NORCROSS, Ga., July 5, 2018 /PRNewswire/ — Lipogems, a leader in medical technologies for orthopaedic physicians, announced U.S. Food and Drug Administration (FDA) clearance of the company’s Lipogems Microfragmented Adipose Tissue Transplant System.  Federal regulators have cleared the way for this exciting new device and technology to be used in orthopaedic and arthroscopic procedures. Lipogems successfully uses a patient’s own body fat (known clinically as adipose tissue) to assist in the healing process and, in some cases, used in conjunction with traditional orthopaedic surgery. Lipogems is attractive to orthopaedic physicians because it is compliant with the latest FDA guidelines and is cleared for use in orthopaedics and arthroscopic surgery unlike many other technologies.

“The use of reparative technologies in orthopaedics is rapidly expanding and medicine is forced to keep up with patient demands and the forces that are placed on their bodies. This is true for all types of patients from young athletes to professional athletes, from weekend warriors to the elderly,” said world renowned sports medicine surgeon Dr. Champ Baker, Jr., of the respected Hughston Clinic in Columbus, GA. “As a result, we are understanding more about reparative medicine options and the science behind them.

“Orthopaedic conditions are the number one cause of disability in patients in the United States and they take a toll on their physical and emotional health, and the ability to support their families. Patients are living longer and are more highly active. They are really trying to maintain their quality of life and function freely,” said Dr. Baker.

The Power of Fat

“Many patients are looking for another option to major invasive surgery. Fat has many important cells and is easy to get from the patient’s body. I believe cells from their own body are the best cells that a patient can use,” said Dr. Baker. “Lipogems may be a great option for patients who have tried physical therapy, nonsteroidal anti-inflammatory drugs, or steroid injections, and other treatments that have not provided enough relief.

“If surgery is needed, Lipogems may be ideal to help provide cushion and support to facilitate the healing environment and optimize recovery,” he added.

Orthopaedic physicians are always looking for convenient technologies that are compliant with current standards. The Lipogems system arrives in a comprehensive kit and uses a minimally invasive procedure to harvest, concentrate, then transfer the patient’s own adipose tissue, typically from the patient’s belly or “love handles.”

The procedure can be performed in the office or surgical setting in under an hour.  The Lipogems system uses only saline to rinse and remove contaminants, typically oil, blood and cell debris, from the harvested fat. Lipogems then resizes, or “microfragments”, the tissue to an optimum size while retaining the fat tissue’s natural and beneficial properties.

The “clean” Lipogems tissue provides cushion and support for the area. In accordance with homologous use, the tissue processed in the Lipogems system may be used to facilitate the natural healing process by supporting the repair, replacement or reconstruction of damaged or injured tissue.

If a patient suffers from multiple orthopaedic conditions, additional fat can be removed (in the same procedure) and processed through the Lipogems technology to help address those additional conditions.

“For procedures performed in the office, there is minimal recovery time and the patients can leave the facility right away and go home with minimal pain medication,” Dr. Baker said. “For patients needing arthroscopic surgery, the introduction of microfragmented fat to their shoulder, hip, or knee may provide cushion and support of the damaged tissue, and optimize the surgical recovery.”

In November 2017, the FDA finalized its rules guiding the use of Human Cellular and Tissue Products.  The Agency reaffirmed that the Lipogems system meets the new guidelines’ criteria for minimal manipulation of the tissue, and that it is intended for homologous use. “Fat has been used for many years in support of the repair or replacement of damaged or injured tissue,” according to Dr. Arnold Caplan of Case Western Reserve University in Cleveland, Ohio. “Fat has a high concentration of reparative cells and is a very powerful tissue. How the fat is processed makes a huge difference on the quality of the tissue and if it meets the new FDA guidelines.”

Dr. Diego Correa, Assistant Professor, Department of Orthopaedics (Division of Sports Medicine) & Diabetes Research Institute- Cell Transplant Center at the University of Miami’s Miller School of Medicine is also impressed by the Lipogems technology.  “Fat has a lot of important structural and reparative cells (including pericytes, adipocytes, and other cells) and they need to be kept together to meet the new guidelines by the FDA. Lipogems is unique because it keeps the cells and tissue intact, and thus functions much like the way it does naturally in the human body—and meets the new FDA guidelines for minimal manipulation.”

Accept No Substitutes

According to Carl Llewellyn, President of Lipogems, USA, “There are many stem cell treatment centers and clinics using technologies that are not FDA cleared or approved.  Many of these clinics are selling stem cell treatments unproven for safety and efficacy, and these lack FDA review and oversight.”

“In fact, many of these clinics are using a process to create a ‘stromal vascular fraction’ of cells isolated from fat tissue, which the FDA considers to be more than minimally manipulated, and thus, requiring significant regulatory oversight as an experimental drug. Lipogems is offered by leading orthopaedic physicians from around the world and encourages patients to seek care from board certified orthopaedic physicians and to ensure the technology they are using is cleared or approved by the FDA.”

Lipogems is pleased to announce its participation at the annual meeting of the American Orthopaedic Society for Sports Medicine (AOSSM), July 5-8, 2018, this year at the Manchester Grand Hyatt in San Diego. (Lipogems will occupy Booth 402 at this year’s gathering.)  The AOSSM meeting draws sports medicine surgeons from around the world and spotlights scientific and clinical presentations about the latest advancements in operative and non-operative care for sports medicine patients.

Arthroscopic Surgery

Arthroscopic surgery is another treatment getting a potential boost from Lipogems. Arthroscopy is the minimally invasive surgical procedure in which an orthopaedic surgeon uses a specialized tool with a tiny camera (i.e. arthroscope) to gain access to the damaged joint. Millions of such procedures are performed each year on the hips, knees, and shoulders of patients young and old. Advancements in technology have improved arthroscopic surgical techniques and patient care. But surgeons continue to be hampered by the limited healing capacity of damaged tissue. But with Lipogems, a patient’s own microfragmented fat may be used to help provide some badly needed cushion and support to facilitate healing.

About Lipogems

Lipogems’ vision is to bring responsible, effective medical technologies to physicians and patients—and to establish the Lipogems system as a mainstream solution.  Lipogems strives to provide physicians and patients with adipose tissue solutions to help maintain or restore patient lifestyles and to improve quality of life and recovery times.

These solutions may offer another option to those who may not want, or who are not candidates for, major, invasive surgery.

The Lipogems system is the company’s first product to receive 510(k) clearance in the United States and is indicated for the harvest, concentration, and transfer of autologous adipose tissue. The system meets new FDA guidelines for minimal manipulation and is intended for homologous use. The company is based in Milan, Italy and Norcross, Georgia, USA. Lipogems is distributed in 27 countries around the world.

For more information, please visit www.lipogems.eu and follow us on Facebook at Lipogems International.

SOURCE Lipogems

Related Links

http://www.understandlipogems.com

June 28, 2018

Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Alex M. Azar III, announced today the largest ever health care fraud enforcement action involving 601 charged defendants across 58 federal districts, including 165 doctors, nurses and other licensed medical professionals, for their alleged participation in health care fraud schemes involving more than $2 billion in false billings.  Of those charged, 162 defendants, including 76 doctors, were charged for their roles in prescribing and distributing opioids and other dangerous narcotics.  Thirty state Medicaid Fraud Control Units also participated in today’s arrests.  In addition, HHS announced today that from July 2017 to the present, it has excluded 2,700 individuals from participation in Medicare, Medicaid, and all other Federal health care programs, which includes 587 providers excluded for conduct related to opioid diversion and abuse.

Attorney General Sessions and Secretary Azar were joined in the announcement by Acting Assistant Attorney General John P. Cronan of the Justice Department’s Criminal Division, Deputy Director David L. Bowdich of the FBI, Assistant Administrator John Martin of the Drug Enforcement Administration (DEA), Deputy Inspector General Gary Cantrell of the HHS Office of Inspector General (OIG), Deputy Chief Eric Hylton of IRS Criminal Investigation (CI), Centers for Medicare and Medicaid Services (CMS) Deputy Administrator and Director of the Center for Program Integrity Alec Alexander and Director Dermot F. O’Reilly of the Defense Criminal Investigative Service (DCIS).

Today’s enforcement actions were led and coordinated by the Criminal Division, Fraud Section’s Health Care Fraud Unit in conjunction with its Medicare Fraud Strike Force (MFSF) partners, a partnership between the Criminal Division, U.S. Attorney’s Offices, the FBI and HHS-OIG.  In addition, the operation includes the participation of the DEA, DCIS, IRS-CI, Department of Labor, other various federal law enforcement agencies, and State Medicaid Fraud Control Units.

The charges announced today aggressively target schemes billing Medicare, Medicaid, TRICARE (a health insurance program for members and veterans of the armed forces and their families), and private insurance companies for medically unnecessary prescription drugs and compounded medications that often were never even purchased and/or distributed to beneficiaries.  The charges also involve individuals contributing to the opioid epidemic, with a particular focus on medical professionals involved in the unlawful distribution of opioids and other prescription narcotics, a particular focus for the Department.  According to the CDC, approximately 115 Americans die every day of an opioid-related overdose.

“Health care fraud is a betrayal of vulnerable patients, and often it is theft from the taxpayer,” said Attorney General Sessions.  “In many cases, doctors, nurses, and pharmacists take advantage of people suffering from drug addiction in order to line their pockets. These are despicable crimes. That’s why this Department of Justice has taken historic new steps to go after fraudsters, including hiring more prosecutors and leveraging the power of data analytics. Today the Department of Justice is announcing the largest health care fraud enforcement action in American history.  This is the most fraud, the most defendants, and the most doctors ever charged in a single operation—and we have evidence that our ongoing work has stopped or prevented billions of dollars’ worth of fraud. I want to thank our fabulous partners with the FBI, DEA, our Health Care Fraud task forces, HHS, the Defense Criminal Investigative Service, IRS Criminal Investigation, Medicare, and especially the more than 1,000 federal, state, local, and tribal law enforcement officers from across America who made this possible. By every measure we are more effective at finding and prosecuting medical fraud than ever.”

“Every dollar recovered in this year’s operation represents not just a taxpayer’s hard-earned money—it’s a dollar that can go toward providing healthcare for Americans in need,” said HHS Secretary Azar.  “This year’s Takedown Day is a significant accomplishment for the American people, and every public servant involved should be proud of their work.”

According to court documents, the defendants allegedly participated in schemes to submit claims to Medicare, Medicaid, TRICARE, and private insurance companies for treatments that were medically unnecessary and often never provided.  In many cases, patient recruiters, beneficiaries and other co-conspirators were allegedly paid cash kickbacks in return for supplying beneficiary information to providers, so that the providers could then submit fraudulent bills to Medicare.  Collectively, the doctors, nurses, licensed medical professionals, health care company owners and others charged are accused of submitting a total of over $2 billion in fraudulent billings.  The number of medical professionals charged is particularly significant, because virtually every health care fraud scheme requires a corrupt medical professional to be involved in order for Medicare or Medicaid to pay the fraudulent claims.  Aggressively pursuing corrupt medical professionals not only has a deterrent effect on other medical professionals, but also ensures that their licenses can no longer be used to bilk the system.

“Healthcare fraud touches every corner of the United States and not only costs taxpayers money, but also can have deadly consequences,” said FBI Deputy Director Bowdich.  “Through investigations across the country, we have seen medical professionals putting greed above their patients’ well-being and trusted doctors fanning the flames of the opioid crisis.  I want to thank the agents, analysts and our law enforcement partners in every field office who work each and every day to stop these criminals and hold them accountable for their actions.”

“DEA is committed to ending the opioid crisis occurring in our communities and preventing prescription drug misuse,” said DEA Assistant Administrator Martin.  “DEA will continue to work with our partners every day to protect our citizens while ensuring that patients have adequate access to these critical medications.”

“This year’s operations, focusing on opioid-related schemes, spotlight the far-reaching impact of health care fraud,” said HHS Deputy Inspector General Cantrell.  “Such crimes threaten the vitally important Medicare and Medicaid programs and the beneficiaries they serve.  Though we have made significant progress in our fight against health care fraud; our efforts are not complete.  We will continue to work with our partners to protect the health and safety of millions of Americans.”

“It takes a special kind of person to prey on the sick and vulnerable as happened in many of these health care fraud schemes,” said Deputy Chief Hylton.  “Medical professionals and others callously placed individuals and vital healthcare services in harm’s way simply because of greed.  IRS-CI special agents continue to work side-by-side with other federal, state and local law enforcement officers to uncover these schemes and hold these criminals accountable for their actions.”

“CMS makes it a top priority to protect the health and safety of millions of beneficiaries who depend on vital federal healthcare programs,” said Alec Alexander, deputy administrator and director of the Center for Program Integrity.  “CMS’ Center for Program Integrity collaborates closely with our law enforcement partners to safeguard precious taxpayer dollars. Under Administrator Seema Verma, we will continue to strengthen this partnership with law enforcement in order to ensure the integrity and sustainability of these essential programs that serve millions of Americans.”

“Heath care fraud wounds our service members and veterans alike, as they rely upon and rightfully expect uncompromised care through the Department of Defense’s TRICARE Program,” said DCIS Director O’Reilly.  “Investigations that culminated in enforcement actions over the past several days underscore the steadfast commitment of the Defense Criminal Investigative Service and our investigative partners to vigorously investigate fraud impacting TRICARE.  We remain vigilant in our efforts to ensure the high standards of care our service members, military retirees, and their dependents deserve while safeguarding American taxpayer dollars.”

The Medicare Fraud Strike Force operations are part of a joint initiative between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country.  The Medicare Fraud Strike Force operates in 10 locations nationwide.  Since its inception in March 2007, the Medicare Fraud Strike Force has charged over 3,700 defendants who collectively have falsely billed the Medicare program for over $14 billion.

READ THE REST HERE

JUN 28, 2018

Episurf Medical (NASDAQ: EPIS B) today announces that the company has reached an important milestone on its strategy to reach the US market. The Investigational Device Exemption (IDE) application that the company has been working on is ready for filing. The application will now be filed to the US Food and Drug Administration (FDA) prior to the end of the second quarter.

An approved IDE allows a medical device to be used in a clinical study in order to collect safety and effectiveness data for submission to the FDA. Episurf Medical is filing the IDE application for the Episealer® knee implant to get approval to initiate a clinical study in the US. The IDE must be approved by the FDA before the study is initiated.

“Episurf has performed thorough work to get the extensive submission package in place. The Episealer® technology is gaining a lot of interest among the potential study investigators and we are continuing the work of getting sites ready for participation” comments Dr. Mike Kelly, Special US Study Advisor to Episurf Medical.

“We are looking forward to getting feedback on the study design from the FDA and continue the constructive dialogue we have had with the FDA in the preparatory phase. We are eager to take the next steps towards the US market and this is a very important milestone in that respect. I think the pieces are falling in place for us. Simultaneously as we are executing on a very clear regulatory strategy in the US, we have a growing business in Europe, where we also have a high level of activity when it comes to clinical activities. Our strategy is very clear, the clinical results are very strong, and this is such an important step. Finally, I am very proud of the team that delivered this in time, it’s been a lot of hard work behind this” comments Pål Ryfors, CEO, Episurf Medical.

For more  information, please contact:

Pål Ryfors, CEO, Episurf Medical

Tel:+46 (0) 709 62 36 69

Email: pal.ryfors@episurf.com

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalised treatment alternatives. Episurf Medical’s Episealer® personalised implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CEST on 28 June 2018.

FREMONT, Calif. – June 26, 2018 – Ceterix Orthopaedics, Inc., a leader in the development of cutting-edge surgical tools for orthopaedic surgeons, today announced the issuance of U.S. Patent No. 10,004,492 related to the company’s method of placing a suture around a tear to repair a damaged meniscus, adding to the company’s already expansive intellectual property portfolio.

Ceterix’s new patent further protects the company’s technology enabling surgeons to arthroscopically repair soft tissue injuries in the knee using minimally invasive techniques. This is the second set of method claims describing Ceterix’s proprietary Circumferential Compression Stitch (CCS), a suture method that provides uniform, anatomic compression of meniscus tears that was not possible to do previously given the tight constraints of the knee.

“Whether you are setting a broken bone or suturing a laceration, injuries heal best when the tissue edges are perfectly lined up and repaired without gaps,” says Dr. Justin Saliman, founder and chief medical officer of Ceterix. “For the first time, orthopaedic surgeons can now apply this principle to meniscus tears with NovoStitch^® Meniscal Repair Systems. We believe that by enabling simultaneous compression of the femoral and tibial sides of meniscus tears, the Ceterix technology can provide surgeons with greater confidence to repair tears that would have previously been considered non-repairable.”^[i],[ii]

“The invention of delivering a Circumferential Compression Stitch within the tight constraints of the knee may be the biggest innovation in meniscal repair in the last 15 years,” says John McCutcheon, president and CEO of Ceterix. “We are committed to expanding options for surgeons to preserve the meniscus and protect normal knee function in their patients.”

READ THE REST HERE

June 13, 2018 / James J Gibson, Jr, PhD, CPA, President at SAGICO

AMSTERDAM, The Netherlands, June 13, 2018 (GLOBE NEWSWIRE) —  Wright Medical Group N.V. (NASDAQ:WMGI) today announced that it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for AUGMENT^® Injectable Bone Graft for the same clinical indications as AUGMENT^® Bone Graft.  AUGMENT Injectable is a combination product consisting of recombinant human platelet derived growth factor (rhPDGF-BB) and a blend of Type I collagen and Beta tri-calcium phosphate, which provides a clinically proven and safe and effective alternative to autograft for use in hindfoot and ankle fusion in an easy to use flowable formulation.

Robert Palmisano, president and chief executive officer, stated, “Building on the commercial and clinical success of AUGMENT Injectable in the Canadian and Australian markets, this important milestone allows Wright to expand our proven AUGMENT franchise and meet the needs of foot and ankle surgeons in the U.S. with a safe and effective alternative to autograft that includes significantly improved handling characteristics to enable easier and more precise delivery to the fusion site.  In addition to the significantly improved handling characteristics with AUGMENT Injectable, one of the key differentiators continues to be the strength of the clinical evidence.  Our approved PMA supplement for AUGMENT Injectable builds upon the existing body of evidence supporting the safety and effectiveness of AUGMENT Bone Graft and leverages clinical data from the U.S. and Canada for the injectable formulation.”

The U.S. launch of AUGMENT Injectable is expected to deliver sustained growth in the U.S. for the AUGMENT Regenerative Solutions platform over the next several years with a gradual ramp as the injectable form is reviewed by hospital value analysis committees and physician education programs are executed.  The company will immediately start the process of finalizing its packaging carrying the FDA approved labeling and expects to begin selling product in the U.S. shortly and complete the rollout in the next four to six weeks.

Dr. Timothy Daniels, Chief of the Division of Orthopaedic Surgery of St. Michael’s Hospital and Professor at the University of Toronto in the Department of Surgery, commented, “In Canada, my colleagues and I have been using AUGMENT Injectable since 2011 based upon its ideal handling characteristics and impressive clinical results.  FDA approval of AUGMENT Injectable provides a valuable enhancement to the existing AUGMENT product line for U.S. foot and ankle surgeons as a front-line biologic alternative that drives the biological healing process and eliminates the costs and clinical impacts of autograft harvesting.”

Dr. Jeremy McCormick, Associate Professor of Orthopaedic Surgery at Washington University School of Medicine in St. Louis, Missouri, added, “I adopted AUGMENT Bone Graft shortly after it launched as a clinically proven tool that has improved patient outcomes. As my confidence in the product has grown, so too has my use of AUGMENT.  Now, with the introduction of the new injectable version, delivery of the product to the fusion site will be simplified and more consistent, helping foot and ankle specialists use it more dependably in patients.”

AUGMENT Injectable is the first clinically proven injectable protein therapeutic to come to the U.S. orthopaedic market offering an alternative to autograft in ankle and/or hindfoot fusion procedures, which translates into an estimated market opportunity of approximately $300 million in the U.S. As FDA-approved alternatives to autograft in ankle and/or hindfoot fusion procedures, AUGMENT Bone Graft and AUGMENT Injectable offer a clear patient benefit by avoiding secondary surgical sites for the harvest of autograft tissue, which can result in prolonged harvest site pain and other comorbidities in some patients.

As a result of this approval, the company plans to update its 2018 annual guidance on its second quarter earnings call scheduled for August 8, 2018.

Internet Posting of Information

Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com.  The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving the quality of life for patients worldwide.  Wright is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics.  For more information about Wright, visit www.wright.com.

™ and ® denote trademarks and registered trademarks of Wright Medical Group N.V. or its affiliates, registered as indicated in the United States, and in other countries.  All other trademarks and trade names referred to in this release are the property of their respective owners.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS  

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the performance, market availability and market acceptance of the company’s products. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, physician acceptance, endorsement, and use of company products; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims; product recalls; the effects of industry, economic or political conditions outside of the company’s control; competitor activities; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 31, 2017 filed by Wright with the SEC on February 28, 2018 and in other subsequent SEC filings by Wright. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Investors & Media:

Julie D. Dewey
Sr. Vice President, Chief Communications Officer
Wright Medical Group N.V.
(901) 290-5817
julie.dewey@wright.com