MARIETTA, Ga., Aug. 29, 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 an update to  its intellectual property portfolio.

Since the last update of the MiMedx patent portfolio in the Company’s November 19, 2015 press release, the U.S. Patent and Trademark Office has issued six new patents to MiMedx. Of these six, five were issued for the Company’s amniotic membrane allograft product lines and one was issued for the Company’s CollaFix technology platform:

The ‘077 patent expands the portfolio of MiMedx patents related to the Company’s proprietary methodology for the linear organization of natural collagen fibers to form the mechanical construct for optimal stiffness and strength to treat orthopedic and other conditions such as tendon repair. The ‘800; ‘801; ‘005; ‘003; and ‘074 patents further add to the portfolio of patents issued to the Company for its proprietary methodology of preparing placental membrane tissue grafts for medical use.

Parker H. “Pete” Petit, Chairman and CEO, said, “We are continually creating and developing new intellectual property as well as adding to our portfolio of patents that protect our existing  intellectual property. At present, the Company’s robust patent portfolio consists of 33 amniotic and placental patents issued and allowed, and nearly 100 amniotic patent applications pending with the U.S Patent and Trademark Office. Counting all of the MiMedx technologies, we currently have over 200 patents issued or pending.”

Bill Taylor, President and COO, added, “We are strongly resolute in enforcing our rights when our patents are infringed upon. Often, this includes complex and costly litigation; however, this is essential if we want to protect our intellectual property to the fullest extent.”

MiMedx also announced today that a finding has been rendered from the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office regarding MiMedx’s United States Patent No. 8,372,437. As with the PTAB’s recent ruling on the ‘687 embossment patent, the PTAB ruled that the ‘437 patent was invalid based on alleged prior art rendering it obvious. This ‘437 patent is not primary to MiMedx’s proprietary processing of amniotic tissues, which processing preserves the cytokines, growth factors, proteins and other critical factors that enhance the clinical performance of the MiMedx dehydrated human amnion/chorion membrane (“dHACM”) allografts.

Petit stated, “The ancillary ‘437 patent is simply one among our robust patent portfolio, and this decision has zero impact on any of our other issued patents and pending applications. Most importantly, the PTAB finding on the ‘437 patent has no bearing on our cornerstone EpiFix® and AmnioFix® patents, the 8,709,494 and 8,323,701 patents, respectively. The validity of these patents was recently upheld by the PTAB. In addition, it should be noted that the PTAB’s decision utilized a far broader standard for construing claims than what is utilized in federal courts. We believe that standard undoubtedly led to the flawed outcome.  And, while the ‘437 patent is by no means one of our primary patents, we believe the decision is fundamentally incorrect and we plan to appeal.”

“We have other claims more relevant to product effectiveness and efficacy that are embedded in our other patents covering the topics included in the broad ‘437 patent. The PTAB ruling does not affect our active district court litigations on the cornerstone EpiFix® and AmnioFix® patents, in which Musculoskeletal Transplant Foundation, Inc. (“MTF”), Liventa Bioscience, Inc. and Medline Industries, Inc. are defendants in the one case, and Transplant Technology, Inc. d/b/a Bone Bank Allografts and Texas Human Biologics, Ltd., are defendants in the other case. Those lawsuits remain pending with upcoming trials. As mentioned in our August 11, 2016 press release, the strength of our patent portfolio and the upheld validity of our cornerstone patents contribute to our high confidence for the successful outcome of our pending lawsuits,” noted Taylor.

Petit added, “We are working diligently to bring our patent litigation to closure and look forward to reporting to shareholders positive results from these first trials.  Some of these litigation issues can be quite complex so we will continue to inform shareholders of relevant actions.  The key issue is that if we are successful in these trials, we will have access to injunctive relief in terms of stopping other competitors from selling products that infringe our patents.  We will then be able to proceed against other violators of our patents and seek injunctive relief to stop their distribution of these infringing products.”

“Businesses ultimately succeed or fail through competition in the marketplace.  We have proven our ability to compete and win in the marketplace with our products over the last five years.  However, as a patent holder, we also believe it is worth investing time and expense on the legal front as well to protect the extensive effort that we have put into the development of our patents,” concluded Petit.

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 birth tissues 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.  The MiMedx allograft product families include our: dHACM family with AmnioFix®, EpiFix® and EpiBurn® brands; Amniotic Fluid family with OrthoFlo brand; Umbilical family with EpiCord™ and AmnioCord™ brands; Placental Collagen family with CollaFix™ brand; Bone family with Physio® brand; and Skin family with AlloBurn™ brand. AmnioFix,  EpiFix, and EpiBurn are our tissue technologies processed from human amniotic membrane; OrthoFlo is an amniotic fluid derived allograft;  EpiCord™ and AmnioCord™ are derived from the umbilical cord; Physio is a unique bone grafting material comprised of 100% bone tissue with no added carrier; AlloBurn is a skin product derived from human skin designed for the treatment of burns; and  CollaFix, our next brand we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair.

We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 600,000 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 the  Company’s approach to new patent filings and applications and enforcing its rights when its patents are infringed upon are essential elements of protecting its intellectual property; the Company’s belief that the PTAB’s finding that the ‘437 patent is invalid was wrongly decided; the Company’s belief that the standard employed by the PTAB led to the flawed ruling; the belief that the ‘437 patent is a novel concept; the Company’s beliefs that claims more relevant to product effectiveness and efficacy are embedded in its other patents covering the topics included in the broad ‘437 patent; the Company’s belief that it has proven its ability to compete and win in the marketplace with its products over the last five years; and the fact that both the ‘494 and ‘701 patents were upheld in IPR challenges gives the Company confidence that it will fully prevail at the conclusion of the two noted lawsuits at trial. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include  the patents that have been developed and the Company’s approach to filing and enforcement of its rights may not provide sufficient protection of the Company’s intellectual property assets; that the Company’s development of patentable technology may not continue at the same pace; the fact that the ‘494 and ‘701 patents were upheld in IPR challenges does not require that the patents be upheld at trial; if appealed, the PTAB decision on the ‘437 patent may still be upheld, despite the Company’s belief that the case was wrongly decided and that the patent is a novel concept; the Company’s ability to successfully compete in the marketplace may change in the future; the normal risks and uncertainties 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 10Q. 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

By Zachary Brennan – August 23, 2016

The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017.

Under the new draft agreement, which is part of the fourth reauthorization of  the Medical Device User Fee Agreement, FDA would use the funds for a whole host of new programs, including the addition of 20 full time employees (FTEs) to establish a new quality management framework, and $30 million to implement a system that improves the quality of real-world evidence (RWE) and linkages among data sources to enable greater use of RWE in the premarket setting.

Other initiatives outlined in the last reauthorization meeting held with industry in May include:

• $12 million to strengthen the Third Party Premarket Review program
• $8.5 million to improve employee retention through incentive pay for managers using existing authorities and policies
• $6 million for an independent assessment of the review process, including a more complete assessment of MDUFA III improvements and outcomes
• Funding for 36 to 43 FTEs to hire reviewers to increase premarket review capacity
• Funding for 34 to 44 FTEs and $3 million to improve the pre-submission process and provide written feedback on 80 to 85% of pre-submissions (depending on number of FTEs supported) within 70 days or 5 calendar days prior to the meeting, whichever comes sooner
• Funding for 28 to 38 FTEs and $1 million to complete 70% of de novo submissions within 120 to 150 days (depending on number of FTEs supported and assuming a workload of 50 de novo submissions per year, which is lower than the assumptions for previous proposals)
• $4.5 million for the development of the my Devices submission and tracking portal
• An unspecified amount of funding for 20 FTEs to hire additional supervisors to reduce the ratio of supervisors to reviewers, thus increasing the capacity of branch chiefs to provide greater oversight and ensure consistency of review procedures
• $4 million to implement more effective recruitment and hiring
• Funding for 13 FTEs and $3.6 million to provide for consistent review of software, streamlining and aligning FDA review processes with software lifecycles, continued engagement in international harmonization efforts related to software review, and other activities related to digital health
• Funding for three FTEs to establish central program management for CLIA Waiver by Application submissions, with an option to fund an additional two FTEs plus $1 million in special operating costs to complete 90% of stand-alone CLIA Waiver applications that do not have a panel meeting in 180 to 150 days (depending on number of FTEs supported), 90% of Dual 510(k) and CLIA Waiver applications in 210 to 200 days, and 90% of stand-alone CLIA Waiver applications that have a panel meeting in 330 to 320 days (pending the review of potential legal impediments)
• Funding for 12 FTEs and $3.5 million to develop internal FDA expertise on patient engagement, support the increased use of patient preference information (PPI) and patient reported outcomes (PROs) in premarket submissions, outline a flexible framework for PRO validation, and clarify the optional use of PROs
• Funding for five FTEs and $2.45 million to establish a conformance assessment program for certified testing laboratories who evaluate medical devices according to certain FDA-recognized standards

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Ness Ziona, Israel, August 17, 2016 – CollPlant Ltd. (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products, today announced positive final extended clinical trial results for Vergenix™STR for the treatment of tendinopathy. The Company anticipates receiving CE mark approval for Vergenix™STR in the third quarter of 2016.

The prospective, open label, single-arm trial was conducted at three leading Israeli hospitals (Meir Medical Center, Assaf Harofeh Medical Center and Hadassah Hospital), and the trial’s objective was to demonstrate the safety and performance of Vergenix™STR in 40 patients suffering from inflammation of the elbow tendon, commonly referred to as tennis elbow. All patients were followed for a total of six months after a single treatment. Product performance was assessed by measuring reduction in pain and recovery of motion, as reported by the specific Patient Related Tennis Elbow Evaluation questionnaire (“PRTEE”).

At three months following treatment, Vergenix™STR patients (N=39) reported an average PRTEE score improvement of 51% over baseline. At six-month follow-up, Vergenix™STR patients (N=36) reported a mean PRTEE score improvement of 59% over baseline.

The performance of Vergenix™STR also compared favorably to published results of corticosteroid injection, which is the standard-of-care therapy for tennis elbow (1) . At three months following treatment, 74% of Vergenix™STR patients reported a 25% or better PRTEE score improvement while, in the published controlled trial, 48% of steroid patients showed at least a 25% reduction in pain and disability(2) . Further, at six month follow-up, 86% of Vergenix™STR patients reported a 25% or better PRTEE score improvement, while 36% of steroid patients showed at least a 25% reduction in pain and disability.

An additional analysis utilizing a threshold of at least 50% improvement in PRTEE score showed that at three months following treatment, 62% of Vergenix™STR patients showed at least a 50% improvement in PRTEE score while, in the published controlled trial, 33% of steroid patients had at least a 50% reduction in pain and disability (3) . At six month follow-up, 64% of Vergenix™STR patients showed at least a 50% improvement in PRTEE score, while 17% of steroid patients showed at least a 50 % reduction in pain and disability.

Yehiel Tal, Chief Executive Officer of CollPlant, stated, “We are very pleased with the final extended trial results, which we believe illustrate the significant potential advantages of Vergenix™STR over steroids, which are traditionally used as first line treatment for tendinopathy patients. CollPlant is making substantial progress towards commercialization, and we look forward to receiving CE Mark approval later this quarter, and making Vergenix™STR available to patients as soon as possible.”

About Vergenix™STR

Vergenix™STR, intended for the treatment of a range of tendon injuries, incorporates CollPlant’s recombinant human collagen in combination with platelet-rich plasma (PRP) derived from the patient’s blood. Following its injection into the injured site, the product transitions from a fluid to a solid phase, whereupon, it releases, in a controlled fashion, platelet-derived proteins. These proteins, in combination with collagen, induce the healing effect on the tendon.

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based rhCollagen technology for the development and commercialization of tissue repair products, initially for the orthobiologics and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary recombinant human collagen (rhCollagen), among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix™STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; Vergenix™FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds, and; Vergenix™BVF (Bone Void Filler), for use in spinal fusion procedures and trauma. CollPlant’s business strategy includes proprietary development and manufacturing of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacturing and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Contact at CollPlant:

Eran Rotem, Chief Financial Office, Tel: +972-73-2325600/612

Email: Eran@collplant.com

Contact at Rx Communications Group, LLC

Paula Schwartz (for US Investors)

Managing Director

Tel: 917-322-2216

Email: pschwartz@RxIR.com

August 29, 2016 – By Stewart Eisenhart, Emergo Group

Brazil’s medical device market regulator ANVISA will implement new rules for more efficient transfers of device registrations between Brazilian Registration Holders (BRH).

After Emergo first reported on ANVISA’s transfer rule change plans in July 2016, the regulator has now issued RDC 102/2016 that introduces official regulation on those changes, set for implementation on December 25, 2016.

“With these new rules, it will be possible to transfer a device registration in Brazil without the need to have a corporate relationship,” explains Luiz Levy, Director of QA/RA at Emergo’s office in Brasilia. Existing regulations allow such transfers only in limited cases such as mergers and acquisitions.

Key features of the new transfer rules

RDC 102/2016 lays out several top-level requirements to which BRHs must adhere for proper transfers of registrations:

• The original registration holder must give contractual permission for transfer to the new holder
• Transfers must be submitted for ANVISA approval within 180 days of agreement signings
• Transfers do not require the consent of the device’s legal manufacturer—a distributor acting as a BRH could sell a registration to another distributor or BRH without notifying the device’s manufacturer
• Transfers may be requested for devices already registered with ANVISA as well as for devices that have been submitted but not yet approved for registration
• Transfers go into effect 90 days after publication in the Official Diary in order to ensure issues such as labeling and stock depletions are addressed

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