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Current Issues in Spine

February 2-4, 2017

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November 21, 2018 OrthoSpineNews
November 21, 2018, Ecole Polytechnique Federale de Lausanne

EPFL researchers have developed a hydrogel – made up of nearly 90% water – that naturally adheres to soft tissue like cartilage and the meniscus. If the hydrogel carries repair cells, it could help damaged tissue to heal.

Some types of body tissue, like cartilage and meniscus, have little or no blood supply and are unable to heal if damaged. One promising approach to this problem is to inject a hydrogel loaded with repair cells or drugs into the damaged area in the hope of stimulating tissue regeneration.

However, commercial  do not stay put after being applied to the treatment area because of pressure from the body’s movements and the flow of bodily fluids. Doctors therefore use special membranes to keep the hydrogel in place, yet those membranes are attached with sutures that perforate the very tissue the hydrogel is supposed to heal.

Two EPFL  groups, led by Dominique Pioletti and Pierre-Etienne Bourban, have created a biocompatible hydrogel that naturally adheres to  like cartilage and the meniscus. Their hydrogel, which is almost 90% water, can withstand  and extensive deformation and therefore eliminates the need for a separate binding process. Their research has been published in ACS Applied Materials & Interfaces.

“Our hydrogel is ten times more adhesive than currently available bioadhesives on the market such as fibrin,” says Pioletti, head of the Laboratory of Biomechanical Orthopedics in EPFL’s School of Engineering. “And thanks to its high water content, our hydrogel is very similar in nature to the natural tissue it’s designed to heal.”

READ THE REST HERE 

 

Photo Credit: Ecole Polytechnique Federale de Lausanne


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November 21, 2018 OrthoSpineNews

November 21, 2018

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec announced today the successful completion of the initial clinical launch of its new GraftGun bone graft delivery system combined with ViBone Viable Bone Matrix prefilled tubes. This early evaluation of the combined products was focused in the Minimally Invasive Spine (MIS) surgery field.

Earlier this year, SurGenTec and Aziyo® Biologics joined forces to bring the first preloaded MIS viable bone matrix cartridges to market for use in orthopedic and spine surgery. SurGenTec is the manufacturer of the GraftGun bone graft delivery system while Aziyo is the manufacturer of ViBone, a next generation viable bone graft.

“The primary goal of our partnership with Aziyo is to provide surgeons with a high quality viable bone matrix product with shorter thaw times and no mix requirements while also eliminating the need for a cumbersome funnel-based fill process,” said Travis Greenhalgh, Chief Executive Officer of SurGenTec LLC. “We are thrilled with the feedback from the initial clinical experience of surgeons and operating room staff which has been overwhelmingly positive. Our goal is to now expand promotion and usage of the combined products into more regions within the U.S.”

Kris Parchuri, DO of Spine & Orthopedic Specialists in Tulsa, Oklahoma said, “I have been able to decrease OR time and deliver a quality bone graft for my patients. This combination makes it easy for the operating room staff and provides more control with less wasted bone graft.”

Shawn Hermenau, MD of the Desert Spine Institute in Yuma, Arizona stated, “The GraftGun MIS system with ViBone allows me to access collapsed disc spaces and confidently deliver the quantity of bone graft to actually fill the entire disc space. The prefilled ViBone cartridges definitely add to efficiency in the OR.”

The GraftGun MIS system prefilled with ViBone has now been used in a variety of procedures including spinal fusions, tibial plateau fractures, total joint revisions and Charcot joint procedures. Prefilled ViBone MIS cartridges are simply thawed for two minutes and then connected to the GraftGun for ease of use. Once ViBone is opened in the operating room, it is delivered directly to the surgical site with precision and control. This innovative approach helps reduce the risk of surgical site contamination. The surgeon may also choose a variety of tip options to access tight spaces.

About GraftGun

GraftGun is part of SurGenTec’s Graft Delivery System (GDS). It is designed to allow for quick and accurate bone graft delivery to a surgical site without the problems of a traditional funnel. Its patented, controlled release method is designed to safely dispense bone graft with enough pressure to easily fill any bone void during surgery. The GraftGun GDS includes SurGenTec’s loading device technology, which provides surgeons the freedom to choose the bone graft that best suits their needs. To learn more visit www.surgentec.com/graftgun.php

About ViBone

ViBone is a next generation viable bone matrix that was designed to perform and handle more like high quality autograft. The proprietary manufacturing process was designed to optimally protect the tissue environment with less disruption. ViBone is based on science that brings bone grafting closer to meeting the surgeon and patient’s needs and provides a better option for bone repair. To learn more visit www.aziyo.com/vibone/

About SurGenTec

SurGenTec is an ISO 13485 certified medical device manufacturer based out of Boca Raton, FL. The company develops innovative products focused on minimally invasive surgical solutions. SurGenTec was recently awarded the 2018 Spine Technology Award presented at NASS for their ALARA Access Needle. This new technology will be released in early December 2018. The company is currently working on CE marks to enter the world market. SurGenTec released their patented GraftGun bone graft delivery system in December 2017. Over the past year it has gained traction and allowed surgeons to facilitate graft delivery in some of the most difficult procedures. SurGenTec bolstered their offerings with prefilled cortical fibers and DBM putty cartridges which were released in November 2018. To learn more visit www.surgentec.com

About Aziyo Biologics

Aziyo Biologics is a fully integrated, commercially oriented regenerative medicine company. Since its founding in 2015 the Company has expanded through acquisitions and strategic partnerships, creating a high growth commercial entity. Its proprietary products are used in orthopedic, cardiovascular and other medical specialties. For learn more visit www.aziyo.com

Contacts

Ricki Goldman
Phone: 561-990-7882
Email: Ricki@surgentec.com


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November 21, 2018 OrthoSpineNews

SALT LAKE CITY, November 19, 2018 – Innovasis, Inc., a fully integrated research, development and manufacturing spinal device company, today announced their expansion into the biologics market by signing a private-label agreement with Stability Biologics, LLC. Stability Biologics®, headquartered in Nashville, Tennessee with a state of-the-art AATB accredited and FDA registered tissue processing and distribution center in San Antonio, Texas will provide Innovasis with an expansive line of private labeled bone allograft tissue products including its flagship product Physio®.

Physio® is a next generation physiologic bone tissue allograft manufactured through Stability’s proprietary patent-pending process and is comprised of 100% donated human tissue, with no added extrinsic carrier. The microstructure of Physio® retains growth factors, osteogenic proteins and CaP minerals while providing excellent handling characteristics.

“We are excited to begin a strategic partnership with Stability Biologics® which will provide Innovasis’ customers with a robust biologics platform to complement our instrumentation portfolio,” said David Oka, Director of Business Development and Clinical Affairs. “We anticipate Physio’s differentiated osteogenic microstructure will provide a potent ecosystem when used with our PEEK-OPTIMA HA Enhanced interbody platform.”

“The potential for working with a company like Innovasis is very exciting,” said Brian Martin, Chief Executive Officer of Stability Biologics®. “We foresee the opportunity of a truly synergistic partnership with our respective companies given our innovative allograft tissue products combined with Innovasis’ revolutionary product offerings allowing us both to increase our respective customer base.”

Innovasis is excited to expand their footprint in the biologics market and anticipates commercialization of their private labeled product lines by December 2018.

About Innovasis, Inc.

Innovasis is a groundbreaking company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery.

About Stability Biologics®

Stability Biologics® is a leading provider of high quality proprietary and competitive allograft tissue products to physicians, hospitals and ambulatory surgery centers both domestically and internationally. Stability Biologics® provides a full line of human allograft tissue products available for distribution in the surgical fields of spine, orthopedics and wound care.

Innovasis Media Contact

Hayley Hendrix, 801-261-2236

hhendrix@innovasis.com

Stability Biologics® Media Contact

Brian Martin, 615-921-5551

bmartin@stabilitybio.com


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November 19, 2018 OrthoSpineNews
Lund, Sweden, 08.00 CET, 19 November 2018 – BONESUPPORT™, an emerging leader in orthobiologics for the management of bone voids, today announces positive top-line data from the CERTiFy (CERAMENT® Treatment of Tibia Plateau Fracture defects) study comparing CERAMENT|BVF with autologous iliac bone graft (autograft).BONESUPPORT CEO Emil Billback said:” Successfully completing the ground-breaking CERTiFy study, to demonstrate CERAMENT BVF is non-inferior to autograft in treating tibia plateau fracture defects, is a major milestone for BONESUPPORT. We expect the results from the study to catalyse a change in the standard of care for this kind of injury given that our synthetic bone graft is now proven to be as good as autograft, which requires a second surgical procedure to harvest bone from the patient’s hip. These data, which clearly differentiate CERAMENT BVF, will play a key role in our commercial strategy to increase our share of the synthetic bone graft substitute market in both Europe and the U.S..”

CERTiFy, a prospective, multi-center, controlled, randomized trial, enrolled 137 patients with fresh traumatic depression fracture of the proximal tibia across 20 participating centers in Germany. Patients were randomized to receive either CERAMENT BVF or autograft. Professor Pol. M. Rommens, Head of Department of Orthopaedics and Traumatology at The University Medical Centre Mainz was the study’s Principle Investigator.

The CERTiFy study met its primary endpoint with CERAMENT BVF being non-inferior to autograft in terms of Physical Component Summary (SF-12 v2) at week 26. A publication providing more complete data from the CERTiFy study is expected in Q1 2019.

Professor P.M. Rommens said: “We are pleased to report positive top-line results from the CERTiFy study. Bone graft substitutes are widely used for augmentation of post-traumatic bone defects. However, no direct randomized clinical comparison to autologous bone grafting, the so-called “gold-standard” in reconstruction of bone defects, has been previously conducted. CERTiFy clearly demonstrates that CERAMENT BVF is non-inferior to autograft across several key clinical parameters. These findings pave the way for a potential change in the standard of care for post-traumatic bone defects given the ease of use and other benefits that CERAMENT BVF delivers. I look forward to providing more data from this ground-breaking study in a publication which is planned for Q1 2019”

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Håkan Johansson, CFO

+46(0) 46 286 53 70

ir@bonesupport.com

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7638 9571

bonesupport@citigatedewerogerson.com

About CERAMENT®|BONE VOID FILLER

CERAMENT|BONE VOID FILLER is used to fill gaps and voids in bone, for example those caused by trauma and benign bone tumors. It is the only injectable and moldable synthetic bone substitute that remodels to host bone within 6-12 months, and is radiopaque, making it ideal for minimally invasive surgery and open procedures. CERAMENT can be used to augment hardware during surgery, and the unique material combination resists crack formation and propagation when drilled.

About BONESUPPORT™

BONESUPPORT is an innovative commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

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

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

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

BONESUPPORT is currently conducting two important clinical trials to generate data demonstrating the clinical and health economic benefits its products deliver. The first trial, CERTiFy, is comparing CERAMENT BVF with autograft, the most widely used approach for managing bone voids. Top line results from this successful study showed that CERAMENT BVF met its primary endpoint of being   non-inferior to autograft. A publication providing more complete data from the CERTiFy study is expected in Q1 2019.

The FORTIFY study is assessing CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial will include the absence of deep infection at the fracture site and a reduction in the number of secondary procedures intended to promote fracture union. Data from this study will be used for a planned Premarket approval filing with FDA in 2020.

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

BONESUPPORT is also preparing to expand its product offering in the US and has entered into strategic agreements with Collagen Matrix Inc. and MTF Biologics to gain access to products that are complementary to CERAMENT BVF.

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

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

BONESUPPORT® and CERAMENT® are registered trademarks

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00am CET on 19 November 2018.

 About Us

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com*CERAMENT G: Not available in the United States, for investigational use only.CERAMENT V: Not available in the United States.BONESUPPORT™ and CERAMENT® are registered trademarks.


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November 16, 2018 OrthoSpineNews

CENTENNIAL, Colo.Nov. 16, 2018 /PRNewswire/ — AlloSource, an organization dedicated to advancing the science and use of transplantable allogeneic cells and tissue, received U.S. patent 10,105,793, titled Enclosure for laser cutting of human tissue.

This patent encompasses AlloSource’s method of producing a closed system that allows a laser beam to pass through and etch allograft tissue, while maintaining a sterile barrier. The proprietary method expedites processing, maximizes the use of tissue, and allows utilization of a specialized laser technology in a clean room setting.

The process is used to create ProChondrix® CR, AlloSource’s fresh cryopreserved osteochondral allograft. ProChondrix CR helps deliver the necessary components for articular cartilage restoration. This next generation of cartilage restoration therapy provides living functional cells and other biological components necessary for replacement, repair and regeneration of damaged cartilage tissues.

“As an organization dedicated to honoring tissue donation, this patent is a great example of our commitment to innovation,” said Dr. Ross Wilkins, AlloSource Senior Medical Director. “Laser etching stimulates the cartilage regenerative system while the graft replaces the missing cartilage in superficial defects down to the bone level. The early clinical results are very encouraging.”

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

Media Contact 
Megan Duggan
AlloSource
720. 382. 2766 
mduggan@allosource.org

SOURCE AlloSource

Related Links

http://www.allosource.org


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November 12, 2018 OrthoSpineNews

PLAINSBORO, N.J., Nov. 12, 2018 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced the appointment of Eric Schwartz as corporate vice president, general counsel and secretary.

“I am pleased to welcome Eric as our new general counsel and latest member of the executive leadership team,” said Peter Arduini, president and chief executive officer, Integra LifeSciences. “His extensive background and leadership experience in life sciences, as well as his global knowledge in mergers and acquisitions, regulatory, and providing board and corporate governance support make him an exceptional addition to Integra.”

Most recently, Eric was the general counsel at Globus Medical, a global orthopedic medical devices company, where he led several strategic transactions, including the largest acquisition in its company history, and led a cross-functional team responsible for integrating operations in over 20 countries.  Before this role, Eric was the COO and chief legal officer of CardioVIP, a technology-enabled clinical provider assisting physicians with comprehensive disease management for their patients with cardiovascular disease. Eric’s experience also includes roles of increasing responsibility in the law departments at Johnson and Johnson, Animas Corporation and Cable & Wireless America. Earlier in his career, Eric was in private practice at Skadden, Arps, Slate, Meagher & Flom LLP and Dechert LLP.

Eric received his bachelor’s degree in English and J.D. from the University of Virginia. He also holds a master’s degree in business from the Wharton School of the University of Pennsylvania.

About Integra

Integra LifeSciences is a global leader in regenerative technologies, neurosurgical and extremity orthopedic solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel®, Bactiseal®, Cadence®, Certas™, Codman®, CUSA®, DuraGen®, DuraSeal®, ICP Express®, Integra®, MediHoney®, MicroFrance®, PriMatrix®, Salto Talaris®, SurgiMend®, TCC-EZ®, Titan™ and VersaTru™.  For the latest news and information about Integra and its brands, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2017 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

CONTACT: Integra LifeSciences Holdings Corporation

Investors
Sravan Emany
Senior Vice President, Strategy, Treasury & Investor Relations
(609) 936-2488
sravan.emany@integralife.com

Michael Beaulieu
Director, Investor Relations
609-750-2827
michael.beaulieu@integralife.com

Media 
Laurene Isip
Senior Director, Global Corporate Communications and Public Relations
609-750-7984
laurene.isip@integralife.com


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November 8, 2018 OrthoSpineNews

CHICAGONov. 8, 2018 /PRNewswire/ — Active people who are struggling with knee pain or knee cartilage abnormalities may benefit from a Rush University Medical Center clinical trial using an innovative new procedure for cartilage regrowth.

Drs. Adam B. Yanke and Brian Cole, orthopedic surgeons and sports medicine physicians at  Midwest Orthopaedics at Rush (MOR) are some of the only physicians nationwide conducting clinical trials for GelrinC.

Using a microfracture procedure, the surgeon creates tiny holes in the bone’s surface so bone marrow cells can repopulate where cartilage has been damaged or deteriorated. GelrinC material is injected in liquid form over the microfracture and UV light turns it into a gel that keeps it in place, which encourages the regeneration of cartilage.

To enroll in the study, patients must be:

  • Between the ages of 18 and 50;
  • Suffering from knee pain but are not yet candidates for knee replacement;
  • OR already diagnosed with a cartilage abnormality and not yet a candidate for knee replacement;
  • Willing to undergo initial evaluation and imaging to determine if pain is caused by cartilage abnormalities;
  • Motivated to participate in the GelrinC microfracture study.

Drs. Yanke and Cole are leading experts in the use of biologics for knee patients. They are also renowned researchers in knee instability. To learn more about the study and how to enroll, email:  Kavita.ahuja@rushortho.com.

About GelrinC

GelrinC is a biodegradable implant used in conjunction with the standard technique of microfracture. The dense gel barrier promotes the regeneration of cartilage and its application ensures that no healthy tissue needs to be removed in the procedure, preserving bone stock. European clinical studies on this procedure have shown promising results. For more information on GelrinC: gelrinc.com.

About Midwest Orthopaedics at Rush

Midwest Orthopaedics at Rush (MOR) doctors are team physicians for the Chicago Bulls, Chicago White Sox, ChicagoFire Soccer Club and Joffrey Ballet, among others. US News & World Report ranks the orthopedic program at Rush University Medical Center – staffed by MOR physicians — as No. 4 in the nation. MOR has offices at Rush UniversityMedical Center in ChicagoOak ParkWestchesterWinfieldMunster, Indiana; and coming soon to Oak Brook and Naperville. For more information or to make an appointment, visit rushortho.com

SOURCE Midwest Orthopaedics at Rush


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November 6, 2018 OrthoSpineNews

MARIETTA, Ga.Nov. 6, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that five poster abstracts reporting on the Company’s EpiFix® dehydrated Human Amnion/Chorion Membrane (dHACM) allograft and EpiCord® dehydrated human umbilical cord (dHUC) allograft will be presented at the Desert Foot 15th Annual Multi-Disciplinary Limb Salvage Conference in Phoenix, Arizona. The conference begins Wednesday, November 7, 2018, and concludes on Saturday, November 10, 2018.

MiMedx will sponsor a symposium entitled, “Clinical Efficacy of EpiFix and AmnioFix dehydrated human amnion/chorion membrane allografts in Surgical and Wound Care Applications” on Wednesday, November 7th in the Phoenix Ballroom main lecture hall. The symposium faculty and presenters include Ray Ortega, MD, MiMedx Medical Director, and Jeremy Lim, PhD, Senior R&D Engineer at MiMedx.

Dr. Ortega, a former Army Special Forces Officer (Green Beret) and Medical Corps plastic surgeon, will review two recent EpiFix and EpiCord multicenter DFU randomized control trial (RCTs) studies.  The first is entitled: “A Confirmatory Study on the Efficacy of Dehydrated Human Amnion/Chorion Membrane (EpiFix®) Allograft in the Management of Diabetic Foot Ulcers: A Prospective, Multicenter, Randomized, Controlled Study of 110 Patients from 14 Wound Clinics.” The second is: “A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers.”

Dr. Lim will provide an overview of the MiMedx research study published in the Journal of Biomedical Materials Research that evaluated dHUC and its biological properties. It was the first published characterization of dHUC tissue.

During a sponsored hands-on workshop on November 8David Kyle, DPM, will present “Application Techniques and Therapeutic Approaches Using EpiFix, EpiCord & AmnioFix Allografts for Wound Healing and Surgical Procedures”. MiMedx will also sponsor a workshop during the Amputation/ Limb Salvage Continuum of Care Skills course on November 10.

The five poster abstracts will report on MiMedx EpiFix and EpiCord allografts, as follows:

  1. William Tettelbach, MD; Shawn Cazzell, DPM; Alexander M. Reyzelman, DPM; Felix Sigal, DPM; Joseph M. Caporusso, DPM; Patrick S. Agnew, DPM: A Prospective, Multicenter, Randomized, Controlled Study Confirming the Efficacy of Dehydrated Human Amnion/Chorion Membrane Allograft in the Management of Diabetic Foot Ulcers
  2. William Tettelbach, MD; Shawn Cazzell, DPM; Felix Sigal, DPM; Joseph M. Caporusso, DPM; Patrick S. Agnew, DPM; Jason Hanft, DPM; Cyaandi Dove, DPM: A Multicenter Prospective Randomized Controlled Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft for the Treatment of Diabetic Foot Ulcers  
  3. Brandon Brooks, DPM PGY-3; Kevin Pham, DPM PGY-4; Bradley Brooks, DO PGY-2; Brady Brooks, MSII; James Henry, MSII; Charles Kean, DPM; Terria Madison, DPM: Intraoperative Use of Umbilical Cord Allograft in Achilles Tendon Surgery for Postoperative Pain Reduction in Diabetics: A Case Series
  4. Brandon Brooks, DPM PGY-3; Bradley Brooks, DO PGY-2; Brady Brooks, MSII; Richa Patel, DPM PGY-2; Anubha Oberoi, DPM PGY-1; Charles Kean, DPM: Concurrent Use of Cyclical Pressure Topical Wound Oxygen Therapy & Umbilical Cord Allograft in a Diabetic with a Pressure Ulceration of the Right Posterior Leg with Exposed Achilles Tendon: A Case Study
  5. Jeremy J. Lim, PhD; Jennifer Lei, PhD;  Jenn D. BullardAnna M. Fallon, PhD; Michelle MasseeThomas J. Koob, PhD: Evaluation of Dehydrated Human Umbilical Cord Biological Properties for Wound Care and Soft Tissue Healing

About MiMedx

MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. The Company processes the human placental tissue utilizing its proprietary PURION® process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date. For additional information, please visit www.mimedx.com.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com


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November 1, 2018 OrthoSpineNews

WALTHAM, Mass., Nov. 01, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today provided an update on the NeoCart regulatory pathway based on preliminary feedback from the Type C meeting held with the U.S. Food and Drug Administration (the FDA) on October 30, 2018.  At the meeting, the top-line results from the NeoCart Phase 3 clinical trial and the potential for the submission of a Biologics License Application (BLA) were discussed.  Following the meeting, the FDA and Histogenics continue to discuss the clinical data generated to date, the potential need for any additional supplemental clinical data (which may include longer-term data from the ongoing Phase 3 trial or additional studies) and potential alternative regulatory pathways for the BLA to be accepted.  The FDA has not made a final decision regarding a potential BLA submission and based on expected feedback from the FDA, Histogenics intends to provide a further update on these negotiations by the end of November 2018.

About Histogenics Corporation

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

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws.  Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements.  Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  expectations regarding the timing and success of ongoing discussions with the FDA regarding the potential submission of a BLA for NeoCart; NeoCart’s potential as a treatment for knee cartilage damage; the timing, associated expenses and ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the market size and potential patient population in markets where Histogenics’ and its partners expect to compete; updated or refined data based on Histogenics’ continuing review and quality control analysis of clinical data; the scope, progress, timing, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following its technology transfer and manufacturing location transition; Histogenics’ expectations regarding its expenses and revenue; Histogenics’ ability to obtain additional debt or equity capital; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov.  Additional factors may be set forth in those sections of Histogenics’ Form 10-Q for the quarter ended September 30, 2018, expected to be filed with the SEC in the fourth quarter of 2018.  In addition to the risks described above and in Histogenics’ Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.  Histogenics has not yet received the official FDA meeting minutes from the Type C meeting and the information in this Press Release may be altered or supplemented by the information contained in the official meeting minutes or any subsequent meetings that may be held with the FDA.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:
Investor Relations:
Tel: +1 (781) 547-7909
InvestorRelations@histogenics.com


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October 31, 2018 OrthoSpineNews

SALT LAKE CITY, Oct. 31, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride for biomedical applications, announced that it has changed its corporate name to SINTX Technologies, Inc. in order to better reflect its focus on silicon nitride science and technologies and robust pipeline of silicon nitride based products in various biomedical applications. The company expects to change its trading symbol on the NASDAQ Capital Market to “SINT” in approximately 10 days. In the meantime, shares will continue to trade under the symbol “AMDA.”

“The previous name, i.e., Amedica, has transferred to CTL Medical, which is now CTL-Amedica. Our new corporate brand reflects both our core competence in the science and production of silicon nitride ceramics, as well as encouraging prospects for the future, as an OEM supplier of spine implants to CTL-Amedica, and several opportunities outside of spine,” said Dr. B. Sonny Bal, Chairman and CEO of SINTX Technologies. “As SINTX Technologies, we will focus on developing silicon nitride in terms of product design, and future biomaterial formulations, for a variety of OEM customers.”

SINTX Technologies is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including the spine, dental, oral maxillofacial, podiatry, and arthroplasty markets.

In connection with its name change, the new CUSIP number for the Company’s shares of common stock is 829392109.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”) that are subject to a number of risks and uncertainties. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. A discussion of those risks and uncertainties can be found in Sintx’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Sintx’s other filings with the SEC. SINTX disclaims any obligation to update any forward-looking statements. Sintx undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report.

Contacts:
SINTX IR
801-839-3502
IR@SINTX.com