Extremity Reconstruction Market is evolving at fast pace

11-13-20017 / Health & Medicine, Press Release from: TMR Research

Extremity reconstruction implies the restoration of limbs and limb functions to patients who have suffered the removal of limbs due to trauma or medical removal after cancer or other issues. This also includes limb removal after vascular diseases, metabolic diseases, infections, or rheumatoid arthritis. Lower extremity reconstruction involves three key segments based on the location of the wound, into knees, feet, and the tibia bone. Extremity reconstruction can allow for a high level of restoration of mobility and lifestyle to patients. Owing to the increasing counts of patients suffering from cancers, chronic diseases, and accident related injuries that result in the removal of extremities, it is becoming increasingly important for developments in this field to take up greater investments from the healthcare industry.

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Plastic surgeons can also make use of flaps or skin grafts to hide the wounds on extremities, giving patients a significantly faster recovery rate into daily life and a normal lifestyle. Nearly all types of extremity reconstruction surgeries will require the use of general anesthesia. Additional care is also needed from the patient’s side post-surgery. For example, they are expected to follow s stricter diet for the speedy recovery of limbs. Smokers are especially encouraged to quit in order to prevent deterioration of wound and to normalize the overall healing rate.

Global Extremity Reconstruction Market : Snapshot

The global market for extremity reconstruction is expected to witness a high level of growth in the next few years. The rising number of cases of abnormalities and injuries in the lower and upper extremity of the human body is one of the vital factors estimated to encourage the growth of the global market in the coming years. In addition, several advancements in the healthcare infrastructure are anticipated to accelerate the development of the market in the near future. The implant devices for different parts of the human body comprises the extremity reconstruction market in the coming years.

A tremendous rise in the geriatric population and the rising incidences of obesity and diabetes are some of the major factors that are estimated to fuel the development of the global extremity reconstruction market in the near future. Moreover, the increasing cases of osteoarthritis and rheumatoid are likely to accelerate the growth of the market in the coming years. The rising awareness regarding the benefits of small joint reconstruction implants among patients is predicted to encourage the growth of the global extremity reconstruction market in the next few years.

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Technological advancements and the availability of required infrastructure are projected to augment extremity reconstruction market in North America market in the next few years. The leading players operating in the extremity reconstruction market across the globe are emphasizing on introducing innovative implants in order to attract a large number of consumers and attain a leading position in the market. Additionally, the rising level of competition is predicted to expand the product portfolio and benefit the patients in the coming years.

Global Extremity Reconstruction Market: Overview

The increasing incidence of injuries, abnormalities, and congenital defects in the upper or lower extremity of human body has fuelled the demand for reconstructive surgical procedures. Implant devices for the shoulder, wrist, ankle joints, digits, elbow, and foot are part of the extremity reconstruction market.

The primary driver of the global extremity reconstruction market is the large pool of geriatric population. According to the Centers of Disease Control and Prevention, with a rise in the geriatric population in the U.S., by the year 2040, the number of patients affected by arthritis is expected to increase to 78 million. Since aged people are more prone to injuries, growth in geriatric population is expected to fuel the demand for reconstructive surgical procedures.

Global Extremity Reconstruction Market: Key Trends

The rising incidence of joint disorders such as rheumatoid and osteoarthritis arthritis, coupled with the globally increasing incidence of diabetes and obesity, and rising geriatric population are driving the global extremity reconstruction market. Moreover, growing awareness among patients about the advantages of small joint reconstruction implants and enhanced technology such as development of reverse shoulder implants, stem less shoulder implants, and ankle reconstruction implants, which aid in recovering ankle mobility are projected to boost the market. The zest to get back to the active lifestyle, post-injury or trauma will supplement the demand for extremity reconstruction surgeries.

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On the downside, complications associated with extremity reconstruction surgeries and unfavorable reimbursement scenario will pose as threat to the global extremity reconstruction market.

Global Extremity Reconstruction Market: Market Potential

The global market for extremity reconstruction surgeries is evolving at fast pace. 3D implants are fast gaining traction among arthritis patients. It helps in better motion, it is less painful, and results in quick recovery. Various market giants have largely invested in this technology, to hold their position over the forecast period.

In February 2016, Zimmer Biomet received the US FDA approval for its 3D printed ankle fusion system. Similarly, in 2015 Stryker added 3D printed patellas and tibial baseplates to their Triathlon Tritanium Cone Augments and Triathlon Tritanium Knee System, which are used in knee surgeries. The company also has plans to build 3D manufacturing facility with investment of around US$ 400 mn.

Recently, a shoulder hemiarthroplasty or a shoulder replacement surgery was successfully carried out in Gandhi Hospital. This is a first-of-its-kind surgery performed by the doctors of the state-run hospital. Shoulder arthroplasty is a fast evolving field of orthopedics concentrated on treating specific, painful ailments of the gleno humeral articulation.

Global Extremity Reconstruction Market: Regional Outlook

The region to hold a leading share of the market is North America, and is expected to grow at a strong rate during the forecast period. Increased awareness regarding the benefits of extremity reconstruction devices, rise in occurrence of joint disorders, coupled with escalating geriatric population, encouraging reimbursement rates, presence of innovative technologies, and quest for better quality of life are the factors fuelling the demand for reconstruction procedures in this region.

During the forecast period, Asia Pacific is forecast to emerge as a lucrative market for extremity reconstruction. The rate of growth can be attributed to increase in acceptance of advanced technologies, presence of ample growth opportunities for the treatment of small joint disorders, and rise in awareness about the advantages of extremity reconstruction surgeries.

Global Extremity Reconstruction Market: Competitive Analysis

Some of the leading players operating in the global extremity reconstruction market are Arthrex, Inc., DePuy Synthes, Integra Lifesciences Holdings Corporation, Acumed, Inc., CONMED Corporation, Stryker Corporation, Zimmer Biomet Holdings, Inc., Wright Medical Group N.V., Smith & Nephew plc, and Skeletal Dynamics LLC.

The key market participants are bringing out innovative implants, which are wear and corrosion resistant to gain a stronghold in the market. Established players to boost clinical outcomes are making improvements in reconstruction procedures.

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Alphatec Holdings, Inc. Reports Third Quarter 2017 Financial Results

CARLSBAD, Calif., Nov. 09, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“Alphatec” or the “Company”) (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, announced today financial results for its third quarter ended September 30, 2017 and recent corporate highlights.

Third Quarter 2017 Financial Highlights

  • Total revenue of $23.1 million; U.S. commercial revenue of $20.7 million;
  • Cash burn improved to $3.7 million from $6.4 million sequentially;
  • Operating expenses improved $0.7 million sequentially; non-GAAP operating expenses improved $1.2 million sequentially.

Organizational, Commercial, and Product Highlights

  • Enhanced senior leadership team with the appointment of Patrick Miles, a globally recognized spine visionary, to the position of Executive Chairman;
  • Expanded the Board of Directors with the appointments of seasoned medical device executive, Quentin Blackford, and capital markets expert, Ward Woods;
  • Continued to drive momentum in transition of sales organization from non-exclusive to dedicated with third quarter sales from dedicated sales agents and distributors of over 30%, up significantly from just over 18% last quarter;
  • Commercially launched the Alphatec SquadronTM Lateral Retractor, a key component of the Battalion® Lateral System, in October.

“I am pleased with the execution of our team during the third quarter. Our financial results were in line with our pre-announced ranges.  In spite of the revenue challenges presented by weather and the sequential loss of two selling days in the quarter, we successfully managed operating expenses and improved cash burn,” said Terry Rich, CEO.   “We also drove momentum in the transition of our sales channel and made excellent progress on the initiatives that remain priorities as we reimagine Alphatec, keeping us on track to grow revenue sequentially in the fourth quarter.”

“I am especially excited to welcome Pat Miles, one of the spine industry’s most respected leaders, to our team,” added Rich. “Under his leadership, and with his passionate contribution to Alphatec’s product development, marketing, and surgeon engagement, we will lead the industry in terms of spine experience, driving innovation that improves the surgical experience and patient outcomes.  We are exceptionally well-positioned to take market share in U.S. spine.”

Comparison of Financial Results for the Third Quarter 2017 to Second Quarter 2017

Following is a table, comparing key third quarter 2017 results to second quarter 2017 results.  At this time, the Company believes that sequential results are the best indicators of performance. These are the comparisons management uses in its own evaluation of continuing operating performance given the re-focus of the Company’s strategy under a new leadership team.

Three Months Ended Change
September 30, 2017   June 30, 2017 $000’s   %
(unaudited)
U.S. commercial revenue $ 20,662 $ 21,877 $ (1,215 ) (5.6 %)
U.S gross profit 14,280 15,521 (1,241 ) (8.0 %)
U.S. gross margin 69.1 % 70.9 %
Operating Expenses
Research and development $ 1,044 $ 990 $ 54 5.5 %
Sales and marketing 10,015 10,298 (283 ) (2.8 %)
General and administrative 4,403 5,351 (948 ) (17.7 %)
Amortization of intangible assets 172 172
Restructuring expenses 139 528 (389 ) (73.7 %)
Gain on sale of assets (856 ) 856
Total operating expenses $ 15,773 16,483 $ (710 ) (4.3 %)
Operating loss $ (1,261 ) $ (735 ) $ (526 ) (71.6 %)
Loss from continuing operations $ (3,076 ) $ (2,629 ) $ (447 ) (17.0 %)
Non-GAAP Adjusted EBITDA $ 1,126 $ 1,218 $ (92 ) (7.6 %)

U.S. commercial revenue for the third quarter of 2017 was $20.7 million, down $1.2 million compared to $21.9 million in the second quarter of 2017.  The sequential decline was driven primarily by the impact of two less surgery days in the third quarter, weather-related impacts, and deliberate decisions to discontinue non-strategic relationships.

U.S. gross profit and gross margin for the third quarter of 2017 were $14.3 million and 69.1%, respectively, compared to $15.5 million and 70.9%, respectively, for the second quarter of 2017. The decrease in gross margin was due to lower sales volume, changes in product mix, and the impact of variations in inventory write-offs as the Company continues to optimize its supply chain.

Total operating expenses for the third quarter of 2017 were $15.8 million, reflecting a decrease of $0.7 million compared to $16.5 million in the second quarter of 2017.  On a non-GAAP basis, excluding restructuring charges and a gain on sale of assets, total operating expenses in the third quarter improved by $1.2 million compared to the second quarter of 2017. The improvements reflected the execution of operational improvement initiatives, including workforce reductions, facilities consolidation, and the success of ongoing efforts to reduce expenses.

GAAP loss from continuing operations for the third quarter of 2017 was $3.1 million, compared to a loss of $2.6 million for the second quarter of 2017.

Non-GAAP Adjusted EBITDA in the third quarter of 2017 was $1.1 million, compared to $1.2 million in the second quarter of 2017.  For more detailed information, please refer to the table, ”Alphatec Holdings, Inc. Reconciliation of Non-GAAP Financial Measures,” that follows.

Current and long-term debt includes $33.0 million in term debt and $9.2 million outstanding under the Company’s revolving credit facility at September 30, 2017. This compares to $33.6 million in term debt and $8.9 million outstanding under the Company’s revolving credit facility at June 30, 2017.

Cash and cash equivalents were $15.4 million at September 30, 2017, compared to $19.1 million reported at June 30, 2017.  In October 2017, the Company secured a commitment for additional equity investments of $3.5 million to $4.0 million, payable on or before January 1, 2018, and generated cash proceeds of $1.7 million from the exercise of warrants.

Comparison of Financial Results for the Three and Nine Months Ended September 30, 2017 and 2016

Revenue decreased on a year-over-year basis as a result of the Company’s execution of its sales organization transition and the impact of lost revenue related to the financial and operational challenges the Company faced in 2016 prior to the sale of its international business.  The year-over-year improvement in operating expenses is the result of a comprehensive initiative to reduce costs and drive operational efficiencies.  For additional information, please reference the following financial statement tables and the Company’s Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission on November 10, 2017.

Non-GAAP Information

To supplement the Company’s financial statements presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company reports certain non-GAAP financial measures such as Adjusted EBITDA.  Adjusted EBITDA included in this press release is a non-GAAP financial measure that represents net income (loss), excluding the effects of interest, taxes, depreciation, amortization, stock-based compensation expenses, and other non-recurring income or expense items, such as sale of assets, impairments, restructuring expenses, severance expenses and transaction-related expenses.  The Company believes that non-GAAP Adjusted EBITDA provides investors with an additional tool for evaluating the Company’s core performance, which management uses in its own evaluation of continuing operating performance, and a baseline for assessing the future earnings potential of the Company.  For completeness, management uses non-GAAP Adjusted EBITDA in conjunction with GAAP earnings and earnings per common share measures. The Company’s Adjusted EBITDA measure may not provide information that is directly comparable to that provided by other companies in the Company’s industry, as other companies in the industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. Adjusted EBITDA should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Included below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

Investor Conference Call

Alphatec will hold a conference today at 1:30 p.m. PT / 4:30 p.m. ET to discuss the results. The dial-in numbers are (877) 556-5251 for domestic callers and (720) 545-0036 for international callers. The conference ID number is 4698936. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at www.atecspine.com.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, Inc., is a medical device company that designs, develops, and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities, and trauma. The Company’s mission is to improve lives by providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www.atecspine.com.

Forward Looking Statements 

This press release contains ”forward-looking statements“ within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the references to the Company’s strategy in significantly repositioning the Alphatec brand and turning the Company into a growth organization.  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 uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any material litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “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.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the Securities and Exchange Commission. Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Investor/Media Contact:

Zack Kubow
The Ruth Group
(646) 536-7000
alphatec@theruthgroup.com

Company Contact:

Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
(760) 431-9286
ir@atecspine.com

 

ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
  (in thousands, except per share amounts – unaudited) 
Three Months Ended Nine Months Ended
September 30,  September 30, 
2017 2016 2017 2016
Revenues $ 23,099 $ 26,711 $ 75,456 $ 93,158
Cost of revenues 8,587 10,849 28,417 31,651
Gross profit 14,512 15,862 47,039 61,507
Operating expenses:
Research and development 1,044 1,087 3,483 6,799
Sales and marketing 10,015 11,764 31,416 39,498
General and administrative 4,403 4,136 15,977 19,416
Amortization of intangible assets 172 83 516 593
Restructuring expenses 139 1,605 1,898 1,736
Goodwill and intangible asset impairment 1,736 1,778
Gain on sale of assets (856 )
Total operating expenses 15,773 20,411 52,434 69,820
Operating loss (1,261 ) (4,549 ) (5,395 ) (8,313 )
Interest and other expense, net (1,822 ) (10,511 ) (5,677 ) (12,869 )
Loss from continuing operations before taxes (3,083 ) (15,060 ) (11,072 ) (21,182 )
Income tax provision (7 ) (4,997 ) 57 (4,962 )
Loss from continuing operations (3,076 ) (10,063 ) (11,129 ) (16,220 )
Loss from discontinued operations (61 ) (3,658 ) (220 ) (9,351 )
Net loss $ (3,137 ) $ (13,721 ) $ (11,349 ) $ (25,571 )
Net loss per share continuing operations $ (0.22 ) $ (1.17 ) $ (0.98 ) $ (1.91 )
Net loss per share discontinued operations (0.01 ) (0.43 ) (0.02 ) (1.10 )
Net loss per share  – basic and diluted $ (0.23 ) $ (1.60 ) $ (1.00 ) $ (3.01 )
Weighted-average shares – basic and diluted 13,938 8,560 11,349 8,505
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands) 
September 30, December 31,
2017 2016
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 15,437 $ 19,593
Accounts receivable, net 13,303 18,512
Inventories, net 29,747 30,093
Prepaid expenses and other current assets 2,019 4,262
Current assets of discontinued operations 236 364
Total current assets 60,742 72,824
Property and equipment, net 13,275 15,076
Intangibles, net 5,482 5,711
Other assets 222 516
Noncurrent assets of discontinued operations 52 61
Total assets $ 79,773 $ 94,188
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable $ 2,865 $ 8,701
Accrued expenses 22,606 27,589
Current portion of long-term debt 3,037 3,113
Current liabilities of discontinued operations 283 732
Total current liabilities 28,791 40,135
Total long term liabilities 60,894 71,954
Redeemable preferred stock 23,603 23,603
Stockholders’ deficit (33,515 ) (41,504 )
Total liabilities and stockholders’ deficit $ 79,773 $ 94,188

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
(in thousands – unaudited) 
Three Months Ended Nine Months Ended
September 30, September 30,
2017 2016 2017 2016
Operating loss, as reported $ (1,261 ) $ (4,549 ) $ (5,395 ) $ (8,313 )
Add back:
Depreciation 1,564 1,623 4,834 5,652
Amortization of intangible assets 234 306 702 915
Total EBITDA 537 (2,620 ) 141 (1,746 )
Add back significant items:
Stock-based compensation and stock price guarantee 450 (12 ) 1,669 1,510
Restructuring and other charges 139 1,605 1,898 1,778
Goodwill and intangible asset impairment 1,736 1,736
Gain on sale of assets (856 )
Adjusted EBITDA $ 1,126 $ 709 $ 2,852 $ 3,278

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF GEOGRAPHIC SEGMENT REVENUES AND GROSS PROFIT
(in thousands, except percentages – unaudited) 
Three Months Ended Nine Months Ended
September 30, September 30,
2017 2016 2017 2016
Revenues by source
U.S. commercial revenue $ 20,662 $ 25,189 $ 65,976 $ 82,445
Other 2,437 1,522 9,480 10,713
Total revenues $ 23,099 $ 26,711 $ 75,456 $ 93,158
Gross profit by source
U.S. $ 14,280 $ 15,209 $ 46,070 $ 56,430
Other 232 653 969 5,077
Total gross profit $ 14,512 $ 15,862 $ 47,039 $ 61,507
Gross profit margin by source
U.S. 69.1 % 60.4 % 69.8 % 68.4 %
Other 9.5 % 42.9 % 10.2 % 47.4 %
Total gross profit margin 62.8 % 59.4 % 62.3 % 66.0 %

Amedica Announces Reverse Stock Split

SALT LAKE CITY, Nov. 10, 2017 (GLOBE NEWSWIRE) — Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company that develops and manufactures silicon nitride as a platform for biomedical applications, today announced a 1-for-12 reverse stock split of its issued and outstanding common stock. The Company’s common stock will open for trading on a split-adjusted basis on Friday, November 10, 2017 (the “Effective Time”).  The split-adjusted shares of Amedica’s common stock will continue trading on the Nasdaq Capital Market under the Company’s existing symbol “AMDA.”  A new CUSIP number of 023435407 has been assigned to the Company’s common stock as a result of the reverse split.

The reverse stock split will reduce the number of shares of common stock outstanding from approximately 36,264,881 million to approximately 3,022,073 million upon commencement of trading on the Effective Time.  The reverse stock split affects all issued and outstanding shares of the Company’s common stock immediately prior to the Effective Time of the reverse stock split. The number of authorized shares of the Company’s common stock will remain unchanged.

American Stock Transfer and Trust Company, Amedica’s transfer agent, will instruct certificate shareholders on the exchange process once the reverse stock split takes effect.  Shareholders holding their shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse stock split.  Beneficial holders are encouraged to contact their bank, broker or custodian with any procedural questions.  No fractional shares will be issued.  Stockholders who otherwise would be entitled to receive fractional shares because they hold a number of shares not evenly divisible by 12, will automatically receive one whole share of common stock in lieu of the fractional share. No stockholders will receive cash in lieu of fractional shares.

About Amedica Corporation

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

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

Forward-Looking Statements

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

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

Solvay helps DiFusion Technologies innovate new ZFUZE osteoconductive PEEK composite for spinal implants

Alpharetta, Ga., Nov. 9, 2017 —Solvay, a leading global supplier of specialty polymers, announced that medical device-maker DiFusion Technologies chose Zeniva® ZA-500 polyetheretherketone (PEEK) as the base polymer for its ZFUZE osteoconductive PEEK composite for spinal implants. The new compound exhibited large areas of new bone formation on all bone implant surfaces in recent testing by DiFusion, who shared its results at the recent NASS 2017 event in Orlando.

PEEK is an attractive alternative to titanium for spinal implants because it shares similar modulus to bone, and its radio transparency allows for easy visualization in X-rays. The polymer is also inert, which means it does not interact with human tissue. While this quality supports biocompatibility, it means that PEEK does not naturally lend itself to bone growth. DiFusion solved this problem by compounding negatively charged zeolites into Solvay’s Zeniva® PEEK polymer.
“It was sort of a penicillin moment,”said Derrick Johns, CEO of DiFusion Technologies. “We started out engineering anti-microbial polymers by first loading zeolite particles with silver before compounding them. But we discovered if we took the silver cations out of the zeolite, they imbued PEEK with a negative charge. Osteoblast cells are attracted to the negatively charged surface at a far higher rate than titanium, and yet we were able to preserve the polymer’s outstanding visualization, modulus and strength benefits.”
Solvay was an early collaborator in the development of DiFusion’s patented ZFUZE composite, combining industry-leading materials expertise with technical and regulatory support for medical devices. Zeniva® ZA-500 PEEK was of particular interest to DiFusion due to the polymer’s higher flow, which facilitates both the compounding process and the extrusion of osteoconductive implants.
“In addition to our materials expertise, Solvay’s open innovation business model was instrumental to the successful innovation of DiFusion’s ZFUZE osteoconductive composite,”said Jeff Hrivnak, global business manager for Healthcare at Solvay’s Specialty Polymers Business Unit. “Our uniquely collaborative approach to customer projects differentiates us from other PEEK suppliers in this industry, and it allowed us to pool our respective capabilities and resources with DiFusion to solve this demanding challenge.”
DiFusion’s ZFUZE composite technology is in the final stages of its 510K approval process with the U.S. Food and Drug Administration. It is expected to be commercially available in the U.S. early next year.
® Zeniva is a registered trademark of Solvay

Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, aromatic ultra-high performance polymers, and high barrier polymers – for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil and Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries. Learn more at www.solvayspecialtypolymers.com.

Solvay is a multi-specialty chemical company, committed to developing chemistry that addresses key societal challenges. Solvay innovates and partners with customers in diverse global end markets. Its products and solutions are used in planes, cars, smart and medical devices, batteries, in mineral and oil extraction, among many other applications promoting sustainability. Its lightweighting materials enhance cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 27,000 employees in 58 countries. Net sales were € 10.9 billion in 2016, with 90% from activities where Solvay ranks among the world’s top 3 leaders. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris (Bloomberg: SOLB.BB – Reuters: SOLB.BR) and in the United States its shares (SOLVY) are traded through a level-1 ADR program.

Founded in 2008 in Austin, Tex., DiFusion Technologies, Inc. is a medical device company focused on reducing the rising incidence of surgical site infections in orthopedic and spine surgery through the development of a suite of patented antimicrobial orthobiologic polymeric implants. Initially focusing on the multi-billion dollar spinal implant market, the company has developed a technology with applicability across a variety of orthopedic segments using well characterized implants with benefits for the patient, surgeon, hospital and payer. For more information about DiFusion Technologies, visit www.difusiontech.com.

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Arthrex Announces Plans for Expansion of Global Headquarters

NAPLES, FL – November 9, 2017 – Arthrex announced details of its planned expansion for its North Naples global headquarters on Thursday in an event with Florida Governor Rick Scott and other state and local elected officials.

Construction is scheduled to begin next month with completion by the end of 2019.

“As Arthrex continues to experience unprecedented growth around the world, we remain committed to expanding in Southwest Florida,” said President and Founder Reinhold Schmieding. “This project was designed to accommodate our growth into the next decade, while maintaining the beautiful aesthetic of the Naples community.”

The project will demolish the Arthrex Manufacturing Inc. North building, located at 1250 Creekside Way, just east of the post office. Two grey office buildings located along Goodlette Road will also be demolished for the project.

Arthrex will construct three facilities for the project. The Arthrex Event and Administration Building will be a six-story, 300,000-square-foot modern office building with meeting space and will include a 15,000-square-foot cafeteria, a six-story parking garage with space for 1,400 vehicles and an outdoor terrace area overlooking a one-acre lake.

The INNovation Hotel, which will be located on the corner of Goodlette Road and Creekside Boulevard, will accommodate Arthrex guests and business travelers. The four-story, 170,000-square-foot full-service hotel will have approximately 160 rooms.

The third building, the Arthrex Wellness and Medical Center, will be located on the current site of the two office buildings along Goodlette Road. The two-story, 38,000-square-foot building will have a fitness center for employees with state-of-the-art equipment and group classes such as spinning and yoga. The building will also have a juice bar and lounge, a retail shop with Arthrex apparel and merchandise, and will be home to the Arthrex Medical Center, which provides free medical care to Arthrex employees and their families.

The campus expansion also includes a road project that will close the mid-section of Creekside Boulevard to create a university-style campus with abundant green space, interconnected walking and bicycle paths, a three-acre outdoor park area with a 1,000-square-foot pavilion for outdoor events and other activities.

Arthrex Boulevard, which is the street that runs between the post office and the Naples Daily News, will become the main entrance to Arthrex’s global headquarters and will undergo a renovation to expand the two-way street to include a median.

The expansion project is expected to create 560 jobs by 2021 and approximately 1,200 construction-related jobs through 2019.

About Arthrex

Arthrex Inc., headquartered in Naples, FL, is a global leader in orthopedic product development and medical education for orthopedic surgeons. More than 11,000 products for arthroscopic and minimally invasive orthopedic surgical procedures have been developed by Arthrex and are currently marketed worldwide. For more information, visit www.Arthrex.com.

DT MedTech Announces 510(k) FDA Clearance for Hintermann Series H2™ Total Ankle Replacement System

BALTIMORENov. 8, 2017 /PRNewswire/ — DT MedTech, LLC (DTM) today announced that the Hintermann Series H2™ Total Ankle Replacement System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The Hintermann Series H2™ is a semi-constrained, total ankle replacement prosthesis developed by Prof. Beat Hintermann, a world-renowned foot and ankle surgeon based in Liestal, Switzerland. The Hintermann Series H2™ Total Ankle Replacement System is indicated for use with bone cement to treat ankle arthritis in either primary or revision surgery of ankle joints damaged by systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis), primary arthritis (e.g., degenerative disease), and secondary arthritis (e.g., post-traumatic, avascular necrosis). The Hintermann Series H2™ is also indicated for patients with a failed total ankle replacement or non-union/mal-union of the ankle arthrodesis, provided that sufficient bone stock is present. The Intellectual Property of the Hintermann Series H2™ is protected by numerous patents with additional patents pending.

DTM’s Hintermann Series H2™ sales and distribution in the United States will be handled directly through its logistics partner HealthLink Europe International from its US headquarters located in Raleigh, NC, and through specialized and select distributors.

David Reicher, President and Chief Executive Officer of DTM, stated, “We are extremely pleased to receive marketing clearance from the FDA for our innovative Hintermann Series H2™ Total Ankle Replacement System. I want to thank our employees, M Squared Associates and other advisors, and key stakeholders, who were all so instrumental in helping DT MedTech achieve this momentous milestone.”

DTM continues to market and distribute its Hintermann Series H3™ mobile-bearing Total Ankle Replacement System outside of the United States in over 30 countries. The Hintermann Series H3™ is a substantiated leader for the international ankle replacement market with more than 17 years of proven clinical efficacy outside of the United States.

Prof. Beat Hintermann, developer of the Hintermann Series™ Total Ankle Systems, stated, “I am looking forward to adding the H2 as a semi-constrained option for my patients alongside the H3* mobile-bearing prosthesis. With the addition of the new H2 prosthesis, I will be able to expand my indications and patient selection for total ankle replacements.”

DTM anticipates a limited release of the Hintermann Series H2™ in early December 2017 outside the United States, as it has already received the CE mark for the device, along with registrations in many additional key markets. DTM will be focusing on training, sales, and distribution of the Hintermann Series H2™ in the United States markets and in markets outside the United States through DT MedTech International Limited (DTMI), DTM’s subsidiary and distribution arm located in Dublin, Ireland, in the upcoming months.

For additional DTM information inside the United States please email info@DTMedTech.com or call Ms. Jeannie Sardaat 410-427-0003; outside the United States, please email dtmedtech@healthlinkeurope.com or call +31 73 303 2537.

About DT MedTech, LLC

DT MedTech, LLC, is the parent company of DTMI and European Foot Platform, S.A.R.L. and DTM and its subsidiary companies maintain offices in Baltimore, MarylandDublin, IrelandSaint-LouisFrance; and Liestal, Switzerland. As a member of the Data Trace family of businesses, leaders in scientific and medical publishing, marketing, surgical training, clinical trial management, medical malpractice insurance, and information services for more than 30 years, DTM provides innovative surgical solutions for lower extremity surgeons with state-of-the-art devices such as The Hintermann Series™ Total Ankle Replacement Systems.*

*Hintermann Series H3™ is not available for sale within the United States and its territories.

SOURCE DT MedTech, LLC

Related Links

http://www.dtmedtech.com

Bone Therapeutics SA : Business Update for Third Quarter 2017

Gosselies, Belgium, 9 November 2017, 7am CET – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today provides a business update for the third quarter ended 30 September 2017.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “During the Third Quarter, Bone Therapeutics has delivered several key milestones that further validated our unique, minimally invasive bone cell technology, bringing us closer to potentially game-changing treatments in the large and growing orthopaedic and bone disease markets. We were delighted to report the positive interim results for our allogeneic product ALLOB® in both spinal fusion and delayed-union fracture trials. Moreover, demonstrating the international appeal and potential of our unique bone cell therapy products, we are pleased to partner with Asahi Kasei for the development and commercialization of PREOB® in Japan, with the potential to expand to other countries in Asia.

Preparations for further clinical development of ALLOB® in delayed union fractures are well under way, as well as a continued focus on process optimization and scale up to ensure a truly commercially viable product. We also look forward to announcing the completion of recruitment in our Phase IIA spinal fusion study at end of 2017 or early 2018.

Business highlights

  • In September, Bone Therapeutics reported strong interim efficacy and safety results for the Phase IIA lumbar spinal fusion study with its allogeneic cell therapy product, ALLOB®. In addition to evidence of successful fusion shown by radiological data collected over a 12-month follow-up period (absence of motion in all patients and continuous bone bridges in 9 out of 15 patients), the interim results revealed substantial clinical improvement in function (55% improvement on the Oswestry Disability Index) and a strong reduction in back and leg pain (59% and 90% respectively). From a safety perspective, treatment with ALLOB® was well tolerated in all patients. Further details are available in the press release of September 14, 2017.
  • The Company also announced positive interim efficacy data for its ALLOB® Phase I/IIA study for delayed-union fractures. At 6 months post administration, all patients treated met the primary endpoint. Radiological evaluation of fracture healing showed an improvement of, on average, 4 points on the TUS (Tomographic Union Score) scale, twice the required minimum of 2 points. The health status of patients, as measured by the Global Disease Evaluation (GDE) score, improved by, on average, 48%, compared to the predetermined minimum of 25%. Based on these interim efficacy results, the Data and Safety Monitoring Board (DSMB) has recommended stopping the trial early due to efficacy results. ALLOB® was shown to be well tolerated. Further details are available in the press release of September 20, 2017.
  • The Company signed an exclusive, royalty-bearing license agreement with one of Japan’s leading industrial companies, Asahi Kasei Corporation. The license agreement covers the development and commercialisation of Bone Therapeutics’ autologous bone cell therapy product, PREOB®, in Japan with the option to extend into additional Asian territories. Further details are available in the press release of September 22, 2017.
  • At the beginning of September, Jean-Luc Vandebroek was appointed Chief Financial Officer. With his extensive international finance experience from major public and privately-owned companies, he will oversee the Company’s financial planning needs as it continues to mature and bring its innovative cell therapy products closer to the market.

Financial highlights

  • Cash used in operating activities amounted to EUR 10.13 million for the first nine months of 2017, compared to EUR 8.95 million for the same period in 2016.
  • Operating loss amounted to EUR 8.76 million compared to EUR 8.87 million for the same period last year.
  • Net cash at the end of September 2017 amounted to EUR 9.11 million.

Outlook

  • Bone Therapeutics expects to complete recruitment of patients into the ALLOB® Phase IIA study in spinal fusion at the end of 2017 or early 2018.
  • The Company plans to initiate the Phase IIB trial with ALLOB® for delayed-union fractures in the second half of 2018.
  • Ongoing recruitment for the pivotal Phase III study in osteonecrosis for PREOB® with interim analysis expected in the second half of 2018. The interim analysis will determine whether the trial could be stopped at this stage.
  • Good cash management will remain a key priority, with a strong focus on net cash burn. Cash burn for the full year 2017 is expected to be approximately EUR 13-14 million, below the previous guidance of EUR 15 million. Based on its strategic priorities, the Company provides guidance that it has sufficient cash to carry out its strategic objectives into Q2 2018. In order to pursue the development of its promising bone-forming cell therapy platform the Company plans to raise funds with existing and new investors to strengthen its cash position.

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis, and is also partnered with Asahi Kasei Corporation for the development and commercialisation of PREOB® in Japan.

Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson and Hendrik Thys
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

SpineGuard Demonstrates the Unique Potential of its DSG™ Technology in Surgical Robotics

November 09, 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 the successful completion of an experimental feasibility study in collaboration with the Institut des Systèmes Intelligents et de Robotique (UPMC /CNRS), Paris, France.

The study demonstrates how DSG™ technology can stop a robot automatically when an impending bone breach is detected and thus can prevent serious surgical complications. Practically, during a vertebral drilling, a DSG™ drill bit mounted on a robot transmits in real time an alert signal to the control unit of the robot.

Olivier Frézal, VP Technical Operations at SpineGuard declared: “We are very satisfied by this result which confirms the potential of our DSG™ technology in surgical robotics thanks to its ability to measure tissue electrical conductivity locally and in real time. A technology breakthrough is now possible, because the robot will be able to automatically drill into the human skeleton, and allow the direct insertion of DSG™ sensing “smart” implants.” I am also delighted by our collaboration with UPMC which again underlines French research excellence.”

Guillaume Morel, ISIR, Professor, Director of the team AGATHE at INSERM: “For years it has been apparent that a sensing technology that could provide robots with a feedback loop would be an indispensable component of the progress of automation of surgical procedures. When SpineGuard contacted us about this research project and presented their DSG technology, we were immediately committed to a collaboration that revealed fruitful.”

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.

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

Contacts

SpineGuard
Stéphane Bette, Tel: +33 (0) 1 45 18 45 19
Chief Executive Officer
s.bette@spineguard.com
or
Manuel Lanfossi, Tel: +33 (0)1 45 18 45 19
Chief Financial Officer
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

NASS 2017 Best Paper Sessions Provide Significant Insights into the Long-Term Results of activL® Artificial Disc

CENTER VALLEY, Pa.Nov. 9, 2017 /PRNewswire/ — Aesculap Implant Systems, LLC today announced the significance of the long-term data presented at the NASS 2017 podium during the NASS Annual Meeting in Orlando, FLOctober 25-27, 2017. At the meeting, three key presentations were made that greatly increase the body of evidence in support of lumbar total disc replacement (TDR) as a standard of care for a subpopulation of patients suffering from degenerative disc disease (DDD).

The five-year outcomes of the activL® Artificial Disc Investigational Device Exemption (IDE) Study, a 7-Year Multi-Center, Randomized Controlled Trial (RCT) which compares outcomes of the activL Artificial Disc and previous generation disc replacements such as ProDisc-L (DePuy Synthes) were presented by one of the co-investigators of the study, Jim Yue, MD (Quinnipiac UniversityNew Haven, CT). The data demonstrates that while both the activL device and the control were effective at addressing patient pain and disability at five years, the activL device was more likely to preserve segmental range of motion at five years (p = 0.03) and had a higher safety profile (p < 0.001).

Additionally, the outcomes of a landmark 5-Year Meta-Analysis of RCTs comparing lumbar disc replacement to fusion were presented by Jack Zigler, MD (Texas Back Institute, Plano, TX). The meta-analysis demonstrated that TDR was superior to fusion at addressing patient disability, reoperation and satisfaction at five years (p=0.05, p=0.002, p=0.01, respectively).

During the data presentations, one audience member posed to the panel, “Is it your opinion that lumbar disc replacement can now be considered a gold standard of care for DDD?” Dr. Zigler replied, “It’s hard to reconcile that insurers still label lumbar TDR as experimental given this five-year level 1a data.” Members of the panel concluded that the evidence supported lumbar TDR as a standard of care that spine surgeons should be offering a subpopulation of their patients and that payers need to make accessible.

Later in the week, Richard Guyer, MD (Texas Back Institute, Plano, TX) presented one of the 21 papers nominated for Best Paper at NASS detailing the outcomes of an ad hoc analysis from the activL IDE study looking at the adjacent segment disease (ASD) outcomes between disc replacement systems at five years. From the analysis conducted by an independent third party, Dr. Guyer presented a 9% ASD rate for the activL device and a 19% rate for the control. The investigators are currently conducting additional data analysis to compare these TDR device outcomes to previously reported fusion ASD rates. Dr. Guyer also presented evidence of a correlation between the protective effect that range of motion has on ASD. “Finally, for those of us that have dedicated our careers to motion preservation, there is holy grail evidence that our theories were correct,” concluded Dr. Guyer from the podium.

The NASS abstracts are indexed and available for reference in The Spine Journal. The presenters and their co-authors are finalizing the full manuscripts relative to this data with the plan to present these outcomes to U.S. payers. In 2017, 16 million additional privately-insured patients now have a positive coverage policy giving them access to lumbar TDR.

About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.

SOURCE Aesculap Implant Systems, LLC

Related Links

http://aesculapimplantsystems.com

OrthoPediatrics Corp. Reports Third Quarter 2017 Financial Results

WARSAW, Ind., Nov. 08, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today its financial results for the third quarter ended September 30, 2017.

Third Quarter and Recent Highlights

  • Total revenue of $12.4 million, up 22% as compared to the third quarter of fiscal year 2016
  • Launched PediFrag™ Pediatric Specific Clavicle Plate in August and Medial Patella Femoral Ligament Reconstruction System in October, expanding our product portfolio offering to 22 surgical systems
  • Secured exclusive distribution rights for FIREFLY® Pedicle Screw Navigation Guides in pediatric hospitals in the United States
  • Completed our initial public offering, raising $59.8 million in gross proceeds, primarily to fund commercial expansion
  • Signed a Letter of Intent to amend debt agreement with Squadron Capital LLC, which lowers interest rate and extends term until 2023

“We delivered strong results in the third quarter, highlighted by 22% total revenue growth and the expansion of gross margin to 77%. This included consistent growth in both the U.S. and international markets and across all of our product categories. We were particularly pleased with the performance of our U.S. spine business, which was our fastest growing domestic category this quarter, driven by increased demand for our RESPONSE and BandLoc products,” said Mark Throdahl, Chief Executive Operator of OrthoPediatrics. “We also continued to expand our product portfolio with the launch of two new products and the addition of innovative, 3D printed, patient-specific FIREFLY® Pedicle Screw Navigation Guides, expanding our offering to 22 systems that address the $2.5 billion global market for pediatric orthopedic products. In October, we completed our initial public offering, raising $59.8 million in gross proceeds that will allow us to invest in implant and instrument sets and research and development initiatives to support future growth.”

Third Quarter Financial Results
Total revenue for the third quarter of 2017 was $12.4 million, a 22.1% increase compared to $10.1 million for the same period last year. U.S. revenue for the third quarter of 2017 was $9.6 million, a 21.3% increase compared to $7.9 million for the same period last year, representing 77.2% of total revenue. International revenue for the third quarter of 2017 was $2.8 million, a 24.7% increase compared to $2.3 million for the same period last year, representing 22.8% of total revenue.

Trauma and deformity revenue for the third quarter of 2017 was $8.7 million, a 21.8% increase compared to $7.2 million for the same period last year. Spine revenue for the third quarter of 2017 was $3.3 million, a 20.9% increase compared to $2.7 million for the same period last year. ACL reconstruction/other revenue for the third quarter of 2017 was $0.3 million, a 45.4% increase compared to $0.2 million for the same period last year.

Gross profit for the third quarter of 2017 was $9.5 million, a 32.6% increase compared to $7.2 million for the same period last year. Gross margin percentage for the third quarter of 2017 was 76.7%, compared to 70.6% for the same period last year.

Total operating expenses for the third quarter of 2017 were $10.2 million, a 33.4% increase compared to $7.7 million for the same period last year. Within operating expenses, research and development expenses for the third quarter of 2017 were $1.1 million, a 125.0% increase compared to $0.5 million for the same period last year. Operating loss for the third quarter of 2017 was $(0.8) million, a 44.6% increase in loss realized compared to $(0.5) million for the same period last year.

Interest expense for the third quarter of 2017 was $0.8 million, a 90.7% increase compared to $0.4 million dollars for the same period last year due to incremental debt incurred.

Net loss for the third quarter of 2017 was $(1.5) million, compared to $(0.8) million for the same period last year. Net loss per share attributable to common stockholders for the third quarter of 2017 was $(1.70) per basic and diluted share, or $(1.38) per basic and diluted share, for the same period last year.

The weighted average number of diluted shares outstanding as of September 30, 2017 was 1,773,385 shares.

Purchases of property and equipment during the third quarter of 2017 were $1.1 million, a 34.4% increase compared to $0.8 million for the same period last year. The primary driver of this increase was the deployment of consigned sets, which include product specific instruments as well as cases and trays.

As of September 30, 2017, cash and cash equivalents were $2.2 million, compared to $2.3 million as of June 30, 2017.

Capitalization Update
In October, OrthoPediatrics completed its initial public offering of 4,600,000 shares of its common stock at a public offering price of $13.00 per share, raising $59.8 million in gross proceeds, before underwriting expenses and commissions and offering expenses.

On November 8, 2017, the Company signed a Letter of Intent to amend its current debt agreement with its largest shareholder, Squadron Capital LLC (“Squadron”), to modify and extend the terms of its existing term notes and revolving credit facility. The Letter of Intent consolidates a majority of the term note amounts into a $20.0 million term loan and reestablishes a $15.0 million revolver. Both facilities will have an interest rate equal to the three month LIBOR plus 8.61%, which in total equals 10.0%, compared to a previous interest rate of 10.0% for the term notes and 11.0% for the revolving credit facility. The Letter of Intent extends the loan period through January 31, 2023 (previously May 31, 2019 or May 31, 2020 based on revenue). As of September 30, 2017, the Company had approximately $27.6 million in total outstanding indebtedness, including $7.5 million outstanding under the revolving credit facility, of which the Company expects to convert $1.6 million to term notes plus pay back $2.5 million in the near term, leaving over $11.0 million in available capacity.

Fred Hite, Chief Financial Officer of OrthoPediatrics, commented, “We are pleased to have signed a Letter of Intent to amend our loan agreement with Squadron, which will provide for a more favorable interest rate and extend the length of the agreement. It demonstrates Squadron’s commitment and confidence in our business and its long-term dedication to supporting the Company.”

Conference Call
OrthoPediatrics will host a conference call on Thursday, November 9, 2017 at 8:00 a.m. ET to discuss its financial results. The dial-in numbers are (855) 289-4603 for domestic callers and (614) 999-9389 for international callers. The conference ID number is 9169647. A live webcast of the conference call will be available online at OrthoPediatrics’ investor relations website, ir.orthopediatrics.com.

A replay of the webcast will remain available online at OrthoPediatrics’ investor relations website, ir.orthopediatrics.com, until OrthoPediatrics releases its fourth quarter and full year 2017 financial results. In addition, a telephonic replay of the conference call will be available until November 16, 2017. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. The replay conference ID number is 9169647.

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

ORTHOPEDIATRICS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In Thousands, Except Share Data)
September 30, December 31,
2017 2016
ASSETS
Current assets:
Cash $ 2,238 $ 1,609
Accounts receivable – trade, less allowance for doubtful accounts of $148 and $152, respectively 5,686 4,098
Inventories, net 18,434 13,962
Inventories held by international distributors, net 579 924
Deferred charges 1,339
Prepaid expenses and other current assets 615 233
Total current assets 28,891 20,826
Property and equipment, net 9,749 8,592
Other assets:
Amortizable intangible assets, net 2,183 998
Other intangible assets 260 260
Total other assets 2,443 1,258
Total assets $ 41,083 $ 30,676
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable – trade 5,102 3,543
Accrued compensation and benefits 2,288 2,219
Current portion of long-term debt with affiliate 111 107
Other current liabilities 2,915 1,382
Total current liabilities 10,416 7,251
Long-term liabilities:
Long-term debt with affiliate, net of current portion 19,986 12,931
Revolving credit facility with affiliate 7,500 4,500
Total long-term liabilities 27,486 17,431
Total liabilities 37,902 24,682
Commitments and contingencies
Redeemable convertible preferred stock:
Series A preferred stock, $0.00025 par value; $8,874 cumulative preferred dividends, September 30, 2017 and $7,439 December 31, 2016; 1,000,000 shares authorized, issued and outstanding 24,874 23,439
Series B preferred stock, $0.00025 par value; $11,793 cumulative preferred dividends, September 30, 2017 and $8,864 December 31, 2016; 6,000,000 shares authorized; 4,446,978 shares issued and outstanding 50,793 47,864
Stockholders’ deficit:
Common stock, $0.00025 par value; 8,040,000 shares authorized; 2,487,589 shares and 2,421,599 shares issued and outstanding as of September 30, 2017 and December 31, 2016 1 1
Additional paid-in capital 9,541 12,824
Accumulated deficit (82,221 ) (78,134 )
Accumulated other comprehensive income 193
Total stockholders’ deficit (72,486 ) (65,309 )
Total liabilities, redeemable convertible preferred stock and stockholders’ deficit $ 41,083 $ 30,676
ORTHOPEDIATRICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In Thousands, Except Share and Per Share Data)
Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
Net revenue $ 12,375 $ 10,135 $ 33,939 $ 27,880
Cost of revenue 2,884 2,978 8,321 7,913
Gross profit 9,491 7,157 25,618 19,967
Operating expenses:
Sales and marketing 5,633 4,289 15,122 12,401
General and administrative 3,487 2,890 10,282 8,842
Research and development 1,127 501 2,482 1,599
Total operating expenses 10,247 7,680 27,886 22,842
Operating loss (756 ) (523 ) (2,268 ) (2,875 )
Other expenses:
Interest expense 761 399 1,857 1,056
Other expense (income) 20 (77 ) (38 ) (992 )
Total other expenses 781 322 1,819 64
Net loss $ (1,537 ) $ (845 ) $ (4,087 ) $ (2,939 )
Net loss attributable to common stockholders $ (3,021 ) $ (2,405 ) $ (8,451 ) $ (7,229 )
Weighted average common shares – basic and diluted 1,773,385 1,744,356 1,754,576 1,744,356
Net loss per share attributable to common stockholders – basic and diluted $ (1.70 ) $ (1.38 ) $ (4.82 ) $ (4.14 )
ORTHOPEDIATRICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In Thousands)
For the Nine Months Ended
September 30,
2017 2016
OPERATING ACTIVITIES
Net loss $ (4,087 ) $ (2,939 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 1,748 1,402
Stock-based compensation 1,081 951
Research and development fee obligation termination (889 )
Changes in certain current assets and liabilities:
Accounts receivable – trade (1,588 ) (74 )
Inventories (3,276 ) (2,834 )
Inventories held by international distributors 345 1,588
Prepaid expenses and other current assets (382 ) (232 )
Accounts payable – trade 1,559 1,798
Accrued expenses and other liabilities 513 (579 )
Research and development fee obligation (628 )
Other 193 0
Net cash used in operating activities (3,894 ) (2,436 )
INVESTING ACTIVITIES
Purchases of licenses (1,337 ) (406 )
Purchases of property and equipment (3,949 ) (2,617 )
Net cash used in investing activities (5,286 ) (3,023 )
FINANCING ACTIVITIES
Proceeds from issuance of debt with affiliate 10,139 3,500
Payments on mortgage notes (80 ) (77 )
Payments of deferred offering costs (250 ) (527 )
Net cash provided by financing activities 9,809 2,896
NET INCREASE (DECREASE) IN CASH 629 (2,563 )
Cash, beginning of year 1,609 3,878
Cash, end of period $ 2,238 $ 1,315
SUPPLEMENTAL DISCLOSURES
Cash paid for interest $ 1,856 $ 1,056
Accretion of redeemable convertible preferred stock $ 4,364 $ 4,290
Transfer of instruments from property and equipment to inventory $ 1,196 $ 196

Net Revenue
The following tables set forth our net revenue by geography and product category for the three and nine months ended September 30, 2017 and 2016:

 Three Months Ended
September 30,
Nine Months Ended
September 30,
Product sales by geographic location: 2017 2016 2017 2016
U.S. $ 9,556 $ 7,875 $ 26,085 $ 21,565
International 2,819 2,260 7,854 6,315
Total $ 12,375 $ 10,135 $ 33,939 $ 27,880
 Three Months Ended
September 30,
Nine Months Ended
September 30,
Product sales by category: 2017 2016 2017 2016
Trauma and deformity $ 8,730 $ 7,168 $ 24,339 $ 20,184
Spine 3,299 2,729 8,652 6,940
ACL reconstruction/other 346 238 948 756
Total $ 12,375 $ 10,135 $ 33,939 $ 27,880