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November 14, 2016 OrthoSpineNews

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TransEnterix (NYSE:TRXC) is betting that the haptics technology in its Senhance robot-assisted surgery platform will help it make headway against Intuitive Surgical (NSDQ:ISRG) and its 10-year lead on the market.

CEO Todd Pope told MassDevice.com that the Senhance’s haptics – the system’s ability to convey a sense of touch and resistance to the surgeon – are an important selling point with physicians.

“The 1 thing that they tell us, as far as a feature that they miss the most on robotics, is the sense of feel or touch. When surgeons do open surgery, they rely on their hands and touch a great deal. Even with laparoscopic surgery, they have that tactile feedback. They have none of that with the current robotics systems today,” Pope told us. “Surgeons have told us when they’re dissecting tissue planes, when they’re working around important vessels or organs, often the sense of touch is just as important for them to discern what they want to do next in the surgery as anything else.”

The TransEnterix haptics tech works on the concept of force feedback, he explained. Senhance’s interaction with tissue is fed back as haptic force to the surgeon’s hands. In demos of the system, surgeons are able to knot a suture while blindfolded, Pope said.

“We had so many surgeons that are using the Senhance say that it was enhancing their senses, it was taking their sense of feel, their sense of touch, and, certainly, their sense of sight and really enhancing it,” he said.

 

READ THE REST HERE


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November 11, 2016 OrthoSpineNews

BELGRADE, Mont., Nov. 11, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development, manufacturing and marketing of orthopedic products for domestic and international markets, reminds rights holders that the subscription period for its previously announced rights offering expires at 5:00 PM Eastern Time on Monday, November 14, 2016. The rights offering is for up to 15,000,000 units, each consisting of one share of common stock and one warrant to purchase one share of common stock. The subscription price is $0.75 per unit, and there will be no further adjustments to the subscription price.

If exercising subscription rights through a broker, dealer, bank or other nominee, rights holders should promptly contact their nominee and submit subscription documents and payment for the units subscribed for in accordance with the instructions and within the time period provided by such nominee. The broker, dealer, bank or other nominee may establish a deadline before November 14, 2016 by which instructions to exercise subscription rights, along with the required subscription payment, must be received.

All holders of rights that wish to participate in the rights offering must deliver by mail, hand or overnight courier, a properly completed and signed subscription rights statement, together with payment of the subscription price for both basic subscription rights and any over subscription privilege election, to the Subscription Agent, to be received before 5:00 PM Eastern Time on November 14, 2016. The Subscription Agent is:

Corporate Stock Transfer, Inc.

3200 Cherry Creek Drive South, Suite 430

Denver, Colorado 80209

Under the proposed rights offering, the Company has distributed two non-transferable subscription rights for each share of common stock held, or underlying convertible notes held, on the record date. Each subscription right entitles the holder to purchase one unit at the subscription price of $0.75 per unit. Each unit consists of one share of common stock and one warrant, with each warrant exercisable to purchase one share of common stock at an exercise price of $0.90 for five years from the date of issuance. After the one-year anniversary of issuance, the Company may redeem the warrants for $0.01 per warrant if the volume weighted average price of the Company’s common stock is greater than $2.25 for each of 10 consecutive trading days.

Holders who exercise their subscription rights in full will be entitled, if available, to subscribe for additional units that are not purchased by other shareholders or convertible note holders, on a pro rata basis and subject to ownership limitations.

Xtant Medical has engaged Maxim Group LLC as dealer-manager in the offering. The offering may only be made by means of a prospectus. Questions about the rights offering or requests for copies of the prospectus may be directed to:

Maxim Group LLC

405 Lexington Avenue

New York, NY 10174

Attention: Syndicate Department

Email: syndicate@maximgrp.com

Telephone: (212) 895-3745.

The Company’s registration statement on Form S-1 was declared effective by the U.S. Securities and Exchange Commission (SEC) on October 31, 2016. The prospectus relating to and describing the terms of the rights offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s web site at http://www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Xtant Medical Holdings

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: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our 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
xtant@cg.capital

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

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November 11, 2016 OrthoSpineNews

WALTHAM, Mass., Nov. 10, 2016 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced its financial and operational results for the quarter ended September 30, 2016.

“We continue to execute on our strategy and operating initiatives in the third quarter of 2016.  We have now enrolled more than three-quarters of the 245 patients required to complete our NeoCart Phase 3 clinical trial, and made continued progress on the manufacturing elements of the NeoCart development program.  Enrollment is expected to be completed prior to the end of the second quarter of 2017, and we are preparing for the top-line data in the middle of 2018 and a BLA submission shortly thereafter,” stated Adam Gridley, President and Chief Executive Officer of Histogenics.  “Furthermore, we believe that the financing completed in the third quarter of 2016 was in large part due to our execution over the last year and the recognition of the market opportunity for this important therapy.  We believe we are now funded to our expected top-line Phase 3 data read-out in mid-2018,” continued Mr. Gridley.

Third Quarter 2016 and Recent Highlights

  • NeoCart Phase 3 Clinical Trial Status:  As of November 9, 2016 Histogenics has enrolled 186 of the 245 patients required under the Special Protocol Assessment (SPA) with the United States Food and Drug Administration (the FDA) in its NeoCart Phase 3 clinical trial.  Enrollment trends have remained strong in each of the completed three quarters of 2016 and continue to run ahead of Histogenics’ expectations.  As a result, Histogenics confirms both its year-end enrollment guidance of 190 to 200 patients and its expectations that patient enrollment will be complete by the end of the second quarter of 2017.  As of November 9, 2016, there were 33 sites participating in the clinical trial.
  • Completion of $30 Million Financing:  Histogenics completed a $30 million private placement of common stock, Series A Convertible Preferred Stock and warrants in September 2016.  The financing was led by new healthcare-focused, institutional investors and supported by existing Histogenics investors.  Histogenics believes the financing will enable it to reach its objective of generating top-line data from the ongoing NeoCart Phase 3 clinical trial in the middle of 2018.
  • Additional Progress on NeoCart Critical Raw Materials:  Having reached agreement with the FDA on internally produced collagen in April 2016, and incorporating this material in the ongoing Phase 3 trial beginning in June 2016, Histogenics reached agreement with the FDA in August 2016 regarding the qualification plan for the NeoCart collagen scaffold to its in-house manufacturing facility in Lexington, Massachusetts.  Histogenics is in the process of qualifying those materials to be used upon commercialization of NeoCart, if approved.
  • Additional Discussions with Japanese Regulatory AuthorityDuring the third quarter of 2016, Histogenics continued its dialog with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) regarding the development of NeoCart for the Japanese market.  There were two informal meetings to discuss the NeoCart Phase 1 and Phase 2 data generated to date, the proposed development program and the required regulatory submission package for potential conditional approval.  In the first half of 2017, Histogenics intends to conduct formal meetings with the PMDA to define and agree upon the regulatory pathway and development requirements for the potential conditional approval of NeoCart in Japan.  Histogenics intends to leverage the results of these meetings to create value in discussions with potential partners for the Japanese market.
  • Intrexon Collaboration:  Histogenics and Intrexon Corporation continue to generate compelling proof-of-concept data demonstrating our ability to make iPSC derived chondrocytes as measured by the same cartilage biomarkers as NeoCart.  The partners are currently working on a strategy to engage with the FDA and other regulatory authorities and anticipate the identification of a development plan in the first half of 2017.
  • Expansion of Scientific Advisory Board:  Histogenics recently expanded its Scientific Advisory Board (SAB) with the addition of Professor Lawrence Bonassar, a leading researcher in the field of cartilage biomechanics and tissue engineering, including the structure-property relationships in cartilage to elucidate mechanisms of disease and inform the design of tissue replacement.  Dr. Bonassar is a Professor at Cornell University in the Meinig School of Biomedical Engineering and the Sibley School of Mechanical and Aerospace Engineering.  As part of a Sponsored Research Agreement, Dr. Bonassar’s lab and Histogenics have successfully demonstrated the biomechanical competence of cartilage tissue engineered using the NeoCart manufacturing technology.  The work has resulted in three presentations including one at the Orthopedic Research Society annual meeting in March 2016 and a more recent presentation at the Biomedical Engineering Society Annual Meeting in October 2016.

Financial Results for the Third Quarter of 2016

For the third quarter of 2016, Histogenics reported a loss from operations of $(6.6) million compared to $(8.0) million in the third quarter of 2015.  The decrease in operating expenses was driven by reductions in both research and development and general and administrative expenses.

Research and development expenses were $4.9 million in the third quarter of 2016, compared to $5.8 million in the third quarter of 2015.  The decrease in expense was primarily due to a reduction in consulting and temporary labor costs, hiring fees, and raw materials and patient recruiting expenses related to the NeoCart Phase 3 clinical trial.  This decrease was partially offset by an increase in clinical trial related expenses and facility-related and other expenses in the third quarter of 2016.  General and administrative expenses were $1.8 million in the third quarter of 2016, compared to $2.2 million in the third quarter of 2015.  The decrease was primarily due to a reduction in hiring fees, facility-related costs and legal and consulting costs which were partially offset by an increase in stock-based compensation expense.

For the third quarter of 2016, Histogenics reported a net loss attributable to common stockholders of $(9.2) million, or $(0.70) per share, compared to $(8.1) million, or $(0.61) per share, in the third quarter of 2015.  The increase in net loss attributable to common stockholders is primarily due to accounting charges related to the warrants issued as part of the financing that was completed in September 2016 and was partially offset by the aforementioned reductions in operating expenses.

At September 30, 2016, Histogenics had cash, cash equivalents and marketable securities of $38.0 million, compared to $30.9 million at December 31, 2015.  Histogenics believes its current cash position will fund its operations into the middle of 2018.

Conference Call and Webcast Information

Management will host a conference call on Thursday, November 10, 2016 at 8:30 a.m. EST.  A question-and-answer session will follow Histogenics’ remarks.  To participate on the live call, please dial (877) 930-8064 (domestic) or (253) 336-8040 (international) and provide the conference ID “73416804” five to ten minutes before the start of the call.

A live audio webcast of the presentation will be available via the “Investor Relations” page of the Histogenics website, www.histogenics.com. A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the presentation.

About Histogenics Corporation

Histogenics is a leading regenerative medicine company developing and commercializing products in the musculoskeletal segment of the marketplace.  Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions to treat musculoskeletal-related conditions.  Histogenics’ first investigational product candidate, NeoCart, is currently in Phase 3 clinical development.  NeoCart is an autologous cell therapy designed to treat cartilage defects in the knee using the patient’s own cells.  Knee cartilage defects represent a significant opportunity in the United States, with an estimated 500,000 or more applicable procedures each year. NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage, characteristics not exhibited in other current treatment options.  For more information, please visit www.histogenics.com.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  the timing and success of Histogenics’ NeoCart Phase 3 clinical trial; possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; the sufficiency of Histogenics’ cash resources and the availability of additional financing on commercially reasonable terms; the early stage of development of the technologies on which Histogenics’ channel partnering agreement with Intrexon Corporation is based; the additional expenses that Histogenics will incur in connection with its exclusive channel collaboration agreement with Intrexon Corporation and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, which are on file with the SEC and available on the SEC’s website at www.sec.gov.  Additional factors may be set forth in those sections of Histogenics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, to be filed with the SEC in the fourth quarter of 2016.  In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except share and per share data)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2016 2015 2016 2015
Revenue $ $ $ $
Operating expenses:
Research and development    4,880    5,848    16,260    17,470
General and administrative   1,768   2,191    6,141    6,035
Total operating expenses   6,648   8,039   22,401   23,505
Loss from operations    (6,648 )    (8,039 )    (22,401 )    (23,505 )
Other (expense) income:
Interest expense, net    (20 )    (23 )    (55 )    (111 )
Other expense, net    (130 )    (16 )    (298 )   (59 )
Warrant expense    (3,056 )    (3,056 )
Change in fair value of warrant liability   539   539
Total other expense, net   (2,667 )   (39 )   (2,870 )    (170 )
Net loss $ (9,315 ) $ (8,078 ) $ (25,271 ) $ (23,675 )
Loss attributable to common stockholders – basic and diluted $ (9,234 ) $ (8,078 ) $ (25,197 ) $  (23,675 )
Loss per common share – basic and diluted: $ (0.70 ) $ (0.61 ) $ (1.90 ) $ (1.79 )
Weighted-average shares used to compute loss per common share – basic and diluted:   13,297,546   13,238,997   13,279,833   13,218,765
HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(in thousands, except share and per share data)
  September 30,   December 31,
  2016   2015
Cash and cash equivalents $   37,994 $   30,915
Prepaid expenses and other current assets     201     321
Property and equipment, net   4,263   5,213
Other assets, net     337     337
  Total assets $   42,795 $   36,786
Current liabilities $     7,209 $     6,359
Warrant and other non-current liabilities   31,550     2,229
Total stockholder’s equity     4,036   28,198
  Total liabilities and stockholders’ equity $   42,795 $   36,786
Contact:

Investor Relations
Tel: +1 (781) 547-7909

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November 11, 2016 OrthoSpineNews

COLUMBIA, Md., Nov. 07, 2016 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ:OSIR), a leading regenerative medicine company focused on developing and marketing products for wound care, orthopaedics, and sports medicine, today announced its preliminary revenue estimates for 2014 and 2015 and its anticipated 2016 revenue.

As previously announced, the Company is working diligently to complete the restatement of its 2014 financial statements as soon as possible.  Once that process is complete, the Company expects to transition to a new independent registered accounting firm and begin work on the 2015 financial statements.  The Company has made substantial progress in its work on the restatement and as a result, the Company is now able to provide revenue estimates for these annual periods.

The Company currently estimates that the restatement will result in revenue of $46 to $50 million in 2014, which is less than the previously reported revenue of $58.8 million, and that it expects to report revenue of $85 to $90 million for 2015.   In addition, the Company also announced today that it expects to report revenue for 2016 of $100 to $110 million.

As a result of the ongoing process to complete the restatement, the revenue estimates in this press release are preliminary and subject to revision.  Due to this ongoing work, the Company is not yet able to estimate net income or earnings per share information.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, is a world leader in researching, developing, and marketing regenerative medicine products that improve health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, the Company continues to advance its research and development in biotechnology by focusing on innovation in regenerative medicine – including bioengineering, stem cell research and viable tissue based products.  Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care, including BIO4 ™, Cartiform®, Grafix®, TruSkin and Stravix.  Osiris, Grafix, Cartiform, TruSkin and Stravix are trademarks of Osiris Therapeutics, Inc., and BIO4 is a trademark of Howmedica Osteonics Corp. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Such forward-looking statements include, without limitation, statements regarding the Company’s estimated range of revenues for 2014 and 2015 and its anticipated financial performance for the remainder of this calendar year.  Forward-looking statements are subject to known and unknown risks and uncertainties and could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Several factors could cause actual results to differ materially from those expressed in or contemplated by the forward-looking statements. Such factors include, but are not limited to, the identification of additional errors in the restatement process, changes in the scope or focus of the accounting adjustments, the risk that additional information may arise prior to the expected filing with the SEC of the restated financial statements and the 2015 and 2016 financial statements or subsequent events that would require us to make adjustments. Other risk factors affecting the Company are discussed in detail in the Company’s filings with the SEC, including its Annual Reports on Form 10-K.  Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

For additional information, please contact:



Diane Savoie

Osiris Therapeutics, Inc.

(443) 545-1834

OsirisPR@Osiris.com

Primary Logo

Source: Osiris Therapeutics, Inc.

News Provided by Acquire Media


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November 11, 2016 OrthoSpineNews

RAYNHAM, Mass., Nov. 11, 2016 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), an established medical technology company targeting the $15 billion global hip and knee replacement device market, announces that surgeons have completed more than 10,000 total knee replacements worldwide using the OMNIBotics robotic-assisted total knee replacement technology platform. The OMNIBotics system enables optimized implant placement using robotics driven by OMNI’s proprietary ART™ software. Surgeons can efficiently plan a procedure that is specific to each patient using patented intra-operative 3-D modeling technique that eliminates the need for preoperative CT scans or x-rays and then execute the procedure using the system’s patented robotic cutting guide technology.

The OMNIBotics system is modular and portable with a compact physical footprint, unlike most competitive systems, enabling it to be seamlessly incorporated into a crowded OR. The OMNI ART software is designed for flexibility and customization to any surgeon’s particular approach to total knee replacement, facilitating a reduced learning curve. The software allows for intraoperative adjustments to be made easily, which can contribute to increased operative efficiency and time- savings, as well as the precise alignment of the implant that many surgeons believe can lead to more rapid recovery and a more natural feeling total knee replacement.

“As an early adopter of the OMNIBotics™ system, I am not at all surprised by the fact that a growing number of orthopaedic surgeons are embracing this technology,” said Tod Northrup, D.O., orthopaedic surgeon at Flagler Hospital in St. Augustine, FL. “The results achieved with OMNIBotics in my practice have been consistently excellent for both my patients as well as for the healthcare system. It enables me to perform a truly patient-specific procedure with unparalleled accuracy, providing faster post-operative recovery time and a high level of patient satisfaction in a cost- effective manner.”

OMNI expects the demand for robotic precision in the total knee replacement market to increase dramatically and so is dedicated to designing novel complementary technologies and high- performance implants, making it more cost-effective for healthcare providers to offer to their patients. OMNI’s unique pay-per-procedure model is anticipated to drive easier adoption of the proven robotic-assisted total knee replacement, eliminating the need for a significant capital investment by the hospital.

“When OMNI’s proven APEX Knee™ implant is precisely implanted and aligned by the surgeon with the aid of OMNIBotics technology, the result is a total knee replacement that benefits both the patient and our healthcare system,” said Rick Randall, CEO. “Recent market research estimates that in the next five years, more than 20% of total knee replacement procedures will be performed using robotic assistance. The more than 10,000 successful OMNIBotics total knee procedures thus far are an excellent validation that OMNI continues to lead the way in Robotic- Assisted Total Knee Replacement surgery.”

About OMNI
OMNI is a privately held company with a proprietary robotic platform, OMNIBotics™, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and improve patient care. For more information about OMNI, please visit www.omnils.com.

Forward-Looking Statements
Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms “plans,” “believes” or similar expressions are “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

Contact
Cindy Holloway, Director of Marketing Communications
Phone: (508) 824-2444
cholloway@omnils.com

Logo – http://photos.prnewswire.com/prnh/20161018/429923LOGO

SOURCE OMNIlife science, Inc.


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November 11, 2016 OrthoSpineNews

Express-News Editorial Board – November 11, 2016

Veterans Day is set aside to honor our military veterans, who have served our nation — often at great cost and sacrifice. We celebrate them today and every day of the year. For our soldiers do not just keep us safe. They elevate us.

Tragedy is patient. It can wait and wait, sometimes for days, sometimes for weeks, sometimes for …

Everyone knows that; everyone knows that setbacks, huge and small, are part of life.

But the darkness, the pall of gloom and suffering, hangs over some of us more oppressively, more constantly, than it does others.

Our brave fighting men and women know the feeling.

They live with it every day, and they face the struggle abroad so that we, all of us, do not have to face it at home.

We should honor that sacrifice and commitment every day, but especially today — Veterans Day.

In 1926, Congress adopted a resolution celebrating world peace in the aftermath of World War I, a decree later expanded to honor all veterans.

Although most of us work on this day, it has taken on the fervor of a national holiday, and with good reason — we owe our livelihoods, if not our very existence, to the brave men and women who have fought to preserve our way of life.

“Our veterans left everything they knew and loved and served with exemplary dedication and courage so we could all know a safer America and a more just world,” President Barack Obama said in his Veterans Day proclamation last year. “They have been tested in ways the rest of us may never fully understand, and it is our duty to fulfill our sacred obligation to our veterans and their families.”

 

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November 11, 2016 OrthoSpineNews

SALT LAKE CITY, UT–(Marketwired – Nov 10, 2016) – Amedica Corporation ( NASDAQ : AMDA ), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, today announced financial results for the third quarter ended September 30, 2016.

Recent Company Highlights

  • Decreased year-to-date operational cash burn by 25%
  • Received FDA clearance for Valeo® II Lateral Lumbar interbody fusion device
  • Submitted 510(k) to FDA for new Taurus metals system with first implantation expected by end of the year
  • The first stage of testing of silicon nitride by the CFDA (chinese FDA) has begun and is expected to be completed by January 2017.
  • Submitted materials testing data and clinical data to the Japan PMDA
  • Reduced headcount by 38% which will reduce operating cash burn by about $2 million per year
  • Submitted response to FDA clarifying 510(k) application for composite silicon nitride spacer (C+CSC)

“Despite the decrease in commercial sales this quarter, we are confident with our commercial sales strategy targeted at adding new surgeons and distributors and expanding our sales into new territories,” said Dr. Sonny Bal, Chairman and Chief Executive Officer. “Later this month, we will announce a new sales leader; a seasoned, proven individual with credibility in the spine field.”

“We believe that our silicon nitride ceramic is the best-characterized biomaterial available, and offers a compelling set of advantages, especially for use in spine surgery. Even as we explore strategic development opportunities with external partners, we will remain focused on driving our spine sales,” added Dr. Bal.

Third Quarter 2016 Financial Results

Total product revenue was $3.4 million in the third quarter of 2016 as compared to $4.8 million in the same period of 2015, a decrease of $1.4 million, or 29%. This decrease was due to lower private label sales during the quarter and weaker than expected commercial sales during the final stages of the implementation of the Company’s commercial sales expansion strategy. We expect that our commercial sales expansion strategy will be substantially completed during the fourth quarter with benefits expected to begin during the first quarter of 2017. The decrease in revenue for the third quarter 2016 was also attributable, in part, to continued market pricing pressure and hospital vendor consolidation.

Cost of revenue decreased $0.9 million, or 53%, as compared to the same period in 2015. The decrease in cost of revenue was primarily due to the decline in product sales. Excluding the impact of excess or obsolete inventory for both periods, third quarter 2016 gross margins ended at 82% of total sales, as compared to 73% during the prior year period. The increase in gross margins as a percentage of sales is primarily attributable to lower private label sales, which have lower gross margins, and to a lesser extent, the impact of the medical device excise tax moratorium.

Operating expenses decreased $0.2 million, or 3%, as compared to the same period in 2015. This decline in operating expenses is primarily due to a decrease of $0.5 million in commissions as a result of decreased sales and a $0.3 million decrease in personnel related expenses. This improvements were offset by an increase of $0.6 million in legal expenses.

Net loss for the third quarter 2016 was $4.3 million, compared to a net loss of $10.1 million in the prior-year period. The reduction in net loss was primarily the result of improved gross profit, decreases in operating costs, and improvements in other income (expense).

Adjusted EBITDA, which is defined as earnings before deductions for interest, taxes, depreciation, amortization, non-cash stock compensation expense, change in fair value of derivative liabilities, offering costs, loss on extinguishment of derivative liabilities and loss on extinguishment of debt for the third quarter 2016 was a loss of $2.7 million, compared to a loss of $2.2 million for the third quarter 2015.

Cash and cash equivalents totaled $10.6 million as of September, 2016. Operating cash burn decreased to $5.3 million for the nine months ended September 30, 2016 as compared to $7.1 million the prior year period, or 25%. Total principal debt obligations were $9.0 million as of September 30, 2016, a decrease of $1.8 million from September 30, 2015.

Conference Call

The Company will hold an investor conference call to discuss the financial results on Thursday November 10, 2016 at 5:00 PM Eastern Time. The Company invites all interested parties to join the call by dialing Toll Free 877-524-8416, any time after 4:50 p.m. Eastern Time on November 10th. The Conference ID number is 13649236. International callers should dial 412-902-1028. For those who are not available to listen to the live webcast, a digital replay will be archived on the investor relations section of the Amedica website under News/Events.


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November 11, 2016 OrthoSpineNews

November 10, 2016

PARSIPPANY, N.J.–(BUSINESS WIRE)–Fidia Pharma USA Inc., a wholly owned subsidiary of Fidia Farmaceutici S.p.A. a worldwide leader in the research development and manufacturing of HA based products, has announced that the Center for Medicare & Medicaid Services (“CMS”) has assigned its product HYMOVIS® a unique Healthcare Common Procedure Coding System (“HCPCS”) code, or J-Code. The new J-Code provides reimbursement coding to healthcare professionals that administer HYMOVIS® and becomes effective on January 1, 2017.

“HYMOVIS® is a true innovation in HA viscosupplementation. Its unique molecular structure results in enhanced biomechanical properties and long-lasting efficacy, all in a convenient two-dose regimen,” said Aldo Donati, President, Fidia Pharma USA Inc. “We are excited that the CMS has issued a unique J-Code for HYMOVIS®. This will facilitate reimbursement and ensure greater access to this unique viscoelastic technology.”

HYMOVIS® is a highly viscoelastic, non-crosslinked hydrogel bioengineered using a proprietary process that increases lubrication and shock absorption properties and results in a natural hyaluronan similar to the hyaluronan found in the synovial fluid present in human joints. The formulation allows this unique molecule to recover its original structure, even after repetitive mechanical stress. Due to reversible hydrophobic interactions, the non-crosslinked HYMOVIS® has increased elasticity, viscosity and residence time in the joint.*

About Fidia Pharma USA Inc.

Fidia Pharma USA Inc is a wholly-owned subsidiary of Italian pharmaceutical manufacturer Fidia Farmaceutici S.p.A., an established leader in the hyaluronic acid market segment.
Fidia Pharma USA Inc. is focused on expanding Fidia’s position in the U.S. and Canadian market, while upholding the company’s mission to provide consumers with innovative products that offer quality, safety and performance. Fidia Pharma USA Inc. is headquartered in Parsippany, NJ.
For more information, please visit www.fidiapharma.us.

About Fidia Farmaceutici S.p.A.

Fidia Farmaceutici S.p.A. is an Italian pharmaceutical company founded in 1946. It is a leader in research and marketing hyaluronic acid-based products, with several applications in the biomedical field, such as rheumatology, orthopaedics, surgery, wound care, tissue repair and dermo-aesthetics. Fidia Farmaceutici is part of the P&R Holding group. The company is located in Italy, with R&D facilities in Abano Terme (Padua) and Noto (Sicily). Fidia has more than 700 employees, and its revenue exceeds €250 million euros. Fidia Farmaceutici S.p.A.’s products are marketed in more than 100 countries, through wholly owned subsidiaries and a comprehensive network of international partnerships and distributors. Thanks to its investment in research, it has created a legacy of products with more than 600 patents to its name. For more information, please visit www.fidiapharma.com.

HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics. HYMOVIS® is contraindicated in patients with known hypersensitivity to hyaluronate preparations or gram positive bacterial proteins or patients with infections/skin diseases in the area of the injection site/joint. The safety and effectiveness of HYMOVIS® has not been tested in pregnant women, nursing mothers or children. See package insert for full prescribing information including adverse events, warnings, precautions, and side effects at www.Hymovis.com.

HYMOVIS and HYADD 4 are registered trademarks of Fidia Farmaceutici S.p.A., Abano, Terme, Italy. ©2016 Fidia Pharma USA Inc., Parsippany, NJ, a wholly owned subsidiary of Fidia Farmaceutici S.p.A. FID445-11.2016

*Preclinical studies may not be indicative of human clinical outcomes.

Rx Only

Contacts

Fidia Pharma USA Inc.
Carolyn Kong, 973-507-5120
ckong@fidiapharma.us


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November 11, 2016 OrthoSpineNews

LEESBURG, Va., Nov. 10, 2016 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (“K2M” or the “Company”), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced an offering of 4,500,000 shares of its common stock by affiliates of Welsh, Carson, Anderson & Stowe XI, L.P. (the “selling stockholders”). The offering is expected to close on or about November 17, 2016, subject to customary closing conditions. In addition, the underwriter has a 30-day option to purchase up to 675,000 additional shares of common stock from the selling stockholders on a pro rata basis.

The Company will not receive any proceeds from the sale of shares of common stock in the offering, including from any exercise by the underwriter of its option to purchase additional shares from the selling stockholders.

Wells Fargo Securities, LLC will act as the sole book-running manager and underwriter for the offering.  Wells Fargo Securities, LLC proposes to offer the shares of common stock from time to time to purchasers directly or through agents, or through brokers in brokerage transactions on the Nasdaq Global Select Market, or to dealers in negotiated transactions or in a combination of such methods of sale, at a fixed price or prices, which may be changed, or at market prices prevailing at the time of sale, at prices related to such prevailing market prices or at negotiated prices.

Following the offering, the selling stockholders will continue to beneficially own 9,486,263 shares, or approximately 22.5%, of K2M’s outstanding common stock after giving effect to the offering (or 8,811,263 shares, or approximately 20.9%, if the underwriter fully exercises its option to purchase additional shares from the selling stockholders).

A registration statement (including a prospectus) relating to these securities has been filed with the U.S. Securities and Exchange Commission (the “SEC”) and has become effective.  Before you invest, you should read the prospectus in that registration statement and other documents filed with the SEC for more information about the Company and this offering.  You may obtain these documents free of charge by visiting the SEC’s website at www.sec.gov. A copy of the prospectus supplement and the accompanying prospectus related to the offering may be obtained from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue New York, New York 10152 or by telephone at: 800-326-5897 or email at: cmclientsupport@wellsfargo.com.

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

About K2M Group Holdings, Inc.

K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the company to favorably compete in the global spinal surgery market.

Forward-Looking Statements

This press release contains forward-looking statements that reflect our current views with respect to, among other things, our operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects, including with respect to our international distribution partners in Australia and Japan. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability; our ability to successfully demonstrate the merits of our technologies; pricing pressure from our competitors, hospitals and changes in third-party coverage and reimbursement; competition and our ability to develop and commercialize new products; aggregation of hospital purchasing from collaboration and consolidation; hospitals and other healthcare providers may be unable to obtain adequate coverage and reimbursement for procedures performed using our products; the safety and efficacy of our products is not yet supported by long-term clinical data; our dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; the proliferation of physician-owned distributorships; concentration of sales from a limited number of spinal systems or products that incorporate these technologies; loss of the services of key members of our senior management, consultants or personnel; ability to enhance our product offerings through our research and development efforts; failure to properly manage our anticipated growth; acquisitions of or investments in new or complementary businesses, products or technologies; ability to train surgeons on the safe and appropriate use of our products; requirements to maintain high levels of inventory; impairment of our goodwill or intangible assets; disruptions in our information technology systems; any disruption or delays in operations at our facilities, including our new headquarter facility; or an ability to ship a sufficient number of our products to meet demand; ability to strengthen our brand; fluctuations in insurance cost and availability; extensive governmental regulation in the United States and foreign jurisdictions; failure to obtain or maintain regulatory approvals and clearances; requirements for new 510(k) clearances, premarket approvals or new or amended CE Certificates of Conformity; medical device reporting regulations in the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; a recall of our products; withdrawal or restrictions on our products or the discovery of serious safety issues with our products; possible enforcement action if we engage in improper marketing or promotion of our products; the misuse or off-label use of our products; delays or failures in any future clinical trials; the results of clinical trials; procurement and use of allograft bone tissue; environmental laws and regulations; compliance by us or our sales representatives with FDA regulations or fraud and abuse laws; U.S. legislative or regulatory healthcare reforms; medical device tax provisions in the healthcare reform laws; our need to generate significant sales to become profitable; potential fluctuations in sales volumes and our results of operations may fluctuate over the course of the year; uncertainty in our future capital needs; failure to comply with the restrictions in our revolving credit facility; continuing worldwide economic instability; our inability to protect our intellectual property rights; our reliance on patent rights that we either license from others or have obtained through assignments; our patent litigation; the outcome of potential claims that we, our employees, our independent sales agencies or our distributors have wrongfully used or disclosed alleged trade secrets or are in breach of non-competition or non-solicitation agreements with our competitors; potential product liability lawsuits; operating risks relating to our international operations; foreign currency fluctuations; our ability to comply with the Foreign Corrupt Practices Act and similar laws associated with our activities outside the United States; possible conflicts of interest with our large shareholders; increased costs and additional regulations and requirements as a result of becoming a public company; our ability to implement and maintain effective internal control over financial reporting in the future; the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. 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.

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA
443-213-0500

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November 11, 2016 OrthoSpineNews

LOGAN, Utah, Nov. 10, 2016 /PRNewswire/ — KATOR, a start-up medical device company focused on advanced tissue-to-bone reattachment systems, announces that it begun a limited product launch of its KATOR Suture Anchor System and the completion of the first surgical case.

The first surgical case using the KATOR Suture Anchor System was an Achilles tendon reattachment procedure performed by Dr. Charles L. Saltzman, Chairman of the Department of Orthopaedics at the University of Utah.  The case utilized two KATOR suture anchors made from PEEK material and four strands of 2mm wide high strength suture tape in conjunction with a transosseous suture routing technique.  The resulting knotless repair construct provided excellent coaptation of the tendon to the bone with no anchors under the tendon to impede healing and no suture knots to cause soft tissue irritation.

“The KATOR Suture Anchor System allows me to create a repair construct similar to double row repair techniques but with a single row of anchors placed with better soft tissue coverage than alternatives,” stated Dr. Saltzman.  Dr. Saltzman continues, “The ability to independently tension each suture strand after placing the anchors in the bone allows me to achieve a more controlled final repair construct, and the transosseous technique holds the potential for better biological healing, better mechanical stability and reduced cost.”

The KATOR Suture Anchor System represents a new paradigm in tissue-to-bone reattachment.  The system combines a transosseous technique with knotless suture anchor fixation to provide repair constructs with superior strength compared to currently marketed suture anchors (data on file). Because of this superior strength, surgeons can repair torn rotator cuffs or reattach Achilles tendons using fewer suture anchors, preserving more bone, increasing the “footprint” area and increasing the blood flow available for tendon healing.

KATOR is a medical device company incubated and operated by Surgical Frontiers.

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use.  Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Lane Hale
Executive Vice President
132682@email4pr.com
www.surgicalfrontiers.com
800-230-3710

SOURCE KATOR, LLC

Related Links

http://www.surgicalfrontiers.com