RTI Surgical® Fills the Void in Anterior Cervical Discectomy and Fusion (ACDF) Procedures

ALACHUA, Fla. (December 8, 2016) – RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, announced today that its C-Plus™ Peek* IBF System is now indicated for use with allograft, including its proprietary map3® cellular allogeneic bone graft.

“This indication is important news because it now gives surgeons options that they didn’t have before,” noted Brian Hutchison, RTI president and chief executive officer. “Previously, the C-Plus Peek IBF System was indicated for use with only autograft, but now surgeons have more options and can tailor treatment to each individual patient’s needs.”

The map3 cellular allogeneic bone graft supports the body’s innate healing mechanisms and provides the scaffold and signals to support bone growth. The implant contains the three essential elements of bone formation (cortical cancellous bone chips supply an osteoconductive scaffold, demineralized bone matrix demonstrates verified osteoinductive potential and MAPC®-class cells, a specific type of stem cell provide osteogenic and angiogenic signals to support the bone healing process). The C-Plus Peek IBF System is a PEEK interbody fusion system that offers multiple options and features designed to provide stability and anatomic restoration, facilitating fusion, when used with autogenous bone graft, and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft, in anterior cervical discectomy and fusion (ACDF) surgery.

“We are pleased to have received this indication for the C-Plus system, which expands our product portfolio that can be used with one of our key product innovations, map3 cellular allogeneic bone graft,” Hutchison said. “We can now offer surgeons an all-inclusive RTI portfolio with C-Plus implants, map3 allograft and the Aspect® Anterior Cervical Plate (ACP) System, proving once more our commitment to providing surgeons with integrated offerings to help their patients.”

*PEEK-OPTIMA® from Invibio® Biomaterial Solutions
® indicates U.S. trademark registration. All trademarks and/or images are the property of their respective owners or holders.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Abyrx® Announces Expansion of Exclusive, Worldwide License Agreement with Bezwada Biomedical; Completes $10M Equity Financing.

IRVINGTON, N.Y., Dec. 6, 2016 /PRNewswire/ — Abyrx®, Inc., a privately-held specialty biosurgical products company, today announced the expansion of its exclusive, worldwide license agreement with Bezwada Biomedical, LLC to include the development, manufacture, and commercialization of Bezwada’s proprietary adhesive technology for soft tissue applications.  Previously, in 2011, Abyrx and Bezwada announced a similar partnership for hard tissue (bone) applications.  With this new partnership, Abyrx gains exclusive access to proprietary materials and manufacturing that it will use to develop products for surgical site hemostasis, sealing, and fixation.

In addition to its announcement of the new technology license with Bezwada, Abyrx also announced it recently completed a $10Mequity financing with strong support from inside investors.  The new funds will be used to manage the growing demand for Abyrx’s bone putty products and to accelerate Abyrx’s pipeline development activities.

John J. Pacifico, Abyrx’s President and Chief Executive Officer, said the additional rights to use Bezwada’s technology for soft tissue applications and the new financing come as growth of Abyrx’s existing commercial business is accelerating.  “We are very pleased by the support of our investors and thrilled to be broadening the scope of our manufacturing and technology platforms with Dr. Bezwada and his team to include new capabilities for soft tissue products,” Mr. Pacifico commented.  “These new developments enhance the level of service we deliver to providers of care and deepen our relevance in the surgical procedures we support.”

“We have been very impressed by Abyrx’s ability to advance our technology platforms from lab-scale production to finished products that solve unmet needs,” stated Rao Bezwada, Ph.D., President and Chief Executive Officer of Bezwada Biomedical. “Given Abyrx’s history of success in developing and commercializing new products, and the support Abyrx continues to receive from the venture capital community, we are excited about our future with Abyrx and we are dedicated to ensuring Mr. Pacifico and his team have everything they need to achieve their objectives for the bone and soft tissue marketplaces.”

Abyrx and Bezwada recently initiated development programs to advance their new products towards commercialization.  Both Abyrx and Bezwada believe they have a significant opportunity to address the limitations of other marketed products for soft tissue hemostasis, sealing, and fixation because of the high rate of reactivity and unique tunability of the Bezwada polymer technology.

The terms of the $10M equity financing were not disclosed but the company named members of its executive team as participants in addition to Canaan Partners, MedEdge, and BB BIOTECH VENTURES through their respective entities.

ABOUT ABYRX

Founded in 2013, Abyrx develops, manufactures, and provides specialty biosurgical products for use during surgical procedures.  Abyrx’s products are protected by over forty issued and pending patents covering a broad range of compositions and methods.

Abyrx is located in Irvington, New York.  For more information, please visit www.abyrx.com.

ABOUT BEZWADA BIOMEDICAL

Bezwada Biomedical designs and manufactures raw materials for use in the production of biocompatible polymers.  Bezwada’s technology is protected by over thirty issued and pending patents covering a broad range of compositions and methods.

Bezwada Biomedical has laboratories, production facilities, and offices in India and Hillsborough, NJ.  For more information, please visit www.bezwadabiomedical.com.

SOURCE Abyrx, Inc.

Related Links

http://www.abyrx.com

International Cartilage Repair Society Launches First Global Patient Registry to Expand Knowledge Base Worldwide

ZURICH, December 7, 2016 /PRNewswire/ —

The International Cartilage Repair Society (ICRS) has launched the first global, web-based patient registry, offering a unique international data pool for articular cartilage injury, history and treatment worldwide.

The Registry will dramatically expand the body of evidence available to clinicians, companies and health funders, providing pooled data that can be harnessed to better understand the most effective, safe, economical and clinically-relevant treatments, devices and practices in the treatment of acute cartilage damage and early osteoarthritis. “This is a fast-moving field with many new techniques”, said Dr Kenneth R. Zaslav, President of the ICRS. “The Registry will allow us to coordinate care and research between our members, and it will help companies see relevant problems sooner, and thereby get a feeling for usage of their technologies. In addition, our hope is that the Registry will serve as a pooled data source for comparing treatments thereby facilitating more rapid enrolment in prospective, randomised studies – in turn shortening the overall time for improvements in patient care.”

Crucially, the Registry uses a simple, intuitive web-based interface to harness the data. First, a patient adds themselves electronically and consents to inclusion in the Registry. The clinician then inputs the clinical data, after which the Registry contacts the patient to record their outcome scores and any complications. Along with new data, the Registry is also able to assimilate existing data sets, thereby immediately bolstering the potential for longer-term follow-up of patients who have previously been in trials, or those already part of smaller registries. “Within the first year of the Registry we will be able to incorporate 10-year data for some patients and techniques”, noted Dr Leela Biant, Chair of the ICRS Registry Steering Committee. Furthermore, in conjunction with core, pooled data sets the Registry software allows clinicians to bolt on additional scores or unique outcome measures relevant to them.

At launch the Registry is available in English with six additional languages planned for the spring of 2017. Current data is restricted to the knee with the ankle, hip and shoulder being incorporated in the near future.

FOR MORE INFORMATION PLEASE VISIT:

http://cartilage.org/society/icrs-patient-registry/

The purpose of the ICRS is charitable: The society envisages the scientific research and the exchange of knowledge among physicians, scientists, patients and researchers of the industry in the field of Cartilage Repair.

CONTACT
Cartilage Executive Office (CEO) GmbH
Email: ceo@cartilage.org
Web: http://cartilage.org/

 

SOURCE The International Cartilage Repair Society (ICRS)

curasan receives approval for orthopedic product in the strategically important US market

Kleinostheim, 7 December 2016 – curasan AG, a leading specialist for medical products in the field of orthobiologics, has received the market clearance of the Food and Drug Administration (FDA) and thus the authorization to market its synthetic bone regeneration material CERASORB Ortho FOAM in the United States.

The innovative product made of resorbable ceramic and porcine collagen can now be used for bone defect treatment in extremities and pelvis on the US market as well as in all other countries where the FDA certification is recognized.  curasan has been actively preparing the market launch of the product in recent months. Back in May, Shane Ray, an experienced orthopedic regenerative medicine sales and marketing executive, was appointed as the President of the US subsidiary curasan, Inc. “The FDA approval of CERASORB Ortho FOAM is an extremely important milestone for us in the re-orientation of our US business, which will open up a potential market worth more than US$ 900 million,” emphasized Michael Schlenk, CEO of curasan AG. “Even before the approval, major customers indicated during exploratory discussions that the flexible and mouldable version of CERASORB meets the demands of the US customers  perfectly, much more so than any of our other products.”

Ahead of the market launch of the product the American subsidiary also successfully completed its structural reorganization in the fourth quarter to align the ability to be successful in dental and orthopedics business within North America. Being able to report this important strategic milestone in the fourth quarter is due to the profound expertise of our internal approval department, which was optimally prepared for the dialogue with the FDA and could answer all of their questions quickly.  I’m very proud of our team!”  

Your contact at curasan AG:
Andrea Weidner
Head of Corporate Communications
+49 6027 40 900-51
andrea.weidner@curasan.com 

Your contact at curasan Inc.:
Beth Lloyd
+001 (919) 941-9770

office@curasan.com 

About curasan AG:

curasan AG develops, manufactures and markets biomaterials and other medical products in the field of bone and tissue regeneration. A pioneer in its industry, curasan is specialized primarily on synthetic bone grafting ­materials for dental and orthopaedic applications. Numerous patents and a comprehensive list of scientific documentation prove the clinical success of the products and the highly innovative strength of curasan. Surgically active dentists, implantologists and oral, maxillary and dentofacial surgeons, as well as orthopaedics, traumatologists and spinal column surgeons worldwide benefit from the broad range of the premium quality and user-oriented portfolio offered by the technology leader. curasan maintains its own high-tech facilities for research, development and manufacturing in Frankfurt/Main, Germany, which are approved by the Food and Drug Administration (FDA) and other international authorities. In addition to its headquarters, the company has a subsidiary, curasan Inc., in the Research Triangle Park, near Raleigh, N.C., USA. The shares of curasan AG are listed in the General Standard at the Frankfurt Stock Exchange.

JLL Partners and Water Street Announce New Investment in Medical Device Services Provider

CHICAGO and NEW YORK, Dec. 7, 2016 /PRNewswire/ — Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, and JLL Partners, a leading middle-market private equity firm, announced today that they have acquired MedPlast, Inc.  Headquartered in Tempe, Arizona, MedPlast is a leading global services provider to the medical device industry.

MedPlast offers a range of engineering and manufacturing capabilities that support the world’s leading original equipment manufacturers (OEMs) with producing diagnostic, orthopedic, surgical and other medical products.  The company employs more than 1,800 engineers, technicians and assembly workers who specialize in technical molding, advanced processing, device assembly and implantables with expertise in plastics.  Over the past five years, MedPlast has expanded its operations to encompass 11 ISO-certified facilities across the United States, China, Mexico and the United Kingdom.

“MedPlast has well-established and trusted relationships with the world’s leading medical manufacturers who value the company’s high-quality standards that meet their demanding industry regulations.  We will work with MedPlast’s team to expand its suite of capabilities into new areas to form a comprehensive, integrated portfolio of end-to-end product solutions,” said Peter Strothman, partner, Water Street.

A $40 billion-dollar market, medical device services continues to grow as increasing numbers of original equipment manufacturers turn to outsourcing providers to generate cost and time efficiencies. It is a highly fragmented sector with hundreds of providers offering design, engineering, manufacturing supply chain and logistical services.

“MedPlast stands out for its health care expertise, extensive global footprint and breadth of high- quality capabilities,” said Daniel Agroskin, partner, JLL Partners.  “Together with Water Street, we will invest our expertise and resources to expand MedPlast’s services into high-value areas and build on its strong base of long-term customer relationships.”

MedPlast is the second collaboration between JLL Partners and Water Street.  The firms recently worked together to build Bioclinica, Inc. into one of the world’s leading providers of specialty outsourced clinical trial solutions.

“Our partnership with JLL and Water Street is an important step toward achieving our goal of building MedPlast into an end-to-end services provider focused on the health care industry,” said MedPlast Chief Executive Officer Harold Faig.  “For the past eight years, we have optimized our capabilities toward health care.  This acquisition will give us access to expertise and resources to grow our core competencies into areas that will bring considerable value to our customers.”

Financial terms of the acquisition are not being disclosed.

About JLL Partners

JLL Partners is a leading middle-market private equity firm with a 28-year track record of adding value to complex investments through its financial and operational expertise. Since its founding in 1988, JLL Partners has committed approximately $5 billion across seven funds, and developed significant expertise in the health care sector. JLL Partners is a control investor and sources its deals from its deep network of industry contacts, applying its proven, value-oriented and growth-driven investment approach to provide limited partners with attractive risk-adjusted returns throughout all investment cycles.  The firm is headquartered in New York.  For more information about JLL Partners, visit jllpartners.com.

About Water Street

Water Street is a strategic investor focused exclusively on health care. The firm has a strong record of building market-leading companies across key growth sectors in health care. It has worked with some of the world’s leading health care companies on its investments including Johnson & Johnson, Medtronic, Smith & Nephew and Walgreen Co. Water Street’s team is comprised of industry executives and investment professionals with decades of experience investing in and operating global health care businesses. The firm is headquartered in Chicago. For more information about Water Street, visit waterstreet.com.

SOURCE Water Street Healthcare Partners

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

Arthrosurface Names Industry Veteran Joe Darling as Executive Chairman

FRANKLIN, Massachusetts, Dec. 7, 2016 /PRNewswire/ –Arthrosurface®, an orthopedic medical technology company focused on the orthopedic upper and lower extremities markets, has named Joe Darling as the Company’s Executive Chairman. Mr. Darling will join the company in this newly created position shaping the future strategic direction with respect to, and overseeing and directing, the company’s commercial activities and business operations. The company has added Mr. Darling to their Board of Directors.

Mr. Darling’s business career spans both the pharmaceutical and medical device markets including senior management positions with Abbott Laboratories, Wyeth Pharmaceuticals, and executive level positions with Baxter International as Vice President of Marketing and Health Systems, Senior Vice President and General Manager of Smith and Nephews Sports Medicine and Biologics business, Global President of Linvatec Corporation, and Executive Vice President, Corporate Commercial Operations with CONMED Corporation, and most recently as Chief Operating Officer with Interventional Spine, Inc.

Joe’s proven leadership skills have spanned many functional areas in general management including sales, marketing, R&D, operations, regulatory and quality, finance and human resources. “Mr. Darling is well known within the orthopedic market and brings a vast knowledge of the industry to Arthrosurface. We are excited to have Joe on board,” said Dana Callow, Managing General Partner of Boston Millennia Partners. “Joe’s depth of experience and leadership skills will provide the Arthrosurface team with the strategic direction and experience necessary to accelerate the global profitable growth of the company.”

“Joe has deep experience in the global development and launch of innovative orthopedic products and we are excited to have him join the Arthrosurface team,” said Steve Ek, CEO and Founder. “We look forward to utilizing Joe’s deep understanding of the orthopedic markets along with his extensive relationships across the industry.”

“I am pleased to join Arthrosurface and look forward to working with the Arthrosurface team as we reshape the strategic direction of the company” Mr. Darling said.

About Arthrosurface


Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. The product offerings include devices, instruments and biologics designed to preserve and restore the joints so patients can maintain an active lifestyle. The Company offers a variety of unique systems that provide less invasive technologies for surgeons that can be used to treat a wide range of joint conditions. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 13 years.

 

© 2016 PR Newswire

 

Paradigm Spine, LLC Announces Publication Of ISASS Guidelines Recommending Coverage Of Interlaminar Stabilization®

NEW YORK, Dec. 6, 2016 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis (LSS) announces publication of the International Society for the Advancement of Spine Surgery (ISASS) Policy Statement on November 10, 2016 by Richard Guyer, M.D., et al of “ISASS Recommendations/Coverage Criteria for Decompression with Interlaminar Stabilization – Coverage Indications, Limitations, and/or Medical Necessity” in the International Journal of Spine Surgery, a high-quality peer-reviewed journal published on behalf of ISASS.  Please find a link to the article here:  http://dx.doi.org/10.14444/3041.

Per the Policy Statement, lumbar decompression with interlaminar stabilization is recommended for coverage in carefully selected LSS patients without gross instability or in which the decompression procedure itself may create iatrogenic instability. The Policy Statement accurately notes that “there exists a population of patients who present with moderate to severe stenosis, with concomitant back pain, where decompression alone does not adequately address back pain.”  Interlaminar stabilization after direct decompression is a non-fusion surgical option that can provide the additional stability over decompression alone without the rigidity of an instrumented fusion.  The Policy recognizes the benefits of coflex compared to fusion and further states, “In select patients within the LSS continuum, decompression with interlaminar stabilization has proven to provide equivalent outcomes with a reduced cost compared to decompression plus fusion.”

As the only spine product that has achieved FDA Premarket Approval (PMA) for up to a Grade I spondylolisthesis with a concomitant decompression, the coflex® Interlaminar Stabilization® non-fusion device maintains motion, reduces both leg and back pain, and preserves foraminal height.  Marc Viscogliosi, Chairman and CEO of Paradigm Spine, LLC comments, “We are excited to have the recognition and support of ISASS in this publication.  The policy statement supports our goals of improving patient access, building awareness among physicians, payors and policy makers, making coflex a compelling covered treatment option for patients with stenosis.”

Hallett Mathews, M.D., MBA, EVP & CMO of Paradigm Spine, LLC  commented “We are very happy that ISASS has issued these important guidelines and are confident that it will be immensely helpful to all physicians and patients. Surgeons, health insurers and policy makers rely on publications issued by societies for current information on leading industry developments, clinical advancements and for guidance in making choices on various treatment methods for their patients.  As the publication appropriately states, with the growing population in the US, there is a rising incidence of LSS and varying options of therapeutic pathways.  Therefore, it is becoming increasingly important for the new treatment alternatives available for LSS to be supported by strong clinical data from long term studies, as coflex has recently published its own five-year study results.  Over the last four years, more than 1,000 physicians in the US have treated nearly 20,000 patients and now with these published guidelines by ISASS and having its own new CPT code becoming effective January 1, 2017, using coflex for interlaminar stabilization after a decompression is quickly becoming the preferred choice of treatment by many physicians in both an in-patient and out-patient setting.”

About Paradigm Spine, LLC
Paradigm Spine, LLC was founded in 2004 and remains focused on the design and development of solutions for the disease management of spinal stenosis.  The Company’s signature product is the coflex® Interlaminar Stabilization® device, which has more than 20 years of clinical history and patients treated in more than 40 countries worldwide.

 

SOURCE Paradigm Spine, LLC

Related Links

http://www.paradigmspine.com

Scientists develop grapheme nanoribbons to help knit together severed and damaged spinal cords

December 2, 2016

The combination of graphene nanoribbons made with a process developed at Rice University and a common polymer could someday be of critical importance to healing damaged spinal cords in people, according to Rice chemist James Tour.

The Tour lab has spent a decade working with graphene nanoribbons, starting with the discovery of a chemical process to ‘unzip’ them from multiwalled carbon nanotubes, as featured in a Nature article in 2009. Since then, the researchers have used them to enhance materials for the likes of deicers for airplane wings, better batteries and less-permeable containers for natural gas storage.

Now their work to develop nanoribbons for medical applications has resulted in a material, dubbed Texas-PEG, that may help knit damaged or even severed spinal cords.

Graphene nanoribbons customised for medical use by William Sikkema, a Rice graduate student and co-lead author of the paper, are highly soluble in polyethylene glycol (PEG), a biocompatible polymer gel used in surgeries, pharmaceutical products and in other biological applications. When the biocompatible nanoribbons have their edges functionalised with PEG chains and are then further mixed with PEG, they form an electrically active network that helps the severed ends of a spinal cord reconnect.

“Neurons grow nicely on graphene because it’s a conductive surface and it stimulates neuronal growth,” said Tour.

In experiments at Rice and elsewhere, neurons have been observed growing along graphene.

“We’re not the only lab that has demonstrated neurons growing on graphene in a petri dish,” said Tour. “The difference is other labs are commonly experimenting with water-soluble graphene oxide, which is far less conductive than graphene, or non-ribbonised structures of graphene.

“We’ve developed a way to add water-solubilising polymer chains to the edges of our nanoribbons that preserves their conductivity while rendering them soluble, and we’re just now starting to see the potential for this in biomedical applications,” he said. He added that ribbonised graphene structures allow for much smaller amounts to be used while preserving a conductive pathway that bridges the damaged spinal cords.

Tour said only one per cent of Texas-PEG consists of nanoribbons, but that’s enough to form a conductive scaffold through which the spinal cord can reconnect.

Texas-PEG succeeded in restoring function in a rodent with a severed spinal cord in a procedure performed at Konkuk University in South Korea by co-authors Bae Hwan Lee and C-Yoon Kim. Tour said the material reliably allowed motor and sensory neuronal signals to cross the gap 24 hours after complete transection of the spinal cord and almost perfect motor control recovery after two weeks.

“This is a major advance over previous work with PEG alone, which gave no recovery of sensory neuronal signals over the same period of time and only 10 per cent motor control over four weeks,”  Tour said.

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