Special Protein in Zebrafish May Lead to Full Spinal Cord Repair

Posted On November 4, 2016 By OrthoSpineNews In Biologics, Neuro /

Nov 04, 2016 – By Rhenn Anthony Taguiam

Researchers have discovered that zebrafish — the two-buck wonders in pet stores — may actually hold the key to do full spinal cord repair. It seems the zebrafish is capable of healing a completely severed spinal cord with special proteins.

An injury of this kind in humans can be paralyzing and can even lead to fatal conditions.

Researchers from Duke University have discovered that zebrafish possess a special protein that allows them to heal their severed spine. According to Medical Xpress, the study, published in Science, could lead to developments in tissue repair in humans.

Duke University’s Kenneth Poss claimed this is one of “nature’s most remarkable feats of regeneration.” This is because its potential implications and usage in the world of medicine is astounding. There are currently very limited methods of tissue repair, and animals like zebrafish may hold the key.

A zebrafish’s severed spinal cord forms a literal “bridge” that connects the gap in the injury. Cells form and extend to distances 10 times their own length to heal themselves. By eight weeks, the animals may have already fully reversed their paralysis.

Poss and his team conducted “molecular fishing” to find out which genes are responsible for such activity. It appears the CTGF or the connective tissue growth factor increases while the supporting cells appear to repair the injury.

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Scientists develop new implant coating derived from mussels

Posted On November 3, 2016 By OrthoSpineNews In Biologics /

November 2, 2016

A team of Japanese researchers has pioneered a new method for improving the biocompatibility of implant surfaces based on the chemical properties of mussels. The study contributes to a field of research that is exploring the use of proteins to ‘immobilise’, or fix, organic cells to metal surfaces.

The authors, based at the RIKEN research institute, Saitama, Japan, identified the natural adhesive properties of mussels as a potential method for improving attachment to metal surfaces. These molluscs use protein secretions to tightly bond their cells with surfaces, including metallic or ceramic ones, and can retain this grip even when submerged under water. The team identified that advances in controlling gene expression may enable them to activate the binding property of specific proteins, which could then be applied to implant surfaces.

The key chemical in the reaction is dopamine (3,4-dihydroxyphenethylamine) which had not previously been integrated into protein-based growth factors for use on implant surfaces. However, the scientists were concerned that the direct incorporation of such a chemical may compromise the protein’s underlying structure, negating the effect.

An innovative two-stage engineering method was devised by the team to express dopamine in a growth factor. The non-intrusive chemical tyrosine was incorporated into the protein, which was subsequently mixed with the enzyme tyrosinase. Tyrosinase has been used in other research to convert tyrosine into dopamine. In this case, the reaction took place without unsettling the tertiary structure of the protein, and dopamine was safely generated within it – closely matching that of the underwater adhesive secreted by mussels.

The authors tested the chemical by applying it to titanium-coated discs. Titanium is commonly used for many medical devices including dental implants. After applying the modified growth factor, significantly enhanced cell growth was observed on the surface of the discs as well as improved cell binding properties.

This outcome could have an impact on implant procedures, as cells may bond with implant surfaces more easily if they are coated with the treated growth factor. As well as having applications in implant dentistry, the new method for expressing dopamine in growth-factor proteins could be harnessed in regenerative medicine and cell culture systems. The study was published in Angewandte Chemie.

Creating a slippery slope on the surface of medical implants

Posted On November 2, 2016 By OrthoSpineNews In Biologics /

November 1, 2016

Implanted medical devices such as left ventricular-assist devices for patients with heart failure or other support systems for patients with respiratory, liver or other end organ disease save lives every day. However, bacteria that form infectious biofilms on those devices, called device-associated infections, not only often sabotage their success but also contribute to the rampant increase in antibiotic resistance currently seen in hospitals.

As reported in Biomaterials, a team led by Joanna Aizenberg, Ph.D., and Elliot Chaikof, M.D., Ph.D., at the Wyss Institute for Biologically Inspired Engineering and the Harvard John A. Paulson School of Engineering and Applied Sciences at Harvard University (SEAS), as well as the Beth Israel Deaconess Medical Center (BIDMC), have created self-healing slippery surface coatings with medical-grade teflon materials and liquids that prevent biofilm formation on medical implants while preserving normal innate immune responses against pathogenic bacteria.

The technology is based on the concept of ‘slippery liquid-infused porous surfaces’ (SLIPS) developed by Aizenberg, who is a Wyss Institute Core Faculty member, Professor of Chemistry and Chemical Biology and the Amy Smith Berylson Professor of Materials Science at SEAS. Inspired by the carnivorous Nepenthes pitcher plant, which uses the porous surface of its leaves to immobilize a layer of liquid water, creating a slippery surface for capturing insects, Aizenberg previously engineered industrial and medical surface coatings that are able to repel unwanted substances as diverse as ice, crude oil and biological materials.

“We are developing SLIPS recipes for a variety of medical applications by working with different medical-grade materials, tuning the chemical and physical features of these solids and the infused lubricants to ensure the stability of the coating, and carefully pairing the non-fouling properties of the integrated SLIPS materials to specific disturbing factors, contaminating environments and performance requirements,” said Aizenberg. “Here we have extended our repertoire of materials classes and applied the SLIPS concept very convincingly to medical-grade teflon, demonstrating its enormous potential in implanted devices prone to bacterial fouling and infection.”

First, the team searched ex vivo for the teflon material that would work best with a selection of compatible lubricants to provide a long-lived repellent surface against a common device-associated bacterial strain. The most advantageous teflon-lubricant combinations had to preserve the anti-bacterial activity of innate immune cells that provide the natural first-line response against invading bacteria. The winning material was ‘expanded polytetrafluoroethylene’ (ePTFE). Used in prosthetic grafts for cardiovascular reconstruction, mesh for hernia repair, as well as implants in a wide variety of reconstructive surgery, ePTFE tested well with lubricants with proven acceptable safety profiles.

Moving to a rodent model, the team compared bacterial and tissue responses to implanted hernia meshes with or without a SLIPS surface after infecting the animals with Staphylococcus aureus.

“SLIPS coatings yielded extremely favorable responses in vivo: they resisted infection by bacteria and were associated with considerably less infiltrating immune cells and inflammatory abscesses than non-coated ePTFE,” said Chaikof, who is a Wyss Institute Associate Faculty member, Chairman of the Roberta and Stephen R. Weiner Department of Surgery and Surgeon-in-Chief at BIDMC.

“At present, patients who receive implants for the repair, reconstruction or replacement of diseased or damaged organs or tissues or otherwise depend upon temporary life sustaining support systems, often require antibiotics at the time of implantation to keep the risk of bacterial infection at bay. SLIPS coatings one day could obviate the widespread use of antibiotics, minimize the development of antibiotic resistant microorganisms, and enhance the capacity of temporary or permanent artificial devices to resist infection,” said Chaikof.

“This new study by Joanna and Elliot exemplifies the Wyss Institute model in which collaborations between basic scientists focused on industrial applications and clinicians working in the medical area are fostered in a way that can lead to unexpected developments — in this case, one that has the potential to have a major positive impact in the clinical setting,” said Don Ingber, M.D., Ph.D., Founding Director of the Wyss Institute, Judah Folkman Professor of Vascular Biology at Harvard Medical School and Boston Children’s Hospital, and Professor of Bioengineering at SEAS.

Previous medical SLIPS applications include coatings that can repel bacteria and blood from small medical implants, tools and surgical instruments that are made of steel or, more recently, coatings that help keep the glass surfaces of endoscopy and bronchoscopy lenses free from highly contaminating body fluids and thus transparent during procedures.

Story Source:

Materials provided by Wyss Institute for Biologically Inspired Engineering at Harvard. Note: Content may be edited for style and length.

Journal Reference:

Jiaxuan Chen, Caitlin Howell, Carolyn A. Haller, Madhukar S. Patel, Perla Ayala, Katherine A. Moravec, Erbin Dai, Liying Liu, Irini Sotiri, Michael Aizenberg, Joanna Aizenberg, Elliot L. Chaikof. An immobilized liquid interface prevents device associated bacterial infection in vivo. Biomaterials, 2017; 113: 80 DOI: 10.1016/j.biomaterials.2016.09.028

Cite This Page:

Wyss Institute for Biologically Inspired Engineering at Harvard. “Creating a slippery slope on the surface of medical implants: Self-healing slippery coating applied on the surface of an implanted medical device protects against infectious biofilm formation.” ScienceDaily. ScienceDaily, 1 November 2016. <www.sciencedaily.com/releases/2016/11/161101111923.htm>.

InVivo Therapeutics Announces Appointment of Jeffrey Hatfield to Board of Directors

Posted On November 2, 2016 By OrthoSpineNews In Biologics, Neuro /

November 02, 2016

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced the appointment of Jeffrey Hatfield to its Board of Directors. Mr. Hatfield most recently served as President, Chief Executive Officer, and Board Member for Vitae Pharmaceuticals and served in those capacities since joining the company in March 2004. Mr. Hatfield funded the company privately from 2005 to 2014 via three separate partnering transactions and took Vitae Pharmaceuticals public in 2014. On September 14, 2016, Allergan Plc announced that it had entered into a definitive agreement to purchase Vitae Pharmaceuticals for approximately $639 million in cash.

Prior to joining Vitae Pharmaceuticals, Mr. Hatfield worked at Bristol-Myers Squibb (BMS) in a variety of executive positions, including: Senior Vice President of BMS’ Immunology and Virology Divisions, where he was responsible for all aspects of the $1B annual revenue division; President and General Manager, BMS-Canada; and Vice President, U.S. Managed Health Care. Mr. Hatfield holds an M.B.A. from The Wharton School of the University of Pennsylvania and a bachelor’s degree in pharmacy from Purdue University, where he is a Distinguished Alumnus and adjunct professor. He has served on the Board of Ambit Biosciences (AMBI) before its acquisition by Daiichi-Sankyo, and is currently a member of the Board of Directors of the Biotechnology Industry Organization (BIO), serving on the Executive Committee of the Emerging Company Section. He is also a member of the advisory committees for Purdue University’s College of Pharmacy, Drexel University’s LeBow College of Business, and the Chapman-KGI School of BioPharmacy.

Mark Perrin, InVivo’s CEO and Chairman, said, “The Board of Directors is pleased to welcome Jeff. His invaluable experience in steering a company to clinical trials, managing successful product launches, business development transactions, and driving valuation leading to corporate acquisition makes him a great asset to the Board.”

“I’m personally very motivated and excited by the company’s work, as I’ve had direct experience with a family member who suffered a serious spinal cord injury at an early age,” Hatfield said. “I’m hopeful that Mark and the InVivo team can make a meaningful difference to the lives of those suffering these kinds of traumatic 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

AMNIOX Highlights Study Demonstrating Improved Outcomes in Patients Treated with CLARIX® Regenerative Matrix as an Adjunct to Lumbar Discectomy

Posted On October 26, 2016 By OrthoSpineNews In Biologics /

October 26, 2016

ATLANTA–(BUSINESS WIRE)–AMNIOX Medical, Inc., a TissueTech™, Inc., company, announced the results of a prospective randomized clinical study of its proprietary cryopreserved Amniotic Membrane (AM) as an adjunct to lumbar discectomy. The findings will be presented at the North American Spine Society 2016 Annual Meeting, by the study’s lead investigator, D. Greg Anderson, M.D. of the Rothman Institute in Philadelphia, PA.

The study included 80 patients, with half of the patients receiving CLARIX 100 in the disc space following removal of the disc herniation and half receiving the standard of care which involved removal of the herniation alone. Patients treated with CLARIX saw statistically significant improvement in Oswestry Disability Index (ODI) scores and SF-12 (Physical Composite Scale) at six weeks and two years. The ODI quantifies disability due to low back pain and the SF-12 assesses the patients’ physical and mental well-being. The study also reports that there were no recurrent herniations in the CLARIX treatment group during the 2-year follow-up period, compared to a 7.5 percent recurrence rate in the control group.

“Degenerative disc disease is the most common source of back pain and lumbar discectomy is the most common surgical intervention to treat this condition. However, residual back pain and recurrent herniations can be as high as 20%” said Dr. Anderson, Professor in the Departments of Orthopaedic and Neurological Surgery at Thomas Jefferson University and Clinical Director of the Spine Section of the Orthopaedic Research Laboratory. “These results indicate that the application of CLARIX can influence the healing response to significantly improve post-surgical outcomes. Patients experience reduced pain and a faster and sustained return to activities of daily living. Additionally, although it was not an endpoint identified in the study protocol, we observed a reduction in the use of narcotics in the patients treated with CLARIX.”

“This Level 1 study is the first one to evaluate the benefits of placental tissue in conjunction with discectomy and is clear evidence that the benefits of CLARIX that have been observed in other orthopedic procedures can be brought to patients undergoing spinal surgery” said Tom Dugan, Chief Executive Officer of Amniox Medical. “Equally important to the clinical benefits observed are the enormous health economic implications of this study. Reductions in the rate of rehospitalization and in the number of future operations for reherniation make this a technology that will be embraced by payers as well as providers.”

Amniox parent TissueTech pioneered the commercialization and clinical application of human umbilical cord and amniotic membrane to promote regenerative healing. This restorative ability is innate to these placental tissues and can be preserved and transplanted to adults. Heavy chain hyaluronic acid/pentraxin-3 (HC-HA/PTX3) is the key protein complex present in these tissues to orchestrate that regenerative healing process. Amniox utilizes its proprietary CryoTek® process, a cryopreservation technology, to preserve the biological and structural integrity of these tissues more effectively than other available technologies. Since the company’s inception, clinicians have performed more than 250,000 human transplants of its products and published more than 300 peer-reviewed studies supporting its technology platform.

About Amniox Medical, Inc.

Founded in 2011 to serve the orthopedic and wound care markets, Amniox Medical is dedicated to developing and marketing regenerative therapies processed from umbilical cord and amniotic membrane utilizing its proprietary CryoTek technology. This process has been proven to preserve the innate biological and structural properties of the matrix, which can then be transplanted to adult wound and surgical environments. Amniox Medical procures its tissue through elective donation following healthy live birth via Cesarean section. Thorough donor screening is performed to ensure safety of its products. For additional information, please visit http://www.amnioxmedical.com.

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and BioTissue®, Inc., pioneered the development and clinical application of regenerative, amniotic tissue-based products. Amniox Medical develops and markets products for use in the musculoskeletal and wound care markets; BioTissue develops and markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) has supported TissueTech’s research with more than 25 continuous years of research grants. Since the company’s inception, clinicians have performed more than 250,000 human implants of the company’s products and published more than 300 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft^®, is the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound healing while suppressing scarring and inflammation.

Contacts

For AMNIOX Medical, Inc.
Chris Gale
(646) 695-2883
cgale@greentarget.com

Isto Biologics will join industry experts at the annual North American Spine Society (NASS) meeting in Boston this week

Posted On October 26, 2016 By OrthoSpineNews In Biologics /

ST. LOUIS, Oct. 25, 2016 /PRNewswire/ — Isto Biologics is wasting no time in showcasing its bone-regeneration technologies and cell-based therapy to industry leaders and spine surgeons. Isto Biologics, resulting from the combination of Isto Technologies and Arteriocyte Medical Systems, will participate in the 2016 North American Spine Society (NASS) annual meeting in Boston Oct. 26-29.

“The combination of Isto Technologies and Arteriocyte Medical Systems expands our best-in-class product portfolios and builds upon our collective, deep scientific expertise in biologics and cell therapy to provide better patient outcomes,” said Phil Kuhn, Isto’s chief commercial officer. “I cannot think of a better place than the NASS meeting for our public debut.”

Orthopedic surgeon Enrico Stazzone, M.D., will give a presentation during the meeting’s Innovative Technologies Sessions highlighting his noteworthy research using concentrated bone marrow aspirate. Dr. Stazzone will share his research comparing marrow-derived progenitor cells from pediatric patients and adults.

We are looking forward to hearing Dr. Stazzone’s research presentation on marrow-derived progenitor cells and his experience using our CellPoint concentrated bone marrow aspirate system. We’re excited that he, along with other experts from our scientific and clinical team, will be on site to answer specific questions about our cutting-edge biologics,” stated Jenny Reid, director of marketing. “NASS provides us the perfect opportunity to share our company announcement and provide more information about our combined product portfolio with leading spine surgeons.”

NASS’s annual meeting is the ideal setting to share the latest information, innovative techniques and best practices with renowned spine care professionals from around the world. The meeting delivers dynamic and challenging educational programs, outstanding exhibitions and the chance to network and build relationships with celebrated spine professionals. NASS 2016 is being held Oct. 26–29 in Boston at the Boston Convention and Exhibition Center.

About Isto Biologics

Isto Biologics was formed in 2016 when St. Louis-based Isto Technologies and Arteriocyte Medical Systems Inc. of Hopkinton, Massachusetts, combined under the Isto Holdings umbrella. Isto Biologics is focused on offering evidence-based solutions for bone regeneration and cell therapy to help improve patient outcomes. The company’s best-in-class product offerings include Arteriocyte’s market-leading MAGELLAN® Autologous Platelet Separator System and Isto’s bone-growth and cell-therapy products including InQu® Bone Graft Extender & Substitute; Influx®, a natural bone-graft material; and CellPoint®, a concentrated bone marrow aspirate system.

For more information, visit www.istobiologics.com

Media Contact:
Jenny Reid
Director of Marketing
314-262-8039
JReid@istotech.com

Logo – http://photos.prnewswire.com/prnh/20161019/430449LOGO

SOURCE Isto Biologics

SANUWAVE Announces Exhibition at MEDICA in Cooperation with Ortho-Medico in Europe

Posted On October 21, 2016 By OrthoSpineNews In Biologics /

SUWANEE, GA / ACCESSWIRE / October 21, 2016 / SANUWAVE Health, Inc. (SNWV) (www.sanuwave.com) SANUWAVE is pleased to announce that the company will exhibit, in conjunction with Ortho-Medico, a member of B&Co, at MEDICA in Dusseldorf, Germany on 14 -17 November, 2016. SANUWAVE and Ortho-Medico cordially invites you to our booth 17D61 in Hall 17. MEDICA is the world’s leading trade fair for the medical industry. SANUWAVE is using this occasion to announce SANUWAVE’s expanded cooperation with Ortho-Medico to strengthen and expand our business in Europe. In this partnership, Ortho-Medico will be the Company’s future contact for all EU distributors concerning sales and service. SANUWAVE sees this as a key initiative to improve our communication with, and responsiveness to all of our partners and customers in the European Community.

Ortho-Medico, with headquarters in Herzele, Belgium, has long been SANUWAVE’s partner in the Benelux region. With their strength, experience and knowledge of the orthopedics and the wound care market, they are well positioned to help expand SANUWAVE’s market penetration via increased clinical presence and to continue to promote the company’s core products, dermaPACE and orthoPACE. Mr. Kevin Richardson from SANUWAVE, and Mr. Jo Schops from Ortho-Medico will look forward to explaining new opportunities.

“We are very excited with our expanded partnership with Ortho-Medico. This arrangement will help us to coordinate and consolidate our activities in Europe,” stated Mr. Richardson, Chief Executive Officer of SANUWAVE. “Our exhibition, alongside Ortho-Medico at MEDICA will be the springboard to re-establish our market presence in the European Community.”

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (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 CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. 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.

About Ortho-Medico

Ortho-Medico has been a known player in the Benelux since 1987 with its full range of orthopedic aids and specific treatments as Shockwave. Ortho-Medico’s final aim, its mission, is to keep the patient as dynamic and active as possible, therefor our innovative expansion in the field of wound care and neurology. Ortho-Medico’s success is founded on a very high-quality, complete product portfolio, very close collaboration with specialists and orthopedic technicians, very quick terms of delivery, reliable advice and an attitude which is aimed at finding solutions.

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.

Isto and Arteriocyte join forces to form leading biologics player, Isto Biologics

Posted On October 19, 2016 By OrthoSpineNews In Biologics, Financial /

ST. LOUIS, Oct. 19, 2016 /PRNewswire/ — Isto Holdings, the parent company of St. Louis-based Isto Technologies – a leader in bone-regeneration technologies and cell-based therapy – has acquired medical-device company Arteriocyte Medical Systems Inc. ofHopkinton, Massachusetts, with plans to integrate the companies under the name Isto Biologics. Isto Biologics will be focused on offering evidence-based solutions to expand its spine, orthopedics, and functional-medicine product portfolios. Isto Biologics will be headquartered in St. Louis, while maintaining operations in Massachusetts.

“We’re excited to bring together two great organizations under the Isto umbrella and build upon their leading biologics platforms,” saidAnthony Chambers, Director at Thompson Street Capital Partners, which provided capital for the transaction. “Both Isto and Arteriocyte have achieved remarkable success by developing innovative, clinically-proven product offerings that help improve patient outcomes. The integrated product portfolio, combined with the expanded sales force and broader distribution network, will allow Isto Biologics to extend its reach within the spine, orthopedics, and functional-medicine markets.”

George Dunbar, current CEO of Isto Technologies, will serve as CEO of Isto Biologics. “We are grateful for the support of Thompson Street Capital Partners and excited to lead Isto Biologics into the future,” said Mr. Dunbar. “The integration of Isto and Arteriocyte presents an opportunity to leverage our combined expertise to establish a strong position in an ever-changing market and better serve our physician partners, as they work to grow their practice and meet the demands of value-based healthcare.”

Isto Biologics’ expanded, best-in-class product portfolio will feature Arteriocyte’s market-leading MAGELLAN® Autologous Platelet Separator and Isto’s bone-growth and cell-therapy products, including InQu® Bone Graft Extender & Substitute; Influx®, a natural bone-graft material; and CellPoint®, a concentrated bone marrow aspirate system.

About Isto Biologics

Isto Biologics was formed in 2016 when St. Louis-based Isto Technologies and Arteriocyte Medical Systems Inc. of Hopkinton, Massachusetts, integrated under the Isto Holdings umbrella. Isto Biologics is focused on offering evidence-based solutions for bone regeneration and cell therapy to help improve patient outcomes. The company’s best-in-class product offerings include Arteriocyte’s market-leading MAGELLAN® Autologous Platelet Separator and Isto’s bone-growth and cell-therapy products including InQu® Bone Graft Extender & Substitute; Influx®, a natural bone-graft material; and CellPoint®, a concentrated bone marrow aspirate system.

For more information, visit istobiologics.com.

Media Contact:
Jenny Reid
Director of Marketing
314-262-8039
JReid@istotech.com

Logo – http://photos.prnewswire.com/prnh/20161019/430449LOGO

SOURCE Isto Biologics

Orthocell Receives Approval for Human Nerve Regeneration Study Using CelGro®

Posted On October 19, 2016 By OrthoSpineNews In Biologics, Neuro /

October 17, 2016

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell has been granted ethics approval for a human study examining the effectiveness of its CelGro® collagen medical device, to guide and promote nerve regeneration in severed peripheral nerves of the hand and upper limb.

The primary objective of this study is to demonstrate the safety, tolerability and effectiveness of CelGro® when used as a conduit in the surgical repair of peripheral nerve injuries. The study will involve 20 patients who have suffered injury to one or more peripheral nerves and will be undertaken at St John of God Hospital beginning in the fourth quarter of calendar 2016.

Peripheral nerve injury is most commonly caused by accidents or other trauma and in the US alone, over 20 million people are affected each year, at a cost of approximately $150 billion in annual health care dollars.

Principal investigator, orthopaedic surgeon Dr Alex O’Beirne said: “This is an exciting development that has the potential to improve patient outcomes by allowing for a suture-less repair to the damaged nerve, to guide nerve regeneration and accelerate the healing process.”

CelGro® is a biological medical device used as a scaffold for a variety of orthopaedic and general reconstructive surgical applications. Orthocell is also undertaking clinical studies using CelGro® to augment repair of the rotator cuff tendon within the shoulder, as an augment to guide and promote bone regeneration, as well as an augment to cartilage repair within the hip joint.

Orthocell Managing Director Paul Anderson said, “This is an exciting new phase in the development of CelGro® and its use as an augment to improve nerve repair. It further validates CelGro as a unique platform technology for soft tissue repair.”

Orthocell has submitted CelGro® for first regulatory approval in Europe and expects to receive notice of approval of its CE Mark application in 2016. Receipt of this approval will enable sales of CelGro® to commence in Europe, and trigger applications for other regulatory approvals in the United States, Australia and Japan in 2017.

About Orthocell Limited

Orthocell is a commercial-stage, regenerative medicine company focused on regenerating mobility for patients and our ageing population by developing products for a variety of tendon, cartilage and soft tissue injuries. Orthocell’s portfolio of products include TGA-approved stem cell therapies Autologous Tenocyte Implantation (Ortho-ATI™) and Autologous Chondrocyte Implantation (Ortho-ACI™), which aim to regenerate damaged tendon and cartilage tissue. The Company’s other major product is CelGro™, a collagen medical device which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications and is being readied for first regulatory approvals.

Contacts

Orthocell Limited
General enquiries
Paul Anderson, +61 8 9360 2888
Managing Director
paulanderson@orthocell.com.au
or
Investor and Media enquiries
WE Buchan
Ben Walsh, +61 411 520 012
bwalsh@buchanwe.com.au

InVivo Therapeutics Announces Foothills Medical Centre in Calgary, Alberta as New Canadian Site for INSPIRE Study

Posted On October 19, 2016 By OrthoSpineNews In Biologics, Neuro /

October 19, 2016

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that the Foothills Medical Centre in Calgary, Alberta has been added as a Canadian clinical site for The INSPIRE Study: InVivo Study of Probable Benefit of theNeuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury. The Foothills Medical Centre is the largest hospital in Alberta and is one of the most recognized medical facilities in Canada, providing advanced healthcare services to over two million people from Calgary and southern Alberta, the northwestern United States, southeastern British Columbia, and southern Saskatchewan.

“InVivo’s Neuro-Spinal Scaffold is one of the more innovative approaches to treating acute spinal cord injury in recent history and we look forward to being a part of the INSPIRE study,” said Steven Casha, M.D., Ph.D., Assistant Professor of Neurosurgery in the Department of Clinical Neurosciences and Principal Investigator at the study site.

Mark Perrin, InVivo’s CEO and Chairman, said, “We are pleased to welcome Dr. Casha and his team at the Foothills Medical Centre to the INSPIRE study. We will continue to expand our footprint in both the US and Canada.”

A new CEO’s Perspective discussing the current status of the INSPIRE study can be found on the InVivo Therapeutics website:http://www.invivotherapeutics.com/about-invivo/ceo-perspective/

There are now 24 clinical sites participating in the clinical study:

Banner University Medical Center, Tucson, AZ
Barnes-Jewish Hospital at Washington University Medical Center, St. Louis, MO
Ben Taub Hospital/Baylor College of Medicine, Houston, TX
Barrow Neurological Institute – St. Joseph’s Hospital and Medical Center, Phoenix, AZ
Carolina Neurosurgery and Spine Associates/Carolinas Rehabilitation, Charlotte, NC
Cooper Neurological Institute, Camden, NJ
Foothills Medical Centre, Calgary, Alberta, Canada
Goodman Campbell Brain and Spine/Indiana University Health Neuroscience Center, Indianapolis, IN
Hospital of the University of Pennsylvania, Philadelphia, PA
Keck Hospital of University of Southern California, Los Angeles, CA
Medical College of Wisconsin/Froedtert Hospital, Milwaukee, WI
Mount Sinai Hospital, New York, NY
Northwestern Medicine, Chicago, IL
Oregon Health & Science University, Portland, OR
Rutgers New Jersey Medical School, Newark, NJ
Thomas Jefferson University Hospital, Philadelphia, PA
Toronto Western Hospital, Toronto, ON, Canada
University of California, Davis Medical Center, Sacramento, CA
University of California, San Diego Medical Center, San Diego, CA
University of Kansas Medical Center, Kansas City, KS
University of Louisville Hospital, Louisville, KY
University of Pittsburgh Medical Center Presbyterian, Pittsburgh, PA
University of Virginia Health System, Charlottesville, VA
Vidant Medical Center, Greenville, NC

For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110

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

Safe Harbor Statement

Any statements contained in this press release or the CEO Perspective referred to herein that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, the expected timing of full enrollment in the INSPIRE study, the timing of the submission of the Humanitarian Device Exemption (HDE), the timing for opening of the pilot cervical SCI study, and the company’s anticipated cash balance. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the ability to complete the INSPIRE study and submit an HDE; the company’s ability to receive regulatory approval for the Neuro-Spinal Scaffold; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2015, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

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

Biologics

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