Here’s Why the Best Is Yet to Come for Intuitive Surgical, Inc.

Keith Speights (TMFFishBiz), March 31, 2017

For several years, it looked like Intuitive Surgical (NASDAQ:ISRG) might be past its prime. The robotic surgical system maker’s stock experienced a malaise throughout much of the period between 2012 and late 2015.

Now, however, Intuitive Surgical is on a roll. Its share price is up close to 20% so far in 2017. Could the best be yet to come for Intuitive? I think so.

Trends in its favor

Most people think about the aging of the baby boomer generation as a key demographic trend. And it is. However, millennials (individuals born between 1981 and 1997) have surpassed baby boomers as the largest generation in the U.S. The aging of both groups should benefit Intuitive Surgical.

Hysterectomy ranks as the top surgical procedure performed using Intuitive’s da Vinci robotic surgical system. More than 40% of da Vinci procedures performed in the U.S. last year were hysterectomies. The average age of American women who have hysterectomies is 42. Many in the millennial generation will reach this age in only a few years.

Intuitive Surgical’s second most performed surgical procedure is radical prostatectomy for patients diagnosed with prostate cancer. The average age of American men who are diagnosed with prostate cancer is 66. Some baby boomers have already reached the prime age for developing prostate cancer, but most aren’t quite that old yet.

It’s not just demographic trends that are working in Intuitive Surgical’s favor. The company generated 71% of total revenue in 2016 from recurring sales of instruments, accessories, and services. This percentage has steadily increased in recent years. Intuitive’s huge recurring revenue provides it stability and flexibility that many other companies don’t enjoy.

 

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SANUWAVE Health to Hold 2016 Financial Results and Business Update Call on Tuesday, April 4, 2017

SUWANEE, GA–(Marketwired – Mar 31, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) announced today that the Company will release financial results for the year ended December 31, 2016, on April 4, 2017.

The Company will also host a conference call on Tuesday, April 4, 2017, beginning at 10AM Eastern Time to discuss the 2016 financial results, provide a business update and answer questions.

Shareholders and other interested parties can participate in the conference call by dialing 866-682-6100 (U.S.) or 862-255-5401 (international) or via webcast at http://www.investorcalendar.com/IC/CEPage.asp?ID=175797.

A replay of the conference call will be available beginning two hours after its completion through April 18, 2017, by dialing 877-481-4010 (U.S.) or 919-882-2331 (international) and entering Conference ID 10303.

About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

CONTACT INFORMATION

Restructuring at Stryker will mean ‘limited reductions of workforce’

By Al Jones | March 29, 2017

PORTAGE, MI — Stryker Instruments division is undergoing an organizational restructuring that will mean a loss of jobs for an undisclosed number of people at the medical technologies company.

“After a thoughtful evaluation, we have determined that organizational changes are needed to help drive efficiencies across our business, including limited reductions in our workforce,” the company stated in a press release issued in response to inquiries Wednesday.

It went on to say, “These changes will allow us to invest in important areas to build new capabilities that will help us keep growing in Kalamazoo and continue meeting the needs of our customers.”

Stryker Instruments designs, manufactures and markets specialty surgical equipment, operating room products, orthopedic saws, drills and accessories. It also make advanced systems for such things as pain management and waste management.

“The Kalamazoo community has played an important role in our company’s history,” the company stated. “Our founder started the business here and today we have multiple manufacturing and corporate offices in the area. We are committed to strengthening that relationship through our upcoming expansion in Portage.”

Portage Mayor Peter Strazdas said he has not been told how many people will be affected by the restructuring and he hopes the company is working to find them other opportunities. But he said he understands that large corporations have ups and downs and hopes internal changes will help make Stryker a stronger company in the long run.

 

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Medeon Biodesign Announces Investing in Panther Orthopedics for Orthopedic Extremity Applications

TAIPEI, Taiwan, March 28, 2017 /PRNewswire/ — Medeon Biodesign, Inc., a Taiwan medical device company, is pleased to announce that the Company led and successfully closed the Series A investment of Panther Orthopedics, Inc., a San Jose, CA start-up pioneering innovative dynamic fixation solutions for orthopedic extremity applications.

The orthopedic extremity device market continues to expand rapidly, primarily due to procedure volume growth, lifestyle influences and favorable demographics. Nevertheless, the market need for better fixation products for both trauma and sports medicine in fracture fixation and joint stabilization applications is still under served. “Current options for fixation include cortical screw and suture button flexible fixation devices. However, many limitations associated with currently marketed products are not being addressed,” said Dr. Kathryn Stecco, CEO and co-founder of Panther Orthopedics. “We have developed an innovative platform for dynamic extremity fixation, which we believe will provide continuous compression during the healing period while still allowing micromotion. The intuitive design of our solutions is easy to use and intended to eliminate the need for most second surgery removal, providing significant benefits for both the patients and the entire healthcare system.”

“We are excited to lead the investment of Panther Orthopedics to address the long-standing need of better clinical fixation during the healing period for orthopedic extremity applications,” said Dr. Yue-Teh Jang, CEO of Medeon Biodesign. “We are impressed with the team’s extensive experience, profound knowledge of orthopedic applications and broad KOL networking. We are confident that the Panther Orthopedics’ unique and innovative dynamic fixation solutions will be very welcome by the clinical community in the near future.”

About Medeon Biodesign

Medeon Biodesign (TPEx: 6499) is a publicly traded company located in Taipei, Taiwan, and currently listed on Taipei Exchange. The company focuses on the development of medical devices for minimally invasive surgeries to treat diseases of sizable patient population, such as cardiovascular, peripheral vascular, orthopedic, neurosurgery, obesity, gastroenterology, hematology, nephrology, gynecology, urology, and plastic surgery. For more information, please visit www.medeonbio.com/en.

Contacts
Dr. Yi-Ju Chen
+886.2.2881.6686
ir@medeonbio.com

SOURCE Medeon Biodesign, Inc.

Related Links

http://www.medeonbio.com/en

Implanet Announces 2016 Annual Results

March 28, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, announces its annual results for the financial year to December 31, 2016, as approved by the Board on March 24, 2017.

Ludovic Lastennet, CEO of Implanet, says: “2016 sales growth, notably with +70% in the U.S. market, combined with diligent cost control enabled us to improve our gross margin and operating results. We are confident in our ability to record further strong growth in JAZZ sales in 2017 by continuing to focus on clinical benefits for the patient, making JAZZ technology a benchmark in spine surgery. The Company’s structure is optimized for future growth, we should continue to realize a significant reduction in our cash requirements.

In € thousands – IFRS 2016 2015 Change
Revenue 7,825 6,653 +18%
of which: Spine 4,102 2,806 +46%
Cost of products sold -3,844 -4,070 -6%
Gross margin 3,981 2,583 +54%
Gross margin % 50.9% 38.8%
Research & Development -870 -732 +19%
Regulatory matters, Quality control -916 -940 -3%
Sales, distribution, marketing -5,105 -4,480 +14%
Operating costs -1,089 -792 +38%
General costs -2,883 -3,271 -12%
Operating P/L -6,881 -7,632 +10%
Net P/L -7,288 -8,008 +9%

NB: Consolidated accounts have been audited, and the auditor’s report is pending.

Revenue: significant JAZZ growth

The Company’s revenue, up +18% in 2016 vs. 2015, totaled €7,825 thousand, driven by the +46% increase in JAZZ activity. This segment’s solid growth was a result of the growing adoption of JAZZ technology in markets in which the Company operates directly (+70% in the United States and +33% in France), with growth of +142% in the high-potential degenerative bone disorder segment (surgical treatment of elderly patients).

Strong gross margin increase, operating cost control

The strong growth in JAZZ activity in France and the U.S., where spinal implant pricing is higher, had a positive impact on Implanet’s gross margin. It improved by 12.1 percentage points to 50.9% of sales in 2016 (vs. 38.8% in 2015).

The Company chose to focus on direct distribution in its priority markets via a network of independent sales agents, resulting in a variable cost increase of +€550 thousand (including +€464 thousand in commissions), in line with the growth in JAZZ revenue.

The Company held the remaining operating expenses at a stable level (+0.9%), despite a +19% increase in R&D, mainly due to the cost of protecting its IP. These costs should remain stable, as the Company believes it has an adequate structure to cope with its medium-term growth.

Implanet thus recorded a 10% improvement in its operating loss to -€6,881 thousand as of December 31, 2016 (vs. -€7,632 thousand in 2015), and a 9% improvement in its net loss to -€7,288 thousand (vs. -€8,008 thousand in 2015).

Cash position and financial investments

2016 cash burn (free cash flow minus loan repayments) improved by 28%, to -€6.3 million versus -€8.8 million in 2015.

As of December 31, 2016, Implanet had cash and financial placements of €7.4 million (vs. €7.1 million as of December 31, 2015).

Implanet also has the option of exercising, under certain conditions, 340 convertible bonds coupled with equity warrants (OCABSA) with L1 EUROPEAN HEALTHCARE OPPORTUNITIES FUND for €3.4 million.

Significant milestones and events

Throughout 2016 and early 2017, Implanet experienced substantial growth in its primary development focus, the JAZZ technology platform. This continued growth was driven by conclusive results, notably in the U.S. and France.

Commercial development:

  • 127 surgeons are users of JAZZ technology in France and the U.S. (vs. 82 as of December 31, 2015);
  • success of the first surgical procedures in France, Italy and the U.S. with the new JAZZ Lock® implant, a major innovation and the first component of a product range devoted to degenerative bone disorder surgery;
  • success of a first idiopathic scoliosis surgical procedure in Brazil;
  • signature with Device Technologies of distribution partnership in Australia and New Zealand.

Innovation and regulatory:

  • U.S. (510k) and European (CE) regulatory clearance granted for the new JAZZ Lock®, JAZZ Claw® and JAZZ Frame® implants;
  • additional key patents granted in the US and Europe for the JAZZ® tensioning system;
  • patent granted for the JAZZ Lock® in France.

Clinical development

  • launch of a multicenter clinical study designed to document the outcomes of JAZZ technology in adult degenerative and adult deformity indications;
  • White Paper publication documenting clinical results of JAZZ technology in hypokyphotic idiopathic scoliosis surgery.

Financing

  • listing on the OTCQX® International market in the U.S.;
  • issuance of the remaining bonds convertible into stock and stock warrants within the framework of the financing put in place in October 2015;
  • zero-interest innovation loan of €800 thousand agreed with Bpifrance;
  • success of Implanet’s capital increase with preferential subscription rights for €6.9 million.

Appointments

  • appointment of Brian T. Ennis as President of Implanet America;
  • appointment of Mary E. Shaughnessy, Senior VP Finance & Planning, Partners Continuing Care, as an independent Board member.

Next financial press release: Q1 2017 revenue, on April 18, 2017

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Compartment C of the Euronext™ regulated market in Paris.

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net

Sports Medicine Devices Market Worth US$ 9.3 billion Globally by 2022

Press release from: Market Research Engine Research Reports

New York, March 24: Market Research Engine has published a new report titled as “Sports Medicine Devices Market By Product Analysis (Accessories, Body Evaluation and Monitoring, Body Repair and Reconstruction, Support and Recovery Products, Orthopedic Products); By Application Analysis (Hand-wrist, Ankle-foot, Shoulders, Arm-elbow, Back-spine, Knee, Hip-groin) and By Regional Analysis – Global Forecast by 2016 – 2022”

How Big is the Global Sports Medicine Devices Market?

The Global Sports Medicine Devices Market is expected to exceed more than US$ 9.3 billion by 2022 and will grow at a CAGR of more than 8% in the given forecast period.

www.marketresearchengine.com/reportdetails/sports-medicin…

Sports medicine is a branch of medication that offers with the prevention and treatment of injuries incurred at some point of sports activities sports, physical activities or bodily fitness education. Sports activities medicine devices consequently, consist of a huge range of goods applied for the prevention, recovery and treatment of accidents related to the above physical sports. Those injuries encompass fractures, sprains, tender tissue harm, joint dislocation, strain and musculoskeletal injuries. The increased global adoption of western sports has given upward thrust to accidents that power the market for sports medicinal drug devices.

The major driving factors of Global Sports Medicine Devices Market are as follows:

• Increasing demand for outpatient
• Increasing awareness regarding the maintenance of an active lifestyle
• Minimally invasive surgeries
• Changing re-imbursement landscape for new surgical technologies

 

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Moximed Closes Oversubscribed $50MM Financing Round

 News Release – March 16, 2017

HAYWARD, Calif.–(Healthcare Sales & Marketing Network)–Moximed®, Inc., developer of unicompartmental load absorber implants for active patients with painful knee osteoarthritis (OA), announced today an oversubscribed Series C round of $50MM with new investors Advent Life Sciences and Future Fund joining existing investors NEA, Morgenthaler Ventures, Gilde Healthcare, GBS Venture Partners, and Vertex Healthcare. As part of the financing, Shahzad Malik, M.D., General Partner at Advent Life Sciences, and Brigitte Smith, Managing Director at GBS Venture Partners, will join the Board of Directors.

Moximed created the category of shock absorbing implants for knee OA, with treatment durability now established to nearly nine years on the initial patients. The Moximed implants do not require bone cutting or bone removal, and, importantly, they absorb excess joint load rather than shift load to other areas of the joint. Moximed has fully enrolled its FDA pivotal clinical study of the KineSpring® System and is currently enrolling an FDA IDE clinical study of the Atlas® System.

“This financing round is timely, as we are completing the primary endpoint follow-up for our FDA pivotal study this month,” said CEO Kevin Sidow. “We expect this investment to fully fund the company through FDA approval and early US commercialization of our products. There is a massive demand for new treatment options by patients who want to maintain an active lifestyle until they are ready for a knee replacement. The tremendous patient interest and surgeon enthusiasm we are witnessing in our current Atlas IDE study is validating our effort to address this clinical need.”

“Patients between the ages of 35 and 65 years old represent the fastest growing segment of the knee OA population,” added Shahzad Malik, of Advent Life Sciences. “These patients are often considered too young for traditional joint replacement and are desperate for a treatment alternative. We are excited to support Moximed’s effort to address this opportunity.”

About Osteoarthritis

Osteoarthritis (OA), the most common form of arthritis, is a degenerative disease affecting the hands, knees, hips, feet and spine. According to a 2017 Centers for Disease Control and Prevention (CDC) report, OA affects 54 million adults (1 in 4) in the US. It is caused by changes in cartilage, the soft tissue that cushions and protects bone, leading to pain and changes in the shape of the joint. In knee OA, as the cartilage wears away, the bone ends may begin to rub against each other, causing severe pain. While often regarded as a disease of the elderly, patients between the ages of 35 – 65 years of age represent the fastest growing segment of knee OA patients.

About Moximed

Moximed, Inc. is dedicated to improving the standard of care for patients with osteoarthritis (OA). OA, the most common form of arthritis, leads to a breakdown of the joint’s cartilage and often results in joint pain and loss of motion. Moximed is supported by world-leading venture investors including NEA, Morgenthaler Ventures, Gilde Healthcare, GBS Venture Partners, Vertex Healthcare, Advent Life Sciences, and Future Fund. More information can be found at www.moximed.com.

About the Atlas System

The Atlas System is designed as an implantable joint unloader for patients with unicompartmental knee osteoarthritis. Placed subcutaneously alongside the knee joint, the Atlas System incorporates advanced biomaterials designed to provide a clinically beneficial 30 lbs. of unloading. Importantly, the Atlas System absorbs excess joint load rather than shift load to otherwise healthy areas of the joint. This is important because load shifting has been shown in clinical studies to accelerate degeneration of otherwise healthy joint tissues. The Atlas System features a streamlined surgical technique that uses the patient’s own anatomy and allows the surgeon to visually confirm device function during the procedure. Finally, treatment with the Atlas System does not require any bone cutting or bone removal, and patients maintain all future treatment options should their osteoarthritis become more severe.

The Atlas System is CE Marked in Europe and is currently only being made available to select centers. The Atlas System is an investigational device in the United States, where it is limited by US law to investigational use.

About Advent Life Sciences

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe, and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The Firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France. For more information, please visit www.AdventLS.com

About Future Fund

The Future Fund is Australia’s sovereign wealth fund and invests for the benefit of future generations of Australians. The Future Fund was established in 2006 and has taken on management of additional public asset funds, including the Disability Care Australia Fund, the Medical Research Future Fund, and two Nation-building Funds. The Fund’s role is to generate high, risk-adjusted returns over the long-term. The Fund operates independently from Government and tailors the management of each fund to its unique investment mandate.

Source: Moximed

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

Alphatec Holdings Announces $18.9 Million Private Placement

CARLSBAD, Calif., March 23, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today that it has entered into a definitive securities purchase agreement to raise approximately $18.9 million in a private placement of common stock, Series A Convertible Preferred Stock and warrants exercisable for common stock. The private placement is being led by new healthcare dedicated institutional investors, with participation by directors and executive officers of Alphatec and other existing investors. The private placement is expected to close on or about March 28, 2017, subject to the satisfaction of customary closing conditions. Alphatec expects to use the net proceeds from the private placement for general corporate and working capital purposes.

“We appreciate the support of our new and existing investors and the confidence this conveys in our strategy to build a high-growth spine company,” said Terry Rich, Alphatec Spine’s Chief Executive Officer.  “We believe the additional capital will allow us to execute on our plans to expand our surgeon customer base, drive growth through the launch of our new products—Arsenal Deformity™, Battalion™ Lateral and XYcor® Expandable Interbody—as well as support the transformation of our distribution channel.”

H.C. Wainwright & Co., LLC, is acting as the exclusive placement agent in connection with this private placement.

Pursuant to the terms of the securities purchase agreement, Alphatec has agreed to sell 1,809,628 shares of common stock at a price of $2.00 per share.  In addition, Alphatec has agreed to sell approximately 15,245 shares of newly created Series A Convertible Preferred Stock, which shares of preferred stock are convertible into approximately 7,622,372 shares of common stock, subject to limitations on conversion until the approval by Alphatec’s stockholders as required in accordance with the NASDAQ Global Select Market rules. Purchasers will also receive warrants to purchase up to approximately 9,432,000 shares of common stock at an exercise price of $2.00 per share. The warrants will be exercisable following approval by Alphatec stockholders, and will expire 5 years from the date of such stockholder approval.

Certain directors and executive officers of Alphatec agreed to purchase an aggregate of $2.35 million of shares of Series A Convertible Preferred Stock, which shares are convertible into approximately 1,175,000 shares of common stock, and warrants to purchase up to 1,175,000 shares of common stock at a price of $2.00 per share.

The securities to be sold in the private placement will not have been registered under the Securities Act of 1933, as amended, or state securities laws as of the time of issuance and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Alphatec has agreed to file one or more registration statements with the SEC registering the resale of the shares of common stock purchased in the private placement and the shares of common stock underlying the warrants and issuable upon conversion of the Series A Convertible Preferred Stock.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops, manufactures and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. via a direct sales force and independent distributors.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward looking statements include statements regarding: Alphatec’s expectations on the completion, timing and size of the private placement and the anticipated use of proceeds therefrom, including such proceeds allowing Alphatec to accelerate its plans to expand its surgeon customer base, drive growth through the launch of new products and support the transformation of its distribution channel.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to, risks and uncertainties associated with: market conditions and the satisfaction of customary closing conditions related to the private placement; the uncertainty of success in launching new products; the uncertainties in Alphatec’s ability to execute upon its strategic operating plan; failure to achieve acceptance of Alphatec Spine’s products by the surgeon community; continuation of favorable third-party payor reimbursement for procedures performed using Alphatec Spine’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or Alphatec’s ability to successfully control its costs or achieve profitability; Alphatec’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement; and other risks and uncertainties inherent in Alphatec’s business, including those detailed from time to time in Alphatec’s SEC reports, including its Annual Report Form 10-K for the year ended December 31, 2015, filed on March 15, 2016 with the Securities and Exchange Commission, and its Amended Annual Report Form 10-K/A filed on April 29, 2016, as well as other filings on Form 10-Q and periodic filings on Form 8-K. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

SpineGuard Reports Full-Year 2016 Financial Results

March 23, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices designed to make spine surgery safer, reported today its full-year 2016 financial results as approved by the Board of Directors on March 23, 2017.

€ thousands – IFRS Audited Dec 31, 2016 Dec 31, 2015
Revenue 7 463 6 346
Gross margin 6 354 5 365
Gross margin (% of revenue) 85,1 % 84,5 %
Sales, distribution & marketing 6 643 6 514
Administrative costs 2 049 1 968
Research & Development 1 295 857
Operating profit / (loss) -3 633 -3 974
Financial Result -545 96
Net profit / (loss) -4 178 -3 878

Pierre Jérôme, CEO and co-founder of SpineGuard, said: “2016 saw SpineGuard’s sales momentum continue and showed the great potential of our DSG™ technology platform. Our commercial organization keeps delivering double-digit growth via our PediGuard family of smart drilling probes, which we expanded with the successful launch of the PediGuard Threaded. At the same time, our R&D investments for the integration of the DSG technology into implantable devices such as pedicle screws has begun to bear fruit with first surgeries in Europe and FDA clearance early in 2017. The US is a key market for SpineGuard where we keep growing significantly year after year. Our focus on operating expenses also allowed the company to improve its operating result. We will continue to pursue this path as one of our corporate objectives for 2017.”

Operating income improves by 9%

In 2016, SpineGuard reported full-year revenue of €7,463k compared with €6,346k for 2015, an 18% increase both on reported basis and cc. 8,603 PediGuard units were sold compared with 7,449 in 2015, including 4,948 in the United States.

The gross margin improved by nearly €1M and 60 bps at 85.1% compared with the prior year of 84.5%, and remains strong. The improvement year-on-year is the result of a combined stability of average selling prices and more favorable country mix with an improved performance on manufacturing cost despite headwinds on currency vs. prior year.

Operating costs increased by €648k (+7%); mainly due to R&D expenses related to the clearance of both PediGuard Threaded and the DSG™ screw (€438k).

With the combination of an improved gross margin and the control of operating expenses, the operating result improved by +€340 k (or +9%) vs. prior year.

The Company reported a net loss of €4,178k for the full-year 2016 compared with a loss of €3,878k for the full-year 2015, impacted by the increase of financial costs related to lower Fx gains of €114k and an increase of interest on loans by €439k.

Working capital was €955k compared with €-65k for the full-year 2015. The increase is mainly due to the building of the inventory of the new products prior to their commercial launch (PediGuard Threaded and DSG modules for the screw), the anticipation of purchases with our Singapore-based manufacturing partner and the Fx Euro/dollar unfavorable impact on the manufacturing cost.

At December 31, 2016, cash and cash equivalents were €1,804k compared with €3,229k at December 31, 2015. The Company has the possibility under certain conditions to draw a €1.5M tranche of debt with IPF Partners.

2016: Excellent sales momentum and strategic objectives achieved

Sales; marketing and regulatory:

2016 was a year of significant breakthroughs in the United States:

  • Contracts with important hospital systems were either signed or consolidated;
  • A partnership agreement with OrthoPediatrics for the exclusive commercialization of PediGuard® in pediatric hospitals was signed;
  • A commercial agreement with Spartan, which is dedicated to veteran and military institutions;
  • The expansion to 36 spine teaching institutions using DSG-enabled devices in their curriculum;
  • A number of non-stocking distributors growing from 77 to 80;
  • The sales team was reinforced with the hiring of a Sr. Sales Manager for the South region and by repositioning a product specialist in the Northeast region;
  • FDA clearance of the PediGuard Threaded was received in June 2016, with a product launch in October 2016 at the North American Spine Society (NASS) congress.

In the rest of the world, the Company focused on procuring extensive training and marketing support to the network of distributors making significant progress in various markets:

  • PediGuard now used in 50% of the French spine teaching institutions (CHU);
  • more than 800 PediGuard units sold in Saudi Arabia through a tender;
  • over 70 surgeons participated to the PediGuard Threaded workshop at EuroSpine congress in Berlin in October 2016.

Clinical:

Eleven surgeons presented their experience with PediGuard in international scientific conventions and five new clinical studies were initiated:

  • 2 prospective mono-centric studies for the use of PediGuard in minimally invasive surgery in France and United Arab Emirates;
  • 1 retrospective mono-centric study for the PediGuard use in so-called bi-cortical techniques in the US;
  • 1 prospective randomized and mono-centric study comparing PediGuard to navigation in the US;
  • 1 study on specimen about the use of the DSG™ screw with Zavation in the US.

2017 perspectives:

After the FDA clearance in the US early 2017 for the DSG™ screw, SpineGuard intends to:

  • Foster adoption of the DSG™ technology through sustained efforts towards surgeons, distributors, teaching institutions and industrial partners;
  • Sign new deals to expand the commercial penetration of the DSG™-enabled screws;
  • Enlarge the scope of the DSG™ platform to other applications such as Bone Quality Measurement (BQM), combination with robotic, licensing agreements for non-spine (trauma, maxillo facial);
  • Continue to grow sales and improve its operating result.

Next financial press release: First Quarter 2017 revenue, on April 6, 2017.

About SpineGuard®

Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 50,000 surgical procedures have been performed worldwide with DSG enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

For further information, visit www.spineguard.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Pierre Jérôme
Chief Executive Officer
Tel: +33 (0)1 45 18 45 19
p.jerome@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.fr
or
US
Ronald Trahan, APR, Ronald Trahan Associates Inc.
+1-508-359-4005, x108

Medtronic Announces Pricing of $2 Billion of Senior Notes

DUBLIN – March 21, 2017 – Medtronic plc (MDT) announced today that its wholly-owned subsidiary, Medtronic Global Holdings S.C.A. (“Medtronic Luxco”), has priced an offering of $1,000,000,000 principal amount of 1.700 percent senior notes due 2019 and $850,000,000 principal amount of 3.350 percent senior notes due 2027 (collectively, the “notes”). All of Medtronic Luxco`s obligations under the notes will be fully and unconditionally guaranteed by Medtronic plc and Medtronic, Inc., a wholly-owned indirect subsidiary of Medtronic Luxco, on a senior unsecured basis.

Medtronic also announced today that, concurrently with the offering by Medtronic Luxco, Medtronic, Inc. has priced an offering of $150,000,000 in principal amount of its 4.625 percent Senior Notes due 2045 (the “reopening notes”). The reopening notes will be a further issuance of, and will form a single series with, the $4,000,000,000 principal amount of Medtronic, Inc.`s currently outstanding 4.625 percent Senior Notes due 2045, and will be fully and unconditionally guaranteed by Medtronic Luxco and Medtronic plc on a senior unsecured basis. The offerings of the notes and the reopening notes are each being conducted pursuant to an effective registration statement under the Securities Act of 1933, as amended (the “Securities Act”).

The net proceeds of the offerings will be used for general corporate purposes. The offerings are expected to close on March 28, 2017, subject to customary closing conditions.

The joint book-running managers for the offerings are Citigroup Global Markets Inc., Goldman, Sachs & Co., Morgan Stanley & Co. LLC and Wells Fargo Securities, LLC. The co-managers for the offerings are BNP Paribas Securities Corp., Deutsche Bank Securities Inc., HSBC Securities (USA) Inc. and Mizuho Securities USA Inc.

The offerings of the notes and the reopening notes may be made only by means of a prospectus and prospectus supplement. You may get these documents for free by visiting EDGAR on the Securities and Exchange Commission (“SEC”) website at www.sec.gov. Alternatively, copies of the prospectus and prospectus supplement for each offering may be obtained from 20 On Hatch, Lower Hatch Street Dublin 2, Ireland, or by contacting Citigroup Global Markets Inc., toll-free at +1-800-831-9146, Goldman, Sachs & Co., toll-free at +1-866-471-2526 or Morgan Stanley & Co. LLC, toll-free at +1-866-718-1649.

About Medtronic
Medtronic plc, headquartered in Dublin, Ireland, is among the world`s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Forward-Looking Statements
This press release may be deemed to contain forward-looking statements regarding future events and the company`s future results that are subject to the safe harbor created under Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act and the Securities Exchange Act of 1934. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including but without limitation, statements relating to the offerings of the notes and the reopening notes and the use of proceeds therefrom, and the expected closing date of the offering of the notes and the reopening notes.

You should pay particular attention to the important risk factors and cautionary statements referenced in the “Risk Factors” section of the prospectuses related to the offerings referenced above, as well as the risk factors and cautionary statements described in Medtronic plc`s filings with the SEC, including the risk factors contained in each of Medtronic plc`s most recent Quarterly Reports on Form 10-Q and Annual Report on Form 10-K. Medtronic plc does not undertake to update its forward-looking statements.

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

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

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medtronic plc via GlobeNewswire