Osiris Therapeutics, Inc Reports Third Quarter 2018 Results

COLUMBIA, Md., Nov. 07, 2018 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, today reported its results for the third quarter ending September 30, 2018.

Business Highlights

  • GrafixPL PRIMETM launched on October 1, 2018
  • Enrollment of patients in a clinical trial evaluating GrafixPL PRIME in the treatment of chronic venous leg ulcers
  • Company re-listed on the Nasdaq Global Market on August 1, 2018

Quarterly Financial Summary

Revenue was $36.5 million for the three-month period ended September 30, 2018, which increased $6.7 million or 22.4%, compared to revenue of $29.8 million for the three-month period ended September 30, 2017.  The increase in revenue was primarily due to higher Grafix®/Stravix® revenue of $5.6 million as a result of increased demand from market awareness and acceptance as we increased selling efforts in the operating room and surgical settings as well as hospital outpatient wound care centers.  In addition, we received a one-time settlement payment of $1.3 million from a former distributor that was accounted for on a cash basis, as collection was not reasonably assured, to settle amounts owed to us from previous years, primarily 2015 and 2016.  BIO revenue increased $1.1 million, or 18.1%, due to increased demand from our distribution arrangement with Stryker.

Gross profit was $26.7 million for the three-month period ended September 30, 2018, which increased $4.8 million or 22.0%, compared with gross profit of $21.9 million for the three-month period ended September 30, 2017.  This increase was primarily due to higher revenues and the collection of the $1.3 million settlement from a former distributor that was accounted for on a cash basis, which did not have any cost of revenue as the cost of revenue was recognized in the periods the product was shipped.

Cash flow from operations was $8.1 million for the three-month period ended September 30, 2018, which was driven by net income of $4.2 million, collection of outstanding accounts receivable of $2.9 million, and the add back of the non-cash accrued shareholder litigation expense of $0.9 million.

See the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of our Quarterly Report on Form 10-Q filed today with the Securities and Exchange Commission for additional information concerning our operating results for the three- and nine month periods ended September 30, 2018.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, researches, develops, manufactures and commercializes regenerative medicine products intended to improve the health and lives of patients and lower overall healthcare costs.  We have achieved commercial success with products in orthopedics, sports medicine and wound care, including the Grafix product line, Stravix®, BIO and Cartiform®.  We continue to advance our research and development by focusing on innovation in regenerative medicine, including the development of bioengineered stem cell and tissue‑based products.  Osiris®, Grafix®, GrafixPL®, GrafixPL PRIME Cartiform®, and Prestige Lyotechnologysm are our trademarks. BIO is a trademark of Howmedica Osteonics Corp., a subsidiary of Stryker Corporation. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

Forward-Looking Statements

Statements herein relating to the future of Osiris Therapeutics, Inc. and the ongoing research and development of our products are forward-looking statements.  Osiris Therapeutics, Inc. cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements.  These risks and uncertainties include those identified under the heading “Risk Factors” in the Osiris Therapeutics Inc. Annual Report on Form 10-K for the years ended December 31, 2017, 2016 and 2015 and Quarterly Report on Form 10-Q for the quarters ended March 31, 2018, June 30, 2018 and September 30, 2018 as filed with the Securities and Exchange Commission (SEC).  We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.  Examples of forward-looking statements may include, without limitation, statements regarding the anticipated efficiencies and advantages of products and the likelihood of customer clinical adoption of any new products.  Although well characterized in scientific literature and studies, preservation of tissue integrity, including cells, may not be indicative of clinical outcome.  Accordingly, you should not unduly rely on these forward-looking statements. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties.  The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements.  Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

For additional information, please contact:
Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1834


(amounts in thousands, except per share data)
  September 30, December 31,
    2018   2017
Current assets            
Cash and cash equivalents $ 31,658 $ 3,081
Short-term investments 8,701 24,807
Trade receivables, net 20,592 26,053
Inventory, net 10,576 11,278
Insurance receivable 4,788 4,788
Prepaid expenses and other current assets 3,421 2,920
Total current assets 79,736 72,927
Property and equipment, net 3,116 3,587
Other assets 1,849 1,608
Total assets $ 84,701 $ 78,122
Liabilities and Equity    
Current liabilities
Accounts payable $ 4,291 $ 5,269
Accrued liabilities 10,704 9,399
Accrued shareholder litigation 19,400 18,500
Other current liabilities 1,994 1,934
Total current liabilities 36,389 35,102
Other long-term liabilities 2,450 1,626
Total liabilities 38,839 36,728
Common stock, $0.001 par value, 72,000 shares authorized, 34,526 shares issued and outstanding at September 30, 2018, and 90,000 shares authorized, 34,526 shares issued and outstanding at December 31, 2017 35 35
Additional paid-in-capital 284,124 283,905
Accumulated other comprehensive loss (330 ) (208 )
Accumulated deficit (237,967 ) (242,338 )
Total equity 45,862 41,394
Total liabilities and equity $ 84,701 $ 78,122
(amounts in thousands, except per share data)
    Three Months Ended Nine Months Ended  
    September 30,   September 30,  
    2018   2017   2018   2017  
Revenue   $ 36,491   $ 29,806   $ 102,001   $ 85,938
Cost of revenue 9,808 7,926 28,333 23,405
Gross profit 26,683 21,880 73,668 62,533
Operating expenses:
Research and development 1,590 909 4,886 3,052
Sales and marketing 15,931 14,825 49,107 44,256
General and administrative 4,302 6,634 15,150 16,920
Shareholder litigation expense 900 900
Total operating expenses 22,723 22,368 70,043 64,228
Income (loss) from continuing operations 3,960 (488 ) 3,625 (1,695 )
Other (expense) income, net (21 ) (1,763 ) 548 (1,371 )
Income (loss) before income taxes from continuing operations 3,939 (2,251 ) 4,173 (3,066 )
Income tax (expense) benefit (100 ) 198 (170 ) 134
Income (loss) from continuing operations 3,839 (2,053 ) 4,003 (2,932 )
Discontinued operations, net of tax 368 9,811 368   9,811
Net income   4,207   7,758   4,371 6,879
Other comprehensive income (loss):
Unrealized (loss) gain on investments (100 ) (21 ) (122 )   33
Comprehensive income   $ 4,107   $ 7,737   $ 4,249   $ 6,912
Net income (loss) per share from continuing operations:        
Basic   $ 0.11 $ (0.06 ) $ 0.12 $ (0.08 )
Diluted   $ 0.11 $ (0.06 ) $ 0.12 $ (0.08 )
Net income per share from discontinued operations:        
Basic   $ 0.01 $ 0.28 $ 0.01 $ 0.28
Diluted   $ 0.01 $ 0.28 $ 0.01 $ 0.28
Net income per share:      
Basic $ 0.12 $ 0.22 $ 0.13 $ 0.20
Diluted $ 0.12 $ 0.22 $ 0.13 $ 0.20
Weighted average common shares outstanding:
Basic 34,526 34,526 34,526 34,524
Diluted 34,594 34,526 34,565 34,525
(amounts in thousands)
    Nine Months Ended September 30,  
    2018   2017  
Net income $  4,371 $  6,879
Adjustments to reconcile net income to net cash provided by (used in) operating activities:    
Receipt of Mesoblast common stock    —    (10,000 )
Shareholder litigation expense    900    —
Provision for excess and obsolete inventory    1,238    180
Loss on disposal of fixed assets  —  123
Realized loss on investments  240  2,102
Depreciation  658  518
Stock-based compensation expense  219  49
Changes in operating assets and liabilities:    
Accounts receivables, net  5,461  1,220
Inventory, net  (536 )  (1,228 )
Prepaid expenses and other assets  (742 )  (651 )
Accounts payable, accrued liabilities, and other liabilities  1,211  (1,791 )
Net cash provided by (used in) operating activities  13,020  (2,599 )
Purchases of property and equipment  (187 )  (718 )
Proceeds from sale of investments  16,248  23,250
Purchases of investments  (504 )  (19,660 )
Net cash provided by investing activities  15,557  2,872
Proceeds from the exercise of options to purchase common stock  —  128
Net cash provided by financing activities  —  128
Cash and cash equivalents at beginning of period  3,081  2,833
Cash and cash equivalents at end of period $  31,658 $  3,234


Bone Therapeutics Business Update for Third Quarter 2018

Gosselies, Belgium, 7 November 2018, 7am CET – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today provides a business update for the third quarter ended 30 September 2018.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “The third quarter was a period of significant clinical and strategic activity for Bone Therapeutics. We were delighted with the positive final readout in the Phase I/IIA delayed union study of the allogeneic bone cell therapy product ALLOB, which paves the way for the next stage of development. More recently, the promising results from our viscosupplement JTA-004 highlighted a complementary addition to our pipeline.

Our focus is now on progressing the clinical development of the ALLOB platform in delayed union fractures and lumbar spinal fusion and of JTA-004 in knee osteoarthritis, following the recommendation of the DSMB to discontinue the PREOB trial in hip osteonecrosis. This will be supported by our ongoing manufacturing optimisation process, which will help us to lay a strong foundation for our future commercialisation strategy.

Business highlights (incl. post period end)

  • In September, Bone Therapeutics announced a positive final readout in the Phase I/IIA delayed-union study of the allogeneic bone cell therapy product, ALLOB, adding to a growing body of clinical efficacy and safety data.
  • Simultaneously, the Company also announced an optimised manufacturing process for ALLOB to improve consistency, scalability, cost effectiveness and ease of use, which are critical for development and commercialisation in cell therapy. The Company plans to implement this optimised process for all future clinical development programmes involving ALLOB and recently received positive feedback on the quality control programme and non-clinical strategy for ALLOB from a Regulatory Agency for the optimisation of the manufacturing process.
  • Also in September, the Company presented preclinical in vitro and in vivo results at the 26th Annual Meeting of the European Orthopaedic Research Society (EORS) in which the scientific community acknowledged the potent bone-forming properties of its allogeneic platform.
  • In October, post period, Bone Therapeutics announced results for a first efficacy study in knee osteoarthritis with the enhanced viscosupplement JTA-004. The study showed that a single intra-articular injection of JTA-004 delivered higher pain reduction than the reference product, a leading viscosupplement. The results support the move to registration studies, broadening the Company’s advanced clinical pipeline.
  • In October, post period, Linda Lebon was appointed Chief Regulatory Officer, joining Company’s Executive Team. An industry veteran, Linda will play a crucial role in defining the regulatory pathway for clinical and development programmes.
  • On 6 November, post period, the Company announced that the Data and Safety Monitoring Board recommended the discontinuation of the PREOB Phase III trial in osteonecrosis of the hip, as the interim results suggested that it is unlikely that the primary objective will be achieved at the final analysis. For more information, please see additional press release dated 6 November 2018.

Financial highlights

  • Cash used in operating activities amounted to € 10.47 million for the first nine months of 2018, compared to € 10.14 million for the same period in 2017.
  • Operating loss amounted to € 8.96 million compared to € 8.76 million for the same period last year.
  • Net cash at the end of September 2018 amounted to € 8.41 million.


  • The Company’s immediate focus is on submitting a new clinical trial application (CTA) with the regulatory authorities to allow the start of a Phase IIB trial in delayed union with its allogeneic product, utilising the optimised production process. Bone Therapeutics is currently generating the non-clinical data required for the application and expects to submit the CTA for a multi-centre, randomised, controlled study in H2 2019.
  • Bone Therapeutics plans to report the top line results from 32 patients of the ALLOB Phase IIA spinal fusion study in mid-2019 after a 12-month follow-up.
  • Good cash management will remain a key priority, with a strong focus on net cash burn. The Company confirms the expected cash burn (excluding proceeds from financing) for the full year 2018 to be in the range of € 15-16 million, in line with previous guidance. Based on its current priorities, the Company expects to have sufficient cash to carry out its objectives until the end of Q3 2019.

About Bone Therapeutics

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

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

The Company’s primary clinical focus is ALLOB, an allogeneic “off-the-shelf” cell therapy platform derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. In addition, the Company also has JTA-004, a viscosupplement in development for the treatment of knee osteoarthritis.

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


Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0) 71 12 10 00

For Belgium Median Enquiries
Laure-Eve Monfort and Sabine Leclercq
Tel: +32 (0)2 290 90 93, +32 (0)2 290 90 91
monfort@comfi.be, sabine.leclercq@comfi.be

International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville
Tel: +44 (0) 20 3709 5701

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

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506

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

SpinalCyte Announces New International Patents

November 07, 2018

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc using Human Dermal Fibroblasts (HDFs), today announced the issuance of new patents in Hong Kong and Europe. The company’s industry leading intellectual property in spine treatments now includes 35 U.S. and foreign patents issued with 41 patents pending, which provide a commanding intellectual property estate for its lead product, CybroCell™. The company’s positive results from its completed clinical trial and strong patent portfolio continue to spur interest among biotech investors for licensing and partnership opportunities.

“These new patents add to our extensive portfolio and bolster the international protections for our fibroblast technology,” said Pete O’Heeron, Chief Executive Officer of SpinalCyte. “SpinalCyte is at the forefront of human dermal fibroblast cell therapy, specifically in disc degeneration. We hold all intellectual property related to HDF treatment for degenerative disc disease (DDD), positioning us as the front-runner in this emerging sector of cell therapies.”

The technologies described in Hong Kong Patent No. HK1197832, “Dermal Fibroblasts for Treatment of Degenerative Disc Disease,” and European Patent No. 3146939, “Composition for Repair of Cartilage Using an In Vivo Bioreactor,” related to generating chondrocyte-like cells and applying them within the spinal disc space. Additional claims surround the paracrine benefit of introducing fibroblasts to the disc environment.

The new patents follow positive clinical trial results of CybroCell™ which show sustained pain relief in the treatment of DDD at 12 months. Orthopedics This Week spotlighted the results Monday in the article, New Study: Intra-Discal Injections for DDD Pain Relief.”

About Degenerative Disc Disease

Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.

About CybroCell™

CybroCell™ is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated after 12 months, patients who were injected with CybroCell™ had sustained improvement in pain relief and increased back mobility.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal disc regeneration using human dermal fibroblasts. Currently, SpinalCyte holds 35 U.S. and international issued patents and has filed for an additional 41 patents pending. SpinalCyte holds 110 U.S. and International Patents pending and issued across a variety of clinical pathways, including disc degeneration, cancer, diabetes, liver failure and heart failure. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.


Russo Partners LLC
David Schull, 858-717-2310
Ned Berkowitz, 646-942-5629
Clinical Contact:

DJO® and SirenMD® Announce Partnership for Collaboration

November 07, 2018

VISTA, Calif.–(BUSINESS WIRE)–DJO®, a leading provider of medical technologies designed to get and keep people moving, announced the partnership with SirenMD, becoming the exclusive sales representative for SirenMD’s sports team market. SirenMD is a workplace collaboration platform designed to increase the quality, efficiency, and timeliness of medical decisions by facilitating coordinated communication between caregivers and patient advocates.

With this new partnership, DJO can now offer existing customers and sales channels a new and innovative coordinated care platform. SirenMD’s software provides more compliant, collaborative and efficient sharing and transfer of patient information. “We are excited to partner with SirenMD so we can provide even greater care to athletes and sports teams,” notes Michael McBrayer, SVP at DJO. “This platform enables care providers to quickly communicate with other healthcare providers on specific cases or patients, and still be HIPAA compliant.”

SirenMD aggregates injury data and provides redacted and confidential injury reports to the conference and member institutions. The platform will use its internal case data for specific injuries for a given set of teams. Injury patterns and frequency can be identified for all body parts, including: shoulder dislocations, knee ligament tears, and ankle sprains.

SirenMD is an app-based enabled platform featuring:

  • Case-based workflow in real-time to minimize costly workplace disruption
  • HIPAA secure infrastructure protects private, patient data
  • Centralized platform enables documentation of communications
  • Intuitive design allows for quick and easy prioritization
  • Timely coordination leads to faster and better care for patients

Of the partnership, Lee Kaplan, MD, CEO of SirenMD, said, “There is a very synergistic opportunity for both SirenMD and DJO. Through this partnership, we can now address some of the medical inefficiencies with a holistic communications platform and improve overall patient care.”

The new partnership begins immediately. Please contact Brian Moore (DJO) or Andrew Willert (SirenMD) for more information.

About DJO

DJO is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. 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®. Visit www.djoglobal.com.

About SirenMD

SirenMD is a workplace collaboration platform designed to increase the quality, efficiency, and documentation of medical decisions. The platform allows medical professionals (such as physicians, athletic trainers, and physical therapists) in a variety of specialties to better coordinate and document critical interactions related to patient health. SirenMD envisions a world where caregivers at all levels are able to connect and collaborate quickly and securely. Such coordination allows for faster decision-making, fewer headaches, and, ultimately, better care. Founded by physicians, and led by healthcare and technology experts, SirenMD’s team is focused on delivering valuable clinical workflow tools to all healthcare teams. Visit www.sirenmd.com.

Individual results may vary. Neither DJO Global, Inc. nor any of its subsidiaries dispense medical advice. The contents of this document do not constitute medical, legal, or any other type of professional advice. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you. The opinions and experiences presented here are for informational purposes only.


Media Contact:
Leda Buster, Marketing Communications Manager
(760) 597-3904
Press Contacts:
Brian Moore brian.moore@djoglobal.com
Dwayne Treolo dwayne.treolo@djoglobal.com
Michael McBrayer michael.mcbrayer@djoglobal.com
Andrew Willert awillert@sirenmd.com
(305) 328-0009

Global Surgical Navigation Systems Market Analysis & Forecasts to 2025 by End Use (Ambulatory Surgical Centers, Hospitals), Application (Neurology, ENT) & Technology

Dublin, Nov. 07, 2018 (GLOBE NEWSWIRE) — The “Surgical Navigation Systems Market Size, Share & Trends Analysis Report By End Use (Ambulatory Surgical Centers, Hospitals), By Technology, By Application (Neurology, ENT), And Segment Forecasts, 2018 – 2025” report has been added to ResearchAndMarkets.com’s offering.

The global surgical navigation systems market size is expected to reach USD 1.25 billion by 2025

It is anticipated to register a CAGR of 7.0% during the forecast period. Rising prevalence of target disorders such as ENT disorders, brain cancer, and orthopedic degenerative diseases is expected to propel the market growth in near future. Moreover, increasing geriatric population base, which is more prone to degenerative disorders of joints, is also likely to have a major impact on the market demand. Osteoarthritis and osteoporosis are the most common disorders in the population aged over 65 years.

As per International Osteoporosis Foundation, total number of hip fractures is expected to increase from 1,433 million in 1950 to 5,395 million in 2050. Furthermore, increasing cases of brain cancer is also contributing the market growth. According to the Central Brain Tumor Registry of the United States (CBTRUS), the incidence rate of all non-malignant brain, primary malignant, and other CNS tumors was 22.64 cases per 100,000 in 2016. Over 78,980 new cases of these tumors are anticipated to be diagnosed in the U.S. in 2018, thereby propelling the demand for surgical navigation systems.

The demand for minimally invasive procedures is increasing across the world. Surgical navigation systems are provide better accuracy and precision in diagnosis and help determine correct implementation of plans during surgery, thereby aiding in minimally invasive procedures with improved outcome. It offers visual imaging at every stage of the surgery, thereby allowing for modification of plans during surgery according to intra-operative findings. It is also cost-effective in joint replacement procedures, as very few patients require revision after a one-time procedure. These factors are also expected to boost the demand for these systems over the forecast period.

Further key findings from the study suggest:

  • Neurology segment held the largest share of a little over 37.0% in 2016. This growth was attributed to the early implementation of surgical navigation in this branch and associated advantages of SNSs that help to perform complex surgeries with increased accuracy
  • ENT segment is expected to register at a lucrative CAGR of 8.0% over the forecast period. Rising prevalence of ENT disorders and increasing adoption of SNSs in ENT surgeries are the key growth-driving factors for the segment
  • On the basis of technology, the electromagnetic SNSs segment held the largest share of the market owing to its low cost and ease of use
  • The optical SNSs segment is expected to witness an exponential CAGR of 7.9% owing to its advantages over electromagnetic SNSs, such as precise and accurate navigation
  • North America held the largest share in the global market due to the presence of major companies and target population base. Shifting trend of surgeries from hospitals to Ambulatory Surgical Centers (ASCs) would drive the region
  • Most of the key companies are engaged in various strategies, such as product or technology development, for better market penetration. For instance, in 2017, Medtronic launched StealthStation ENT, a new SNS for ENT surgeries, thereby expanding its product portfolio.

Key Topics Covered:

Chapter 1 Research Methodology & Scope
1.1 Region Wise Market Calculation
1.1.1 Region Wise Market: Base Estimates
1.1.2 Global Market: CAGR Calculation
1.2 Region based segment share calculation
1.3 List of Secondary Sources

Chapter 2 Executive Summary
2.1 Market Snapshot

Chapter 3 Surgical Navigation Systems Market Variables, Trends & Scope
3.1 Market Segmentation & Scope
3.2 Market Driver Analysis
3.2.1 Increasing demand for minimally invasive surgical procedures
3.2.2 Rising prevalence of target disorders
3.2.3 Advantages of computer-assisted surgery
3.3 Market Restraint Analysis
3.3.1 High instrument and procedural cost
3.4 Penetration & growth prospect mapping
3.5 Surgical Navigation Systems – SWOT Analysis, By Factor (political & legal, economic and technological)
3.6 Industry Analysis – Porter’s

Chapter 4 Surgical Navigation Systems Market: Application Estimates & Trend Analysis
4.1 Surgical Navigation Systems Market: Application Movement Analysis
4.2 ENT
4.2.1 ENT market, 2014 – 2025 (USD Million)
4.3 Orthopedic
4.3.1 Orthopedic market, 2014 – 2025 (USD Million)
4.3.2 Hip Surgery
4.3.3 Spine Surgery
4.3.4 Knee Surgery
4.4 Neurology
4.5 Dental
4.6 Others

Chapter 5 Surgical Navigation Systems Market: Technology Estimates & Trend Analysis
5.1 Surgical Navigation Systems Market: Technology Movement Analysis
5.2 Electromagnetic
5.3 Optical
5.4 Others

Chapter 6 Surgical Navigation Systems Market: End-use Estimates & Trend Analysis
6.1 Surgical Navigation Systems Market: End-use Movement Analysis
6.2 Hospitals
6.3 Ambulatory Surgical Centers

Chapter 7 Surgical Navigation Systems Market: Regional Estimates & Trend Analysis, by Application, Technology and End-use
7.1 Surgical Navigation Systems Market Share By Region, 2017 & 2025

Chapter 8 Competitive Landscape

  • Fiagon GmbH
  • B. Braun Melsungen AG
  • Medtronic
  • Stryker
  • OMNI
  • Brainlab AG
  • Siemens Healthineers
  • CAScination AG
  • Scopis GmbH
  • DePuy Synthes
  • Zimmer Biomet

For more information about this report visit https://www.researchandmarkets.com/research/mv9bmc/global_surgical?w=12

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Related Topics: Surgical Devices

VGI Medical Announces Completion of New Office Buildout and Lab in Largo, FL

VGI Medical is dedicated to creating the next generation of spinal implants and procedures to improve the quality of life for its patients. To do so, VGI Medical is excited to announce the completion of the renovation of its corporate headquarters in Largo, FL. To enhance the training experience for surgeons and distributors, the renovation included the creation of a world-class lab as a focal point of the building.

VGI Medical was founded in 2007 based on an invention developed by Tov Vestgaarden, PhD. It has become a leader in bringing innovation to the market including VerteLoc, CerLoc, SiJoin and VerteLP. The VerteLoc system is specifically designed to stabilize and fuse the facet joint by utilizing a unique patented dual geometric design to limit motion of the affected spinal segment. Applying the principles of this success, VGI Medical has added SiJoin for Sacroiliac Fusion. VerteLP is one of the latest innovations offering an improved implant for lateral procedures featuring its proprietary Talon Technology.

VGI Medical has a robust product pipeline ahead and is looking to continue to provide world-class service offered to its surgeon partners. With an open-door policy, the new buildout encourages surgeons, distributors and hospital administrators alike to gain first-hand experience with this compelling product portfolio.

“An inhouse training facility gives us the ability to quickly respond to a surgeon’s always-changing schedule,” said Tov Vestgaarden, cofounder and CEO of VGI Medical.

“With the growing number of players in the spine market, it is not enough to simply have unique products.  To differentiate ourselves further from the competition, we wanted to create an environment that caters to the development of long-term relationships with our surgeon and distributor partners.  We believe with the completion of the renovations, and more specifically the surgical skills lab, we have the additional means to foster those relationships,” said Mike Anderson, President of VGI Medical.


About VGI Medical

VGI Medical is a disruptive force in the spinal implant industry by creating four unique technologies specifically designed to enhance patient outcomes and improve the overall surgeon experience. Our calling is to provide the ideal solution to each clinical challenge faced with the existing technologies on the market today. With over 12,500 implants used since our inception, our implants and instruments have been thoroughly tested with exceptional results.


K2M Group Holdings, Inc. Stockholders Approve Acquisition by Stryker

LEESBURG, Va., Nov. 07, 2018 (GLOBE NEWSWIRE) — At a special meeting today, stockholders of K2M Group Holdings, Inc. (“K2M” or the “Company”) (NASDAQ: KTWO) approved the adoption of the Agreement and Plan of Merger (the “Merger Agreement”), dated as of August 29, 2018, as it may be amended from time to time, by and among Stryker Corporation (“Stryker”), Austin Merger Sub Corp. (“Merger Sub”) and K2M. Subject to the terms and conditions of the Merger Agreement, Merger Sub, a wholly-owned subsidiary of Stryker, will be merged with and into K2M with K2M surviving the merger as a direct or indirect wholly-owned subsidiary of Stryker.

The parties are actively working towards closing, and K2M continues to anticipate that the merger will close in the fourth quarter of 2018. In addition to K2M stockholder approval, the completion of the merger is subject to other customary closing conditions. Upon the closing of the merger, the Company’s stockholders will have the right to receive $27.50 in cash, without interest and less any applicable withholding taxes (the “Merger Consideration”), for each share of common stock of K2M that they own immediately prior to the effective time of the merger.

Forward-Looking Statements

The foregoing contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend for these forward-looking statements to be covered by the safe harbor provisions of the federal securities laws relating to forward-looking statements. These forward-looking statements include statements relating to the expected timing, completion and effects of the proposed merger, as well as other statements representing management’s beliefs about, future events, transactions, strategies, operations and financial results, including, without limitation, our expectations with respect to the costs and other anticipated financial impacts of the merger; future financial and operating results of K2M Group Holdings, Inc. (“K2M”); K2M’s plans, objectives, expectations and intentions with respect to future operations and services; required approvals to complete the merger by our stockholders and by governmental regulatory authorities, and the timing and conditions for such approvals; the stock price of K2M prior to the consummation of the transactions; and the satisfaction of the closing conditions to the proposed merger. Such forward-looking statements often contain words such as “assume,” “will,” “anticipate,” “believe,” “predict,” “project,” “potential,” “contemplate,” “plan,” “forecast,” “estimate,” “expect,” “intend,” “is targeting,” “may,” “should,” “would,” “could,” “goal,” “seek,” “hope,” “aim,” “continue” and other similar words or expressions or the negative thereof or other variations thereon. Forward-looking statements are made based upon management’s current expectations and beliefs and are not guarantees of future performance. Such forward-looking statements involve numerous assumptions, risks and uncertainties that may cause actual results to differ materially from those expressed or implied in any such statements. Our actual business, financial condition or results of operations may differ materially from those suggested by forward-looking statements as a result of risks and uncertainties which include, among others, those risks and uncertainties described in any of our filings with the Securities and Exchange Commission (the “SEC”). Certain other factors which may impact our business, financial condition or results of operations or which may cause actual results to differ from such forward-looking statements are discussed or included in our periodic reports filed with the SEC and are available on our website at www.k2m.com under “Investor Relations.” You are urged to carefully consider all such factors.  Although it is believed that the expectations reflected in such forward-looking statements are reasonable and are expressed in good faith, such expectations may not prove to be correct and persons reading this communication are therefore cautioned not to place undue reliance on these forward-looking statements which speak only to expectations as of the date of this communication.  We do not undertake or plan to update or revise forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections, or other circumstances occurring after the date of this communication, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized.  If we make any future public statements or disclosures which modify or impact any of the forward-looking statements contained in or accompanying this communication, such statements or disclosures will be deemed to modify or supersede such statements in this communication.

About K2M Group Holdings, Inc.

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, enables K2M to compete favorably in the global spine surgery market. For more information, please visit: www.K2M.com.

From time to time, K2M may use its website as a distribution channel of material company information. Financial and other important information regarding the Company is routinely accessible through and posted on its website at www.investors.k2m.com.

MiMedx Adopts Limited Duration Shareholder Rights Plan In Response To Delisting From Nasdaq

MARIETTA, Ga.Nov. 7, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that its Board of Directors has unanimously authorized the adoption of a limited duration shareholder rights plan (the “Rights Plan”) following receipt of notification from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that Nasdaq will suspend trading in the Company’s stock effective at the open of business on Thursday, November 8, 2018.

Charles R. Evans, Chairman of the Board, said, “The Rights Plan provides the Board with appropriate time to make informed decisions that are in the best long-term interests of MiMedx and our shareholders. This does not prevent us from considering any offer that is fair and maximizes value for our shareholders.”

The Rights Plan was adopted by the Board following evaluation and consultation with the Company’s advisors, and is similar to plans adopted by numerous publicly traded companies. Given the Company’s current market capitalization, the delisting of the Company’s common stock from Nasdaq and the anticipated substantial and volatile trading activity following Nasdaq’s suspension of trading in the Company’s stock, the Board determined that the Company and its shareholders are particularly vulnerable to a creeping acquisition of actual or de facto control, whereby an investor could acquire a substantial percentage of outstanding shares of MiMedx common stock prior to making any public disclosure regarding its control intent and without paying a control premium.

The Rights Plan is intended to enable all MiMedx shareholders to realize the full potential value of their investment in the Company and to protect the interests of the Company and its shareholders by reducing the likelihood that any person or group gains control of MiMedx through open market accumulation or other tactics without appropriately compensating all shareholders.

Pursuant to the Rights Plan, the Company will issue, by means of a dividend, one preferred share purchase right for each outstanding share of the Company’s common stock to shareholders of record on the close of business on November 19, 2018. Initially, these rights will not be exercisable and will trade with, and be represented by, the shares of the Company’s common stock.

Under the Rights Plan, the rights would become exercisable only if a person, group or persons acting in concert (each, an “acquiring person”) acquires beneficial ownership of 10% or more of MiMedx’s common stock in a transaction not approved by the MiMedx Board. In that situation, each holder of a right (other than the acquiring person, whose rights will become void and will not be exercisable) will have the right, upon payment of the exercise price and in accordance with the terms of the Rights Plan, to purchase additional shares of MiMedx common stock at a 50% discount.

Unless earlier redeemed, terminated or exchanged pursuant to the terms of the Rights Plan, the rights will expire at the close of business on November 6, 2019.  The Board intends to terminate the Rights Plan before that date if the Board determines that there is no longer a threat to shareholder value.

If a shareholder beneficially owns 10% or more of the Company’s outstanding common stock at the time of the announcement of the Rights Plan, then that shareholder’s existing ownership percentage will be grandfathered, although, with certain exceptions, the rights will become exercisable if at any time after the announcement of the Rights Plan such shareholder increases its ownership of the Company’s common stock.

Further details about the Rights Plan will be contained in a Form 8-K to be filed by the Company with the Securities and Exchange Commission.

PJT Partners LP is serving as financial advisor to the Company. Sidley Austin LLP, Simpson Thacher & Bartlett LLP, and Stearns Weaver Miller Weissler Alhadeff & Sitterson, P.A. are serving as legal counsel to MiMedx.

About MiMedx

MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. The Company processes the human placental tissue utilizing its proprietary PURION® process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements including statements regarding the Board’s intention to terminate the Rights Plan in certain circumstances. Forward-looking statements may be identified by words such as “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” “would” and similar expressions and are based on current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ materially from those set forth in the forward-looking statements as a result of various factors. There can be no assurance that the Board will terminate the Rights Plan prior to its expiration date. For more detailed information on the risks and uncertainties that may apply to the Company’s business and the ownership of Company common stock, please review the Risk Factors section of the Company’s most recent annual report filed with the SEC. Any forward-looking statements speak only as of the date of this press release, and except as required by law, the Company assumes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

SOURCE MiMedx Group, Inc.

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Spinal Elements® Announces FDA Clearance of Ti-Bond® Titanium Coating as a Macro-, Micro-, and Nano-Surface

November 07, 2018

CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a Carlsbad, CA-based spine technology company, today announced FDA clearance for claims related to the macro-, micro-, and nano-surface structure of its Ti-Bond® surface coating technology. Highlighting Spinal Elements’ portfolio are a number of products featuring Ti-Bond, including the most recently introduced Lucent® XP height- and lordosis- expandable interbody device.

Interbody fusion products featuring Ti-Bond technology are comprised of a PEEK body which provides the favorable modulus and imaging characteristics surgeons have come to trust while the multi-structured Ti-Bond-coated surfaces are designed to provide a favorable environment at the vertebral endplate. Since its initial introduction in 2012, products featuring the Ti-Bond surface coating technology have benefitted tens of thousands of patients.

“Spinal Elements has had a long, successful experience with the clinical application of Ti-Bond technology in the spine,” stated Jason Blain, President and CEO of Spinal Elements. “This FDA clearance represents an important scientific element of the overall Ti-Bond story – one that will expand even more as the platform continues to flourish, and we provide an increasing number of technology-based solutions to improve patient outcomes.”

Ti-Bond was one of the many innovations introduced to the spine fusion market by Spinal Elements. Since its introduction, other technologies have emerged, each with their own compromises when considered for fusion. Ti-Bond allows the spine surgeon to have the latest, proven technology without compromising imaging characteristics, spinal loading conditions, or long-term performance. This clearance further demonstrates the complex surface environment provided by Ti-Bond coating adjacent to boney structures.

Spinal Elements is a technology-driven company headquartered in Carlsbad, CA. A leading designer, developer, manufacturer and marketer of innovative medical devices used in spinal surgical procedures, our mission is to combine leading medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. For more information, please visit www.spinalelements.com.


for Spinal Elements
Laura Charlton (formerly Johnson)

Siemens Healthineers Announces FDA Clearance of Cios Spin Mobile 3D C-Arm

Malvern, PA |  Nov 06, 2018

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the Cios Spin, a new mobile C-arm that delivers precise 3D images for intraoperative quality assurance. By enabling surgeons to perform intraoperative corrections based on 3D images and confirm their results, the Cios Spin can help surgeons work with greater precision, transform the delivery of patient care, and achieve optimal treatment results.

Capable of integrating seamlessly into the clinical routine, the Cios Spin provides 3D computed tomography (CT)-like imaging for orthopedic, trauma and spine surgery. These 3D images can help reduce the rate of revisions with intraoperative evaluation as well as the need for post-operative CT. Cios Spin provides versatility to support both 2D and 3D imaging for a wide variety of procedures, including vascular imaging. The system’s NaviLink 3D digital navigation provides easy-to-use connectivity to surgical navigation.

Cios Spin is equipped with state-of-the-art flat panel detector technology and is available with a range of optional software packages. The Easy 3D package ensures fast, efficient setup, and image acquisition. The Screw Scout package enables system software to recognize and automatically label screws in a 3D X-ray image, saving time and effort for the surgeon.

The system’s high generator power addresses the challenge of imaging large patients and dense anatomy to enable precise clinical evaluation of images. And the Cios Spin is the first commercially available mobile C-arm with an antimicrobial coating for comprehensive infection control.

“Siemens Healthineers is proud to offer the Cios Spin, a dynamic new mobile 3D C-arm that illustrates our expertise in mobile X-ray imaging,” said Robert Dewey, Vice President of Surgical Solutions at Siemens Healthineers North America. “This system will help our customers improve the quality of patient care using precision medicine as well as reduce the additional costs imposed by revision surgery.”

Contact for journalists
Jeff Bell
Phone: (484) 868-8346; Email: jeffrey.t.bell@siemens-healthineers.com

Siemens Healthineers enables healthcare providers worldwide to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving patient experience and digitalizing healthcare. A leader in medical technology, Siemens Healthineers is constantly innovating its portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular medicine. Siemens Healthineers is also actively developing its digital health services and enterprise services. In fiscal 2017, which ended on September 30, 2017, Siemens Healthineers generated revenue of €13.7 billion and adjusted profit of €2.5 billion and has about 48,000 employees worldwide. Further information is available at www.siemens-healthineers.com.