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February 2-4, 2017
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Biologics

Fidia Announces Presentation of New Data Evaluating HYMOVIS® Effects on Cartilage Volume and Type II Collagen Turnover at Osteoarthritis Research Society Int’l (OARSI) World Congress Meeting

April 26, 2018 OrthoSpineNews

April 25, 2018

ABANO TERME, Italy–(BUSINESS WIRE)–Fidia Farmaceutici, a world leader in the research, development and manufacturing of hyaluronic acid (HA)-based products and its wholly owned subsidiary, Fidia Pharma USA Inc., announces that new data will be presented at the Osteoarthritis Research Society International (OARSI) World Congress Meeting in Liverpool, U.K., April 26-29.

The pilot study “MOKHA,” coordinated by Fidia Farmaceutici, which involved eight sites in France and Belgium, aimed to explore the potential structural modifying effect of HYMOVIS®, an HA viscosupplement, in patients suffering from symptomatic knee osteoarthritis (OA) using a combination of clinical outcomes and objective measurements including biological and MRI-based imaging markers. This open, multicenter, prospective study on 46 patients showed that HYMOVIS® significantly enhanced type II collagen turnover as suggested by the increase of Coll2-1 (p<0.001) and PIINAP (p<0.001) soluble biomarkers and by the decrease over time of the ratios Coll2-1/PIIANP and CTX-II/PIIANP (p<0.005). Cartilage volume and thickness enhancement was observed by MRI in some knee compartments (p<0.05). Furthermore, WORMS effusion (Whole-Organ Magnetic Resonance Imaging Score), an indicator of synovitis, significantly decreased (p<0.016).

In addition, global KOOS (Knee Injury and Osteoarthritis Outcome Score) and subscales significantly increased over time (p<0.001) while pain at rest, walking pain, and patients or investigators global assessment of disease activity decreased (p<0.001). Furthermore, HYMOVIS® showed a favorable safety profile with no serious adverse events related to the product and low incidence of injection-site pain. “Importantly, this study highlights the potential beneficial effect of HYMOVIS® on pain and function. Altogether, this data suggests that HYMOVIS® could have a structural modifying effect in knee OA and provides critical information for the design of a larger clinical trial,” said Dr. Pascal Richette, Service de Rhumatologie, Hôpital Lariboisière, Paris, France.

The new data will be presented at the Osteoarthritis Research Society International (OARSI) World Congress Meeting in Liverpool, U.K., April 26-29. Poster Title: “Hyaluronan Derivative Hymovis® Increases Cartilage Volume and Type II Collagen Turnover in Osteoarthritis Knee: Data from MOKHA (MRI, BiOmarkers, Knee, Hymovis®, OsteoArthritis) Study” – Henrotin Y. et al.

About HYMOVIS®

HYMOVIS® is a highly viscoelastic non-crosslinked hydrogel bioengineered using a proprietary process that increases lubrication and shock absorption properties. This results in a natural hyaluronan similar to the hyaluronan found in the synovial fluid present in human joints. The formulation allows this unique molecule to recover its original structure, even after repetitive mechanical stress. Due to reversible hydrophobic interactions, the non-crosslinked HYMOVIS® has increased elasticity, viscosity and residence time in the joint.* Its unique molecular structure results in enhanced biomechanical properties and long-lasting efficacy, all in a convenient two-dose regimen.

*Preclinical studies may not be indicative of human clinical outcomes.

In Europe, HYMOVIS® is indicated for the treatment of pain in osteoarthritic joints and in the conservative treatment of the meniscal lesion of the knee and for the improvement of joint mobility through the enhancement of synovial fluid viscoelasticity.

In the U.S., HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics.

HYMOVIS® is contraindicated in patients with known hypersensitivity to hyaluronate preparations or gram-positive bacterial proteins or patients with infections/skin diseases in the area of the injection site/joint. The safety and effectiveness of HYMOVIS® has not been tested in pregnant women, nursing mothers or children. See package insert for full prescribing information including adverse events, warnings, precautions, and side effects at www.hymovis.com.

Rx Only. HYMOVIS® and HYADD®4 are registered trademarks of Fidia Farmaceutici S.p.A., Abano Terme, Italy. ©2018 Fidia Pharma USA Inc., Florham Park, N.J., a wholly owned subsidiary of Fidia Farmaceutici S.p.A. FID622-04.2018

About Fidia Farmaceutici

Fidia Farmaceutici is part of Fidia Pharma Group, an Italian multinational company, with R&D, manufacturing and sales capabilities, and an extensive product portfolio mainly based on natural and functionalized hyaluronic acid (over 650 patents), in joint care, wound healing, ophthalmology, aesthetics and regenerative medicine. Manufacturing operations are FDA-inspected and approved, and the company extends its global reach through wholly-owned subsidiaries and partners in 100 countries worldwide. For more information, please visit www.fidiapharma.com.

Contacts

For more information:
FIDIA FARMACEUTICI S.p.A.
Tel: (+39) 0498232111
info@fidiapharma.it
or
FIDIA PHARMA USA INC.
Carolyn Kong, 1-973-507-5120
info@fidiapharma.us

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Biologics

MTF Biologics Wound Care To Introduce AmnioBand® Viable Membrane, Present Advanced Clinical and Scientific Research

April 25, 2018 OrthoSpineNews

EDISON, N.J., April 25, 2018 /PRNewswire/ — MTF Biologics Wound Care has expanded its portfolio of innovations with AmnioBand® Viable Membrane, an aseptically processed and cryopreserved human amnion membrane for use as an acute or chronic wound covering. MTF Biologics Wound Care will feature the novel tissue graft at the Symposium on Advanced Wound Care (SAWC) Spring | Wound Healing Society (WHS) meeting held at the Charlotte Convention Center in Charlotte, N.C., April 25-29, 2018.

In addition to introducing AmnioBand® Viable Membrane at the meeting, MTF Biologics Wound Care will host a symposium on outcomes for placental and dermal innovations in wound care, and its tissue grafts will be featured in three poster presentations.  It also will announce new support for SAWC’s 2018 Martin Salia Scholarship Fund.

“Wounds remain a significant challenge for the healthcare community,” said Kim Rounds, Vice President of Wound Care at MTF Biologics. “More than six million Americans will struggle with chronic non-healing wounds this year alone. AmnioBand® Viable Membrane is an important new option for clinicians working to heal difficult wounds of all kinds. Leveraging our 20 years of processing and providing living cell tissue forms, and recognizing that there is no single solution in wound care, we continue to deliver on our mission of honoring the donated gift, serving patients, and advancing science by releasing the next generation living allograft placental matrix.”

A recent study published by Matthew Regulski, DPM, in Wounds titled, “Utilization of Viable Human Amnion Membrane Allograft in Elderly Patients with Chronic Lower Extremity Wounds of Various Etiologies,” demonstrates the potential for AmnioBand® Viable Membrane to help the closure of non-healing wounds in elderly patients with multiple comorbidities.

“We are dedicated to innovation in allograft science to improve clinical outcomes and support healthcare providers,” said Marc Long, PhD, Vice President of R&D at MTF Biologics. “We ensure that each AmnioBand® Viable donation is tested for viability, offer the tissue with an intelligent colorimetric change to indicate graft readiness, and provide the graft on a flexible backing for an enhanced yet intuitive clinical application. Processing and quality matters, and we are excited to showcase the translation of our scientific development with our proven clinical results.”

MTF Biologics has provided a grant to HMP, a leading healthcare events and education company, and organizers of the annual SAWC Spring and Fall meetings. The funding will be used to support the 2018 Martin Salia Scholarship Fund giving surgical residents from the Pan-African Academy of Christian Surgeons (PAACS) the opportunity to participate in the 2018 SAWC Fall meeting, taking place November 2-4, 2018, in Las Vegas, Nevada. The program is named in memory of Dr. Martin Salia, a graduate of the PAACS program. Dr. Salia was one of 136 physicians treating a population of 6 million in Sierra Leone when he contracted the Ebola virus and died in November of 2014.

“Access to advanced wound care therapies is limited in many rural African communities,” said Jeffrey Cartmell, PhD, Associate Director of Intellectual Property and Grants at MTF Biologics. “We are committed to the evidence-based education that recipients of the Martin Salia Scholarship will receive at SAWC. We are honored to play a role in assisting these physicians as they seek to improve their ability to care for the patients in their communities.”

MTF Biologics’ symposium, “Level 1 Clinical Outcomes for Placental & Dermal Innovations,” will feature perspective on recently published Level 1 clinical outcomes for aseptically processed placental and dermal innovations from Dennis Orgill, MD, PhD, Charles Zelen, DPM, FACFAS, Lawrence DiDomenico, DPM, FACFAS, and Jarrod P. Kaufman, MD, FACS. The complimentary lunch symposium will be held in Room 217D on Thursday, April 26, from 12 p.m. – 1:30 p.m. Onsite registration will be available.

Additional clinical & scientific poster presentations at the meeting will include:

  • The Safety, Efficacy, and Cost to Closure of a Unique Aseptically Processed Dehydrated Allogeneic Amnion and Chorion graft versus Standard of Care in the Treatment of Chronic Diabetic Foot Ulcers: A Prospective, Randomized, Controlled, Multi-centre Trial – DiDomenico et al. Abstract: CR-007
  • Preliminary Observations on the Mechanism of Viable Human Amnion Membrane Allograft* in the Diabetic Wound, using the db/db Mouse Splinted Excisional Wound Model – Xie et al. Abstract: LR -076
  • Aseptically Processed Dehydrated Human Amnion/Chorion Allografts Restores Type II Diabetic Cell-Mediated Granulation, Angiogenesis and Epithelialization Activities that Support Wound Healing – Dasgupta et al. Abstract: LR-014

About MTF Biologics
MTF Biologics, also known as the Musculoskeletal Transplant Foundation, is a nonprofit organization based in Edison, N.J. It is a consortium comprised of leading organ procurement organizations, tissue recovery organizations and academic medical institutions, and governed by a board of clinicians who are leading experts in tissue transplantation. As the world’s largest tissue bank, MTF Biologics saves and heals lives by honoring donated gifts, serving patients and advancing science. Since its inception in 1987, the organization has received tissue from more than 125,000 donors and distributed more than 8 million grafts for transplantation. Through its IIAM subsidiary, it has placed more than 55,000 non-transplantable organs for research. Through its Statline subsidiary, it has managed more than 10 million donor referrals. For more information, visit www.mtfbiologics.org.

SOURCE MTF Biologics

Related Links

https://www.mtf.org

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Biologics

CollPlant Opens a New rhCollagen Production Facility

April 25, 2018 OrthoSpineNews

NESS ZIONA, Israel, April 23, 2018 /PRNewswire/ —

CollPlant (NASDAQ: CLGN) (TASE:CLGN), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products today announced the opening of a new rhCollagen production facility in Rehovot, Israel.

This 6,000 square foot cGMP facility was designed for purification of rhCollagen and formulation of end-products, including BioInks for 3D bioprinting and its proprietary tissue repair products. The facility includes clean rooms, logistic support areas, and dedicated production equipment to support the company’s production demand for the next few years.

Yehiel Tal, CEO of CollPlant commented: “The new facility will enable operational flexibility and cost reduction for the rhCollagen and end products. Consequently, we believe the new facility will enhance our competitiveness and profitability. Additionally, we expect this facility to serve for process development of new production technologies.”

The first production runs have been successfully completed, and validation is expected to take place during the second quarter of 2018.

About CollPlant

CollPlant is a regenerative medicine company focused on 3D bioprinting of tissues and organs, and on developing and commercializing tissue repair products for orthobiologics, and advanced wound care markets. Our products are based on our rhCollagen (recombinant human collagen) that is produced with CollPlant’s proprietary plant based genetic engineering technology.

Our products address indications for diverse fields of organ and tissue repair, and are ushering in a new era in regenerative medicine. Our flagship rhCollagen BioInk product line is ideal for 3D bioprinting of tissues and organs, and our unique Vergenix line of rhCollagen products includes a soft tissue repair matrix for treating tendinopathy and a wound repair matrix to promote a rapid optimal healing of acute and chronic wounds.

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

Safe Harbor Statements

This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant’s objectives plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that Collplant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant’s actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company’s history of significant losses and its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the Company’s expectations regarding the timing and cost of commencing clinical trials with respect to tissues and organs which are based on its rhCollagen based Bioink, VergenixSTR, and VergenixFG; the Company’s ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based BioInk, VergenixSTR, and VergenixFG including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company’s rhCollagen based BioInk, VergenixSTR, and VergenixFG; the Company’s ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company’s ability to establish and maintain strategic partnerships and other corporate collaborations; the Company’s reliance on third parties to conduct some or all aspects of its product manufacturing; the scope of protection we are able to establish and maintain for intellectual property rights and the Company’s ability to operate its business without infringing the intellectual property rights of others; the overall global economic environment; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates; projected capital expenditures and liquidity; changes in the Company’s strategy; and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting Collplant is contained under the heading “Risk Factors” included in CollPlant’s most recent annual report on Form 20-F filed with the SEC, and in other filings that Collplant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant’s current views with respect to future events, and Collplant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact at CollPlant:   
Eran Rotem
Deputy CEO and CFO
Tel: + 972-73-2325600/612
Email: Eran@collplant.com

IR Contact 
Amato and Partners, LLC
90 Park Avenue, 17th Floor
New York, NY 10016
admin@amatoandpartners.com

SOURCE CollPlant

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Biologics

Organogenesis Showcases New Product Offerings and Research at SAWC Spring 2018

April 24, 2018 OrthoSpineNews

CANTON, Mass. and CHARLOTTE, N.C., April 24, 2018 /PRNewswire/ — The latest advanced wound care research and product offerings from Organogenesis Inc. – including the recently-launched PuraPly® Antimicrobial 1.6 cm small size – will be showcased during the nation’s largest interdisciplinary wound care forum, the Symposium on Advanced Wound Care Spring | Wound Healing Society (SAWC Spring | WHS) meeting, held April 25-29 in Charlotte, NC.

Organogenesis Inc., a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the advanced wound care, surgical and sports medicine markets, will feature its full suite of advanced wound care and surgical biologic product offerings at exhibit booth #419.

Scientific presentations will feature several products within the Organogenesis portfolio, and exhibit booth attendees will have the chance to learn more about the company’s comprehensive wound care portfolio designed to empower personalized healing for a wide variety of wound types across the wound care continuum.

Organogenesis is also a proud sponsor of the Thursday, April 26 Lunch Symposium, “Understanding the Latest Evidence: A Fresh Look at the Use of Skin Substitutes Across the Wound Care Continuum,” featuring speakers Daniel Kapp, MD; George Koullias, MD; and Katie C. Mowry, PhD.

POSTER AND ORAL PRESENTATIONS OF INTEREST INCLUDE:

Assessment of Composition and Specificity of Extracellular Matrix and Growth Factor Targets Within Dehydrated Amnion/Chorion Grafts
John P. McQuilling, PhD; Katie C. Mowry, PhD

Human Amnion/Chorion Grafts Alter the Gene Expression Profile of Cells Associated with the Wound Microenvironment In Vitro (POSTER AND ORAL PRESENTATION)
John P. McQuilling, PhD; MaryRose Kammer, MS; Katie C. Mowry, PhD

The Use of Indocyanine Green Fluorescent Angiography (LUNA) to Follow Improvements in Wound Healing After Application of a Fresh Amniotic Membrane
Thomas E. Serena, MD, FACS, MAPWCA, FACHM; Bryan Donor, DO; Keyer Patel, DO; Laura Serena, LPN; Judith A. Fulton, PhD

Fresh Amniotic Membrane: Uncovering the Mechanism of Action
Judith A. Fulton, PhD; Thomas E. Serena, MD, FACS, MAPWCA, FACHM

Use of Amniotic Suspension Allograft and a Dehydrated Amnion Chorion Graft to Treat Non-Healing Venous Leg Ulcers (POSTER AND ORAL PRESENTATION)
Windy Cole, DPM, FACFAS

Use of a Purified Native Collagen Matrix Plus Polyhexamethylene Biguanide (PHMB) Antimicrobial in the Management of Chronic Wounds
Woods, Gorenstein et al.

Use of a Purified Collagen Matrix Plus Polyhexamethylene Biguanide Antimicrobial in the Management of Non- Healing Pressure Ulcers
Oropallo et al.

Preliminary Evaluation of Purified Native Collagen Matrix with Polyhexamethylene Biguanide Reducing Methicillin Resistant Staphylococcus Aureus Infections and Altering Cytokine Profile Using a Porcine Deep Dermal Wound Model
Solis et al.

About Organogenesis Inc.
Organogenesis Inc. is a leading regenerative medicine company offering a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Organogenesis’s comprehensive portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com.

Contact:
Angelyn Lowe
(781) 830-2353
alowe@organo.com

SOURCE Organogenesis Inc.

Related Links

http://organogenesis.com

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Biologics

MiMedx to Highlight Efficacy of Its Allografts in Presentations at SAWC Spring Conference

April 23, 2018 OrthoSpineNews

MARIETTA, Ga., April 23, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced the Company’s participation in the 2018 Symposium on Advanced Wound Care Spring | Wound Healing Society (SAWC Spring/WHS) meeting being held April 25-29, 2018 in Charlotte, North Carolina.

During the five-day conference, the clinical and cost-effective healing results of the Company’s allografts will be highlighted in a Breakfast Symposium, two dinner presentations, five clinical poster presentations, and in-booth education sessions. MiMedx will be exhibiting in booth #830 from April 26, 2018 through April 28, 2018.

Now in its 31st year, the SAWC Spring/WHS conference is the leading national wound healing forum connecting the foremost experts with your entire wound care team to improve patient outcomes through education.  No other wound care conference offers the level of education, advanced state-of-the-art clinical reviews and emerging research findings.

MiMedx will sponsor a Breakfast Symposium entitled “EpiFix® – First and Only Amnion/Chorion Allograft with Statistically Significant Level I Evidence for healing in DFUs and VLUs” on Friday morning, April 27, 2018 from 7:30 am to 9:00 am. The Company will also host two dinner presentations on Thursday, April 26th and Friday, April 27th entitled “Using MiMedx Placental Tissues in the Lower Extremity“, which will review the use of various products in wound and surgical applications.

Hands-on product demonstrations will be provided by expert physicians during booth hours on April 26th and April 27thin the MiMedx booth.

The poster presentations will report on the clinical effectiveness of MiMedx EpiFix dHACM (dehydrated Human Amnion/Chorion Membrane) placental tissue allografts in the healing of diabetic foot ulcers, venous leg ulcers, pressure ulcers and refractory non-healing wounds, as well as the use of AmnioCord umbilical cord allografts for reducing Achilles tendon pain. These independent case studies and respective conclusions will include:

  • Abstract: “EpiFix VLU Study Group: A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Dehydrated Human Amnion/Chorion Membrane Allograft for the Treatment of Venous Leg Ulcers”
    Authors: Christian Bianchi, MD, FACS; Shawn Cazzell, DPM, FACFAS; Dean Vayser, DPM, FACFAS; Alexander M. Reyzelman, DPM, FACFAS; Hasan Dosluoglu, MD, FACS; Gregory Tovmassian, DPM
  • Abstract: “EpiFix DFU Study Group: A Confirmatory Study on the Efficacy of Dehydrated Human Amnion/Chorion Membrane (dHACM) Allograft in the Management of Diabetic Foot Ulcers: A Prospective, Multicenter, Randomized, Controlled Study”
    Authors: William Tettelbach, MD; Shawn Cazzell, DPM; Alexander M. Reyzelman, DPM; Felix Sigal, DPM; Joseph M. Caporusso, DPM; Patrick S. Agnew, DPM
  • Abstract: “The Application of Dehydrated Human Amnion Chorion Membrane dHACM Allografts to Expedite Healing in Patients with Six Major Types of Refractory Non-Healing Wounds, 157 Patients”
    Authors: Aamir Mahmood, DPM; Justin Goldsmith, DPM; Anna Tien, DPM; Mike Czurylo, DPM; Laith Shaman, DPM; Kelda Beachy, DPM; Neal Patel, DPM; Shayan Alamgir, DPM; Matthew Garoufalis, DPM, FASPS, FACFAOM
  • Abstract: “Use of Umbilical Cord Allograft for Pain Reduction in Achilles Tendon Pathologies: A Case”
    Authors: Brandon Brooks, DPM; Kevin Pham, DPM; Bradley Brooks, DO; Brady Brooks, MS-1; James Henry, MS-1; Terria Madison, DPM
  • Abstract: “Safety and Efficacy of Weekly Application of Dehydrated Human Amnion/Chorion Membrane in the Treatment of Pressure Ulcers: a Case Series”
    Authors: Chi Chi Berhane, MD, MBA; Kimberly Brantley, BSN, RN, CRRN; Sandra Williams, NP-C, APN, WCN; Erica Sutton, MA; Carlyn Kappy, RD, LD, CCRP

“For more than 30 years, SAWC and WHS have been dedicated to continuous advancements in wound care and have worked tirelessly toward their goal of decreasing the number and severity of wounds of all types.” said Parker H. “Pete” Petit, MiMedx Chairman and CEO. “We are honored to be a part of this year’s meeting, and MiMedx will continue to work with SAWC and other organizations to raise the level of scientific and clinical expertise and the professional processes within the wound care sector of healthcare.”

Bill Taylor, President and COO of MiMedx, added, “We are pleased that our EpiFix, AmnioCord and AmnioFill allografts will be so prominently demonstrated at this year’s SAWC. We look forward to participating in the conference and highlighting the significant investments made in the science and clinical study of placental technology.”

About MiMedx

MiMedx® is a 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 the Company’s mission to give physicians products and tissues to help the body heal itself.  The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has 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.

 

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

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Biologics

Spikes of Graphene Can Kill Bacteria on Knee & Hip Implants

April 19, 2018 OrthoSpineNews

By Chalmers University of Technology – 04.16.18

A tiny layer of graphene flakes becomes a deadly weapon and kills bacteria, stopping infections during procedures such as implant surgery. This is the findings of new research from Chalmers University of Technology, Sweden, recently published in the scientific journal Advanced Materials Interfaces.

Operations for surgical implants, such as hip and knee replacements or dental implants, have increased in recent years. However, in such procedures, there is always a risk of bacterial infection. In the worst-case scenario, this can cause the implant to not attach to the skeleton, meaning it must be removed.

Bacteria travel around in fluids, such as blood, looking for a surface to cling on to. Once in place, they start to grow and propagate, forming a protective layer, known as a biofilm.

A research team at Chalmers has now shown that a layer of vertical graphene flakes forms a protective surface that makes it impossible for bacteria to attach. Instead, bacteria are sliced apart by the sharp graphene flakes and killed. Coating implants with a layer of graphene flakes can therefore help protect the patient against infection, eliminate the need for antibiotic treatment, and reduce the risk of implant rejection. The osseointegration—the process by which the bone structure grow to attach the implant—is not disturbed. In fact, the graphene has been shown to benefit the bone cells.

Chalmers University is a leader in the area of graphene research, but the biological applications did not begin to materialise until a few years ago. The researchers saw conflicting results in earlier studies. Some showed that graphene damaged the bacteria, others that they were not affected.

“We discovered that the key parameter is to orient the graphene vertically. If it is horizontal, the bacteria are not harmed” said Ivan Mijakovic, Professor at the Department of Biology and Biological Engineering.

 

READ THE REST HERE

 

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Biologics

Histogenics Corporation Announces the Appointment of Susan Washer to Its Board of Directors

April 19, 2018 OrthoSpineNews

WALTHAM, Mass., April 18, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, today announced the appointment of Susan Washer to its Board of Directors.

“Having known and worked with Sue for over 15 years, we are extremely pleased to welcome her to Histogenics’ Board of Directors,” stated Garheng Kong, M.D., Ph.D., Chairman of the Board of Directors of Histogenics.  “We believe Sue’s experience in the growing area of cell and gene therapies combined with her expertise in the development of novel gene therapies make her an excellent choice for the Histogenics Board of Directors.”

“The Histogenics restorative cell therapy platform and the NeoCart product opportunity are compelling for patients and clinicians, and I’m excited to be joining the Board of Directors,” noted Sue Washer, President & Chief Executive Officer of Applied Genetic Technologies Corporation (AGTC).  “I look forward to contributing to the growth of Histogenics as it prepares for potential FDA submissions and commercialization and continues to broaden its product platform both internationally and in other potential therapeutic applications.”

Ms. Washer is the President and Chief Executive Officer of AGTC, where she has served in such capacity since March 2002 and as a member of its board of directors since November 2003. Ms. Washer was also AGTC’s Chief Operating Officer from October 2001 to March 2002. From June 1994 to October 2001, Ms. Washer led two entrepreneurial firms including serving as president and CEO of Scenic Productions and as the Founding Executive Director and then Business Advisor for the North Florida Technology Innovation Center, a public-private organization financing and providing services to entrepreneurial companies licensing STEM based technology from Florida universities.  Ms. Washer currently serves on the board of directors of Biotechnology Innovation Organization (BIO) and the Alliance for Regenerative Medicine. Previously, Ms. Washer served as chairman of the BioFlorida board and the Southeast BIO board and continues her involvement with both organizations as a member of their respective boards.

From October 1983 to June 1994, Ms. Washer served in various research and pharmaceutical management positions with Abbott Laboratories and Eli Lilly and Company. Ms. Washer received a B.S. in biochemistry from Michigan State University and an M.B.A. from the University of Florida.

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018. NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.




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Biologics
OrthoTrophix Will Present Data on Long-Term Clinical Benefit of TPX-100 in Mild to Severe Knee Osteoarthritis Patients at OARSI Annual Meeting 2018
April 17, 2018 OrthoSpineNews




OAKLAND, Calif., April 17, 2018 /PRNewswire/ — OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today that the company plans to report long-term clinical benefits in mild to severe knee osteoarthritis (OA) patients who were treated with TPX-100 at the 2018 OARSI annual meeting (Liverpool, U.K., 26-29 April 2018).










OrthoTrophix previously presented the results of a Phase 2 clinical study in which the company’s OA drug candidate, TPX-100 improved knee function and physical quality of life at 6 and 12 months after treatment compared with placebo (N=93). A follow-on protocol, TPX-100-4, assessed the same patient reported outcomes in subjects who participated in TPX-100-1. The average time from the initial TPX-100 treatment was 30 months, with a range of 28 – 35 months.  Exclusion criteria included knee surgery or investigational drugs for OA in the interim between TPX-100-1 and TPX-100-4.  Of the 93 subjects in TPX-100-1, 53 enrolled in TPX-100-4. Topline results of this follow-on study will be included in the poster session of the 2018 OARSI annual meeting under the abstract entitled “TPX-100 LEADS TO MARKED, SUSTAINED IMPROVEMENTS IN SUBJECTS WITH KNEE OSTEOARTHRITIS.”


The company’s Chief Medical Officer, Dawn McGuire, MD., FAAN stated, “The long-term follow-on study enrolled over half the TPX-100-1 subjects, despite being an observational study only. The sustained improvement in knee function for more than two years in knees injected with TPX-100  confirms our confidence in TPX-100 as a drug with the potential to modify the disease of knee osteoarthritis as patients actually experience it.”


About OrthoTrophix, Inc.


OrthoTrophix, Inc., based in Oakland, California, is a privately held biopharmaceutical company focused on the development and commercialization of revolutionary therapeutics for the treatment of diseases and conditions involving the hard tissues.  Founded by three co-founders in 2011, the primary focus of OrthoTrophix has been regeneration and repair of cartilage in the knee and other joints with its novel proprietary compounds which promote formation of new cartilage and bone tissues and thereby repair the respective defects.  OrthoTrophix has received over $30 million from its preferred stock financing and research and development revenues since its inception.


This press release contains “forward-looking” statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. OrthoTrophix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect OrthoTrophix’ business.


Company Contact

Yoshi Kumagai

President and CEO

Tel:  (510) 488-3824


 


SOURCE OrthoTrophix, Inc.


Related Links


http://www.orthotrophix.com






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Biologics
SANUWAVE Announces Attendance and Exhibition at SAWC; Visit Us at Booth Number 108
April 10, 2018 OrthoSpineNews
SUWANEE, GA, April 10, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company will exhibit at SAWC (Symposium on Advanced Wound Care) in Charlotte, NC on April 25 – 29, 2018. This will be SANUWAVE’s first opportunity to present their flagship wound care device, the dermaPACE System, to the U.S. market since receiving US FDA clearance in December, allowing the company to market the device in the US.


“We are excited to be back presenting at SAWC spring in Charlotte.  Since FDA clearance, the support coming from the wound care community has been overwhelmingly positive,”  stated Kevin R. Richardson, CEO and Chairman of the Board.  Mr. Richardson continued, “We are glad to be making our shift from an R&D centered company to a marketing based company.  This will be the start of our re-emergence in the wound care space.”  The Company is using this occasion to formally introduce their lead wound care product, the dermaPACE® System.  SANUWAVE’s proprietary PACE® (Pulsed Acoustic Cellular Expression) technology, based upon the focused, electrohydraulic shockwave principle, has been proven in two US based clinical trials enrolling 336 subjects to be safe and effective in the treatment of Diabetic Foot Ulcers.  Within a few weeks of initial treatment, wounds treated with dermaPACE reduce in area at superior rates compared to control subjects.  The dermaPACE System exhibits superiority in wound area reduction within 12 weeks of initial treatment and exhibits superiority in wound closure within 20 weeks of initial treatment.  The use of the dermaPACE System allows the clinician to more easily, and more cost-effectively, manage wounds.  More importantly, the patient’s quality of life improves significantly.


If you are interested in scheduling a meeting with the team, please contact Peter Stegagno via e-mail at peter.stegagno@sanuwave.com; otherwise, please stop by Booth Number 108.  Also, look for us in the New Product Showcase area of the exhibit hall.


About SANUWAVE Health, Inc. 

SANUWAVE Health, Inc. (OTCQB:SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is US FDA cleared for the treatment of Diabetic Foot Ulcers.  The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.


Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.


For additional information about the Company, visit www.sanuwave.com.


Contact:

Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com

SANUWAVE Health, Inc.
Peter Stegagno 
Vice President Operation, Regulatory, and Clinical
678-578-0111 (Office)
678-670-9478 (Mobile)
peter.stegagno@sanuwave.com


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Biologics
AlloSource Announces Two Presentations On ProChondrix At The International Cartilage Repair Society World Congress
April 10, 2018 OrthoSpineNews




CENTENNIAL, Colo., April 10, 2018 /PRNewswire-USNewswire/ — AlloSource, an organization dedicated to advancing the science and use of transplantable allogeneic cells and tissue, today announced that clinical and scientific data on its ProChondrix® osteochondral allograft will be presented at the International Cartilage Repair Society’s 14th World Congress on Wednesday, April 11 from 13:00-14:00 in the Almaty 3 Room.










Dr. Vishal Mehta will present his 24-month clinical experience with ProChondrix in the knee. Dr. Mehta performed the first ProChondrix implantation in December of 2014 and will share his clinical experience with the product.


“ProChondrix has been a valuable addition to my cartilage restoration treatment protocol and my patient outcomes have been encouraging,” said Dr. Mehta. “I look forward to sharing these clinical results with the international cartilage community.”


AlloSource’s Chief New Ventures Officer, Peter Stevens, PhD, is presenting on “ProChondrix CR Post-Cryopreservation Cell Viability and Basic Science.” AlloSource’s research demonstrates that ProChondrix CR contains viable and metabolically active cells that are comparable to fresh osteochondral allografts. The cryopreservation technology ensures cellular viability for a longer period of time than many osteochondral allografts available today.


“This study demonstrates our commitment to advancing the science behind biologics,” said Stevens. “Our proprietary process enables us to provide a cryopreserved graft that maintains cellular viability with a longer shelf-life, allowing ProChondrix CR to help more patients return to an active lifestyle.”


ProChondrix CR is a laser-etched, cryopreserved osteochondral allograft that helps deliver the necessary components for articular cartilage restoration. This next generation of cartilage restoration therapy provides the viable cells and other biological components necessary for repair and regeneration of damaged cartilage tissues.


About AlloSource

AlloSource is dedicated to advancing the science and use of transplantable allogeneic cells and tissue through pioneering research in regenerative therapies. The organization offers life-saving and life-enhancing solutions in orthopedic, spine, burn and wound procedures to help restore patient health and mobility. As a world leader in cell-based products, fresh cartilage tissue for joint repair and skin allografts to help heal severe burns, AlloSource’s products bridge the proven science of allografts with the advanced technology of cells. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org.


Media Contact:

Megan Duggan

AlloSource

720. 382. 2766

mduggan@allosource.org


SOURCE AlloSource


Related Links


http://www.allosource.org


 






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