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CMS Proposed Rule to Let Patients Access Care at Preferred Sites

Posted On July 26, 2018 By OrthoSpineNews In Financial /  

By Sara Heath

 – CMS has proposed changes to the Medicare Hospital Outpatient Prospective Payment System (OPPS) to create site-neutral payments, thus allowing senior patients to access the care they need in their preferred care site.

Creating site-neutral payments for Medicare patients would allow CMS to reimburse the same amount of clinic visits in hospital outpatient settings as in the physician office setting.

Currently, CMS must reimburse more for clinic visits, which the agency defines as “essentially check-ups with a clinician,” in outpatient hospital settings than in physician office settings, despite the fact that the agency says both providers are delivering the same type of care.

Making site-neutral payments will give patients the freedom to seek clinical care at whichever care site they choose without large financial implications for the Medicare program, the agency said.

The change could also have positive impacts on patients, saving them nearly $150 on copayments for visits in outpatient hospital settings.

CMS also proposed extending site-neutral payments to other sites of care, creating more patient freedom. Specifically, CMS proposes to:

  • Expand the number of procedures payable at ASCs to include additional procedures that can safely be performed in that setting;
  • Ensure ASC payment for procedures involving certain high-cost devices parallels the payment amount provided to hospital outpatient departments for these devices; and
  • Help ensure that ASCs remain competitive by stabilizing the differential between ASC payment rates and hospital outpatient department payment rates.

This most recent CMS announcement also proposed changes to the pharmaceutical landscape both as it relates to rising drug costs and combatting the opioid crisis.

 

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Integra LifeSciences Reports Second Quarter 2018 Financial Results

Posted On July 26, 2018 By OrthoSpineNews In Financial /  

PLAINSBORO, N.J., July 25, 2018 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today reported financial results for the second quarter ending June 30, 2018.

Second Quarter 2018 Consolidated Results

  • Reported revenue was $366.2 million, an increase of 29.8% compared to the second quarter of 2017; the acquisition of Codman contributed $79.2 million of revenue to the second quarter, and organic revenues increased 3.4%. Using foreign currency rates in effect when the company provided guidance in April 2018, the second quarter revenues would have been $368.4 million;
  • GAAP earnings per share was $0.14, flat compared to the second quarter of 2017;
  • Adjusted earnings per share was $0.60, reflecting an increase of 33.3% compared to the second quarter of 2017;
  • The company has successfully exited the first wave of Codman transition services agreements and assumed full operational control of all commercial services and functions covering approximately 60% of the revenue associated with the acquired business;
  • The company is raising the low end of its full-year 2018 total revenue and earnings per share guidance as follows:
    • Total revenue of $1.475 billion to $1.490 billion (previously $1.470 billion to $1.490 billion);
      • Guidance range reflects lower foreign currency benefit based on current rates (expected foreign currency benefit was reduced from $15 million to $8 million)
    • GAAP EPS of $0.71 to $0.77 (previously $0.69 to $0.77);
    • Adjusted EPS of $2.36 to $2.42 (previously $2.34 to $2.42); and
  • The company is reiterating full-year 2018 organic sales growth guidance of approximately 5%.

Total revenues for the second quarter of 2018 were $366.2 million, reflecting an increase of 29.8% over the second quarter of 2017. Sales in the Codman Specialty Surgical segment increased 49.8% compared to the second quarter of 2017, driven by the Codman acquisition and strong performance in the Dural Access and Repair and Advanced Energy businesses.  Sales in the Orthopedics and Tissue Technologies segment increased 3.6%, reflecting broad-based strength in our regenerative technologies business, following the completion of the commercial expansion strategy.

Total organic revenues increased 3.4% over the second quarter of 2017, excluding acquisitions, divestitures and the effect of currency exchange rates.

“We look forward to an acceleration in organic growth in the second half of 2018, as we realize the benefits of a larger sales organization, improved sales productivity and an expanded product portfolio,” said Peter Arduini, Integra’s president and chief executive officer.  “The successful integration of Codman and the completion of the hiring associated with our OTT channel expansion strategy increase our confidence for the second half of the year.”

The company reported GAAP net income of $11.4 million, or $0.14 per diluted share, for the second quarter of 2018, compared to GAAP net income of $10.8 million, or $0.14 per diluted share, in the second quarter of 2017. The slight increase in GAAP net income is a result of higher revenues and better operating expense leverage.

The adjusted measures discussed below are computed with the adjustments to GAAP reporting that are set forth in the attached reconciliation.

Adjusted EBITDA for the second quarter of 2018 was $85.9 million, or 23.5% of revenue, compared to $62.7 million, or 22.2% of revenue, in the second quarter of 2017. The margin improvement was largely based on better operating expense leverage, mostly from selling, general and administrative costs.

Adjusted net income for the second quarter of 2018 was $50.5 million, an increase of 42.7% from the prior year’s quarter. Adjusted earnings per share for the second quarter of 2018 was $0.60, an increase of 33.3% over the prior year’s quarter.

2018 Full-Year Outlook

The company is raising the low end of its full-year 2018 total revenue guidance by $5 million to a new range of $1.475 billion to $1.490 billion.  The company is also raising the low end of its full-year 2018 GAAP earnings per share guidance range to $0.71 to $0.77, and adjusted earnings per share guidance range to $2.36 to $2.42, an increase of two cents.

The company expects full-year 2018 organic revenue growth to be approximately 5.0%, consistent with prior guidance.

“We were pleased with the strong operational performance from both segments in the second quarter, which enabled us to achieve 40% growth in adjusted net income and 130 basis points of adjusted EBITDA margin expansion, compared to the prior year’s quarter,” said Glenn Coleman, Integra’s chief financial officer.  “Given the strong momentum we expect in the second half of 2018, we are raising the low-end of our revenue and EPS guidance ranges.”

In the future, the company may record, or expects to record, certain additional revenues, gains, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 AM ET today, Wednesday, July 25, 2018, to discuss financial results for the second quarter and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.

Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.

Access to the live call is available by dialing (334) 323-0522 and using the passcode 7616000. The call can also be accessed via a webcast link provided on investor.integralife.com.  A replay of the call will be available through July 30, 2018 by dialing (719) 457-0820 and using the passcode 7616000. The webcast will also be archived on the website.

About Integra

Integra LifeSciences is a global leader in regenerative technologies, neurosurgical and extremity orthopedic solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel®, Bactiseal®, Cadence®, Certas™, Codman®, CUSA®, DuraGen®, DuraSeal®, ICP Express®, Integra®, MediHoney®, MicroFrance®, PriMatrix®, Salto Talaris®, SurgiMend®, TCC-EZ®, Titan™ and VersaTru™.  For the latest news and information about Integra and its brands, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that involve risks and uncertainties, and reflect the Company’s judgment as of the date of this release.  Forward-looking statements include, but are not limited to, statements concerning future financial performance, including projections for revenues, GAAP and adjusted net income, GAAP and adjusted earnings per diluted share, non-GAAP adjustments such as global enterprise resource planning (“ERP”) system implementation charges, acquisition-related charges, litigation charges, goodwill impairment charges, non-cash amortization of imputed interest for convertible debt, intangible asset amortization, and income tax expense (benefit) related to non-GAAP adjustments.  It is important to note that the Company’s goals and expectations are not predictions of actual performance.  Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Such risks and uncertainties include, but are not limited, to the following: the Company’s ability to execute its operating plan effectively; the Company’s ability to successfully integrate the Codman Neurosurgery business and other acquired businesses; the Company’s ability to manufacture and ship sufficient quantities of its products to meet its customers’ demands; the ability of third-party suppliers to supply us with raw materials and finished products; global macroeconomic and political conditions; the Company’s ability to manage its direct sales channels effectively; the Company’s ability to maintain relationships with customers of acquired entities and businesses; physicians’ willingness to adopt and third-party payors’ willingness to provide or maintain reimbursement for the Company’s recently launched, planned and existing products; initiatives launched by the Company’s competitors; downward pricing pressures from customers; the Company’s ability to secure regulatory approval for products in development; the Company’s ability to remediate quality systems violations; fluctuations in hospitals’ spending for capital equipment; the Company’s ability to comply with and obtain approvals for products of human origin and comply with regulations regarding products containing materials derived from animal sources; difficulties in controlling expenses, including costs to procure and manufacture our products; the impact of changes in management or staff levels; the impact of goodwill and intangible asset impairment charges if future operating results of acquired businesses are significantly less than the results anticipated at the time of the acquisitions, the Company’s ability to leverage its existing selling organizations and administrative infrastructure; the Company’s ability to increase product sales and gross margins, and control non-product costs; the Company’s ability to achieve anticipated growth rates, margins and scale and execute its strategy generally; the amount and timing of acquisition and integration-related costs; the geographic distribution of where the Company generates its taxable income; the effect of legislation effecting healthcare reform in the United States and internationally; fluctuations in foreign currency exchange rates; the amount of our bank borrowings outstanding and other factors influencing liquidity; and the economic, competitive, governmental, technological, and other risk factors and uncertainties identified under the heading “Risk Factors” included in Item 1A of Integra’s Annual Report on Form 10-K for the year ended December 31, 2017 and information contained in subsequent filings with the Securities and Exchange Commission.

These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events, or otherwise.

Discussion of Adjusted Financial Measures

In addition to our GAAP results, we provide organic revenues, adjusted earnings before interest, taxes, depreciation and amortization (“EBITDA”), adjusted net income, adjusted earnings per diluted share, free cash flow and adjusted free cash flow conversion.  Organic revenues consist of total revenues excluding the effects of currency exchange rates, acquired revenues and product discontinuances.  Adjusted EBITDA consists of GAAP net income excluding: (i) depreciation and amortization; (ii) other income (expense); (iii) interest income and expense; (iv) income taxes; and (v) those operating expenses also excluded from adjusted net income.  The measure of adjusted net income consists of GAAP net income, excluding: (i) global enterprise resource planning (“ERP”) implementation charges; (ii) structural optimization charges; (iii) acquisition- and integration-related charges; (iv) litigation charges; (v) intangible asset amortization expense; (vi) discontinued product lines charges; and (vii) income tax impact from adjustments, and other items. The adjusted earnings per diluted share measure is calculated by dividing adjusted net income attributable to diluted shares by diluted weighted average shares outstanding.  The measure of free cash flow consists of GAAP net cash provided by operating activities from less purchases of property and equipment.  The adjusted free cash flow conversion measure is calculated by dividing free cash flow by adjusted net income.

Reconciliations of GAAP revenues to adjusted revenues and GAAP Adjusted Net Income to adjusted EBITDA, and adjusted net income, and GAAP earnings per diluted share to adjusted earnings per diluted share all for the quarters ended June 30, 2018 and 2017, and the free cash flow and free cash flow conversion for the quarters ended June 30, 2018 and 2017, appear in the financial tables in this release.

The Company believes that the presentation of organic revenues and the various adjusted EBITDA, adjusted net income, adjusted earnings per diluted share, free cash flow and free cash flow conversion measures provide important supplemental information to management and investors regarding financial and business trends relating to the Company’s financial condition and results of operations.  For further information regarding why Integra believes that these non-GAAP financial measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to the Company’s Current Report on Form 8-K regarding this earnings press release filed today with the Securities and Exchange Commission.  This Current Report on Form 8-K is available on the SEC’s website at www.sec.gov or on our website at www.integralife.com.

 

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DePuy Synthes Launches CONCORDE LIFT Expandable Interbody Implant as Part of a New Procedural Solution for Minimally Invasive Spine Surgery (MIS)

Posted On July 26, 2018 By OrthoSpineNews In Spine, Top Stories /  

RAYNHAM, Mass., July 26, 2018 /PRNewswire/ — Johnson & Johnson Medical Devices Companies* today announced that DePuy Synthes** is launching the CONCORDE LIFT Expandable Interbody Device in the U.S. The CONCORDE LIFT Implant is designed to treat patients suffering from degenerative disc disease as part of the new offering called UNLEASH MIS TLIF (Transforaminal Lumbar Interbody Fusion) Procedural Solution. The complete system includes a comprehensive set of solutions to help simplify key stages of this surgery by enhancing surgical efficiency.

During spinal fusion surgery, the degenerated disc is removed and the CONCORDE LIFT Expandable Interbody Device is implanted in its place to help restore the disc height between the two vertebrae in the spine.

“I’ve had the privilege of performing one of the first cases of spinal fusion surgery using the CONCORDE LIFT Implant in the United States and have been very happy with what I have been able to achieve using this device,” said John Hall, M.D., Spine and Orthopaedic Trauma Surgeon***. “I believe that being able to access the disc through a small space and then controllably expanding the cage to fill the disc space allowed me to achieve a reliable fusion.”

By 2020, it is estimated that half of all spinal fusion procedures will be performed using a minimally invasive approach.1While it has a steep learning curve, minimally invasive spine surgery has been associated with reducing complications, blood loss, muscular damage and pain, with a faster recovery for patients compared to conventional open spine surgery.2,3

This MIS TLIF Procedural Solution was developed by DePuy Synthes Spine to simplify key stages of the MIS TLIF surgery and additionally includes the CONCORDE Clear MIS Discectomy Device and the VIPER PRIME System for percutaneous pedicle screw insertion.  Here are the steps involved in the procedure:

  • The single-use CONCORDE Clear MIS Discectomy Device allows the degenerated disc-clearing process to occur with fewer instrument passes while increasing the amount of disc material removed compared to standard discectomy tools.4
  • The CONCORDE LIFT Expandable Interbody Device is inserted once the disc has been cleared. With this implant, the surgeon can expand the cage to specifically fit the cage to an individual patient’s anatomy without being confined to pre-set intervals. The streamlined instrumentation provides tactile feedback during the expansion maneuver and the system offers surgeons the option to back-fill the space with bone graft even after the cage has been fully expanded.
  • The VIPER PRIME System, aimed at efficiency, combines multiple instruments into one screw inserter tool enabling the surgeon to perform percutaneous pedicle screw insertion in a single instrument pass.

This new offering exemplifies the company’s commitment to innovative platforms that are designed to reduce surgical complexity, improve patient outcomes and decrease costs. In an anatomic lab study, this MIS TLIF Solution suggested a potential reduction in instrument passes and showed a reduction in procedure time during disc removal, cage implantation and screw placement compared to a control group of current product offerings****. Based on the early indications of this promising cadaveric study, DePuy Synthes is investing in a health economic study in addition to a clinical study to evaluate the potential benefits of the UNLEASH MIS TLIF Procedural Solution as compared to traditional MIS TLIF procedures.

“This UNLEASH Solution delivers a new offering to help reduce the complexity associated with minimally invasive spine surgery while reducing costs and OR footprint,” said Nadav Tomer, Worldwide President, DePuy Synthes Spine. “DePuy Synthes is committed to innovating the tools and technology required to serve more patients globally in a range of care settings by delivering disruptive procedural solutions that improve outcomes supported by real world clinical and economic evidence.”

About the Johnson & Johnson Medical Devices Companies

As the world’s most comprehensive medical devices business, we are building on a century of experience, leveraging science and technology, to shape the future of healthcare. With unparalleled breadth, depth and reach in surgery, orthopaedics and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. Learn more about our latest innovations by visiting: https://www.jnjmedicaldevices.com.

About DePuy Synthes 

DePuy Synthes provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.

**DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.

***Consultant to DePuy Synthes Spine

****Comparing CONCORDE Clear MIS Discectomy Tool to traditional discectomy tools, CONCORDE LIFT Expandable Interbody Device to the CONCORDE Bullet Lumbar Interbody System, and VIPER PRIME System to the VIPER 2 MIS Spine System. Results based on non-clinical study (n=3). Cadaveric test results may not necessarily be indicative of clinical performance.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding CONCORDE LIFT Expandable Interbody Implant as part of a new procedural solution for minimally invasive spine surgery that enhances surgical efficiency. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes, Inc., any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes, Inc., any of the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

©DePuy Synthes 2018. All rights reserved. 

095402-180719

1 Huang, Tsung-Jen. The State of the Art in Minimally Invasive Spine Surgery. Biomed Res Int. 2017. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5350391/.

2 Peng, CW et al. Clinical and radiological outcomes of minimally invasive versus open transforaminal lumbar interbody fusion. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1385-9.

3  Phan, K et al. Minimally invasive versus open transforaminal lumbar interbody fusion for treatment of degenerative lumbar disease: systematic review and meta analysis. Eur Spine J 24:1017-1030. 2015.

4 Lavelle, W et al. An In Vitro Study Examining a Novel Suction Curette Device for Lumbar Discectomy Compared with Standard Manual Discectomy. J Neurosurg Spine 26:454-458. 2017.

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

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206 Ortho Secures a Core Patent for Bio-Inspired Technology that Could Eliminate the Billions Spent on Implant Removal Surgeries

Posted On July 26, 2018 By OrthoSpineNews In Regulatory /  

DEERFIELD, N.H. (PRWEB) JULY 24, 2018

206 Ortho announced today that the United States Patent and Trademark Office has issued US 10,010,609 entitled “Method and Apparatus for Treating Bone Fractures, and/or for Fortifying and/or Augmenting Bone, Including the Provision and Use of Composite Implants.” This patent covers a new bio-inspired composite and implants developed by the company that could fix broken bones without the need for removal surgery. The issuance of this patent is a major step towards replacing permanent metal implants.

206 Ortho’s biocompatible composite is designed to repair load-bearing bone and then resorb leaving no trace. The company has created a high strength biodegradable material made of fibers composed of minerals naturally found in the body bound by a biodegradable polymer. These materials are already proven and in use in orthopedic implants, sutures and other medical devices.

Metal implants have been used for over 100 years to provide stability for fractured bones during healing. However, roughly 4 out of 5 patients live with pain and discomfort and ~40% of patients undergo surgery to remove the metal implant due to the pain. These implant removal surgeries significantly increase the average cost of overall treatment, adding over $12 Billion dollars to the cost of healthcare and additional patient trauma.
206 Ortho’s technology has the potential to improve patient outcomes and quality of life while eliminating the Billions of dollars spent on the removal of metallic implants.

“This patented technology adds to our existing and growing portfolio of patented biomaterials and implants capable of changing the way orthopedic injury will be treated and managed,” said Jeff D’Agostino, Founder and CEO of 206 Ortho. “We are confident that the 206 Ortho’s expanding intellectual property estate, including this newly issued patent, will impact the effectiveness and costs associated with orthopedic surgery. This is particularly important as our global healthcare system evolves to a value-based patient care model.”

With the issuance of this new patent, 206 Ortho intends to seek additional funding and potential commercialization partners for its orthopedic surgical products.

206 Ortho is a privately held company founded in 2011 through the Arthur M. Blank Center for entrepreneurship at Babson College to develop and commercialize solutions for healing bone fractures which would positively impact patients’ lives and make healthcare more affordable globally. Their goal is to help people with bone fractures get back to their lives faster without permanent implants, fewer complications, less discomfort and at a reduced treatment cost. Bringing together the best thinking from across a broad range of industries they have created and protected the optimal solution, including patent 26 filings. 206 Ortho’s resorbable composite delivers the next generation in orthopedic care.

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BioRestorative Therapies Appoints Jason M. Lipetz, M.D. to its Scientific Advisory Board

Posted On July 25, 2018 By OrthoSpineNews In Spine /  

MELVILLE, N.Y., July 25, 2018 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative” or the “Company”) (OTC:BRTX), a life sciences company focused on stem cell-based therapies, today announced that Jason M. Lipetz, M.D. has been appointed to the Company’s Scientific Advisory Board.

Dr. Lipetz is the founder of Long Island Spine Rehabilitation Medicine, a prominent spine and musculoskeletal care center specializing in the non-surgical treatment of the spine and orthopedic rehabilitation.

In 2014, Dr. Lipetz was appointed Chief of Spine Medicine for the Northwell Health Spine Center and previously served as the Director of the Center for Spine Rehabilitation for the North Shore Long Island Jewish healthcare system from 1999-2006. In his current capacity, Dr. Lipetz is responsible for the development of non-surgical spine care services for the Northwell Health System.

Dr. Lipetz has served as a representative to national medical organizations since his residency years, including Chair of the Education Committee of the Physiatric Association of Spine, Sports, and Occupational Rehabilitation (PASSOR). Dr. Lipetz has most recently served as a member of the research committee of the International Spine Intervention Society. He served as the Residency Training Program Director for the Division of Physical Medicine and Rehabilitation at Long Island Jewish Medical Center from 2003 to 2005, and is an Assistant Professor of Rehabilitation Medicine at Hofstra University School of Medicine. Dr. Lipetz is uniquely triple board certified in Physical Medicine & Rehabilitation, Pain Management, and Electrodiagnostic Medicine.

Dr. Lipetz has authored over thirty original articles and abstracts in peer reviewed journals and several textbook chapters, including chapters within the leading texts in both the Interventional Spine Care and Physical Medicine and Rehabilitation literature.  He has lectured nationally and has been featured in both regional and national TV and newspaper segments.

Dr. Lipetz received his specialized and interventional spine medicine training during a fellowship year at the Penn Spine Center of the Hospital of the University of Pennsylvania. After receiving his medical degree with Alpha Omega Alpha honors from Columbia University’s College of Physicians and Surgeons, Dr. Lipetz completed his residency in Physical Medicine and Rehabilitation at the Kessler Institute for Rehabilitation and the University of Medicine and Dentistry of New Jersey. He was elected and served as Academic Chief Resident during his senior year of residency. Dr. Lipetz received his bachelor’s degree in biology with summa cum laude honors through the Presidential Honors Program of the State University of New York at Buffalo.

Mark Weinreb, Chief Executive Officer of BioRestorative Therapies, said, “We are pleased to welcome Dr. Lipetz to our Scientific Advisory Board, as he brings a wealth of medical knowledge, relationships, and expertise that will be invaluable as we advance our spine program through clinical trials.”

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells.  Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

  • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells.  In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery.  We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs.
  • Metabolic Program (ThermoStem®): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including those set forth in the Company’s Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:
Email: ir@biorestorative.com

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Anika Reports Second Quarter 2018 Financial Results

Posted On July 25, 2018 By OrthoSpineNews In Financial /  

July 25, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the second quarter ended June 30, 2018, along with business progress in the period.

“Anika’s strategic initiatives in the second quarter were focused on opportunities to accelerate revenue growth in 2019 and beyond,” said Joseph Darling, President and Chief Executive Officer of Anika Therapeutics. “We strengthened our senior leadership team, increased our focus on strategic M&A, and began executing on multiple strategies to gain U.S. regulatory approval of CINGAL. Bringing CINGAL to U.S. patients and physicians remains one of Anika’s top strategic priorities. We are committed to both maximizing our current business opportunities and pursuing new growth initiatives to create near- and long-term value for shareholders.”

Second Quarter Financial Results

  • Product revenue increased 8% year-over-year in the second quarter of 2018, due primarily to higher MONOVISC revenue in the U.S. Global MONOVISC revenue increased 26% year-over-year in the second quarter of 2018.
  • U.S. Viscosupplementation revenue increased $2.3 million year-over-year for the second quarter of 2018. International Viscosupplementation revenue decreased $0.7 million year-over-year for the second quarter of 2018, due primarily to the timing of orders. Domestically, ORTHOVISC and MONOVISC maintained the number one position in the combined multi- and single-injection segments in the second quarter of 2018.
  • Total revenue for the second quarter of 2018 was $30.5 million, compared to $33.5 million for the second quarter of 2017. The year-over-year decline was due to the achievement of $5.0 million of milestone revenue in the second quarter of 2017, as a result of MONOVISC reaching $100 million in U.S. end-user sales within a consecutive 12-month period.
  • Total operating expenses for the second quarter of 2018 were $19.3 million, compared to $15.7 million for the second quarter of 2017. The increase in total operating expenses was due primarily to product revenue growth, increased personnel costs, and expanded worldwide commercial initiatives.
  • Net income for the second quarter of 2018 was $10.1 million, or $0.68 per diluted share, compared to $11.4 million, or $0.76 per diluted share, for the second quarter of 2017. The decline in net income was due primarily to the increase in operating expenses previously discussed.

Recent Business Highlights

  • Announced that initial top-line results for the CINGAL 16-02 clinical trial, an active-comparator Phase III study conducted to support U.S. approval, did not reach statistical significance, although it did maintain the durability of strong pain relief throughout the 26 weeks, consistently demonstrating the long-term benefits of CINGAL. The magnitude of pain reduction demonstrated incremental improvement compared to the previous CINGAL Phase III study, and the duration of patient improvement after CINGAL injection was maintained near peak levels throughout the 26-week study. Anika has engaged external regulatory and legal experts to assist in the strategic approach for seeking CINGAL approval in the U.S. market. Anika remains fully committed to working closely with regulators to gain U.S. approval of CINGAL.
  • Strengthened the senior leadership management team with the newly created position of Vice President of International Sales based in Europe to maximize sales impact and optimize the Company’s commercial reach in our foreign markets.
  • Added a new Vice President of Operations to senior leadership team to focus on operation efficiency and margin improvements.
  • Redirected internal efforts of Chief Technology and Strategy Officer with spear-heading the assessment of strategic M&A opportunities.
  • Completed the Company’s $30 million accelerated share repurchase program in July, under which Anika repurchased approximately 800,000 shares of its outstanding common stock.

Full Year 2018 Revised Corporate Outlook
Based on currently available information, the Company revised its guidance for the full year of 2018. Anika currently does not expect licensing, milestone and contract revenue of $5.0 million in 2018. The Company continues to anticipate product revenue to be flat for the full year of 2018. The Company continues to expect that it will resume the shipment of products that were the subject of the previously-disclosed voluntary recall by the end of this year. Total operating expenses are now expected to be in the low $90 million range for the full year of 2018, adjusted for the reduction of CINGAL pre-launch marketing expenses.

Conference Call Information
Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights tomorrow, Thursday, July 26 at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the “Investor Relations” section of Anika’s website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika’s website approximately two hours after the completion of the event.

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic and regenerative medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements
The statements made in the section captioned “Full Year 2018 Revised Corporate Outlook” of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s 2018 revenue and total operating expense expectations and to the Company’s timeline to resume shipping of products that were the subject of the previously-disclosed voluntary recall. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Anika Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
For the Three Months Ended June 30,

For the Six Months Ended June 30,
2018 2017 2018 2017
Product revenue $ 30,542 $ 28,340 $ 51,800 $ 51,721

Licensing, milestone and contract revenue

 6 5,122 12 5,127
Total revenue 30,548 33,462 51,812 56,848
Operating expenses:
Cost of product revenue

8,152

 6,315 15,996 12,398
Research and development

4,733

 4,449 9,895 8,679
Selling, general and administrative 6,417 4,972 22,507 10,039
Total operating expenses 19,302 15,736 48,398 31,116
Income from operations 11,246 17,726 3,414 25,732
Interest and other income, net 290 16 385 74
Income before income taxes 11,536 17,742 3,799 25,806
Provision for income taxes 1,445 6,373 394 8,944
Net income $ 10,091 $ 11,369 $ 3,405 $ 16,862
Basic net income per share:
Net income $ 0.69 $ 0.78 $ 0.23 $ 1.16

Basic weighted average common shares outstanding

 14,652 14,588 14,666 14,582
Diluted net income per share:
Net income $ 0.68 $ 0.76 $ 0.23 $ 1.12
Diluted weighted average common shares outstanding 14,915 15,044 15,045 15,046
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except per share data)
(unaudited)
June 30, December 31,
ASSETS 2018 2017
Current assets:
Cash and cash equivalents $ 126,047 $ 133,256
Investments 13,250 24,000
Accounts receivable

23,389

 23,825
Inventories, net 24,060 22,035

Prepaid expenses and other current assets

 4,245 3,211
Total current assets

190,991

 206,327
Property and equipment, net 55,377 56,183
Other long-term assets 1,157 1,254
Intangible assets, net 9,876 10,635
Goodwill 8,013 8,218
Total assets $

265,414

 $ 282,617
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $

5,074

 $ 6,747
Accrued expenses and other current liabilities

7,459

 6,326
Total current liabilities

12,533

 13,073
Other long-term liabilities 882 660
Deferred tax liability 5,396 5,393
Commitments and contingencies
Stockholders’ equity:

Preferred stock, $0.01 par value; 1,250 shares authorized, no shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively

 – –
Common stock, $0.01 par value; 90,000 shares authorized, 14,584 and 14,688 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively 146 147
Additional paid-in-capital 48,656 68,617
Accumulated other comprehensive loss (5,115 ) (4,784 )
Retained earnings 202,916 199,511
Total stockholders’ equity 246,603 263,491
Total liabilities and stockholders’ equity $

265,414

 $ 282,617
Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data
Revenue by Product Line and Product Gross Margin
(in thousands, except percentages)
(unaudited)
For the Three Months Ended June 30, For the Six Months Ended June 30,
Product Line: 2018 % 2017 % 2018 % 2017 %
Orthobiologics $ 26,192 86% $ 24,468 86% $ 45,681 88% $ 44,695 86%
Surgical 1,263 4% 1,335 5% 2,509 5% 2,631 5%
Dermal 623 2% 453 2% 83 0% 878 2%

Other

 2,464 8% 2,084 7% 3,527 7% 3,517 7%
Product Revenue $ 30,542 100% $ 28,340 100% $ 51,800 100% $ 51,721 100%
Product Gross Profit $

22,390

 $ 22,025 $

35,803

 $ 39,323
Product Gross Margin 73% 78% 69% 76%
Product Revenue by Geographic Region
(in thousands, except percentages)
(unaudited)

For the Three Months Ended June 30,

 For the Six Months Ended June 30,
2018 % 2017 % 2018 % 2017 %
Geographic Region:
United States $ 24,773 81% $ 22,331 79% $ 41,682 81% $ 41,261 80%
Europe 3,498 11% 4,060 14% 5,889 11% 6,889 13%
Other 2,271 8% 1,949 7% 4,229 8% 3,571 7%
Product Revenue $ 30,542 100% $ 28,340 100% $ 51,800 100% $ 51,721 100%

Contacts

Anika Therapeutics, Inc.
Joseph Darling, President & CEO
Sylvia Cheung, CFO
Tel: 781-457-9000

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JOURNEY™ II BCS Knee System demonstrates improved patient outcomes and lower healthcare costs

Posted On July 25, 2018 By OrthoSpineNews In Recon, Top Stories /  

LONDON, July 25, 2018 /PRNewswire/ — Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, announced positive clinical results concerning its JOURNEY™ II Bi-Cruciate Stabilized (BCS) knees. These results suggest JOURNEY II BCS is associated with significant healthcare economic benefits in patients implanted with this device compared to other knee systems.

In a retrospective cohort study from the Premier Perspective Database1, JOURNEY II BCS patients exhibited lower mean hospital stays and overall reduced mean costs when compared to other knee patients.  When comparing 1,692 JOURNEY II BCS patients to the same number of other comparable knee patients, data revealed JOURNEY II BCS patients were:

  • 51% less likely to be readmitted to the hospital within 30 days;
  • 35% more likely to be discharged to their home; and
  • 41% less likely to be discharged to a skilled nursing facility for further care.

The results also showed patients with JOURNEY II BCS experienced statistically significantly reduced length of stay and reduced hospital costs, equivalent to approximately 10% in savings to the overall procedure cost ($16,187 vs. $17,877).

Andy Weymann MD, Chief Medical Officer of Smith & Nephew, commented: “To have a knee system that improves patient outcomes while reducing healthcare costs is a tremendous feat for Smith & Nephew.  When we introduced the JOURNEY II Knee System, we wanted to build upon our 150+ years of supporting healthcare professionals and patients in a way that addressed the market where patient outcome measures go beyond implant survivorship.  We know hospitals and healthcare professionals have a wide choice in knee implants and this new retrospective analysis supports our view that JOURNEY II BCS is the leading knee platform available in today’s market.”

The Premier Perspective Database study is not the only recent evidence reporting improved patient outcomes with the JOURNEY II BCS Knee System. In another multi-center study published in Techniques in Orthopaedics, JOURNEY II BCS patients demonstrated a smoother recovery, improved function and increased patient satisfaction.2-6 Specifically, study patients implanted with JOURNEY II BCS had 23 degrees more flexion than patients implanted with another comparable knee system along with significantly improved mean knee society scores (89 vs 81; p<0.001) at 1 year follow-up.2

“Every knee product we manufacture is designed to improve patient outcomes while decreasing hospital costs. It is rewarding to see JOURNEY II BCS patients demonstrating a smoother recovery1-2 and higher patient satisfaction than what we have seen in the past. These outcomes illustrate the value that Smith & Nephew constantly strives to provide to our healthcare system,” Brad Cannon, Chief Marketing Officer.

The JOURNEY II BCS is a member of the JOURNEY II Total Knee Arthroplasty (TKA) system, which also includes JOURNEY II Cruciate Retaining (CR) and the recently launched bi-cruciate retaining JOURNEY II XR.

About Smith & Nephew 

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com

Forward-looking Statements 

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include:

economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

™Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.

  1. Mayman DJ, Patel AR, Carroll KM. Hospital Related Clinical and Economic Outcomes of a Bicruciate Knee System in Total Knee Arthroplasty Patients.Poster presented at: ISPOR Symposium; May 19-23, 2018; Baltimore, Maryland, USA.
  2. Nodzo, SR; Carroll KM, Mayman DJ. The Bicruciate Substituting Knee Design and Initial Experience. Tech Orthop. 2018;33:37-41.
  3. Scott CE, Howie CR, MacDonald D, Biant LC; Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9)
  4. J Orthop. 2017 Jan 7;14(1):201-206. doi: 10.1016/j.jor.2016.12.005. eCollection 2017. Bi-cruciate substituting total knee arthroplasty improved medio-lateral instability in mid-flexion range
  5. In Vivo Kinematic Comparison of a Bicruciate Stabilized Total Knee Arthroplasty and the Normal Knee Using Fluoroscopy Trevor F. Grieco, MS a, *, Adrija Sharma, PhD a, Garett M. Dessinger, BS a, Harold E. Cates, MD b, Richard D. Komistek, PhD. The Journal of Arthroplasty, September 2017
  6. A comparison of Rolback Ratio between Bicruciate Substituting Total Knee Arthroplasty and Oxford Unicompartmental Knee Arthroplasty. DOI: 10.1055/s-0037-1604445. ISSN 1538-8506. The Journal of Knee Surgery. Takanori Iriuchishima, Keinosuke Ryu

SOURCE Smith & Nephew

Related Links

http://www.smith-nephew.com

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FBC Device ApS Receives First FDA Clearance For Spinal Interbody Implant Providing Lordosis Adjustment from 9 to 21 Degrees to Aid Surgeons & Patients

Posted On July 24, 2018 By OrthoSpineNews In Regulatory, Spine /  

July 24, 2018

AARHUS, Denmark–(BUSINESS WIRE)–FBC Device ApS, a medical device company focused on restoring natural alignment of the spine through innovative interbody implants, has received its first US FDA clearance for its technology, enabling access to the US market.

Professor Finn Christensen, MD, PhD and founder and CEO of FBC Device says: “There is overwhelming evidence that poor spinal alignment is associated with back pain and disability. When we started the company, our goal was to commercialize a series of implants to help surgeons easily restore alignment when performing spinal fusions, so that more of their patients would achieve good or even great results. We have now accomplished three elements crucial to reaching our goal:

  • Regulatory approval, now in the US along with a second implant that has been CE marked since 2013.
  • Patents granted around the world to protect these two implant designs as well as others to follow.
  • Documented clinical evidence demonstrating that the technology enables surgeons to restore normal alignment and that patients receiving the technology have excellent results in patient-based outcome measures.”

The FDA clearance brings FBC Device one step closer to its goal. To fully commercialize its products, the Company will immediately engage interested parties capable of bringing the technology to large markets across the world.

For more information, visit www.fbcdevice.com

About the FBC Technology

Each individual has different alignment requirements – it is not one size fits all. The FBC technology is a two-piece interbody fusion device that allows for in-situ adjustment from 9-21 degrees, enabling surgeons to simply adjust alignment for each patient’s need and then lock the two pieces relative to each other.

Contacts

FBC Device ApS
Prof. FB Christensen
Email – finn@fbcdevice.com

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Bone Biologics Completes $5.9 Million of Financing

Posted On July 23, 2018 By OrthoSpineNews In Financial /  

July 23, 2018

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics (OTCQB: BBLG), a developer of orthobiologic products for domestic and international spine fusion markets, announced today the completion of $5.9 million funding; $3.9 million in equity and a $2 million credit facility. Proceeds will be used for working capital, protein development, animal testing, regulatory and clinical expenses, as well as for other purposes not presently contemplated herein but which are related directly to growing the Company’s current business, research and development activities and the repayment of a secured promissory note in the principal amount of $600,000.

The securities offered have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws.

About Bone Biologics

Bone Biologics (OTCQB:BBLG) was founded to pursue regenerative medicine for bone.

Bone Biologics Corporation is undertaking groundbreaking work with select strategic partners, building on unprecedented research on the Nell-1 molecule that has produced a significant number of studies and publications in peer reviewed scientific literature.

Bone Biologics is currently focusing its development efforts for its bone graft substitute product on bone regeneration in spinal fusion and has rights to trauma and osteoporosis applications. Nell-1 is a recombinant human protein growth factor that is essential for normal bone development.

For more information, please visit the company’s website at www.bonebiologics.com.

Bone Biologics trades on the OTCQB venture stage marketplace for early stage and developing U.S. and international companies. OTCQB companies are current in their reporting and undergo an annual verification and management certification process. Investors can find Real-Time quotes and market information for the company on www.otcmarkets.com.

Forward-Looking Statements

This press release contains forward-looking statements that reflect the Company’s current beliefs, expectations or intentions regarding future events. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “will,” “will be,” “anticipate,” “predict,” “continue,” “future,” and similar expressions are intended to identify such forward-looking statements.

Disclaimer

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Contacts

Bone Biologics
Jeff Frelick, Chief Operating Officer
jfrelick@bonebiologics.com
or
Media Inquiries:
Tracy Williams, 310-824-9000
tracy@olmsteadwilliams.com

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Histogenics Chief Operating Officer, Stephen Kennedy Appointed to Advanced Regenerative Manufacturing Institute’s Technology Advisory Sub-Committee

Posted On July 23, 2018 By OrthoSpineNews In Biologics /  

WALTHAM, Mass., July 23, 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, announced that Stephen Kennedy, Executive Vice President & Chief Operating Officer, has been appointed to the BioFabUSA Leadership Advisory Council and Technology Advisory Subcommittee (TASC) of the Advanced Regenerative Manufacturing Institute (ARMI).

ARMI is a new public-private Manufacturing USA initiative that brings together a consortium of nearly 100 organizations from industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cell and gene-based therapies.

“Innovation and the implementation of cutting-edge manufacturing process technologies has been a critical component of Histogenics’ development of NeoCart, and we know first-hand the importance of such technologies to realize the promise of restorative cell therapies,” said Mr. Kennedy. “I am pleased that ARMI has recognized Histogenics’ achievements in enabling this transformative therapeutic modality and grateful to have the opportunity to collaborate with other leaders in the cellular therapy field. The diverse backgrounds and perspectives of TASC’s members will help to ensure the development of manufacturing processes and technologies that support the clinical and commercial success of a broad array of cell therapies.”

Stephen Kennedy joined Histogenics in 2013 and has more than 30 years of experience in biological manufacturing and process development, including 18 years at Genzyme Corporation. He has also served as Executive Director of the Novartis/MIT Center for Continuous Manufacturing at the Massachusetts Institute of Technology. Stephen holds a B.S. from the University of Michigan, an M.S. from the University of Rochester and an M.B.A. from Boston University.

“We are delighted to have Steve Kennedy join the ARMI | BioFabUSA Leadership Advisory Council and Technology Advisory Subcommittee,” said inventor Dean Kamen, ARMI’s chairman. “His intelligence, experience and collaborative attitude are exactly what we need to bring engineers and scientists together to move this industry forward.”

About Advanced Regenerative Manufacturing Institute
The Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is the 12th Manufacturing USA Institute. It brings together a consortium of nearly 100 partners from across industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs. ARMI will work to organize the current fragmented domestic capabilities in tissue Biofabrication technology to better position the U.S. relative to global competition. For more information on ARMI, please visit www.ARMIUSA.org.

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 may prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  Histogenics completed enrollment of its NeoCart Phase 3 clinical trial in the second quarter of 2017 and expects to report top-line, one-year superiority data in the third quarter of 2018.  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,  the timing and success of Histogenics’ NeoCart Phase 3 clinical trial 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 March 31, 2018, 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 June 30, 2018, to be filed with the SEC in the third quarter of 2018.  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
InvestorRelations@histogenics.com.

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