16 November 2016

BELGRADE, Mont., Nov. 17, 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, announced today the closing of its rights offering (the “Offering”) of units at a subscription price of $0.75 per unit, for aggregate gross proceeds to the Company of approximately $3.8 million.

Pursuant to the Rights Offering, Xtant sold an aggregate of 5,055,345 units consisting of a total of 5,055,345 shares of common stock and 5,055,345 warrants, with each warrant exercisable to purchase one share of common stock an exercise price of $0.90 for five years from the date of issuance. The warrants are anticipated to commence trading on the OTCBB under the symbol “XTNTW” as early as Wednesday, November 23, 2016.

Maxim Group LLC acted as sole dealer manager for the Offering.

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

Company Contact
Xtant MedicalMolly Mason
mmason@xtantmedical.com

By Sandra G. Boodman,  November 14, 2016

They are a little-known presence in many operating rooms, offering technical expertise to surgeons installing new knees, implanting cardiac defibrillators or performing delicate spine surgery.

Often called device reps — or by the more cumbersome and less transparent moniker “health-care industry representatives” — these salespeople are employed by the companies that make medical devices: Stryker, Johnson & Johnson and Medtronic, to name a few. Their presence in the OR, particularly common in orthopedics and neurosurgery, is part of the equipment packages that hospitals typically buy.

Many “people who don’t work in health care don’t realize that industry reps are sometimes in the OR,” said Josephine Wergin, a risk management analyst for the ECRI Institute, a Pennsylvania nonprofit that conducts research on medical subjects for the health-care industry. “A lot of times they are the real experts on their products.”

Unlike rotating teams of nurses and surgical techs, reps are a consistent presence, experts say, often functioning as uber-assistants to surgeons with whom they cultivate close relationships and upon whom their six-figure salaries depend.

Although they don’t scrub in, reps are expected to be intimately familiar with the equipment they sell, making sure it is at the ready for the surgeon and poised to answer technical questions.

But how much influence do reps wield, how necessary and costly are their services and does their presence in the OR, which may not be disclosed to patients, raise ethical questions about informed consent? A string of court cases has raised questions about their involvement in surgeries that went awry, dating back to the late 1970s when a New York sales manager who had not graduated from high school tried for three hours to fix a prosthetic hip while one of the surgeons is said to have left the OR.

Despite their role, device reps have received little scrutiny, in sharp contrast to drug salespeople, whose role has been the subject of considerable research.

“There’s so little public awareness of this,” said Adriane Fugh-Berman, an associate professor of pharmacology at the Georgetown University School of Medicine and director of PharmedOut, a project that focuses on prescribing and drug-marketing practices. Fugh-Berman is the co-author of a recent study that raises questions about whether surgeons rely too heavily on reps for technical expertise and assistance, to the potential detriment of patients.

But the cost of medical devices, an industry with about $150 billion in annual U.S. sales, combined with concerns about conflicts of interest by doctors who must report industry payments as part of the Affordable Care Act, has resulted in increased scrutiny, as hospitals from Savannah to Stanford seek to standardize and circumscribe the activities of device salespeople.

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November 14, 2016

Kalamazoo, Michigan – November 14, 2016 – Stryker Corporation (SYK), one of the world`s leading medical technology companies, announced today a multi-year collaboration with Indo UK Institute of Health`s (IUIH) Medicity Program to serve as a preferred partner in the orthopaedic areas of hip, knee, and trauma products and services. Stryker and IUIH`s new relationship will provide greater access to affordable primary joint replacements and other healthcare services to patients in India.

The unprecedented 20-year partnership between Stryker and IUIH, a forward-looking healthcare provider, will create and deliver real value throughout the continuum of orthopaedic care, driven by a combination of Stryker`s quality implants and products, streamlined patient pathways and world-class commercial services.

“We are proud to partner with Indo UK Institute of Health to make quality healthcare more accessible and affordable to the people of India, not only through the broad portfolio of products that we offer but also in our commitment to research and medical education,” said Kevin A. Lobo, Chairman and Chief Executive Officer.

In addition to its commitment to provide access to its joint replacement and trauma products and technology, Stryker`s commitment includes the sponsorship of a post-graduate training and education center on the campus of one of IUIH`s medicities and R&D collaboration with Stryker`s longstanding Global Technology Center in India.

“The partnership with Stryker is set to redefine the existing paradigms in healthcare industry,” said Ajay Rajan Gupta, Managing Director and Group CEO, IUIH. “With predictable orthopaedic spend, improved cash flow and optimized use of technology resources, the agreement with Stryker will enhance IUIH`s value in healthcare space in years to come.”

Forward-looking statements

This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for our products; changes in foreign exchange markets; legislative and regulatory actions; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the ultimate total cost with respect to the Rejuvenate and ABG II matter; the impact of investigative and legal proceedings and compliance risks; resolution of tax audits; the impact of the federal legislation to reform the United States healthcare system; changes in financial markets; changes in the competitive environment; our ability to integrate acquisitions; and our ability to realize anticipated cost savings. Additional information concerning these and other factors is contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

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

About Indo UK Institute of Health
On November 12, 2015, the United Kingdom Prime Minister, Mr. David Cameron, and the Prime Minister of India, Mr. Narendra Modi, signed a joint statement to support the development of 11 Indo UK Institutes of Health across 11 states in India. The Indo UK Institute of Health project brings the best of National Health Service (NHS) to India to develop a new healthcare ecosystem which is available, affordable, accountable and appropriate to all. Each Indo UK Institute of Health will have a 1,000 bed NHS hospital, a nursing college, medical college, post graduate training center, implant manufacturing unit, eHealth center and accommodation. Please visit www.iuih.co.uk for more information or contact victoria.lusher@iuih.co.uk.

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

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 Authority:  During 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.

Contact:

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

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 BIO^{4 ™}, 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

Source: Osiris Therapeutics, Inc.

News Provided by Acquire Media

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 10^th. 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.