Cerapedics Announces Presentation of Results from the IVANOS Study of i-FACTOR™ Peptide Enhanced Bone Graft in Uninstrumented Lumbar Posterolateral Spine Surgery

WESTMINSTER, Colo.May 21, 2018 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced results from the IVANOS study evaluating i-FACTOR™ Peptide Enhanced Bone Graft in lumbar posterolateral spine surgery. Results were presented by Mikkel O Andersen, MD, from the Sector for Spine Surgery and Research at Middelfart Hospital in Denmark, at the 7th Annual Global Spine Congress held May 2-5 in Singapore.

i-FACTOR Peptide Enhanced Bone Graft is based on proprietary synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment and activation. In spinal fusion procedures, surgeons use bone graft to join and stabilize vertebrae. i-FACTOR Peptide Enhanced Bone Graft was approved in the European Union in 2008 and in Australia in 2010 for use in the repair of bony voids or defects in orthopedic applications throughout the skeletal system (i.e., the spine and extremities). In the United States, i-FACTOR Peptide Enhanced Bone Graft was approved via a PMA in 2015 only for use in single level anterior cervical fusion procedures.

In the single center, double-blind, randomized IVANOS study, 98 patients (240 treated levels) age 60 and older with lumbar spinal stenosis (LSS) and concomitant degenerative olisthesis (DS) were treated with non-instrumented lumbar posterolateral spine surgery and received either i-FACTOR Peptide Enhanced Bone Graft or allograft. Results demonstrated a 50 percent fusion rate (63/126) using i-FACTOR Peptide Enhanced Bone Graft compared to a 20 percent fusion rate (23/114) using allograft at one-year postoperative follow-up. Patients with 1-level DS achieved estimated fusion rates of 40 percent (29/72) with i-FACTOR Peptide Enhanced Bone Graft versus 21 percent (17/80) with allograft. Patients with 2-level DS achieved estimated fusion rates of 63 percent (34/54) with i-FACTOR Peptide Enhanced Bone Graft versus 18 percent (6/34) with allograft.

“In Denmark the current surgical standard is the use of non-instrumented fusion in treating elderly patients with spinal stenosis and concomitant degenerative olisthesis. This patient population presents a challenging environment to obtain fusion due to their mechanical instability and biology,” said Dr. Andersen. “These data indicate that i-FACTOR Peptide Enhanced Bone Graft offers significant potential benefits in fusion rates compared to allograft.”

“This data from the IVANOS study is another significant milestone as we advance on our commitment to increase the level of clinical evidence evaluating our P-15 technology, and we are proud to be leading the effort to address the evidence gap around commercial bone grafts often used in spinal fusion procedures,” said Glen Kashuba, chief executive officer of Cerapedics.

Cerapedics received approval from the U.S. Food and Drug Administration (FDA) to initiate an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of its proprietary P-15 technology for use in transforaminal lumbar interbody fusion (TLIF) surgery in March 2018. The company is initiating enrollment in the study with the expectation that the results will support an additional Premarket Approval (PMA) application. P-15 currently remains investigational in the United States for use in the lumbar spine.

About Cerapedics

Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.

i-FACTOR Peptide Enhanced Bone Graft Indications for Use

Europe and Australia: i-FACTOR Peptide Enhanced Bone Graft is a bone graft substitute material for use in the repair of bony voids or defects in orthopedic applications throughout the skeletal system (i.e., the spine and extremities). The bony voids may be surgically created defects or may result from traumatic injury to the bone.

USA: i-FACTOR™ Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. i-FACTOR™ Peptide Enhanced Bone Graft must be used inside an allograft bone ring and with supplemental anterior plate fixation.

Media contact:
Jenna Iacurci
Berry & Company Public Relations
212-253-8881
jiacurci@berrypr.com

SOURCE Cerapedics

Related Links

https://cerapedics.com

Amplitude Surgical Granted the Euronext Tech 40 Label

May 18, 2018

VALENCE, France–(BUSINESS WIRE)–Regulatory News:

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global surgical technology market for lower-limb orthopedics, announces that it has joined the list of innovative companies listed on the Euronext comprising the “Tech 40” label.

Launched in April 2015 on EnterNext’s initiative, this label incorporates emblematic Tech sector companies listed on the Euronext markets in Paris, Amsterdam, Brussels and Lisbon that operate in one of the following fields of activity: life sciences, eco-industries or TMT. The 40 companies granted this label are selected by an independent group of European experts based on their business, financial and stock market performance.

Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “All of Amplitude Surgical’s staff and I, founder of the Group in 1997, are particularly proud to be joining the other technological players listed on the Euronext that have been granted this label. This TECH 40 label rewards the hard work undertaken by our teams to implement a winning growth strategy, based on an international deployment and a portfolio of innovative products.”

About Amplitude Surgical
Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents distributing its products in more than 30 countries. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. At June 30, 2017, Amplitude Surgical had a workforce of nearly 370 employees and recorded sales of over 93 million euros.

Contacts

Amplitude Surgical
Philippe Garcia
CFO
finances@amplitude-surgical.com
+33 (0)4 75 41 87 41
or
NewCap
Investor Relations
Marc Willaume
amplitude@newcap.eu
+33 (0)1 44 71 00 13
or
NewCap
Media Relations
Nicolas Merigeau
amplitude@newcap.eu
+33 (0)1 44 71 98 55

Medtronic Announces 2018 Institutional Investor and Analyst Meeting and Webcast

DUBLIN – May 18, 2018 – Medtronic plc (NYSE:MDT) announced today that the company will host its biennial Institutional Investor and Analyst Meeting on Tuesday, June 5, 2018, in New York City from 8:00 a.m. to approximately 2:00 p.m. Eastern Daylight Time. The meeting will include remarks from the Medtronic executive management team on the company’s strategies for creating long-term value for its shareholders.

Omar Ishrak, Medtronic chairman & chief executive officer, and Karen Parkhill, Medtronic executive vice president & chief financial officer, will give presentations on the company. In addition, Medtronic executives from all four of the company’s business groups and all four of the company’s global regions are expected to present or participate in the event.

Medtronic will host a webcast of the meeting to provide access to all interested stakeholders. The webcast can be accessed by clicking on the Investor Events link at http://investorrelations.medtronic.com on June 5, 2018. Slides from the meeting will be available to those viewing the webcast. Within 24 hours of the webcast, a replay including presentation slides will be available by clicking on the Investor Events link at http://investorrelations.medtronic.com.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:
Fernando Vivanco
Public Relations
+1-763-505-3780

Ryan Weispfenning
Investor Relations
+1-763-505-4626

DJO Announces Appointment of Mark Dorris as President, Bracing and Supports

May 16, 2018

SAN DIEGO–(BUSINESS WIRE)–DJO (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced the appointment of W. Mark Dorris as President of Bracing and Supports, DJO’s largest business unit.

Mr. Dorris is a seasoned executive with more than 30 years of experience in the healthcare industry, most recently serving as the President of Zimmer Surgical for seven years, where he significantly grew revenue and operating profit. Prior to Zimmer, Mr. Dorris was the President of Medegen Medical Products, a private equity portfolio business of Nautic Partners, where he oversaw all functional areas and execution of an aggressive acquisition strategy. He has held positions of increasing responsibility in sales and marketing, including Vice President, Marketing at Tyco Healthcare during his 15 years there. Mr. Dorris began his career in sales at Johnson & Johnson.

Mr. Dorris received a Bachelor of Science in Business Management from Western Kentucky University.

“I’m confident that Mark’s history of commercial success, operational excellence and keen understanding of the orthopedic space will significantly accelerate the performance of our BAS business,” said Brady Shirley, DJO’s President and Chief Executive Officer.

“I couldn’t be more excited to join DJO at this pivotal point in the Company’s growth trajectory,” said Mr. Dorris. “DJO’s Bracing & Supports business continues to expand market and mind share with its flagship brands of DonJoy® and Exos®. With the recent introduction of the cloud-based X4™ Smart Brace with Motion Intelligence™, and a robust innovation pipeline, DJO understands the power of blending technology, quality and results to ensure our customers’ around the world get and keep moving.”

About DJO

DJO is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation, enabling people to regain or maintain their natural motion. Its products are used by orthopaedic surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopaedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO’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.

Contacts

DJO Media Contact:
Brittany Knudson
Sr. Director, Marketing Communications
760.734.5628
Brittany.Knudson@djoglobal.com
or
DJO Investor Contact:
David Smith
SVP, Treasurer and Investor Relations
760.734.3075
IR@djoglobal.com

BONESUPPORT creates its own US Commercial Platform

Lund, Sweden, 08.45 CET, 17 May 2018 – BONESUPPORT HOLDING AB (publ) announces today that the current distribution agreement has been terminated and will be replaced by a network of independent distributors and its own commercial organization. This will allow BONESUPPORT to increase its market penetration while creating a stronger platform for current products and future launches in the US market.

“Taking control of our commercial platform in the US is crucial to the execution of our strategy to become a leading global orthobiologics company. We will be able to create a more direct relation with the US customers while better capitalizing the potential of our highly differentiated products, particularly CERAMENT G, which we hope will take to the market in 2021”, says Emil Billbäck, CEO of BONESUPPORT.

The company intends to create the optimal US commercial platform by:

  •  Building its own network of independent distributors driving the sales of the BONESUPPORT’s products, to a broad range of orthopedic indications.
  •  Extend the product offering based on new formulations of CERAMENT as well as synergistic bone graft substitute products.
  •  Increase the own commercial organization from 12 to 23 persons.

BONESUPPORT will start selling direct on October 20th 2018.

“CERAMENT G will be a highly innovative product – the first of its kind in the US market – the recruitment of the FORTIFY IDE study, which will provide data for the PMA application of CERAMENT G in 2020, is running according to plan. Expanding our commercial footprint, establishing direct access with our customers, and bolstering our product offering in the US will allow us to build a strong and increasing foundation in the world’s largest market for bone graft substitutes.”, comments Patrick O’Donnell, Executive Vice President of Commercial Operations, North America.

The Company expects that this decided change in market commercialization eventually will generate higher sales volumes in the US. In the short term, the turnover will be less in the US. This could also lead to that the 2020 targets will be achieved later than previously communicated. We will present updated objectives during Q3 2018 after the initiated strategic review is completed.


Conference Call/Webcast Details

The Company will host a conference call and an online presentation at 09:30 am CET on Thursday 17 May.

The dial-in numbers for the conference call are:

UK: +44 20 3008 9808
SE: +46 85 063 95 49
US: +1 85 5831 5946

Webcast

The presentation will also be webcast and can be accessed from the following web address:

https://tv.streamfabriken.com/2018-05-17-bonesupport-pressconference

Hosts: Emil Billbäck, CEO and Björn Westberg, CFO

For more information contact: BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform. The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com.

*CERAMENT G: Not available in the United States, for investigational use only.
CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 07.45 CET on 17 May 2018.

K2M Announces US Launch of First-to-Market 3D-Printed Expandable Interbody MOJAVE™ PL 3D Expandable Featuring Lamellar 3D Titanium Technology™

LEESBURG, Va., May 16, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, today announced the U.S. commercial launch of its MOJAVE PL 3D Expandable Interbody System. Designed with K2M’s Lamellar 3D Titanium Technology, MOJAVE PL 3D incorporates a porous structure in conjunction with rough surfaces, with the goal of allowing for bony integration throughout the endplates. K2M was the first leading spine company to market a 3D-printed titanium interbody device and offers the most comprehensive portfolio of 3D-printed spinal devices on the market.

The MOJAVE PL 3D Expandable Interbody System, which received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) in June 2017, is a first-of-its-kind fusion device designed to allow for independent control of the anterior and posterior heights in the lumbar spine. Featuring infinite adjustment within the expansion range, the implant may be locked at any desired height and lordosis to aid in the restoration of sagittal balance.

“Advancements in expandable interbody technology are giving new hope to surgeons who treat sagittal imbalance, which often causes patients to live in chronic pain and discomfort,” said Michael P. Donahue, DO, Director of Spine Surgery and President at the Center for Advanced Orthopedics and Sports Medicine in Auburn Hills, MI. “The MOJAVE PL 3D Expandable Interbody System is a first-of-its-kind solution. Designed with Lamellar 3D Titanium Technology, it uses a breakthrough 3D-printing method to allow for bony integration throughout the implant, and its infinite adjustment tools allow me to precisely match the implant to the unique anatomies of my patients.”

K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the MOJAVE endplates are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and a rough surface architecture that pre-clinical data have associated with bone growth activity.

“The launch of the MOJAVE PL 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology marks a significant advancement in expandable interbody technology,” said K2M Chairman, President, and CEO Eric Major. “Its infinite adjustment and comprehensive height and lordotic expansion capabilities provide surgeons with a more flexible means to facilitate 3D sagittal balance in their patients. We are proud to reiterate our commitment to excellence in 3D spinal innovation by inventing new solutions, that when supported by our Balance ACS platform, allow spine surgeons worldwide to facilitate quality outcomes in their patients.”

Balance ACS® (or BACS®) provides surgical solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

For more information about the MOJAVE PL 3D Expandable Interbody System and K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

About K2M

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

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. 

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

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

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

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

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

OrthoPediatrics Corp. Reports First Quarter 2018 Financial Results

WARSAW, Ind., May 14, 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 first quarter ended March 31, 2018.

First Quarter & Recent Highlights

  • Increased total revenue 23.9% to $12.1 million for first quarter 2018, from $9.8 million in first quarter 2017
  • Deployed $5.5 million of consignment sets during the first quarter 2018
  • Added 9 incremental U.S. sales representatives in the first quarter 2018 for a total of 84
  • Launched Titanium PediPlates® and upgraded PediFlex™ Advanced system
  • Received FDA 510(k) clearance for 25th surgical system, Pediatric Nailing Platform | FEMUR
  • Recognized as one of the 100 Best Places to Work in Indiana for second year

Mark Throdahl, Chief Executive Officer of OrthoPediatrics, commented, “We are very pleased by our solid start to the year with greater than anticipated first quarter revenue growth of 24%. Since becoming a public company last October, we have exceeded anticipated growth in every quarter. While all of our product lines contributed, strong domestic scoliosis sales continued to outpace the industry, further establishing our leading market position in pediatric orthopedics. In addition, we significantly increased our investment in consignment sets to $5.5 million and R&D by 77%, which helped support the FDA 510(k) clearance of our Pediatric Nailing Platform | FEMUR. These investments will further enable our expanding sales force to drive future growth. Once again, we are honored to be recognized as one of the 100 Best Places to Work in Indiana, which validates our culture and its commitment to transforming the lives of children around the world with orthopedic conditions.”

First Quarter 2018 Financial Results
Total revenue for the first quarter of 2018 was $12.1 million, a 23.9% increase compared to $9.8 million for the same period last year. U.S. revenue for the first quarter of 2018 was $8.7 million, a 18.0% increase compared to $7.3 million for the same period last year, representing 71.5% of total revenue. International revenue was $3.4 million, a 41.8% increase compared to $2.4 million for the same period last year, representing 28.5% of total revenue.

Trauma and Deformity revenue for the first quarter of 2018 was $9.1 million, an 17.9% increase compared to $7.7 million for the same period last year. Scoliosis revenue was $2.7 million, a 39.7% increase compared to $1.9 million for the first quarter 2017. Sports Medicine/Other revenue for the first quarter of 2018 was $0.3 million, a 186.0% increase compared to $0.1 million for the same period last year.

Gross profit for the first quarter of 2018 was $8.9 million, a 20.3% increase compared to $7.4 million for the same period last year. Gross profit margin for the first quarter of 2018 was 73.7%, compared to 76.0% for the same period last year, primarily driven by a higher mix of international revenue, including instrument set sales.

Total operating expenses for the first quarter of 2018 were $13.3 million, a 61.3% increase compared to $8.3 million for the same period last year. The increase in operating expenses was primarily driven by $2.2 million of non-cash stock compensation in the first quarter of 2018 reflecting restricted stock accelerated vesting six months after our IPO.  This compared to $0.3 million in non-cash stock compensation in the first quarter of 2017.  The operating expense increase was also driven by higher commissions, R&D, and the addition of public company expenses.  Operating loss for the quarter increased to ($4.4) million from ($0.8) million for the same period last year.

Net interest expense for the first quarter of 2018 was $0.6 million, a 24.0% increase compared to $0.4 million for the same period last year, due to the use of incremental debt during 2017.

Net loss for the first quarter of 2018 was ($5.0) million, compared to ($1.3) million for the same period last year. Net loss per share attributable to common stockholders for the first quarter of 2018 was ($0.41) per basic and diluted share, compared to ($1.55) per basic and diluted share for the same period last year. Adjusted EBITDA for the first quarter of 2018 was ($1.2) million as compared to zero for the first quarter of 2017. The change was primarily driven by higher R&D and legal expenses.  See below for additional information and a reconciliation of non-GAAP financial information.

The weighted average number of diluted shares outstanding as of March 31, 2018 was 12,073,776 shares.

As of the first quarter of 2018 our independent sales agencies in the United States employed 84 full-time equivalent sales representatives specifically focused on pediatrics, up 9 from the 75 employed in the fourth quarter of 2017.  This increase is well ahead of the 18 planned additions for the full year 2018.

Purchases of property and equipment during the first quarter of 2018 were $2.8 million, a 108.0% increase compared to $1.3 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 March 31, 2018, cash and cash equivalents were $34.6 million, compared to $42.6 million as of December 31, 2017, and the Company had approximately $25.4 million in total outstanding indebtedness, including $3.9 million outstanding under the revolving credit facility.

Conference Call
OrthoPediatrics will host a conference call on Tuesday, May 15, 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 2290769. 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 second quarter 2018 financial results. In addition, a telephonic replay of the conference call will be available until May 22, 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 2290769.

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’ Annual Report on Form 10-K filed with the SEC on March 15, 2018. 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 metric 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 Net Income to non-GAAP Adjusted EBITDA.

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 25 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 38 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
 (In Thousands, Except Share Data)

  March 31, December 31,
    2018   2017
    (unaudited)  
ASSETS
Current assets:
Cash $   34,591 $   42,582
Accounts receivable – trade, less allowance for doubtful accounts of
$131 and $143, respectively 6,838   5,603
Inventories, net   22,004   19,498
Inventories held by international distributors, net   1,402   1,047
Prepaid expenses and other current assets   1,114   831
Total current assets   65,949   69,561
Property and equipment, net   12,280   10,391
Other assets:
Amortizable intangible assets, net   2,154   2,089
Other intangible assets   260   260
Total other assets   2,414   2,349
Total assets $   80,643 $   82,301
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable – trade $   7,197 $   5,495
Accrued compensation and benefits   2,313   2,905
Current portion of long-term debt with affiliate   114   113
Other current liabilities   946   954
Total current liabilities   10,570   9,467
Long-term liabilities:
Long-term debt with affiliate, net of current portion   21,389   21,418
Revolving credit facility with affiliate   3,930   3,921
Total long-term liabilities   25,319   25,339
Total liabilities   35,889   34,806
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.00025 par value; 50,000,000 shares authorized;
12,770,796 shares and 12,621,781 shares issued and outstanding as
of March 31, 2018 (unaudited) and December 31, 2017 2 2
Additional paid-in capital   152,601   150,424
Accumulated deficit   (108,066 )   (103,066 )
Accumulated other comprehensive income   217   135
Total stockholders’ equity   44,754   47,495
Total liabilities and stockholders’ equity $   80,643 $   82,301

 

READ THE REST HERE

 

Laser Spine Institute Welcomes M. Kathleen Donald as Chief Marketing Officer

May 16, 2018

TAMPA, Fla.–(BUSINESS WIRE)–Laser Spine Institute, the leader in minimally invasive spine surgery, is pleased to announce the appointment of marketing, branding and operations veteran M. Kathleen Donald as Chief Marketing Officer.

With nearly three decades of success at some of the nation’s most influential brands, Donald brings an impressive mix of strategic marketing, digital media, thought leadership and advertising savvy to the role. Her natural ability to consume and process large amounts of complex information, and then visualize, implement and drive organizational innovation, are some of the many reasons she was chosen to serve on the executive leadership team. Donald will work alongside Laser Spine Institute’s President and Chief Executive Officer, Roger Cary, to engineer the integrated marketing roadmap, further amplifying the organization’s strong commitment to providing the highest level of patient-centered care.

Donald is no stranger to back pain. In fact, it was her own search to find relief from a painful back condition that led Donald to her new role at Laser Spine Institute. She says the organization’s purpose-driven mission was what piqued her interest in becoming a part of an organization that helps people find hope and healing from the same pain that plagued her for years.

“Because I’ve walked that same, painful path so many of our patients are currently on, I understand what they’re going through,” she said. “It’s why I wanted to be part of helping them find a solution.”

Donald’s insatiable sense of curiosity and creative prowess are the bedrocks upon which her career was built. They also landed her key leadership roles where her big-picture thinking helped solve multi-level challenges. Prior to joining Laser Spine Institute, Donald was general manager at Dassault Systemes’ 3DXCITE, chief operating officer at Campbell Ewald, and regional group brand director/senior European account director at Ogilvy & Mather. She helped elevate brands such as Ford, USAA, Pier 1 Imports, Edward Jones and the United States Navy to new heights.

“Kathleen is a seasoned, results-driven professional who has developed a reputation as a collaborative and innovative leader who builds high performance, cross-functional teams,” Cary said. “We are absolutely thrilled to welcome Kathleen as a core member of our executive leadership team.”

As CMO, Donald will lead all aspects of Laser Spine Institute’s brand development, including direct marketing, advertising, internal communications, public relations, stakeholder engagement and strategic planning. She will also analyze all current direct marketing functions, including technological tools, analytic tools, agency relationships, other partnerships, communication objectives and/or strategies and reporting; work with the leadership team to implement necessary changes and maximize efficiencies, timelines and processes within the department.

Donald earned her certification in applied strategic marketing planning from the University of Michigan’s Ross School of Business. She holds a bachelor’s degree in business studies from Wayne State University in Michigan and holds a certification in Japanese language studies from the University of Detroit. Donald was named a Champion of the New Economy in 2016 by Business Magazine, and the 2014 Distinguished Alumna by Wayne State University’s School of Business Administration.

For more information, visit http://news.laserspineinstitute.com/.

About Laser Spine Institute

Headquartered in Tampa, Florida, Laser Spine Institute currently operates seven, state-of-the-art surgery centers across the country, in Tampa, Florida; Scottsdale, Arizona; Philadelphia; Oklahoma City; Cleveland, St. Louis and Cincinnati. Laser Spine Institute has performed more than 75,000 patient procedures to help patients find relief from debilitating neck and back pain caused by spinal stenosis, degenerative disc disease, pinched nerves, bone spurs, bulging/herniated discs, sciatica and other chronic conditions. Laser Spine Institute has been repeatedly recognized for outstanding patient satisfaction and reports an enterprise-wide patient satisfaction score of more than 96.

Laser Spine Institute has been named a top employer by Modern Healthcare, Tampa Bay Times, Tampa Bay Business Journal, Philly.com and okc.BIZ and a Most Admired Company by BestCompaniesAZ. Opening in Tampa in 2005 with one just operating room and nine employees, Laser Spine Institute has grown to seven, state-of-the-art facilities with nearly 1,000 corporate and health care professionals across the country.

Contacts

Edelman
Maura Devetski, 404-832-6788
maura.devetski@edelman.com

Globus Medical Announces Positive Clinical Results for Lateral Expandable Technology

AUDUBON, Pa., May 15, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the results of the study “Clinical and radiographic analysis of expandable versus static lateral lumbar interbody fusion devices with two-year follow-up” published in the Journal of Spine Surgery, supporting benefits of Globus’ expandable lateral spacers.

The study co-authored by Joseph O’Brien, MD, orthopedic surgeon at Washington Spine and Scoliosis Institute and Dr. Richard Frisch, orthopedic surgeon at Southeastern Spine Institute, compared clinical and radiographic outcomes of fifty-six patients who underwent minimally invasive lateral lumber interbody fusion (LLIF) for symptomatic degenerative disc disease. At two-years post-operative, patients in both the expandable and static spacer groups reported similar improvements in back pain scores and no significant differences in clinical outcomes. Radiographic evidence confirmed solid fusion was achieved in 100% of levels treated in both groups, however, significant differences in the rate of implant subsidence were observed.

While no subsidence was found in patients treated with expandable LLIF spacers, implant subsidence occurred in 16% of levels treated with static LLIF spacers.  “Subsidence is a greater concern with the minimally invasive LLIF technique since it relies heavily on indirect decompression of the neural elements as compared to alternative posterior approaches,” said Dr. O’Brien. “The ability to insert Globus’ expandable spacers with less impaction and to control height expansion from within the disc space helps to minimize endplate damage and in this study resulted in a reduced risk of implant subsidence.”

Globus Medical is the market leader in expandable technology with over 20 expandable implant systems designed to be inserted at a minimized profile and expanded in situ to optimize fit and minimize endplate damage.

Access the full study and learn more about Globus Medical’s lateral expandable interbody spacers portfolio at www.GlobusMedical.com/LLIF

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email:  investors@globusmedical.com
www.globusmedical.com

Global Joint Replacement Market is expected to Witness a CAGR of 7.7% during 2018-2024

NEW YORK, May 15, 2018 (GLOBE NEWSWIRE) — The global joint replacement market is expected to grow from USD 19,144 million in 2017 to USD 31,889 million in 2024 at a CAGR 7.7% from 2018-2024. Factors driving the market are growing number of ageing population and increasing number of chronic medical condition such as, rheumatoid arthritis, osteoarthritis, and osteoporosis. Moreover, technological advancements in hip and knee implantation such as robotic-assisted surgeries, and 3D printing are further boosting the market growth. However, high cost of surgery may hamper the market growth.

Emergence of New Technologies in Joint Replacements

Osteoarthritis is the most common joint disease worldwide and primarily affects the hip, knee, spine, shoulder, and ankle. It is a leading cause of disability among individuals aged above 40 years. With a traditional knee and hip replacement, various size options are available but mostly they are all of the same shape. The advancement in technology such as 3D planning and 3D printing, material, and robotic-assisted joint replacement surgeries improve the patient’s life and enhance the market growth. 3D planning and 3D printing prosthesis has important applications in case of complex joint and bone condition where the shape and size is different.

In recent years, manufacturer has developed innovative metals and plastics that make the replacement joint more durable, dependable and long-lasting. Another major advancement has been developed in surgical implantation technology using robotic-assisted technology. It is commonly employed for prosthetic implantation in the management of degenerative condition of joints. The technology enhances the accuracy and precision in the alignment and placement of the joint implant.

Global Joint Replacement Market– Regional Insights

North America held the maximum share of the global market in 2017, owing to growing number of aging population affected by joint disorders, serious research, and development activities in knee and hip implant industry, and major players has introduced technologically advanced products to the consumer. Moreover, increasing government initiative to approve and support medical devices are propelling the growth such as insurance coverage and adoption of new technology. Europe held the second largest market share of the global market, owing to growing number of aging population suffering from autoimmune diseases such as rheumatoid arthritis, and technological advancement in surgery technique (robotics-assisted). In the United Kingdom around 85,000 knee replacement operations, every year due to growing incidence of knee joint disorders and a significant increase in obesity rates are contributing towards the growth of market. Asia-Pacific is expected to be the fastest growing market due to growing number of chronic diseases such as osteoporosis, osteoarthritis, and rheumatoid arthritis.

Browse full research report with TOC on “Global Joint Replacement Market Outlook, Trend and Opportunity Analysis, Competitive Insights, Actionable Segmentation & Forecast 2024” at: https://www.energiasmarketresearch.com/global-joint-replacement-market-report/

To purchase report: sales@energiasmarketresearch.com

Key findings from the report:

  • On the basis of type, the knee replacement segment held major share of the market in 2017 owing to increasing physical injuries, and technological advancement in knee implantation
  • Based on end-user, the hospital segment held major share of the market in 2017
  • Geographically, North America has witnessed to hold the maximum share of the global market. The growth is attributed in this region due to rising prevalence joint deformities, and presence of large pool of knee and hip implant manufacturers in this region.
  • Some of the key companies operating in the market include B. Braun Melsungen AG; Stryker Corporation; AK Medical Holdings Limited; Dragonbio; Corin Group; Mathys AG Bettlach; Smith & Nephew Plc; Waldemar LINK GmbH & Co. KG; Medacta International; Exactech, Inc.; DePuy Synthesand; Zimmer Biomet; Johnson & Johnson Services, Inc., and among others

By Type

  • Knees Replacement
    • Total Knee Replacement
    • Partial Knee Replacement
    • Revision Knee Replacement
  • Hip Replacement
    • Total Hip Replacement
    • Partial Hip Replacement
    • Revision Hip Replacement
    • Hip Resurfacing
  • Ankle Replacement
  • Shoulder Replacement
  • Others

By End-user

  • Hospitals
  • Orthopedic Centers
  • Ambulatory Surgery Center
  • Others

Region

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle East and Africa

About Energias Market Research Pvt. Ltd.

Energias Market Research Pvt. Ltd. publishes high quality reports, in-depth market research studies, to help clients obtain investment level clarity on current business scenario, trends and segmentation for their future developments. We are committed to our client’s needs, by providing high quality custom reports solutions best fit for strategy development and implementation to high return of invest (RoI). We believe that exceptional problems need expertise to solve, and with the help of our industries expertise we are able to offer an in depth understanding of what’s crucial, what’s applicable, and what it takes to ensure accomplishment in any business or venture.

With a wide range of expertise from various industrial sectors and more than 50 industries that includes energy, chemical and materials, information and communication technology, semiconductor and electronics industries, healthcare and daily consumer goods, etc. We strive to provide our clients with a one-stop solution for all research and consulting needs.

Contact:

Mr. Manas Nagi

Business Development Manager

For any queries email us: info@energiasmarketresearch.com

To purchase report: sales@energiasmarketresearch.com

Call us: +1-716-239-4915

Visit: https://www.energiasmarketresearch.com