Regentis Biomaterials Performs the First Cases in GelrinC Pivotal Study

Posted On November 30, 2017 By OrthoSpineNews In Biologics, Regulatory /

PRINCETON, New Jersey and OR AKIVA, Israel, November 28, 2017 /PRNewswire/ —

Regentis Biomaterials announced today the start of its Phase III pivotal clinical trial of GelrinC for the treatment of focal knee cartilage defects with successful surgery on three patients in the U.S. and Denmark. These procedures are part of a Food and Drug Adminstration (FDA) approved Investigational Device Exemption (IDE) clinical study to compare GelrinC to microfracture, the current standard of care treatment. The clinical study will be used to support a Pre-market Approval Application (PMA) which will allow Regentis to market GelrinC in the U.S.

The US procedures were performed by Dr. Jason Scopp at the Peninsula Orthopaedic Clinic in Salisbury, Maryland and by Dr. Bryan Huber at Mansfield Orthopaedics at Copley Hospital in Morrisville, Vermont while the Denmark procedure was completed by Dr. Martin Lind in Aarhus University Hospital in Aarhus.

“We are entering our next evolution in the field of joint preservation. While many current techniques involve transplanting cartilage from a donor, the GelrinC implant allows us to harness the benefits of our patient’s own mesenchymal stem cells,” said Dr. Jason Scopp from Peninsula Orthopaedic Clinic. “The technique was extremely quick, adding a mere 10 minutes to a standard practice procedure. Product application to the lesion was easy with the assistance of Regentis’s proprietery delivery device. It completely filled the defect and after a short exposure to UV light, an optimal implant was formed.”

“The success of these three clinical procedures is a significant milestone for Regentis and represents a big step to helping US and European patients recover from damaged articular knee cartilage,” said Regentis President and CEO Alastair Clemow, Ph.D. “In our previous study in Europe, GelrinC demonstrated outstanding clinical outcomes, and we look forward to continue demonstrating the effectiveness of this novel treatment for US patients.”

The FDA trial will appraise the safety and efficacy of GelrinC compared to the raw level data of a historical microfracture control arm. This study design overcomes the limitation of randomized control studies in this field, and is expected to generate faster patient enrollment and significantly reduce the time for product approval.

With an estimated market opportunity in excess of $1 billion, cartilage repair is the largest unmet need in orthopedic sports medicine today. Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. Focal defects of the cartilage layer are extremely painful for patients and usually occur due to sudden trauma. Surgical intervention is often required because of the limited capacity for cartilage to repair itself. The current standard of care treatment is microfracture but this only provides short term relief and often requires surgical re-intervention.

About Regentis Biomaterials
With offices in Or Akiva, Israel and Princeton, NJ, Regentis Biomaterials is a privately held company focused on developing and commercializing proprietary hydrogels for tissue regeneration. The company’s core technology is Gelrin™, a biodegradable hydrogel based on polyethylene glycol diacrylate and denatured human fibrinogen originally developed at the Technion – Israel Institute of Technology by Dr. Dror Seliktar. The Gelrin hydrogel platform combines the stability and versatility of a synthetic material with the bio-functionality of a natural substance for a range of clinical applications. For more information, please visit http://www.regentis.co.il.

For media inquiries, please contact:
Josh Turner
Media Relations
Phone: 011-972-54-949-6526
josh@jtpublicrelations.com

USA
Alastair Clemow, PhD
President & CEO
+1-508-930-8865

Israel
Livnat Ben Zur
General Manager
011-972-52-860-4735

SOURCE Regentis Biomaterials Ltd.

curasan Inc. announces Orthopedic Private Label Distribution Agreement

Posted On November 30, 2017 By OrthoSpineNews In Biologics /

Kleinostheim, Germany / Research Triangle Park, NC, USA, November 2, 2017 – curasan Inc., the US-subsidiary of curasan AG (ISIN DE0005494538), a leading medical supplier specializing in dental and orthopedic biomaterials, announced a private label distribution agreement with Xtant Medical (NYSE:XTNT Belgrade, Montana USA), a leader in the development and distribution of regenerative and orthopedic fixation medicine products.

Xtant Medical will distribute several key orthopedic curasan products in the USA and Canada utilizing curasan’s flagship CERASORB foam technology using Xtant’s brand Matriform. With the addition of Matriform foam to Xtant’s portfolio, Xtant will now offer an innovative synthetic platform with demonstrated clinical results and excellent handling characteristics complementing their current allograft and hardware portfolio ultimately providing surgeons with a choice in grafting materials.

“We are excited to be enhancing our biologic portfolio offering with a line of synthetic scaffolds, which will make us a comprehensive biologic supplier for our customers and their patients,” said Carl O’Connell, CEO of Xtant Medical. “Our team has been very strategic in finding a partner with a product that meets our expectations for superior handling and clinical efficacy with proven mechanisms of action.”

“Thanks to the cooperation with such a forward-thinking company as Xtant Medical we will expand our distribution footprint within North America substantially,” said Michael Schlenk, CEO of curasan AG. “Xtant has a great reputation for providing innovative and relevant products to orthopedic surgeons.” Therefore, curasan expects the first significant sales from the cooperation in 2018.

Contact at curasan AG:
Investor Relations &
Corporate Communications
+49 6027 40 900-51
ir@curasan.com

About curasan AG:
curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, curasan, Inc., in the Research Triangle Park area, near Raleigh, N.C., USA. curasan’s innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide. curasan AG is a public company listed in the General Standard at the Frankfurt Stock Exchange.

About Xtant Medical:
Xtant Medical Holdings, Inc. (NYSE American:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

02.11.2017 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Language:	English
Company:	curasan AG
	Lindigstraße 4
	63801 Kleinostheim
	Germany
Phone:	06027/40 900 0
Fax:	06027/40 900 29
E-mail:	info@curasan.de
Internet:	www.curasan.de
ISIN:	DE0005494538
WKN:	549453
Listed:	Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange


End of News	DGAP News Service

curasan signs new cooperation with Implantcast for the DACH-region

Posted On November 30, 2017 By OrthoSpineNews In Biologics /

Kleinostheim, 30 November 2017 – curasan AG (ISIN DE0005494538), a leading specialist for medical products in the field of orthobiologics, has signed an exclusive distribution agreement with Implantcast GmbH, Buxtehude, Germany.

Already starting mid-December the worldwide acting orthopedics company, specialized on primary-, revision- and tumor endoprosthesis will market curasan AG’s bone regeneration materials (CERASORB^(R)) in Germany, Austria and Switzerland.

“For many years Implantcast has established itself as a specialist for orthopedics in the DACH-region, especially in the field of endoprosthesis. The company has built up a successfully working worldwide sales structure, which we consider a significant improvement for the distribution of our CERASORB^(R)orthopedics portfolio”, explains Michael Schlenk, CEO of curasan AG. “This cooperation will give us to access a considerable number of new potential customers. Together we are going to increase the awareness for our bone regeneration materials and expand our market share. ”

“The cooperation of the two companies will go beyond pure distribution. For example, we also agreed on a joint concept for the inclusion of key opinion leaders, on common medical monitoring projects and studies with leading centers for endoprosthesis as well as on collaborative participation in congresses, symposia and advanced training courses for clinical users”, adds Florian Früh, Head of Product Management of curasan AG. “Our joint measures shall emphasize the importance of the synergies existing between innovative individual implant solutions for the patient and therapies for complete bone regeneration”.

“With curasan’s innovative bone regeneration materials we shall be able to offer a comprehensive treatment concept for various degenerative and pathological diseases of the human skeletal system to clinical surgeons”, says Jens Saß, Managing Director and CEO of Implantcast GmbH. “By combining our resources and our medical and scientific expertise and competence as well as our long-time experience in orthopedics we are going to create a much higher awareness in the market. ”

Both parties consider to expand the distribution agreement also to other countries with an existing Implantcast sales network.

About Implantcast GmbH:
Implantcast GmbH is a highly-specialized and innovative medical technology company based in Buxtehude near Hamburg, Germany. Today, Implantcast has more than 480 employees. The company operates in the fields of product development, manufacturing, sterile packaging as well as sales and distribution of primary, revision and tumor endoprosthesis to offer an ideal solution for each individual patient. The company also has a worldwide sales network with 10 sales offices and more than 65 sales partners. Its headquarters and R&D are located at Buxtehude, the place of foundation. From here all cooperation partners are provided with endoprosthetics and instruments and in the future also with bone regeneration materials.
www.implantcast.de

Contact:
Andrea Weidner
Investor Relations / Corporate Communications
Tel. +49 6027 40900-51
Fax +49 6027 40900-39
andrea.weidner@curasan.com

30.11.2017 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Language:

English

Kuros Biosciences’ Chief Medical Officer to Retire

Posted On November 28, 2017 By OrthoSpineNews In Biologics /

Schlieren (Zurich), Switzerland, November 28, 2017

Kuros announced today that its Chief Medical Officer, Dr. Virginia Jamieson, has reached retirement age and will retire from full-time employment with effect as of May 31, 2018. Her succession will be announced in due course.

Dr. Joost de Bruijn, appointed CEO of Kuros Biosciences commented: “I would like to thank Dr. Jamieson for her many contributions and years of service as the Chief Medical Officer of Kuros. She successful designed and delivered clinical studies for the Neuroseal and PTH programs KUR-111, KUR-112 and KUR-113. Dr. Jamison will continue to drive clinical development and be actively engaged in identifying her successor.”

For further information, please contact:

Kuros Biosciences Ltd

Harry Welten, MBA

Chief Financial Officer

Tel +41 79 750 15 64

harry.welten@kurosbio.com

About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland, and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

CollPlant Expands European Sales Network: The Company Has Signed a Distribution Agreement in Greece and Cyprus for Vergenix®FG

Posted On November 28, 2017 By OrthoSpineNews In Biologics /

NESS ZIONA, Israel, Nov. 28, 2017 /PRNewswire/ — CollPlant (TASE: CLPT, OTC: CQPTY) – a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products (recombinant human, “rhCollagen”), announced that it has signed an agreement with a distributor in Greece and Cyprus. Under the terms of the agreement, the distributor undertook to make the first order for the product when signing the agreement, in an amount that is not material to the Company. The distributor is a Greek company operating in the field of medical devices, and the agreement is exclusive for a period of three years, with an option for an extension.

Yehiel Tal, CEO of CollPlant: “The agreement is the continuation of the implementation of our penetration strategy of the product into Europe and to increase of sales. This is the fifth distributor that has come on board to distribute the product, while in parallel we are continuing to receive positive feedback from treatments carried out in Europe, reflected in rapid recovery of chronic wounds.”

Vergenix^®FG is based on the Company’s collagen technology, and is designed to treat chronic hard-to-heal wounds such as diabetic ulcers, pressure sores, surgical cuts and trauma wounds. The product is injected directly into the wound, filling it and contributing to the healing process until full wound closure, without any side effects.

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics, 3D Bio-printing of tissue and organs, and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary 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; and Vergenix^®FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds. CollPlant’s business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products.

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

Contact at CollPlant:	Contact at Rx Communications Group, LLC:
Eran Rotem	Paula Schwartz (for US Investors)
Deputy CEO & Chief Financial Officer	Managing Director
Tel: +972-73-2325600/612	Tel: +1-917-322-2216
Email: Eran@collplant.com	Email: pschwartz@rxir.com

SOURCE CollPlant

MiMedx Provides Update On Its Reimbursement Coverage

Posted On November 21, 2017 By OrthoSpineNews In Biologics /

MARIETTA, Ga., Nov. 21, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, provided a reimbursement update today.

Parker H. “Pete” Petit, Chairman and Chief Executive Officer, said “With the publication of the Venous Leg Ulcer (VLU) study earlier this quarter, one of the nation’s largest not-for-profit health plans serving more than 3 million people recently decided to add EpiFix® coverage for Diabetic Foot Ulcers (DFUs), VLUs and burns. We also added another state Medicaid with nearly 2 million lives adding EpiFix coverage for DFUs, VLUs and burns. We expect many more health plans to follow suit with this type of decision in the future.”

The Company also provided a reimbursement update in light of the recently issued Food and Drug Administration (FDA) Final and Draft Guidance documents related to human tissue titled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use” (the “HCT/P Guidance”).

Over the years, the Centers for Medicare and Medicaid Services (CMS), through its sub-committee, the Healthcare Common Procedure Coding System (HCPCS) Committee, has assigned Q Codes for numerous products. These Q codes are assigned based on the Committee’s review and are maintained by the HCPCS national panel, composed of representatives from Blue Cross/Blue Shield Association, the Health Insurance Association of America and CMS. Once assigned, payers typically then determine whether to reimburse those Q Codes. The payers further develop coding decisions based on the product’s efficacy. Since MiMedx’s EpiFix was introduced to the market in 2011, this is the process that payers have followed regarding EpiFix payment policy. Based on the clearly demonstrated efficacy of EpiFix in the numerous Randomized Controlled Trials (RCTs) in which EpiFix was the focus, the reimbursement coverage of EpiFix for the treatment of wounds has continued to grow over the years.

Petit added, “With the issuance of the final HCT/P Guidance document by the FDA, we believe the payer coverage for EpiFix will further improve. The only changes we anticipate from the final HCT/P Guidance are the addition of more payers covering EpiFix. Our recently published landmark multicenter VLU clinical trial and completed DFU study, along with the rest of our compendium of clinical data including an EpiFix comparative RCT, should further solidify MiMedx’s leadership position in the wound care market. Payers have long stated they want products that help to close wounds faster thereby reducing reduce hospital days and other expenses. It is important to note that the HCPCS Committee has assigned Q codes for product indications as a ‘cover’ as well as ‘wound healing’ with similar reimbursement rates. Based on product efficacy, the payers have traditionally utilized both ‘cover’ and ‘wound healing’ codes for their coverage decisions. We expect this traditional practice will be fully continued by the payers with the issuance of the final HCT/P guidance.”

Bill Taylor, President and Chief Operating Officer, commented, “With the recent publication of the VLU study, which is the first large scale successful VLU study completed in nearly 20 years, and the first large RCT of this quality on an amniotic membrane, we announce that we anticipate a robust increase in the level of reimbursement coverage for VLU procedures from commercial payers. Please recall that we have Medicare reimbursement coverage for both VLUs and DFUs; however, the breadth of our reimbursement coverage with commercial payers is primarily for DFUs. With the publication of the VLU study and the outstanding results in VLU healing rates, we are expecting a significant revenue opportunity to develop as commercial payers add EpiFix coverage for treatment of VLUs. On a very conservative basis, we have communicated that we could obtain VLU coverage for approximately 133 million additional commercial lives.”

“We view the impact of the final HCT/P Guidance as having a very positive effect on not only sustaining our current levels of EpiFix reimbursement coverage, but also being highly complementary to our on-going initiative with commercial payers in the adoption of coverage for the treatment of VLUs. The body of evidence demonstrating the clinical efficacy of EpiFix in the treatment of DFUs and VLUs is overwhelming,” concluded Petit.

About MiMedx
MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the Company’s belief that EpiFix RCTs are responsible for the growth in reimbursement coverage over the years and that this coverage will continue to improve, that the final HCT/P Guidance will have a positive effect on the Company and the only change anticipated is the addition of more payers covering EpiFix for DFU’s and VLUs, that the combination of the VLU and DFU studies and the Company’s compendium of clinical data should solidify the Company’s position in the wound care market, and the Company’s belief that it could obtain VLU coverage for approximately 133 million more commercial lives. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the guidance documents may not be implemented as expected; payers may decide not to add reimbursement coverage notwithstanding the clinical data and the guidance documents available; unexpected results or concerns may arise from data or analysis from our clinical trials; EpiFix RCTs may not have been responsible for the growth in reimbursement coverage over the years and therefore this coverage may not continue to improve with further clinical data; additional reimbursement coverage may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals; and the Company’s clinical trial successes may not translate to commercial advantages. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

BONESUPPORT™ Signs Commercialization Agreement for the Italian Market

Posted On November 21, 2017 By OrthoSpineNews In Biologics, Top Stories /

Lund, Sweden, 08.00 CET, 20 November 2017 – BONESUPPORT™, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT® platform today announces it has signed a second distribution agreement for Italy with Citieffe Srl to strengthen its access to trauma and orthopaedic surgeons in this market.Citieffe is a trauma implant manufacturer based in Bologna. It is part of the Medistream Group, owned by ArchiMed an independent French Healthcare Investment Firm. Citieffe, which has a direct sales force in Italy with national coverage, views BONESUPPORT’s CERAMENT® products as a very synergistic addition to its current implant offering to trauma surgeons in particular.

This new commercialization agreement in Italy will improve coverage for BONESUPPORT’s products in a key European market. BONESUPPORT markets its products directly in five European countries: the UK, Germany, Switzerland, Sweden and Denmark. BONESUPPORT has a commercial team of 20 people in Europe focused on driving the sales of its antibiotic-eluting injectable bio-ceramic bone substitute products, CERAMENT® G and CERAMENT® V.

Richard Davies, CEO of BONESUPPORT, commented: “I am pleased that we have signed this agreement with Citieffe, a commercial partner that will give us access to a portfolio of new trauma customers in the Italian market. We see Italy as a particularly important sales opportunity for CERAMENT® G and CERAMENT® V given the size of the market and the clear clinical and economic benefits that our antibiotic-eluting products deliver. I look forward to a mutually beneficial relationship with Citieffe.”

For more information contact:

Richard Davies, CEO

+46 (0) 46 286 53 71

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

Citigate Dewe Rogerson

Pip Batty, David Dible, Marine Perrier

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

About BONESUPPORT™

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

About Us

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bioceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.BONESUPPORT’s marketed synthetic bone graft substitutes CERAMENT™ BONE VOID FILLER (BVF), CERAMENT™ G* and CERAMENT™ V* are all based on the Company’s novel and proprietary CERAMENT technology platform.The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot. The Company’s research and development is focused on the continuing development and refinement of its existing technology to extend its use into additional indications by the elution of other drugs and therapeutic agents.BONESUPPORT’s products are based on an innovative technology backed by an intellectual property portfolio of approximately 100 registered and/or pending patents. BONESUPPORT has a nine year track record of safety and efficacy in treating patients with an estimated number of 30,000 procedures performed to date with its products worldwide based on sales data.BONESUPPORT’s total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent.The Company’s financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.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 listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152).Further information is available at ww.bonesupport.com*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United StatesBONESUPPORT™ is a registered trademark.

Invibio Investing to Accelerate Innovation for Medical Device Companies

Posted On November 17, 2017 By OrthoSpineNews In Biologics, Top Stories /

THORNTON CLEVELEYS, UNITED KINGDOM (PRWEB) NOVEMBER 16, 2017

Invibio Biomaterial Solutions has implemented a series of investments to help achieve the best possible clinical outcomes and lower total healthcare costs, a challenge faced by both the medical profession and industry, including medical device companies, globally. By assisting medical device companies to change the way they develop new products Invibio is focused on accelerating the time-to-market of new innovations. To deliver on this and provide greater clinical efficacies, the company has invested in clinical-study expertise, component manufacturing facilities and component testing. The innovator of implantable PEEK-OPTIMA™ polymer is also launching a new website that efficiently provides information on materials and applications to OEMs and Health Care Professionals (HCPs), and a comprehensive journal with further scientific information and clinical evidence.

John Devine, Medical Business Director at Invibio Biomaterial Solutions explains the quandary of innovative medical device makers: “When faced with delivering a consistent quality of healthcare at the lowest cost, the market has yet to create an environment that encourages more ambitious solutions than simply preserving the status quo at a fractionally reduced price.”

Redefining the total cost of care

Defining “best clinical outcomes” while delivering healthcare at the lowest possible cost is challenging, because clinical outcomes are typically obtained through clinical studies, which are expensive and time-consuming. In addition, there could be variations in the level of clinical evidence by region and different types of stakeholders and their needs, which can, for example, depend on where they sit on the curve of the diffusion of innovation. As a consequence, the medical device industry faces a difficult task, when seeking to demonstrate that new product innovations are addressing these issues and, ultimately, improving patient care.

John Devine sums it up: “The majority of current cost metrics focus on up-front purchasing costs rather than the total cost of care. For example, no standards exist for accurately assessing complication rates, or measuring the cost of revision surgeries, and reflecting these in purchasing decisions.”

As a leading pioneer in the use of PEEK-OPTIMA polymer solutions in medical applications, Invibio is convinced it can deliver the greatest clinical and economic benefits in four key areas, Dental, Spine, Orthopedics, and Trauma.

Establish and maintain clinical efficacy

To help raise its own bar for patient care and provide even greater clinical efficacy, Invibio recently recruited a clinical study manager and is working with Health Care Professionals (HCPs), medical device manufacturers and other stakeholders to determine the clinical and economic impact of its solutions. The company has also brought in clinical relations expertise to interact with HCPs, hospitals and payers. Martin Court, Executive Director at Victrex, emphasizes: “Doing so ensures that the clinical evidence we develop is not only shared in the marketplace, but accurately supports the benefits our materials can offer patients and the entire healthcare community.” As a result of these enhanced research and clinical data capturing efforts, Invibio has become more certain of the effectiveness of its solutions.

Investments in component manufacturing and testing

In addition, the company´s investments have made it easier for medical device companies to innovate and change the way they develop new products. Court continues: ”Our investment in component manufacturing facilities and component testing, for example, gives us a greater role in the design, development and commercialization of trauma fracture plates made of PEEK-OPTIMA™ Ultra Reinforced, a carbon-fiber-reinforced polymer. We have also pledged more support for our customers’ new product development programs. In addition, we are continuing to help customers worldwide navigate the challenging, regulatory pathway toward product safety and efficacy. It’s a win-win for Invibio, our customers, and patients alike.”

“Invibio Insider” journal and a new website for additional insights

Invibio is also launching a new comprehensive annual journal, the “Invibio Insider”, the first edition of which offers a detailed insight into key topics that will help to pioneer progress in the medical arena. Focused topics are intended to provide a greater understanding of the levels of clinical evidence, and what that may mean in combination with the company´s strategic drive to improve patient and clinical outcomes. It also explores approaches for treating challenging patients, taking into account the HCP’s perspective, and showcases recent clinical evidence while also discussing its potential economic impact.

The company´s new website will serve as a hub for OEMs and Health Care Professionals (HCPs) alike. For OEMs, it is a go-to practical and educational resource for implantable PEEK related knowledge and clinical data, including product offerings, manufacturing, quality and partnering for custom-design and regulatory services. For HCPs, it aims to facilitate the clinical adoption of new medical devices made of the company´s high-performance polymer, by providing implantable PEEK-related knowledge, clinical data and information concerning the potential benefits of Invibio´s solutions for HCPs and ultimately their patients. With a new emphasis on clinical evidence and an easy to navigate online academy, Invibio is not only addressing the needs of different target groups, but also hoping to contribute to achieving the best possible clinical outcomes and lowering the total costs of care.

Further information is available on Invibio´s new website: https://invibio.com.

About Invibio Biomaterial Solutions
Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in ~9 million implanted devices worldwide. INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved.

About Victrex plc
Victrex is an innovative world leader in high performance polymer solutions, focused on the strategic markets of automotive, aerospace, energy (including manufacturing & engineering), electronics and medical. Every day, millions of people use products and applications, which contain our materials – from smart phones, aeroplanes and cars to oil and gas operations and medical devices. With over 35 years’ experience, we develop world leading solutions in PEEK and PAEK-based polymers, and selected semi-finished and finished parts which shape future performance for our customers and our markets, and drive value for our shareholders. Find out more at http://www.victrex.com

MiMedx Market Leadership Well Positioned In Light Of FDA New Guidance Document

Posted On November 17, 2017 By OrthoSpineNews In Biologics, Regulatory /

MARIETTA, Ga., Nov. 17, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the Food and Drug Administration (FDA) issued numerous Final and Draft Guidance documents. Among them was the final Guidance document related to human tissue titled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use” (the “HCT/P Guidance”). Additionally, “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies,” Draft Guidance for Industry was published (the “RMAT Guidance”).

In the final HCT/P Guidance document, FDA updated and clarified its previous draft Guidance documents regarding HCT/Ps. In summary, MiMedx views the final HCT/P Guidance document as generally beneficial to the Company, physicians and patients. Bill Taylor, President and Chief Operating Officer, commented, “While there are a few items that are not consistent with the regulations, in general, we believe it should be viewed as a positive development in the industry. MiMedx is by far the leader in clinical and scientific studies and related publications on placental tissue. This places the Company years ahead of its competition. Note that the Final Guidance is largely in line with the MiMedx expectations for both micronized and sheet products as discussed on the Company’s September 2016 conference call. As expected, MiMedx’s sheet products are largely unaffected, but may require slight changes to the Company’s labeling and marketing documents. MiMedx micronized products are the subject of our four ongoing IND/BLA clinical studies.”

In FDA’s news release announcing the final HCT/P Guidance document, the Agency also stated that it would “apply a risk-based approach to enforcement,” and “for the first 36 months following issuance of the final guidance document, the FDA intends to exercise enforcement discretion for certain products.” In contrast, “the FDA does not intend to exercise such enforcement discretion for those products that pose a potential significant safety concern,” noting that “this risk-based approach allows product manufacturers time to engage with the FDA, and to determine if they need to submit a marketing authorization application.” MiMedx has a proven track record of safety based on its experience in distributing over 1 million allografts. The Company’s products have been allowed to proceed to Phase 3 with its plantar fasciitis and Achilles tendonitis Investigational New Drug/Biologic License Application (IND/BLA) studies.

The HCT/P Guidance document addresses many aspects of HCT/Ps, with the two most relevant items to MiMedx being Minimal Manipulation and Homologous Use. Minimal Manipulation relates to the way the tissue is processed and Homologous Use refers to the “intended use” as reflected by labeling, advertising, etc.

Taylor commented, “The HCT/P Guidance document clearly reiterates that products such as the MiMedx amniotic tissue in sheet form are considered to be minimally manipulated. This is consistent with the previous FDA positioning and what has been communicated to MiMedx by FDA.”

The final HCT/P Guidance document also maintains FDA’s position that micronized amnion is more than minimally manipulated. Parker H. “Pete” Petit, Chairman and Chief Executive Officer, said, “Although MiMedx still believes this is a flawed position and is not consistent with the HCT/P preamble and regulations, MiMedx has been following the IND/BLA pathway since 2014. At present, MiMedx has four IND clinical trials under way for our micronized amniotic tissue, AmnioFix® Injectable. Two of the studies are for plantar fasciitis (Phase 2B and 3), one for Achilles tendonitis (Phase 3), and the fourth is for osteoarthritis of the knee (Phase 2B). Based on the work we have done over the past four years and the finalization of this guidance document, MiMedx believes that we are years ahead of our competition relative to our micronized product platform.”

Taylor stated, “With respect to Homologous Use, FDA was largely consistent between the draft and final guidance issued as they relate to amniotic tissue. The Agency’s position remains that homologous use of amniotic tissue would include its use as a cover or to offer protection in repair and reconstruction procedures. MiMedx will review this Guidance Document and our marketing materials regarding our sheet products and determine what adjustments, if any, will be required. As stated in our September 6, 2016 shareholder call, with the completion of our multicenter Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU) trials, when combined with the rest of our compendium of clinical data including an EpiFix® comparative RCT, MiMedx is well-positioned to file for IND/BLAs for specific indications for EpiFix, if we find it desirable to do so. Recall that both of these studies were designed as adequate and well controlled trials able to support a BLA by adhering to FDA’s Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment.”

In a statement on the RMAT Guidance release, FDA Commissioner Scott Gottlieb, M.D. stated, “The suite of four guidance documents we are making public today also delivers on important provisions of the 21st Century Cures Act, including our continued promise to fully implement the Regenerative Medicine Advanced Therapy (RMAT) designation program, which is designed to expedite the development and review of regenerative medicine advanced therapies.”

The RMAT designation as laid out in the 21^st Century Cures Act offers companies with regenerative medicine products such as MiMedx a pathway for conditional and expedited approvals. In Dr. Gottlieb’s statement, he clearly signals the FDA’s commitment to fully implement the RMAT program.

Petit commented, “Related to our IND/BLA studies, MiMedx reminds shareholders that it issued a press release announcing that we were allowed to proceed with our Phase 2B IND for osteoarthritis. Supporting osteoarthritis as a serious condition, the FDA guidance included hypothetical examples of regenerative medicine therapies, one of which is severe osteoarthritis. The MiMedx IND/BLA for osteoarthritis protocol inclusion criteria addresses severity levels 2 and 3 which clearly aligns with severe osteoarthritis. We plan to explore every pathway afforded by the FDA. We are in the process of evaluating the steps needed in order to file for the RMAT designation for AmnioFix injectable and will update shareholders once we determine our pathway.”

“In summary, the finalization of this HCT/P Guidance document is generally in a form that MiMedx anticipated, and it should facilitate our continued progression with our IND/BLA studies. We expect to have completed the prerequisites and be in a position to file our first BLA within the next two years or earlier if we get the RMAT designation. Importantly, we do not expect our forecasted revenue to change. Reimbursement for our sheet allografts is established for wound care and studies are completed. With micronized and RMAT guidance, we believe this could be a pathway to reducing timelines and accelerate our five-year revenue growth. MiMedx is clearly the leader in our market sector; this reinforces and enhances our position in relation to the rest of the market,” concluded Petit.

MiMedx also reiterates its revenue guidance for the fourth quarter and full year 2017:

Fourth quarter of 2017 revenue forecasted to be in the range of $87 to $88 million
2017 revenue guidance increased to the range of $320.6 to $321.6 million
Gross profit margins for 2017 expected to be in the range of 89% to 90%
GAAP EPS (FD) for 2017 projected to be in the range of $0.31 to $0.32
Adjusted EPS(FD)* for 2017 projected to be in the range of $0.31 to $0.32

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding expectations for fourth quarter and full year 2017 revenue, full year 2017 gross profit margin, EPS and Adjusted EPS for 2017, statements regarding the significance of the draft guidance documents for MiMedx, the Company’s belief that it is years ahead of competitors in terms of its clinical study progress, and statements regarding the Company’s belief that it might qualify for RMAT designation for certain applications and that this could accelerate associated product revenues. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that actual fourth quarter and full year 2017 financials may not materialize as expected; the draft guidance documents may not be implemented as expected; unexpected results or concerns may arise from data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals; advantages in clinical studies progress may not translate into market advantage; and the Company may not qualify for RMAT designation for certain applications, or even if the Company obtains RMAT designation for certain applications, this may not translate into accelerated revenues. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Kuros Announces Management Changes

Posted On November 16, 2017 By OrthoSpineNews In Biologics, Top Stories /

Schlieren (Zurich), Switzerland, November 16, 2017

Kuros Biosciences AG announced today the promotion of Dr. Joost de Bruijn to Chief Executive Officer (CEO), effective December 4, 2017. Dr. de Bruijn is co-founder and current managing director of Kuros Biosciences BV (formerly known as Xpand Biotechnology BV), a wholly owned subsidiary of Kuros. Dr. Ivan Cohen-Tanugi has decided to step down as CEO and member of the Board of Directors. Further, Kuros’ founding CEO and current President, Didier Cowling, will retire from the Executive Management team to serve as a senior advisor to the CEO and continue to serve as a Director on the company’s Board.

During the course of 2017, Kuros has made significant progress with its lead program MagnetOs, a novel synthetic bone graft substitute designed to regenerate bone in the implanted site in the body, which received clearance in the US and in Europe for commercial sale. Currently, the Company is preparing the launch of the product.

Dr. Christian Itin, Chairman of the Board commented: “We welcome Joost as the new CEO of Kuros and are looking forward to his leadership of the Company. With his intimate knowledge of our key products, and the orthobiologics space, he is very well positioned to take the Company to its next stage.”

Dr. Joost de Bruijn commented: “I am delighted and honored by the trust of the Board to take on the role of CEO. We have significant opportunities with MagnetOs and KUR-111/KUR-113 to build an outstanding orthobiologics company and, together with the team, I look forward to bringing our products to market and building value for patients and shareholders.”

Dr. Christian Itin added: “We would like to thank Dr. Ivan Cohen-Tanugi for making progress towards commercial launch during a transitional year highlighted by product approvals and wish him all the best in his future endeavors. Also, the Board would like to thank Didier Cowling for his valued and dedicated service to the Company as its founding CEO and for supporting the Company to reach commercial stage.”

About Joost de Bruijn

Dr. Joost de Bruijn founded Xpand Biotechnology BV in 2005 and was managing director ever since. He holds the positions of Professor of Biomaterials at Queen Mary University of London, UK (since 2004) and Professor of Regenerative Medicine and Entrepreneurship at Twente University, the Netherlands (since 2011). In 2007, he founded Progentix Orthobiology that signed an exclusive development agreement with NuVasive in 2009 for a novel family of calcium phosphate synthetic bone substitutes. Prior to founding Xpand he was Research Director Bone at IsoTis for seven years, during which he specialized in bone tissue engineering technologies that were brought to clinical application. Dr. de Bruijn has more than 20 years of experience in academia and the life science industry. He has published 165 papers in peer-reviewed journals, and is the inventor of 24 patent families. Dr. de Bruijn is scientific editor and reviewer for numerous international biomaterials, tissue engineering and regenerative medicine journals. He received his PhD from Leiden University in 1993.

For further information, please contact:

Kuros Biosciences AG

Harry Welten

Chief Financial Officer

Tel: +41 44 733 46 46

harry.welten@kurosbio.com

About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

Media Release (PDF)

Kuros Biosciences Ltd, Wagistrasse 25, CH-8952 Schlieren

Biologics