Kyphoplasty for Vertebral Fractures Reduces Pain, Opioid Use

Nancy A. Melville – May 11, 2017

LOS ANGELES — Balloon kyphoplasty shows safety and efficacy in improving quality of life, pain, and functional outcomes, while reducing opioid use, among patients treated for vertebral compression fractures (VCFs), new research suggests.

“We found that all primary endpoints demonstrated statistical improvement and these were maintained or improved throughout a 12-month follow-up,” said first author, John W. Amburgy, MD, a resident with the Department of Neurosurgery at the University of Alabama, Birmingham, in presenting the findings here at the American Association of Neurological Surgeons (AANS) 2017 Annual Meeting.

“Secondary endpoints, including opioid usage, activity, angulation correction, and height  restoration, also showed statistical improvement,” he reported.

In balloon kyphoplasty, a minimally invasive treatment for VCFs caused by bones weakened from osteoporosis or cancer, the compressed bone is gently raised to its normal position and the cavity created is filled with orthopedic cement to stabilize the fracture.

The procedure differs from vertebroplasty only in the use of the balloon approach.

The prospective EVOLVE outcomes analysis, which Dr Amburgy noted is the largest prospective outcomes trial for kyphoplasty to date, involved 350 patients with painful, acute, or subacute VCF who were enrolled at 24 sites and underwent kyphoplasty.

The patients had a mean age of 78 years; 77% were female. All had one to three acute or subacute fractures less than 4 months old. Approximately half (54.9%) had bilateral kyphoplasty.

Most patients had VCF due to osteoporosis (343 of 350), and the remaining cases were due to cancer.

The patients’ average pain scores were greater than 7 on a scale of 1 to 10, and disability on the Oswestry Disability Index (ODI) was greater than 30 on a scale of 0 to 100.

Follow-up data collected at 1-, 3-, 6-, and 12-month time points showed significant improvements in various measures.

 

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CURASAN Bone Graft Foam Debuts In LA Knee Fusion

By JSHAMP – 5-11-2017

A California surgeon has performed the first U.S. bone graft using a pliable foam produced by Research Triangle Park–based medical biomaterials company CURASAN Inc.

Divakar Krishnareddy, M.D., used CURASAN’s CERASORB Ortho Foam bone graft product in a knee fusion procedure, technically called knee arthrodesis, at Los Angeles Community Hospital.

It was the first surgery using CERASORB since the U.S. Food and Drug Administration approved it in December 2016.

“It’s exciting to see a product that has both excellent handling and strong clinical evidence become available in the U.S.A.,” said Krishnareddy. “CERASORB Ortho Foam’s handling is very easy to adapt to underlying anatomy, preventing large gaps while allowing graft placement where you need it.”

 

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Colorado Therapeutics Appoints Medtronic Executive John Lorbiecki as Chief Operating Officer in Advance of XI-S+™ Launch

BROOMFIELD, Colo., May 15, 2017 (GLOBE NEWSWIRE) — Colorado Therapeutics LLC, a commercial-stage medical device company with a proprietary technology platform for the production of innovative cross-linked tissue products, announced that John Lorbiecki has been appointed to the newly created position of chief operating officer effective March 21, 2017. Mr. Lorbiecki brings broad leadership experience from a career at Medtronic in finance, business development and commercial operations to Colorado Therapeutics.

“John’s experience in the areas of marketing, regulatory, reimbursement and financial accounting will be a significant benefit to Colorado Therapeutics as we prepare to launch our first FDA cleared commercial product, XI‑S+™,” stated Joseph B. Horn, Colorado Therapeutics’ president and CEO. “His experience with surgical biologics products is particularly applicable to our product line, which has shown utility in the repair of hernia and other soft tissue applications. We welcome John to our team and look forward to capitalizing on his experience with our impending product launch as well as our open Series A financing.”

“From my experience, I believe that the team at Colorado Therapeutics has developed a truly unique biologic tissue product. The characteristics of XI-S+™ will provide surgeons with a blend of strength, flexibility, and biocompatibility that is not currently available on the market in either synthetic or biologic products,” Mr. Lorbiecki added. “I’ve spent my career at a large, established medical device company. The opportunity to join a nimble, innovative organization at this stage of commercial growth was one I could not pass by.”

During his 25-year career at Medtronic, Mr. Lorbiecki held several positions of increasing responsibility, most recently as Senior Finance Director of Strategic Scientific Operations where he was responsible for developing long-term and annual operating goals, providing business support to clinical, regulatory, reimbursement, and other strategic scientific operations in the company.  Prior to that role, Mr. Lorbiecki held two divisional CFO roles, managed financial integration of multiple acquisitions, and provided analytical and strategic insight on high-value business development opportunities.  During his term, he dedicated six years to managing the development of pricing strategy and tactics for the Cardiac Surgery division, including national accounts.  He earned a MBA from the University of Chicago and a BA in economics from the University of St. Thomas in St. Paul, Minnesota.

About Colorado Therapeutics
Colorado Therapeutics is a commercial-stage company developing strong, durable and biocompatible tissue from xenogenic sources using a proprietary cross-linked tissue processing technology. Resulting tissue products demonstrate superior benefits compared to currently available biologic or synthetic products. XI-S+™, Colorado Therapeutics first commercial product, received U.S. FDA 510(k) clearance in 2016 for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Colorado Therapeutics’ products target the $2.25 billion U.S. soft tissue reinforcement and regeneration markets, and may have utility in a broad range of applications. Colorado Therapeutics’ corporate headquarters and pre-commercialization facilities are located in Broomfield, Colorado. For more information on Colorado Therapeutics technology and career opportunities, please visit the Colorado Therapeutics website at www.co-therapeutics.com.

Eric Schauble, Vice President	
Colorado Therapeutics LLC
(303) 469-9459
eschauble@co-therapeutics.com

Aline Sherwood
Scienta Communications
Telephone: (312) 238-8957
asherwood@scientapr.com 

Primary Logo

 

© GlobeNewswire 2017

Xtant Medical Announces OrbiMed Financing and Engagement of Aurora Management Partners

BELGRADE, Mont., May 12, 2017 (GLOBE NEWSWIRE) — Xtant™ Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced it has entered into an amendment to its senior credit facility with affiliates of OrbiMed Advisors (“OrbiMed”) for a financing of up to $15 million with the proceeds being used to pay off its outstanding balance of approximately $9 million under its accounts receivable credit facility with Silicon Valley Bank (“SVB”) with the remainder for general working capital purposes.  Additionally, OrbiMed has deferred the interest originally due under the senior credit facility January 2, 2017 and March 31, 2017 to June 30, 2017.

Xtant Medical also announced it has entered into an agreement on May 8, 2017 with Aurora Management Partners Inc. to engage David Baker and Wayne Tanner as restructuring officers to assist with day-to-day operations of the company and implementation of an operating business plan. The restructuring officers will report to the special restructuring committee of Xtant Medical’s Board of Directors.

About Xtant Medical Holdings, Inc.

Xtant Medical Holdings, Inc. (NYSE MKT:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof.

Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

 

Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

Arthroscopic Surgery Doesn’t Help With Arthritis Knee Pain

Carmen Heredia Rodriguez, Kaiser Health News – May 11, 2017

An international panel of surgeons and patients has challenged the effectiveness of one of the most common orthopedic procedures and recommended strongly against the use of arthroscopic surgery for patients with degenerative knee problems.

The guidelines, published Wednesday in the journal BMJ, reviewed 13 studies involving nearly 1,700 patients and found the surgery did not provide lasting pain relief or improve function for most of them. Those studies compared the surgery with a variety of options, including physical therapy, exercise and even placebo surgery.

Fewer than 15 percent of patients felt an improvement in pain and function three months after the procedure, and that those effects disappeared after one year, the review found. In addition, the surgery exposed patients to “rare but important harms,” such as infection.

Casey Quinlan, 64, who had the surgery in 2003 and was on the panel issuing the guidelines, said her orthopedist told her the procedure would not only help restore mobility in her knee after a nasty ski accident but also improve her arthritis.

Quinlan, of Richmond, Va., said the procedure did not deliver, since her arthritis remained unchanged. “It was not what I was told to expect,” she says.

In an arthroscopic knee surgery, physicians make several small incisions around the joint and insert a tiny camera that allows them to see inside the knee as well as insert small instruments to correct problems they identify. Often the surgery is performed to remove part of a damaged meniscus, a disc of cartilage that helps cushion the knee.

The panel said meniscal tears “are common, usually incidental findings, and unlikely to be the cause of knee pain, aching or stiffness.”

 

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ConforMIS Reports First Quarter 2017 Financial Results

BILLERICA, Mass., May 10, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are customized to fit each patient’s unique anatomy, announced today financial results for the first quarter ended March 31, 2017.

Q1 Summary:

  • Total revenue of $20.5 million, up 1% year-over-year on a reported basis and up 2% on a constant currency basis
  • Product revenue of $20.4 million, up 2% year-over-year on a reported basis and up 3% on a constant currency basis
    –  U.S. product revenue increased 9% year-over-year
    –  Rest of World product revenue decreased 16% year-over-year on a reported basis and decreased 12% year-over-year on a constant currency basis

“We reported better than expected revenue results in the first quarter of 2017,” said Mark Augusti, President and Chief Executive Officer of ConforMIS, Inc. “Revenue exceeded the mid-point of the first quarter 2017 guidance range in excess of $2 million. Our full year guidance remains unchanged as we work through this year of transition.”

First Quarter 2017 Financial Results

Three months ended March 31, Increase/decrease
($, in thousands) 2017 2016 $
Change
%
Change
%
Change
(as reported) (constant
currency)
United States $   15,964 $   14,708 $   1,256 9 % 9 %
Rest of world   4,415   5,274   (859 ) -16 % -12 %
Product revenue   20,379   19,982   397 2 % 3 %
Royalty revenue   76   268   (192 ) -72 % -72 %
Total revenue $   20,455 $   20,250 $   205 1 % 2 %

Total revenue increased $0.2 million to $20.5 million, or 1% year-over-year on a reported basis and increased 2% on a constant currency basis. Total revenue in the first quarter of 2017 included royalty revenue related to patent license agreements of $0.1 million as compared to $0.3 million in the first quarter of 2016.

Product revenue increased $0.4 million to $20.4 million, or 2% year-over-year on a reported basis and increased 3% on a constant currency basis. U.S. product revenue increased $1.3 million to $16.0 million, or 9% year-over-year, and Rest of World product revenue decreased $0.9 million to $4.4 million, or 16% year-over-year on a reported basis and decreased 12% on a constant currency basis. Product revenue from sales of iTotal CR, iDuo and iUni was $15.3 million for the three months ended March 31, 2017 compared to $17.6 million for the three months ended March 31, 2016, a decrease of $2.3 million, or 13% year-over-year, on a reported basis and 12% on a constant currency basis.  Product revenue from sales of iTotal PS was $5.1 million for the three months ended March 31, 2017 compared to $2.4 million for the three months ended March 31, 2016, an increase of $2.7 million, or 113% year-over-year, on a reported and constant currency basis.

Total gross profit decreased $0.2 million to $6.5 million, or 32% of revenue, in the first quarter of 2017, compared to $6.7 million, or 33% of revenue, in the first quarter of 2016. The decrease in gross margin year-over-year was driven primarily by the impact of foreign currency exchange rate changes and the timing of royalty payments received.

Total operating expenses increased $2.0 million to $23.8 million, or 9% year-over-year. The increase in operating expenses was driven primarily by higher general and administrative expense, including a $1.4 million increase in patent litigation expense and a $0.7 million increase in personnel costs compared to last year.

Net loss was $17.2 million, or $0.40 per basic share, in the first quarter of 2017, compared to a net loss of $15.0 million, or $0.37 per basic share, for the same period last year. The change in first quarter net loss was driven primarily by higher general and administrative expense year-over-year.

As of March 31, 2017, the Company’s cash and cash equivalents and investments totaled $68.5 million, compared to $65.5 million as of December 31, 2016.  As previously announced, in January 2017 the Company secured up to $50 million in term debt financing from Oxford Finance, of which $15 million was borrowed in January.

2017 Financial Guidance

ConforMIS reaffirms the financial guidance provided on February 15, 2017. For the full year 2017, the Company continues to expect total revenue in a range of $80 to $84 million and total gross margin in a range of 36% to 38%.

Note on Non-GAAP Financial Measures

In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain information regarding the Company’s financial results or projected financial results on a non-GAAP “constant currency basis.” This information estimates the impact of changes in foreign currency rates on the translation of the Company’s current or projected future period financial results as compared to the applicable comparable period. This impact is derived by taking the adjusted current or projected local currency results and translating them into U.S. Dollars based upon the foreign currency exchange rates for the applicable comparable period. It does not include any other effect of changes in foreign currency rates on the Company’s results or business. Non-GAAP information is not a substitute for, and is not superior to, information presented on a GAAP basis.

Conference Call

As previously announced, ConforMIS will conduct a conference call and webcast today at 4:30 PM Eastern Time. Management will discuss financial results and strategic matters. To participate in the conference call, please call 877-809-6331 (or 615-247-0224 for international) and use conference ID number 5263799 or listen to the webcast in the investor relations section of the company’s website at ir.conformis.com. The online archive of the webcast will be available on the company’s website for 30 days.

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 450 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about our strategy, future operations, future financial position and results, market growth, total revenue and revenue mix by product and geography, gross margin, operating trends, the potential impact and advantages of using customized implants, and potential transition at the Company as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our revenue, gross margin, expenses, revenue growth, transition and other results of operations, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

CONFORMIS, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share data)
Three Months Ended
March 31
2017 2016
Revenue
Product $   20,379 $   19,982
Royalty   76   268
Total revenue   20,455   20,250
Cost of revenue   13,960   13,586
Gross profit   6,495   6,664
Operating expenses
Sales and marketing   10,816   11,115
Research and development   4,560   4,398
General and administrative   8,458   6,295
Total operating expenses   23,834   21,808
Loss from operations   (17,339 )   (15,144 )
Other income and expenses
Interest income   103   139
Interest expense   (307 )   (25 )
Foreign currency exchange transaction income   390   —
Total other expenses   186   114
Loss before income taxes   (17,153 )   (15,030 )
Income tax provision   7   4
Net loss $   (17,160 ) $   (15,034 )
Net loss per share – basic and diluted $   (0.40 ) $   (0.37 )
Weighted average common shares outstanding – basic and diluted   42,874,743 40,993,485
CONFORMIS, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
(in thousands, except share and per share data)
March 31, 2017 December 31, 2016
 
Assets  (unaudited) 
Current Assets
Cash and cash equivalents $ 36,392 $ 37,257
Investments 27,910 28,242
Accounts receivable, net 13,052 14,675
Inventories 11,383 11,720
Prepaid expenses and other current assets 2,910 3,954
Total current assets 91,647 95,848
Property and equipment, net 15,760 15,084
Other Assets
Restricted cash 762 300
Investments 4,192
Intangible assets, net 684 746
Goodwill 753 753
Other long-term assets 29 79
Total assets $ 113,827 $ 112,810
Liabilities and stockholder’s equity
Current liabilities
Accounts payable $ 5,768 $ 5,474
Accrued expenses 8,875 8,492
Deferred revenue 305 305
Total current liabilities 14,948 14,271
Other long-term liabilities 161 164
Deferred revenue 4,243 4,320
Long-term debt,less debt issuance costs 14,718
Total liabilities 34,070 18,755
Commitments and contingencies
Stockholders’ equity
Preferred stock, $0.00001 par value:
Authorized: 5,000,000 shares authorized at March 31, 2017 and December 31, 2016, respectively, no shares outstanding as of March 31,2017 and December 31, 2016.
Common stock, $0.00001 par value:
Authorized: 200,000,000 shares at March 31, 2017 and December 31, 2016; 43,840,318 and 43,399,547 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively
Additional paid-in capital 480,022 476,486
Accumulated deficit (400,401 ) (382,930 )
Accumulated other comprehensive loss 136 (499 )
Total stockholders’ equity 79,757 94,055
Total liabilities and stockholders’ equity $ 113,827 $ 112,810
CONTACT:    

Investor contact
Oksana Bradley
ir@conformis.com
(781) 374-5598

Alphatec Holdings Reports First Quarter 2017 Financial Results

CARLSBAD, Calif., May 11, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today recent corporate highlights and financial results for first quarter ended March 31, 2017.

First Quarter 2017 Highlights and Recent Accomplishments

Financial Highlights

  • Total net revenues of $28.0 million; revenue from the Company’s U.S. commercial business of $23.4 million
  • U.S. commercial gross margin of 68%
  • Gross proceeds of $18.9 million from private placement
  • Cash balance of $25.5 million at March 31, 2017

Organizational and Product Highlights

  • Completed its seven-person senior leadership team with appointments of Chief Financial Officer and Executive Vice President of Strategic Marketing and Product Development.
  • Initiated transition of sales organization from non-exclusive to dedicated.
  • Added three new Area Vice Presidents with a history of building strong, dedicated distribution channels in spine.
  • Reduced headcount from 195 in September 2016 to approximately 140 today, and implemented cost-control measures, including consolidating the Company’s operations into one building.
  • Completed a limited user release of Arsenal™ Deformity Adolescent Idiopathic Scoliosis (AIS) System, and introduced a limited user release of Battalion™ Lateral System, both which have  been well-received by surgeons.

“We are very pleased with our progress in evolving the Alphatec organization over the past few months,” said Terry Rich, CEO of Alphatec.  “Our strategy for the Company centers on combining our broad product portfolio with new leadership, dedicated distribution partners, and a high-performance culture in order to significantly re-position the Alphatec brand to customers, investors, employees, and business partners. In the short time that our new team has been together, we have taken many important steps to provide a solid base to return Alphatec to a growth organization.”

Financial Results for the First Quarter Ended March 31, 2017

As a result of the sale of the Company’s international business in September 2016, the financial results and related assets and liabilities of the former international business have been excluded from continuing operations for all periods herein and reported as discontinued operations.

U.S. commercial revenues for the first quarter of 2017 were $23.4 million, down 19.8%, compared to $29.2 million reported for the first quarter of 2016. On a sequential basis, U.S. commercial revenues in the first quarter of 2017 were down $1.1 million, or 4.3%, compared to $24.5 million in the fourth quarter of 2016.

These decreases are largely the result of financial and operational challenges the Company faced in 2016, which led to the sale of the Company’s international business in order to sustain operations.  This resulted in a reduction in volume from several distributors and surgeons. Revenue was also impacted by the Company’s decision to exit the stocking distributor and terminate distributor relationships that are not representative of the Company’s long-term business and rebranding strategy.

U.S. gross profit and gross margin for the first quarter of 2017 were $16.0 million and 68.3%, respectively, compared to $23.5 million and 80.6%, respectively, for the first quarter of 2016. Gross margins declined primarily as a result of increased supply costs from reduced sourcing and manufacturing volumes, and an increase in inventory kit write-offs due to distributor turnover.

On a sequential basis, U.S. gross margin of 68.3% in the first quarter of 2017 increased from 62.2% in the fourth quarter of 2016.

Total operating expenses for the first quarter of 2017 were $20.2 million, reflecting a decrease of $7.8 million, an approximate 28% improvement over the first quarter of 2016. On a non-GAAP basis, excluding restructuring charges, total operating expenses in the first quarter of 2017 decreased $8.9 million, or approximately 32%, compared to the first quarter of 2016.  These decreases reflect the impact of cost reduction initiatives, including the workforce reductions the Company implemented in October 2016 and February 2017.

On a sequential basis, total operating expenses in the first quarter of 2017 were down $1.5 million, or approximately 7%, compared to $21.7 million in the fourth quarter of 2016.  On a non-GAAP basis, excluding restructuring charges, total operating expenses in the first quarter of 2017 decreased $2.2 million, or approximately 11%, compared to the fourth quarter of 2016.

GAAP loss from continuing operations for the first quarter of 2017 was $5.4 million, compared to a loss of $4.2 million for the first quarter of 2016, and a loss of $10.2 million for the fourth quarter of 2016.

Adjusted EBITDA in the first quarter of 2017 was $0.5 million, compared to $71,000 in for the first quarter of 2016 and a loss of $2.2 million for the fourth quarter of 2016. Please refer to the table, “Alphatec Holdings, Inc. Reconciliation of Non-GAAP Financial Measures” that follows for more detailed information.

Total Current and Long-term debt, includes $34.2 million in term debt and $10.3 million outstanding under the Company’s revolving credit facility at March 31, 2017. This compares to $34.8 million in term debt and $12.5 million outstanding under the Company’s revolving credit facility at December 31, 2016.

Cash and cash equivalents were $25.5 million at March 31, 2017, compared to $19.6 million reported at December 31, 2016. In March, the Company raised gross proceeds of $18.9 million in a private placement of common stock, Series A Convertible Preferred Stock and warrants exercisable for common stock.

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 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.

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 delivering advancements in spinal fusion technologies.  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 re-positioning 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 clearance or approval or international regulatory approvals 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
March 31,
2017 2016
Revenues $ 27,978 $ 34,206
Cost of revenues 11,199 9,719
Gross profit 16,779 24,487
60.0 % 71.6 %
Operating expenses:
Research and development 1,449 3,641
Sales and marketing 11,103 14,940
General and administrative 6,223 9,004
Amortization of intangible assets 172 255
Restructuring expenses 1,231 89
Total operating expenses 20,178 27,929
Operating loss (3,399 ) (3,442 )
Interest and other expense, net (1,976 ) (783 )
Loss from continuing operations before taxes (5,375 ) (4,225 )
Income tax provision 49 23
Loss from continuing operations (5,424 ) (4,248 )
Loss from discontinued operations (91 ) (2,369 )
Net loss $ (5,515 ) $ (6,617 )
Net loss per share continuing operations $ (0.60 ) $ (0.50 )
Net loss per share discontinued operations (0.01 ) (0.28 )
Net loss per share  – basic and diluted $ (0.61 ) $ (0.78 )
Weighted-average shares – basic and diluted 9,005 8,466

 

ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
March 31, December 31,
2017 2016
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 25,485 $ 19,593
Accounts receivable, net 14,212 18,512
Inventories, net 30,088 30,093
Prepaid expenses and other current assets 2,451 4,262
Current assets of discontinued operations 170 364
Total current assets 72,406 72,824
Property and equipment, net 15,408 15,076
Intangibles, net 5,477 5,711
Other assets 222 516
Noncurrent assets of discontinued operations 58 61
Total assets $ 93,571 $ 94,188
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable $ 4,245 $ 8,701
Accrued expenses 26,173 27,589
Current portion of long-term debt 2,616 3,113
Current liabilities of discontinued operations 293 732
Total current liabilities 33,327 40,135
Total long term liabilities 65,774 71,954
Redeemable preferred stock 23,603 23,603
Stockholders’ deficit (29,133 ) (41,504 )
Total liabilities and stockholders’ deficit $ 93,571 $ 94,188

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
(in thousands, except per share amounts – unaudited)
Three Months Ended
March 31,
2017 2016
Operating loss, as reported $ (3,399 ) $ (3,442 )
Add back:
Depreciation 1,634 2,254
Amortization of intangible assets 234 306
Total EBITDA (1,531 ) (882 )
Add back significant items:
Stock-based compensation 516 58
Stock price guarantee 292 806
Restructuring and other charges 1,231 89
EBITDA, as adjusted for significant items $ 508 $ 71

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF GEOGRAPHIC SEGMENT REVENUES AND GROSS PROFIT
(in thousands, except percentages – unaudited)
Three Months Ended
March 31, % Change
2017 2016
Revenues by source
U.S. commercial revenue $ 23,437 $ 29,233 (19.8 %)
Other 4,541 4,973 (8.7 %)
Total revenues $ 27,978 $ 34,206 (18.2 %)
Gross profit by source
U.S. $ 16,015 $ 23,548
Other 764 939
Total gross profit $ 16,779 $ 24,487
Gross profit margin by source
U.S. 68.3 % 80.6 %
Other 16.8 % 18.9 %
Total gross profit margin 60.0 % 71.6 %

Investor/Media Contact: Nick Laudico or Zack KubowThe 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

Source: Alphatec Holdings, Inc.

Read more: http://www.nasdaq.com/press-release/alphatec-holdings-reports-first-quarter-2017-financial-results-20170511-01491#ixzz4gsX1xShD

Preop Opioid Use Linked to Worse Spine Surgery Outcomes

Nancy A. Melville – May 10, 2017

LOS ANGELES — The preoperative use of opioid analgesics is associated with worse clinical postoperative outcomes at 12-month follow-up of lumbar fusion surgery for degenerative lumbar conditions, new research shows.

“The results suggest the use of opioid medication is a potentially modifiable factor that could be controlled to maximize clinical outcomes,” said first author, Alan T. Villavicencio, MD, from Boulder Neurosurgical Associates, Colorado.

He presented the findings here at the American Association of Neurological Surgeons (AANS) 2017 Annual Meeting.

While a high number of patients with low back pain can be expected to have been prescribed opioid medications for pain, research on the relationship between use of the medications before surgery and lumbar fusion surgery outcomes is lacking.

For the prospective study, Dr Villavicencio and colleagues enrolled 93 patients receiving one- to two-level transforaminal lumbar interbody fusion surgeries for degenerative low back conditions.

Of the patients, who had an average age of 59 years, 60 (64.5%) had preoperatively used prescribed opioids, with an average preoperative dose of 64.4 mg (range, 10 to 270 mg).

Demographic and surgical characteristics did not significantly differ between patients who did and didn’t have preoperative opioid use, with the exception of average symptom duration, which was longer in nonusers (113 months vs 56 months; P = .008).

In the opioid use group, preoperative disability was higher than in nonusers (average Oswestry Disability Index, 40.3 vs 33.7; P = .04) and measures of mental health were lower (Short Form-36 [SF-36] Mental Component Summary [MCS], 42.7 vs 49.2; P = .01).

However, other clinical scores of back and leg pain visual analogue scale and SF-36 Physical Component Summary (PCS) were not statistically different.

 

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SANUWAVE Appoints LOK North America as Territory Sales Manager for Sourcing and Screening of Potential Distributors for Company’s Products in Canada

SUWANEE, GA–(Marketwired – May 11, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company has appointed LOK North America to act as Territory Sales Manager for sourcing and screening of potential distributors for SANUWAVE’s products in Canada.

André Mouton, V.P. International Sales and Relations of SANUWAVE, stated, “This decision to engage LOK North America was made to increase visibility within the Canadian market and to maximize the exposure that SANUWAVE can get for their registered and approved product line in Canada. LOK North America will give us an extended reach and establish rigorous evaluation methods of the regional distribution options in Canada to ensure the development of a strong distribution network. All of these factors will lead to faster market entry and closer ties with identified Key Opinion Leaders (KOL’s),” concluded André Mouton.

Eric Fillion, V.P. Sales and Marketing of LOK North America, stated, “LOK North America is an ideal partner for SANUWAVE by providing both regulatory and commercial support when introducing and expanding the Company’s medical device portfolio in Canada.”

“LOK North America will provide targeted assistance to SANUWAVE with a team of professionals that are dynamic individuals with diversified backgrounds and each having his/her own area of expertise,” continued Mr. Fillion. “Our multidisciplinary approach enables us to offer our services in an integrated and efficient way. Our commercial support expertise, with its in-depth knowledge of the Canadian medical landscape will allow SANUWAVE to have the maximum impact in the shortest time span.”

SANUWAVE is using this occasion to further educate on our lead wound care product dermaPACE®. This Extracorporeal Shockwave Technology (ESWT) device, based upon electrohydraulic principles, is CE Marked and has enjoyed success in certain markets within the European Union treating a wide variety of skin conditions such as pressure ulcers, burns, post-operative wounds, and scar reduction. dermaPACE has been proven, in two US based clinical trials enrolling 336 subjects, to be safe and effective in the treatment of Diabetic Foot Ulcers. Within a few weeks of initial treatment, wounds treated with dermaPACE reduce in area at superior rates compared to control subjects. dermaPACE exhibits superiority in wound area reduction within 12 weeks of initial treatment and exhibits superiority in wound closure within 20 weeks of initial treatment. The use of dermaPACE allows the clinician to more easily, and more cost-effectively, manage wounds. More importantly, the patient’s quality of life improves significantly.

For more information on SANUWAVE’s technology, please read our blog, “Shock This”, on our website at www.sanuwave.com.

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.

About LOK North America
Based out of Laval, Québec, Canada, LOK North America is a member of the LOK Network, which currently maintains 12 offices worldwide and has the combined expertise of over 150 seasoned professionals around the world. The consortium presents global solutions for start-ups, mid-size and multinational companies to accelerate their market entry and the commercialization of their products worldwide. Lok North America is your partner for both regulatory and commercial support when introducing medical devices in Canada. LOK North America has a wealth of expertise and experience advising clients on a range of issues by providing medical devices manufacturers with solutions ranging from market entry strategy, regulatory for Health Canada and FDA, quality system, clinical requirements, distributor identification and selection, distributor agreement negotiations to sales management

Forward-Looking Statements

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

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

CONTACT INFORMATION

  • Millennium Park Capital LLC
    Christopher Wynne
    312-724-7845
    cwynne@mparkcm.com

    SANUWAVE Health, Inc.
    Andre Mouton
    Vice President International Sales and Relations
    +1-678-578-0117 (Office)
    +1-615-823-9907 (Cell)
    +1-678-569-0881(Fax)
    Skype: andre.w.mouton
    Andre.Mouton@sanuwave.com

On the heavier side of the news, American Airlines sued by man ‘cramped’ by obese passengers

By  – May 5, 2017

An Australian man is suing American Airlines, alleging that he suffered serious injuries after being seated next to two passengers he claims were “grossly obese.”

Michael Anthony Taylor, of Wollongong, New South Wales, was flying from Sydney, Australia to Los Angeles in December 2015—a 14-hour journey.

Taylor was seated in the window seat of economy class and, according to court documents, two overweight passengers were seated in his row. According to the lawsuit, the body of the passenger next to Taylor “spilt over and encroached” upon his seat, forcing him to “contort his body into a series of positions including standing up, crouching, keeling and leaning forward,” reports news.com.au.

Though it’s been well over a year since the trip, Taylor, who suffered from a pre-existing spinal curvature, claims that he suffered even more severe back injuries and neck pain, arguing that the uncomfortable plane ride exacerbated his condition.

Taylor’s lawyer, Thomas Jansen of Shine Lawyers, said his client  asked the cabin crew if he could change seats but was reportedly denied re-accommodation requests multiple times.

 

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