VTI has Partnered with Medikon to Distribute Its InterFuse® Products in Turkey

VTI – Vertebral Technologies, Inc. a MIS spinal implant medical device company based in Minneapolis, MN, has partnered with the Turkish Medical Distribution company Medikon to distribute its InterFuse® product line in Turkey. Medikon will serve as an extension to VTI to meet the growing demand of high quality spinal fusion products in Turkey.

“We are excited to start working with Medikon, the company has been serving the Turkish spine surgeon community since 1995 with highly differentiated products and I’m convinced they will do an excellent job selling the InterFuse® product line,” says VTI’s Vice President of International Sales Ben Wasscher.

Sinan Kazmaci Managing Director of Medikon stated, “At Medikon we are excited to be working with the InterFuse® modular cage. When we presented the product to our most important surgeons, there was a great deal of enthusiasm and excitement for the product. Surgeons thought that the modular approach to achieve a large footprint through a small access channel was a great idea and many of them are keen to start with InterFuse®, especially for their more challenging patients.”

ABOUT MEDIKON
Medikon Ltd. Was founded in 1995, and is active in the field of spinal surgery, neurosurgery and orthopedic surgery products. Medikon is the foremost distributor of unique spinal products manufactured by some of the world’s leading companies. The company employs close to 100 people operates with 7 branches and 15 dealers all over Turkey including Ankara and İstanbul. Learn more about Medikon here: http://www.medikon.net/

ABOUT VTI’S INTERFUSE® SPINAL FUSION SYSTEM
VTI’s InterFuse® System is an intra-operative assembly technology, which allows surgeons to implant a large footprint device through a minimally invasive approach. The shape of each device is biomechanically optimized to match the contours of the endplate and the unique anatomical shape and size of each patient’s disc space. Learn more about VTI’s InterFuse product here: http://www.vti-spine.com/product/interfuse/

ABOUT VTI – VERTEBRAL TECHNOLOGIES, INC.
VTI – Vertebral Technologies, Inc. is a privately held company based in Minneapolis, MN, USA. VTI is dedicated to the design, development, manufacturing and marketing of medical devices to address painful conditions of the spine through less-invasive surgical approaches. VTI’s products utilize its unique modular-assembly technology to deliver solutions optimized for both surgeons and their patients. VTI sells its InterFuse® modular interbody fusion devices worldwide. Learn more about VTI here: http://www.vti-spine.com/

For more information, visit: http://www.vti-spine.com or contact Brian Thron at marketing(at)vti-spine(dot)com or + 1.877.912.5401.

Anika Reports First Quarter 2017 Financial Results

BEDFORD, Mass., May 03, 2017 (GLOBE NEWSWIRE) — Anika Therapeutics, Inc. (NASDAQ:ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the first quarter ended March 31, 2017, along with business progress in the periods.

“We made important progress executing our long-term growth strategy in the first quarter of 2017,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “We finalized the clinical study design for an additional Phase III clinical trial of CINGAL, and we commenced planning and site initiation activities for the trial in the quarter. MONOVISC continued its strong momentum with revenue growth of 24% year-over-year for the quarter, and we achieved a significant milestone in our global expansion with the launch of ORTHOVISC-T in Europe.”

First Quarter Financial Results

  • Total revenue for the first quarter of 2017 increased 5% to $23.4 million, compared to $22.3 million for the first quarter of 2016.
  • Worldwide Orthobiologics revenue grew 3% year-over-year in the first quarter of 2017. MONOVISC revenue increased 24% year-over-year in the first quarter of 2017, and it was the main revenue growth driver in the period.
  • International Orthobiologics revenue increased 12% for the first quarter of 2017, due primarily to the global expansion of MONOVISC, as well as the growth of CINGAL in Europe and Canada. Domestically, ORTHOVISC and MONOVISC continue to maintain a combined market leading position.
  • Total operating expenses for the first quarter of 2017 were $15.4 million, compared to $11.6 million for the first quarter of 2016. The increase in total operating expenses was due primarily to higher research and development spending required to advance the Company’s product pipeline, expanded operational efforts, and increased professional service fees.
  • Net income for the first quarter of 2017 was $5.5 million, or $0.37 per diluted share, compared to $6.9 million, or $0.45 per diluted share, for the first quarter of 2016. The decline in net income was due primarily to the planned increase in operating expenses previously discussed.

Recent Business Highlights
The Company made key commercial, operational, pipeline, and financial advancements, including:

  • Finalizing the clinical study design for an additional Phase III clinical trial of CINGAL, and commencing site initiation activities for the trial. The trial is a randomized, double-blind, active comparator controlled, multi-center study of CINGAL to demonstrate that CINGAL provides symptomatic relief of osteoarthritis of the knee in patients who have not responded to conservative treatment.
  • Launching ORTHOVISC-T in Europe to relieve pain and restore function in tendons affected by chronic lateral epicondylosis.
  • Advancing its product pipeline with continued progress on enrolling patients in the FastTRACK Phase III HYALOFAST Study for cartilage repair, as well as the Phase III MONOVISC study for the treatment of osteoarthritis pain in the hip.
  • Progressing the consolidation of the Company’s global manufacturing operations at Anika’s Bedford, Massachusetts corporate headquarters.
  • Completing the build-out of the Company’s new European headquarters and training center in Padova, Italy.

Conference Call Information
Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights tomorrow, Thursday, May 4th at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the “Investor Relations” section of Anika’s website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika’s website approximately two hours after the completion of the event.

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ:ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements
The statements made in this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

 

Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
     
    For the Three Months Ended March 31,
2017 2016
Product revenue $ 23,381 $ 22,278
Licensing, milestone and contract revenue 5 5
Total revenue 23,386 22,283
Operating expenses:
Cost of product revenue 6,083 5,425
Research & development 4,230 2,159
Selling, general & administrative 5,067 3,990
Total operating expenses 15,380 11,574
Income from operations 8,006 10,709
Interest income, net 58 72
Income before income taxes 8,064 10,781
Provision for income taxes 2,571 3,886
Net income $ 5,493 $ 6,895
Basic net income per share:
Net income $ 0.38 $ 0.46
Basic weighted average common shares outstanding 14,576 14,875
Diluted net income per share:
Net income $ 0.37 $ 0.45
Diluted weighted average common shares outstanding 15,043 15,307
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
(unaudited)
 
    March 31,    December 31, 
ASSETS   2017 2016
Current assets:
Cash and cash equivalents $ 119,368 $ 104,261
Investments 19,250 20,500
Accounts receivable, net of reserves of $196 and $194 at March 31,
2017 and December 31, 2016, respectively
21,079 27,598
Inventories 16,180 15,983
Prepaid expenses and other current assets 1,173 2,098
Total current assets 177,050 170,440
Property and equipment, net 51,593 52,296
Long-term deposits and other 1,234 69
Intangible assets, net 10,162 10,227
Goodwill 7,328 7,214
Total assets $ 247,367 $ 240,246
LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities:  
Accounts payable $ 6,050 $ 2,303
Accrued expenses and other current liabilities 4,167 6,496
Total current liabilities 10,217 8,799
Other long-term liabilities 400 2,126
Deferred tax liability 6,722 6,548
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $.01 par value; 1,250 shares authorized, no shares
issued and outstanding at December 31, 2016 and December 31,
2015, respectively
Common stock, $.01 par value; 60,000 and 30,000 shares
authorized, 14,655 and 14,627 shares issued and outstanding at
March 31, 2017 and December 31, 2016, respectively
146 146
Additional paid-in-capital 63,719 61,735
Accumulated other comprehensive loss (7,025 ) (7,317 )
Retained earnings 173,188 168,209
Total stockholders’ equity 230,028 222,773
Total liabilities and stockholders’ equity $ 247,367 $ 240,246

 

Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data 
             
 
Revenue by Product Line and Product Gross Margin
(in thousands, except percentages)
(unaudited)
  For the Three Months Ended March 31, 
Product Line:  2017 %   2016 %
Orthobiologics $ 20,227 87 % $ 19,587 88 %
Surgical 1,296 5 % 1,318 6 %
Dermal 425 2 % 381 2 %
Other 1,433 6 % 992 4 %
Product Revenue $ 23,381 100 % $ 22,278 100 %
Product Gross Profit $ 17,298 $ 16,853
Product Gross Margin 74% 76%
             
Product Revenue by Geographic Region
(in thousands, except percentages)
(unaudited)
             
  For the Three Months Ended March 31, 
  2017 % 2016 %
Geographic Region:     
United States $ 18,930 81 % $ 18,011 81 %
Europe 2,829 12 % 2,565 11 %
Other 1,622 7 % 1,702 8 %
Product Revenue $ 23,381 100 % $ 22,278 100 %

CONTACT:
Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D., President and CEO
Sylvia Cheung, CFO
Tel:  781-457-9000

InVivo Therapeutics Provides Clinical Update and Reports 2017 First Quarter Financial Results

May 04, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today provided a clinical update, an update on patients in the INSPIRE study of the Neuro-Spinal Scaffold™, and reported financial results for the quarter ended March 31, 2017.

“The AIS grade improvement rate observed thus far in the INSPIRE study compares favorably to the natural history of spinal cord injury”

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Clinical/Regulatory Update

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “In the first quarter, we continued to make significant progress at InVivo and with the INSPIRE study. By early April, we had enrolled four new patients into the INSPIRE study, with three patients enrolled within 30 days of each other. We also announced four new clinical sites for the INSPIRE study.

In addition to progress with INSPIRE enrollment and sites, we achieved several regulatory milestones. Health Canada approved the company’s Investigational Testing Authorization application to commence a clinical study of the Neuro-Spinal Scaffold in patients with acute, complete (AIS A) cervical (C5-T1) spinal cord injuries (SCIs), and we announced the opening of our first site for the cervical study, Toronto Western Hospital. We also announced the Medicines Healthcare Products Regulatory Agency (MHRA) approval of the company’s Clinical Trial Authorization Application to commence the INSPIRE study in the United Kingdom. Finally, we submitted the first module of our Humanitarian Device Exemption (HDE) application to the FDA.

Looking forward, we anticipate completing enrollment in the INSPIRE study in the third quarter and filing an HDE application for marketing approval of the Neuro-Spinal Scaffold in early 2018.”

INSPIRE Patient Updates

There are currently 14 INSPIRE patients in follow-up, and eight have reached the six-month primary endpoint. Of these eight patients, five had an AIS grade improvement (compared to baseline) and three did not have an AIS grade improvement at 6 months post-injury (a 62.5% conversion rate at 6 months). The INSPIRE AIS improvement rate remains considerably higher than rates observed in a range of SCI natural history databases.

InVivo announced in January 2017 that a patient enrolled into INSPIRE in December 2016 had improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury at the one-month evaluation. At a recent follow-up visit (the first since January), the patient was assessed to have reverted back to a complete AIS A spinal cord injury.

Separately, in March 2017 InVivo announced that a patient enrolled in January 2017 had improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury at the two-month evaluation. At the recent three-month follow-up evaluation, the patient was assessed to have reverted back to a complete AIS A spinal cord injury.

There are previously published examples of patients with baseline AIS A spinal cord injury that are assessed to have an AIS grade improvement followed by a return to complete AIS A status within the first year after injury. In a 2009 article, 12.5% (2/16) of baseline AIS A spinal cord injury patients (cervical and thoracic) who experienced an AIS grade improvement were later assessed to return to complete AIS A status within the first year after injury. Of those two patients, one patient improved back to an incomplete AIS grade within the same year.*

“The AIS grade improvement rate observed thus far in the INSPIRE study compares favorably to the natural history of spinal cord injury,” CEO and Chairman Mark Perrin said. “We look forward to monitoring these patients’ progress as they reach the primary endpoint at six months post-injury and as we work towards completing enrollment of INSPIRE.”

Financial Results

For the three-month period ended March 31, 2017, the Company reported a net loss of approximately $6.4 million, or $0.20 per diluted share, compared to a net loss of $6.6 million, or $0.24 per diluted share, for the three-month period ended March 31, 2016. The results for the three-month period ended March 31, 2017 were unfavorably impacted by increases in operating expenses of $816,000 in research and development and $286,000 in general and administrative, partially offset by a non-cash gain on the derivative warrant liability of $241,000 reflecting changes in the fair market value of the derivative warrant liability. The results for the three-month period ended March 31, 2016 were unfavorably impacted by a non-cash loss on the derivative warrant liability of $1.0 million. Excluding the impact of the derivative warrant liability, adjusted net loss for the three-month period ended March 31, 2017 was $6.6 million, or $0.21 per diluted share, compared to adjusted net loss of $5.6 million, or $0.20 per diluted share, for the three-month period ended March 31, 2016.

The Company ended the quarter with $26.8 million of cash, cash equivalents, and marketable securities.

Adjusted net loss and adjusted net loss per share are non-GAAP financial measures that exclude the impact of the derivative warrant liability. A reconciliation of these measures to the comparable GAAP measure is included with the tables contained in this release. The Company believes a presentation of these non-GAAP measures provides useful information to investors to better understand the Company’s operations, on a period-to-period comparable basis, with financial amounts both including and excluding the identified items.

* Spiess et al. Conversion in ASIA Impairment Scale during the First Year after Traumatic Spinal Cord Injury. Journal of Neurotrauma 26: 2027-2036 (November 2009).

About The INSPIRE Study

The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. The FDA has recommended that InVivo include a control arm in the study as part of a Study Design Consideration. We are in discussions with the FDA on this recommendation, and we continue to believe that our current study design is sufficient to demonstrate safety and probable benefit in support of an HDE application for marketing approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110.

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, refer to https://clinicaltrials.gov/ct2/show/study/NCT03105882.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold and the progress of the clinical program. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to complete The INSPIRE Study, submit an HDE application, and receive regulatory approval for the Neuro-Spinal Scaffold, the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended March 31, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

InVivo Therapeutics Holdings Corp.
Consolidated Balance Sheets
Unaudited
As of

March 31, 2017

December 31, 2016
ASSETS:
Current assets:
Cash and cash equivalents 14,440 21,464
Restricted cash 361 361
Short-term marketable securities 11,649 11,577
Prepaid expenses and other current assets 940 451
Total current assets 27,390 33,853
Long-term marketable securities 751
Property, equipment and leasehold improvements, net 395 510
Other assets 415 421
Total assets 28,951 34,784
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities:
Accounts payable 1,038 1,011
Loan payable, current portion 430 423
Derivative warrant liability 1,073 1,314
Deferred rent, current portion 147 141
Accrued expenses 1,421 1,959
Total current liabilities 4,109 4,848
Loan payable, net of current portion 742 852
Deferred rent, net of current portion 95 135
Other liabilities 36
Total liabilities 4,982 5,835
Stockholders’ equity:
Common stock, $0.00001 par value, authorized 100,000,000 shares; issued and

outstanding 32,123,392 shares at March 31, 2017; issued and outstanding 32,044,087

shares at December 31, 2016

1

1

Accumulated other comprehensive loss (2)
Additional paid-in capital 187,523 185,955
Accumulated deficit (163,553) (157,007)
Total stockholders’ equity 23,969 28,949
Total liabilities and stockholders’ equity 28,951 34,784
InVivo Therapeutics Holdings Corp.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Three Months Ended March 31,
2017 2016
Operating expenses:
Research and development 3,384 2,568
General and administrative 3,285 2,999
Total operating expenses 6,669 5,567
Operating loss (6,669) (5,567)
Other income (expense):
Interest income 57 54
Interest expense (20) (63)
Derivatives gain (loss) 241 (1,047)
Other income (expense), net 278 (1,056)
Net loss (6,391) (6,623)
Net loss per share, basic and diluted (0.20) (0.24)
Weighted average number of
common shares outstanding, basic and diluted 32,080,141 28,171,606
Other comprehensive loss:
Net loss (6,391) (6,623)
Other comprehensive loss:
Unrealized loss on marketable securities (2)
Comprehensive loss (6,393) (6,623)
Reconciliation of GAAP to non-GAAP measures
InVivo Therapeutics Holdings Corp.
(In thousands, except share and per share data)
Three Months Ended
March 31,
2017 2016
Reported GAAP net loss (6,391) (6,623)
Derivatives (gain) loss (241) 1,047
Adjusted net loss (6,632) (5,576)
Reported GAAP net loss per diluted share (0.20) (0.24)
Derivative (gain) loss per diluted share (0.01) 0.04
Adjusted net loss per diluted share (0.21) (0.20)

Contacts

InVivo Therapeutics Holdings Corp.
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

Stricter Medical Device Regulations Will Improve Patient Outcomes, Says Infiniti Research

LONDON–(BUSINESS WIRE)–Regulations for medical and diagnostic devices are changing in tune with advances in technology, new and innovative medical treatments, and the need for more effective diagnostic practices. Infiniti Research expects the market for medical devices to experience positive growth in the coming years as new rules and regulations eliminate counterfeit and dangerous products, increasing consumers’ trust and allowing established and reputable vendors to flourish.

Market Insights

New European Union regulations on medical devices will help to modernize public health and increase patient safety and outcomes. First proposed in 2012, the new rules (titled “the EU Medical Devices Regulation and In-Vitro Medical Devices Regulation”) came into effect in early April of this year following trilogue negotiations between the European Parliament, European Council, and European Commission. They will fully apply after a transitional period of three years for medical devices and five years for in-vitro diagnostic devices.

These regulations are replacing and modernizing three directives pertaining to in-vitro diagnostic products and medical devices with an aim to ensure both patient safety and product innovation. Both of the new regulations will improve the quality and safety of medical devices, increase market safety and monitoring, and will make important information about vendors and medical device products more easily available for patients to access. They now allow for random inspections of producers’ facilities after devices have been placed on the market, require clinical evidence of medical device safety to be provided by manufacturers, introduce an “implant card” for patients that will enable healthcare practitioners to track and monitor which product has been implanted, and have been expanded to cover aesthetic products—such as coloured contacts—that have the potential to harm consumers.

How Can Infiniti Research Help?

As technological standards and regulations for the healthcare industry and medical devices continue to change, it can be difficult for vendors to anticipate demand and prepare for new challenges. Market intelligence can be extremely beneficial in allowing vendors to understand how new laws will affect their business, strategize to overcome major obstacles and challenges, and to identify key competitors. It also enables them to adhere to region-specific regulations in each country they do business in, ensuring the safety of their customers.

Infiniti Research was recently approached by a global manufacturer and supplier of medical devices to assess the market landscape for radiography systems in the US. The insights provided by Infiniti’s analysts helped the client to gain a comprehensive understanding of the distribution structure for floor mounted radiography systems, as well as the growth strategies followed by market leaders.

Request a brochure and see how you can benefit from Infiniti’s services.

Looking for additional research on medical devices and healthcare? Request a free proposal

About Infiniti Research

Established in 2003, Infiniti Research is a leading market intelligence company providing smart solutions to address your business challenges. Infiniti Research studies markets in more than 100 countries to help analyze competitive activity, see beyond market disruptions, and develop intelligent business strategies. With 13 years of experience and offices across three continents, Infiniti Research has been instrumental in providing a complete range of competitive intelligence, strategy, and research services for over 550 companies across the globe.

Contacts

Infiniti Research
Jesse Maida
Media & Marketing Executive
US: +1 630 333 9501
UK: +44 208 123 1770
www.infinitiresearch.com
Contact Us

K2M to Highlight Balance ACS™ Platform & Three-Dimensional Total Body Balance™ at EPOSNA 2017

LEESBURG, Va., May 03, 2017 (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 that it will showcase the Balance ACS (or BACS™) platform at the 2017 combined meeting of The European Paediatric Orthopaedic Society and The Pediatric Orthopaedic Society of North America (EPOSNA) from May 3–6 in Barcelona, Spain, at Stand #13. The Company will also host a clinical symposium in 3D spinal solutions on May 4 in Sala H3.

“K2M is excited to participate in this year’s EPOSNA, a keynote meeting encompassing the latest science, education, and advocacy to improve surgical care in children across Europe and North America with spinal deformities,” said K2M President and CEO, Eric Major. “We look forward to further introducing Balance ACS—a comprehensive platform of products, services, and research—to surgeons across Europe and North America. With BACS, our goal is to help surgeons holistically manage the entire patient experience over the full episodic care continuum, and ultimately, achieve Total Body Balance for spine patients.”

Balance ACS provides solutions to balance the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success. During the meeting, K2M will demo the BACS System services offering—which includes BACS Preauthorization, BACS Surgical Planner, BACS Anatomical Models, and BACS Data Management—and the BACS app, a convenient portal for surgeons to access the BACS System.

K2M will also host an interactive clinical symposium entitled: “Techniques to Optimize Spinal Balance” facilitated by Dennis P. Devito, MD, an orthopaedic surgeon and director of the Spine Program at Children’s Healthcare of Atlanta. The session will begin at 12:45 p.m. on May 4 in Sala H3.

For more information about Balance ACS and K2M, visit www.BACS.com and www.K2M.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 Facebook, Twitter, Instagram, LinkedIn, 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 the merits 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 payors; 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 our 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 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 in our main facility or information technology systems;  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 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 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 the 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; continuing 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 due to sales of additional shares by our pre-IPO owners or otherwise; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; 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

Dr. Richard Rothman Recognized As 100 Great Health Care Leaders To Know In 2017

Richard H. Rothman, MD, Ph.D, Founder, Rothman Institute and Professor of Orthopaedic Surgery at Sidney Kimmel Medical College at Thomas Jefferson University, was named one of the 100 Great Health Care Leaders to Know in 2017, by Becker’s Hospital Review. The list was comprised of, “100 exemplary leaders of health care providers, government agencies, insurers and companies with successful track records leading their organizations.” Other notable leaders appearing on the list include: President of the Joint Commission, Director of the National Institutes of Health, Director of the World Health Organization, and the Secretary of Health and Human Services.

“It is an honor to be recognized by such a well-known medical publication,” said Dr. Rothman. “This list includes some of the best and brightest minds in medicine today. To be included with such select company is truly humbling.”

“Dr. Rothman is not just a leader, but a visionary in the world of orthopaedic medicine,” said Alexander R. Vaccaro, MD, Ph.D, MBA, President, Rothman Institute, Richard H. Rothman Professor and Chairman, Department of Orthopaedic Surgery, at Sidney Kimmel Medical College at Thomas Jefferson University. “He is a master clinician, a passionate educator, a dedicated researcher and a selfless philanthropist. He embodies all of the qualities a medical leader needs in this day and age. On behalf of all Rothman Institute we congratulate him on a recognition well deserved.”

 

READ THE REST HERE

CEO says it’s a good time to be at Stryker in Kalamazoo

By Al Jones | ajones5@mlive.com – May 4, 2017

KALAMAZOO, MI — Stryker Corp. is strong financially and is growing, its chairman and chief executive officer says.

“It is a good time to be at Stryker and a good time to be at Stryker in Kalamazoo,” Kevin A. Lobo said, following the medical technologies company’s 38th annual shareholders meeting Wednesday afternoon in Kalamazoo.

He told the stockholders that the Kalamazoo-based company is proud to have surpassed the $11 billion mark for sales last year. It reported $11.3 billion in net sales during 2016. And he said the company’s stock price grew by 28.9 percent during 2016 versus the 9.5 percent performance of others tracked by Standard and Poor’s.

“Stryker is a growing company,” he said. “We’ve continue to outpace the med-tech (medical technologies) market, growing at the high end of med-tech.”

Lobo’s comments to more than 250 company shareholders, executives and others Wednesday came eight days after its first-quarter release of sales and earnings The company’s numbers surpassed Wall Street expectations.

On April 25, the maker of powered surgical implements, hospital beds and replacement joints reported net earnings of $444 million for the period ended March 31. That was up 10.4 percent from $401 million during the same period a year ago. Net sales for the period were $2.96 billion, up 18.4 percent over first-quarter 2016.

Stryker reported net earnings of $1.19 per fully diluted share, up 9.3 percent from $1.07 a year ago. On an adjusted basis, that was per share earnings of $1.48, which exceeded a $1.43 consensus estimate by analysts.

Sales for its three business segments grew at rates of: 36.2 percent for Medical-Surgical; 7.4 percent for Orthopaedics; and 7.3 percent for Neurotechnology and Spine.

 

READ THE REST HERE

Misonix Reports Third Quarter Fiscal Year 2017 Financial Results

FARMINGDALE, N.Y., May 02, 2017 (GLOBE NEWSWIRE) — Misonix, Inc. (Nasdaq:MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today financial results for the three and nine months ended March 31, 2017.

Financial Highlights for the Third Quarter and Nine-Months:

  • For the third quarter of fiscal year 2017, the Company reported net sales of $7.2 million, an increase of 32% compared with $5.4 million in the third quarter of fiscal 2016. For the nine-month period, net sales increased 16% to $19.4 million compared with $16.7 million in the comparable 2016 period.
  • Domestic sales increased 31% to $4.0 million versus $3.1 million in third quarter of fiscal 2017. For the nine-month period, domestic sales increased 29% to $12.0 million compared with $9.3 million in the comparable 2016 period.
  • Consumables sales in the United States increased 39% to $3.7 million for the quarter.
  • During the quarter the Company delivered its initial equipment stocking order and completed product training with the personnel of its new distributor in China.
  • The gross profit percentage in the third quarter was 71%, up from 66% in the third quarter of fiscal 2016, primarily from a stronger mix of higher margin consumables revenue. For the quarter, operating expenses increased by $1.1 million to $6.5 million driven in part by professional fees relating to the recently completed internal investigation, along with higher sales commissions related to higher sales volumes.
  • The Company reported a net loss of $0.1 million, or $(0.02) per diluted share, compared to a net loss of $0.7 million, or $(0.09) per diluted share, in the third quarter of fiscal 2016.
  • At March 31, 2017, the Company maintained cash and cash equivalents of $11.9 million with no long-term debt.

Stavros Vizirgianakis, president and chief executive officer of Misonix, said, “We turned in a solid performance in the third quarter of fiscal 2017 driven by a 39% increase in domestic consumables sales and delivery of our initial stocking order to our new distributor in the People’s Republic of China. From a strategic standpoint, we firmly believe that our business in the United States offers the best opportunity for growth and we are focused on expanding consumables sales and driving recurring revenue in this market. To that end, we have expanded the number of Clinical Sales Specialists in our domestic sales and marketing group and the results to date have been excellent, as evidenced by the strong increase in domestic consumables sales in the third quarter.

“Internationally, significant progress has been achieved with our new distributor in China with the delivery of our initial equipment stocking order, and completing product training with their personnel. I believe both parties feel we are at the starting line of a significant opportunity in a rapidly growing market.”

Mr. Vizirgianakis continued, “We had a very favorable product mix during the quarter, which was weighted in higher margin consumables products. That favorable product mix drove gross margin for the third quarter to 70.6% compared to 65.7% in last year’s third quarter; a 490-basis point increase versus last year’s comparable quarter.”

“Heading into the fourth quarter of the fiscal year, we have a strong cash position of approximately $12 million, with no long-term debt. We look forward to a strong finish in fiscal year 2017, and to head into fiscal 2018 with momentum.”

Conference Call

The Company has scheduled a conference call for Tuesday, May 2, 2017, at 4:30 pm ET to review the financial results.

Interested parties can access the conference call by dialing (844) 861-5497 or (412) 317-6579 or can listen via a live Internet webcast, which is available in the Investor Relations section of the Company’s website at www.misonix.com.

A teleconference replay of the call will be available for three days at (877) 344-7529 or (412) 317-0088, confirmation # 10106217. A webcast replay will be available in the Investor Relations section of the Company’s website at www.misonix.com for 30 days.

About Misonix

Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s website at www.misonix.com.

Safe Harbor Statement

With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2016, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Financial Tables to Follow

MISONIX INC. and Subsidiaries
Consolidated Balance Sheets
March 31, June 30,
2017 2016
(unaudited)
Assets
Current assets:
Cash and cash equivalents $ 11,856,503 $ 9,049,327
Accounts receivable, less allowance for doubtful accounts of $96,868 and $96,868, respectively 4,357,156 3,869,427
Inventories, net 4,909,415 5,822,935
Prepaid expenses and other current assets 664,249 530,564
Total current assets 21,787,323 19,272,253
Property, plant and equipment, net of accumulated amortization and depreciation of $7,610,152 and $6,976,282, respectively 3,413,116 2,492,815
Patents, net of accumulated amortization of $965,996 and $885,394, respectively 710,070 604,916
Goodwill 1,701,094 1,701,094
Intangible and other assets 300,341 266,603
Deferred income tax 3,581,551 3,394,690
Total assets $ 31,493,495 $ 27,732,371
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable $ 1,433,608 $ 1,402,797
Accrued expenses and other current liabilities 1,994,387 1,887,337
Total current liabilities 3,427,995 3,290,134
Deferred lease liability 9,331 9,262
Deferred income 17,737 31,685
Total liabilities 3,455,063 3,331,081
Commitments and contingencies
Shareholders’ equity:
Common stock, $.01 par value-shares authorized 20,000,000; 9,162,203 and 7,948,234 shares issued and 9,023,354 and 7,809,385 outstanding in each period, respectively 91,622 79,482
Additional paid-in capital 37,410,034 32,502,521
Accumulated deficit (8,363,872 ) (7,081,361 )
Treasury stock, at cost, 138,849 shares in each period (1,099,352 ) (1,099,352 )
Total shareholders’ equity 28,038,432 24,401,290
Total liabilities and shareholders’ equity $ 31,493,495 $ 27,732,371

 

MISONIX INC. and Subsidiaries
Consolidated Statements of Operations
For the three months ended For the nine months ended
March 31, March 31,
2017 2016 2017 2016
Net sales $ 7,177,763 $ 5,426,147 $ 19,379,768 $ 16,716,487
Cost of goods sold, exclusive of depreciation from consigned product 2,112,099 1,859,749 5,842,778 5,578,349
Gross profit 5,065,664 3,566,398 13,536,990 11,138,138
Operating expenses:
Selling expenses 3,587,859 3,319,385 10,184,680 8,967,352
General and administrative expenses 2,484,962 1,515,559 6,504,202 4,994,569
Research and development expenses 465,863 548,278 1,398,311 1,340,339
Total operating expenses 6,538,684 5,383,222 18,087,193 15,302,260
Loss from operations (1,473,020 ) (1,816,824 ) (4,550,203 ) (4,164,122 )
Other income (expense):
Interest income 18 19 56 63
Royalty income and license fees 953,235 963,025 2,846,351 2,969,557
Other (6,940 ) (5,464 ) (15,576 ) (16,898 )
Total other income 946,313 957,580 2,830,831 2,952,722
Loss from operations before income taxes (526,707 ) (859,244 ) (1,719,372 ) (1,211,400 )
Income tax benefit (219,000 ) (15,000 ) (275,000 ) (322,000 )
Loss from continuing operations (307,707 ) (844,244 ) (1,444,372 ) (889,400 )
Discontinued operations:
Income from discontinued operations net of tax expense of $88,139 and $85,000 respectively 161,861 165,000 161,861 165,000
Net income from discontinued operations 161,861 165,000 161,861 165,000
Net loss from operations (145,846 ) (679,244 ) (1,282,511 ) (724,400 )
Net loss per share – Basic continuing Operations $ (0.04 ) $ (0.11 ) $ (0.17 ) $ (0.11 )
Net loss per share – Diluted continuing operations $ (0.04 ) $ (0.11 ) $ (0.17 ) $ (0.11 )
Net income per share – Basic discontinued operations $ 0.02 $ 0.02 $ 0.02 $ 0.02
Net income per share – Diluted discontinued operations $ 0.02 $ 0.02 $ 0.02 $ 0.02
Net loss per share – Basic $ (0.02 ) $ (0.09 ) $ (0.16 ) $ (0.09 )
Net loss per share – Diluted $ (0.02 ) $ (0.09 ) $ (0.16 ) $ (0.09 )
Weighted average shares – Basic 8,613,354 7,789,174 8,263,343 7,772,761
Weighted average shares – Diluted 8,613,354 7,789,174 8,263,343 7,772,761

 

Corporate Contact
Joe DwyerMisonix, Inc.
631-927-9113
jdwyer@misonix.com

Investor Contact
Joe DiazLytham Partners
602-889-9700
mson@lythampartners.com

Source: Misonix, Inc.

Read more: http://www.nasdaq.com/press-release/misonix-reports-third-quarter-fiscal-year-2017-financial-results-20170502-01489#ixzz4g7ch1M67

Smith & Nephew signs exclusive worldwide distribution agreement for the revolutionary MolecuLight i:XTM imaging device

3 May 2017

Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces it has signed a worldwide distribution agreement with MolecuLight®, Inc., a developer of innovative imaging technology for the clinical assessment of wounds.

This agreement supports Smith & Nephew’s strategic priority to innovate for value by delivering solutions that help healthcare professionals better improve the lives of their patients.

“Smith & Nephew, through products such as ACTICOAT antimicrobial silver dressings and IODOSORB cadexomer gel ,has long been committed to helping customers manage infection in chronic and acute wounds,” said Andy Weymann, MD, Chief Medical Officer at Smith & Nephew.  “The MolecuLight i:X imaging device enables healthcare professionals to see what they have never been able to see before, the actual accumulation of several common bacteria in a wound, even when not visible to the naked eye.  Moleculight  i:X enhances clinicians’ ability to choose the right therapy, at the right time for their patient 1,2 In addition, it has also the potential to enhance other areas of current wound care practice such as helping to guide wound sampling and debridement, monitoring of  wound progression, providing more insight in conversation between the clinician and the patient, and greater detail when documenting treatment decisions.”

Rosemary Hill, BSN, CWOCN, CETN(C), of Lions Gate Hospital (Vancouver, Canada) added ‘’The MolecuLight i:X is more than a bacteria visualization device. The information it is providing is positively impacting our antimicrobial stewardship program and empowering my overall wound treatment decision making.’’

The MolecuLight i:X  is a handheld point-of-care imaging device that uses fluorescence imaging to display potentially harmful concentrations of bacteria that fluoresce in violet light on screen, in real-time.  Clinicians can capture and view still images and video, as well as measure the surface area of a wound and then save and add those images to the patient’s electronic health record 2,3.

“When combined with clinical best practice, the information provided by the MolecuLight i:X on bacterial presence and distribution can guide early interventions to potentially reduce bioburden and promote wound healing2,” said Craig Kennedy, CEO MolecuLight.  “Partnering with Smith & Nephew, a world leader in advanced wound care, allows this revolutionary technology to rapidly reach a worldwide customer base and begin the process of becoming a routine step in wound assessment.”

The MolecuLight i:X is currently available in Canada and the European Union with regulatory clearance in the U.S. pending.

Enquiries

Media
Dave Snyder +1 (978) 749-1440
Kirsti Harefallet +44 (771) 008 5253
Smith & Nephew

 

About MolecuLight Inc. 

MolecuLight Inc. is a privately owned, Canadian medical imaging company delivering real-time fluorescence image-guidance solutions that provide clinicians with new information about wound bacterial burden and wound surface area to assist clinicians in making improved diagnostic and treatment decisions1,2,4,5,6,7,8,9,10.  The company was founded in 2012 by Dr. Ralph DaCosta, Principal Investigator and Scientist at the Princess Margaret Cancer Center, University Health Network (Toronto, Canada), currently the company’s Chief Scientific Officer and Director. MolecuLight’s premiere product – the MolecuLight i:X is a Wound imaging Device that allows clinicians to quickly, safely and easily visualize  bacteria that fluoresce in violet light and measure wound surface area at the point of care so they have maximum insights for accurate treatment and accelerated healing 2.

The MolecuLight i:X™ Imaging Device is approved by Health Canada (Medical License #95784) and has CE Marking (Certificate # G1160292355002) for sale in the European Union. The MolecuLight i:X™ Imaging Device is pending US FDA De Novo approval and is not available in the US.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

To learn more about what we do to help reduce wound infections, please visit www.closertozero.com.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.

 References:

  1. Wu YC, Smith M, Chu A, Lindvere-Teene L, Starr D, Tapang K, Wong O, Linden R, DaCosta RS. Handheld fluorescence imaging device detects subclinical wound infection in an asymptomatic patient with chronic diabetic foot ulcer: a case report. Int Wound J. 2016 Aug;13(4):449-53.
  2. DaCosta RS, Kulbatski I, Lindvere-Teene L, Starr D, Blackmore K, Silver JI, Opoku J, Wu YC, Medeiros PJ, Xu W, et al. Point-of-care autofluorescence imaging for real-time sampling and treatment guidance of bioburden in chronic wounds: first-in-human results. PLoS One. 2015 Mar 19;10(3).
  3. Hill R and Douglas JJ. Effect of bacterial fluorescence imaging on patient care and wound management in a hospital setting: a pilot study. Proceedings of the Annual Symposium on Advanced Wound Care (SAWC); 2017 Apr 5-9; San Diego, CA. (accepted poster)
  4. Ottolino-Perry K, Chamma E, Blackmore KM, Lindvere-Teene L, Starr D, Tapang K, Rosen CF, Pitcher B, Panzarella T, Linden R, DaCosta RS. Improved detection of clinically relevant wound bacteria using autofluorescence image-guided sampling in diabetic foot ulcers. Int Wound J. 2017; doi: 10.1111/iwj.12717.
  5. MolecuLight Inc. Case Study 0051 Track Wound Size and Bacterial Presence with the MolecuLight i:X. 2016.
  6. Rennie MY. A prospective, single-blind evaluation of the positive predictive value (PPV) of the MolecuLight i:X device to predict the presence of porphyrin-producing bacteria in chronic wounds. MolecuLight final report TR054. 2017 Jan.
  7. MolecuLight Inc. Case Study 0051 Track Wound Size and Bacterial Presence with the MolecuLight i:X. 2016.
  8. Raizman R. Point-of-care fluorescence imaging device guides care and patient education in obese patients with surgical site infections. Presented at: CAWC 2016. Proceedings of the 22nd Annual Canadian Association of Wound Care Conference; 2016 Nov 3-6, Niagara Falls, ON.
  9. Raizman R. Fluorescence imaging positively predicts bacterial presence and guides wound cleaning and patient education in a series of pilonidal sinus patients. Proceedings of the Annual Wounds UK Conference; 2016 Nov 14-16; Harrogate, UK.
  10. Hoeflok J, Teene L, Chamma E, Chu A, DaCosta RS. Pilot clinical evaluation of surgical site infections with a novel handheld fluorescence imaging device. Proceedings of the Annual Military Health System Research Symposium (MHSRS); 2014 Aug 18-21; Fort Lauderdale, FL.  

Globus Medical Reports First Quarter 2017 Results

AUDUBON, Pa., May 03, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced its financial results for the first quarter ended March 31, 2017.

  • Worldwide sales were $155.8 million, an increase of 11.9% as reported, or 12.1% in constant currency
  • First quarter net income was $28.7 million, or 18.4% of sales
  • Diluted earnings per share (EPS) were $0.30
  • Non-GAAP diluted EPS were $0.32
  • Non-GAAP adjusted EBITDA was 37.1% of sales

David Paul, Chairman and CEO said, “Our worldwide sales for the first quarter were $155.8 million, an increase of 11.9% over the first quarter of 2016.  Our adjusted EBITDA margins remained at an outstanding 37.1% and we also delivered non GAAP EPS of $0.32.

“We are very pleased with our performance during the first quarter.  We launched three new spine products, received our first trauma 510(k) clearance, had a strong competitive rep hiring quarter, further expanded our in-house manufacturing capacity, and continued to run an extremely efficient organization with best in class adjusted EBITDA margins.  We remain confident in our long-term growth prospects and our ability to sustain industry-leading profitability by continuing to execute on our strategy of rapid product introduction, expansion of our U.S. and international sales footprints, and diligent expense control.”

First quarter sales in the U.S. increased by 1.6% compared to the first quarter of 2016.  International sales increased by 123.4% over the first quarter of 2016 on an as reported basis and 126.5% on a constant currency basis due to the Alphatec acquisition included in the first quarter of 2017.  Sales from the Alphatec acquisition contributed $15.2 million in the quarter.

First quarter GAAP net income was $28.7 million, an increase of 2.5% over the same period last year.  Diluted EPS for the first quarter was $0.30, as compared to $0.29 for the first quarter 2016.  Non-GAAP diluted EPS for the first quarter was $0.32, compared to $0.30 in the first quarter of 2016.

The company generated net cash provided by operating activities of $53.4 million and non-GAAP free cash flow of $41.9 million in the first quarter.  Cash, cash equivalents and marketable securities ended the quarter at $389.2 million.  The company remains debt free.

2017 Annual Guidance
The company reaffirms guidance for full year 2017 sales of $625 million and non-GAAP fully diluted earnings per share of $1.27.

Conference Call Information
Globus Medical will hold a teleconference to discuss its 2017 first quarter results with the investment community at 5:30 p.m. Eastern Time today.  Globus invites all interested parties to join the call by dialing:

1-855-533-7141  United States Participants
1-720-545-0060  International Participants
There is no pass code for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at investors.globusmedical.com.

The call will be archived until Wednesday, May 9, 2017.  The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 6940-2658.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal implant 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.

Non-GAAP Financial Measures
To supplement our financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), management uses certain non-GAAP financial measures.  For example, non-GAAP adjusted EBITDA, which represents net income before interest income, net and other non-operating expenses, provision for income taxes, depreciation and amortization, stock-based compensation, provision for litigation, and acquisition related costs, is useful as an additional measure of operating performance, and particularly as a measure of comparative operating performance from period to period, as it is reflective of changes in pricing decisions, cost controls and other factors that affect operating performance, and it removes the effect of our capital structure, asset base, income taxes and interest income and expense.  Our management also uses non-GAAP adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections.  Provision for litigation represents costs incurred for litigation settlements or unfavorable verdicts when the loss is known or considered probable and the amount can be reasonably estimated, or in the case of a favorable settlement, when income is realized.  Acquisition related costs represents the change in fair value of business-acquisition-related contingent consideration; costs related to integrating recently acquired businesses including but not limited to costs to exit or convert contractual obligations, severance, and information system conversion; and specific costs related to the consummation of the acquisition process such as banker fees, legal fees, and other acquisition- related professional fees.

In addition, for the period ended March 31, 2017 and for other comparative periods, we are presenting non-GAAP net income and non-GAAP diluted earnings per share, which represents net income and diluted earnings per share excluding the provision for litigation, amortization of intangibles, acquisition related costs and the tax effects of such adjustments.  The tax impact of these non-GAAP adjustments is calculated based on the consolidated effective tax rate on a GAAP basis, applied to the non-GAAP adjustments, unless the underlying item has a materially different tax treatment, in which case the estimated tax rate applicable to the adjustment is used.  We believe these non-GAAP measures are also useful indicators of our operating performance, and particularly as additional measures of comparative operating performance from period to period as they remove the effects of litigation, amortization of intangibles, acquisition related costs, and the tax effects of such adjustments, which we believe are not reflective of underlying business trends.  Additionally, for the periods ended March 31, 2017 and for other comparative periods, we also define the non-GAAP measure of free cash flow as the net cash provided by operating activities, adjusted for the impact of restricted cash, less the cash impact of purchases of property and equipment.  We believe that this financial measure provides meaningful information for evaluating our overall liquidity for comparative periods as it facilitates an assessment of funds available to satisfy current and future obligations and fund acquisitions.  Furthermore, the non-GAAP measure of constant currency sales growth is calculated by translating current year sales at the same average exchange rates in effect during the applicable prior year period.  We believe constant currency sales growth provides insight to the comparative increase or decrease in period sales, in dollar and percentage terms, excluding the effects of fluctuations in foreign currency exchange rates.

Non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth are not calculated in conformity with U.S. GAAP within the meaning of Item 10(e) of Regulation S-K.  Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for financial measures prepared in accordance with U.S. GAAP.  These measures do not include certain expenses that may be necessary to evaluate our liquidity or operating results.  Our definitions of non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth may differ from that of other companies and therefore may not be comparable.  Additionally, we have recast prior periods for non-GAAP net income and non-GAAP diluted earnings per share.

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 successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become 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 our 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.

GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
Three Months Ended
(In thousands, except per share amounts) March 31,
2017
March 31,
2016
Sales $ 155,809 $ 139,264
Cost of goods sold 35,600 31,519
Gross profit 120,209 107,745
Operating expenses:
Research and development 10,666 10,030
Selling, general and administrative 67,059 53,798
Amortization of intangibles 1,782 392
Acquisition related costs 388 674
Total operating expenses 79,895 64,894
Operating income 40,314 42,851
Other income, net 2,100 760
Income before income taxes 42,414 43,611
Income tax provision 13,700 15,601
Net income $ 28,714 $ 28,010
Earnings per share:
Basic $ 0.30 $ 0.29
Diluted $ 0.30 $ 0.29
Weighted average shares outstanding:
Basic 95,996 95,398
Diluted 97,148 96,293
GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value) March 31,
2017
December 31,
2016
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $ 182,435 $ 132,639
Restricted cash 477 477
Short-term marketable securities 143,663 157,673
Accounts receivable, net of allowances of $3,627 and $2,771, respectively 94,232 91,983
Inventories 113,037 112,692
Prepaid expenses and other current assets 7,008 14,502
Income taxes receivable 47 3,800
Total current assets 540,899 513,766
Property and equipment, net of accumulated depreciation of $173,890 and $166,711, respectively 124,840 124,229
Long-term marketable securities 63,066 60,444
Note receivable 30,000 30,000
Intangible assets, net 61,343 61,706
Goodwill 106,215 105,926
Other assets 954 928
Deferred income taxes 33,104 30,638
Total assets $ 960,421 $ 927,637
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable $ 17,013 $ 17,472
Accrued expenses 37,409 46,401
Income taxes payable 11,708 1,911
Business acquisition liabilities, current 9,239 14,108
Total current liabilities 75,369 79,892
Business acquisition liabilities, net of current portion 6,087 5,972
Deferred income taxes 8,261 7,876
Other liabilities 1,819 1,819
Total liabilities 91,536 95,559
Commitments and contingencies
Equity:
Common stock; $0.001 par value.  Authorized 785,000 shares; issued and outstanding 96,077 and 95,930 shares at March 31, 2017 and December 31, 2016, respectively 96 96
Additional paid-in capital 217,257 211,725
Accumulated other comprehensive loss (6,081 ) (8,642 )
Retained earnings 657,613 628,899
Total equity 868,885 832,078
Total liabilities and equity $ 960,421 $ 927,637
GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Three Months Ended
(In thousands) March 31,
2017
March 31,
2016
Cash flows from operating activities:
Net income $ 28,714 $ 28,010
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 12,240 6,676
Amortization of premium on marketable securities 1,008 953
Write-down for excess and obsolete inventories 1,671 2,225
Stock-based compensation expense 3,491 2,770
Allowance for doubtful accounts 794 88
Change in fair value of contingent consideration 478
Change in deferred income taxes (2,399 ) 391
(Increase)/decrease in:
Restricted cash 15,668
Accounts receivable (2,225 ) 2,201
Inventories (2,102 ) (2,252 )
Prepaid expenses and other assets 8,628 1,209
Increase/(decrease) in:
Accounts payable (172 ) (1,238 )
Accrued expenses and other liabilities (10,170 ) (15,661 )
Income taxes payable/receivable 13,493 14,517
Net cash provided by operating activities 53,449 55,557
Cash flows from investing activities:
Purchases of marketable securities (51,215 ) (104,208 )
Maturities of marketable securities 55,280 69,656
Sales of marketable securities 6,505 7,798
Purchases of property and equipment (11,533 ) (9,366 )
Net cash used in investing activities (963 ) (36,120 )
Cash flows from financing activities:
Payment of business acquisition liabilities (5,001 ) (300 )
Proceeds from exercise of stock options 1,990 1,895
Net cash (used in)/provided by financing activities (3,011 ) 1,595
Effect of foreign exchange rate on cash 321 91
Net increase in cash and cash equivalents 49,796 21,123
Cash and cash equivalents, beginning of period 132,639 60,152
Cash and cash equivalents, end of period $ 182,435 $ 81,275
Supplemental disclosures of cash flow information:
Interest paid 8 1
Income taxes paid $ 2,656 $ 774
Supplemental Financial Information
Sales by Geographic Area:
(Unaudited) Three Months Ended
(In thousands) March 31,
2017
March 31,
2016
United States $ 129,663 $ 127,560
International 26,146 11,704
Total sales $ 155,809 $ 139,264
Sales by Product Category:
(Unaudited) Three Months Ended
(In thousands) March 31,
2017
March 31,
2016
Innovative Fusion $ 81,872 $ 70,046
Disruptive Technology 73,937 69,218
Total sales $ 155,809 $ 139,264
Liquidity and Capital Resources:
(Unaudited) March 31,
2017
December 31,
2016
(In thousands)
Cash and cash equivalents $ 182,435 $ 132,639
Short-term marketable securities 143,663 157,673
Long-term marketable securities 63,066 60,444
Total cash, cash equivalents and marketable securities $ 389,164 $ 350,756
Available borrowing capacity under revolving credit facility 50,000 50,000
Working capital $ 465,530 $ 433,874

The following tables reconcile GAAP to Non-GAAP financial measures.

Non-GAAP Adjusted EBITDA Reconciliation Table:
(Unaudited) Three Months Ended
(In thousands, except percentages) March 31,
2017
March 31,
2016
Net income $ 28,714 $ 28,010
Interest income, net (1,418 ) (496 )
Provision for income taxes 13,700 15,601
Depreciation and amortization 12,240 6,676
EBITDA 53,236 49,791
Stock-based compensation expense 3,491 2,770
Acquisition related costs 1,086 674
Adjusted EBITDA $ 57,813 $ 53,235
Net income as a percentage of sales 18.4 % 20.1 %
Adjusted EBITDA as a percentage of sales 37.1 % 38.2 %
Non-GAAP Net Income Reconciliation Table:
(Unaudited) Three Months Ended
(In thousands) March 31,
2017
March 31,
2016
Net income $ 28,714 $ 28,010
Amortization of intangibles 1,782 392
Acquisition related costs 1,086 674
Tax effect of adjusting items (926 ) (382 )
Non-GAAP net income $ 30,656 $ 28,694
Non-GAAP Diluted Earnings Per Share Reconciliation Table:
(Unaudited) Three Months Ended
(Per share amounts) March 31,
2017
March 31,
2016
Diluted earnings per share, as reported $ 0.30 $ 0.29
Amortization of intangibles 0.02
Acquisition related costs 0.01 0.01
Tax effect of adjusting items (0.01 )
Non-GAAP diluted earnings per share $ 0.32 $ 0.30
Non-GAAP Free Cash Flow Reconciliation Table:
(Unaudited) Three Months Ended
(In thousands) March 31,
2017
March 31,
2016
Net cash provided by operating activities $ 53,449 $ 55,557
Adjustment for impact of restricted cash (15,668 )
Purchases of property and equipment (11,533 ) (9,366 )
Non-GAAP free cash flow $ 41,916 $ 30,523
Non-GAAP Sales on a Constant Currency Basis Comparative Table:
(Unaudited) Three Months Ended Reported
Growth
Currency
Impact on
Current Period
Constant
Currency
Growth
(In thousands, except percentages) March 31,
2017
March 31,
2016
United States $ 129,663 $ 127,560 1.6 % 1.6 %
International 26,146 11,704 123.4 % $ (364 ) 126.5 %
Total sales $ 155,809 $ 139,264 11.9 % $ (364 ) 12.1 %

 

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com