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India introduces price controls for knee implants

Posted On August 16, 2017 By OrthoSpineNews In Financial, Recon, Top Stories /  

NEW DELHI, Aug 16 (Reuters) – India has capped prices of orthopaedic knee implants, in the country’s latest move to bring down prices of medical devices.

The introduction of price controls marks the latest step by Prime Minister Narendra Modi’s government to make drugs and medical devices more affordable. In February, it imposed a 75 percent price cut for certain heart stents – wire mesh tubes used to treat blocked arteries, which caused protests among manufacturers.

India’s drug pricing authority said on Wednesday that orthopaedic implants in India had unjustified, unreasonable and irrationally high trade margins, leading to exorbitant pricing.

Ananth Kumar, Minister of Chemicals and Fertilisers, told a news briefing the government had capped knee implant prices “in public interest.”

Kumar said the price of the widely used cobalt chromium knee implant, priced at up to 250,000 rupees ($3,895) at Indian hospitals, would now be capped at 54,720 rupees ($852).

 

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Stryker’s Spine Division Receives FDA Clearance for Serrato Pedicle Screw

Posted On August 16, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

August 16, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that its Serrato™ Pedicle Screw, intended for use in the non-cervical spine as part of the company’s successful Xia® 3 Spinal System, has received 510(k) clearance from the U.S. Food and Drug Administration.

Serrato Pedicle Screws feature enhanced serrated cutting flutes, a unique dual-thread pattern with an increased number of leads for rapid insertion, and a patented buttress thread locking mechanism designed to minimize cross threading and splaying of the screw head.1,2 The screws accommodate a variety of rod diameters and materials to suit the patient’s needs—5.5 and 6.0mm diameter rods in commercially pure titanium, titanium alloy, and Vitallium.

“Pedicle screws have been used for decades with very few changes to their design,” said Bradley Paddock, President of Stryker’s Spine division. “The design innovations incorporated into Serrato reinforce our commitment to making industry-leading investments focused on providing the advanced spinal products and differentiated technologies that our surgeon customers have come to expect.”

Serrato leverages the broad portfolio of the Xia 3 Spinal System, an orthopaedic spinal system comprised of a variety of shapes and sizes of screws, blockers, and hooks that affix several different types of rods and connectors to vertebrae or the spinal column for purposes of stabilization, or corrective action through the application of force.

Intended Use

The Xia 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. For the full Indications for Use, please refer to the Xia 3 Spinal System Instructions for Use.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

References

1. Stryker Patent #6,074,391
2. Stryker Design History File DHF0000016688

Content ID TLSER-PR-1_14675

Contacts

Sullivan & Associates
Barbara Sullivan, 714/374–6174
bsullivan@sullivanpr.com

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Global Medical Equipment Markets 2017-2022 – Market is Expected to Reach Over $500 Billion in 2020 – Research and Markets

Posted On August 16, 2017 By OrthoSpineNews In Financial /  

August 16, 2017

DUBLIN–(BUSINESS WIRE)–The “Medical Equipment Market Global Report 2017” report has been added to Research and Markets’offering.

The Medical Equipment Market Global Report provides strategists, marketers and senior management with the critical information they need to assess the global medical equipment sector.

The global medical equipment market is expected to reach over $500 billion in 2020. One of the key drivers of the medical equipment market include Technology – Technology is expected to be a continued driver of market growth during this period. Areas of particular development are likely to be robotics and minimally invasive surgery technologies. Markets such as this one will benefit from the greater efficiencies offered by these technologies. For example, ConforMIS iFit image-to-implant technology allows surgeons to 3D print joint replacement implants to suit the needs of each patient’s body, thereby reducing the duration of knee replacement surgery as well as patient recovery time.

Use of medical devices for the home based diagnosis and treatment of medical conditions is increasing. Technological developments in devices such as glucose monitors, insulin delivery devices, nebulizers and oxygen concentrators have enabled diagnosis and monitoring of many diseases at home. Remote control technology is also allowing healthcare professionals to support home based treatments which is leading to preference for home and self-care treatment .

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography. It places the market within the context of the wider healthcare market, and compares it with other markets.

Scope:

  • Markets Covered: Cardiovascular Devices, In-Vitro Diagnostics, Orthopaedic Devices, Ophthalmic Devices, Diagnostic Equipment, Hospital Supplies, Diabetes Care Devices, Patient Monitoring Devices, Anesthesia And Respiratory Devices, Nephrology And Urology Devices, Wound Care Devices, ENT Devices, Neurology Devices, Surgical Equipment, Dental Equipment And Supplies
  • Companies Mentioned: Medtronic, Johnson & Johnson, GE Healthcare, Siemens Healthcare, and Philips Healthcare
  • Countries: Brazil, China, France, Germany, India, Italy, Japan, Spain, Russia, UK, USA and Australia
  • Regions: Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East And Africa
  • Time Series: Five years historic and forecast
  • Data: Ratios of market size and growth to related markets, GDP, Expenditure Per Capita, The Medical Equipment Indicators Comparison
  • Data Segmentations: country and regional historic and forecast data, market share of competitors, market segments
  • Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes

For more information about this report visit https://www.researchandmarkets.com/research/wzhwph/medical_equipment

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices

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Renowned Orthopaedic Specialists Publish First Collection of Rebound Bracing Clinical Articles

Posted On August 16, 2017 By OrthoSpineNews In Sports Medicine, Top Stories /  

August 15th, 2017

A group of internationally recognized orthopaedic surgeons has published the first collection of clinical cases utilizing Rebound® braces from Össur. The innovative Rebound line includes indication-specific Functional Healing braces designed to optimize patient healing while maintaining function and mobility.

“We are gratified that some of the world’s most respected thought-leaders in orthopaedic surgery have contributed these clinical evaluations of Rebound bracing,” said Dr. Axel Schulz, Medical Director for Össur, the global medical technology leader renowned for its advanced prosthetic and orthopaedic innovations. “Their experience will be very helpful in formulating longer-term clinical protocols for these technologies, which have been specifically designed to help accelerate recovery from PCL, ACL and cartilage-based knee injuries.”

LaPrade Case Demonstrates Rebound PCL’s Effectiveness

The Rebound PCL Brace from Össur is the world’s first dynamic force brace for rehabilitating posterior cruciate ligament (PCL) ruptures. It is part of the Functional Healing® line of innovative indication-specific, dynamic orthopaedic solutions intended to optimize healing while maintaining patient function and mobility.

Össur’s Rebound product family is built on decades of experience and designed to protect bone and soft tissue during healing through innovative technology and proven biomechanical approaches. Rebound PCL, the world’s first and only dynamic force brace for rehabilitating posterior cruciate ligament (PCL) ruptures, reflects the company’s Functional Healing approach to orthopaedic innovation, which focuses on developing proprietary technologies according to specific indication-based protocols and clinically relevant outcomes.

In his case study, Robert LaPrade, M.D., Ph.D., Complex Knee and Sports Medicine Surgeon at The Steadman Clinic, reports that use of the Rebound PCL brace helped aid an adult male gymnast recover after double bundle PCL reconstruction, a complete anatomic posterolateral corner knee reconstruction and a medial meniscus root repair following a severe varus noncontact injury. With full restoration of knee motion and complete healing of his PCL and PCL reconstructions, the patient had an excellent outcome and returned to a national level of competition just one year following his surgery.

According to Dr. LaPrade, PCL reconstruction recovery historically tends to stretch out over time due to the effects of gravity, but the Rebound PCL brace “negates the negative effects of gravity by applying an anterior translation force at higher knee flexion angles,” thereby protecting the PCL graft in early post-op applications.

“Patients with serious multiple ligament knee injuries can be restored back to high levels of activity with modern anatomic-based reconstructions. The additional use of the Rebound PCL brace facilitates a safe initiation of knee motion in the early postoperative period,” he concluded.

Other renowned clinicians who have contributed cases to the Rebound Bracing collection include:

  • Dr. Mats Brittberg, Professor, Region Halland Orthopedics at Kungsbaca Hospital, Sweden
  • Dr. Tobias Jung, Senior Physician, Section Head Knee Surgery and Sports Traumatology at Charité-University Medicine Berlin, Germany
  • Dr. Christos Kondogiannis, Orthopaedic Surgeon at Royal Melbourne Hospital St. Vincent’s Private Hospitals, Australia
  • Dr. Thomas Stein, Executive Senior Physician in the Department for Sport Traumatology at Berufsgenossenschaftliche Unfalklinik Frankfurt am Main, Germany
  • Dr. Peter Verdonk, full knee specialist at the Antwerp Orthopaedic Center, Department of Orthopaedic Surgery at Antwerp University Hospital, Netherlands

The full collection of Rebound case studies is available online at https://www.ossur.com/rebound.

“The clinical community’s response to the current line of Rebound braces has been so overwhelmingly positive that we look forward to introducing additional Rebound products in the future, which will complement our Functional Healing products in the continuum of care,” Dr. Schulz said.

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Materialise Reports Surge in 3D Printing For End Part Manufacturing

Posted On August 16, 2017 By OrthoSpineNews In Financial /  

 – 

Materialise NV (NASDAQ:MTLS) has reported financial results for the second quarter of 2017, and business is booming.

Headquartered in Leuven, Belgium the company is one of the pioneers in the 3D printing industry having written early software to improve additive manufacturing.

Materialise now reports revenue across 3 segments – software, medical and manufacturing. All segments have shown a year-on-year increase, with manufacturing growing the fastest. For the three months ended June 2017, Materialise posted €33.42 million in total revenue, a 21% increase on the comparative figure.

Revenue from software sales and end parts accounts for 81% of the Q2 2017 figures.

The company’s operating profit position improved by €0.86 million, with a loss of €0.3 million for the period. Adjusted earnings before interest, taxes, depreciation, and amortization were €2.7 million (€1.03M), a 164% increase on the comparative.

Executive Chairman Peter Leys said, “Materialise turned in another sound quarter, delivering strong revenue growth in all our segments, particularly Manufacturing, where, driven by a surge in end part manufacturing, revenue rose 32.5%.”

The latest results for the Manufacturing segment also beat reported final quarter growth of 19.4% for 2016.

€ Million Variance
Q2 2017 Q2 2016 € Million
Revenue 33.61 27.6 6.01
Operating profit -0.295 -1.151 0.856
Net income -0.955 -0.436 -0.519
Adjusted EBITDA 2.732 1.034 1.698
Basic EPS -0.02 -0.01

Data via Materialise NV.

Expanding capacity

The strong numbers reflect, “the pick-up in the demand environment for 3D printing this year, revenue from our Software segment increased 19.0%, while Medical rose almost 10% on the strength of solid software revenues,” Leys continued.

The company increased revenue while undergoing a period of expansion, opening new manufacturing facilities in Leuven and Poland. Gradual “scale effects and efficiency gains” from the expanded capacity are anticipated for the third quarter.

 

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Colorado pediatric-surgery tech maker reaches deal with California’s Intuitive Surgical

Posted On August 16, 2017 By OrthoSpineNews In Robotics /  

Aug 15, 2017 – Reporter , Denver Business Journal

A Colorado medical device startup making surgical tools for minimally-invasive operations on children has reached a deal with one of the best-known makers of surgery robotics used on adults.

Louisville-based JustRight Surgical expects its new licensing pact with Intuitive Surgical, the Sunnyvale, California-based maker of maker of da Vinci robotic surgery systems, will expand the use of JustRight technology beyond the pediatric market and drive growth at the company it otherwise wouldn’t have.

“You can’t really just step into robotic surgery, so having a partner of their scale is perfect for us,” said Robert Kline, JustRight CEO. “It’s certainly a positive development, and it’ll provide us with the capability to expand our business.”

JustRight has 25 employees, most of them based at its Louisville office. It developed smaller surgical tools for laparoscopic procedures, giving surgeons the first energy-based blood-vessel sealing and tissue stapling devices that weren’t designed for adults.

The devices were meant to improve surgeon’s maneuverability during operations on younger patients, from babies to young teenagers.

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Administration Signals Likely End to Medicare Bundled Payments Initiative

Posted On August 15, 2017 By OrthoSpineNews In Financial, Regulatory /  

August 15, 2017- Jim Burger, Outpatient Surgery > Legal & Regulatory

Medicare’s mandatory bundled payments program for total joints appears to be on the way out.

Tom Price, MD, Secretary of the Department of Health and Human Services (HHS), has been a vocal opponent of mandatory bundles and other service delivery models, and a newly proposed rule posted on the Office of Management and Budget Website strongly suggests that HHS is looking to eliminate mandatory bundling for joint replacements and cardiac care. The programs, delayed twice since the Trump administration took over, are due to take effect in January.

The only public information available about the new proposal is its title: “Cancellation of Advancing Care Coordination through Episode Payment and Cardiac Rehabilitation Incentive Payment Models; Changes to Comprehensive Care for Joint Replacement Payment Model.”

As a Congressman from Georgia, Dr. Price claimed that the Center for Medicare and Medicaid Innovation had “exceeded its authority, failed to engage stakeholders and … upset the balance of power between the legislative and executive branches” with its proposed payment reforms.

 

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SANUWAVE Health Reports Second Quarter Financial Results and Provides a Business Update

Posted On August 15, 2017 By OrthoSpineNews In Financial /  

SUWANEE, GA–(Marketwired – Aug 14, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV), today reported financial results for the three and six months ended June 30, 2017 and provided a business update. The Company will host a conference call at 10:30AM Eastern Time on Tuesday, August 15, 2017.

Highlights of the second quarter and recent weeks:

  • The Company appointed Dr. Maj-Britt Kaltoft to its Board of Directors. Dr. Kaltoft currently heads the business development and patent functions at the Danish State Serum Institute, an institution under the Danish Ministry of Health.
  • The Company appointed retired Colonel Dr. Patrick Sesto to its Medical and Science Advisory Board. Dr. Sesto served 27 years active duty in the US Army and during that time was appointed by Major General Peake, US Army Surgeon General, to be his Consultant for Army Podiatry, a position he held for seven years.
  • SANUWAVE signed a third amendment with HealthTronics, Inc. to extend the due date of its two promissory notes from January 31, 2018 to December 31, 2018.
  • SANUWAVE entered into a Memorandum of Understanding with eKare, Inc. to develop novel wound care analysis and management solutions. Linking SANUWAVE’s dermaPACE wound treatment device with eKare’s inSight® 3D wound imaging and analytics system, the two companies will strive to produce the industry’s most comprehensive wound management solution.
  • SANUWAVE appointed LITHOMED to act as distributors for the orthopedic products in Taiwan. LITHOMED has a wealth of experience within this specific indication in Taiwan as well as access and relationships with key opinion leaders which will prove to be of immense value for market development.
  • SANUWAVE appointed Alat Medika Indonesia as distributor for dermaPACE® and liaison for clinical trials participation for their wound care product in Indonesia. It is well known that diabetes and related concerns need to be addressed within Indonesia and having access to outstanding technology such as SANUWAVE’s within the country is a positive step.
  • SANUWAVE appointed Interventional Concepts, Inc. to act as Territory Sales Manager for sourcing and screening of potential distributors for the Company’s products in Columbia. Interventional Concepts will give SANUWAVE access to a multidisciplinary team of life science professionals in Columbia that provide regulatory and commercial support when introducing SANUWAVE’s products.

“The second quarter came in below plan but we remain confident we will achieve our seven goals for 2017 and as you can see we make great progress toward reaching these goals,” stated Kevin Richardson, CEO and Chairman. “The seven goals that we projected for 2017 were:

1. FDA approval in late 2017 or early 2018,
2. Add 7 to 10 new countries/regions to our portfolio,
3. Expand Board of Directors members from 4 to 7,
4. Expand Medical Advisory Board members from 2 to 5,
5. Produce record international sales,
6. Launch clinical work both domestically and internationally, and
7. Obtain at least one non-medical partner.

If we can achieve these goals in 2017, we will be well prepared for a rapid sales increase in 2018 as our commercialization efforts take effect,” concluded Mr. Richardson.

Second Quarter Financial Results

Revenues for the three months ended June 30, 2017 were $111,045, compared to $203,406 for the same period in 2016, a decrease of $92,361, or 45%. Revenues resulted primarily from sales in Europe, Asia and Asia/Pacific of our orthoPACE device and related applicators. The decrease in revenues for 2017 was due to lower sales of new orthoPACE devices and applicators in Europe and Asia/Pacific in 2017.

Research and development expenses for the three months ended June 30, 2017 were $437,909, compared to $476,167 for the same period in 2016, a decrease of $38,258, or 8%. Research and development expenses decreased in 2017 due to lower payments to consultants related to the de novo petition submission to the FDA in July 2016 and lower travel costs. This was partially offset by non-cash stock compensation expense for stock options issued in June 2017.

General and administrative expenses for the three months ended June 30, 2017 were $951,908, as compared to $589,896 for the same period in 2016, an increase of $362,012, or 61%. The increase in general and administrative expenses was due non-cash stock compensation expense for stock options issued in June 2017, tradeshow attendance in Europe and related travel expenses and increase in bad debt reserve.

Net loss for the three months ended June 30, 2017 was $1,415,937, or ($0.01) per basic and diluted share, compared to a net loss of $1,122,123, or ($0.01) per basic and diluted share, for the same period in 2016, an increase in the net loss of $293,814, or 26%. The increase in the net loss for 2017 was primarily due to the stock compensation expense for stock options issued during in June 2017 and an increase in the bad debt reserve and was partially offset by lower research and development expenses as noted above.

Six Months Ended June 30, 2017 Financial Results

Revenues for the six months ended June 30, 2017 were $260,614, compared to $472,730 for the same period in 2016, a decrease of $212,116, or 45%. Revenues resulted primarily from sales in Europe, Asia and Asia/Pacific of our orthoPACE device and related applicators. The decrease in revenues for 2017 was due to lower sales of new orthoPACE devices and applicators and lower applicator refurbishments in Europe and Asia/Pacific in 2017.

Research and development expenses for the six months ended June 30, 2017 were $698,247, compared to $786,122 for the same period in 2016, a decrease of $87,875, or 11%. Research and development expenses decreased in 2017 as a result of lower payments to consultants related to the de novo petition submission to the FDA in July 2016, which was partially offset by higher audit costs related to ISO certification and non-cash stock compensation expense for stock option issued in June 2017.

General and administrative expenses for the six months ended June 30, 2017 were $1,400,514, as compared to $1,089,028 for the same period in 2016, an increase of $311,486, or 29%. The increase in general and administrative expenses was due to non-cash stock compensation expense for stock options issued in June 2017, tradeshow attendance in Europe and related travel expenses and increase in bad debt reserve.

Net loss for the six months ended June 30, 2017 was $1,909,469, or ($0.01) per basic and diluted share, compared to a net loss of $2,846,699, or ($0.03) per basic and diluted share, for the same period in 2016, a decrease in the net loss of $937,230, or 33%. The decrease in the net loss for 2017 was primarily due to a gain on the warrant valuation and lower operating expenses as noted above.

Conference Call

The Company will also host a conference call on Tuesday, August 15, 2017, beginning at 10:30AM Eastern Time to discuss the second quarter 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/event/19907.

A replay of the conference call will be available beginning two hours after its completion through August 29, 2017, by dialing 877-481-4010 (U.S.) or 919-882-2331 (international) and entering Conference ID 19907.

About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB: SNWV) (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.

SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
June 30, December 31,
2017 2016
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 62,069 $ 133,571
Accounts receivable, net of allowance for doubtful accounts 191,932 460,799
Inventory, net 198,778 231,953
Prepaid expenses 95,741 87,823
TOTAL CURRENT ASSETS 548,520 914,146
PROPERTY AND EQUIPMENT, at cost, less accumulated depreciation 64,860 76,938
OTHER ASSETS 13,977 13,786
TOTAL ASSETS $ 627,357 $ 1,004,870
LIABILITIES
CURRENT LIABILITIES
Accounts payable $ 1,188,459 $ 712,964
Accrued expenses 470,585 375,088
Accrued employee compensation 65,154 64,860
Advances from related parties 421,690 –
Interest payable, related parties 388,095 109,426
Short term loan, net 100,000 47,440
Warrant liability 816,521 1,242,120
Notes payable, related parties, net 5,369,361 5,364,572
TOTAL LIABILITIES 8,819,865 7,916,470
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ DEFICIT
PREFERRED STOCK, SERIES A CONVERTIBLE, par value $0.001, 6,175 authorized; 6,175 shares issued and 0 shares outstanding in 2017 and 2016 – –
PREFERRED STOCK, SERIES B CONVERTIBLE, par value $0.001, 293 authorized; 293 shares issued and 0 shares outstanding in 2017 and 2016, respectively – –
PREFERRED STOCK – UNDESIGNATED, par value $0.001, 4,993,532 shares authorized; no shares issued and outstanding – –
COMMON STOCK, par value $0.001, 350,000,000 shares authorized; 139,099,843 and 137,219,968 issued and outstanding in 2017 and 2016, respectively 139,100 137,220
ADDITIONAL PAID-IN CAPITAL 93,077,145 92,436,697
ACCUMULATED DEFICIT (101,342,917 ) (99,433,448 )
ACCUMULATED OTHER COMPREHENSIVE LOSS (65,836 ) (52,069 )
TOTAL STOCKHOLDERS’ DEFICIT (8,192,508 ) (6,911,600 )
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT $ 627,357 $ 1,004,870
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
Three Months Ended Three Months Ended Six Months Ended Six Months Ended
June 30, June 30, June 30, June 30,
2017 2016 2017 2016
REVENUES $ 111,045 $ 203,406 $ 260,614 $ 472,730
COST OF REVENUES (exclusive of depreciation and amortization shown below) 24,695 77,988 79,839 151,169
OPERATING EXPENSES
Research and development 437,909 476,167 698,247 786,122
General and administrative 951,908 589,896 1,400,514 1,089,028
Depreciation 5,958 837 12,078 1,673
Amortization – 76,689 – 153,378
Gain on sale of property and equipment – – – (1,000 )
TOTAL OPERATING EXPENSES 1,395,775 1,143,589 2,110,839 2,029,201
OPERATING LOSS (1,309,425 ) (1,018,171 ) (1,930,064 ) (1,707,640 )
OTHER INCOME (EXPENSE)
Gain (loss) on warrant valuation adjustment and conversion 35,410 28,250 358,633 (769,447 )
Interest expense, net (143,281 ) (129,334 ) (336,019 ) (363,764 )
Gain (loss) on foreign currency exchange 1,359 (2,868 ) (2,019 ) (5,848 )
TOTAL OTHER INCOME (EXPENSE), NET (106,512 ) (103,952 ) 20,595 (1,139,059 )
NET LOSS (1,415,937 ) (1,122,123 ) (1,909,469 ) (2,846,699 )
OTHER COMPREHENSIVE LOSS
Foreign currency translation adjustments (15,552 ) (5,684 ) (13,767 ) (2,713 )
TOTAL COMPREHENSIVE LOSS $ (1,431,489 ) $ (1,127,807 ) $ (1,923,236 ) $ (2,849,412 )
LOSS PER SHARE:
Net loss – basic and diluted $ (0.01 ) $ (0.01 ) $ (0.01 ) $ (0.03 )
Weighted average shares outstanding – basic and diluted 138,992,669 102,645,697 138,517,370 88,933,089
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
Six Months Ended Six Months Ended
June 30, June 30,
2017 2016
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (1,909,469 ) $ (2,846,699 )
Adjustments to reconcile net loss to net cash used by operating activities to net cash used by operating activities
Depreciation 12,078 1,673
Change in allowance for doubtful accounts 116,833 5,613
Amortization – 153,378
Stock-based compensation – employees, directors and advisors 482,295 116,550
(Gain) loss on warrant valuation adjustment (358,633 ) 769,447
Amortization of debt discount 57,349 11,472
Amortization of debt issuance costs – 87,548
Loss on conversion option of promissory note payable – 75,422
Gain on sale of property and equipment – (1,000 )
Changes in assets – (increase)/decrease
Accounts receivable – trade 152,034 (28,313 )
Inventory 33,175 54,002
Prepaid expenses (7,918 ) 26,165
Other (191 ) (45 )
Changes in liabilities – increase/(decrease)
Accounts payable 475,495 (50,989 )
Accrued expenses 95,497 (63,551 )
Accrued employee compensation 294 167,397
Interest payable, related parties 278,669 (131,579 )
Promissory notes, accrued interest – (77,615 )
NET CASH USED BY OPERATING ACTIVITIES (572,492 ) (1,731,124 )
CASH FLOWS FROM INVESTING ACTIVITIES
Proceeds from sale of property and equipment – 1,000
NET CASH PROVIDED BY INVESTING ACTIVITIES – 1,000
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from warrant exercise 93,067 –
Advances from related parties 421,690 –
Proceeds from 2016 Public Offering, net – 1,596,855
Proceeds from convertible promissory notes, net – 106,000
NET CASH PROVIDED BY FINANCING ACTIVITIES 514,757 1,702,855
EFFECT OF EXCHANGE RATES ON CASH (13,767 ) (2,713 )
NET DECREASE IN CASH AND CASH EQUIVALENTS (71,502 ) (29,982 )
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 133,571 152,930
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 62,069 $ 122,948
SUPPLEMENTAL INFORMATION
Cash paid for interest, related parties $ – $ 392,516

CONTACT INFORMATION

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NuVasive Appoints Rajesh J. Asarpota As Chief Financial Officer

Posted On August 15, 2017 By OrthoSpineNews In Spine /  

SAN DIEGO, Aug. 15, 2017 /PRNewswire/ — NuVasive, Inc. (Nasdaq: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today the appointment of Rajesh (Raj) J. Asarpota as the Company’s new executive vice president and chief financial officer (CFO), effective September 1, 2017.

As a member of NuVasive’s global executive team, Mr. Asarpota will be responsible for the Company’s global finance functions including accounting, FP&A, treasury and tax. He joins NuVasive with nearly 25 years of experience in financial and executive leadership roles across the healthcare industry.

Mr. Asarpota began his career at General Electric (GE) in the GE Financial Management program, including finance roles in commercial operations, plant and manufacturing analysis, sourcing and R&D analysis. He then joined the GE Corporate Audit Staff program and from there moved to GE Healthcare where he held a variety of key finance operating roles. In the last 15 years, he has accumulated critical experience in both public and private enterprises, highlighted by his decade-long tenure at Life Technologies where he helped drive the growth from a small biotech company to a $4 billion life sciences leader. More recently, Mr. Asarpota was the CFO of publicly-traded Questcor Pharmaceuticals and supported the sale of that company, and then worked in private equity-backed healthcare companies for the last several years in executive financial and operational roles.

“Raj brings a strong financial and operational background to the NuVasive leadership team as we continue to focus on driving revenue growth and expanding profitability,” said Gregory T. Lucier, NuVasive’s chairman and chief executive officer. “I have worked closely with Raj at multiple companies where we were successful at expanding market share and transforming operations. He’s a proven leader who will drive significant shareholder value.”

Mr. Asarpota earned a bachelor’s degree from the University of Bombay in Bombay, India and an MBA from Marquette University in Milwaukee, Wisconsin.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements.  The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

 

SOURCE NuVasive, Inc.

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Pennsylvania Hospital Neurosurgeon Performs the First Endoscopic Minimally Invasive Spinal Surgery in Pennsylvania

Posted On August 15, 2017 By OrthoSpineNews In Spine, Top Stories /  

August 10, 2017-Penn Medicine News

PHILADELPHIA – Spine disc related low back and leg pain is a major challenge and is the second most common reason that patients visit the doctor in the United States—outnumbered only be respiratory infections—and is the leading cause of disability worldwide. Compression of the spinal nerves is one of the most common diagnoses and is frequently reversible with surgery.

Kevin Clark, 51, is one of 200,000 individuals in America who suffer with debilitating back pain, leg cramps, and difficulty standing, bending or walking due to spinal nerve compression and stenosis each year. He sought help from Penn Medicine neurosurgeons, and today, Clark is celebrating three months of being pain-free after suffering debilitating back pain, leg pain and thigh numbness for over a year. He became the first patient in Pennsylvania to undergo a life-changing, minimally invasive spine surgery through a single incision in his side that had him up and walking just hours after surgery. Neil R. Malhotra, MD, an assistant professor of Neurosurgery and Orthopaedic Surgery and the vice chairman of operations in the department of Neurosurgery, performed Clark’s procedure—called an endoscopic percutaneous lumbar spinal nerve decompression and discectomy—at the Hospital of the University of Pennsylvania in May.

Clark, a bridge inspector from Quakertown, Pa., had been experiencing back pain and numbness in his right upper leg and thigh for nearly a year. Clark previously had undergone open spinal laminectomy surgery—a procedure during which a small portion of the bone over the nerve root and/or disc material is removed to give the nerve root more space— three years earlier for nerve compression causing symptoms in the back and below the knees. He had an excellent surgical result, with 100 percent improvement of his symptoms, but he felt that the surgery recovery was tough, with incision pain lasting nearly three months. But since the surgery helped, he was prepared to do it again to get relief from his new problem above the knee. When he heard that there was another option for his problem, Clark agreed to become the first patient in the state to receive the new minimally invasive treatment. Following the procedure, Clark said, “The speed of recovery alone has been amazing. I was able to walk around without pain the same day.” He noted that he had rapid results for his different problems with both surgeries, but with this surgery there was almost no incision pain — relief without suffering the more typical side effects of surgery.

 

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