January 20, 2017

By Jof Enriquez – December 29, 2016

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has posted the lists of medical device guidance documents it will prioritize for fiscal year 2017, pursuant to the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-114).

CDRH provides three lists: (1) a list of guidance documents that the Agency fully intends to publish (the “A-list”); (2) a list of guidance documents that the Agency intends to publish as resources permit (the “B-list”); and (3) a list of final guidance documents issued in 2007, 1997, 1987, and 1977 subject to focused retrospective review, as well as possible revision or withdrawal.

Among the A-list are final guidance documents on medical device cybersecurity, next-generation sequencing-based diagnostic devices, and the use of real-world evidence (RWE) to aid regulatory decision-making. Cybersecurity and RWE also are included in CDRH’s top ten science priorities for 2017, announced in September.

Included in the B-list are final guidance documents on unique device identification (UDI) and investigational device exemption (IDE) categories to support CMS coverage decisions. Also included is the draft guidance on electromagnetic compatibility of electrically powered medical devices, developed with the help of early stakeholder input.

CDRH says it issued 20 of 33 guidances on the FY 2016 list (14 from the A-list, 6 from the B-list). Several guidance documents that were not published in FY 2016, but were deemed high priority through stakeholder feedback, are now on the annual agenda for FY 2017, according to RAPS.

FDA says in a notice in the Federal Register that it welcomes comments on any or all of the guidance documents on the FY 2017 lists, allowing CDRH to better prioritize and more efficiently draft or finalize guidances, and to delete guidance documents that no longer represent the Agency’s interpretation, thinking, or policy on a regulatory issue.

READ THE REST HERE

BY MAURY THOMPSON, THE POST-STAR, GLENS FALLS, N.Y. / DECEMBER 28, 2016

(TNS) — The federal Food and Drug Administration has required medical companies testing new products to get permission from multiple separate regional FDA review boards across the country wherever test subjects live.

Legislation that President Barack Obama signed earlier this month will allow medical device companies the option of reporting to one centralized FDA review board, saving the companies time and expenses involved with the previous duplicative process.

“Particularly for many of our start-up or smaller companies, a provision like that is really a beautiful regulatory efficiency proposal that doesn’t do anything to change the importance or the soundness of the clinical trial,” said JC Scott, chief advocacy officer for AdvaMed, a medical device industry trade organization.

The provision is an example of myriad regulatory reforms of significance to the medical device industry in the 21st Century Cures Act, which Obama signed Dec. 13.

The comprehensive legislation streamlines the regulatory process for pharmaceutical and medical device companies, sets medical research policy, and provides federal funding for medical research, including $1.8 billion in new funding for cancer research.

“This critical legislation invests more in science and research, removes barriers that stand in the way of modern treatments, and advances personal medicine to ensure that patients can be treated based on their unique characteristics,” said U.S. Rep. Elise Stefanik, R-Willsboro, in a news release.

READ THE REST HERE

Maury Thompson, The Post-Star, Glen Galls, N.Y – December 29, 2016

(TNS) — The federal Food and Drug Administration has required medical companies testing new products to get permission from multiple separate regional FDA review boards across the country wherever test subjects live.

Legislation that President Barack Obama signed earlier this month will allow medical device companies the option of reporting to one centralized FDA review board, saving the companies time and expenses involved with the previous duplicative process.

“Particularly for many of our start-up or smaller companies, a provision like that is really a beautiful regulatory efficiency proposal that doesn’t do anything to change the importance or the soundness of the clinical trial,” said JC Scott, chief advocacy officer for AdvaMed, a medical device industry trade organization.

The provision is an example of myriad regulatory reforms of significance to the medical device industry in the 21st Century Cures Act, which Obama signed Dec. 13.

The comprehensive legislation streamlines the regulatory process for pharmaceutical and medical device companies, sets medical research policy, and provides federal funding for medical research, including $1.8 billion in new funding for cancer research.

“This critical legislation invests more in science and research, removes barriers that stand in the way of modern treatments, and advances personal medicine to ensure that patients can be treated based on their unique characteristics,” said U.S. Rep. Elise Stefanik, R-Willsboro, in a news release.

READ THE REST HERE

By Jof Enriquez – December 29, 2016

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has posted the lists of medical device guidance documents it will prioritize for fiscal year 2017, pursuant to the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-114).

CDRH provides three lists: (1) a list of guidance documents that the Agency fully intends to publish (the “A-list”); (2) a list of guidance documents that the Agency intends to publish as resources permit (the “B-list”); and (3) a list of final guidance documents issued in 2007, 1997, 1987, and 1977 subject to focused retrospective review, as well as possible revision or withdrawal.

Among the A-list are final guidance documents on medical device cybersecurity, next-generation sequencing-based diagnostic devices, and the use of real-world evidence (RWE) to aid regulatory decision-making. Cybersecurity and RWE also are included in CDRH’s top ten science priorities for 2017, announced in September.

Included in the B-list are final guidance documents on unique device identification (UDI) and investigational device exemption (IDE) categories to support CMS coverage decisions. Also included is the draft guidance on electromagnetic compatibility of electrically powered medical devices, developed with the help of early stakeholder input.

CDRH says it issued 20 of 33 guidances on the FY 2016 list (14 from the A-list, 6 from the B-list). Several guidance documents that were not published in FY 2016, but were deemed high priority through stakeholder feedback, are now on the annual agenda for FY 2017, according to RAPS.

FDA says in a notice in the Federal Register that it welcomes comments on any or all of the guidance documents on the FY 2017 lists, allowing CDRH to better prioritize and more efficiently draft or finalize guidances, and to delete guidance documents that no longer represent the Agency’s interpretation, thinking, or policy on a regulatory issue.

READ THE REST HERE

By JUDITH GRAHAM – December 22, 2016

Doctors have complained for years that they’re not paid adequately for time-consuming work associated with managing care for seriously ill older patients: consulting with other specialists, talking to families and caregivers, interacting with pharmacists and more.

That will change on Jan. 1, as a new set of Medicare regulations go into effect.

Under the new rules, physicians will be compensated for legwork involved in working in teams — including nurses, social workers and psychiatrists — to improve care for seniors with illnesses such as diabetes, heart failure and hypertension.

Care coordination for these “high need” patients will be rewarded, as will efforts to ensure that seniors receive effective treatments for conditions such as anxiety or depression.

Comprehensive evaluations of older adults with suspected cognitive impairment will get a lift from new payments tied to the standards that physicians now will be required to follow.

The new Medicare policies reflect heightened attention to the costliest patients in the healthcare system — mostly older adults who have multiple chronic conditions that put them at risk of disability, hospitalization, and an earlier-than-expected death. Altogether, 10 percent of patients account for 65 percent of the nation’s health spending.

It remains to be seen how many physicians will embrace the services that the government will now reimburse. Organizations that advocated for the new payment policies hope they’ll make primary care and geriatrics more attractive areas of practice in the years ahead.

READ THE REST HERE

MARIETTA, Ga., Dec. 27, 2016 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today that the Audit Committee of its Board of Directors has reported preliminary findings of its investigation to the Board of Directors regarding allegations made by two former employees against the Company.

As previously disclosed in its December 15, 2016 press release, the Company terminated two employees when it was discovered that the employees were selling products for other companies, some of which were competitive, in violation of their contractual and common law duties to MiMedx. Following their terminations, the Company filed suit against the employees for these breaches, and the employees in turn filed suit against the Company alleging that the Company engaged in certain fraudulent business practices, including practices that allegedly would affect the Company’s revenue recognition policy.  As the Company has previously stated publicly, management believes the claims made in the lawsuit brought by these former employees, including claims made about the Company’s sales practices, are without merit, and the Company does not anticipate any material effect on the Company’s financial statements resulting from these allegations.

The Audit Committee is working closely with independent counsel and its external auditors to conduct an extensive internal investigation into the claims alleged in the lawsuit.  The Audit Committee has provided preliminary findings to the Board of Directors and Company management, but the investigation into the claims is ongoing.  The Audit Committee has advised the Company’s management and the Board of Directors that it has found no credible evidence to indicate that any changes to previously issued financial statements are necessary in light of these allegations.

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other human birth tissues, such as amniotic fluid, umbilical cord and placental collagen, and human skin and bone.  “Innovations in Regenerative Biomaterials” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of amniotic tissue, having supplied over 700,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, statements regarding the litigation and the preliminary findings of the investigation. These statements are based on current information and belief, and are not guarantees of future performance.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the normal risks of litigation, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2015, and its most recent Form 10Q filing.  By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.