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Current Issues in Spine

February 2-4, 2017

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January 2, 2019 OrthoSpineNews

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.”


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December 26, 2018 OrthoSpineNews

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.

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.

 

READ THE REST HERE

 

Photo: Nick Graham/Staff

 


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December 20, 2018 OrthoSpineNews

December 20, 2018 / FDA News Release

The U.S. Food and Drug Administration has warned Genetech, Inc. of San Diego, California and its president, Edwin N. Pinos for marketing stem cell products without FDA approval and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may have led to microbial contamination, potentially causing serious blood infections in patients. Genetech processed umbilical cord blood into unapproved human cellular products, which was distributed by Liveyon, LLC.

Additionally, as part of the FDA’s overall goal to support the responsible development of safe and effective products for patients, the agency is sending letters to reiterate the FDA’s compliance and enforcement policy to other manufacturers and health care providers who may be offering stem cell treatments.

“The FDA is committed to advancing the field of cell-based regenerative medicine. We’re implementing new policies to make it more efficient to safely develop these promising new technologies. At the same time, we’re also focusing more resources on enforcement when we see companies skirt safety measures and put patients at risk. In this case, the company’s failure to put in place appropriate safeguards may have led to serious blood infections in patients,” said FDA Commissioner Scott Gottlieb, M.D. “We remain committed to supporting the development of safe and effective cell-based regenerative medicine and advancing our comprehensive regenerative medicine policy framework. These efforts include our work to encourage manufacturers to engage with the FDA early so that we can provide guidance about any applicable regulatory requirements. Even though a few sponsors have come to us, we are discouraged by the overall lack of manufacturers wanting to interact with the agency in this enforcement discretion period. The letters we’re issuing today to manufacturers, health care providers and clinics around the country are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients. Time is running out for firms to come into compliance during our period of enforcement discretion. We’ll be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.”

As highlighted last year with the release of the FDA’s comprehensive regenerative medicine policy framework, including the FDA’s final guidance (Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use), the FDA intends to apply a risk-based approach to enforcement of cell-based regenerative medicine products, taking into account how products are being administered as well as the diseases and conditions for which they are intended to be used. However, the FDA does not intend to exercise such enforcement discretion for those products that pose a potential significant safety concern to patients.

Under this policy, the agency noted that it intends to exercise enforcement discretion for certain products until November 2020 with respect to the FDA’s investigational new drug application and premarket approval requirements when the use of the product does not raise reported safety concerns or potential significant safety concerns. Although the FDA has not evaluated the application of the compliance and enforcement policy to the specific manufacturers and health care providers who received the letters, or evaluated their products, the letters are intended to serve as a reminder of the enforcement discretion period and to encourage all affected manufacturers and health care providers to engage with the agency in advance of that date to determine if their products are subject to the agency’s premarket approval requirements.

The FDA offers opportunities for this type of engagement between potential manufacturers and the agency, such as through the INTERACT program, to facilitate product development. It also encourages the use of its expedited programs whenever applicable, in addition to the collaborative development of products as the FDA Commissioner and Center for Biologics Evaluation and Research director discussed in a New England Journal of Medicinedisclaimer icon perspective.

In the case of Genetech, the FDA inspected the company’s facility this past June and found the company was processing cellular products from human umbilical cord blood for administration by intra-articular (joint) injection, intravenous injection or application directly to the affected tissue to treat a variety of orthopedic conditions. These products were distributed by Liveyon in Yorba Linda, California as ReGen5, ReGen10 and ReGen30. The Genetech products are not intended for homologous use (products that are intended for the same function in the recipient as the donor), and while the products have a systemic effect, they are not intended for allogeneic (genetically similar) use in a first or second-degree blood relative. As such, the products are regulated as both drug and biological products. To lawfully market these products, an approved biologics license application is needed. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or INDs exist for the Genetech-processed, Liveyon-distributed products.

During the inspection, the FDA documented evidence of significant deviations from CGTP and CGMP requirements in the manufacture of the umbilical cord blood-derived products, including: deficient donor eligibility practices; unvalidated manufacturing processes; uncontrolled environment; lack of control over the components used in production and a lack of defined areas or a control system to prevent contamination and mix-ups. These deviations pose a significant risk that the products may be contaminated with microorganisms or have other serious product quality defects.

The FDA and the Centers for Disease Control and Prevention have received numerous reports of safety issues including those involving microbial contamination and are aware of 12 patients who received Genetech products from Liveyon and subsequently became ill due to blood and other infections caused by a number of bacteria, including Escherichia coli (E. coli), as described in a forthcoming Morbidity and Mortality Weekly Report (MMWR), titled “Notes from the Field: Bloodstream and Joint Infections in Patients After Receiving Bacterially Contaminated Umbilical Cord Blood-derived Stem Cell Products for Non-hematopoietic Conditions — United States, 2018.”

In September, Liveyon suspended shipment of all product pending an inquiry by the FDA into the source of the adverse reactions. Liveyon also voluntarily recalled all Genetech products it may have distributed.

“The FDA remains committed to taking action against products being unlawfully marketed and which pose a potential significant risk to patient safety at this time. However, the agency is also committed to ensuring that patients have access to safe and effective regenerative medicine products as efficiently as possible,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

The FDA requested a response from Genetech, within 15 working days of the letter’s issuance, that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by companies and owners could lead to enforcement action such as seizure, injunction or prosecution.

Health care professionals and consumers should report any adverse events related to treatments with the Liveyon products, Genetech products or other stem cell treatments to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed formcan be submitted online or via fax to 1-800-FDA-0178. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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December 20, 2018 OrthoSpineNews

 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 announcedFingerhut 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.

READ THE REST HERE

Photo: (Getty Images/alfexe)

 


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December 10, 2018 OrthoSpineNews

SAN DIEGODec. 10, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of its Monolith®Corpectomy System, providing surgeons with a modular PEEK interbody solution for cervical corpectomy procedures.

The FDA 510(k) indications for expanded use of the Company’s Monolith Corpectomy System include procedures in the cervical spine (C3-C7 vertebral bodies) to treat a diseased or damaged vertebral body caused by fracture, tumors, osteomyelitis or to support reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissue in cervical degenerative disorders.

“Expanding the indicated use of our Monolith Corpectomy System to include cervical corpectomy procedures demonstrates the Company’s continued commitment to expanding our cervical spine interbody portfolio,” said Matt Link, president, Strategy, Technology and Corporate Development for NuVasive. “We are pleased to provide surgeons with a PEEK cervical interbody solution to help round out our cervical portfolio as we continue to advance our mission to improve patient lives.”

NuVasive’s Monolith Corpectomy System was initially cleared by the FDA for indicated use in thoracolumbar corpectomy procedures in 2015, offering a fully modular, imaging-friendly PEEK implant solution. The system is comprised of a monolithic core with modular endcaps that allow surgeons to customize the device to meet the patient’s specific anatomical requirements. The endcaps are available in multiple footprint and lordosis options intended to help maximize endplate coverage while addressing the surgeon’s alignment goals. The Monolith cage is constructed entirely from PEEK and includes radiographic markers, which provides increased clarity in postoperative x-rays and imaging, allowing surgeons to more easily assess fusion following procedures. The cage also includes large central graft apertures designed to help facilitate bony through-growth and fusion.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400-person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com


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December 6, 2018 OrthoSpineNews

LOGAN, UtahDec. 6, 2018 /PRNewswire/ — IntraFuse, a start-up medical device company operated by Surgical Frontiers, is focused on advanced surgical devices for improving outcomes for orthopedic extremity procedures, announced today that the United States Patent and Trademark Office has recently granted the company a key patent related to its FlexThread Intramedullary Fracture Fixation system.

US Patent 10,136,929 entitled “Flexible Bone Implant” is the first patent to issue from the intellectual property portfolio held by the company that includes additional pending US and international patent applications. The patent covers the novel combination of an intramedullary rod with cross fixation on end and a flexible bone screw on the other end. This platform technology enables percutaneous, secure fracture fixation of long bones of the extremities, especially for curved bones or where the surgical technique requires an off-axis approach to the intramedullary canal.

The simple and elegant design is easier to implant and lower cost than today’s standard-of-care fracture fixation hardware. Incorporating IntraFuse’s proprietary FlexThread technology, the distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod. Upon insertion of the implant into the bone, the rigid rod portion of the implant spans and supports the fracture and the flexible screw portion bends as needed to thread into the intramedullary canal. With internal screw fixation on one side of the fracture and cross screw fixation through the rod on the other side of the fracture, proper bone alignment and length can be maintained during the healing period.

The FlexThread System is currently FDA 510(k) cleared for fibula and clavicle indications, and the FlexThread™ technology is in further development for additional indications, include fractures of the fifth metatarsal bone, also known as a Jones fracture.

IntraFuse is a development stage medical device company incubated and operated by Surgical Frontiers.

About Surgical Frontiers
Surgical Frontiers develops advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Media Contact:
Mr. Wade Fallin 
CEO
205883@email4pr.com 
http://surgicalfrontiers.com/intrafuse/ 
800-230-3710

SOURCE Surgical Frontiers

Related Links

http://surgicalfrontiers.com


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December 5, 2018 OrthoSpineNews

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.

 

READ THE REST HERE

 


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November 30, 2018 OrthoSpineNews

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.


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November 29, 2018 OrthoSpineNews

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.


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November 28, 2018 OrthoSpineNews

November 28, 2018

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using its universal donor product, CybroCell™, today announced the FDA has cleared its Investigational New Drug (IND) protocol for human trials in the U.S., considered to be the first IND approval for a fibroblast cell therapy in a chronic condition outside of dermatological uses. The clearance allows SpinalCyte to begin recruiting and screening patients for the study. The trial is to be initiated after the first production run is tested for quality and safety to meet the FDA stated criteria.

“The clearance of the IND for our fibroblast-based therapy, CybroCell™, in the treatment of degenerative disc disease validates our clinical science and is our biggest step toward commercialization,” said SpinalCyte Chief Executive Officer, Pete O’Heeron. “After the extremely positive results from our Phase 1/Phase 2 clinical trial, this clearance by the FDA will allow us to continue testing CybroCell™ and will further our mission of bringing back pain relief to the millions of Americans who suffer from it every year. The applications of CybroCell™ go beyond degenerative disc disease and hold promise in other disease pathways including cancer, diabetes, osteoarthritis, liver failure and heart failure.”

The Phase 1/Phase 2 trial assessed pain and structural improvements in patients using the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and MRI scans. The data showed that 54% of the treatment arm patients met all three endpoints as compared to only 17% with the placebo (p=0.0003). More than 90% of patients in the treatment group had an over a 10-point reduction in Oswestry Disability Index (ODI), 100% had improvement in Visual Analogue Scale (VAS) and over 84% had an increase or no change in disc height.

“CybroCell’s pain and MRI data show clear superiority to all other cell therapy treatments for degenerative disc disease,” said SpinalCyte Chief Scientific Officer, Thomas Ichim, Ph.D. “This IND clearance allows us to continue our research and application of CybroCell™. This treatment which targets the source of chronic pain in degenerative disc disease is a medical breakthrough. The persistent structural and functional improvements we have observed in patients demonstrate that CybroCell™ has the potential to help combat the opioid epidemic by eliminating chronic pain.”

About Degenerative Disc Disease

Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.

About CybroCell™

CybroCell™ is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated after 12 months, patients who were injected with CybroCell™ had sustained improvement in pain relief and increased back mobility.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal disc regeneration using human dermal fibroblasts. Currently, SpinalCyte holds 35 U.S. and international issued patents and has filed for an additional 41 patents pending. SpinalCyte holds 116 U.S. and International Patents pending and issued across a variety of disease pathways, including disc degeneration, cancer, diabetes, liver failure and heart failure. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contacts

David Schull or Ned Berkowitz
Russo Partners LLC
858-717-2310
646-942-5629
david.schull@russopartnersllc.com
ned.berkowitz@russopartnersllc.com

SpinalCyte, LLC
info@spinalcyte.com