Integra LifeSciences Announces Expansion and Extension of Credit Facility to $1.5 Billion

PLAINSBORO, N.J., Dec. 07, 2016 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation(NASDAQ:IART) today announced that it has increased its credit facility with its bank group led by Bank of America, N.A.

The expanded and extended credit facility includes the following terms:

  • An increase in the credit facility from $1.1 billion to $1.5 billion, consisting of a $1 billion revolving line of credit and a term loan of $500 million;
  • An option to increase the aggregate size of the facility by at least $250 million with additional commitments;
  • No change in pricing terms or commitment fees to the existing facility; and,
  • Maturity of the credit facility is extended to December 7, 2021.

“We are pleased to announce this expansion and two-year extension of our credit facility under favorable credit terms,” said Glenn Coleman, Integra’s Chief Financial Officer.  “This new agreement strengthens our balance sheet and provides increased financial flexibility to pursue our long-term growth strategy.”

Integra LifeSciences plans to use a portion of the term loan to repay the outstanding indebtedness under the existing credit facility and cover fees and expenses incurred in connection with the new credit facility. Borrowings from the new revolving facility will be used to refinance the Convertible Notes that are due December 15, 2016 and for general corporate purposes.

Integra LifeSciences does not expect this increase in credit facility to have a material impact on 2016 financial performance.

About Integra

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for caregivers, so they can concentrate on providing the best patient care.  Integra LifeSciences offers innovative solutions, including leading regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies.  For more information, please visit www.integralife.com.

Forward-Looking Statements

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 Integra LifeSciences’ judgment as of the date of this release.   Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. These risks and uncertainties include market conditions and other factors beyond Integra LifeSciences’ control and the economic, competitive, governmental, technological and other factors identified under the heading “Risk Factors” included in item 1A of Integra LifeSciences’ Annual Report on Form 10-K for the year ended December 31, 2015, and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results. These forward-looking statements are made only as of the date thereof, and Integra LifeSciences undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Integra LifeSciences Holdings Corporation

Investor Relations: 
Angela Steinway
(609) 936-2268
angela.steinway@integralife.com 

Michael Beaulieu
(609) 750-2827
michael.beaulieu@integralife.com

Executives, Surgeons, Physicians, and Others Affiliated with Forest Park Medical Center (FPMC) in Dallas Indicted in Massive Conspiracy

December 1, 2016

DALLAS — Founders and investors of the physician-owned Forest Park Medical Center (FPMC) in Dallas, other executives at the hospital, and physicians, surgeons, and others affiliated with the hospital, have been charged in a federal indictment, returned by a grand jury in Dallas last month and unsealed today, with various felony offenses stemming from their payment and/or receipt of approximately $40 million in bribes and kickbacks for referring certain patients to FPMC.  The announcement was made this afternoon by U.S. Attorney John Parker of the Northern District of Texas.

FPMC was an out-of-network hospital.  According to the indictment, the referred patients were primarily ones with high reimbursing out-of-network private insurance benefits or benefits under certain federally-funded programs.  FPMC’s owners, managers, and employees also attempted to sell patients with lower reimbursing insurance coverage, namely unwitting Medicare and Medicaid beneficiaries, to other facilities in exchange for cash.  As a result of the bribes, kickbacks, and other inducements, from 2009 to 2013, FPMC billed such patients’ insurance plans and programs well over half of a billion dollars and collected over $200 million in paid claims.

The below-listed defendants are charged in the indictment:

Alan Andrew Beauchamp, 64, of Dallas
Richard Ferdinand Toussaint, Jr., 58, of Dallas
Wade Neal Barker, 51, of Dallas
Wilton McPherson Burt, 61, of Costa Rica
Andrea Kay Smith, 37, of Rockwall, Texas
Carli Adele Hempel, 40, of Plano, Texas
Kelly Wade Loter, 48, of Dallas
Jackson Jacob, 53, of Murphy, Texas
Douglas Sung Won, 45, of Dallas
Michael Bassem Rimlawi, 45, of Dallas
David Daesung Kim, 54, of Southlake, Texas
William Daniel Nicholson IV, 46, of Dallas
Shawn Mark Henry, 46, of Fort Worth, Texas
Mrugeshkumar Kumar Shah, 42, of Garland, Texas
Gerald Peter Foox, 69, of Tyler, Texas
Frank Gonzales Jr., 41, of Midland, Texas
Israel Ortiz, 49, of Dallas
Iris Kathleen Forrest, 56, of Dallas
Andrew Jonathan Hillman, 40, of Dallas
Semyon Narosov, 51, of Dallas
Royce Vaughn Bicklein, 44, of San Antonio, Texas

“Medical providers who enrich themselves through bribes and kickbacks are not only perverting our critical health care system, but they are committing a serious crime,” said U.S. Attorney John Parker. “Massive, multi-faceted schemes such as this one, built on illegal financial relationships, drive up the cost of healthcare for everyone and must be stopped.”

“The charges announced today show that the government will not tolerate corrupt practices by medical providers motivated by greed,” said Dallas FBI Special Agent in Charge Thomas M. Class, Sr. “The FBI will continue to work with our law enforcement partners to identify those who manipulate and defraud our healthcare system and to seek their prosecution.”

“The Defense Criminal Investigative Service (DCIS), in partnership with our federal law enforcement partners, will continue to aggressively investigate those who defraud the federal government, and ultimately the American taxpayers, in order to protect the integrity of federal health care programs,” said Special Agent in Charge Janice M. Flores of the DCIS Southwest Field Office.  “Fraud and abuse by healthcare providers poses a significant threat to the viability of government health care programs, and today’s arrests demonstrate the commitment of DCIS and it partners in rooting out health care fraud and to hold those accountable for their actions.”

“I would like to acknowledge and thank our OIG criminal investigators, and their law enforcement partners, for their tireless efforts in pursuing this case,” said Deputy Inspector General Norbert E. Vint.  “Their fine work protects the Federal Employees Health Benefits Program from those who would manipulate the health care system in order to steal taxpayer dollars.”

“An important mission of the Office of Inspector General is to investigate allegations relating to fraud involving the Federal Employees’ Compensation Act. We will continue to work with our law enforcement partners to investigate these types of allegations,” stated Steven Grell, Special Agent-in-Charge of the Dallas Regional Office of the United States Department of Labor, Office of Inspector General.

“The allegations against the defendants in this indictment indicate that patient trust was broken by the payments of kickbacks and bribes used to induce surgeons to use their hospital to perform services,” said Special Agent in Charge Tamera Cantu. “IRS Criminal Investigation, along with our law enforcement partners, will vigorously pursue corporate owners and managers that use their company to violate laws, including healthcare regulations.”

FPMC was founded by Beauchamp, Toussaint, Barker, Burt, and others as an out-of-network hospital; as such, it was free to set its own prices for services and was generally reimbursed at substantially higher rates than in-network providers.  FPMC’s strategy was to maximize profit for physician investors by refusing to join the networks of insurance plans for a period of time after its formation, allowing its owners and managers to enrich themselves through out-of-network billing and reimbursement.

Toussaint and Barker co-owned FPMC; Beauchamp and Burt managed it.  Beauchamp was FPMC’s Chief Operating Officer and was an investor in FPMC.  Toussaint, an anesthesiologist, was the President of FPMC’s board of directors.  Barker, a bariatric surgeon, was on FPMC’s board of directors.  Burt was a Managing Partner of FPMC and was also an investor in FPMC.

FPMC’s referral coordinator, Smith, owned a shell entity known as Unique Healthcare that the coconspirators created to funnel bribe and kickback payments to surgeons in exchange for those individuals referring patients to FPMC.  Smith tracked surgeries and referrals so surgeons and referral sources could receive “credit.”  Another FPMC employee, Hempel, was FPMC’s Director of Bariatric Services; she led efforts to sell Medicare and Medicaid referrals from certain coconspirators to a non-FPMC facility.

Jacob owned a shell entity known as Adelaide Business Solutions that he and others used to funnel bribe and kickback payments to surgeons, primary care physicians, chiropractors, lawyers, worker’s compensation preauthorization specialists, and others in exchange for those individuals referring patients to FPMC or to surgeons who used the hospital’s facilities to perform certain medical procedures, including surgeries.  Another company, Entity A, co-owned by Toussaint and Barker, was a commercial real estate group that provided commercial real estate services to FPMC and was used by the coconspirators as a conduit for bribe and kickback payments.  Loter owned an advertising agency that received bribe and kickback payments on behalf of physicians.

According to the indictment, two bariatric surgeons, Kim and Nicholson, investors in FPMC, received $4,595,000 and $3,400,000, respectively, in bribe and kickback payments in exchange for referring their patients to FPMC.  Three spinal surgeons, Won, Rimlawi, and Henry, also received bribe and kickback payments in exchange for referring their patients to FPMC.  The indictment alleges that Won received $7,000,000 and Rimlawi received $3,800,000 in bribe and kickback payments.  Henry was also an investor in FPMC.  The surgeons spent the vast majority of the bribe payments marketing their personal medical practices, which benefitted them financially, or on personal expenses, such as cars, diamonds, and payments to family members.

Other physicians who received bribe and kickback payments in exchange for referring patients to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital include Shah, a pain management doctor; Gonzales, a chiropractor who received approximately $385,000 in bribes and kickbacks; and Foox, who owned an orthopedic clinic in Tyler, Texas, and received approximately $500,000 in bribes and kickbacks.

Forrest, a worker’s compensation preauthorization specialist, received approximately $450,000 in bribe and kickback payments in exchange for referring patients, including those she was preauthorizing, to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital.  Bicklein was a worker’s compensation lawyer who received approximately $100,000 in bribe and kickback payments in exchange for referring patients, including his clients, to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital.

Ortiz owned a clinic that received approximately $1,100,000 in bribe and kickback payments for referring its patients to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital,

Collectively, Hillman and Narosov controlled a hospital consulting company, and they received approximately $190,000 in bribe and kickback payments in exchange for referring patient to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital.

According to the indictment, as part of the conspiracy, certain coconspirators also paid bribes and kickbacks of $500 per month to approximately 40 primary care physicians and practices to refer patients to the hospital or to surgeons associated with the hospital.  In addition to paying surgeons and primary care physicians, certain coconspirators also paid a host of others, including FECA beneficiaries, workers’ compensation preauthorization specialists, lawyers, businesses, runners, and chiropractors.  Certain coconspirators also “rented” space in doctors’ and chiropractors’ offices in outlying cities, including Foox’s clinic in Tyler, and clinics in Midland and Odessa, Texas, in exchange for patients being referred to FPMC or to surgeons who performed medical procedures at the hospital.

The bribes and kickbacks resulted in victim plans and programs being billed well over half of a billion dollars, including more than $10 million to the Department of Defense healthcare program TRICARE, more than $25 million to the Department of Labor FECA healthcare program, and more than $60 million to the federal employees’ and retirees’ FEHBP healthcare program, and FPMC collecting more than $200 million in tainted and unlawful claims.

Each of the 21 defendants is charged with one count of conspiracy to pay and receive health care bribes and kickbacks; the maximum statutory penalty upon conviction is five years in federal prison and a $250,000 fine.

Beauchamp is charged with 10 counts of offering or paying and soliciting or receiving illegal remuneration, in violation of the federal Anti-Kickback Statute, and aiding and abetting.  Toussaint, Barker, and Burt are each charged with five counts of this offense.  Jacob is charged with eight, Shah with three, Rimlawi with two, and Won, Kim, Nicholson, Gonzales, and Forrest each with one count of this offense.  The maximum statutory penalty upon conviction is five years in federal prison and a $25,000 fine.

Beauchamp is also charged with seven counts of violating the federal Travel Act and aiding and abetting.  Jacob is also charged with six counts of this offense; Toussaint, Barker, Burt, and Jacob are also each charged with four counts of this offense; Foox is also charged with two counts of this offense; and Won, Kim, Nicholson, Henry, and Gonzales are also each charged with one count.  The maximum statutory penalty upon conviction is five years in federal prison and a $250,000 fine.

Beauchamp, Toussaint, Barker, and Burt are also each charged with two counts of conspiracy to commit money laundering.  Jacob and Henry are also each charged with one count of this offense.  The maximum statutory penalty upon conviction is 20 years in federal prison and a $250,000 fine.

The indictment also includes a forfeiture allegation that would require the defendants, upon conviction, to forfeit to the U.S. any property, real or personal, which constitutes or is derived from proceeds traceable to the offenses.  Restitution could also be ordered.

An indictment is an accusation by a federal grand jury, and a defendant is entitled to the presumption of innocence unless proven guilty.

The case was investigated by the FBI, the U.S. Department of Labor Office of Inspector General, the U.S. Department of Labor Employee Benefits Security Administration, the U.S. Department of Defense – Defense Criminal Investigative Service, the U.S. Office of Personnel Management Office of Inspector General, and Internal Revenue Service Criminal Investigation, with assistance from the Food and Drug Administration and the U.S. Postal Inspection Service.

Assistant U.S. Attorneys Andrew Wirmani, Kate Pfeifle and Mark Tindall are prosecuting the case.

Topic:
Healthcare Fraud
Updated December 1, 2016

Osiris Provides Update Regarding NASDAQ Listing Matters

COLUMBIA, Md., Dec. 02, 2016 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ:OSIR) (the “Company”) today provided an update regarding the status of its compliance with the Listing Rules of the NASDAQ Stock Market (“NASDAQ”).

As previously disclosed, the Company participated in a hearing before the NASDAQ Hearings Panel (the “Hearings Panel”) on November 10, 2016 in connection with the Company’s late filings and the Company’s anticipated financial restatement relating to prior periods. At the hearing, the Company requested that the Hearings Panel grant the Company additional time to file its delinquent reports with the Securities and Exchange Commission (the “SEC”) and regain compliance with NASDAQ’s continued listing requirements.

On December 1, 2016, the Company received a decision letter from NASDAQ’s Office of General Counsel stating that the Hearings Panel has granted the Company’s request and, accordingly, the Company’s common stock will continue to trade on the NASDAQ Stock Market provided that the Company becomes current in its periodic filings with the SEC on or before March 10, 2017. The letter stated that March 10, 2017 represents the full extent of the Hearing Panel’s discretion to grant continued listing while the Company is non-compliant.

The Company is continuing to work diligently to complete its previously announced accounting reviews, restatement of prior period financial statements, transition to a new independent registered public accounting firm and 2015 audit so that it will be in a position to file its delinquent periodic reports with the SEC as soon as possible. However, there can be no assurance that the Company will be able to complete all of this work and become current in its SEC filings by March 10, 2017. If the Company is not able to file all of its delinquent periodic reports with the SEC by March 10, 2017, then the Hearings Panel will issue a final delist determination and the Company will be suspended from trading on the NASDAQ Stock Market. There can be no assurance regarding the timing or ultimate outcome of this process or the ability of the Company to successfully maintain its NASDAQ listing.

About Osiris Therapeutics

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

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding any of the following: the outcome of the NASDAQ delisting process; the ability of the Company to successfully maintain its NASDAQ listing; the outcome of the restatement, including the materiality, significance, nature, subject matter, timing or quantitative effects of the Company’s restated financial statements; the timing of the transition to a new independent registered public accounting firm; the completion of the audit of the Company’s 2015 financial statements; and the timing of the filing of the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 and its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016, June 30, 2016 and September 30, 2016. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled “Risk Factors” in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with the SEC. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.

For additional information, please contact:



Diane Savoie

Osiris Therapeutics, Inc.

(443) 545-1834

OsirisPR@Osiris.com

Primary Logo

Source: Osiris Therapeutics, Inc.

News Provided by Acquire Media

Johnson & Johnson Just Got Hit With a $1B Verdict Over Faulty Hip Implants

 

By  – December 2, 2016

A federal jury in Dallas on Thursday ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay more than $1 billion to six plaintiffs who said they were injured by Pinnacle hip implants.

The jurors found that the metal-on-metal Pinnacle hip implants were defectively designed and that the companies failed to warn consumers about the risks.

J&J JNJ 0.47% , which faces more than 8,000 lawsuits over the hip implants, said in a statement it would immediately appeal the verdict and was committed to defending itself and DePuy from further litigation over the Pinnacle devices.

The six plaintiffs awarded more than $1 billion are California residents who were implanted with the hip devices and experienced tissue death, bone erosion and other injuries they attributed to design flaws. Plaintiffs claimed the companies promoted the devices as lasting longer than devices that include ceramic or plastic materials.

Both companies denied any wrongdoing stemming from the development and marketing of the devices.

According to plaintiff’s lawyer Mark Lanier, the total verdict of $1.041 billion included $32 million in compensatory damages. The rest were punitive damages.

 

READ THE REST HERE

 

 

Memphis Looks to Medical Manufacturing to Cut Poverty

BY JOHNNY MAGDALENO | DECEMBER 2, 2016

Poverty rates have dropped in Memphis, Tennessee, since the start of the decade, but it’s still one of the poorest large urban areas in the U.S. With 18.4 percent of its 1.3 million residents taking home annual incomes below the federal poverty threshold, it’s second only to Tucson, Arizona, when it comes to lacking opportunity for a living wage.

One local industry could help: medical device manufacturing. And the city was just awarded nearly $6 million from the U.S. Department of Labor to help fortify the system of community colleges, manufacturers and workforce organizations pulling talent from Memphis’ poorest communities to prep them for this booming sector.

Similar cash injections went to 22 similar efforts throughout the U.S. — 18 of which are urban areas with populations greater than 50,000 — as part of President Barack Obama’s community college reimbursement plan, called America’s Promise. The $111 million doled out during this round will help these cities build up the types of cross-sector workforce programs backed by federal law through the Workforce Innovation and Opportunity Act, enacted back in 2014. It’ll also help cover community college costs for disadvantaged workers looking for additional training.

Pauline Vernon, of the Greater Memphis Alliance for a Competitive Workforce (GMACWorkforce), says her region has been building a pipeline around medical device makers for the past few years. Shelby County hosts the second-largest cluster of these manufacturers in the U.S.

Part of the reason why the region is so attractive to this sector? Expediency. Memphis is home to FedEx’s World Hub, the company’s largest express shipping location.

“If somebody needs a knee replacement on the West Coast tomorrow, it can be manufactured here today and in the surgeon’s hands tomorrow,” says Vernon. “And that’s the basis for a lot of our biomedical facilities here.”

She says this Department of Labor support was “a pretty easy award” to get. Seventeen of the region’s medical device manufacturers formed a nonprofit in March 2015 to tackle the same issues at the core of the America’s Promise program. That coalition, the Greater Memphis Medical Device Council (GMMDC), brought a laundry list of job demands to Vernon and her co-workers.

READ THE REST HERE

Amplitude Surgical Successfully Carries out a 65 Million Euro Bond Financing Placement

December 01, 2016 – VALENCE, France–(BUSINESS WIRE)–

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading player on the global surgical technology market for lower-limb orthopedics, today announces the completion of a new 65 million euro bond issue. This new bond debt has enabled the Group to carry out the early repayment of 35 million euros of its previous debt while providing it with an additional 30 million euros, which will give the Group the necessary financial resources to pursue its international development.

Philippe Garcia, CFO of Amplitude Surgical, says: “This bond issuance represents a key milestone to strengthen our financial structure. With a more favorable interest rate and greater financial flexibility, this additional 30 million euros of funding will enable us to finance our expansion, notably in the United States, and to move into new territories.

This new bond debt carries a 5% annual coupon and has a maturity of six years. The terms of the existing residual debt have been significantly improved, with a 100-bp reduction in the margin and a 2-year extension of the maturity date to September 2023.

About Amplitude Surgical

Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. Amplitude Surgical distributes its products in more than 30 countries. At June 30, 2016, Amplitude Surgical had a workforce of almost 300 employees and recorded sales of over 80 million euros.

Contacts

Amplitude Surgical
Philippe Garcia, +33 (0)4 75 41 87 41
CFO
philippe.garcia@amplitude-ortho.com
or
NewCap
Investor Relations
Marc Willaume, +33 (0)1 44 71 00 13
amplitude@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 98 55
amplitude@newcap.eu

OrthoSpace Completes Equity Financing Round

CAESAREA, Israel, Dec. 1, 2016 /PRNewswire/ — OrthoSpace, Ltd. (http://orthospace.co.il/), a global innovative shoulder implant company, today announces that it has closed on a $7 million equity financing round.  The funds will be used to support the ongoing US Investigational Device Exemption (IDE) FDA Study, build out the Company’s commercial activities in Europe, South America and Asia and provide working capital.  Existing investors, HealthpointCapital LLC, Smith & Nephew and TriVentures participated in this round, alongside a new investor, Johnson & Johnson Innovation – JJDC, Inc.

The Company’s product, InSpace™, is an orthopedic biodegradable balloon system that is a simple, minimally invasive method that addresses unmet clinical needs in rotator cuff repair.  InSpace is marketed in Europe, Israel, Russia and Hong Kong where 10,000 balloons have been implanted. It is indicated for patients who suffer from a rotator cuff injury, and it reduces shoulder pain and improves the range of motion. The procedure can be performed in an outpatient setting.

Itay Barnea, CEO of OrthoSpace, commented, “This is an exciting time for OrthoSpace.  We are seeing great traction for InSpace among the European shoulder community where surgeons are grateful for a simple, effective option to treat rotator cuff injury.  US surgeons have begun to learn about and gain experience with our device through participation in the US IDE Study, where enrollment is well underway.  We are pleased to complete this financing to continue to invest in the Company’s growth, and we look forward to offering InSpace in additional major markets worldwide.”

OrthoSpace, Ltd.

OrthoSpace is a privately held medical device company located in Caesarea, Israel.  The Company’s product, InSpace, is an orthopedic biodegradable balloon system that is simple, safe and a minimally invasive method that addresses unmet clinical needs in rotator cuff repair.  InSpace is CE Marked and commercialized in Europe, Israel, Russia and Hong Kong and has been granted an Investigational Device Exemption (IDE) to initiate a pivotal human clinical study of the system in the United States.

HealthpointCapital, LLC

HealthpointCapital is a values-driven, research-based private equity firm exclusively focused on the orthopedic and dental device businesses. HealthpointCapital has more than $800 million of institutional capital under management and is the only firm of its kind to focus exclusively on the $45 billion worldwide orthopedic and dental device industry.

Smith & Nephew plc

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 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

TriVentures

TriVentures is a venture capital fund focused on investing in medical device and digital health technologies from seed stage to industry leaders. TriVentures has over $130 million under management dedicated to ventures primarily in Israel and the United States.

Johnson & Johnson Innovation – JJDC, Inc. (JJDC)

Johnson & Johnson Innovation – JJDC is the venture capital subsidiary of Johnson & Johnson that has been investing since 1973 in the medical device, diagnostic, pharmaceutical, and consumer health areas. JJDC’s goal is to create opportunities that meet the strategic needs of its operating affiliates while providing visibility to innovative emerging technology, businesses and business models. JJDC invests in companies across the continuum from early stage seed investments to advanced stages of series venture management.

 

Contact: Ariella Golomb, 212-810-4742

SOURCE OrthoSpace, Ltd.

 

JRI Orthopaedics strengthens Chinese links

30 Nov 2016 – By Aimee Robinson, Business Quarter

British healthcare company JRI Orthopaedics has strengthened its presence in China and the Far East after securing a new multi-million pound deal.

The company has secured regulatory approval to sell its hip product portfolio in China and has signed an exclusive distribution deal with China’s largest domestic orthopaedic producer, AK Medical.

The Chapeltown firm expects to sell a minimum of 10,000 hip implants in China over the next five years.

Keith Jackson, JRI Orthopaedics chief executive, said: “China has a population of 1.3 billion but currently only 250 million people have access to a hip replacement. The potential is huge and we see this as a significant market for the company.

“There is a really good appetite for high-quality, innovative British brands. Our proven, world class, precision manufacturing capabilities and efficiencies means we have defied convention to manufacture Chinese-designed products for the Chinese market here in Sheffield.

 

READ THE REST HERE

 

UnitedHealthcare Launches New Value-Based Care Payment to Help Improve Health Outcomes and Reduce Costs for Knee, Hip and Spine Procedures

December 01, 2016

MINNETONKA, Minn.–(BUSINESS WIRE)–UnitedHealthcare has launched a new value-based care payment for knee, hip and spine procedures that focuses on quality patient care and better outcomes. The initiative – the Spine and Joint Solution – is available to employers nationwide and works with health care facilities that perform a higher number of these surgeries and have demonstrated better outcomes and fewer complications.

The Spine and Joint Solution gives UnitedHealthcare employer-sponsored plan participants access to surgeons and facilities that qualify as UnitedHealthcare Centers of Excellence and accept bundled case rates for certain procedures, including knee and hip replacement, spinal fusion and spinal disc repair. The program currently includes more than 40 health care facilities in 25 markets across the country, with plans to expand to more than 40 markets during 2017.

The bundled payment method reimburses a care provider or hospital for a defined episode of care, such as knee or hip replacement, under a single fee or payment. This is a shift away from the common fee-for-service structure in which a care provider is paid for each treatment, appointment or test, generating multiple claims within a single, broader episode of care.

The Spine and Joint Solution is currently available nationwide to large and mid-sized companies with self-funded health plans, helping expand access to high-quality, cost-effective care and potentially saving employees out-of-pocket costs. Since the program’s introduction as a pilot in 2015, participating employers have recorded an average savings of $10,000 or more per operation when compared with median costs in the same metropolitan area. Through the initiative, eligible employees may save more than $1,000 in out-of-pocket costs per procedure when accessing a participating facility rather than another in-network medical facility.

Musculoskeletal procedures are becoming increasingly common due to an aging population and higher obesity rates. For instance, the number of knee replacement surgeries performed nationally is expected to increase by 500 percent by 2030, according to a recent studyfrom the Healthcare Cost and Utilization Project. Moreover, these surgical procedures are expensive (knee/hip replacements average $35,000 per operation), and costs vary widely among care providers.

“Knee, hip and spine surgeries are among of the fastest increasing categories of medical procedures, so this program provides a new way to help improve the quality of care, produce better outcomes for patients and better manage costs for employers,” said Sam Ho, M.D., chief medical officer of UnitedHealthcare. “Our partnership with participating health care providers and facilities is an important step toward achieving better health outcomes while reducing the overall cost of care.”

UnitedHealthcare Value-Based Care Portfolio Continues to Grow
Value-based care models have made tremendous gains in adoption across America’s health care system over the last few years. UnitedHealthcare’s care provider reimbursements that are tied to a variety of value-based care arrangements have nearly tripled in the last three years to nearly $50 billion annually, and are expected to reach $65 billion by the end of 2018. To date, more than 14 million people, or nearly one in every three people enrolled in UnitedHealthcare benefit plans, currently access care from providers in value-based care relationships.

The Spine and Joint Solution currently partners with health care facilities that have been independently evaluated for providing quality patient care and better outcomes. Participating facilities are located in major markets nationwide, including Boston, Chicago, Dallas and Los Angeles.

“Providing the best outcomes and an exceptional patient experience in an affordable way are key to helping our patients live healthier lives,” said Tim Cappel, executive director of Population Health Management for Cincinnati’s The Christ Hospital, one of first facilities to participate in the program. “Employers seeking effective cost-containment strategies recognize the value of fixed and competitive prices. Through these and other innovative approaches, The Christ Hospital Health Network is transforming the way our patients receive care.”

For more information about the Spine and Joint Solution and Value-Based Care, visit www.uhc.com/valuebasedcare.

About UnitedHealthcare
UnitedHealthcare is dedicated to helping people nationwide live healthier lives by simplifying the health care experience, meeting consumer health and wellness needs, and sustaining trusted relationships with care providers. The company offers the full spectrum of health benefit programs for individuals, employers, military service members, retirees and their families, and Medicare and Medicaid beneficiaries, and contracts directly with 1 million physicians and care professionals, and 6,000 hospitals and other care facilities nationwide. UnitedHealthcare is one of the businesses of UnitedHealth Group (NYSE: UNH), a diversified Fortune 50 health and well-being company. For more information, visit UnitedHealthcare at www.uhc.com or follow @myUHC on Twitter.

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Contacts

UnitedHealthcare
Will Shanley, 714-204-8005
will.shanley@uhc.com

JOT Study Finds Generic Orthopaedic Implants Clinically Equivalent and Provide High Value

December 01, 2016

RENO, Nev.–(BUSINESS WIRE)–The Orthopaedic Implant Company (OIC), a medical device company that specializes in high-value orthopaedic implants, announced today the publication of an independent study examining the clinical and economic impact high-value orthopaedic implants have on the market.

The Clinical and Economic Impact of Generic Locking Plate Utilization at a Level II Trauma Center,” published in the Journal of Orthopaedic Trauma, examines the performance of a hospital’s cost containment program utilizing high-value orthopaedic trauma implants provided by The Orthopaedic Implant Company (OIC). Plates available for the study were pre-contoured, anatomic and variable-angle locking plates indicated for small fragment fractures of the clavicle, radius, humerus, tibia and fibula.

The study compares the cost and outcomes of 828 patients, half of whom received generic implants while the other half received conventional implants. Conclusions found clinical outcomes to be comparable and savings averaged $1,197 per case, or $458,080 collectively.

“We are pleased to see the positive impact our products have had for patients , not just clinically but financially as well,” said Itai Nemovicher, President and CEO of OIC. “Similar to the results seen with generic pharmaceuticals, this study validates the effectiveness that generic implants have in today’s value-driven healthcare environment.”

About Orthopaedic Implant Company: OIC entered the medical device market in 2010 with an innovative approach to delivering the highest quality implants at the lowest possible prices. OIC implants cost 50 to 60 percent less than the average market price of premium implants, saving health care systems millions of dollars a year. OIC’s high-quality, low-cost implants and products can be used for a variety of procedures, including treatment of orthopaedic trauma and spinal injuries.

Contacts

Orthopaedic Implant Company
Steve Lichtenthal, 1-775-636-8281
steve@orthoimplantcompany.com