New Clinical Evidence Continues to Support the Effectiveness and Value of AMNIOX Medical Products

May 08, 2017

ATLANTA–(BUSINESS WIRE)–AMNIOX Medical, Inc., a TissueTech, Inc. company, announced today that nine clinical posters demonstrating the effectiveness of NEOX® Wound Allograft – Amniox’s proprietary cryopreserved Umbilical Cord and Amniotic Membrane (UC/AM) product for chronic wound management – were presented at the Symposium on Advanced Wound Care (SAWC) and Wound Healing Society Meeting. The meeting was held at the San Diego Convention Center in San Diego, California, from April 5-9.

Following peer review, all nine posters were accepted for presentation at the symposium. These posters present therapeutic and surgical applications of NEOX Wound Allograft in a range of severe wound types that are resistant to the current standard of care. These wounds include wounds resulting from radiation therapy; wounds due to Charcot arthropathy; severe burns; trauma wounds; chronic non-healing ulcers; skin grafts and wounds post-treatment for Basal Cell Carcinoma. With all of these complex, hard-to-heal cases, patients achieved closure of their wounds subsequent to applications of NEOX, including a number of situations where these patients had failed other advanced therapies.

“The posters presented at SAWC highlight NEOX’s clinical effectiveness and value in a variety of wounds that are difficult to treat with typical wound care modalities,” said Thomas J. Dugan, Chief Executive Officer of Amniox Medical. “Across all of this clinical experience, patients treated with NEOX experienced closure of hard-to-heal wounds. The strength of this clinical evidence continue to drive demand for unique regenerative properties of umbilical cord tissue.”

Studies presented at SAWC included the following posters:

  • Cryopreserved Umbilical Cord* (cUC) Treatment of Radiation Wound Post Melanoma Removal Involving Soft Tissue and Bone, David F. Fernandez, MD
  • Injectable Lyophilized Human Umbilical Cord and Amniotic Membrane (UC/AM) as an Interventional Treatment in Early Charcot Foot Presentation, Wayne J. Caputo, DPM
  • Use of Cryopreserved Umbilical Cord as Adjunctive Therapy for Multiple Burn Wounds of the Lower Extremity, Kimberly Jackman, MD, and Leslie Harris, APRN
  • Cryopreserved Umbilical Cord * (cUC) Use for Acute Orthopedic Trauma Wounds, Kaitlyn Griffin, BS and Christopher Stewart, MD
  • Combination of Cryopreserved Umbilical Cord (cUC)* with Negative Pressure Therapy for the Treatment of Chronic Non-Healing Ulcers, Allen Raphael, DPM
  • The Use of Cryopreserved Umbilical Cord/Amniotic Membrane (cUC) to Generate Granulation Tissue over Scalp Post Basal Cell Carcinoma (BCC) Removal in Order to Prep for a Split-thickness Skin Graft, Charles L. Dupin, MD, Meghan Bias, MD, Amanda Gregoire, NP and Renata Falgout, RN
  • The Use of Cryopreserved Human Amniotic Membrane and Umbilical Cord (AM/UC) Allografts to Expedite Healing in Patients with Chronic Non-healing Wounds, Justin Goldsmith, DPM, Aamir Mahmood, DPM, Patrick Sanchez, DPM, Anna Tien, DPM, Sarah Park, DPM, Jake Ruff, DPM, Andrea Seat, DPM, Michael Czurylo, DPM, Laith Shaman, DPM and Matthew Garoufalis, DPM, FASPS, FACFAOM, CWS
  • The Use of Cryopreserved Human Umbilical Cord in the treatment of an Irradiated Tissue Wound Post Treatment for Basal Cell Carcinoma, Amesh Patel, MD, and Carolyn Hewett, RN, CWOCN
  • Surgical Implantation Technique for Treating Chronic Ulcers with Cryopreserved Umbilical Cord*, Allen Raphael, DPM

Amniox parent TissueTech pioneered the commercialization and clinical application of human umbilical cord and amniotic membrane to promote regenerative healing. In utero, wound healing occurs rapidly and with minimal scar. 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 Medical is the first provider of a human tissue allograft composed of both umbilical cord and amniotic membrane. Amniox utilizes its proprietary CRYOTEKTM process, a cryopreservation technology that preserves the biological and structural integrity of these tissues more effectively than other available technologies. Since inception, more than 300,000 human transplants of its products have been performed and more than 300 peer-reviewed studies supporting its technology platform have been published.

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 Bio-Tissue®, 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; Bio-Tissue develops and markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) have supported TissueTech’s research with more than 30 continuous years of research grants. Since the company’s inception, clinicians have performed more than 300,000 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

MiMedx EpiFix® Receives Coverage From Kaiser Permanente

MARIETTA, Ga., May 4, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the Company’s EpiFix® product has received coverage from insurer Kaiser Permanente, effective April 1, 2017.

Founded in 1945 and headquartered in Oakland, California, Kaiser Permanente is one of the nation’s largest not-for-profit health plans. With this coverage decision, the Kaiser 7.4 million commercial members now have coverage for EpiFix. Kaiser’s medical policy, “Wound Care Treatments,” now includes EpiFix for up to eight applications in 12 weeks when there is evidence of wound healing. Kaiser considers EpiFix medically necessary for treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). EpiFix is the first and only placental-based product covered by Kaiser for the treatment of DFUs and VLUs.

Parker H. “Pete” Petit, Chairman and CEO said, “We are pleased to have received coverage from Kaiser and to add them to our list of insurers providing access to our dehydrated Human Amnion/Chorion Membrane (dHACM) allografts for their covered members. Kaiser joins the broad list of insurers providing coverage, which list already includes major national health plans such as Aetna, Cigna, Anthem and virtually all of the other Blue Cross/Blue Shield health plans, plus a vast number of regional insurers. With the addition of Kaiser, over 317 million commercial covered lives and Medicare/Medicaid beneficiaries now have reimbursement access to EpiFix.”

Bill Taylor, President and COO, commented, “Our evidence-based publications demonstrating the clinical efficacy and cost effectiveness of our allografts have been instrumental in gaining coverage for our allografts from both the commercial payers such as Kaiser, as well as the federal and state payers. Our Compendium, now totaling 46 peer-reviewed published studies including completed Randomized Control Trials (RCTs), scientific studies and significant case studies, is unmatched in our industry, and it is the catalyst for our success in gaining awards of coverage. We are very gratified that so many commercial health plan members and federal and state beneficiaries have access to the positive clinical outcomes that our allografts produce.”

About MiMedx

MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 800,000 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.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, the Company’s belief that evidence-based publications demonstrating the clinical efficacy and cost effectiveness of its allografts have been instrumental in gaining coverage for the allografts from both commercial payers and federal and state payers. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that future evidence-based publications may not be as impactful in gaining reimbursement coverage, reimbursement is always subject to change and may therefore impact cost effectiveness of care, access to coverage may not translate into broader use of the Company’s products, individual results from using the Company’s products may vary, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2016 and its most recent 10-Q filing.  By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

Smith & Nephew signs exclusive worldwide distribution agreement for the revolutionary MolecuLight i:XTM imaging device

3 May 2017

Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces it has signed a worldwide distribution agreement with MolecuLight®, Inc., a developer of innovative imaging technology for the clinical assessment of wounds.

This agreement supports Smith & Nephew’s strategic priority to innovate for value by delivering solutions that help healthcare professionals better improve the lives of their patients.

“Smith & Nephew, through products such as ACTICOAT antimicrobial silver dressings and IODOSORB cadexomer gel ,has long been committed to helping customers manage infection in chronic and acute wounds,” said Andy Weymann, MD, Chief Medical Officer at Smith & Nephew.  “The MolecuLight i:X imaging device enables healthcare professionals to see what they have never been able to see before, the actual accumulation of several common bacteria in a wound, even when not visible to the naked eye.  Moleculight  i:X enhances clinicians’ ability to choose the right therapy, at the right time for their patient 1,2 In addition, it has also the potential to enhance other areas of current wound care practice such as helping to guide wound sampling and debridement, monitoring of  wound progression, providing more insight in conversation between the clinician and the patient, and greater detail when documenting treatment decisions.”

Rosemary Hill, BSN, CWOCN, CETN(C), of Lions Gate Hospital (Vancouver, Canada) added ‘’The MolecuLight i:X is more than a bacteria visualization device. The information it is providing is positively impacting our antimicrobial stewardship program and empowering my overall wound treatment decision making.’’

The MolecuLight i:X  is a handheld point-of-care imaging device that uses fluorescence imaging to display potentially harmful concentrations of bacteria that fluoresce in violet light on screen, in real-time.  Clinicians can capture and view still images and video, as well as measure the surface area of a wound and then save and add those images to the patient’s electronic health record 2,3.

“When combined with clinical best practice, the information provided by the MolecuLight i:X on bacterial presence and distribution can guide early interventions to potentially reduce bioburden and promote wound healing2,” said Craig Kennedy, CEO MolecuLight.  “Partnering with Smith & Nephew, a world leader in advanced wound care, allows this revolutionary technology to rapidly reach a worldwide customer base and begin the process of becoming a routine step in wound assessment.”

The MolecuLight i:X is currently available in Canada and the European Union with regulatory clearance in the U.S. pending.

Enquiries

Media
Dave Snyder +1 (978) 749-1440
Kirsti Harefallet +44 (771) 008 5253
Smith & Nephew

 

About MolecuLight Inc. 

MolecuLight Inc. is a privately owned, Canadian medical imaging company delivering real-time fluorescence image-guidance solutions that provide clinicians with new information about wound bacterial burden and wound surface area to assist clinicians in making improved diagnostic and treatment decisions1,2,4,5,6,7,8,9,10.  The company was founded in 2012 by Dr. Ralph DaCosta, Principal Investigator and Scientist at the Princess Margaret Cancer Center, University Health Network (Toronto, Canada), currently the company’s Chief Scientific Officer and Director. MolecuLight’s premiere product – the MolecuLight i:X is a Wound imaging Device that allows clinicians to quickly, safely and easily visualize  bacteria that fluoresce in violet light and measure wound surface area at the point of care so they have maximum insights for accurate treatment and accelerated healing 2.

The MolecuLight i:X™ Imaging Device is approved by Health Canada (Medical License #95784) and has CE Marking (Certificate # G1160292355002) for sale in the European Union. The MolecuLight i:X™ Imaging Device is pending US FDA De Novo approval and is not available in the US.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

To learn more about what we do to help reduce wound infections, please visit www.closertozero.com.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.

 References:

  1. Wu YC, Smith M, Chu A, Lindvere-Teene L, Starr D, Tapang K, Wong O, Linden R, DaCosta RS. Handheld fluorescence imaging device detects subclinical wound infection in an asymptomatic patient with chronic diabetic foot ulcer: a case report. Int Wound J. 2016 Aug;13(4):449-53.
  2. DaCosta RS, Kulbatski I, Lindvere-Teene L, Starr D, Blackmore K, Silver JI, Opoku J, Wu YC, Medeiros PJ, Xu W, et al. Point-of-care autofluorescence imaging for real-time sampling and treatment guidance of bioburden in chronic wounds: first-in-human results. PLoS One. 2015 Mar 19;10(3).
  3. Hill R and Douglas JJ. Effect of bacterial fluorescence imaging on patient care and wound management in a hospital setting: a pilot study. Proceedings of the Annual Symposium on Advanced Wound Care (SAWC); 2017 Apr 5-9; San Diego, CA. (accepted poster)
  4. Ottolino-Perry K, Chamma E, Blackmore KM, Lindvere-Teene L, Starr D, Tapang K, Rosen CF, Pitcher B, Panzarella T, Linden R, DaCosta RS. Improved detection of clinically relevant wound bacteria using autofluorescence image-guided sampling in diabetic foot ulcers. Int Wound J. 2017; doi: 10.1111/iwj.12717.
  5. MolecuLight Inc. Case Study 0051 Track Wound Size and Bacterial Presence with the MolecuLight i:X. 2016.
  6. Rennie MY. A prospective, single-blind evaluation of the positive predictive value (PPV) of the MolecuLight i:X device to predict the presence of porphyrin-producing bacteria in chronic wounds. MolecuLight final report TR054. 2017 Jan.
  7. MolecuLight Inc. Case Study 0051 Track Wound Size and Bacterial Presence with the MolecuLight i:X. 2016.
  8. Raizman R. Point-of-care fluorescence imaging device guides care and patient education in obese patients with surgical site infections. Presented at: CAWC 2016. Proceedings of the 22nd Annual Canadian Association of Wound Care Conference; 2016 Nov 3-6, Niagara Falls, ON.
  9. Raizman R. Fluorescence imaging positively predicts bacterial presence and guides wound cleaning and patient education in a series of pilonidal sinus patients. Proceedings of the Annual Wounds UK Conference; 2016 Nov 14-16; Harrogate, UK.
  10. Hoeflok J, Teene L, Chamma E, Chu A, DaCosta RS. Pilot clinical evaluation of surgical site infections with a novel handheld fluorescence imaging device. Proceedings of the Annual Military Health System Research Symposium (MHSRS); 2014 Aug 18-21; Fort Lauderdale, FL.  

Axolotl Biologix Launches AxoBioMembrane™ to Expand Amnion-Derived Allograft Products for Wound Care

Phoenix – May 2, 2017 — Axolotl Biologix, an innovator in regenerative medicine technologies that improve patient outcomes with less pain and lower costs, today announced that it has begun shipping its second amniotic allograft product, AxoBioMembrane™, to meet a wide range of wound care needs.

AxoBioMembrane is a dehydrated human amniotic membrane allograft that helps accelerate and improve soft tissue repair, while helping inhibit bacteria and infection, inflammation, and scar tissue formation. Containing extracellular matrix components and providing a natural biological wound barrier, AxoBioMembrane offers many clinical applications in wound care for surgical, orthopedic, podiatric, ophthalmic, maxillofacial and other applications.

AxoBioMembrane is available for order immediately in three standard sizes 1×2 cm, 2×3 cm, and 4×4 cm, as well as custom sizes which may be ordered.

“Launching our second new amnion-derived product so far this year, we are excited to be rapidly building a portfolio of regenerative treatment products that provide significant improvement in patient outcomes, while delivering high value for clinicians,” noted Bob Maguire, founder and CEO of Axolotl Biologix.

About Axolotl Biologix, Inc.

Axolotl Biologix, Inc., is expanding the human body’s ability to regenerate by developing and manufacturing regenerative human cell and tissue medical technologies that are disrupting traditional, more invasive, painful, and expensive treatment protocols.  The Phoenix-based company is rapidly building a portfolio of unique, patented regenerative treatment products to improve patient outcomes with less pain and lower costs.  For more information, please visit the company’s website at www.axobio.com.

 

Media:

bsamson@axobio.com

714-955-3951

MiMedx Receives Innovative Technology Supplier of the Year Award from Vizient, Inc.

MARIETTA, Ga., May 1, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today it has received the Innovative Technology Supplier of the Year Award from Vizient, Inc., the nation’s largest member-driven health care improvement company in the country.  The award recognizes MiMedx for its positive impact on patient care provided through Vizient members in 2016. The award was presented earlier this month at the 2017 Vizient Supplier Summit.

The award honors MiMedx for the high level of member adoption of the EpiFix® dehydrated Human Amnion/Chorion Membrane (dHACM) allograft, which received an Innovative Technology contract in May 2015. The contract was based on recommendations from experts at Vizient member hospitals that the MiMedx allograft offers unique and incremental benefit over other products available on the market today.

Chris Cashman, MiMedx Executive Vice President and Chief Commercialization Officer, said, To be chosen as one of three finalists and then be selected as the top supplier in this category is something for which we are very proud.  MiMedx received this recognition for a number of reasons. There has been a very wide adoption of our technology by Vizient members, and utilization within our contract with Vizient has grown by over 500% since its inception in 2015. We have seen the utilization of our allografts produce many extremely positive outcomes and improvements in patient care.”

Vizient’s diverse membership base includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers, and represents more than $100 billion in annual aggregate purchasing volume.

“We are pleased to recognize MiMedx Group, Inc. with the Innovative Technology award for 2016. This achievement reflects their commitment to bringing innovative products to the market and to our members that offer improvements to patient care,” said Pete Allen, Executive Vice President, Sourcing Operations for Vizient. “MiMedx has backed their innovative products with clinical support and service excellence that has helped them to be widely adopted as a part of delivering exceptional care for patients by organizations within our membership.”

Bill Taylor, MiMedx President and COO, noted, “We have built a strong relationship with Vizient since contract inception as demonstrated by the significant utilization growth. We are pleased to work with Vizient, and share a common goal with them to improve patient outcomes while controlling costs. Vizient brings clinical and cost effective resources to hospitals, health systems, physician practices and other entities they serve. Our allografts have been recognized for improving patient outcomes, reducing costs and eliminating waste. We believe our mutual focus to this cause has contributed to our rapid growth and success with Vizient.”

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative and therapeutic biopharmaceutical products processed from donated placental tissues. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 800,000 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.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, the the positive outcomes and improvements in patient care produced by MiMedx products, the Company’s belief that the focus on clinical and cost effectiveness by both the Company and Vizient has contributed to the Company’s rapid growth and success with Vizient.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the results achieved utilizing MiMedx products may vary, the focus on clinical and cost effectiveness by MiMedx may not have contributed to the Company’s rapid growth and success with Vizient or may not continue to result in growth and success with Vizient, MiMedx allografts may not continue to be cost effective, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2016.  By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

Biologics Market to Reach $399 Billion by 2025 – Research and Markets

April 28, 2017

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Biologics Market, 2014-2025” report to their offering.

The global biologics market is anticipated to reach USD 399.5 billion by 2025. Introduction of targeted therapies coupled with rising adoption of patient centric personalized medicine anticipated to fuel demand. Ever-increasing understanding of the cell physiology and stress, as well as the factors involved in protein production and heterologous gene expression have empowered the use of different living factories.

These living factories are the prokaryotic and eukaryotic cells. Enhancement of drug functionality through achieving successful protein folding and post-translational modifications is supportive for projected progress rate.

Moreover, rising adoption of biopharmaceuticals over chemically synthesized molecules is expected to propel revenue generation significantly. In addition to this, presence of several metabolic disorders that can be treated through the use of biologics is attributive to influence demand.

Combination of advanced bioengineering technologies for biopharmaceutical production is expected to boost progress in pharmaceutical industry. With recent advances in automation, the selection process can be done through high throughput screening (HTS) system for selection of viable clones.

Aforementioned method enables robust production of biopharmaceutical products by obtaining high-producing cell line. Advances with respect to upstream and downstream processing would directly translate into the growth in revenue for this market at a larger level.

However, development of biosimilars is expected to restrain the biologics year on year growth to certain extent. Although, the regulatory approval pathway for these products is not framed yet some drug manufacturers are opting to invest in the development of biobetters.

Companies Mentioned

  • Samsung BioLogics
  • Amgen
  • Novo Nordisk A/S
  • AbbVie Inc.
  • Sanofi
  • Johnson & Johnson Services, Inc
  • Pfizer Inc.
  • Merck & Co., Inc.
  • GSK group of companies
  • Celltrion
  • Precision Biologics, Inc.
  • Merck KGaA
  • Eli Lilly and Company
  • Novartis AG
  • Bayer AG
  • F. Hoffmann-La Roche Ltd
  • AstraZeneca

Key Topics Covered:

1 Research Methodology

2 Executive Summary

3 Biologics Market Variables, Trends & Scope

4 Biologics Market: Source Estimates & Trend Analysis

5 Biologics Market: Product Estimates & Trend Analysis

6 Biologics Market: Manufacturing Estimates & Trend Analysis

7 Biologics Market: Disease Category Estimates & Trend Analysis

8 Biologics Market: Regional Estimates & Trend Analysis, by Source, Product, Manufacturing, & Disease Category

9 Competitive Landscape

For more information about this report visit http://www.researchandmarkets.com/research/kcqf7v/biologics_market

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Biopharmaceuticals

Lennart Johansson to Join BONESUPPORT™ Board of Directors

LUND, Sweden, April 28, 2017 /PRNewswire/ —

BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces the election of Lennart Johansson to its Board of Directors.

Mr Johansson has been a Senior Advisor at Patricia Industries AB since 2015, and was previously Managing Director (Business Development, Operating and Financial Investments) at Investor AB (2006-2015). Before that, he was Partner and Chief Executive Officer of Emerging Technologies ET AB. He is currently Board Member of Swedish Orphan Biovitrum AB and Hi3G Access AB; Deputy Board Member of Mölnlycke Health Care AB; and Chairman of Vectura AB. Mr Johansson holds an MBA from the Stockholm School of Economics (1980).

Håkan Björklund, Chairman of BONESUPPORT, said: “We are pleased to welcome Lennart to the BONESUPPORT Board. This is an exciting period for the Company and we are confident that Lennart’s experience will be a valuable asset assisting us to achieve our goals.”

Mr Johansson added: “I very much look forward to working with the BONESUPPORT management team and Board to help capitalize on the Company’s potential to become a global leader in the management and treatment of bone disease via its unique CERAMENT[]platform.”

About BONESUPPORT™

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to 12 months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

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

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

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

BONESUPPORT™ and CERAMENT™ are registered trademarks.

Contact Information

Björn Westberg
Chief Financial Officer
+46-(0)-46-286-53-24
info@bonesupport.com

SOURCE BONESUPPORT AB

SANUWAVE Announces Cooperation With Ortho-Medico in Europe and Exhibition at EWMA

SUWANEE, GA–(Marketwired – Apr 27, 2017) – SANUWAVE Health, Inc. ( OTCQB : SNWV ) is pleased to announce that the company will exhibit, in conjunction with Ortho-Medico, at EWMA (European Wound Management Association) in Amsterdam, The Netherlands on 3-5 May 2017. With renewed energy and focus, SANUWAVE is intent on continuing to strengthen our association with doctors, hospitals and wound care centers and re-establishing the Company’s products into the EU market.

The Company is using this occasion to promote our lead wound care product dermaPACE®. This Extracorporeal Shockwave Technology (ESWT) device, based upon electrohydraulic principles, is CE Marked and has enjoyed success in certain markets within the European Union treating a wide variety of skin conditions such as pressure ulcers, burns, post-operative wounds, and scar reduction. dermaPACE 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. dermaPACE 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 dermaPACE allows the clinician to more easily, and more cost-effectively, manage wounds. More importantly, the patient’s quality of life improves significantly.

For more information on SANUWAVE’s technology, please read our blog, “Shock This”, on our website at www. sanuwave.com.

SANUWAVE and Ortho-Medico cordially invite you to our booth Number 3 E14 to discuss how dermaPACE can work for you. Our booth is located on the side of the floorplan which can be accessed at: https://www.ewmaexhibition2017.org/ehome/index.php?eventid=155542&.

The conference will be held at: Amsterdam RAI, Europaplein 22, NL 1078 GZ Amsterdam, The Netherlands, www.rai.nl.

Mr. Pete Stegagno and Mr. André Mouton from SANUWAVE and Mr. Jo Schops from Ortho-Medico will be on hand to talk about some new opportunities for 2017 which will be very important for your business or practice and we welcome your visit to our booth. If you are attending EWMA, we thank you for informing us about the timing of your potential visit to our booth to ensure we organize our meeting with you.

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 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.

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

Xtant Medical Recognized as Montana Ambassador Business of the Year

BELGRADE, Mont., April 25, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development, manufacturing and marketing of orthopedic products for domestic and international markets, today announced it has been named as the Montana Ambassador Business of the Year. Xtant Medical was honored for making an outstanding contribution to the economic development in Montana.

“We are incredibly humbled to receive this recognition from the Governor of Montana, Steve Bullock, and to be selected by the Montana Ambassadors,” said Carl O’Connell, CEO of Xtant Medical. “We have exceptional people that are the engine of Xtant Medical, who embody the Montana spirit, and who are passionate about the work we perform and the ability to make a difference in the lives of others. For us, this not only speaks to our Montana-base, but to our employees across the country. We would like to commend the Governor and the Montana Congressional Delegation for the work they do to support and advocate for businesses headquartered in Montana.”

“Biosciences is a flourishing industry, and we felt it was important to recognize a successful Montana company in this space, and to prove that these companies can flourish in the state,” said Kurt Burgess, Montana Ambassador. “Xtant Medical is the perfect example of a company that has encompassed the exceptional resources Montana has to offer to businesses. They are recognized worldwide as strong competitors in the biologics industry, and therefore deserve to be recognized for their many accomplishments.”

The Montana Ambassadors is a volunteer, not-for-profit organization of leaders in business, education, and local and state government with a common dedication to living and doing business in Montana and to furthering the best interests of the state. At the pleasure of the Governor, its members act as official Ambassadors of the State of Montana. Xtant Medical will formally accept this award at the Innovate Montana Symposium’s Montana Ambassador’s Awards Dinner on July 11, 2017.

About Xtant Medical Holdings

Xtant Medical Holdings, Inc. (NYSE MKT:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

The De Angelis Group Retained on Search for Vice President of Regulatory & Clinical Affairs in Orthobiologics

Scottsdale, Arizona (PRWEB) April 25, 2017

The De Angelis Group, an Executive Search Firm focused exclusively in Orthopedics, Spine and Orthobiologics, was recently retained on a search to assist an innovative orthopedic implant company in hiring their most senior leader for Regulatory and Clinical Affairs. The client has developed combination medical device and biologic products that are typically used in patients with early signs of arthritis but before they need a total joint replacement. With revenues of over $100mm in sales, their strategy thus far has been to partner with Regulatory and Clinical consultants, but their product development pipeline is now so flush with innovation that it requires broad and complex innovative strategies to obtain approvals from regulatory bodies globally. They have decided that now is the time to expand the executive team by creating this new Vice President’s role.

The new executive will have a seat at the table strategically to influence new product development innovations that leverage the current IP portfolio as well as adding new products to the pipeline. This role is based in the New England area and requires the executive to live within a commutable distance from the company’s headquarters.

“We are excited to be able to help such a tremendous group of people as they build their company and increase the ways they help patients relieve pain and restore function.” Said Drue De Angelis, Managing Partner of The De Angelis Group.

If you know of someone that should be considered for this role or would like to learn more, please send inquiries to The De Angelis Group (info(at)thedeangelisgroup(dot)com).

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About The De Angelis Group:
The De Angelis Group (http://www.orthospinesearch.com) is a national retained search firm which focuses primarily in the acquisition of executive leadership in Orthopedic Industry. Founded in 2000, The De Angelis Group is a leader in executive search, attending many trade shows and specialty meetings throughout the year and around the US.