September 08, 2016

September 2, 2016 – Ajayan Group/Rice University

The Rice lab of materials scientist Pulickel Ajayan and colleagues in Texas, Brazil and India used spark plasma sintering to weld flakes of graphene oxide into porous solids that compare favorably with the mechanical properties and biocompatibility of titanium, a standard bone-replacement material.

The discovery is the subject of a paper in Advanced Materials.

The researchers believe their technique will give them the ability to create highly complex shapes out of graphene in minutes using graphite molds, which they believe would be easier to process than specialty metals.

“We started thinking about this for bone implants because graphene is one of the most intriguing materials with many possibilities and it’s generally biocompatible,” said Rice postdoctoral research associate Chandra Sekhar Tiwary, co-lead author of the paper with Dibyendu Chakravarty of the International Advanced Research Center for Powder Metallurgy and New Materials in Hyderabad, India. “Four things are important: its mechanical properties, density, porosity and biocompatibility.”

Tiwary said spark plasma sintering is being used in industry to make complex parts, generally with ceramics. “The technique uses a high pulse current that welds the flakes together instantly. You only need high voltage, not high pressure or temperatures,” he said. The material they made is nearly 50 percent porous, with a density half that of graphite and a quarter of titanium metal. But it has enough compressive strength — 40 megapascals — to qualify it for bone implants, he said. The strength of the bonds between sheets keeps it from disintegrating in water.

The researchers controlled the density of the material by altering the voltage that delivers the highly localized blast of heat that makes the nanoscale welds. Though the experiments were carried out at room temperature, the researchers made graphene solids of various density by raising these sintering temperatures from 200 to 400 degrees Celsius. Samples made at local temperatures of 300 C proved best, Tiwary said. “The nice thing about two-dimensional materials is that they give you a lot of surface area to connect. With graphene, you just need to overcome a small activation barrier to make very strong welds,” he said.

READ THE REST HERE

Lund, Sweden, 1 September 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioresorbable bone graft substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced the publication of a paper in The Bone and Joint Journal: Single-stage treatment of chronic osteomyelitis with a new absorbable gentamicin-loaded, calcium sulphate/hydroxyapatite biocomposite – A prospective series of 100 cases. McNally et al, The Bone and Joint Journal, 2016, Vol. 98-B, No. 9, p1289-96.

The paper provides 12-34 month follow up data from the first 100 patients in a prospective study evaluating CERAMENT G for dead space (void) management in patients with chronic osteomyelitis (bone infection) using a single stage surgical procedure. These data showed that this approach, augmented by the use of CERAMENT G, was highly effective, delivering a 96% prevention of infection recurrence rate, a 3.0% fracture rate and a total wound leakage rate of 6.0%.  This is significantly lower than published results with alternative bone graft substitutes that deliver antibiotics locally.

These results highlight the essential properties of CERAMENT G in the management of chronic osteomyelitis. The very encouraging infection recurrence prevention rate is supported by CERAMENT G’s attractive local delivery properties, which enable it to provide an initial targeted ultra-high concentration of gentamicin into the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) of the bacteria that initially caused the osteomyelitis. This unique antibiotic-eluting profile helps protect the bone healing process and promote bone remodeling.

The bone healing and bone remodeling properties of CERAMENT G, when combined with gentamicin, make it an ideal solution for dead space management in patients with chronic osteomyelitis. It is able to fill the void completely due to its injectibility and to provide initial structural stability due to its self-setting properties.

The use of CERAMENT G to deliver gentamicin locally could play an important role in improving antibiotic stewardship in hospitals by increasing compliance and reducing the need for patients with chronic osteomyelitis to receive long term systemic antibiotics.

Mr Martin McNally, Consultant Bone Infection and Limb Reconstruction Surgeon at Oxford University Hospitals (Oxford, UK) and lead author of the paper said, “The results that we have achieved with the single stage surgical procedure using CERAMENT G for the dead space management of patients with chronic osteomyelitis are a significant improvement on past experience. These results reflect CERAMENT G’s unique local antibiotic delivery profile and its attractive bone remodelling capabilities. We are increasingly using CERAMENT G in the treatment of patients with chronic osteomyelitis and infected fractures. It allows a more patient-friendly treatment, preventing repeated operations and recurrent infections. We expect it to become the mainstay of our dead space management, given the major clinical and health economic benefits that it supports.”

The paper covers the first 100 patients in a prospective cohort study utilising CERAMENT G for dead space management in a single stage surgical procedure for chronic osteomyelitis. The mean duration of chronic osteomyelitis in this patient group was 10.4 years (0.5 to 68 years). All surgeries were performed by two surgeons and were completed in a single operative session. All patients were given similar systemic antibiotic therapy and rehabilitation. Patients were followed up for at least 12 months (mean 19.5 months, range 12 -34 months) with infection recurrence, fracture rate and wound leakage rate as the primary outcome measure. The study showed that the single stage surgical procedure with CERAMENT G, was highly effective delivering a 96% infection recurrence prevention rate, a 3.0% fracture rate and a total wound leakage rate of 6.0%.

Richard Davies, CEO of BONESUPPORT said, “The results that have been published today highlight the clear clinical benefits  with CERAMENT G’s ability to deliver sustained bactericidal levels of gentamicin locally to support the eradication of underlying infections in patients with chronic osteomyelitis. By using CERAMENT G in a single stage procedure to help patients with chronic osteomyelitis return to a normal life, we can deliver significant health economic benefits to payors who are struggling to contain the significant and growing costs of treating severely debilitating bone infection.”

Reference

McNally et al, The Bone and Joint Journal, 2016, Vol. 98-B, No. 9, p1289-96.

Notes to Editor

About BONESUPPORT™

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

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

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

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

BONESUPPORT™ is a registered trademark.

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici

+44 (0)20 7282 2949/1050

bonesupport@citigatedr.co.uk

BONESUPPORT AB 

Richard Davies, CEO

Phone +46 46 286 53 59

Richard.Davies@bonesupport.com

ENGLEWOOD, Colo., Aug. 30, 2016 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced today publication in the peer-reviewed journal Biochemistry and Biophysics Reports that further describes the modes of action (MOA) of Ampion™ in the treatment of Osteoarthritis. The publication is titled:

“The low molecular weight fraction of human serum albumin upregulates COX2, prostaglandin E2, and prostaglandin D2 under inflammatory conditions in osteoarthritic knee synovial fibroblasts.”  Elizabeth D. Frederick, Ph.D.; Melissa A. Hausburg, Ph.D.;Gregory W. Thomas, BS; Leonard Rael, MS; Edward Brody, MD; David Bar-Or, MD and can be retrieved athttp://dx.doi.org/10.1016/j.bbrep.2016.08.015

Dr. David Bar-Or, Ampio’s Chief Science Officer, noted, “This manuscript reports that in the presence of either IL-1β or TNFα, LMWF-5A (Ampion™) increased the expression of both COX2 mRNA and protein, and this increase was significant compared to that observed with IL-1β- or TNFα-stimulated, saline-treated cells. LMWF-5A appears to trigger increased anti-inflammatory PG signaling, and this may be a primary component of its therapeutic mode of action in the treatment of OAK.” In simple words, these findings indicate that the mechanism of action of Ampion™ is through the production of beneficial prostaglandins by synoviocytes for both the resolution of inflammation and tissue regeneration.

About Osteoarthritis

Osteoarthritis (OA) is a progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. The incidence of developing osteoarthritis of the knee over a lifetime is approximately 45%. As this disease is associated with age, obesity, and diabetes this number will continue to grow. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.

About Ampio Pharmaceuticals

Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process, and (iii) decreasing vascular permeability.

Forward Looking Statements

Ampio’s statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include statements regarding Ampio’s scientific presentations on our Ampion™ product. The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including without limitation, under Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Gregory A. Gould
Ampio Pharmaceuticals, Inc.
Phone: (720) 437-6500
E-mail: info@ampiopharma.com

(1) Burden of Major Musculoskeletal Conditions; Woolf, Pfleger; Bulletin of the World Health Organization

Logo – http://photos.prnewswire.com/prnh/20120516/MM09116LOGO 

SOURCE Ampio Pharmaceuticals, Inc.

Aug 30, 2016

The bioabsorbable fourth generation Bioretec Activa implants have shown excellent results over the past 10 years with 100,000 patients operated: implants maintain their strength and are safely absorbed in the body. The rate of complications has been only 0.01%.

Orthopedic surgeons as well as trauma and sports medicine surgeons have used bioabsorbable fourth generation Bioretec Activa implants for the past 10 years primarily to treat leg, ankle, knee, foot and upper limb fractures and injuries. The Bioretec Activa and CiproScrew™ product families include nails, screws and pins as well as antibiotic-releasing screws.

10 years 100,000 patients and complication rate only 0.01%

Bioretec Activa implants have been used in 33 countries including the United States, France, China, Russia and Brazil. The most systematic monitoring can be found from the Maude system in the United States where no implant-related complications have been reported out of 25,000 patients operated.

“I have used Bioretec bioabsorbable products since 2008, specially Bioretec ActivaScrew™. I encountered no screw breakage during the implantation, neither have we seen any cysts or adverse tissue reactions related to the Bioretec´s implants. I am very pleased with results,” says professor and Chief Surgeon Tero Järvinen from Tampere University School of Medicine.

The unique material of Bioretec implants offers the required strength and safe bioabsorption

• Maintains its adequate strength for at least eight weeks while being elastic like bone
• Controlled bioabsorption within approx. two years
• No removal operations, typical to metal implants needed: related possible infections eliminated and patient treatment costs are reduced
• Implants do not remain in a child’s growing bone or an elderly person’s fragile bone
• Patient satisfaction: no removal operations, thus shorter treatment time and more certain healing

Bioretec’s implants have been developed to work together with their environment: the implant is strong when the bone is at its weakest and degrades as the bone becomes stronger. Thanks to the Self-Locking™ technology the diameter of the implant expands, while the Auto-Compression™ ensures the longitudinal contraction of the implant. These features keep the damaged bone under sufficient compression for eight weeks. Once the damaged area has healed sufficiently, the implant degrades by hydrolysis, forming lactic and glycolic acid until it is finally metabolized into carbon dioxide and water. The bioabsorption of the implant takes approximately two years without remarkable fluid accumulation, infections or rejection.

Bioretec Ltd. is a Finnish material technology company focused on the development, manufacturing, marketing and sales of bioabsorbable, bioactive and drug-releasing surgical implants. All Bioretec implants are designed and manufactured in Finland.

Further information:

Simo Hietaniemi, CEO
Tel. +358 40 750 8352
E-mail: simo.hietaniemi@bioretec.com
Website: www.bioretec.com

MARIETTA, Ga., Aug. 30, 2016 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today that it will attend the Morgan Stanley Global Healthcare Conference in New York, NY.  Parker H. “Pete” Petit, Chairman and CEO, William C. Taylor, President and COO, and Michael J. Senken, Chief Financial Officer, are scheduled to participate in one-on-one and small group meetings on Wednesday, September 14, 2016, at the Grand Hyatt New York.

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues and human skin and bone.  “Innovations in Regenerative Biomaterials” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  The MiMedx allograft product families include our: dHACM family with AmnioFix®, EpiFix® and EpiBurn® brands; Amniotic Fluid family with OrthoFlo brand; Umbilical family with EpiCord™ and AmnioCord™ brands; Placental Collagen family with CollaFix™ brand; Bone family with Physio® brand; and Skin family with AlloBurn™ brand. AmnioFix,  EpiFix, and EpiBurn are our tissue technologies processed from human amniotic membrane; OrthoFlo is an amniotic fluid derived allograft;  EpiCord™ and AmnioCord™ are derived from the umbilical cord; Physio is a unique bone grafting material comprised of 100% bone tissue with no added carrier; AlloBurn is a skin product derived from human skin designed for the treatment of burns; and  CollaFix, our next brand we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair.

We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 600,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

August 25, 2016

A new biomaterial can be used to study how and when stem cells sense the mechanics of their surrounding environment, found a team led by Robert Mauck, PhD, the Mary Black Ralston Professor for Education and Research in Orthopaedic Surgery, in the Perelman School of Medicine at the University of Pennsylvania. With further development, this biomaterial could be used to control when immature stem cells differentiate into more specialized cells for regenerative and tissue-engineering-based therapies. Their study appears as an advance online publication in Nature Materials this month.

During early development in an embryo, the progenitor cells of many types of musculoskeletal tissue start out in close contact to each other and over time transition into an organized network of individual cells surrounded by an extracellular matrix (ECM). This matrix is made up of polysaccharides and fibrous proteins secreted by cells, providing structural and biochemical support to the cells within.

Throughout the course of embryo development, the ECM gets stiffer due to increased amounts of matrix material and crosslinking, eventually guiding stem cells to develop into more specialized cells across various tissue types. It also acts as a medium through which mechanical information is transmitted to cells (such as forces generated with such normal activities as walking or running).

Mauck and his colleagues developed a new biomaterial that allows scientists to systematically study how the cell-to-cell interactions present in early development combined with cell-ECM interactions to regulate stem-cell differentiation.

Cells can sense the inherent stiffness of their surrounding environment, which plays an important role in guiding stem-cell differentiation and generating the mechanical properties of tissues. During musculoskeletal development, a cell’s surrounding environment gradually transitions from one that is rich in cell-to-cell interactions to one that is dominated by cell-extracellular matrix interactions. However, how these stem cells balance their interpretation of seeing one another and seeing this increasingly stiff matrix are not well understood.

To examine the response of stem cells to different mechanical and material inputs, Mauck and colleagues looked at protein complexes that move to the nucleus in response to these signals, called YAP/TAZ proteins. Once in the nucleus, these proteins help guide the differentiation of stem cells to become the specialized cells that reside in various tissue types.

The team showed that this new biomaterial platform can enable scientists to study how the proteins involved in cell-cell contact (N-cadherins) are able to mask stem cell inputs from the accumulating ECM (fibronectins) across a range of tissue stiffness.

The cell-to-cell cues presented by the biomaterial reduced the ability of stem cells to pull on the ECM molecules, which in turn reduced the amount of YAP/TAZ molecules present in the nuclei of developing cells. This resulted in an altered interpretation of ECM stiffness by the cells and ultimately how these cells differentiated.

“We want to learn how we can trick these cells to think that they’re in a softer environment,” says Mauck. This could enable scientists and clinicians to keep stem cells in an uncommitted state longer during regenerative therapies, so as to increase cell number and keep them from committing to a certain, final fate, which may increase their physiological impact when implanted.

“Our long-term goal is to be able to intercept how a cell determines the stiffness of its surrounding environment,” said first author Brian D. Cosgrove, a doctoral student in the Mauck lab. “For example, we ideally want to put stem cells into stiff materials for cartilage repair that would withstand the forces present in everyday life, but then the stem cells preferentially turn into bone and other fibrous tissue types. We need to find new ways to trick them into thinking they’re in the correct environment so they will remain specialized cartilage cells.”

This fine control of what a precursor cell ultimately senses and the resulting tissue it produces may be important for treating disorders, such as out-of-place bone growth called heterotopic ossification.

Explore further: Development of ‘matrix’ material controlling differentiation of stem cells

More information: Brian D. Cosgrove et al. N-cadherin adhesive interactions modulate matrix mechanosensing and fate commitment of mesenchymal stem cells, Nature Materials (2016). DOI: 10.1038/nmat4725

Journal reference: Nature Materials

Provided by: Perelman School of Medicine at the University of Pennsylvania
Read more at: http://phys.org/news/2016-08-stem-cell-perception-tissue-stiffness.html#jCp