stéphane Bette
Chief Executive Officer
Tel: +33 (0) 1 45 18 45 19
s.bette@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
Tel: +33 (0)1 45 18 45 19
m.lanfossi@spineguard.com
or
NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.fr

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BiologicsExtremitiesSports MedicineTop Stories

OrthoPediatrics Corp. to Start Distributing Bioretec Devices via Private Label

November 13, 2017 OrthoSpineNews

WARSAW, Ind., Nov. 13, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, and Bioretec Ltd. (“Bioretec”), announced today that they have amended their existing distribution agreement in order for OrthoPediatrics to market and sell Bioretec’s unique, bioresorbable orthopaedic bone and soft-tissue fixation implants under the OrthoPediatrics brand, TorqLoc™. Bioretec’s bioresorbable implants are ideal for repairing musculoskeletal defects of children and young people. Treatment of musculoskeletal defects and trauma related bone and soft-tissue injuries are steadily increasing, as well as the need for surgeries related to treating such conditions. Bioretec’s fully bioresorbable implants have shown excellent results in repairing the growing bones of children and young people.

“We are excited to start OrthoPediatrics’ private label collaboration, whose enthusiasm towards developing and improving surgical care for children, we admire.  Our products are ideal for surgeries of children, since the bioresorption of our implants eliminates the need for secondary removal operation after the healing of musculoskeletal tissues. This is especially important with children, for whom the risks and inconveniences associated with surgical procedures are much higher,” commented Tomi Numminen, CEO of Bioretec.

OrthoPediatrics’ Vice President for Trauma & Deformity Correction, Joe Hauser, added, “This evolving strategic partnership and collaboration with Bioretec represents another area for tremendous growth within OrthoPediatrics’ portfolio.  The TorqLoc™ screw portfolio will provide a truly innovative option for many unmet pediatric orthopedic sports and tissue repair surgical needs.  In addition to OrthoPediatrics’ all epiphyseal ACL system, we now can help our surgeon partners with MPFL, foot, shoulder, and hand solutions by providing this new generation bioabsorbable implant offering.”

About Bioretec
Bioretec Ltd. is a Finnish material technology company focused on the development, manufacturing and marketing of bioabsorbable, bioactive and drug-releasing surgical implants for orthopedic, trauma and sport medicine surgeries. Bioretec implants, designed and manufactured in Finland, have been used in 33 countries, including United States, China, Russia, UK, Germany, Italy and Spain.

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is the only diversified orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market. OrthoPediatrics is dedicated to the cause of improving the lives of children with orthopedic conditions. OrthoPediatrics currently markets 22 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contact
The Ruth Group
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com

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Robotics

TransEnterix Announces Senhance US Sale Agreement With Florida Hospital

November 13, 2017 OrthoSpineNews

November 13, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced that Florida Hospital entered into an agreement to purchase the Company’s Senhance™ Surgical Robotic System.

The Florida Hospital Orlando campus will be home to the first commercial unit of the Senhance Surgical System to be installed in the United States.

Now available in the United States, the recently FDA-cleared Senhance Surgical System represents an innovative technology designed to assist surgeons in performing minimally invasive surgery. The system features multiple robotic arms that are controlled by a surgeon seated comfortably at a console. The surgeon controls small surgical instruments with robotic precision while at the same time moving a small scope that tracks the eye movement of the surgeon. The Senhance is the first surgical robotic system to offer the security of haptic force feedback that allows surgeons to feel the forces the instruments generate when handling delicate tissue. The Senhance represents a new era of digital laparoscopy designed to support responsible economics for the hospital, patient and today’s value-based healthcare system.

“We are pleased to announce our first US sale of the Senhance Surgical System,” said Todd M. Pope, President and CEO at TransEnterix. “Florida Hospital is a global leader in the application of next generation technologies to care for patients. It’s fitting that Florida Hospital will be the first in the United States to adopt this technology for patient care.”

“The digital operating room of the future has arrived, and our surgeons will continue to be leaders in applying robotic technology, like the Senhance, to benefit our patients across a full range of procedures and specialties,” said Dr. Steve Eubanks, surgeon and Executive Medical Director for the Institute for Surgical Advancement at Florida Hospital. “Our team of clinicians selected the Senhance Surgical System to further our minimally invasive offerings. We believe this robotic system will support our surgeons in maximizing their precision and control during procedures while minimizing costs.”

About Florida Hospital

Florida Hospital is a member of Adventist Health System, which operates 45 hospitals in 9 states, making it one of the largest not-for-profit healthcare systems in the United States, caring for more than 5 million patients annually. Florida Hospital continues to be at the forefront of health-care innovation. In addition to the Florida Hospital Institute for Surgical Advancement, it’s also home to the Florida Hospital Nicholson Center, a facility specializing in training surgeons from around the globe on the latest surgical technology and techniques, and the Global Robotics Institute, a world leader in the robotic-assisted treatment of prostate cancer.

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The company is also developing the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System is available for sale in the US, the EU and select other countries. For more information, visit the TransEnterix website at www.transenterix.com.

Forward Looking Statements

This press release includes statements relating to the Senhance Surgical Robotic System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the Senhance Surgical Robotic System will benefit Florida Hospital’s patients and whether the Senhance Surgical Robotic System will support Florida Hospital’s surgeons in maximizing their precision and control during procedures while minimizing costs. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 7, 2017 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1 443-213-0501
invest@transenterix.com
or
Media Contact:
Joanna Rice, + 1 951-751-1858
joanna@greymattermarketing.com

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RegulatoryTop Stories

Trump picks Alex Azar to lead the Health and Human Services Department

November 13, 2017 OrthoSpineNews

By Juliet Eilperin and Amy Goldstein / November 13, 2017

President Trump has selected Alex Azar, a former pharmaceutical executive and a top health official during the George W. Bush administration, to lead the Health and Human Services Department.

The decision to enlist the 50-year-old Azar — who served as president of Lilly USA, the biggest affiliate of Eli Lilly and Co., before stepping down in January to work as a health-care consultant — represents a pragmatic pick. An establishment figure with a reputation as a conservative thinker and methodical lawyer, Azar would be expected to use his experience as HHS general counsel and deputy secretary to pursue Trump’s goals through executive action.

In announcing the nomination Monday morning, Trump tweeted that Azar “will be a star for better healthcare and lower drug prices!” He has a close rapport with the department’s top political appointees as well as Vice President Pence.

Azar has been highly critical of the Affordable Care Act, telling Fox Business in May that the law was “certainly circling the drain” and saying in a speech two months ago that many of its problems “were entirely predictable as a matter of economic and individual behavior.”

In a June interview on Bloomberg Television, Azar made it clear he thought the administration could shift the ACA in a more conservative direction even if congressional Republicans failed to repeal much of it. “I’m not one to say many good things about Obamacare, but one of the nice things in it is it does give tremendous amount of authority to the secretary of HHS,” he said.

He also supports converting Medicaid from an entitlement program covering everyone who is eligible into block grants, a long-standing GOP goal that has sparked opposition from Democrats as well as some centrist Republicans. He has opposed expanding the program under the ACA to people with slightly higher incomes.

The nominee boasts sterling conservative credentials, clerking for the late Supreme Court Justice Antonin Scalia before working under special counsel Kenneth Starr to investigate Bill Clinton’s failed Whitewater real estate investments. Still, administration officials think he could work more deftly with competing health-care interests and politicians than his predecessor, Tom Price.

 

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