materialise-HQ-1050x525.jpg

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.

 

READ THE REST HERE

Read More
davinci1.jpg

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.

READ THE REST HERE

Read More
price.jpg

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.

 

READ THE REST HERE

Read More
financial-1-1.jpg

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

Read More
NuVasive_1_Full.jpg

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.

Related Links

http://www.nuvasive.com

Read More
4-pennsylvania-1.jpg

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.

 

READ THE REST HERE

Read More
1-3.jpeg

Camber Spine Technologies Announces FDA Clearance And National Launch Of SPIRA™ Open Matrix ALIF

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

WAYNE, Pa., Aug. 15, 2017 /PRNewswire/ — Camber Spine Technologies announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SPIRA™ Open Matrix ALIF device, a unique, interbody fusion implant consisting of spiral support arches and Surface by Design™ technology.  This clearance marks Camber’s tenth line of spinal implant systems to be released in the US market.

SPIRA™ was designed specifically to increase fusion rates and stabilization. The spiral support arches decrease subsidence by load sharing over the entire endplate, while also maximizing bone graft capacity. The Surface by Design™ technology is a deliberately designed roughened surface that facilitates bone growth through an optimized pore diameter, strut thickness and trabecular pattern.

“Camber Spine is very excited to be launching our first in a series of spinal implants using 3D printed – additive manufacturing. This specialized manufacturing technology allows us to create these truly unique patented structures featuring open arched matrices and proprietary surfaces designed to enhance fusion and promote bone growth. In the coming months we will be launching a series of five SPIRA™ spinal interbody cages for cervical, lateral, and posterior lumbar spine. Extremity implants and custom implants for salvage and complex deformity implants are also under development.”

“We believe that the addition of SPIRA™ and ENZA™ MIS Integrated interbody devices to our product portfolio create a foundation of patented implant solutions that will drive the growth of Camber Spine.”  

–Daniel Pontecorvo, CEO Camber Spine

The Camber Spine SPIRA™ Open Matrix ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. SPIRA™ Open Matrix ALIF is intended to be used with additional FDA-cleared supplementary fixation systems.

About Camber Spine

Camber Spine Technologies, LLP, is a medical device company focused on the design, development and commercialization of innovative and proprietary musculoskeletal implant systems. The company is committed to delivering surgeon inspired new technologies to the spine market.  Camber Spine, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine.

All of Camber Spine’s products are proudly MADE IN THE USA.

If you would like more information about this topic, please contact Mindy Elgart, Marketing Director at 484.420.4671 or email at melgart@cambermedtech.com

SOURCE Camber Spine Technologies

Related Links

http://cambermedtech.com

Read More
1-2.jpeg

Renovis® Surgical Receives FDA Clearance for 3D-Printed Posterior Lumbar Interbody Fusion Systems

Posted On August 14, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

REDLANDS, Calif., Aug. 11, 2017 /PRNewswire/ — Renovis Surgical Technologies, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market posterior lumbar Tesera® porous titanium interbody fusion systems.

These systems feature implants for direct posterior (PLIF) or transforaminal (TLIF) approaches in both straight and curved options. Multiple heights, widths and lengths are available to better fit varying patient anatomies. All Tesera implants are produced through additive manufacturing (3D printing) and the company’s proprietary Tesera Trabecular Technology®, a highly porous structure that allows for bone attachment to implant surfaces and the potential for biologic fixation deep into the pore structure for long-term stability.

This is the fifth product group featuring the Tesera porous titanium structure for which Renovis Surgical has received FDA clearance; the Tesera SA system for stand-alone anterior spinal fusion was cleared by the FDA in October of 2013, the Tesera acetabular system for total hip reconstruction was cleared in April of 2014, the first-generation Tesera posterior lumbar interbody family was cleared in March of 2015, and the Tesera SC system for stand-alone anterior cervical fusion was cleared in March of 2016.

For more information on the Tesera® porous structure, visit: www.teseratrabeculartechnology.com.

About Renovis Surgical
Renovis Surgical Technologies, Inc. was founded in 2009 with the express mission of creating the highest quality implants for orthopedics, spine and trauma. The company is headquartered in Redlands, California.

For additional information on the Company, please visit www.renovis-surgical.com.

 

SOURCE Renovis Surgical Technologies, Inc.

Related Links

http://www.renovis-surgical.com

Read More
5818-Building_CRW_4599-509x400.jpg

Alphatec Holdings, Inc. Reports Second Quarter 2017 Financial Results

Posted On August 14, 2017 By OrthoSpineNews In Financial /  

CARLSBAD, Calif., Aug. 10, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“Alphatec” or the “Company”) (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, announced today recent corporate highlights and financial results for its second quarter ended June 30, 2017.

Second Quarter 2017 Financial Highlights

  • Total revenues of $24.4 million; revenue from the Company’s U.S. commercial business of $21.9 million
  • General and administrative expenses declined by approximately $0.9 million sequentially
  • Cash burn improved to $6.4 million from $11.5 million sequentially; cash balance of $19.1 million at June 30, 2017
  • Operating loss of $0.7 million, sequential improvement from $3.4 million in the first quarter
  • Non-GAAP adjusted EBITDA of $1.2 million improved sequentially from $0.5 million in the first quarter
  • U.S. commercial gross margin of 71%

Organizational and Product Highlights

  • Continued transition of sales organization from non-exclusive to dedicated, building exceptional momentum with current and new potential distributors and surgeons. Sales from dedicated sales agents and distributors increased from less than 15% of U.S. commercial revenue in the first quarter to more than 18% in the second quarter
  • Enhanced sales, marketing and product development organizations with the addition of key sales leadership and engineering talent
  • Awarded patent for its innovative and novel uniplanar and monoaxial screws, currently marketed under the Arsenal Deformity product line
  • Awarded patent that distinguishes and protects proprietary features of the Alphatec Squadron Lateral Retractor, a key component of the Company’s Battalion Lateral System, which will be fully launched in late 2017 and will mark the Company’s entry into the $500M U.S. Lateral market

“We delivered results that were firmly in-line with our expectations,” said Terry Rich, CEO of Alphatec.  “Importantly, we continued to make excellent progress executing on our priorities as we reposition the Alphatec brand. Despite our deliberate decision to disrupt short-term revenue by exiting non-strategic relationships, we continue to see positive traction from new and existing distributors. This sets us up well for revenue growth in the second half of 2017.  I am extremely confident in the team, the culture we are building, and the expertise that surrounds me, and I believe that Alphatec is exceptionally well-positioned to drive future growth and shareholder value.”

Comparison of Financial Results for the Second Quarter 2017 to First Quarter 2017

Following is a table, comparing key second quarter 2017 results to key first quarter 2017 results.  The Company believes that sequential results, at this time, are the best indicators for evaluating the Company’s core performance. These are the comparisons management uses in its own evaluation of continuing operating performance, given the re-focus of the Company’s strategy under Alphatec’s new leadership team.

Three Months Ended Change
June 30, 2017 March 31, 2017 $000’s %
(unaudited)
U.S. commercial revenue $   21,877 $   23,437 $   (1,560 ) (6.7 %)
U.S gross profit   15,521   16,269   (748 ) (4.6 %)
U.S. gross margin 70.9 % 69.4 % 1.5 %
Operating Expenses
  Research and development $   990 $   1,449 $   (459 ) (31.7 %)
  Sales and marketing   10,298   11,103   (805 ) (7.3 %)
  General and administrative   5,351   6,223   (872 ) (14.0 %)
  Amortization of intangible assets   172   172   –
  Restructuring expenses   528   1,231   (703 ) (57.1 %)
  Gain on sale of assets   (856 )   –   (856 )
    Total operating expenses $   16,483   20,178 $   (3,695 ) (18.3 %)
Operating loss $   (735 ) $   (3,399 ) $   2,664 78.4 %
Loss from continuing operations $   (2,629 ) $   (5,424 ) $   2,795 51.5 %
Non-GAAP Adjusted EBITDA $   1,218 $   508 $   710 139.8 %

U.S. commercial revenues for the second quarter of 2017 were $21.9 million, down $1.6 million, or approximately 7%, compared to $23.4 million in the first quarter of 2017.  The sequential revenue decline was largely driven by deliberate decisions to discontinue non-strategic relationships.

U.S. gross profit and gross margin for the second quarter of 2017 were $15.5 million and 70.9%, respectively, compared to $16.3 million and 69.4%, respectively, for the first quarter of 2017. The gross margin improvement was a result of supply chain optimization and a sequential reduction in inventory kit write-offs related to distributor turnover.

Total operating expenses for the second quarter of 2017 were $16.5 million, reflecting a decrease of $3.7 million, an approximate 18% improvement over the first quarter of 2017.  On a non-GAAP basis, excluding restructuring charges and a gain on sale of assets, total operating expenses in the second quarter of 2017 improved $2.1 million, or approximately 11%, compared to the first quarter of 2017. The improvements reflect the execution of operational improvement initiatives, including workforce reductions implemented in October 2016 and February 2017, consolidation of facilities, and ongoing successful efforts to reduce expenses.

GAAP loss from continuing operations for the second quarter of 2017 was $2.6 million, compared to a loss of $5.4 million for the first quarter of 2017.

Non-GAAP Adjusted EBITDA in the second quarter of 2017 was $1.2 million, compared to $0.5 million in the first quarter of 2017.  For more detailed information, please refer to the table, “Alphatec Holdings, Inc. Reconciliation of Non-GAAP Financial Measures” that follows.

Current and Long-term debt includes $33.6 million in term debt and $8.9 million outstanding under the Company’s revolving credit facility at June 30, 2017. This compares to $34.2 million in term debt and $10.4 million outstanding under the Company’s revolving credit facility at March 31, 2017.

Cash and cash equivalents were $19.1 million at June 30, 2017, compared to $25.5 million reported at March 31, 2017.

Comparison of Financial Results for the Three and Six Months Ended June 30, 2017 and 2016

Revenue decreased on a year-over-year basis, resulting from the Company’s execution of the transition of its sales organization, in addition to the impact of lost revenue related to the financial and operational challenges the Company faced in 2016 prior to the sale of its international business.  The year-over-year improvement in operating expenses is the result of a comprehensive initiative to reduce costs and drive operational efficiencies.  For additional information, please reference the following financial statement tables and the Company’s Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission on August 11, 2017.

Non-GAAP Information

To supplement the Company’s financial statements presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company reports certain non-GAAP financial measures such as Adjusted EBITDA.  Adjusted EBITDA included in this press release is a non-GAAP financial measure that represents net income (loss), excluding the effects of interest, taxes, depreciation, amortization, stock-based compensation expenses, and other non-recurring income or expense items, such as sale of assets, impairments, restructuring expenses, severance expenses and transaction-related expenses.  The Company believes that non-GAAP Adjusted EBITDA provides investors with an additional tool for evaluating the Company’s core performance, which management uses in its own evaluation of continuing operating performance, and a baseline for assessing the future earnings potential of the Company.  For completeness, management uses non-GAAP Adjusted EBITDA in conjunction with GAAP earnings and earnings per common share measures.  The Company’s Adjusted EBITDA measure may not provide information that is directly comparable to that provided by other companies in the Company’s industry, as other companies in the industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. Adjusted EBITDA should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.   Included below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

Investor Conference Call

Alphatec will hold a conference today at 1:30 p.m. PT / 4:30 p.m. ET to discuss the results. The dial-in numbers are (877) 556-5251 for domestic callers and (720) 545-0036 for international callers. The conference ID number is 57049951. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at www.alphatecspine.com.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, Inc., is a medical device company that designs, develops, 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 providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.

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. The Company 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 the references to the Company’s strategy in significantly repositioning the Alphatec brand and turning the Company into a growth organization.  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:  the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. 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.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and periodic reports, filed with the  Securities and Exchange Commission. 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.

ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
  (in thousands, except per share amounts – unaudited) 
Three Months Ended Six Months Ended
June 30, June 30,
2017 2016 2017 2016
Revenues $   24,379 $   32,242 $   52,357 $   66,448
Cost of revenues   8,631   11,083   19,830   20,802
Gross profit 15,748 21,159 32,527 45,646
Operating expenses:
  Research and development   990   2,072   2,439   5,713
  Sales and marketing   10,298   12,794   21,401   27,734
  General and administrative 5,351 6,274 11,574 15,278
  Amortization of intangible assets 172 255 344 510
  Restructuring expenses   528   84   1,759   173
  Gain on sale of assets   (856 )   –   (856 )   –
    Total operating expenses 16,483 21,479 36,661 49,408
Operating loss (735 ) (320 ) (4,134 ) (3,762 )
  Interest and other expense, net (1,879 ) (1,578 ) (3,855 ) (2,361 )
Loss from continuing operations before taxes (2,614 ) (1,898 ) (7,989 ) (6,123 )
  Income tax provision   15   11   64   34
Loss from continuing operations   (2,629 )   (1,909 )   (8,053 )   (6,157 )
Loss from discontinued operations   (68 )   (3,324 )   (159 )   (5,693 )
Net loss $   (2,697 ) $   (5,233 ) $   (8,212 ) $   (11,850 )
Net loss per share continuing operations $   (0.24 ) $   (0.22 ) $   (0.80 ) $   (0.73 )
Net loss per share discontinued operations   (0.01 )   (0.39 )   (0.02 )   (0.67 )
Net loss per share  – basic and diluted $   (0.24 ) $   (0.62 ) $   (0.82 ) $   (1.40 )
Weighted-average shares – basic and diluted 11,047 8,488 10,033 8,477
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands) 
June 30, December 31,
2017 2016
(unaudited)
ASSETS
Current assets:
 Cash and cash equivalents $   19,107 $   19,593
 Accounts receivable, net 13,126 18,512
 Inventories, net 29,810 30,093
 Prepaid expenses and other current assets 2,114 4,262
 Current assets of discontinued operations 69 364
Total current assets 64,226 72,824
Property and equipment, net 14,467 15,076
Intangibles, net 5,243 5,711
Other assets 222 516
Noncurrent assets of discontinued operations 39 61
Total assets $   84,197 $   94,188
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
 Accounts payable $   2,861 $   8,701
 Accrued expenses 23,917 27,589
 Current portion of long-term debt 2,333 3,113
 Current liabilities of discontinued operations 464 732
Total current liabilities 29,575 40,135
 Total long term liabilities   62,569   71,954
 Redeemable preferred stock   23,603   23,603
 Stockholders’ deficit   (31,550 )   (41,504 )
Total liabilities and stockholders’ deficit $   84,197 $   94,188

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
(in thousands – unaudited) 
Three Months
Ended		 Three Months Ended Six Months Ended
March 31, June 30, June 30,
2017 2017 2016 2017 2016
Operating loss, as reported $   (3,399 ) $   (735 ) $   (320 ) $   (4,134 ) $   (3,762 )
Add back:
  Depreciation   1,634   1,636   1,775   3,270   4,029
  Amortization of intangible assets   234   234   270   468   540
Total EBITDA (1,531 ) 1,135 1,725 (396 ) 807
Add back significant items:
 Stock-based compensation and stock price guarantee   808   411   659   1,219   1,523
 Restructuring and other charges   1,231   528   84   1,759   173
 Gain on sale of assets   –   (856 )   –   (856 )   –
EBITDA, as adjusted for significant items $   508 $   1,218 $   2,468 $   1,726 $   2,503

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF GEOGRAPHIC SEGMENT REVENUES AND GROSS PROFIT
(in thousands, except percentages – unaudited) 
Three Months Ended Six Months Ended
June 30, June 30,
2017 2016 2017 2016
Revenues by source
U.S. commercial revenue $   21,877 $   28,279 $   45,314 $   57,512
Other 2,502 3,963 7,043 8,936
Total revenues $   24,379 $   32,242 $   52,357 $   66,448
Gross profit by source
U.S. $   15,521 $   20,251 $   31,790 $   43,974
Other   227   908   737   1,672
Total gross profit $   15,748 $   21,159 $   32,527 $   45,646
Gross profit margin by source
U.S. 70.9 % 71.6 % 70.2 % 76.5 %
Other 9.1 % 22.9 % 10.5 % 18.7 %
Total gross profit margin 64.6 % 65.6 % 62.1 % 68.7 % 
Investor/Media Contact:

Zack Kubow
The Ruth Group
(646) 536-7000
alphatec@theruthgroup.com

Company Contact:

Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc. 
(760) 431-9286
jblack@alphatecspine.com
Read More
58eea12baf69d159faa38de1_Patent-4.jpg

Expanding Orthopedics Inc. Granted Two Additional US Patents in the Expandable Interbody Domain

Posted On August 14, 2017 By OrthoSpineNews In Regulatory, Spine /  

OR-AKIVA, Israel, August 14, 2017 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is excited to announce that it has been granted two additional US Patents by the USPTO covering its unique and diverse expandable cage technology, strengthening its position in the expandable devices’ fast growing market.

Dr. Mark M. Levy, an orthopedic surgeon, founder and CTO of EOI, said that “these new patents recognize the innovation of our expandable cage technology and proprietary instruments”. He explained that “the company was founded on the principal of providing innovative, simple to use, products that will benefit both patients and surgeons. These new granted patents continue to fulfil our guiding principal with simple and cleaver instrumentation design and the addition of a new expandable platform, already in development, offering novel expanding mechanism and bone grafting solution as well as great versatility in the type of surgery approaches”.

Mr. Ofer Bokobza, EOI’s CEO, noted that “These new patents strengthen our IP portfolio of anatomically fit expandable devices and demonstrate our continuous commitment to innovation. We aim to deliver state-of-the-art devices reinforcing our position as a fast growing, expandable devices’ spine company.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by seasoned management team, and is advised by prominent spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through MIS approach.

Contact info:
David Elkaim, VP Marketing and Sales
E-mail: david@xortho.com
Phone: (347)-321-9683

Read More