TiGenix Appoints Dr. June Almenoff to its Board of Directors

LEUVEN, Belgium, Sept. 22, 2016 (GLOBE NEWSWIRE) — TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, today announced that it has appointed June Almenoff, M.D., Ph.D., as a member of its Board of Directors in replacement of Dirk Reyn.

“Her background is a perfect fit for TiGenix, and the projects we have under development. She has a strong clinical development record, and has successfully led the process toward FDA approval for a GI product; experience with early-stage development, scientific licensing and business development; an expertise in infectious diseases, and a clear focus on the US market,” said Eduardo Bravo, CEO, TiGenix. “With Cx601 close to start its second pivotal Phase III study towards BLA filing and the rest of the assets moving into mid to late stage clinical development, June is a great complement to our outstanding Board of Directors.”

“I am very excited to be joining the Board of TiGenix,” said Dr. June Almenoff. “TiGenix currently has the most advanced cell therapy pipeline in Europe, with positive pivotal Phase III data and European filing of their lead product candidate, Cx601, announced earlier this year. The product has then been licensed ex-US to Takeda. These are remarkable accomplishments. As a Board member, I look forward to leveraging my clinical development and regulatory experience with the FDA to move Cx601 along the pathway toward approval in the US, as well as to advance the company’s pipeline initiatives in acute myocardial infarction and severe sepsis.”

Dr. Almenoff is replacing Dirk Reyn (R&S Consulting BVBA), who is stepping down. “I regretfully leave my position at TiGenix due to my increasing commitment to eTheRNA immunotherapies, where I am CEO,” said Dirk Reyn. “During my five-year tenure as a Board member at TiGenix, together with the Management Team, we have transformed the company, secured funding from marquee investors and achieved the first ever positive pivotal trial with an allogeneic cell therapy product that led to the very successful licensing agreement with Takeda. I am very proud of the work we have done together.”

“We have made tremendous progress during Dirk’s tenure. We sincerely owe him our gratitude for his help getting us to where we are today” said Jean Stéphenne, Chairman of the Board of Directors of TiGenix. “As we march toward approval of Cx601 in the US and we advance our pipeline in new and exciting indications I am confident that Dr. June Almenoff, given her clinical development background and experience working with the FDA, is the ideal person for our Board going forward.”

June S. Almenoff MD, PhD, is an accomplished pharmaceutical executive with close to 20 years of industry experience. She has extensive expertise in clinical development, translational medicine and business development. Dr. Almenoff recently served as President, Principal Executive Officer and Chief Medical Officer of Furiex Pharmaceuticals, a publicly held biopharma company.  During her 4-year tenure, the company’s valuation increased ~10-fold, culminating in its acquisition by Actavis plc (now Allergan) for ~$1.2B in 2014. Furiex’s lead product, eluxadoline (Viberzi TM), a novel gastrointestinal drug, received FDA approval in 2015.  Prior to joining Furiex, Dr. Almenoff was at GlaxoSmithKline (GSK), where she held positions of increasing responsibility.   During her 12 years at GSK, she was a Vice President in the R&D organization, chaired a PhRMA-FDA working group and also worked in the area of scientific licensing. Dr. Almenoff led the development of pioneering systems for minimizing risk in early- and late-stage drug development which are now widely used by pharmaceutical companies and regulatory agencies. Dr. Almenoff is currently an independent biopharma consultant and Board Director: she is the Executive Chair of RDD Pharma and a member of the Boards of Ohr Pharmaceuticals (Nasdaq: OHRP) and Valanbio. She also serves on the investment advisory board of the Harrington Discovery Institute (Case Western Univ.) and the advisory boards of Redhill Biopharma (Nasdaq: RDHL) and numerous private companies. Dr. Almenoff received her B.A. cum laude from Smith College and graduated with AOA honors from the M.D.-Ph.D. program at the Icahn (Mt. Sinai) School of Medicine. She completed post-graduate medical training at Stanford University Medical Center (Internal Medicine, Infectious Diseases) and served on the faculty of Duke University School of Medicine. She is an adjunct Professor at Duke and a Fellow of the American College of Physicians.

The appointment of June Almenoff is effective immediately subject to final appointment by the next shareholders’ meeting.

For more information

Claudia D’Augusta Chief Financial Officer

T: +34 91 804 92 64

claudia.daugusta@tigenix.com

About TiGenix

TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two products from the adipose-derived stem cell technology platform are currently in clinical development. Cx601 is in Phase III for the treatment of complex perianal fistulas in Crohn’s disease patients. Cx611 has completed a Phase I sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product, AlloCSC-01, is currently in a Phase II clinical trial in acute myocardial infarction (AMI). In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication. On July 4, 2016, TiGenix entered into a licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to commercialize Cx601 for complex perianal fistulas outside the United States. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain). For more information, please visit http://www.tigenix.com.

Forward-looking information

This press release may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company’s control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this press release. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

Graphene nanoribbons show promise for healing spinal injuries

September 20, 2016 – Rice University

The Tour lab has spent a decade working with graphene nanoribbons, starting with the discovery of a chemical process to “unzip” them from multiwalled carbon nanotubes, as revealed in a Nature paper in 2009. Since then, the researchers have used them to enhance materials for the likes of deicers for airplane wings, better batteries and less-permeable containers for natural gas storage.

Now their work to develop nanoribbons for medical applications has resulted in a material dubbed Texas-PEG that may help knit damaged or even severed spinal cords.

A paper on the results of preliminary animal-model tests appears in the journal Surgical Neurology International.

Graphene nanoribbons customized for medical use by William Sikkema, a Rice graduate student and co-lead author of the paper, are highly soluble in polyethylene glycol (PEG), a biocompatible polymer gel used in surgeries, pharmaceutical products and in other biological applications. When the biocompatible nanoribbons have their edges functionalized with PEG chains and are then further mixed with PEG, they form an electrically active network that helps the severed ends of a spinal cord reconnect.

“Neurons grow nicely on graphene because it’s a conductive surface and it stimulates neuronal growth,” Tour said.

In experiments at Rice and elsewhere, neurons have been observed growing along graphene.

“We’re not the only lab that has demonstrated neurons growing on graphene in a petri dish,” he said. “The difference is other labs are commonly experimenting with water-soluble graphene oxide, which is far less conductive than graphene, or nonribbonized structures of graphene.

“We’ve developed a way to add water-solubilizing polymer chains to the edges of our nanoribbons that preserves their conductivity while rendering them soluble, and we’re just now starting to see the potential for this in biomedical applications,” he said. He added that ribbonized graphene structures allow for much smaller amounts to be used while preserving a conductive pathway that bridges the damaged spinal cords. Tour said only 1 percent of Texas-PEG consists of nanoribbons, but that’s enough to form a conductive scaffold through which the spinal cord can reconnect.

Texas-PEG succeeded in restoring function in a rodent with a severed spinal cord in a procedure performed at Konkuk University in South Korea by co-authors Bae Hwan Lee and C-Yoon Kim. Tour said the material reliably allowed motor and sensory neuronal signals to cross the gap 24 hours after complete transection of the spinal cord and almost perfect motor control recovery after two weeks.

“This is a major advance over previous work with PEG alone, which gave no recovery of sensory neuronal signals over the same period of time and only 10 percent motor control over four weeks,” Tour said.

The project began when Sikkema read about work by Italian neurosurgeon Sergio Canavero. Sikkema thought nanoribbons might enhance research that depended on PEG’s ability to promote the fusion of cell membranes by adding electrical conductivity and directional control for neurons as they spanned the gap between sections of the spinal cord. Contact with the doctor led to a collaboration with the South Korean researchers.

Tour said Texas-PEG’s potential to help patients with spinal cord injuries is too promising to be minimized. “Our goal is to develop this as a way to address spinal cord injury. We think we’re on the right path,” he said.

“This is an exciting neurophysiological analysis following complete severance of a spinal cord,” Tour said. “It is not a behavioral or locomotive study of the subsequent repair. The tangential singular locomotive analysis here is an intriguing marker, but it is not in a statistically significant set of animals. The next phases of the study will highlight the locomotive and behavioral skills with statistical relevance to assess whether these qualities follow the favorable neurophysiology that we recorded here.”


Story Source:

The above post is reprinted from materials provided by Rice University. Note: Content may be edited for style and length.


Journal Reference:

  1. JamesM Tour, BaeHwan Lee, C-Yoon Kim, WilliamK. A. Sikkema, In-Kyu Hwang, Hanseul Oh, UnJeng Kim. Spinal cord fusion with PEG-GNRs (TexasPEG): Neurophysiological recovery in 24 hours in rats. Surgical Neurology International, 2016; 7 (25): 632 DOI:10.4103/2152-7806.190475

ConvaTec Extends Protection for Surgical Wounds with Launch of AQUACEL® Ag SURGICAL SP Dressing

LUXEMBOURG, Sept. 19, 2016 /PRNewswire/ — ConvaTec, a leading global medical technology company, today announced the U.S. launch of AQUACEL® Ag SURGICAL SP dressing, extending the company’s range of AQUACEL® Ag SURGICAL cover dressings developed to help reduce surgical site infections.*

AQUACEL® Ag SURGICAL SP dressing has a thin adhesive layer, to aid conformability for specific types of surgical wounds such as cesarean section and lumbar spine surgery. The new slim profile dressing is also designed to provide the same antimicrobial protection benefits** as AQUACEL® Ag SURGICAL cover dressings.

Surgical site infections (SSIs) can be devastating to a patient’s health and costly for health care providers. In addition to the burdens of further treatment, under the Affordable Care Act, hospitals in the U.S. with high rates of patient readmissions 30 days post-surgery are subject to reduced reimbursement from Medicare.

“Postoperative wound infection is a leading cause of patient readmission following surgery, and a significant issue for both patients and health care providers,” said Bryan D. Springer, MD, Fellowship Director at OrthoCarolina Hip & Knee Center. “Reducing the risk of SSI is a major focus for our facility. Our experience with AQUACEL® Ag SURGICAL dressings is that these advanced dressings offer compelling value in terms of patient satisfaction, clinical outcomes and cost.”

“Patients undergoing back, abdominal and other types of surgeries have unique needs to support their post-operative healing and daily activities such as bathing, changing clothes and sleeping,” said Fiona Adam, Vice President and General Manager of Advanced Wound Care. “ConvaTec developed AQUACEL® Ag SURGICAL SP dressing in response to these specific needs as well as to address the risk of SSIs across a broad range of surgical wounds – in keeping with our commitment to the community of wound care specialists and patients whom we serve and whose lives we touch, every day.”

Published Studies Support Value of AQUACEL® Ag SURGICAL Dressings

In previous studies, AQUACEL® Ag SURGICAL cover dressings significantly demonstrated the ability to reduce the incidence of post-operative infection and other complications, such as skin blistering, and improve patient satisfaction.

In a retrospective clinical study of 1,778 patients undergoing hip and knee replacement surgery (total joint arthroplasty or “TJA”), published in The Journal of Arthroplasty, the use of AQUACEL® Ag Surgical cover dressing vs. standard gauze surgical dressing reduced periprosthetic joint infection (“PJI”) by 76 percent (0.4% vs. 1.7%, p=0.005).

Further results of a randomized controlled trial of 262 TJA patients, published in the American Journal of Orthopedics, found the use of AQUACEL® Ag SURGICAL cover dressing vs. standard surgical dressing reduced skin blistering by 88 percent (0.7% vs. 6%, p=0.026).  The study also found overall patient satisfaction improved 14 percent (mean satisfaction score of 92 vs. 81 out of 100, p=<.0001).

Like AQUACEL® Ag SURGICAL cover dressing, the new AQUACEL® Ag SURGICAL SP dressing features Hydrofiber® Technology, ConvaTec’s proprietary technology designed to help create a beneficial moist wound environment that supports healing. The antimicrobial silver dressing is highly conformable and provides a waterproof viral and bacterial barrier*** that supports patient comfort and hygiene, such as the ability to shower, after surgery.

AQUACEL® Ag SURGICAL SP received 510(k) clearance from the U.S. Food and Drug Administration earlier this year and is available in a range of sizes to cover a variety of surgical site incisions.

For more information about the AQUACEL® family of advanced wound dressings and Hydrofiber® Technology, visitwww.convatec.com or call ConvaTec customer service at 1-800-422-8811.

About ConvaTec
ConvaTec is a global medical products and technologies company focused on therapies for the management of chronic conditions with leading market positions in advanced wound care, ostomy care, continence and critical care, and infusion devices. ConvaTec’s products provide a range of clinical and economic benefits including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care. The company is owned by Nordic Capital and Avista Capital Partners.

AQUACEL and Hydrofiber are trademarks of ConvaTec Inc.
© 2016 ConvaTec Inc.
AP-016879-US

*Indicated for wounds healing by primary intent.  Refer to product Instructions for Use for more information.
**As demonstrated in vitro
**Provided the dressing remains intact and there is no leakage.  The use of this dressings neither guarantees nor warranties against AIDS or Hepatitis virus transmission.

– References available on request –

Contact:

Punnie Donohue
ConvaTec
punnie.donohue@convatec.com

SOURCE ConvaTec

Related Links

http://www.convatec.com

New Amniotic “Stem Cell” Review Paper: Misinformed or Misleading?

One of the things that’s often hard for patients to understand is that when it comes to using stem cells for orthopedic conditions, the universities are way behind private-practice physicians. The good news is that we’re seeing some universities, like Stanford, Emory, and the Mayo Clinic, begin to embrace simple cell therapies. The bad news is that other universities are still way behind the average private-practice doctor in using these therapies. An example of that issue is a recently published amniotic stem cell review paper by physicians at Rush University in Chicago. These guys are likely well meaning, but they clearly have little knowledge of what’s not in commercially available amniotic tissues being sold on the market today.

What Are Amniotic Tissues?

While I’ve blogged on this topic many times, amniotic tissues are derived from the waste products of the delivery of a child—namely, the amniotic fluid that surrounds the baby as well as the birth sac and placenta. Given that these tissues are cheap and plentiful, they’ve been sold for many years for use in wound healing, neurosurgery, and ophthalmology. These same amniotic products have been more recently used in orthopedic injuries, despite a lack of data showing that they could help these problems. More concerning is that many physicians have been convinced by sales reps that commercially available amniotic tissues contain stem cells, but they, in fact, contain no live cells. Even more concerning is that many physicians extend this ruse to their patients, convincing them to spend big bucks on amniotic “stem cell” injections that, in fact, contain no stem cells.

Conflicts?

Before I read many papers, I always do a little snooping on the authors, just to see who they are, who they work for, and whether there may be bias in what they write. In this paper, they list 14 different companies that have funded research, paid royalties or speaking or consulting fees, or provided stock or stock options. While this isn’t automatically a significant conflict, three of the companies (NuTech, Arthrex, and Zimmer) make or vend amniotic tissues. Hence, the authors have conflicts of interest on this topic. Having said that, I run a large, international, medical-group practice that has chosen not to use amniotic stem cells, so some would say that I have the opposite bias.

The Familiar Amniotic Stem Cell Shuffle Is Alive and Well 

Here’s my big concern with this paper. While I expect the usual rank-and-file uneducated physician to make the mistake that commercial amniotic products contain living stem cells, I don’t expect university physicians to make that same mistake.

 

READ THE REST HERE

Bioventus Launches EXOGEN® Ultrasound Bone Healing System in the Kingdom of Saudi Arabia

September 19, 2016

HOOFDDORP, The Netherlands–(BUSINESS WIRE)–Bioventus, a leader in orthobiologic solutions, today announced the launch of itsEXOGEN Ultrasound Bone Healing System in the Kingdom of Saudi Arabia. EXOGEN uses safe, effective low-intensity pulsed ultrasound to help stimulate the body’s natural healing process.1 It also has an 86% heal rate for fractures not healing on their own2 and provides 38% faster healing of fresh fractures.3,4 In addition, 89% of patients with high-energy fractures reported healing when treated with EXOGEN.5

“This announcement marks another milestone as Bioventus continues expanding to international markets and growing its global footprint in orthobiologics,” said Tony Bihl, CEO Bioventus. “ZIMMO, which has more than 40 years of experience serving the healthcare sector in the region, is working with us to distribute EXOGEN.”

“Earlier this spring a team from Bioventus that included representatives from sales and marketing and medical science experts and consultant, visited Riyadh and Jeddah and, trained more than 30 surgeons and key opinion leaders on how to use EXOGEN with patients for both fresh fractures and non-unions,” said Andrew Hosmer, Managing Director International, for Europe, Middle East and Africa, Bioventus. “In addition, this move further grows our relationship with ZIMMO as the company also distributes DUROLANE®, our single injection hyaluronic acid osteoarthritis product.”

EXOGEN is available in the Kingdom of Saudi Arabia now and more information can be found at www.exogen.com.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus LLC. DUROLANE is a registered trademark of Galderma.

EXOGEN – Indications for use in the Middle East.

EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes:

• Treatment of delayed unions and non-unions

• Accelerating the time to heal of fresh fractures

• Treatment of stress fractures

• Accelerating repair following osteotomy

• Accelerating repair in bone transport procedures

• Accelerating repair in distraction osteogenesis procedures

• Treatment of joint fusion

A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.

There are no known contraindications to the use of EXOGEN.

1. Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus. J Bone Miner Res. 2001; 16(4):671-680.

2. Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH Low-intensity pulsed ultrasound in the treatment of non-unions.J Trauma. 2001; 51(4):693−703.

3. Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF Acceleration of tibial fracture-healing by non-invasive, low intensity pulsed ultrasound. J Bone Joint Surge [Am].

1994; 76(1):26−34.

4. Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo controlled study. J Bone Joint Surg [Am]. 1997; 79(7):961−973.

5. Lerner A, Stein H, Soudry M. Compound high-energy limb fractures with delayed union: our experience with adjuvant ultrasound stimulation (EXOGEN). Ultrasonics. 2004; 42(1):915-917.

Contacts

Bioventus
Media Contacts:
Thomas Hill
+1 919-474-6715
thomas.hill@bioventusglobal.com
or
Berdine Vonk
+31 (0)23 554 88 14
berdine.vonk@bioventusglobal.com

Tissue Regenix Group plc: DermaPure® – Two Peer Reviewed Clinical Papers Published

September 15, 2016

LEEDS, England–(BUSINESS WIRE)–

Tissue Regenix Group (TRX.L) (“Tissue Regenix” or “The Group”) will publish for the first time retrospective analysis on wound care product DermaPure® providing real world evidence of its use in clinical practice.

Retrospective Observational Analysis of the Use of an Architecturally Unique Dermal Regeneration Template (DermaPure®) for the Treatment of Hard-to-Heal Wounds by Kimmel, Howard, Gittleman, Haley, is now available online and will feature in the ‘International Wound Journal’, the first time a US physician has published a DermaPure® study in a peer reviewed journal.

The data which has been collated from 37 patients across 29 treatment centres, mainly focusses on the use of DermaPure® in the treatment of chronic wounds such as Diabetic Foot Ulcers (DFU) 37.8% and Venous Leg Ulcers (VLU’s) 18.9%, with the remaining patients being treated for either traumatic or surgical wounds.

At the time of application, the average wound size was 12.88cm2 and had been present for 56 weeks. The end point of the study was considered to be once complete closure was established, something which was achieved with one application of DermaPure in an average time of 10.58 weeks.

The retrospective data analysed proved to be consistent with what has been observed in published studies previously undertaken by NHSBT in the UK and showed complete healing for:

  • DFU’s – 52% at 4 weeks

73% at 8 weeks

85% at 12 weeks

Average time to heal 8.21 weeks

  • VLU’s – 49% at 4 weeks

70% at 8 weeks

81% at 12 weeks

Average time to heal 11.29 weeks

When compared with two other retrospective trials of acellular dermis used to treat DFUs DermaPure® was proven to heal more effectively with fewer applications.

Alongside this, a study undertaken at the University of Manchester looking into gene expression and the effect that this has on healing chronic wounds has been published in ‘Wound Repair and Regeneration’.

The findings of this research, led by Dr. Ardeshir Bayat, is of particular importance as optimal wound healing is dependent upon appropriate gene expression. The outcome of this study has confirmed that by applying DermaPure® to a chronic wound, such as a DFU, post debridement, the wound is converted to an acute wound, allowing the body to progress naturally through the wound healing cycle. Chronic wounds that did not receive this treatment had different gene expression and remained unable to advance appropriately through the healing process. Thus, proving a treatment such as DermaPure® to have a significant advantage when treating patients suffering with chronic wounds, such as DFU’s, where the amputation rate can be as high as 15%.

Greg Bila, President, Tissue Regenix Wound Care Inc. said: “The publication of this clinical data is key in highlighting the problems physicians face when treating chronic wounds, and how regenerative treatments such as DermaPure®address, and potentially revolutionize, the outlook for these patients. Many times products illustrate outcomes in the study environment that are seldom seen in the real world clinical environment. However, we now have two substantive pieces of research that illustrate the effectiveness of Tissue Regenix dCELL® Technology in the treatment of chronic and acute wounds, and demonstrates the potential effectiveness of this technology in other areas of healthcare.”

A full copy of the peer reviewed paper is available here

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. The company’s patented decellularisation (‘dCELL®‘) technology removes DNA and other cellular material from animal and human tissue leaving an acellular tissue scaffold which is not rejected by the patient’s body which can then be used to repair diseased or worn out body parts. The potential applications of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.

Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds. The company commercialises academic research conducted by our partners around the World.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States – ‘Tissue Regenix Wound Care Inc.’, as part of its commercialisation strategy for its dCELL® technology platform.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160915005782/en/

Surface Solutions Group to Showcase Medical Device Coating Solutions at MD&M Minneapolis

September 13, 2016

CHICAGO–(BUSINESS WIRE)–Surface Solutions Group, LLC, (SSG) an industry leading automated applicator of coating technologies for the medical device industry, announced today that it will be exhibiting its FluoroBond®-PT process and other coating solutions in Booth #1832 at the Medical Design & Manufacturing Conference & Expo (MD&M) in Minneapolis on September 21-22, 2016.

MD&M Expo attendees are invited to meet with SSG’s team and learn more about FluoroBond®-PT, a revolutionary process that solves PTFE (polytetrafluoroethylene) adhesion problems of PFOA-free (Perfluorooctanoic Acid) coatings in the medical device industry.

“The medical device industry has been experiencing PFOA-free PTFE delamination, primarily on stainless steel guide wires and similar products. The PFOA-free coatings are sensitive to saline, which degrades the hydrophobicity of PTFE, making them vulnerable to electro/chemical attack,” said George Osterhout, President of SSG. “FluoroBond®-PT solves those problems.”

FluoroBond®-PT is a unique environmentally friendly treatment process developed by SSG for stainless steel, nitinol, and other metals that solves the PTFE coating delamination issues experienced in catheterization labs, operating rooms, and doctor’s offices. SSG’s FluoroBond®-PT is used to hyper clean the substrate, and remove free iron and iron oxides from the surface of the substrate, without removing material or changing the dimension of the substrate’s surface. “There has been no delamination in the field on guide wires that were coated with SSG’s unique FluoroBond®-PT process,” stated Osterhout.

About Surface Solutions Group

Surface Solutions Group is dedicated to developing innovative coating solutions for the medical device industry. With over 50 years of coating industry experience, SSG’s coating technologies, extensive automation and state of the art facility provides its customers with consistently applied coatings on medical devices that follow stringent quality processes, and meet its customers’ demanding performance requirements. Its customers include some of the largest names in the medical device industry. To learn more about SSG’s capabilities, visit www.surfacesolutionsgroup.com or call 773-427-2084.

Contacts

Surface Solutions Group, LLC
Mike Osterhout
773-427-2084 x 169
mike@surfacesolutionsgroup.com
or
Custom Direct, Inc.
Patty Martucci
630-529-1936 x 224
martucci@customdirect.com

Chemists devise revolutionary 3D bone-scanning technique

Chemists from Trinity College Dublin, in collaboration with RCSI, have devised a revolutionary new scanning technique that produces extremely high-res 3D images of bones — without exposing patients to X-ray radiation.

The chemists attach luminescent compounds to tiny gold structures to form biologically safe ‘nanoagents’ that are attracted to calcium-rich surfaces, which appear when bones crack – even at a micro level. These nanoagents target and highlight the cracks formed in bones, allowing researchers to produce a complete 3D image of the damaged regions.

The technique will have major implications for the health sector as it can be used to diagnose bone strength and provide a detailed blueprint of the extent and precise positioning of any weakness or injury. Additionally, this knowledge should help prevent the need for bone implants in many cases, and act as an early-warning system for people at a high risk of degenerative bone diseases, such as osteoporosis.

The research, led by the Trinity College Dublin team of Professor of Chemistry, Thorri Gunnlaugsson, and Postdoctoral Researcher, Esther Surender, has just been published in the leading journal Chem, a sister journal to Cell, which is published by CellPress.

Professor Gunnlaugsson said: “This work is the outcome of many years of successful collaboration between chemists from Trinity and medical and engineering experts from RCSI. We have demonstrated that we can achieve a three-dimensional map of bone damage, showing the so-called microcracks, using non-invasive luminescence imaging. The nanoagent we have developed allows us to visualise the nature and the extent of the damage in a manner that wasn’t previously possible. This is a major step forward in our endeavour to develop targeted contrast agents for bone diagnostics for use in clinical applications.”

The work was funded by Science Foundation Ireland and by the Irish Research Council, and benefited from collaboration with scientists at RCSI (Royal College of Surgeons in Ireland), led by Professor of Anatomy, Clive Lee.

Professor Lee said: “Everyday activity loads our bones and causes microcracks to develop. These are normally repaired by a remodelling process, but, when microcracks develop faster, they can exceed the repair rate and so accumulate and weaken our bones. This occurs in athletes and leads to stress fractures. In elderly people with osteoporosis, microcracks accumulate because repair is compromised and lead to fragility fractures, most commonly in the hip, wrist and spine. Current X ray techniques can tell us about the quantity of bone present but they do not give much information about bone quality.”

He continued: “By using our new nanoagent to label microcracks and detecting them with magnetic resonance imaging (MRI), we hope to measure both bone quantity and quality and identify those at greatest risk of fracture and institute appropriate therapy. Diagnosing weak bones before they break should therefore reduce the need for operations and implants – prevention is better than cure.”

In addition to the unprecedented resolution of this imaging technique, another major step forward lies in it not exposing X-rays to patients. X-rays emit radiation and have, in some cases, been associated with an increased risk of cancer. The red emitting gold-based nanoagents used in this alternative technique are biologically safe – gold has been used safely by medics in a variety of ways in the body for some time.

Dr Esther Surender, Trinity, said: “These nanoagents have great potential for clinical application. Firstly, by using gold nanoparticles, we were able to lower the overall concentration of the agent that would have to be administered within the body, which is ideal from a clinical perspective. Secondly, by using what is called ‘two-photon excitation’ we were able to image bone structure using long wavelength excitation, which is not harmful or damaging to biological tissues.”

She added: “These nanoagents are similar to the contrast agents that are currently being utilised for MRI within the clinic, and hence have the potential to provide a novel means of medical bone diagnosis in the future. Specifically, by replacing the Europium with its sister ion Gadolinium, we can tune into the MRI activity of these nanoagents for future use alongside X-ray and computed tomography (CT) scans.”

Professor Gunnlaugsson and his research team are based in the Trinity Biomedical Sciences Institute (TBSI), which recently celebrated its 5-Year anniversary. Professor Gunnlaugsson presented his research at a symposium to mark the occasion, along with many other world-leaders in chemistry, immunology, bioengineering and cancer biology.

Article: Two-Photon Luminescent Bone Imaging Using Europium Nanoagents, Esther M. Surender, Steve Comby, Brenton L. Cavanagh, Orlaith Brennan, T. Clive Lee, Thorfinnur Gunnlaugsson, Chem, doi: 10.1016/j.chempr.2016.08.011, published online 8 September 2016.

Fractures That Fail to Heal May Be Predictable Based on Patient Risk Factors

September 08, 2016

DURHAM, N.C.–(BUSINESS WIRE)–Recent research has shed light on the predictability of fractures that fail to heal, known as nonunions. All nonunions are a function of severity, location and disease comorbidity and while risk factor interaction is complex, a new study reports that it may become possible to predict nonunion based on the patient-specific presentation of risk factors. The findings are published in the September 7, 2016 issue of JAMA Surgery available at http://archsurg.jamanetwork.com/article.aspx?articleid=2547685.

The study found that in 2011, among 309,330 fractures in 18 bones, the overall nonunion rate was 4.93%. However, higher nonunion risk was associated with severe fractures, high body mass index, smoking and alcoholism. While females had more fractures, males were more prone to nonunion. In addition, the risk of nonunion increased for patients who used certain medications including antibiotics, anticoagulants, and opioids, as well as for patients who had diseases such as obesity, osteoarthritis and osteoporosis.

“We hypothesized that the interplay between a patient’s physiological risk factors and fracture characteristics increased the risk of fracture nonunion,” said Dr. R. Grant Steen, Manager of Medical Affairs, Bioventus. “We now believe clinicians can use this information to describe the epidemiology of fracture nonunion in adult patients.”

The study was funded by Bioventus and used fracture patients from a health plan database. Patients with fracture were identified and continuous enrollment in the database was required for 12 months after fracture, to allow sufficient time to capture a nonunion diagnosis.

Authors of this study include Robert Zura, MD, LSU Health Science Center, New Orleans, Ze Xiong, MS, Dept. of Statistics, North Carolina State University, Thomas Einhorn, MD, NYU Langone Medical Center, J. Tracy Watson, MD Saint Louis University School of Medicine, Robert F. Ostrum, MD University of North Carolina, Michael J. Payson, MD, Wright State University, Gregory J. Della Rocca, MD, PhD, University of Missouri, Samir Mehta, MD, Hospital of the University of Pennsylvania, Todd McKinley, MD, Indiana University, Zhe Wang, MS, Dept. of Statistics, North Carolina State University and R. Grant Steen, PhD, Manager of Medical Affairs, Bioventus.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal

Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

InVivo Therapeutics to Present at 55th International Spinal Cord Society Annual Scientific Meeting

September 07, 2016

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that Kristin Neff, Vice President of Clinical Operations & Project Management, is scheduled to present at the 55th International Spinal Cord Society (ISCoS) Annual Scientific Meeting to be held September 14-16, 2016 in Vienna, Austria. Ms. Neff was invited to present along with several other leaders in the field of spinal cord injury clinical research on September 14 during the symposium titled “Clinical Trials Update for 2016.” The symposium, organized by the Spinal Cord Outcomes Partnership Endeavor (SCOPE), is intended to provide an update on current clinical research to foster communication between researchers and clinicians on advancements and challenges in clinical research.

“I am excited to share our encouraging progress to date and partake in the discussion on the challenges of conducting clinical studies in the spinal cord injury patient population,” Ms. Neff said.

For more information regarding the meeting, visit:https://www.iscosmeetings.org/

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffoldreceived the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Contacts

InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com