WALTHAM, Mass., Sept. 26, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today announced that the U.S. Food and Drug Administration (the FDA) has granted a Type C meeting on October 30, 2018 to discuss the top-line results from the NeoCart Phase 3 clinical trial and Histogenics’ planned Biologics License Application submission. Histogenics submitted its briefing materials regarding the top-line data of the NeoCart Phase 3 clinical trial to the FDA in mid-September 2018, and has been working closely with the FDA to schedule the meeting. Histogenics expects to provide an update following this meeting in early November 2018, with meeting minutes expected by late November 2018 or early December 2018.  During the third quarter of 2018, Histogenics has sold an aggregate of 3,550,416 shares of common stock in at-the-market offerings pursuant to Histogenics’ equity distribution agreement with Canaccord Genuity Inc. for aggregate net proceeds of $2.72 million after deducting sales agent fees and expenses. Histogenics believes that its existing cash and cash equivalents will be sufficient to fund its projected cash needs late into the fourth quarter of 2018.

About Histogenics Corporation

Histogenics (Nasdaq:  HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications.  For more information on Histogenics and NeoCart, 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:  expectations regarding the timing and success of discussions with the FDA regarding the submission of a biologics license application for NeoCart; NeoCart’s potential as a treatment for knee cartilage damage; the timing, associated expenses and ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the market size and potential patient population in markets where Histogenics’ and its partners expect to compete; updated or refined data based on Histogenics’ continuing review and quality control analysis of clinical data; the scope, progress, timing, 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 following its technology transfer and manufacturing location transition; Histogenics’ expectations regarding its expenses and revenue; Histogenics’ ability to obtain additional debt or equity capital 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, 2017 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov.  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.

CARLSBAD, Calif., Sept. 26, 2018 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc.  (“ATEC” or the “Company”) (Nasdaq: ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its OsseoScrew^® System, making it available for clinical use for the first time in the United States.

“I am exceptionally pleased that OsseoScrew has been cleared for the U.S. market,” said Pat Miles, Chairman and Chief Executive Officer. “The system will create new market opportunities for ATEC by uniquely addressing an unmet need for an underserved patient population.  We are building an organic innovation machine and today’s announcement represents another significant step toward creating a clinically distinguished portfolio.”

The OsseoScrew System

OsseoScrew is a next-generation expandable pedicle screw system, intended to restore the integrity of the spinal column in elderly patients with advanced stage tumors involving the thoracic and lumbar spine. It is designed to be implanted into the pedicle, then expanded after implantation to achieve increased screw fixation and reduced post-operative pullout in bone with poor density.  OsseoScrew has been clinically proven to increase pullout and holding strength, improving fixation in the bone-implant interface by 29%, as compared to conventional pedicle screws.  It performs comparably to cemented fenestrated screws without the risk associated with cement leakage.

Alphatec will display OsseoScrew this week at the North American Spine Society (NASS) 2018 Annual Meeting, which is being held from September 26-29 at the Los Angeles Convention Center.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly-owned subsidiaries, Alphatec Spine, Inc. and SafeOp Surgical, Inc., is a medical device company that designs, develops, and markets technology for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Alphatec, Alphatec Spine, the Alphatec logo, SafeOp Surgical and OsseoScrew are trademarks or registered trademarks of Alphatec Holdings, Inc., its affiliates and/or subsidiary companies. All other marks are the property of their owners. Additional information can be found at www.atecspine.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the references to the Company’s strategy in significantly repositioning the ATEC brand and turning the Company into a growth organization.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including OsseoScrew, Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the Securities and Exchange Commission. ATEC disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Investor/Media Contact:
Tina Jacobsen
Investor Relations
tjacobsen@moreeffectiveir.com

Company Contact:
Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
ir@atecspine.com

September 25, 2018

14th September 2018

Contaminated pedicle screws cost hundreds of thousands of US dollars a year, and through an increase in surgical site infections result in additional and avoidable patient morbidity. Anand Agarwal (University of Toledo, Toledo, USA) and colleagues are calling for a change in the standard of care revolving around implant handling and delivery, cutting costs and improving patient safety.

Less widely recognised is the fact that contamination of pedicle screws still occurs in the sterile field, with intraoperative bacterial contamination needing an urgent solution.

So the issue of contamination is two-fold: outside of the operating room, concerning the reprocessing of pedicle screws, and inside the operating room, when pedicle screws are left exposed on trays and are infected with several common bacterial strains.

Reprocessed pedicle screws have been shown to still have residual microbial and non-microbial contaminants on them. In a study conducted by Aakash Agarwal (Department of Bioengineering and Orthopaedic Surgery, Engineering Center for Orthopaedic Research Excellence, University of Toledo, Toledo, USA) and colleagues, published in the Global Spine Journal, traces of saccharides (including biofilm, endotoxins and fatty tissue), soap residue, and salt residue were identified on six pedicle screws randomly selected from four different trays of cleaned, wrapped and purportedly sterilised implants. In fact, there is evidence that the amount of carbohydrate residue increases following reprocessing. The investigators also found corrosion stains present on the outer surface of the implants.

The screws were retrieved using clean gloves, and immediately placed inside of clean zip-lock polybags before undergoing optical microscopy, scanning electron microscopy with energy dispersive spectroscopy, and Fourier transform infrared spectroscopy.

That reprocessed pedicle screws are not always fully sterile has already influenced policy decisions in some nations. Japan and Scotland have banned the reprocessing of spinal implants used for spinal surgery. The Scottish Health Department said in a statement that repeatedly reprocessing implants in the hospital “is a suboptimal procedure”, following a letter in 2006 from the then chief medical officer for Scotland, Harry Burns.

Burns wrote: “Most orthopaedic units in NHS Scotland use screws, small plates and other small orthopaedic implants which have been repeatedly reprocessed (cleaned and sterilised) by the local Central Decontamination Unit in racks or trays. Concerns have been raised that these implants cannot be properly cleaned, and we have photomicroscopic evidence that they retain or acquire organic and/or chemical residues during reprocessing. Legally, many of these devices are classified as ‘single use’, which means they must not be re-used following contact with a patient, but also that they should only be cleaned and sterilised once, prior to first use. We suspect many of these devices have been recirculating for many years, some perhaps for over two decades. Besides generic concerns over infection and CJD [Creutzfeldt-Jakob Disease] contamination, there is evidence to suggest that reprocessed steel implants can cause inflammatory reactions to a much greater degree than ‘pristine’ devices as delivered by the manufacturer, and there are also issues of corrosion and weakening caused by repeated processing. This has clear implications for reducing implant failures, and we have no option but to address the legal, regulatory and governance issues this practice raises.”

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 BILLERICA, Mass., Sept. 17, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that fit each patient’s unique anatomy, announced today that it has entered into a settlement and license agreement with Smith & Nephew that resolves all patent disputes between Conformis and Smith & Nephew.

Pursuant to the agreement, Smith & Nephew is required to pay $10.5M to Conformis, and the parties have entered into a limited patent cross-license.

“We are very pleased to announce the complete settlement of the various patent proceedings we have with Smith & Nephew. Through this settlement, we have once again monetized our patient-specific instrument patents and steadfastly protected our core business of patient-specific implants,” stated Mark Augusti, Conformis’ President and Chief Executive Officer.

About Conformis, Inc.

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

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

Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release about our future expectations, plans and prospects, including statements about the collection of royalty payments and settlement of patent disputes, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. You should not place undue reliance on our forward-looking statements. Actual results could differ materially from the expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

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

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