MARIETTA, Ga., Aug. 30, 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, provided an update today on the status of key clinical trials.

Plantar Fasciitis Investigational New Drug (“IND”) Study Receives FDA Approval for Protocol Amendment Reducing Follow-up Requirements by One Year

Pursuant to the Company’s agreement with the Food and Drug Administration (“FDA”) to pursue a Biologics License Application (“BLA”) with the Company’s AmnioFix® Injectable product, MiMedx entered a Phase IIB Randomized Control Trial (“RCT”) for the treatment of plantar fasciitis in August, 2014.  The FDA approved the clinical study protocol which targets 146 subjects at up to 20 clinical sites.  The study has met a very significant milestone. In the initial protocol, a 24-month follow-up blood draw was requested by the Agency in order to determine if the micronized dHACM injection elicited an immune response in patients. An amendment was submitted to the FDA based on generated data requesting a protocol amendment to remove the 24-month follow-up requirement for this clinical trial.  Because of the excellent safety profile and the lack of immunogenic response seen in the study patients thus far, the FDA has agreed that two year data is NOT needed and reduced the requirement to one year.  This is a major milestone for this study.

Parker H. “Pete” Petit, Chairman and CEO, said, “At present, 109 of the 146 patients have been consented and 103 randomized in the plantar fasciitis study, in a total of 13 sites, and the study should be fully enrolled by the end of the year.   In terms of cost, the total expenditure for this study is projected to be slightly over $2 million, a large portion of which has already been expensed since the inception of the study in late 2014.”

BLA/PMA Compliant Chronic Wound Clinical Trials Near Completion

Bill Taylor, President and COO, stated, “In anticipation of additional needs for future regulatory and/or reimbursement purposes, we have had two large, multi-center chronic wound studies under way since 2014. One study is for diabetic foot ulcers (“DFUs”) and the other is for venous leg ulcers (“VLUs”). These large studies follow the multiple clinical trials with EpiFix® concluded over the years, including the published 100 patient comparative effectiveness trial against a competitive product, and complete the DFU and VLU clinical trials for EpiFix.  As with the comparative effectiveness study, the two studies that are underway follow the 2006 FDA Guidance for Industry-Chronic Cutaneous Ulcer and Burn Wounds.  This is the guidance document that outlines clinical trial design for Premarket Approval (“PMA”) and BLA products.”

The multi-center DFU study was designed to have in excess of 10 sites and a target enrollment of 130 patients.  This study currently has 12 sites enrolling patients, with 105 enrolled to date.  The Company expects to complete enrollment by the end of this year.  This study has been ongoing since 2014. The total cost of the study is expected to be less than $2 million, and a large portion of this estimated $2 million has already been expensed by the Company.

The multi-center VLU study targeted in excess of 10 sites and 120 patients.  At present, 11 sites have enrolled 123 patients.  MiMedx expects that this study will conclude enrollment shortly, and will be completed by the end of this year.  This study is also expected to cost under $2 million. As with the other two studies mentioned above, a large portion of the cost of this study has already been expensed.

Investments in Clinical Trials Position MiMedx Favorably for Any Outcome from FDA Industry Meeting

Petit commented, “We expect the industry meetings that the FDA is holding on September 8, 12 and 13, 2016 to be very enlightening and productive relative to questions that have arisen over the last several years on amniotic membrane and other tissue allografts.  We will be extending a thank you to the FDA for the approach it is now taking to these two meetings. Including industry, physicians, scientists and patients in the deliberations will be very beneficial. Regardless of how these discussions are perceived, we believe MiMedx is the best positioned organization to fulfill further regulatory requirements in the future, if they are mandated.  As a matter of fact, we have already incurred much of the expenses to do so. In addition, we are now past the half way point in patient enrollment for our IND/BLA study for our micronized allograft, and we expect completion of patient enrollment near the end of 2016.”

“It is well known that the FDA is reviewing its HCT/p 361 regulations and Draft Guidance documents, and considering potentially further modifications of the regulations.  By early 2017, MiMedx will have completed a total of three large multi-center clinical trials for EpiFix on chronic wounds that will meet the FDA’s 2006 Guidance Document for Phase III clinical trials of chronic wounds.  The FDA typically only requests two such studies in BLA programs, so we are extremely well positioned for any potential changes in regulations related to HCT/ps and their use in chronic wounds.  Also, MiMedx has already spent the majority of the dollars needed for those clinical trials. Should the FDA update its regulations such that our EpiFix product line would need a BLA after a suitable transition period, or frankly, if we decide to voluntarily request a BLA for a specific indication for use, we feel that the data we will have from these three large clinical trials should be sufficient to meet the FDA’s clinical trials requirement for a BLA.  Therefore, we believe that MiMedx is in the leadership position in this area, no matter which direction the FDA takes relative to updating its Draft Guidance documents and regulations,” added Taylor.

Petit commented, “In the event that the FDA Draft Guidance Document on Homologous Use is finalized exactly as published in the draft documents, we would disagree that the science supports such a result; however, we will comply with the new regulations.  If we don’t appeal or otherwise contest the changes, we will simply change our marketing material to match the examples in the Draft Guidance.  If that happens, I expect that we will immediately begin to enter the process for a BLA.  We expect that the clinical data that we will have from our three Phase III level studies will meet the study requirements for a BLA for chronic wounds.  The two remaining studies should be complete and submitted for publication early next year.”

Shareholder Call

MiMedx management will host a live broadcast of its conference call to discuss the clinical studies highlighted in this press release. In light of the upcoming Labor Day holiday, the conference call will be held on Wednesday, September 7, 2016, beginning at 10:30 a.m. eastern time.  A listen-only simulcast of the MiMedx Group conference call will be available on-line at the Company’s website at www.mimedx.com.  A 30-day on-line replay will be available approximately one hour following the conclusion of the live broadcast. The replay can also be found on the Company’s website at www.mimedx.com.

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™ and AmnioFill™ brands; 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 belief that it is the best positioned organization to fulfill further regulatory requirements in the future, if they are mandated by the FDA;  that MiMedx is in a leadership position related to clinical trial requirements for BLAs, no matter which direction the FDA takes relative to updating its guidance documents; that in the event the FDA finalizes its Draft Guidance on Homologous Use in its current state, the Company will immediately begin to enter the process for a BLA, so as to claim wound healing; that the Company expects that the clinical data it will have from its three Phase III level studies will meet the study requirements for a BLA for chronic wounds, and that the two remaining studies should be complete and submitted for publication early next year. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the FDA may impose regulations that are not anticipated by the Company, that the data the Company will have from its three large clinical trials may not be sufficient to meet the FDA’s clinical trials requirements for a BLA or that the requirements may change, that the Company may not be able to enter the process for a BLA so as to claim wound healing should this become necessary, that the two remaining Phase III level studies may not be completed on schedule and may not be ready for publication early next year or may  not ultimately be accepted for publication, 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 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.

Related Links

http://www.mimedx.com

By Bob Herman  | August 29, 2016

The CMS proposed rules Monday afternoon that would make several changes to the Affordable Care Act marketplaces and refine the law’s risk adjustment, heeding calls from the health insurance industry.

The proposed rules (PDF), which normally are released in November, come after weeks of intense scrutiny and uncertainty about the viability of the new ACA insurance exchanges. Aetna, Humana and UnitedHealth Group, which have bigger footprints in the employer and Medicare Advantage markets, all have announced major retrenchments for the 2017 season, which begins Nov. 1.

One of the biggest changes involves the ACA’s permanent risk-adjustment program. Lawmakers created risk adjustment to compensate plans for taking on sicker enrollees who have higher healthcare costs, thereby attempting to eliminate the incentive to cherry-pick healthier people.

Starting in 2018, risk adjustment would factor in prescription drug data in addition to all the normal conditions and illnesses that are factored into someone’s risk score. Health insurers have argued their members look healthier than they actually are because the program doesn’t account for the medicines people are taking. But some risk-adjustment experts believe using drug data could create perverse incentives for doctors to write unnecessary prescriptions.

The CMS said the change was worth pursuing while considering those concerns. “We sought to strike a reasonable balance between increasing predictive accuracy and reducing incentives for overprescription,” the agency said. “One way we sought to do so was by focusing on drugs for which guidelines on when they should be prescribed are clear.”

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Lund, Sweden, 30 August 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that presentations and posters covering research with its CERAMENT G and CERAMENT V will feature extensively at the upcoming 35th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) taking place September 1-3 in Oxford, UK – which is a key congress for physicians and surgeons managing patients with bone infections. CERAMENT G and CERAMENT V are the only CE-marked injectable antibiotic eluting bone graft substitutes which provide local sustained delivery of gentamicin and vancomycin, respectively.

The EBJIS annual meeting will feature 25 abstracts highlighting research and clinical findings with CERAMENT G and CERAMENT V. This is a significant increase in the number of presentations and posters that were made at the 34^th Annual EBIJS meeting reflecting the impressive clinical performance reported, the launch of CERAMENT V in 2016 and the growing interest in the only injectable antibiotic eluting bone graft substitutes that are available in Europe. Both CERAMENT G and CERAMENT V are able to deliver an initial high concentration of antibiotic to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to promote and protect bone healing and remodeling.

Richard Davies, CEO of BONESUPPORT, said: “The broad range of research and clinical data on CERAMENT G and CERAMENT V being presented at this year’s EBJIS Annual meeting highlights the significant increase in interest in these novel injectable antibiotic eluting bone graft substitutes. The new data also underscores BONESUPPORT’s commitment to supporting high-quality research that will help improve the management of important bone diseases. We are confident that the growing body of clinical evidence in support of both CERAMENT G and CERAMENT V will allow them to be used increasingly in patients with problematic bone infections including osteomyelitis, as well as prophylactically in patients at risk for developing an infection.”

BONESUPPORT recently received approval from the US Food and Drug Administration (FDA) to begin the FORTIFY study, an IDE (Investigational Device Exemption) study, with CERAMENT G.  This study is a randomized multicenter controlled trial that will evaluate the safety and efficacy of CERAMENT G as part of surgical repair of open diaphyseal tibial fractures. The first patient is expected to be recruited into the FORTIFY study by the end of 2016. Data from the FORTIFY study will be an important component of BONESUPPORT’S planned PMA to gain US approval for CERAMENT G.

EBJIS is a European association of orthopedic surgeons, trauma surgeons, infection specialists and microbiologists. The aim of the Society is to promote the knowledge of all infections affecting the Musculoskeletal system (bone and joint infections) and to promote the prevention and treatment of these infections. The complete program of the EBJIS meeting is available at http://ebjis.org/

 Notes to Editor

About BONESUPPORT

BONESUPPORT has developed CERAMENT an innovative range of radiopaque injectable bone graft substitute products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (CERAMENT BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT BVF’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT G and CERAMENT V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden with subsidiary locations in the U.S. and Germany. www.bonesupport.com

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici

+44 (0)20 7282 2949/1050

bonesupport@citigatedr.co.uk

BONESUPPORT AB 

Richard Davies, CEO

Phone +46 46 286 53 59

Richard.Davies@bonesupport.com

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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August 26, 2016

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