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

Posted On April 25, 2018 By OrthoSpineNews In Biologics /

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

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

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

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

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

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

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

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

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

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

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

SOURCE MTF Biologics

CollPlant Opens a New rhCollagen Production Facility

Posted On April 25, 2018 By OrthoSpineNews In Biologics /

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

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

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

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

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

About CollPlant

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

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

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

Safe Harbor Statements

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

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

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

SOURCE CollPlant

Organogenesis Showcases New Product Offerings and Research at SAWC Spring 2018

Posted On April 24, 2018 By OrthoSpineNews In Biologics /

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

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

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

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

POSTER AND ORAL PRESENTATIONS OF INTEREST INCLUDE:

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

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

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

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

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

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

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

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

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

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

SOURCE Organogenesis Inc.

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

Posted On April 23, 2018 By OrthoSpineNews In Biologics /

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

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

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

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

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

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

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

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

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

About MiMedx

MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to give physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

SOURCE MiMedx Group, Inc.

Spikes of Graphene Can Kill Bacteria on Knee & Hip Implants

Posted On April 19, 2018 By OrthoSpineNews In Biologics /

By Chalmers University of Technology – 04.16.18

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

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

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

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

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

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

READ THE REST HERE

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

Posted On April 19, 2018 By OrthoSpineNews In Biologics /

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

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

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

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

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

About Histogenics Corporation

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

Directors and Officers

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

Posted On April 17, 2018 By OrthoSpineNews In Biologics /

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

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

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

About OrthoTrophix, Inc.

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

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

Company Contact
Yoshi Kumagai
President and CEO
Tel: (510) 488-3824

SOURCE OrthoTrophix, Inc.

SANUWAVE Announces Attendance and Exhibition at SAWC; Visit Us at Booth Number 108

Posted On April 10, 2018 By OrthoSpineNews In Biologics /

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

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

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

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

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

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

Contact:

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

SANUWAVE Health, Inc.
Peter Stegagno 
Vice President Operation, Regulatory, and Clinical
678-578-0111 (Office)
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AlloSource Announces Two Presentations On ProChondrix At The International Cartilage Repair Society World Congress

Posted On April 10, 2018 By OrthoSpineNews In Biologics /

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

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

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

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

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

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

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

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

SOURCE AlloSource

Anika Announces Plans to Showcase HYALOFAST Hyaluronic Acid-Based Scaffold at the 2018 World Congress of the International Cartilage Repair Society

Posted On April 6, 2018 By OrthoSpineNews In Biologics /

April 06, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced plans to showcase HYALOFAST^®, a biodegradable, HA-based cartilage repair scaffold, at the 14^th World Congress of the of the International Cartilage Repair Society (ICRS). The ICRS World Congress, which is being held in Macau, China during April 9-12, 2018, is the world’s largest gathering of scientists, clinicians and industry participants focused on clinical cartilage repair and basic cartilage research.

“HYALOFAST represents a major advancement in the treatment of cartilage injuries and defects, evidenced by the positive reception it has received from physicians across 15 global markets,” said Joseph Darling, President and CEO, Anika Therapeutics. “The ICRS World Congress is the ideal venue to showcase the significant advantages HYALOFAST offers over invasive open surgical techniques and traditional scaffolds, to the largest gathering of cartilage repair specialists from around the world. At this year’s meeting, we’ve developed a robust educational agenda featuring world-renowned thought-leaders with HYALOFAST expertise sharing their technical know-how and providing hands-on, guided training sessions with our custom-built HYALOFAST Virtual Surgical Simulator. We believe that peer-to-peer education and technical training is central to prompting the HYALOFAST trial, which we hope will increase commercial adoption.”

HYALOFAST is a non-woven, single-step, off-the-shelf, biodegradable HA-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. HYALOFAST is commercially available in over 15 countries and has been used to successfully treat more than 14,000 patients internationally, and with strong five-year patient follow-up data. HYALOFAST is pending regulatory submission in the United States and its FastTRACK Phase III trial is currently enrolling patients across the U.S. and Europe.

Company-Sponsored Lunch Symposium
Location: Room Almaty 3, Sheraton Grand Macau Hotel

Tuesday, April 10, 2018

12:30 – 13:30 Almaty 3 Room, Lunch Symposium: HYALOFAST One-step Procedure: Best Practice and New Evidence in Cartilage Repair.
Moderator: Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy
Speakers: Dr. Bogusław Sadlik, St. Luke Hospital – Bielsko Biala – Poland, Dr. Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy, Prof. Stephan Nehrer, Danube University, Krems – Austria

Company-Sponsored Physician Education Availability
Location: Anika Booth #16, Sheraton Grand Macau Hotel

Monday, April 9, 2018

15:15 – 16:15 Dr. Tho Kam San, Mount Alvernia and Gleneagles Hospitals – Singapore, will be available at the booth for guided training sessions with the HYALOFAST Virtual Surgical Simulator.

Tuesday, April 10, 2018

11:00 – 12:00 Dr. Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy, will be available at the booth for guided training sessions with the HYALOFAST Virtual Simulator.

Wednesday, April 11, 2018

13:00 – 14:00 Dr. Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy, will be available at the booth for guided training sessions with the HYALOFAST Virtual Simulator.

About ICRS

The ICRS (International Cartilage Repair Society) is the main forum for international collaboration in cartilaginous tissue research that brings together basic scientists, clinical researchers, physicians and members of industry, engaged or interested in the field of articular biology, its genetic basis and regenerative medicine. It provides continuing education and training to physicians and scientists with an active interest in the prevention and treatment of joint disease to improve patient care through regenerative medicine approaches.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC^®, MONOVISC^®, and CINGAL^®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the second and third paragraphs of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to HYALOFAST’s impact and its regulatory trajectory. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all, obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, or timely file and receive FDA or other regulatory approvals or clearances of its products, or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (ii) the Company’s research and product development efforts, and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (iii) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations and production planning; (iv) the strength of the economies in which the Company operate or will be operating, as well as the political stability of any of those geographic areas; (v) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (vi) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (vii) the Company’s ability to provide an adequate and timely supply of its products to its customers; (viii) the Company’s ability to continue to successfully manage Anika Therapeutics S.r.l.’s business; and (ix) the Company’s ability to achieve its growth targets.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418
sonal@purecommunicationsinc.com

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