United Orthopedic Corporation Launches UTS™ Hip Stem and an Extension of its U-Motion II™ Acetabular System at AAOS Annual Meeting

IRVINE, Calif.March 7, 2018 /PRNewswire/ — United Orthopedic Corporation, a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments, announced today, at the American Academy of Orthopaedic Surgeons Annual Meeting in New Orleans, the launch of the UTS (United Tri-tapered Short Stem) hip stem and an extension of the U-Motion II Acetabular System.

“We are committed to developing quality, innovative orthopedic products that improve patient outcomes and address the market’s needs,” said Calvin Lin, President of United Orthopedic Corporation USA. “Our unique vertically integrated manufacturing model has enabled us to launch two products which provide surgeons with more treatment options for total hip replacement. One is the UTS™ hip stem, which facilitates less invasive surgery and aids in rapid recovery. The other is a new cup and cup liner – an extension of the U-Motion II Acetabular System – which is designed to reduce the risk of dislocation following a total hip replacement.”

The UTS™ hip stem – ideal for the direct anterior approach for total hip replacement – is a tapered wedge short stem suitable for less invasive primary hip replacement surgery. It is designed for easier insertion through small incisions and requires simpler femoral preparation, enabling rapid recovery. Shorter stems preserve bone, which allows for more favorable conditions in future revisions.i The UTS hip stem is available in 14 refined proximal sizes. Its features include:

  • Standard and high offset options for restoring joint biomechanics
  • Triple taper design with Titanium Plasma coating that provides initial fixation and enhances rotation stability
  • Reduced lateral shoulder designed to conserve bone in the greater trochanter

The demand for primary total hip arthroplasties is estimated to grow by 174% to 572,000 by 2030, while the demand for hip revisions is projected to double by 2026.ii Dislocation continues to be one of the most common causes of failure after primary and revision total hip arthroplasty. Clinical studies show large femoral heads decrease the incidence of dislocation after total hip arthroplasty.iii

The extension of the U-Motion II Acetabular System for total hip replacement surgery includes a 50mm acetabular cup and cup liner, which is compatible with the 36mm BIOLOX® delta ceramic and CoCrMo metal femoral heads. The pole thickness of the liner is 5.3mm, which is greater than ISO 21315’s requirement of 5mm to reduce the risk of breakage. The 36mm femoral head with the new U-Motion II 50mm Acetabular cup will provide patients a greater range of motioniv, increase jumping distance, improve stability and lower the risk of dislocation.

About United Orthopedic Corporation
United Orthopedic Corporation is a leading international designer, manufacturer, and distributor of innovative, regulatory compliant orthopedic implants and instrument sets used by surgeons around the globe. United Orthopedic Corporation’s offering includes a flexible range of clinically proven solutions used to perform total hip/knee replacements and revisions, plus clinical education, service and support for surgeons and hospital staff. United Orthopedic Corporation operates Quality Management Systems (QMS) that comply with ISO 9001/13485, FDA, and CE requirements. For more information about United Orthopedic Corporation, visit www.uocusa.com.

Media Contact
Erich Sandoval
Lazar Partners Ltd.
Tel: +1 917-497-2867
Email: esandoval@lazarpartners.com

_____________________________
i Molli RG,et al. A Short Tapered Stem Reduces Intraoperative Complications in Primary Total Hip Arthroplasty. Clin Orthop Relat Res. 2012 Feb;470(2):450-61.

ii Kurtz, et al. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5.

iii Howie, et al. Large femoral heads decrease the incidence of dislocation after total hip arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2012 Jun 20;94(12):1095-102. doi: 10.2106/JBJS.K.00570.

iv Guyen O. Constrained liners, dual mobility or large diameter heads to avoid dislocation in THA. EFORT Open Reviews. 2016;1(5):197-204. doi:10.1302/2058-5241.1.000054.

 

SOURCE United Orthopedic Corporation

Related Links

http://www.uocusa.com

WishBone Medical, Inc. and Hospital for Special Surgery (HSS) Collaborate to Develop a Novel Pediatric Total Hip Implant.

NEW YORK, March 07, 2018 (GLOBE NEWSWIRE) — WishBone Medical, Inc., a new global pediatric orthopedic company, committed to providing anatomically appropriate innovative implants, entered into a license agreement with the global leader in orthopedic surgery, Hospital for Special Surgery (HSS), for the development of a novel Pediatric Total Hip. The system will be developed to address treatment of juvenile idiopathic arthritis (JIA) patients or young patients with congenital dysplastic hip (CDH) disease.

“We look forward to working with HSS on a Pediatric Total Hip system designed just for kids,” said Nick Deeter, Chairman of the Board and CEO at WishBone Medical. “HSS is the premier musculoskeletal hospital in the world and their expertise and collaboration will be invaluable to develop this technology.”

“HSS’s clinical leadership, biomechanical engineering and innovation expertise together with Wishbone’s experience developing technologies to serve pediatric patients, position us to improve the quality of life of these young patients who do not have many therapeutic options,” said Louis A. Shapiro, president and CEO of HSS. “As an inventor of these technologies, Dr. Mark Figgie, our Chief of the Surgical Arthritis Service at HSS is a leading expert in the field, who along with our biomechanical engineers have a long history in both treating and innovating for this patient population,” Shapiro added.

About WishBone Medical, Inc.

WishBone Medical is a Global pediatric orthopedic company, committed to providing anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits, to prevent infection, reduce overall costs for our customers and achieve the best outcomes for children around the world who are still growing. To learn more about WishBone Medical, visit www.WishBoneMedical.com

For more information, please call Andrew Miclot, Vice-Chairman and President at 574-306-4006 or email CustomerService@WishBoneMedical.com.

About HSS | Hospital for Special Surgery

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the eighth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2017-2018). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients from 80 countries and performed more than 32,000 surgical procedures. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Innovation Institute was formed in 2015 to realize the potential of new drugs, therapeutics and devices; the global standard total knee replacement was developed at HSS in 1969, and in 2017 HSS made 130 invention submissions (more than 2x the submissions in 2015). The HSS Education Institute provides continuing medical curriculum to more than 15,000 subscribing musculoskeletal healthcare professionals in 110 countries. Through HSS Global, the institution is collaborating with medical centers worldwide to advance the quality and value of care and to make world-class HSS care more accessible to more people.

Onkos Surgical® and 3D Systems Team to Advance Personalized Surgical Oncology Solutions

PARSIPPANY, N.J.March 6, 2018 /PRNewswire/ — Onkos Surgical, Inc. announced today that it signed a 4-year agreement with 3D Systems (NYSE: DDD) to advance the delivery of personalized surgical solutions and help improve patient outcomes. The agreement provides Onkos Surgical priority access to 3D Systems’ VSP® (Virtual Surgical Planning) Orthopedic product line for surgical planning, as well as 3D printed anatomical models. Additionally, the companies will collaborate on next-generation 510(k) clearances for 3D printed implants and instruments for tumor reconstruction.

Through this partnership, the companies aim to advance the delivery of personalized surgical solutions to help improve outcomes for patients with tumors and lesions occurring in the pelvis and long bones (i.e., the large bones found in the arms and legs) associated with musculoskeletal cancers. The combination of VSP and 3D printing allows surgeons to preoperatively plan a surgical procedure, as well as design surgical tools and implants for each patient’s unique case.

Established by 3D Systems, VSP technology received FDA market clearance for the cranio-maxillofacial region as a service-based approach to personalized surgery, combining expertise in medical imaging, surgical simulation and 3D printing. The surgeon initiates the process, bringing their clinical knowledge and desired surgical plan to an online web meeting with a 3D Systems biomedical engineer to simulate and plan the surgical procedure. The outcome is a digital plan that is transferred to the operating room via accurate 3D printed patient-specific models, guides and templates.

“We are delighted to announce this partnership with 3D Systems, a true visionary and leader in medical device 3D printing and surgical planning,” said Patrick Treacy, co-founder and chief executive officer, Onkos Surgical.  “As an early stage investor in Onkos, they understand the criticality of our connection to the customer, the unique challenges these surgeons and patients face and the tremendous opportunity we have to make a difference for these patients while building a high value and scalable business.”

Onkos Surgical was founded in 2015 to deliver high quality implants and instruments that meet the unique needs of musculoskeletal tumor patients. The company quickly embraced 3D printing as a technology that could address the particular needs of both the cancer patient, and the cancer surgeon. Onkos Surgical realized the profound impact they could make if they combined personalized 3D printed medical devices and instrumentation with patient-specific surgical simulation.

“When we launched our Precision Oncology initiative at MSTS 2017 in Denver, it was met with great enthusiasm from the surgeon community,” said Sean Curry, senior vice president of commercial operations, Onkos Surgical. “The relationship with 3D Systems enhances our capabilities with product bundles and patient-specific solutions that will deliver on our promise of bringing focus and dedication to this space.”

“3D Systems is pleased to partner with Onkos Surgical delivering adaptive tools designed to provide insights, processes and outcomes for musculoskeletal oncology cases,” said Kevin McAlea, executive vice president, general manager, Metals and Healthcare, 3D Systems. “The combination of VSP and 3D printing provides an advantage for surgeons to personalize the surgical plan, instruments and implants for each unique case.”

According to the NIH – National Cancer Institute (cancer.gov), there were 3,260 new primary bone cancer cases reported in 2017. In addition to chemotherapy and radiation, two common surgical options for musculoskeletal cancer patients are amputation and limb salvage. Through limb salvage, the surgeon removes the cancer and some healthy tissue with the goal of leaving the limb largely intact. The section of bone that was removed can be replaced either with a bone graft from the patient or another person, or with an internal prosthesis (i.e., implants) made of metal and other materials.

Forward-Looking Statements
Certain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward looking statements can be identified by terms such as “believes,” “belief,” “expects,” “may,” “will,” “estimates,” “intends,” “anticipates” or “plans” or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions and current expectations and may include comments as to the company’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the company. The factors described under the headings “Forward-Looking Statements” and “Risk Factors” in the company’s periodic filings with the Securities and Exchange Commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as the date of the statement. 3D Systems undertakes no obligation to update or review any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise.

About Onkos Surgical
Based in Parsippany, NJ., Onkos Surgical is a privately held surgical oncology company founded in 2015. Onkos Surgical believes surgical oncology deserves attention, focus and innovation. Through dedication and strategic partnerships, Onkos Surgical will advance surgical oncology solutions and advocate for and support the surgeons and caregivers that dedicate their lives to the surgical treatment of cancer. For more information, visit www.onkossurgical.com

About 3D Systems
3D Systems provides comprehensive 3D products and services, including 3D printers, print materials, on demand manufacturing services and digital design tools. Its ecosystem supports advanced applications from the product design shop to the factory floor to the operating room. 3D Systems’ precision healthcare capabilities include simulation, Virtual Surgical Planning, and printing of medical and dental devices as well as patient-specific surgical instruments. As the originator of 3D printing and a shaper of future 3D solutions, 3D Systems has spent its 30-year history enabling professionals and companies to optimize their designs, transform their workflows, bring innovative products to market and drive new business models. More information on the company is available at www.3dsystems.com.

Media contacts:
Sean P. Curry
Senior Vice President, Commercial Operations
scurry@onkossurgical.com
(973) 264-5400

Greg Caldwell
Vice President, Global Content and Communications
3D Systems
press@3dsystems.com

SOURCE Onkos Surgical

Related Links

http://www.onkossurgical.com

Captiva Spine Marks First Surgeries Using TransFasten™ Posterior SI Fusion System, Addition of VP of Sales & Business Development and HyperLOX™ Posterior Cervical System

Captiva Spine, Inc., which designs, manufactures and distributes elegant and intuitive spine device solutions, announces the first surgeries using the company’s proprietary TransFasten™ Posterior SI Fusion System; the well-timed addition of Vice President of Sales and Business Development, Daniel Abromowitz; the addition of a new posterior cervical system – HyperLOX™.

Captiva Spine’s thoughtful solutions for the entire spinal column will be on display at the AAOS (American Academy of Orthopaedic Surgeons) Annual Meeting March 7-9, 2018 in New Orleans at booth 4213.

TransFasten Posterior SI Fusion System

The first cases using the company’s proprietary TransFasten Posterior SI Fusion System were successfully completed across the USA starting in December 2017. TransFasten’s use of a favorable posterior approach will potentially reduce operative time and neurovascular complications. With proprietary QuadraCentric joint preparation, TransFasten provides multiple implant contact points for biomechanical stability during fusion. An initial TransFasten surgeon, Dr. Pedro Ramirez, M.D. of Central Florida Neurosurgery Institute, stated “the intuitive TransFasten instrumentation allows me to place the implant accurately, utilizing a safe posterior approach while obtaining a true biologic fusion of the sacroiliac joint.” Over the past several years there has been a resurgence in the recognition of the SI Joint as a potential source of low back pain as treatment options for SI Joint dysfunction have advanced. Captiva Spine is committed to launch devices that align clinical and economic outcomes on behalf of all key stakeholders. TransFasten is on a track for completion of its alpha launch, and Captiva Spine will be training additional surgeons on this posterior SI approach nationwide as early as the end of March 2018.

Hired: VP Sales & Business Development, Daniel Abromowitz

In supporting Captiva Spine’s commitment towards continuous growth and business development, the addition of Daniel Abromowitz to Captiva Spine’s leadership team and business is significant. Dale Mitchell, Captiva Spine’s Founder and CEO, stated, “We have been looking forward to expanding our leadership team and increasing business presence throughout the USA. Daniel is a welcome addition as a strategic business leader with a proven record of profitably building high-performing sales teams in the spinal device and healthcare marketplaces.”

Introducing: HyperLOX Posterior Cervical System

The commercial launch of the HyperLOX Posterior Cervical System provides Captiva Spine a comprehensive solution for posterior stabilization and fusion of the cervical and thoracic spine. HyperLOX can be constructed into a multitude of configurations based on individual patient anatomy. Offering exceptional versatility and ease-of-use, HyperLOX features a wide range of hyper-angulating top loading polyaxial screws, hooks (straight, angled, and offset), offset connectors, multiple rod-to-rod connector configurations, cross connectors, and transitional rods. Inquiries from tenured professionals looking to partner with a company to build a relationship for the long run are always welcome. Captiva Spine can be contacted direct by phone at 561-277-9480 or via their website www.captivaspine.com/contact-us.

Discover Strength Through Connections at www.captivaspine.com.

About Captiva Spine, Inc.

Captiva Spine is a privately owned medical device organization founded in 2007. Captiva Spine supports spine surgeons, tenured spine distributors, and healthcare facilities in providing patients with progressive spinal care and an obsessive focus on quality; they strive to create and maintain sincere, honest, collaborative relationships. By valuing their relationships, above all else, fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high quality, smart, elegant, and intuitive patient solutions. Captiva Spine operates as a family of industry professionals that take pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm.

OrthoPediatrics Corp. Reports Fourth Quarter and Full Year 2017 Financial Results

WARSAW, Ind., March 07, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp.(NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today its financial results for the fourth quarter and full year ended December 31, 2017.

Fourth Quarter / Full Year 2017 and Recent Highlights

  • Total revenue of $11.7 million for fourth quarter 2017 and $45.6 million for full year 2017, up from $9.4 million or 24.0% and $37.3 million or 22.3% year-over-year, respectively, and in-line with preliminary results provided on January 5, 2018
  • Improved profitability with gross margin of 75.6% for fourth quarter 2017 and 75.5% for full year 2017, compared to 68.0% for the fourth quarter 2016 and 70.7% for full year 2016
  • Reported adjusted EBITDA of $(0.1) million for full year 2017, up 94.1% from $(1.0) million for full year 2016. See below for additional information and a reconciliation of non-GAAP financial information.
  • Launched a record of five new systems over the past 12 months, expanding product portfolio offering to 24 surgical systems
  • Provided financial guidance of 22.0% revenue growth for 2018

Mark Throdahl, Chief Executive Officer of OrthoPediatrics, commented, “2017 was a transformational year in which the Company increased sales growth and profitability, completed a public offering, and changed the lives of approximately 20,000 children. While all three of our product lines contributed to the 22% annual revenue growth, we were particularly pleased with the growth of our U.S. Scoliosis segment, which significantly outpaced that of the industry. Our strong U.S. Scoliosis growth rate confirms our specialized pediatric selling organization as an efficient model, and we intend to replicate our U.S. sales agency structure with certain international distributors. We approach 2018 with five recent product introductions and 24 surgical systems with more than 3,000 individual products, which is the most extensive pediatric surgical offering in the orthopedic industry. Furthermore, we have a robust product pipeline with five additional systems targeted for launch in 2018. We are confident that our operational competencies and strategic strengths, coupled with the proceeds from our IPO, position the Company for substantial future growth.”

Fourth Quarter and Full Year 2017 Financial Results
Total revenue for the fourth quarter of 2017 was $11.7 million, a 24.0% increase compared to $9.4 million for the same period last year. U.S. revenue for the fourth quarter of 2017 was $8.8 million, a 21.3% increase compared to $7.3 million for the same period last year, representing 75.5% of total revenue. International revenue for the fourth quarter of 2017 was $2.9 million, a 33.1% increase compared to $2.1 million for the same period last year, representing 24.5% of total revenue.

Total revenue for 2017 was $45.6 million, a 22.3% increase compared to $37.3 million for 2016. U.S. revenue for 2017 was $34.9 million, a 21.0% increase compared to $28.8 million for 2016, representing 76.5% of total revenue. International revenue for 2017 was $10.7 million, a 26.6% increase compared to $8.5 million for 2016, representing 23.5% of total revenue.

Trauma and deformity revenue for the fourth quarter of 2017 was $8.5 million, a 27.1% increase compared to $6.7 million for the same period last year. Scoliosis revenue for the fourth quarter of 2017 was $2.9 million, a 21.8% increase compared to $2.4 million for the same period last year. Sports medicine/other revenue for the fourth quarter of 2017 was $286 thousand, a 17.8% decrease compared to $348 thousand for the same period last year.

Trauma and deformity revenue for 2017 was $32.8 million, a 22.2% increase compared to $26.8 million for 2016. Scoliosis revenue for 2017 was $11.6 million, a 23.9% increase compared to $9.3 million for 2016. Sports medicine/other revenue for 2017 was $1.2 million, an 11.7% increase compared to $1.1 million for 2016.

Gross profit for the fourth quarter of 2017 was $8.8 million, a 38.0% increase compared to $6.4 million for the same period last year, and $34.5 million for 2017, a 30.7% increase compared to $26.4 million for 2016. Gross profit margin for the fourth quarter of 2017 was 75.6%, compared to 68.0% for the same period last year, and was 75.5% for 2017, compared to 70.7% for 2016.

Total operating expenses for the fourth quarter of 2017 were $13.0 million, a 35.1% increase compared to $9.7 million for the same period last year, and $40.9 million for 2017, a 25.9% increase compared to $32.5 million for 2016. Operating expenses for both fourth quarter and full year 2017 included increased research and development expenses of 50.8% and 54.0% year-over-year, respectively, as well as one-time expenses related to our October 2017 IPO. Operating loss for the fourth quarter of 2017 was $(4.2) million, a 29.3% increase in loss realized compared to $(3.3) million for the same period last year. Operating loss for 2017 was $(6.5) million, a 5.6% increase in loss realized compared to $(6.1) million for 2016.

Interest expense for the fourth quarter of 2017 was $0.6 million, a 50.7% increase compared to $0.4 million for the same period last year, and was $2.5 million for 2017, a 68.7% increase compared to $1.5 million for 2016. The increase was due to the use of incremental debt.

Net loss for the fourth quarter of 2017 was $(4.8) million, compared to $(3.6) million for the same period last year. This reflects, in part, accelerated vesting of restricted stock upon our IPO and new public company expenses. Net loss per share attributable to common stockholders for the fourth quarter of 2017 was $(4.35) per basic and diluted share, compared to $(3.03) per basic and diluted share for the same period last year. Adjusted EBITDA for the fourth quarter of 2017 was $(0.6) million as compared to $(0.5) million for the fourth quarter of 2016. See below for additional information and a reconciliation of non-GAAP financial information.

Net loss for 2017 was $(8.9) million, compared to $(6.6) million for 2016. Net loss per share attributable to common stockholders for 2017 was $(6.12), compared to $(7.14) per basic and diluted share for 2016. Adjusted EBITDA for the full year 2017 increased approximately $0.9 million, or 94.2%, to $(0.1) million, compared to $(1.0) million for the full year 2016.

The weighted average number of diluted shares outstanding as of December 31, 2017 was 4,817,079 shares.

Purchases of property and equipment during the fourth quarter of 2017 were $1.3 million, a 27.3% decrease compared to $1.7 million for the same period last year, and $5.2 million for 2017, a 19.8% increase compared to $4.3 million for 2016. 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 December 31, 2017, cash and cash equivalents were $42.6 million, compared to $1.6 million as of December 31, 2016.

Capitalization Update
On October 12, 2017, the Company completed a public offering selling 4,600,000 shares at a price of $13.00 per share, including 600,000 shares sold to the underwriters upon exercise of the option to purchase additional shares. The public offering generated net proceeds of approximately $46.9 million, after deducting the underwriting discount, related offering expenses, and the payment of Series B Preferred Stock dividends.

In December 2017, we amended our debt agreement with Squadron Capital, our largest shareholder, to modify and extend the terms of our term notes and revolving credit facility. We consolidated a majority of the term note amounts into a $20.0 million term loan and re-established a $15.0 million revolver. As of December 31, 2017, the Company had approximately $25.5 million in total outstanding indebtedness, including $3.9 million outstanding under the revolving credit facility.

2018 Financial Guidance
The Company estimates 2018 revenue growth of 22.0%. We expect the annual investment in consigned sets to increase to $10.0 million in 2018 from an average of $3.5 million historically.

Conference Call
OrthoPediatrics will host a conference call on Thursday, March 8, 2018 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 7586297. 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 first quarter 2018 financial results. In addition, a telephonic replay of the conference call will be available until March 15, 2018. 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 7586297.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “goals,” “potential,” “objective,” “would” and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond OrthoPediatrics’ control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ Registration Statement on Form S-1/A filed with the SEC on October 10, 2017 and its most recent Quarterly Report on Form 10-Q. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.

Use of Non-GAAP Financial Measures
This press release includes the non-GAAP financial measure of Adjusted EBITDA, which differs from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”).  Adjusted EBITDA in this release represents net loss, plus interest expense (income), net plus other expense (income), depreciation and amortization, stock-based compensation expense, accelerated vesting of restricted stock upon our IPO, public company costs and initial public offering costs. Adjusted EBITDA is presented because the Company believes it is a useful indicator of its operating performance. Management uses the measure as a measure of the Company’s operating performance and for planning purposes, including financial projections. The Company believes this measure is useful to investors as supplemental information because it is frequently used by analysts, investors and other interested parties to evaluate companies in its industry.  The Company believes Adjusted EBITDA is useful to its management and investors as a measure of comparative operating performance from period to period.  Adjusted EBITDA is a non-GAAP financial measure and should not be considered as an alternative to, or superior to, net income or loss as a measure of financial performance or cash flows from operations as a measure of liquidity, or any other performance measure derived in accordance with GAAP, and it should not be construed to imply that the Company’s future results will be unaffected by unusual or non-recurring items. In addition, the measure is not intended to be a measure of free cash flow for management’s discretionary use, as it does not reflect certain cash requirements such as debt service requirements, capital expenditures and other cash costs that may recur in the future. Adjusted EBITDA contains certain other limitations, including the failure to reflect our cash expenditures, cash requirements for working capital needs and other potential cash requirements. In evaluating Adjusted EBITDA, you should be aware that in the future the Company may incur expenses that are the same or similar to some of the adjustments in this presentation. The Company’s presentation of Adjusted EBITDA should not be construed to imply that its future results will be unaffected by any such adjustments. Management compensates for these limitations by primarily relying on the Company’s GAAP results in addition to using Adjusted EBITDA on a supplemental basis. The Company’s definition of this measure is not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation. The schedules below contain a reconciliation of Adjusted EBITDA to Net Income.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 24 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 37 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

ORTHOPEDIATRICS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In Thousands, Except Share Data)

  As of December 31,
  2017   2016
   
ASSETS
Current assets:
Cash $     42,582 $     1,609
Accounts receivable – trade, less allowance for doubtful accounts of $143 and $152, respectively     5,603    4,098
Inventories, net    19,498   13,962
Inventories held by international distributors, net      1,047        924
Prepaid expenses and other current assets        831        233
Total current assets   69,561   20,826
Property and equipment, net  10,391     8,592
Other assets:
Amortizable intangible assets, net      2,089       998
Other intangible assets        260        260
Total other assets      2,349     1,258
Total assets $    82,301 $   30,676
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable – trade $      5,495 $     3,543
Accrued compensation and benefits      2,905    2,219
Current portion of long-term debt with affiliate        113      107
Other current liabilities        954     1,382
Total current liabilities     9,467     7,251
Long-term liabilities:
Long-term debt with affiliate, net of current portion 21,418   12,931
Revolving credit facility with affiliate     3,921   4,500
Total long-term liabilities    25,339   17,431
Total liabilities    34,806   24,682
Commitments and contingencies (Note 16)
Redeemable convertible preferred stock:
Series A preferred stock, $0.00025 par value; $0 cumulative preferred dividends, December 31, 2017 and $7,439 December 31, 2016; 0 and 1,000,000 shares authorized, issued and outstanding as of December 31, 2017 and 2016, respectively                 –            23,439
Series B preferred stock, $0.00025 par value; $0 cumulative preferred dividends, December 31, 2017 and $8,864 December 31, 2016; 0 and 6,000,000 shares authorized as of December 31, 2017 and 2016, respectively; 0 and 4,446,978 shares issued and outstanding as of December 31, 2017 and 2016, respectively                –            47,864
Stockholders’ equity (deficit):
Common stock, $0.00025 par value; 50,000,000 shares and 12,000,000 shares authorized at December 31, 2017 and 2016, respectively; 12,621,781 shares and 2,421,599 shares issued and outstanding as of December 31, 2017 and 2016, respectively             2                     1
Additional paid-in capital  150,424   12,824
Accumulated deficit  (103,066 )  (78,134 )
Accumulated other comprehensive income          135           –
Total stockholders’ equity (deficit)     47,495  (65,309 )
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) $  82,301 $   30,676

CrossRoads® Extremity Systems Announces Launch of the DynaFORCE® Active Stabilization™ Vero Medial Column Implant System

MEMPHIS, Tenn.March 7, 2018 /PRNewswire/ — CrossRoads® Extremity Systems, a privately held medical device company offering innovative foot & ankle fixation implant systems and services, announced that it has recently launched the DynaFORCE® Active Stabilization™ Vero Medial Column Implant System. This launch represents the latest addition to the DynaFORCE Portfolio originally launched in July 2017. The Vero Medial Column Implant System combines stability of a plate with active compression of nitinol clips. It is available in various sizes and is delivered to the operating room completely sterile packaged.

Chad Hollis, Co-Founder of CrossRoads, comments, “We believe the Vero plating system is a robust platform for medial column fusion with multiple fixation points throughout the plate. It provides surgeons with the ability to address compression across multiple joints at the same time without violating the joint surface.”

About CrossRoads Extremity Systems

CrossRoads was founded in 2014 and is headquartered in Memphis, TN. CrossRoads has experienced rapid growth through creative product development and a strong distributorship network. CrossRoads’ goal is to provide a steady rhythm of novel and clinically relevant new products that distinguish us from other companies.

In addition to providing novel products, CrossRoads strives to find ways to help hospitals save money and improve efficiency. CrossRoads believes that as customers experience the EcoSMART™ model of using high quality, surgical grade instruments in sterile kits, our EcoSMART Service will become the preferred model of surgeons, O.R. staff, and materials management.

For more information, please visit www.crextremity.com or www.activestabilization.com

©2018 CrossRoads Extremity Systems, LLC.  All Rights Reserved

Vernon Hartdegen
President & CEO of CrossRoads Extremity Systems, LLC
pr@crextremity.com

SOURCE CrossRoads Extremity Systems

Related Links

http://www.crextremity.com

Stryker unveils market’s first reusable suture passer for arthroscopic rotator cuff repair, Cobra

KALAMAZOO, Michigan, USA, March 7, 2018 /PRNewswire/ — Stryker announced today at the American Academy of Orthopaedic Surgeons annual meeting (booth #2451) the launch of its new reusable suture passing technology for use in rotator cuff repair, Cobra.  This first-of-its-kind technology leverages novel needle manufacturing and an innovative jaw design to produce the first reusable needle technology.

Compared to other suture passers on the market, Cobra offers improved needle stiffness to address issues associated with intraoperative misfires and distal tip needle breakages.  In addition, the value-based robust needle technology offers customers a more cost-effective solution. This suture passer utilizes technology that Stryker acquired from Arthrogenx, LLC in 2017.

“We are excited about the launch of the Cobra technology because it provides a unique opportunity for us to significantly increase clinical performance from the current standard of care, while also reducing cost to customers,” said Matt Moreau, Stryker’s Sports Medicine Vice President and General Manager.  “We recognize that our customers will continue to be under tremendous pressure to increase quality while also reducing cost.  Launching the Cobra passer will allow Stryker to better partner with our customers and align with their financial objectives while also improving patient safety.”

Stryker will showcase its latest technologies, including Cobra, at the AAOS meeting from March 7-9, 2018.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Media contact
Heather Morrison
heather@inprela.com
Phone:  612 677 2023

SOURCE Stryker

Related Links

http://www.stryker.com

Corin Group Launches Unity Knee™ with EquiBalance™ at AAOS 2018 Annual Meeting

NEW ORLEANSMarch 7, 2018 /PRNewswire/ — Corin Group, a global orthopaedic manufacturer and leader in functional implant positioning, today announced the launch of the new Unity Knee™ with EquiBalance™ instrumentation designed to facilitate ligament balancing and soft tissue preservation during total knee replacement. The announcement was made here at the American Academy of Orthopaedic Surgeons (AAOS) 2018 Annual Meeting.

While conventional instruments used in knee replacement may alter the natural joint line, the Unity Knee with EquiBalance preserves the joint line to help enable ligament balancing and medial collateral ligament (MCL) isometry, effectively achieving functional positioning of the knee. This may improve implant stability and performance, and reduce pain and discomfort after knee replacement.

“The new knee system minimizes the impact on soft tissue and enables maintenance of both the distal and posterior medial joint line throughout the range of motion, which may result in improved patient function and joint stability,” said orthopaedic surgeon Stefan Kreuzer, MD of INOV8 Orthopedics in Houston, TX.* “Everybody’s knee is different and what may be natural alignment for one may be different for another. The Unity Knee with EquiBalance lets surgeons make adjustments based on specific patient anatomy and movement,” said Dr. Kreuzer.

“Corin continues to embrace and advance the science and practice of personalization and functional positioning in joint replacement with meaningful and evidence-based innovation that respects the individual differences in patient anatomy and movement,” said Paul Berman, President, Corin USA.

About Corin Group

Corin is a European orthopaedic manufacturer based in the UK that markets its products throughout the world.

Corin is committed to:

…improving patient satisfaction with personalized technologies that optimize our clinically proven joint replacements

…delivering a personal approach to our customers, combining the spirit of our local companies with the strength of our global, integrated organization

…empowering and rewarding our global talented teams to deliver excellence to our customers

For further information about Corin, please visit www.coringroup.com.

*Paid consultant to Corin

 

Life Spine Announces First Clinical Use of SENTRY™ 2 Lateral Plating System

March 07, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today the first clinical use of SENTRY 2 Lateral Plating System with Dr. Tien Le of Tampa, Florida.

SENTRY 2 lateral plating system joins Life Spine’s full lateral procedural offering, which consists of PLATEAU-X Lateral Spacer System, LONGBOW Expandable Spacer System, CENTRIC® Expandable Retractor System, as well as the graft delivery system OSTEO-LINE. The SENTRY 2 Lateral Plating System offers a simple yet comprehensive stabilization solution designed to provide supplemental fixation from a lateral single position approach. SENTRY 2, along with SENTRY 4 Lateral Plating System, provides the surgeon the ability to perform a complete stabilization and fixation procedure while the patient is in the lateral decubitus position. This single approach concept negates the time and cost usually associated with the need for patient repositioning for posterior fixation, while providing ample stability. Additionally, the narrow profile of SENTRY 2 allows the surgeon to minimize retraction and trauma to the psoas and lumbar plexus, as well as providing a surgical solution when exposure is limited by the iliac crest or ribs.

“The SENTRY 2 Lateral Plating System provided me great stability in a challenging revision procedure, minimizing the cost, time and impact to the patient due to repositioning for posterior fixation, as well as the challenges associated with revision of a previous posterior fusion” stated Tien Le, MD, Spinal Neurosurgeon at NeuroSpine Center in Tampa, FL. “Single approach surgery with SENTRY 2 provides a true medical economic advantage, as well as reducing risks associated with patient repositioning and preparation. In my hands, the system provided the stability and security required for a minimally invasive lateral procedure. SENTRY 2 has a variety of plate and screw configurations to accommodate even the most challenging patient anatomies.”

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

DonJoy® Transforms Patient-Physician Communication: Introducing the X4™ Smart Brace

March 07, 2018

SAN DIEGO–(BUSINESS WIRE)–DonJoy, a leading provider of bracing and supports and part of the DJO® brand family, announces the launch of the X4™ Smart Brace with Motion Intelligence™, a revolutionary cloud-based remote patient monitoring solution.

X4 with Motion Intelligence is the first knee brace for total knee arthroplasty that monitors patient recovery and compliance in real time, enabling on-demand, insightful patient/physician connectivity throughout the continuum of care.

During pre- and post-op phases of reconstructive knee surgery, the digitally connected X4 smart brace with Motion Intelligence records patient data and transfers it from the patient app to the physician for review. X4 supports the knee while simultaneously allowing healthcare professionals to evaluate knee joint range of motion and rehabilitation compliance in real time.

“At DJO, we believe in powering motion. Our mission is to drive innovation to keep patients moving,” said Brady Shirley, CEO, DJO. “We believe X4 with Motion Intelligence will set a new bar in enhancing positive outcomes for orthopedic patients and providers.”

X4 with Motion Intelligence is comprised of four innovative components:

  • X4 Smart Brace: Features a comfortable, anatomical design with malleable aluminum hinges for support and adaptability to different leg shapes.
  • Motion Intelligence 360 Sensor (embedded in the X4 Knee Brace): Enables on-demand monitoring of patients’ rehabilitation progress (range of motion), as well as exercise and activity levels (daily step count).
  • Motion Intelligence App: With the easy-to-use app, patients can track rehabilitation goals, view daily exercises, record pain levels, and communicate directly with healthcare providers.
  • Physician Portal: Gives providers access to patient information via an intuitive dashboard that monitors and tracks patient information and integrates EMR/PM and surgical site photos.

All information is stored and sent in the HITRUST certified MotionMD® platform, which means DJO meets and exceeds the highest requirements to create, access, store or exchange sensitive and/or regulated data.

In addition to remote monitoring of post-op rehabilitation, X4™ with Motion Intelligence™ also helps improve patient compliance and engagement by empowering at-home recovery and enhancing patient/physician communication, allowing for more collaborative, connected managed care.

“The DJO team is committed to helping patients realize the health benefits of motion and regular physical activity,” said Shirley. “We are uniquely positioned across the entire orthopedic continuum of care, and we are proud to help patients and physicians truly work as a team, getting patients back to the activities they enjoy and the good health they deserve as quickly and safely as possible after total knee replacement.”

About Reconstructive Knee Surgery in the US

More than 600,000 knee replacements are performed each year in the United States, according to the American Academy of Orthopaedic Surgeons.1 With an aging population staying in the workforce longer and obesity on the rise, demand for total knee replacement surgery is expected to exceed 3 million by the year 2030. In addition one in every two Americans will experience symptomatic knee osteoarthritis (OA) in their lifetime.2 Patients diagnosed with knee OA are getting younger as compared to 20 years ago.3

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 after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine 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 orthopedic 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

1 AAOS Website – http://www.anationinmotion.org/value/knee/
2 http://www.cdc.gov/arthritis
3 Losina W, et al. Impact of obesity and knee osteoarthritis on morbidity and mortality in older Americans. Ann Intern Med. 2011 Feb. 15;154(4):217-26

Contacts

DJO Media Contact:
Brittany Knudson, 760.734.5628
Sr. Director, Marketing Communications
Brittany.Knudson@djoglobal.com