ROCKVILLE, Md., July 27, 2018 /PRNewswire/ — Healthcare market researcher Kalorama Information believes this week’s vote to repeal the medical device tax in the House could have real effects on a relatively slow-growing U.S. device market, though those effects might be long-term.  The United States device market revenues grow 22% slower than the global market, according to the firm’s report The Global Market for Medical Devices, 8^th Edition.  The firm said that although the largest component of the market is in the United States, the majority of sales are non-US, and considerable future growth is occurring in other markets.

“Repeal won’t immediately lead to a spike to revenues, but we do suspect some revisited R&D budgets and more interest from venture capital in medical devices,” said Bruce Carlson.  “That in turn could fuel investment which may lead to new products, and new innovations boost markets.”

The same report said the market for medical devices was estimated at $386.1 billion in 2016.  With average 3.8% growth, the market will grow to $483.8 billion in 2022.  The United States is the largest medical device market with 47% of the global market and over $180 billion dollars in revenue.  Growth in device sales are expected to be at 3.1% over the next five years.  The use of technologically superior devices combined with a steady replacement rate to remain competitive in the industry will be significant factors for growth.

Another development that could be even more helpful for the U.S. device tax repeal – aging population with more healthcare needs and shifting many reusable devices for single-use devices due to risk mitigation strategies to reduce healthcare acquired infections.

As part of the Affordable Care Act, the medical device industry was taxed 2.3% on medical devices products sold.  The healthcare market researcher said that while there are other challenges U.S. devicemakers face, such as limited reimbursement, recent increases in registration fees and FDA approval processes, the tax was an additional burden and its repeal will be welcomed by the industry.

Beyond the market dynamic, Kalorama believes medical devices also have impacts on the general healthcare economy and patient outcomes.  While medical device spending has grown, as total spending has, the price of most medical devices have not risen as fast as other medical services and products.  The cost of medical devices has remained constant as a share of total national health expenditures.  During much of the past fifteen years, a significant driver of changed medical practice has been the development of new medical devices from stents to implantable defibrillators to artificial hips and knees to new imaging modalities to new diagnostic tests to new surgical tools.

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama’s website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog on our company website: https://www.kaloramainformation.com/.

Press Contact: 

Bruce Carlson 

212 807 2262      

bcarlson@marketresearch.com

SOURCE Kalorama Information

Related Links

https://www.kaloramainformation.com

July 25, 2018 – Beth Jones Sanborn, Managing Editor

Evidence continues to mount that non-physician providers can positively contribute to a medical practice’s vitality, both in terms of care and the bottom line. New data from the Medical Group Management Association found that medical practices that use more non-physician providers see a boost in both revenue and productivity.

Based on comparative data from more than 3,000 organizations, the 2018 MGMA DataDive cost and revenue data represents various practice types including physician and hospital-owned, as well as small and large practices.

Primary care practices with 0.41 NPPs per physician or more did report greater expenses, but they also reported earning more revenue after operating costs than practices with fewer NPPs (0.20 or fewer NPPs per physician), no matter the specialty. Practices with 0.41 or more NPPs reported $100,748 more in revenue after operating expenses per physician and in hospital-owned primary care practices, the difference was $131,770 more in revenue per physician after operating costs.

“Because these non-physician providers can effectively complement primary care services for the organization, access to care increases. Ultimately, both the number of patient encounters as well as their satisfaction can increase,” said Ken Hertz, principal consultant at MGMA.

The DataDive results showed that over the past five years, median operating costs for primary care practices had gone from $391,798 per physician to $441,559 per physician, a rise of 13 percent.  Evergreen expenses are a steady presence, such as general operating costs, which make up 32 cents of every dollar collected in physician-owned practices. IT represents 2 cents, drug supply 6 cents, and building occupancy 6 cents.

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PLAINSBORO, N.J., July 25, 2018 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today reported financial results for the second quarter ending June 30, 2018.

Second Quarter 2018 Consolidated Results

• Reported revenue was $366.2 million, an increase of 29.8% compared to the second quarter of 2017; the acquisition of Codman contributed $79.2 million of revenue to the second quarter, and organic revenues increased 3.4%. Using foreign currency rates in effect when the company provided guidance in April 2018, the second quarter revenues would have been $368.4 million;
• GAAP earnings per share was $0.14, flat compared to the second quarter of 2017;
• Adjusted earnings per share was $0.60, reflecting an increase of 33.3% compared to the second quarter of 2017;
• The company has successfully exited the first wave of Codman transition services agreements and assumed full operational control of all commercial services and functions covering approximately 60% of the revenue associated with the acquired business;
• The company is raising the low end of its full-year 2018 total revenue and earnings per share guidance as follows:
  • Total revenue of $1.475 billion to $1.490 billion (previously $1.470 billion to $1.490 billion);
    • Guidance range reflects lower foreign currency benefit based on current rates (expected foreign currency benefit was reduced from $15 million to $8 million)
  • GAAP EPS of $0.71 to $0.77 (previously $0.69 to $0.77);
  • Adjusted EPS of $2.36 to $2.42 (previously $2.34 to $2.42); and
• The company is reiterating full-year 2018 organic sales growth guidance of approximately 5%.

Total revenues for the second quarter of 2018 were $366.2 million, reflecting an increase of 29.8% over the second quarter of 2017. Sales in the Codman Specialty Surgical segment increased 49.8% compared to the second quarter of 2017, driven by the Codman acquisition and strong performance in the Dural Access and Repair and Advanced Energy businesses.  Sales in the Orthopedics and Tissue Technologies segment increased 3.6%, reflecting broad-based strength in our regenerative technologies business, following the completion of the commercial expansion strategy.

Total organic revenues increased 3.4% over the second quarter of 2017, excluding acquisitions, divestitures and the effect of currency exchange rates.

“We look forward to an acceleration in organic growth in the second half of 2018, as we realize the benefits of a larger sales organization, improved sales productivity and an expanded product portfolio,” said Peter Arduini, Integra’s president and chief executive officer.  “The successful integration of Codman and the completion of the hiring associated with our OTT channel expansion strategy increase our confidence for the second half of the year.”

The company reported GAAP net income of $11.4 million, or $0.14 per diluted share, for the second quarter of 2018, compared to GAAP net income of $10.8 million, or $0.14 per diluted share, in the second quarter of 2017. The slight increase in GAAP net income is a result of higher revenues and better operating expense leverage.

The adjusted measures discussed below are computed with the adjustments to GAAP reporting that are set forth in the attached reconciliation.

Adjusted EBITDA for the second quarter of 2018 was $85.9 million, or 23.5% of revenue, compared to $62.7 million, or 22.2% of revenue, in the second quarter of 2017. The margin improvement was largely based on better operating expense leverage, mostly from selling, general and administrative costs.

Adjusted net income for the second quarter of 2018 was $50.5 million, an increase of 42.7% from the prior year’s quarter. Adjusted earnings per share for the second quarter of 2018 was $0.60, an increase of 33.3% over the prior year’s quarter.

2018 Full-Year Outlook

The company is raising the low end of its full-year 2018 total revenue guidance by $5 million to a new range of $1.475 billion to $1.490 billion.  The company is also raising the low end of its full-year 2018 GAAP earnings per share guidance range to $0.71 to $0.77, and adjusted earnings per share guidance range to $2.36 to $2.42, an increase of two cents.

The company expects full-year 2018 organic revenue growth to be approximately 5.0%, consistent with prior guidance.

“We were pleased with the strong operational performance from both segments in the second quarter, which enabled us to achieve 40% growth in adjusted net income and 130 basis points of adjusted EBITDA margin expansion, compared to the prior year’s quarter,” said Glenn Coleman, Integra’s chief financial officer.  “Given the strong momentum we expect in the second half of 2018, we are raising the low-end of our revenue and EPS guidance ranges.”

In the future, the company may record, or expects to record, certain additional revenues, gains, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 AM ET today, Wednesday, July 25, 2018, to discuss financial results for the second quarter and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.

Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.

Access to the live call is available by dialing (334) 323-0522 and using the passcode 7616000. The call can also be accessed via a webcast link provided on investor.integralife.com.  A replay of the call will be available through July 30, 2018 by dialing (719) 457-0820 and using the passcode 7616000. The webcast will also be archived on the website.

About Integra

Integra LifeSciences is a global leader in regenerative technologies, neurosurgical and extremity orthopedic solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel®, Bactiseal®, Cadence®, Certas™, Codman®, CUSA®, DuraGen®, DuraSeal®, ICP Express®, Integra®, MediHoney®, MicroFrance®, PriMatrix®, Salto Talaris®, SurgiMend®, TCC-EZ®, Titan™ and VersaTru™.  For the latest news and information about Integra and its brands, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that involve risks and uncertainties, and reflect the Company’s judgment as of the date of this release.  Forward-looking statements include, but are not limited to, statements concerning future financial performance, including projections for revenues, GAAP and adjusted net income, GAAP and adjusted earnings per diluted share, non-GAAP adjustments such as global enterprise resource planning (“ERP”) system implementation charges, acquisition-related charges, litigation charges, goodwill impairment charges, non-cash amortization of imputed interest for convertible debt, intangible asset amortization, and income tax expense (benefit) related to non-GAAP adjustments.  It is important to note that the Company’s goals and expectations are not predictions of actual performance.  Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Such risks and uncertainties include, but are not limited, to the following: the Company’s ability to execute its operating plan effectively; the Company’s ability to successfully integrate the Codman Neurosurgery business and other acquired businesses; the Company’s ability to manufacture and ship sufficient quantities of its products to meet its customers’ demands; the ability of third-party suppliers to supply us with raw materials and finished products; global macroeconomic and political conditions; the Company’s ability to manage its direct sales channels effectively; the Company’s ability to maintain relationships with customers of acquired entities and businesses; physicians’ willingness to adopt and third-party payors’ willingness to provide or maintain reimbursement for the Company’s recently launched, planned and existing products; initiatives launched by the Company’s competitors; downward pricing pressures from customers; the Company’s ability to secure regulatory approval for products in development; the Company’s ability to remediate quality systems violations; fluctuations in hospitals’ spending for capital equipment; the Company’s ability to comply with and obtain approvals for products of human origin and comply with regulations regarding products containing materials derived from animal sources; difficulties in controlling expenses, including costs to procure and manufacture our products; the impact of changes in management or staff levels; the impact of goodwill and intangible asset impairment charges if future operating results of acquired businesses are significantly less than the results anticipated at the time of the acquisitions, the Company’s ability to leverage its existing selling organizations and administrative infrastructure; the Company’s ability to increase product sales and gross margins, and control non-product costs; the Company’s ability to achieve anticipated growth rates, margins and scale and execute its strategy generally; the amount and timing of acquisition and integration-related costs; the geographic distribution of where the Company generates its taxable income; the effect of legislation effecting healthcare reform in the United States and internationally; fluctuations in foreign currency exchange rates; the amount of our bank borrowings outstanding and other factors influencing liquidity; and the economic, competitive, governmental, technological, and other risk factors and uncertainties identified under the heading “Risk Factors” included in Item 1A of Integra’s Annual Report on Form 10-K for the year ended December 31, 2017 and information contained in subsequent filings with the Securities and Exchange Commission.

These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events, or otherwise.

Discussion of Adjusted Financial Measures

In addition to our GAAP results, we provide organic revenues, adjusted earnings before interest, taxes, depreciation and amortization (“EBITDA”), adjusted net income, adjusted earnings per diluted share, free cash flow and adjusted free cash flow conversion.  Organic revenues consist of total revenues excluding the effects of currency exchange rates, acquired revenues and product discontinuances.  Adjusted EBITDA consists of GAAP net income excluding: (i) depreciation and amortization; (ii) other income (expense); (iii) interest income and expense; (iv) income taxes; and (v) those operating expenses also excluded from adjusted net income.  The measure of adjusted net income consists of GAAP net income, excluding: (i) global enterprise resource planning (“ERP”) implementation charges; (ii) structural optimization charges; (iii) acquisition- and integration-related charges; (iv) litigation charges; (v) intangible asset amortization expense; (vi) discontinued product lines charges; and (vii) income tax impact from adjustments, and other items. The adjusted earnings per diluted share measure is calculated by dividing adjusted net income attributable to diluted shares by diluted weighted average shares outstanding.  The measure of free cash flow consists of GAAP net cash provided by operating activities from less purchases of property and equipment.  The adjusted free cash flow conversion measure is calculated by dividing free cash flow by adjusted net income.

Reconciliations of GAAP revenues to adjusted revenues and GAAP Adjusted Net Income to adjusted EBITDA, and adjusted net income, and GAAP earnings per diluted share to adjusted earnings per diluted share all for the quarters ended June 30, 2018 and 2017, and the free cash flow and free cash flow conversion for the quarters ended June 30, 2018 and 2017, appear in the financial tables in this release.

The Company believes that the presentation of organic revenues and the various adjusted EBITDA, adjusted net income, adjusted earnings per diluted share, free cash flow and free cash flow conversion measures provide important supplemental information to management and investors regarding financial and business trends relating to the Company’s financial condition and results of operations.  For further information regarding why Integra believes that these non-GAAP financial measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to the Company’s Current Report on Form 8-K regarding this earnings press release filed today with the Securities and Exchange Commission.  This Current Report on Form 8-K is available on the SEC’s website at www.sec.gov or on our website at www.integralife.com.

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July 25, 2018

July 23, 2018

MISGAV, Israel, July 23, 2018 /PRNewswire/ —

OrthoSpin Ltd. (“OrthoSpin”), a portfolio company of The Trendlines Group Ltd. (“Trendlines”) (SGX: 42T) (OTCQX: TRNLY), announced that it completed an investment round of $3 million for its smart, robotic external fixation system for orthopedic treatments. Johnson & Johnson Innovation – JJDC, Inc. (“JJDC”) led the investment round.

External fixation devices are a common treatment choice for bone lengthening, setting complex fractures, and correcting deformities. Patient compliance challenges and a lack of real-time feedback for physician follow-up present substantial challenges. Currently, effective treatment necessitates that patients manually adjust fixation devices on a daily basis, requiring complicated patient training. This often causes adjustment errors and non-compliance results in poor clinical outcomes.

The OrthoSpin system makes pre-programmed adjustments automatically and continuously – without the need for patient involvement. Integrated software enables physicians to chart patient progress, and, when required, immediately adjust treatment programs. The accurate OrthoSpin system eliminates the need for weekly follow-up and is generally expected to improve patient experience resulting from smaller incremental adjustments with reduced soft tissue damage.

“We are delighted to have this investment and support from JJDC, as we continue the development of OrthoSpin,” said Oren Cohen, CEO of OrthoSpin. “The funding will enable us to accelerate our development process and broaden our clinical trials. We are confident that this investment will be an important step in bringing OrthoSpin’s system to market.”

About OrthoSpin 

OrthoSpin was founded in December 2014, to offer a new robotic treatment system for use in orthopedics, specifically external fixation. OrthoSpin’s innovative system has the potential to change the outcomes of various orthopedic treatments, such as bone lengthening, setting complex fractures, and correcting deformities.

About Trendlines 

Trendlines is an innovation commercialization company that invents, discovers, invests in, and incubates innovation-based medical and agricultural technologies to fulfil its mission to improve the human condition. As intensely hands-on investors, Trendlines is involved in all aspects of its portfolio companies from technology development to business building. Trendlines’ shares are traded on the Singapore Stock Exchange (SGX: 42T) and in the United States as an American Depositary Receipt (ADR) on the OTCQX International (OTCQX: TRNLY).

For further information: 

Oren Cohen

CEO OrthoSpin

oren@orthospin.com 

Phone +972-54-334-2651

SOURCE OrthoSpin Ltd. and The Trendlines Group Ltd.

FARMINGDALE, N.Y., July 19, 2018 (GLOBE NEWSWIRE) — Misonix, Inc. (NASDAQ:MSON) (“Misonix” or the “Company”), a provider of minimally-invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today announced the appointment of Gwen Watanabe to its Board of Directors. Ms. Watanabe replaces John Gildea, the founding principal of Gildea Management Co., who has retired from his position on the Board of Directors.

“Gwen is a highly respected executive in the medical device sector who brings outstanding entrepreneurial skills to the Misonix Board as well as a proven, long-term track record of success in mergers and acquisitions at Teleflex,” stated Stavros Vizirgianakis, President and Chief Executive Officer of Misonix. “The ongoing execution of our cohesive strategy to grow Misonix’s leading ultrasonic surgical product platform is providing the Company with a solid foundation to continue expanding market share domestically as well as abroad. As we pursue the next phase of inorganic and organic growth for Misonix, we are confident Gwen’s presence on the Board of Directors will be tremendously valuable in helping the Company achieve our goals for sustainable revenue growth and profitability, as well as the enhancement of long-term shareholder value.”

Ms. Watanabe commented, “I am very excited at the opportunity to join the Misonix Board of Directors and be part of a fast-growing company that is leveraging its unique proprietary ultrasonic technology to bring to market medical devices that deliver demonstrated clinical benefits and improve patient outcomes. I look forward to sharing the experience and business relationships built over my career working with medical device start-ups and large public organizations to offer sound business counsel to Misonix as the Company continues to pursue its strategic growth initiatives and expand its leadership position in the ultrasound medical device industry.”

Stavros Vizirgianakis added, “I want to thank John Gildea for his many contributions and service to the Board and the Company over the last fourteen years. His leadership and financial expertise were instrumental in guiding Misonix through a period of significant change and positioning the Company for continued growth in the future.”

Gwen Watanabe has over 24 years of financial and executive management experience in the medical device industry. Ms. Watanabe presently serves as the vice president of global corporate development, strategy, and strategic partnerships for Teleflex Incorporated, a global provider of medical technology products, where she also serves as a member of the executive leadership team, reporting to Teleflex’s CEO. In her role at Teleflex, she is responsible for worldwide corporate strategy and mergers and acquisitions.

Prior to Teleflex, Ms. Watanabe served as president and chief executive officer of medical device start-up Hotspur Technology, Inc., where she led the company from initial idea and design concept in 2009 through commercial release before negotiating the successful sale of the business to Teleflex in 2012. From 2004 to 2009, Ms. Watanabe served as chief business officer and chief financial officer of Nellix Endovascular, Inc., a medical device start-up that she co-founded, where she successfully raised venture capital financing and led a broad range of strategic initiatives that resulted in the acquisition of the company by Endologix. Earlier in her career, she served as a business development manager at Bacchus Vascular, Inc. (acquired by Covidien) and a project engineer at Aneurx, Inc. (acquired by Medtronic). In addition, Ms. Watanabe was a general partner at Saratoga Ventures V, L.P. and Saratoga Ventures VI, L.P., which were all medical device venture funds.

Ms. Watanabe earned a Bachelor of Science degree in Mechanical Engineering from the Massachusetts Institute of Technology. She obtained her Master of Science in Mechanical Engineering, Design Division from Stanford University and a Master in Business Administration from Harvard University. She formerly served on the Board of Directors for Hotspur Technologies, Catharos Medical, NovaSom (formerly Sleep Solutions), Axis Surgical, Tibion, American Red Cross of Hawaii and the Gift Foundation of Hawaii.

About Misonix, Inc.

Misonix, Inc. (NASDAQ:MSON) designs, develops, manufactures and markets ultrasonic medical devices for the precise removal of hard and soft tissue, including bone removal, wound debridement and ultrasonic aspiration. Misonix is focused on leveraging its proprietary ultrasonic technology to become the standard of care in operating rooms and clinics around the world. Misonix’s proprietary ultrasonic medical devices are used in a growing number of medical procedures, including spine surgery, neurosurgery, orthopedic surgery, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. At Misonix, Better Matters to us. That is why throughout the Company’s history, Misonix has maintained its commitment to medical technology innovation and the development of ultrasonic surgical products that radically improve patient outcomes. Additional information is available on the Company’s web site 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, 2017, 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.