WARSAW, Indiana, Jan. 02, 2019 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, today issued a statement from Daniel Gerritzen, Vice President and General Counsel, concerning actions it filed against Robert von Seggern, a former employee, and WishBone Medical, Inc. in an Indiana state court in late December 2018 (the “Sanctions Motion”).  These actions are part of OrthoPediatrics’ existing lawsuit against von Seggern and WishBone Medical for, in part, violations of Indiana’s and federal trade secrets statutes (OrthoPediatrics Corp. v. Robert von Seggern & WishBone Medical, Inc. Whitley Superior Court, Cause No. 92D01-1705-PL-000150).

The underlying lawsuit alleges that von Seggern stole OrthoPediatrics’ trade secrets and confidential information and then turned those over to WishBone Medical for its use in developing pediatric orthopedic products.  The Sanctions Motion requests the Whitley Superior Court to sanction von Seggern and WishBone Medical for their repeated, deliberate efforts to subvert the discovery process by refusing to produce responsive documents and information, hiding or otherwise destroying evidence, and making misstatements to OrthoPediatrics and the Court concerning the existence of responsive documents and its efforts to find and produce such materials.

“OrthoPediatrics welcomes legitimate competition because that means more kids with pediatric orthopedic conditions will have greater opportunities to be helped,” stated Gerritzen.  “However, we will not tolerate individuals or entities misappropriating our property, in part, to leapfrog years of design and testing work and avoid the significant monetary expense of bringing competing products to market.  With this in mind, we will continue to aggressively pursue every legal remedy to protect and safeguard our research and product development efforts to improve the lives of children with pediatric conditions.  This includes holding those accountable who attempt to use, without authorization, OrthoPediatrics’ trade secrets and confidential information.  The trade secrets and confidential information we have become aware von Seggern and WishBone Medical misappropriated relates to aspects of our current Trauma and Deformity Correction medical devices.  While very serious, the misappropriation does not significantly jeopardize our overall research and development pipeline.”

Gerritzen continued, “OrthoPediatrics takes active measures to protect its trade secrets and confidential information.  These safeguards continue to be refined and adapted in light of ever-changing threats. Due to its ongoing lawsuit, OrthoPediatrics will not provide any additional comments or details regarding this matter other than what is reflected in court filings and Court orders.”

Dec 26, 2018 / By: Kaitlin Schroeder, Journal-News.com

Prices hospitals charge for their services will all go online Jan. 1 under a new federal requirement, but patient advocates say the realities of medical-industry pricing will make it difficult for consumers to get much out of the new data.

A federal rule requires all hospitals to post online a master list of prices for the services they provide so consumers can review them starting Jan. 1.

The health care industry nationally has a reputation for having little price transparency, which can make it difficult for consumers to price compare. But the hospital’s master list prices, sometimes called a chargemaster, is also not a complete look, consumer advocates say.

That’s because the final bill a patient receives is almost never the same as the sticker price for the services they received. Insurance companies negotiate discounts on the sticker prices. Co-pays, co-insurance, deductibles also add other layers of complexity that bring discounts or increased costs before a final charge is determined.

“The list prices are so high that the vast majority of hospitals don’t even try to collect list prices from uninsured patients,” said Benedic Ippolito, with the American Enterprise Institute, who has researched hospital list prices.

The federal rule is being brought out as a measure to improve competition and help educate consumers.

“We are just beginning on price transparency,” Seema Verma, head of U.S. Centers for Medicare & Medicaid told the Associated Press. “We know that hospitals have this information and we’re asking them to post what they have online.”

But real transparency comes when consumers can easily see what they will pay to a provider based on their insurance benefits, said Thomas Campanella, Baldwin Wallace University health care MBA program director. He said some insurance companies are providing that information through price comparison tools.

“I almost see it being more of a political ‘look at what we did,’” Campanella said of the requirement to post list prices.

Kettering Health Network, which has eight hospitals in the Dayton, Ohio area, said the chargemaster will be posted on its patient pricing webpage after Jan. 1. Premier Health, which has three hospitals in the same region, said the information will be on its hospitals’ websites by Jan. 1. and consumers will find the list of charges where they currently find other pricing, insurance and billing information.

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Photo: Nick Graham/Staff

Dec 19, 2018 / Paige Minemyer

The former head of Cleveland Clinic Innovations, who pleaded guilty to defrauding the health system out of nearly $3 million, was sentenced to 30 months in prison.

Gary Fingerhut, 58, was also ordered to pay the more than $2.7 million that was diverted from the Cleveland Clinic as part of the scheme in restitution, the Department of Justice announced. Fingerhut pleaded guilty to one count of wire services fraud and one count of making false statements for his role in October 2017.

Fingerhut was expected to be sentenced in January, and attorneys anticipated that he could face between 41 and 51 months in jail.

Fingerhut was the executive director of Cleveland Clinic Innovations for two years before the FBI uncovered the fraud scheme in 2015. Fingerhut conspired with Wisam Rizk, chief technology officer of Interactive Visual Health Records, a spinoff of Innovations that was formed to build a digital charting tool for the clinic’s doctors.

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Photo: (Getty Images/alfexe)

By Susannah Luthi  | December 4, 2018

The American Hospital Association on Tuesday led a lawsuit against the Trump administration over the CMS’ final rule imposing a site-neutral payment policy, which cuts some Medicare rates for outpatient hospital sites to match the rates for physicians’ offices.

The lawsuit, filed in the U.S. District Court for the District of Columbia, challenges the “serious reductions to Medicare payment rates” as executive overreach. The rate reduction is scheduled to start Jan. 1. In 2019, hospitals’ reimbursements will drop approximately $380 million in 2018, according to the CMS.

“This court should reject CMS’ attempts to replace Congress’s unequivocal directives with the agency’s own policy preferences,” the hospitals wrote in their complaint. “CMS may not contravene clear congressional mandates merely because the agency wishes to make cuts to Medicare spending.”

The outpatient pay rule was finalized in November. The timing and strategy of this lawsuit resembles the hospitals’ effort in late 2017 to block roughly $1.6 billion in Medicare Part B drug reimbursement cuts for 340B providers before they went into effect in early 2018. At the last minute, the presiding federal judge tossed that suit as premature because the cuts had not yet gone into effect. Hospitals lost their appeal over the summer and in September lodged their complaint again.

The Association of American Medical Colleges, the trade group of academic centers that will see a big hit from the site-neutral policy, joined AHA, along with three independent health systems: Michigan’s Mercy Health Muskegon, Washington State’s Clallam County Public Hospital and Maine’s York Hospital.

The policy roiled the hospital industry when it was introduced in a proposed rule over the summer. Hospitals have been lobbying Congress to intervene with the administration and reverse the policy.

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November 30, 2018 / John Russell

Dr. Rick C. Sasso, an Indiana spine surgeon and inventor, has won a sweeping, five-year legal battle against medical-device giant Medtronic, with a jury this week awarding him $112 million in damages.

Sasso, 58, president of Carmel-based Indiana Spine Group, had claimed that Medtronic had violated a contract by not paying royalties he was due for spinal implants and screw-implant systems he had invented and sold to the company more than a decade ago. The systems became one of the company’s largest product lines, with annual sales of more than $200 million.

Along the way, Medtronic paid Sasso more than $20 million in royalties, but he contended the company shortchanged him, breaching its obligations and acting in bad faith.

A six-person jury in Marshall County Circuit Court returned the verdict in favor of Sasso on Wednesday, wrapping up a nearly month-long trial.

Medtronic—based in suburban Minneapolis with operations in Warsaw, Indiana—had acknowledged that Sasso played a role in inventing several products. But the company argued Sasso was seeking payment “far in excess of the value of his contributions.”

In a regulatory filing Thursday, the company said it has “strong arguments to appeal the verdict” and will file post-trial motions with appellate courts.

But Sasso’s attorney, Frederick Emhardt of Plews Shadley Racher & Braun, said the jury—which included two science teachers–spoke loudly with their verdict, sifting through a complicated set of facts and circumstances.

“After a month of evidence, they learned much about spine surgery and the business of medical device sales and the need to honor contractual commitments, even if they were made by persons no longer with a company,” he said in an email. “In a period of six hours, they unanimously rendered a verdict awarding to a dollar what Dr. Sasso requested—$112,452,269. The jury system is a bedrock of our way of life. It worked exactly the way intended by our founders.”

Inventive surgeon

For more than a decade, Sasso appeared to have a model business relationship with Medtronic, one of the nation’s largest makers of spinal devices.

Court papers show Sasso considered himself a key member of the invention and engineering team at Medtronic. In one filing, he pointed out that he “attended several retreats with executives and engineers of Medtronic Spine and other inventors/surgeons like himself.” He added that he “contributed know-how and technical information to all phases of Medtronic Spine’s product designs.”

In addition to being an inventor, Sasso “is a world-class—and that’s not exaggeration—spine surgeon,” Plymouth-based attorney Jere L. Humphrey, who served as local counsel in the case, told the Pilot News in Plymouth, Indiana, where the trial was held. “He goes all over the world and gives instructions on how to do spine surgery.”

Sasso in recent weeks did not respond to several requests from IBJ to comment on the dispute. But in voluminous court filings and interviews with other outlets over the years, a picture emerges of a focused surgeon interested in finding new ways to do things.

He grew up in Warsaw, a city nicknamed the orthopedic capital of the world for the prevalence of medical-device companies focusing on the spine and joints. Sasso’s father was a veterinarian, and as a boy, Sasso wanted to become one too. He was accepted into Purdue University, but on his father’s advice, he changed his sights to human medicine and entered Wabash University, according to a 2007 profile story in the college magazine.

After getting his bachelor’s degree in 1982, Sasso entered the Indiana University School of Medicine, and later did his residency in orthopedic surgery at the University of Texas Medical School in Houston.

During a fellowship at Northwestern University in Chicago, Sasso noticed that surgeons had a difficult time tending certain spinal fractures and were still using primitive methods, such as wires, rods and big hooks.

“Nothing made sense,” Sasso told Wabash magazine. “Nothing worked. I’m training with these world experts and they say, ‘Oh yeah, this is the way we do things.’ I think, ‘This is the most ridiculous way.’”

So he soon began experimenting with a new system of his own. In 1994, Sasso and an engineer, Dan Justin, filed a patent application for a spine-implant device, involving screws and rods that would provide stability in the upper neck.

Around the same time, Sasso formed a start-up company, See LLC, with his brother and father-in-law, to manage his intellectual property. He and Justin were issued a patent in 1997.

They initially had trouble getting medical device companies interested in the invention because there were no similar surgical systems on the market, according to court papers filed by Sasso.

But Sasso finally had a breakthrough after being introduced to Robert Compton, an Indiana venture capitalist who was president of Sofamor Danek Group, a maker of spinal instruments based in Memphis, Tennessee, that had operations in Warsaw.

Compton is well-known in Indiana as one of the early financial backers of the email-marketing firm ExactTarget, which was cofounded by Sasso’s brothers-in-law, Scott Dorsey and Chris Baggott. See LLC transferred its intellectual property rights to Sofamor Danek in return for $100,000 in cash, 1,500 shares of stock, and royalties.

Just a year later, Sofamor Danek Group was acquired by Medtronic for $3.3 billion, and in the ensuing years, Sasso entered into several agreements with Medtronic for a series of medical devices related to spinal stabilization.

WALTHAM, Mass., Nov. 29, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today provided an update on the NeoCart regulatory pathway based on its ongoing dialogue with the U.S. Food and Drug Administration (the FDA).  Since the initial Type C meeting in October 2018, Histogenics and the FDA have continued their discussions on the clinical data generated to date, the potential need for any additional supplemental clinical data (which may include longer-term data from the ongoing Phase 3 trial or additional studies) and potential alternative regulatory pathways for the NeoCart Biologics License Application (BLA).  The FDA has not yet made a final decision regarding a potential BLA submission.  Histogenics intends to provide a further update by the end of 2018 or early 2019 based on additional feedback from the FDA, once available.

“We very much appreciate the FDA’s consideration and active review of our request to evaluate the existing Phase 3 clinical data for a potential NeoCart BLA submission.  We continue to work very closely with the FDA to review the data from the NeoCart development program.  Our discussions have covered many areas including the clinical data, patient population and related statistics from the NeoCart Phase 3 clinical trial, potential alternative pathways for the BLA as well as the current treatment paradigms for knee cartilage defects in relation to the design of the NeoCart Phase 3 clinical trial,” said Adam Gridley, President and Chief Executive Officer of Histogenics.  “We continue to believe, based on the totality of the data, that NeoCart, if the BLA were accepted and approved by the FDA, may offer patients a treatment alternative that provides a more rapid recovery from pain and return to daily activity than other currently available options to treat damaged knee cartilage.”

About Histogenics Corporation

Histogenics (Nasdaq: HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications.  For more information on Histogenics and NeoCart, please visit www.histogenics.com.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws.  Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements.  Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  expectations regarding the timing and success of ongoing discussions with the FDA regarding the potential submission or acceptance of a BLA for NeoCart; NeoCart’s potential as a treatment for knee cartilage damage; the timing, associated expenses and ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the market size and potential patient population in markets where Histogenics’ and its partners expect to compete; updated or refined data based on Histogenics’ continuing review and quality control analysis of clinical data; the scope, progress, timing, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following its technology transfer and manufacturing location transition; Histogenics’ expectations regarding its expenses and revenue; Histogenics’ ability to obtain additional debt or equity capital; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov.  In addition to the risks described above and in Histogenics’ Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.  Histogenics has not yet received the official FDA meeting minutes from the Type C meeting and the information in this Press Release may be altered or supplemented by the information contained in the official meeting minutes or any subsequent meetings that may be held with the FDA.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

November 28, 2018