Extremity Reconstruction Market – Detailed Study Analysis and Forecast by 2025

Albany, NY — (SBWIRE) — 03/24/2017 — Global Extremity Reconstruction Market: Overview

The increasing incidence of injuries, abnormalities, and congenital defects in the upper or lower extremity of human body has fuelled the demand for reconstructive surgical procedures. Implant devices for the shoulder, wrist, ankle joints, digits, elbow, and foot are part of the extremity reconstruction market.

The primary driver of the global extremity reconstruction market is the large pool of geriatric population. According to the Centers of Disease Control and Prevention, with a rise in the geriatric population in the U.S., by the year 2040, the number of patients affected by arthritis is expected to increase to 78 million. Since aged people are more prone to injuries, growth in geriatric population is expected to fuel the demand for reconstructive surgical procedures.

Obtain Report Details @ https://www.tmrresearch.com/extremity-reconstruction-market

Global Extremity Reconstruction Market: Key Trends

The rising incidence of joint disorders such as rheumatoid and osteoarthritis arthritis, coupled with the globally increasing incidence of diabetes and obesity, and rising geriatric population are driving the global extremity reconstruction market. Moreover, growing awareness among patients about the advantages of small joint reconstruction implants and enhanced technology such as development of reverse shoulder implants, stemless shoulder implants, and ankle reconstruction implants, which aid in recovering ankle mobility are projected to boost the market. The zest to get back to the active lifestyle, post-injury or trauma will supplement the demand for extremity reconstruction surgeries.

 

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InVivo to Initiate Cervical Spinal Cord Injury Study

March 23, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that Health Canada has approved the company’s Investigational Testing Authorization application to commence a clinical study of the Neuro-Spinal Scaffold™ in patients with acute, complete (AIS A) cervical (C5-T1) spinal cord injuries (SCIs). InVivo currently is in late stage conversation with several site Research Ethics Boards and expects to announce its first Canadian site in the coming weeks.

“This approval is an important step towards our goal of redefining the life of the spinal cord injury patient,” said Mark Perrin, InVivo’s CEO and Chairman. “We are dedicated to helping as many SCI patients as we can, and this approval helps us to evaluate our investigational product in the most severe spinal cord injury cases, with neurologically complete cervical injuries involving impairment of the arms, hands, trunk, and legs. As I explain further in my CEO’s Perspective, moving into the cervical spinal cord is exciting, since each level of the cervical spinal cord has a substantial functional impact. If the Neuro-Spinal Scaffold were able to preserve, remyelinate and/or regenerate just a small area of spinal cord, we believe this could have significant functional consequences. We look forward to bringing sites onboard in Canada to commence enrollment and ultimately to expanding our study of cervical patients to the United Kingdom and the United States.”

A new CEO’s Perspective discussing the differences between thoracic and cervical spinal cord injuries can be found on the InVivo Therapeutics website: http://www.invivotherapeutics.com/about-invivo/ceo-perspective/

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffoldreceived the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, the ability of the company to open a site in Canada or enroll patients in Canada, and the ability to expand the trial to the United Kingdom and the United States. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the impact of achieving the OPC on the FDA approval process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2016, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

Alphatec Holdings Announces $18.9 Million Private Placement

CARLSBAD, Calif., March 23, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today that it has entered into a definitive securities purchase agreement to raise approximately $18.9 million in a private placement of common stock, Series A Convertible Preferred Stock and warrants exercisable for common stock. The private placement is being led by new healthcare dedicated institutional investors, with participation by directors and executive officers of Alphatec and other existing investors. The private placement is expected to close on or about March 28, 2017, subject to the satisfaction of customary closing conditions. Alphatec expects to use the net proceeds from the private placement for general corporate and working capital purposes.

“We appreciate the support of our new and existing investors and the confidence this conveys in our strategy to build a high-growth spine company,” said Terry Rich, Alphatec Spine’s Chief Executive Officer.  “We believe the additional capital will allow us to execute on our plans to expand our surgeon customer base, drive growth through the launch of our new products—Arsenal Deformity™, Battalion™ Lateral and XYcor® Expandable Interbody—as well as support the transformation of our distribution channel.”

H.C. Wainwright & Co., LLC, is acting as the exclusive placement agent in connection with this private placement.

Pursuant to the terms of the securities purchase agreement, Alphatec has agreed to sell 1,809,628 shares of common stock at a price of $2.00 per share.  In addition, Alphatec has agreed to sell approximately 15,245 shares of newly created Series A Convertible Preferred Stock, which shares of preferred stock are convertible into approximately 7,622,372 shares of common stock, subject to limitations on conversion until the approval by Alphatec’s stockholders as required in accordance with the NASDAQ Global Select Market rules. Purchasers will also receive warrants to purchase up to approximately 9,432,000 shares of common stock at an exercise price of $2.00 per share. The warrants will be exercisable following approval by Alphatec stockholders, and will expire 5 years from the date of such stockholder approval.

Certain directors and executive officers of Alphatec agreed to purchase an aggregate of $2.35 million of shares of Series A Convertible Preferred Stock, which shares are convertible into approximately 1,175,000 shares of common stock, and warrants to purchase up to 1,175,000 shares of common stock at a price of $2.00 per share.

The securities to be sold in the private placement will not have been registered under the Securities Act of 1933, as amended, or state securities laws as of the time of issuance and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Alphatec has agreed to file one or more registration statements with the SEC registering the resale of the shares of common stock purchased in the private placement and the shares of common stock underlying the warrants and issuable upon conversion of the Series A Convertible Preferred Stock.

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

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops, manufactures and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. via a direct sales force and independent distributors.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec 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 statements regarding: Alphatec’s expectations on the completion, timing and size of the private placement and the anticipated use of proceeds therefrom, including such proceeds allowing Alphatec to accelerate its plans to expand its surgeon customer base, drive growth through the launch of new products and support the transformation of its distribution channel.  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, risks and uncertainties associated with: market conditions and the satisfaction of customary closing conditions related to the private placement; the uncertainty of success in launching new products; the uncertainties in Alphatec’s ability to execute upon its strategic operating plan; failure to achieve acceptance of Alphatec Spine’s products by the surgeon community; continuation of favorable third-party payor reimbursement for procedures performed using Alphatec Spine’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or Alphatec’s ability to successfully control its costs or achieve profitability; Alphatec’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement; and other risks and uncertainties inherent in Alphatec’s business, including those detailed from time to time in Alphatec’s SEC reports, including its Annual Report Form 10-K for the year ended December 31, 2015, filed on March 15, 2016 with the Securities and Exchange Commission, and its Amended Annual Report Form 10-K/A filed on April 29, 2016, as well as other filings on Form 10-Q and periodic filings on Form 8-K. 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.  Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

Stamford Health Names New Chair Of Orthopedic Surgery Department

By John Haffey – March 21, 2017

STAMFORD, Conn. — Dr. Charles “Chip” Cornell has been named chair of the newly created Department of Orthopedic Surgery at Stamford Health, effective March 1. As department chair, Cornell will be responsible for the direction of all orthopedic services, including subspecialty divisions and HSS Orthopedics at Stamford Health.

The hospital’s new collaboration with Hospital for Special Surgery was announced last month.

“We are proud to have someone of Dr. Cornell’s recognized leadership and surgical expertise join Stamford Health as we expand orthopedic services,” said Dr. Sharon Kiely, senior vice president of Medical Affairs and chief medical officer at Stamford Health. “This follows the announcement of our collaboration with Hospital for Special Surgery and complements our vision of further developing leading specialty services in orthopedics.”

Throughout his career, Cornell has studied the outcome of total knee replacement as treatment for osteoarthritis of the knee. His current research interests include investigating novel approaches to pain management following total knee replacement surgery as well as analysis of the benefit of implementing Clinical Pathways for total knee replacement. He is also collaborating on a study investigating the effect of pre-operative synovitis in patients with osteoarthritis of the knee and its effect on range of motion and stiffness following this procedure.

Cornell is professor of Clinical Orthopedic Surgery at Weill Cornell Medical College and an attending orthopedic surgeon at Hospital for Special Surgery. He served as clinical director of orthopedics for HSS beginning in 2006, and holds the Dr. Richard Laskin, chair in Orthopedic Surgery since 2011. Cornell has been active in the Resident and Medical School program throughout his career and recognized for his dedication to education, receiving the Philip Wilson Teaching Award three times.

To learn more about the new HSS Orthopedics at Stamford Health, click here.

SpineGuard Reports Full-Year 2016 Financial Results

March 23, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices designed to make spine surgery safer, reported today its full-year 2016 financial results as approved by the Board of Directors on March 23, 2017.

€ thousands – IFRS Audited Dec 31, 2016 Dec 31, 2015
Revenue 7 463 6 346
Gross margin 6 354 5 365
Gross margin (% of revenue) 85,1 % 84,5 %
Sales, distribution & marketing 6 643 6 514
Administrative costs 2 049 1 968
Research & Development 1 295 857
Operating profit / (loss) -3 633 -3 974
Financial Result -545 96
Net profit / (loss) -4 178 -3 878

Pierre Jérôme, CEO and co-founder of SpineGuard, said: “2016 saw SpineGuard’s sales momentum continue and showed the great potential of our DSG™ technology platform. Our commercial organization keeps delivering double-digit growth via our PediGuard family of smart drilling probes, which we expanded with the successful launch of the PediGuard Threaded. At the same time, our R&D investments for the integration of the DSG technology into implantable devices such as pedicle screws has begun to bear fruit with first surgeries in Europe and FDA clearance early in 2017. The US is a key market for SpineGuard where we keep growing significantly year after year. Our focus on operating expenses also allowed the company to improve its operating result. We will continue to pursue this path as one of our corporate objectives for 2017.”

Operating income improves by 9%

In 2016, SpineGuard reported full-year revenue of €7,463k compared with €6,346k for 2015, an 18% increase both on reported basis and cc. 8,603 PediGuard units were sold compared with 7,449 in 2015, including 4,948 in the United States.

The gross margin improved by nearly €1M and 60 bps at 85.1% compared with the prior year of 84.5%, and remains strong. The improvement year-on-year is the result of a combined stability of average selling prices and more favorable country mix with an improved performance on manufacturing cost despite headwinds on currency vs. prior year.

Operating costs increased by €648k (+7%); mainly due to R&D expenses related to the clearance of both PediGuard Threaded and the DSG™ screw (€438k).

With the combination of an improved gross margin and the control of operating expenses, the operating result improved by +€340 k (or +9%) vs. prior year.

The Company reported a net loss of €4,178k for the full-year 2016 compared with a loss of €3,878k for the full-year 2015, impacted by the increase of financial costs related to lower Fx gains of €114k and an increase of interest on loans by €439k.

Working capital was €955k compared with €-65k for the full-year 2015. The increase is mainly due to the building of the inventory of the new products prior to their commercial launch (PediGuard Threaded and DSG modules for the screw), the anticipation of purchases with our Singapore-based manufacturing partner and the Fx Euro/dollar unfavorable impact on the manufacturing cost.

At December 31, 2016, cash and cash equivalents were €1,804k compared with €3,229k at December 31, 2015. The Company has the possibility under certain conditions to draw a €1.5M tranche of debt with IPF Partners.

2016: Excellent sales momentum and strategic objectives achieved

Sales; marketing and regulatory:

2016 was a year of significant breakthroughs in the United States:

  • Contracts with important hospital systems were either signed or consolidated;
  • A partnership agreement with OrthoPediatrics for the exclusive commercialization of PediGuard® in pediatric hospitals was signed;
  • A commercial agreement with Spartan, which is dedicated to veteran and military institutions;
  • The expansion to 36 spine teaching institutions using DSG-enabled devices in their curriculum;
  • A number of non-stocking distributors growing from 77 to 80;
  • The sales team was reinforced with the hiring of a Sr. Sales Manager for the South region and by repositioning a product specialist in the Northeast region;
  • FDA clearance of the PediGuard Threaded was received in June 2016, with a product launch in October 2016 at the North American Spine Society (NASS) congress.

In the rest of the world, the Company focused on procuring extensive training and marketing support to the network of distributors making significant progress in various markets:

  • PediGuard now used in 50% of the French spine teaching institutions (CHU);
  • more than 800 PediGuard units sold in Saudi Arabia through a tender;
  • over 70 surgeons participated to the PediGuard Threaded workshop at EuroSpine congress in Berlin in October 2016.

Clinical:

Eleven surgeons presented their experience with PediGuard in international scientific conventions and five new clinical studies were initiated:

  • 2 prospective mono-centric studies for the use of PediGuard in minimally invasive surgery in France and United Arab Emirates;
  • 1 retrospective mono-centric study for the PediGuard use in so-called bi-cortical techniques in the US;
  • 1 prospective randomized and mono-centric study comparing PediGuard to navigation in the US;
  • 1 study on specimen about the use of the DSG™ screw with Zavation in the US.

2017 perspectives:

After the FDA clearance in the US early 2017 for the DSG™ screw, SpineGuard intends to:

  • Foster adoption of the DSG™ technology through sustained efforts towards surgeons, distributors, teaching institutions and industrial partners;
  • Sign new deals to expand the commercial penetration of the DSG™-enabled screws;
  • Enlarge the scope of the DSG™ platform to other applications such as Bone Quality Measurement (BQM), combination with robotic, licensing agreements for non-spine (trauma, maxillo facial);
  • Continue to grow sales and improve its operating result.

Next financial press release: First Quarter 2017 revenue, on April 6, 2017.

About SpineGuard®

Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 50,000 surgical procedures have been performed worldwide with DSG enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

For further information, visit www.spineguard.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Pierre Jérôme
Chief Executive Officer
Tel: +33 (0)1 45 18 45 19
p.jerome@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.fr
or
US
Ronald Trahan, APR, Ronald Trahan Associates Inc.
+1-508-359-4005, x108

Centrexion Therapeutics to Present Data on CNTX-4975 from the Treatment of Knee Osteoarthritis Pain at IX SIMPAR-ISURA

March 23, 2017

BOSTON–(BUSINESS WIRE)–Centrexion Therapeutics, a company focused on advancing the treatment of chronic pain with one of the largest exclusively pain-focused pipelines of non-opioid therapies in active development, today announced it will present 12-week data from TRIUMPH, a Phase 2b clinical trial of CNTX-4975 for the treatment of moderate to severe knee pain associated with osteoarthritis, at the IX SIMPAR-ISURA (Study in Multidisciplinary Pain Research – International Symposium of Ultrasound for Regional Anesthesia and Pain Medicine) meeting taking place March 29 – April 1, 2017 in Florence, Italy.

Full abstracts are available online at http://www.simpar-pain.com/. Details of the poster presentation are listed below. Additional data from the TRIUMPH study will be presented at medical meetings later this year.

Abstract Title (#41): CNTX-4975 Administration in Subjects With Knee Pain Associated With Osteoarthritis: 12-Week Results of a Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study
Poster Viewing: Noon CET, March 30 – 4:00 p.m. CET, April 1, 2017
Poster Discussion: 4:00 – 4:30 p.m. CET, March 31, 2017
Location: Florence Congress Palace

About CNTX-4975

CNTX-4975 is based on Centrexion’s proprietary STRATI® technology (Synthetic TRans cApsaicin ulTra-pure Injection), a highly potent, ultrapure, synthetic form of trans-capsaicin (a medicine traditionally derived from the chili plant). CNTX-4975 is designed to be injected directly into the site of pain to provide rapid onset, large reduction and long duration of relief from moderate to severe pain without affecting touch sensibility or position sense.

CNTX-4975 works by selectively targeting the capsaicin receptor (TRPV1) to rapidly inactivate only the local pain fibers transmitting signals to the brain. With a short half-life, STRATI® is cleared from the body within 24 hours. This approach provides pain relief that can last for months until the ends of the local pain fibers regenerate, while maintaining normal sensation, such as touch, pressure and position, and without the risks of toxicities of NSAIDs and injected corticosteroids or the side effects, including abuse and addiction, associated with opioid treatments.

About Centrexion Therapeutics

Centrexion Therapeutics, Corp. is focused on advancing the treatment of chronic moderate to severe pain with one of the largest exclusively pain-focused pipelines of non-opioid, non-addictive therapies in active development. Centrexion Therapeutics recognizes the needs of over a quarter of a billion people living with chronic pain worldwide, and aims to develop new, safer and more effective therapies that overcome the limitations and challenges associated with current pain treatments. Founded by world-renowned leaders in drug development and well-funded by key investors, Centrexion Therapeutics is building a pain treatment powerhouse to address the substantial and growing global chronic pain epidemic. Centrexion Therapeutics has recently relocated from Baltimore, Md. to Boston, Mass.

For more information about Centrexion, visit http://www.centrexion.com.

Contacts

Pure Communications, Inc.
Julie Normart, +1-415-946-1087
jnormart@purecommunications.com

Proposed US FDA User Fee Increase would Impact Smaller Medical Device Firms the Most

March 20, 2017 by

EMERGO SUMMARY OF KEY POINTS:

  • The Trump Administration has proposed user fee increases for drug, medical device and other FDA registrants in 2018.
  • Few specifics on the proposed increases make it difficult to determine exactly how medical device firms would be impacted.
  • Smaller manufacturers make up the vast majority of the US medical device industry, and would be most substantially affected by higher FDA fees.

US Food and Drug Administration user fee increases in the Trump Administration’s proposed 2018 federal budget would disproportionately impact smaller medical device companies, as these firms make up the majority of the US medical device industry.

President Trump’s recently released budget blueprint for 2018 would adjust FDA user fees for 2018 to more than $2 billion, “approximately $1 billion over the 2017 annualized…level, and replaces the need for new budget authority to cover pre-market review costs.” These increases would be offset by administrative initiatives to boost regulatory efficiencies and speed up market authorization timeframes, according to the text of the proposed budget.

 

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Bergen County, New Jersey, Doctor Charged With Taking Bribes

Dept. Of Justice U.S. Attorney’s Office, District of New Jersey – March 8, 2017

NEWARK, N.J. – A family doctor practicing in Bergen County, New Jersey, was charged today with accepting bribes in exchange for test referrals as part of a long-running and elaborate scheme operated by Biodiagnostic Laboratory Services LLC (BLS), of Parsippany, New Jersey, its president and numerous associates, U.S. Attorney Paul J. Fishman announced.

Bernard Greenspan, 78, of Saddlebrook, New Jersey, was indicted by a federal grand jury in Newark. The 10-count indictment charges Greenspan with one count of conspiring to commit violations of the Anti-Kickback Statute, the Federal Travel Act and wire fraud; three substantive violations of the Anti-Kickback Statute; three substantive violations of the Federal Travel Act; and three substantive violations of wire fraud. Greenspan will be arraigned at a later date.

“The charges contained in the indictment allege an extremely lucrative pattern of soliciting and accepting illegal payments for referrals to a specific testing lab,” said U.S. Attorney Fishman. “This indictment is part of our continued commitment to prosecute those physicians who sought to enrich themselves through their involvement in the BLS bribery scheme.”

“The FBI, in conjunction with our law enforcement partners, the U.S. Department of Health and Human Services’ Office of Inspector General, the Internal Revenue Service, and the U.S. Postal Inspection Service, will continue to investigate allegations of fraud and kickback schemes that undermine the integrity of our health care system,” stated Acting Special Agent in Charge Andrew Campi. “We urge anyone aware of this type of illegal activity to contact the FBI.”

“This indictment is another reminder that kickbacks in connection with federal health care programs are illegal and unacceptable,” said Scott J. Lampert, Special Agent in Charge, Office of Inspector General, U.S. Department of Health and Human Services. “Taking such payments subverts the notion that patients should come before profits.”

 

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Medtronic Announces Pricing of $2 Billion of Senior Notes

DUBLIN – March 21, 2017 – Medtronic plc (MDT) announced today that its wholly-owned subsidiary, Medtronic Global Holdings S.C.A. (“Medtronic Luxco”), has priced an offering of $1,000,000,000 principal amount of 1.700 percent senior notes due 2019 and $850,000,000 principal amount of 3.350 percent senior notes due 2027 (collectively, the “notes”). All of Medtronic Luxco`s obligations under the notes will be fully and unconditionally guaranteed by Medtronic plc and Medtronic, Inc., a wholly-owned indirect subsidiary of Medtronic Luxco, on a senior unsecured basis.

Medtronic also announced today that, concurrently with the offering by Medtronic Luxco, Medtronic, Inc. has priced an offering of $150,000,000 in principal amount of its 4.625 percent Senior Notes due 2045 (the “reopening notes”). The reopening notes will be a further issuance of, and will form a single series with, the $4,000,000,000 principal amount of Medtronic, Inc.`s currently outstanding 4.625 percent Senior Notes due 2045, and will be fully and unconditionally guaranteed by Medtronic Luxco and Medtronic plc on a senior unsecured basis. The offerings of the notes and the reopening notes are each being conducted pursuant to an effective registration statement under the Securities Act of 1933, as amended (the “Securities Act”).

The net proceeds of the offerings will be used for general corporate purposes. The offerings are expected to close on March 28, 2017, subject to customary closing conditions.

The joint book-running managers for the offerings are Citigroup Global Markets Inc., Goldman, Sachs & Co., Morgan Stanley & Co. LLC and Wells Fargo Securities, LLC. The co-managers for the offerings are BNP Paribas Securities Corp., Deutsche Bank Securities Inc., HSBC Securities (USA) Inc. and Mizuho Securities USA Inc.

The offerings of the notes and the reopening notes may be made only by means of a prospectus and prospectus supplement. You may get these documents for free by visiting EDGAR on the Securities and Exchange Commission (“SEC”) website at www.sec.gov. Alternatively, copies of the prospectus and prospectus supplement for each offering may be obtained from 20 On Hatch, Lower Hatch Street Dublin 2, Ireland, or by contacting Citigroup Global Markets Inc., toll-free at +1-800-831-9146, Goldman, Sachs & Co., toll-free at +1-866-471-2526 or Morgan Stanley & Co. LLC, toll-free at +1-866-718-1649.

About Medtronic
Medtronic plc, headquartered in Dublin, Ireland, is among the world`s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Forward-Looking Statements
This press release may be deemed to contain forward-looking statements regarding future events and the company`s future results that are subject to the safe harbor created under Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act and the Securities Exchange Act of 1934. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including but without limitation, statements relating to the offerings of the notes and the reopening notes and the use of proceeds therefrom, and the expected closing date of the offering of the notes and the reopening notes.

You should pay particular attention to the important risk factors and cautionary statements referenced in the “Risk Factors” section of the prospectuses related to the offerings referenced above, as well as the risk factors and cautionary statements described in Medtronic plc`s filings with the SEC, including the risk factors contained in each of Medtronic plc`s most recent Quarterly Reports on Form 10-Q and Annual Report on Form 10-K. Medtronic plc does not undertake to update its forward-looking statements.

Contacts:
Fernando Vivanco
Public Relations
+1-763-505-3780

Ryan Weispfenning
Investor Relations
+1-763-505-4626

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medtronic plc via GlobeNewswire

Global Spine Biologics Market Expected to Reach $2,214 Million by 2022 – Allied Market Research

PORTLAND, Oregon and PUNE, India, March 22, 2017 /PRNewswire/ —

Global spine biologics market was valued at $1,644 million in 2015, and is projected to reach $2,214 million by 2022, growing at a CAGR of 4.3% during the forecast period 2014-2022, according to a new report published by Allied Market Research.

Spine biologics are used during spine fusion surgery for the treatment of spinal deformities such as trauma, tumors, degenerative disc disease, and spinal cord injuries by stimulating bone growth formation through inflammatory stage, repair stage, and remodeling stage. Therefore, surge in the number of spinal fusion surgeries have fueled the adoption of biologics.

Get access to detailed report at: https://www.alliedmarketresearch.com/spine-biologics-market

The market is driven by factors such as increase in geriatric population and advantages of biologics such as minimal postoperative time, faster recovery, and ability to activate cellular growth. However, unfavorable reimbursement scenario, higher cost of bone grafts, and ethical issues related to bone grafting procedures hamper the market growth.

The bone graft substitutes segment generated the highest revenue in the global market, accounting for more than half of the total spine biologics market. In addition, the cell-based matrices segment is projected to grow rapidly, registering a CAGR of 5.9% during the forecast period.

According to Deepa Tatkare, Senior Analyst, Healthcare Research, Allied Market Research, “The emergence of biologic materials is one of the recent developments of spine fusion surgery. Earlier, autografts were considered as the ideal primary bone graft. However, allograft evolved as a better treatment option, owing to various associated complications such as pain, infection, and weakened bone. Thus, the use of biologics in spine surgeries is expected to witness higher demand in the future because of the constant development of new products.

KEY FINDINGS OF SPINE BIOLOGICS MARKET:

  • The demineralized bone matrix segment is expected to grow at a CAGR of 3.4%, owing to its ability to stimulate bone formation.
  • Synthetic bone grafts segment accounted for more than half of the global bone graft substitutes market in 2015.
  • North America contributed two-thirds share of the global spine biologics market in 2015.
  • France and Germany jointly accounted for more than one-third share of the European spine biologics market in 2015.
  • Japan is the major shareholder in the Asia-Pacific spine biologics market, accounting for more than one-third share in 2015.

North America is expected to maintain its dominance throughout the forecast period. However, Asia-Pacific region is projected to grow rapidly during the forecast period, registering a CAGR of 5.3%. Improving healthcare infrastructure and increase in expenditures in the emerging markets, such as India and China, to cater to the unmet medical needs in these countries have bolstered the market growth.

The key players in the spine biologics market are focused on expanding their business operations in the fast-growing economies with new product launches as the preferred strategy. The major companies profiled in the report include Alphatec Holdings, Inc., Depuy Synthes (Johnson & Johnson), Exactech, Inc., Globus Medical, Inc., Medtronic plc, NuVasive, Inc., Orthofix International N.V., RTI Surgical, Inc., SeaSpine, and Zimmer Biomet Holdings, Inc.

Read more about this research into the Medical Devices market: https://www.alliedmarketresearch.com/life-sciences/medical-devices-market-report

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SOURCE Allied Market Research