ChoiceSpine Launches Biologics Portfolio at National Sales Meeting

Posted On June 27, 2017 By OrthoSpineNews In Biologics, Spine, Top Stories /

KNOXVILLE, TN (PRWEB) JUNE 27, 2017

ChoiceSpine™, a privately-held spinal device manufacturer based in Knoxville, TN, launched its new biologics portfolio at its National Sales Meeting last week in Nashville, TN.

“We are extremely excited about the launch of our Biologics Portfolio. We wanted to come out of the gate strong so we are proud to have an offering that includes various allograft and synthetic bone graft options in addition to a full amnion offering,” commented Christy Cote, Vice President of Biologics and ChoiceSpine’s Tissue Bank Director. “We believe the addition of a biologics platform to our already strong product portfolio is an important strategic milestone.”

The Biologics product portfolio is marketed under two brands named after the Stratotanker™ plane that refuels military aircraft inflight. STRATOFUSE™ was designed to fuel fusion in spine and orthopedic surgical procedures. The STRATOFUSE brand will promote demineralized bone allograft putties and sponges, synthetic bone graft substitute putties and strips, structural allograft and allograft bone extenders. The STRATOGEN™ line will focus on a full amnion offering.

“STRATOFUSE and STRATOGEN exemplify our dedication to developing and distributing spinal products that are innovative and surgeon-focused,” said Rick Henson and Marty Altshuler, co-founders of ChoiceSpine. “We look forward to continuing to serve our surgeon customers with innovative products that deliver excellent clinical outcomes.”

Fueling their philanthropic passion, ChoiceSpine has pledged a portion of all biologics proceeds to be donated to the Smoky Mountain Service Dogs charitable organization. This non-profit organization is dedicated to helping wounded veterans. Their mission is to enhance the quality of life for veterans with disabilities by providing custom-trained, mobility-assistance service dogs.

About ChoiceSpine

ChoiceSpine is a privately-held spinal device company located in Knoxville, TN. The Company prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon-focused systems that are designed to be safe, efficient and easy-to-use. By working closely with physicians and maintaining a service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to market.

Contact
KC Gilbert
Vice President Marketing & Professional Education
865-246-3333
kgilbert(at)choicespine.com
choicespine.com

Bone Therapeutics receives Intent to Grant Notice from European Patent Office for allogeneic bone cell therapy platform

Posted On June 26, 2017 By OrthoSpineNews In Biologics, Regulatory, Top Stories /

Gosselies, Belgium, 26 June 2017; 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces that the European Patent Office (EPO) has notified the Company of its intention to grant a key patent covering its first-in-class allogeneic cell therapy technology.

Once granted, the patent titled, “Osteogenic differentiation of bone marrow stem cells and mesenchymal stem cells using a combination of growth factors”, will provide legal protection to Bone Therapeutics both for the manufacturing methods and for the distinct cell type used in its allogeneic cell therapy technology. Specifically, the patent covers methods to manufacture differentiated and biologically active osteoblastic (bone-forming) cells from bone marrow stem cells, using a specific combination of growth factors, and also covers a new class of osteoblastic cells suitable for allogeneic administration to the patient.

Bone Therapeutics will now validate the patent in several countries in the European Union, potentially allowing IP protection for its allogeneic bone cell therapy platform until 2029. Patents from the same patent family have already been granted in Japan, Australia and Singapore and applications are pending in the USA, Canada, India and South Korea. ALLOB^®, Bone Therapeutics’ most advanced allogeneic bone cell therapy product, is currently being evaluated in Phase I/IIA clinical trials for delayed-union fractures and spinal fusion, for which interim results are expected in the third quarter this year.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “This notice from the European Patent Office confirms our allogeneic bone cell therapy technology is both innovative and distinctive. When granted, this European patent will significantly strengthen our IP position in the field of bone cell therapy, giving us further validation for the scientific and commercial development of our cell therapy products whilst also enhancing our position with respect to new partnerships.”

Dr. Miguel Forte, Chief Medical Officer of Bone Therapeutics, further noted: “Obtaining this patent is an important step in the development of our allogeneic bone cell therapy technology. It will provide a solid IP protection for our current work and for future technological advances, allowing us to continue our efforts to create patient-centric and commercially interesting bone cell therapy solutions.”

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.
Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.
Our primary clinical focus is ALLOB^®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB^®, obtained from patient’s own bone marrow and currently in Phase III development for osteonecrosis and non-union fractures.

Bone Therapeutics’ cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Osiris Appoints Linda Palczuk to serve as its President & CEO

Posted On June 26, 2017 By OrthoSpineNews In Biologics /

COLUMBIA, Md., June 26, 2017 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (Pink Sheets:OSIR) is pleased to announce that its Board of Directors has appointed Ms. Linda Palczuk, age 55, to serve as President and CEO, effective July 10, 2017. She will stand for election to the Board of Directors at the next shareholder meeting. Ms. Palczuk had an extensive and successful 30 year career with AstraZeneca Pharmaceuticals and its legacy companies, serving in senior level commercial and general management roles, including Vice President, Mature Brands and Vice President Global Commercial Excellence, Vice President Sales & Marketing, and Vice President Sales. Afterward Ms. Palczuk was an independent consultant providing business expertise within the pharmaceutical sector.

Ms. Palczuk holds a BA in Biology from Franklin & Marshall College and a Master of Business Administration from the University of Delaware.

“I am very excited to join Osiris during this time of transformation,” said Ms. Palczuk. “I am impressed with the scientific foundation of the company and the current products and emerging pipeline that Osiris offers to patients. I look forward to working with the management team and the board of directors to successfully lead Osiris through its next stage of growth.”

“I’m delighted to welcome Linda as the CEO to Osiris to lead the organization into a new future. With her experience in the industry and leadership skills, Linda is well equipped for success. Most importantly Linda has the passion, commitment and thoughtfulness to execute on the promising technology Osiris has to bring great products to patients. Leading our mission will create value for all shareholders,” said Peter Friedli, Chairman.

Departure of Interim President & CEO.

David A. Dresner is no longer the Interim President & CEO, effective June 21, 2017. Until Ms. Palczuk’s arrival Jason Keefer the VP of Marketing for Osiris shall become the Interim President & CEO.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, is a leader in researching, developing and marketing cellular regenerative medicine products that improve the health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, Osiris works to further advance the medical field. Osiris’ research and development in biotechnology focuses on innovation in regenerative medicine – including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care, including BIO^4®, a viable bone matrix, Cartiform^®, a viable osteochondral allograft, Grafix^®, a cryopreserved placental membrane, and Stravix^®, a durable placental allograft. Osiris, Grafix, Cartiform, and Stravix are trademarks of Osiris Therapeutics, Inc. BIO⁴ is a registered trademark of Howmedica Osteonics Corp. More information can be found on the company’s website, www.osiris.com. (OSIR-G)

For additional information, please contact:

Diane Savoie

Osiris Therapeutics, Inc.

(443) 545-1839

OsirisPR@Osiris.com

Source: Osiris Therapeutics, Inc.

News Provided by Acquire Media

Nasdaq Stockholm Welcomes Bonesupport to the Main Market

Posted On June 22, 2017 By OrthoSpineNews In Biologics, Financial /

Stockholm, June 21, 2017 — Nasdaq (Nasdaq: NDAQ) announced that Bonesupport Holding AB (short name: BONEX), a small cap company within the health care sector, has started trading of its shares on the main market of Nasdaq Stockholm. Bonesupport is the 63^rd company to list at Nasdaq’s Nordic markets* in 2017.

Bonesupport is a Swedish commercial stage orthobiologics company aiming to improve the lives of patients suffering from bone disorders. The company develops and commercializes injectable bioceramic bone graft substitutes to treat bone voids, based on its novel, proprietary Cerament technology platform. Bonesupport is headquartered at the Ideon Science Park in Lund, Sweden, with additional sales offices in Germany and the US. For more information, please visit www.bonesupport.com.

“We are pleased to have completed our IPO on the Nasdaq Stockholm main market and that our shares have started trading today,” said Richard Davies, CEO of Bonesupport. “Our listing is a key step in supporting Bonesupport’s growth strategy. Our IPO has provided us with the funds to drive our sales in both the US and Europe, to generate additional clinical data to enhance the competitive positioning of our products, to complete the Fortify study, which is key to gaining US approval for Cerament G, and to invest in our pipeline. This strategy will allow us to deliver our 2020 financial targets and to generate significant value for shareholders.”

“We welcome Bonesupport to the Nasdaq Stockholm main market,” said Adam Kostyál, SVP and Head of European listings at Nasdaq. “We continue to see a strong inflow of health care sector companies leveraging the public markets as a platform for future growth, and Bonesupport will make an exciting addition to that list.”

*Main markets and Nasdaq First North at Nasdaq Copenhagen, Nasdaq Helsinki, Nasdaq Iceland and Nasdaq Stockholm.
About Nasdaq

Nasdaq (Nasdaq: NDAQ) is a leading global provider of trading, clearing, exchange technology, listing, information and public company services. Through its diverse portfolio of solutions, Nasdaq enables customers to plan, optimize and execute their business vision with confidence, using proven technologies that provide transparency and insight for navigating today’s global capital markets. As the creator of the world’s first electronic stock market, its technology powers more than 89 marketplaces in 50 countries, and 1 in 10 of the world’s securities transactions. Nasdaq is home to 3,800 total listings with a market value of $11 trillion. To learn more, visit: http://business.nasdaq.com

Nasdaq Copenhagen, Nasdaq Helsinki, Nasdaq Iceland, Nasdaq Riga, Nasdaq Stockholm, Nasdaq Tallinn, Nasdaq Vilnius, Nasdaq Clearing and Nasdaq Broker Services are respectively brand names for the regulated markets of Nasdaq Copenhagen A/S, Nasdaq Helsinki Ltd., Nasdaq Iceland hf., Nasdaq Riga, AS, Nasdaq Stockholm AB, Nasdaq Tallinn AS, AB Nasdaq Vilnius, Nasdaq Clearing AB and Nasdaq Broker Services AB. Nasdaq Nordic represents the common offering by Nasdaq Copenhagen, Nasdaq Helsinki, Nasdaq Iceland and Nasdaq Stockholm. Nasdaq Baltic represents the common offering by Nasdaq Tallinn, Nasdaq Riga and Nasdaq Vilnius.

Cautionary Note Regarding Forward-Looking Statements

The matters described herein contain forward-looking statements that are made under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about Nasdaq and its products and offerings. We caution that these statements are not guarantees of future performance. Actual results may differ materially from those expressed or implied in the forward-looking statements. Forward-looking statements involve a number of risks, uncertainties or other factors beyond Nasdaq’s control. These factors include, but are not limited to factors detailed in Nasdaq’s annual report on Form 10-K, and periodic reports filed with the U.S. Securities and Exchange Commission. We undertake no obligation to release any revisions to any forward-looking statements.

Media Relations Contact:
Erik Granström
+46 73 449 78 07
erik.granstrom@nasdaq.com

Kuros receives CE certification for Neuroseal®, a novel dural sealant

Posted On June 21, 2017 By OrthoSpineNews In Biologics, Regulatory, Top Stories /

Schlieren (Zurich), Switzerland, June 21, 2017 – Kuros Biosciences (SIX:KURN) announced today that it has received CE certification for its novel dural sealant, Neuroseal® . The CE certification allows for the commercialization of the product anywhere in the European Economic Area. As part of the supporting evidence, Neuroseal® has been tested clinically and demonstrated effective sealing. Furthermore, Neuroseal® is specifically designed for ease of preparation, use and handling thereby reducing the risk of adverse effects which may result in longer hospitalizations and an increase in healthcare costs. With this approval and together with MagnetOsTM, Kuros has now two products ready to be commercialized in Europe.

The Conformité Européene (CE) mark allows Kuros to sell Neuroseal® , a Class III medical device, in all 27 member states of the European Union, the three countries of the European Free Trade Association (EFTA) plus Switzerland and Turkey. The CE certification testifies that Neuroseal® has been assessed to meet stringent regulatory requirements. The receipt of the CE approval involved a comprehensive audit of Kuros’ quality system and a thorough conformity assessment of Neuroseal® to assure that the product performs safely and as designed. As a result of the CE certification, Kuros is eligible for receiving a payment of USD 533, 000.

Dr. Ivan Cohen-Tanugi, Chief Executive Officer of Kuros, commented: “Today’s CE approval means that the entire European market is now open for us to commercially distribute Neuroseal® . The CE certification is another significant milestone as we continue to deliver on promises made. With Neuroseal® and MagnetOsTM, our portfolio now consists of two approved and commercial-stage products.” He continued: “Neuroseal® ensures watertight closure of the dura following brain surgery. It reduces the risk of postoperative leakage thereby improving quality of life of patients while also reducing hospitalizations costs. We believe the clinically proven advantages of Neuroseal® could make it the preferred option for physicians, patients, and payers.”

Neuroseal® effectively seals the dura reducing the risk of infections

Neuroseal® is a novel sealant designed as an adjunct to suturing to seal the dura after cranial surgery. The dura is a membrane surrounding the brain and spine and separates the central nervous system from the rest of the body. The dura acts as a protective barrier and ensures that the brain and spinal cord are bathed in cerebrospinal fluid (CSF), which is essential for the healthy functioning of the central nervous system. Amongst other functions it serves as cushion for the brain and protects against physical impacts and infections. During cranial procedures in which the dura is incised, the watertight closure is compromised, potentially leading to postoperative CSF leakage. CSF leakage may lead to clinical symptoms, neurological complications, and increased risk of infection. This may result in longer or recurrent periods of hospitalizations and associated increase in healthcare costs. Hence, there is a clear medical need to reduce the risk of CSF leakage after cranial surgery in which the dura is compromised.

Neuroseal® contains two synthetic polymers that are applied via a hand-spray device. The two polymers cross-link at the site of application to form a gel that seals the suture line. Results from a European clinical trial support Neuroseal® ’s safety and effectiveness. All clinical end-points were met with no safety issues observed.

For further information, please contact:

Kuros Biosciences Ltd

Harry Welten, Chief Financial Officer

Phone +41 79 750 15 64

harry.welten@kuros.ch

About Kuros Biosciences Ltd

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kuros.ch for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

Kuros Biosciences Ltd, Wagistrasse 25, CH-8952 Schlieren

SANUWAVE Health Appoints Maj-Britt Kaltoft to its Board of Directors; Extensive International and Strategic Partnership Strength Added

Posted On June 16, 2017 By OrthoSpineNews In Biologics /

SUWANEE, GA–(Marketwired – Jun 16, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) today announced the appointment of Maj-Britt Kaltoft to its Board of Directors. Dr. Kaltoft brings 20 years of international specialization in development and successful execution of business development strategies, contractual structures and alliance management within all sectors of the life science industry. Dr. Kaltoft currently heads the business development and patent functions at the Danish State Serum Institute, an institution under the Danish Ministry of Health. She has obtained outstanding results in the areas of business development, licensing and alliance management in the pharmaceutical and biotech industry at Lundbeck, Nycomed, EffRx and Novo Nordisk. With this appointment, the Company’s Board of Directors has expanded to five members.

“We are delighted to welcome Dr. Kaltoft to our Board of Directors,” said Kevin A. Richardson II, CEO and Chairman of the Board of Directors of SANUWAVE Health, Inc. “Dr. Kaltoft’s international experience will prove invaluable as we continue our international expansion in Europe, Southeast Asia, Middle East and recently South America. Her extensive network in the life science industry and senior experience with alliances, joint ventures, and partnerships will help us navigate the numerous opportunities we have on our plate currently, and in the future.”

Dr. Kaltoft is a Danish citizen. She holds a MSc in Biochemistry and PhD in Protein chemistry and Molecular biology from the University of Copenhagen and a Master in International Business Administration from Seattle University.

Commenting on her appointment, Dr. Kaltoft said, “I am very excited to join SANUWAVE’s Board of Directors at this pivotal time. I am impressed with SANUWAVE’s commitment in researching and developing new approaches to treating cumbersome medical conditions and non-medical opportunities, especially in industrial biofilms. An exciting opportunity to grow internationally and in the United States awaits the FDA approval of dermaPACE®. Through the establishment of global alliances, the availability of the SANUWAVE’s technology could provide an improvement in quality of life to diabetic patients.”

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 de novo petition 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.

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 INFORMATION

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

investorrelations@sanuwave.com

SANUWAVE Health, Inc.
Kevin Richardson II
CEO & Chairman of the Board
617-306-1350
kevin.richardson@sanuwave.com

Scientific And Clinical Review Confirms Potential Of MiMedx dHACM Allografts For Regenerative Applications In Orthopedics

Posted On June 16, 2017 By OrthoSpineNews In Biologics /

MARIETTA, Ga., June 15, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the latest peer-reviewed scientific and clinical review article of the MiMedx dehydrated human amnion/chorion membrane (“dHACM”) allografts has been electronically published in the journal Techniques In Orthopaedics.

The paper entitled “Dehydrated Human Amnion/Chorion Membrane Allografts as a Therapy for Orthopedic Tissue Repair“ was authored by Jennifer Lei, PhD; Lauren B. Priddy, PhD; Jeremy J. Lim, PhD; and Thomas J. Koob, PhD. The electronic publication in Techniques In Orthopaedics can be found at http://journals.lww.com/techortho/Abstract/publishahead/Dehydrated_Human_Amnion_Chorion_Membrane__dHACM_.99929.aspx. The article will also be published in a special Symposium issue of Techniques in Orthopaedics on “Emerging and Evolving Materials for Orthopaedics.” Guest Editors for this Symposium issue are David L. Safranski, PhD (MedShape, Inc., Atlanta, GA) and Ken Gall, PhD (Duke University, Durham, NC).

Over 226 growth factors and bioactive proteins have been identified to date in dHACM allografts, and these collective proteins have been shown to regulate activity of a variety of cell types, including stem cells that are critical for orthopedic repair. An independent comparison by a contract research organization demonstrated that micronized MiMedx PURION® Processed dHACM has significantly higher content of growth factors and bioactive proteins than two other commercially available placental-derived flowable products: FloGraft® FREEDOM (Applied Biologics) cryopreserved amnion and amniotic fluid product and PX50® (Skye Biologics) placental tissue matrix. Therefore, dHACM retains high levels of growth factors, cytokines, and chemokines.

In addition to an established history in promoting healing of chronic wounds, amniotic membrane allografts have recently been used in various orthopedic applications to reduce pain, prevent scar tissue formation, and promote healing. MiMedx PURION Processed dHACM (EpiFix® and AmnioFix®) allografts have been used in various orthopedic applications, including tendon and ligament repair, treatment of cartilage and joint space disorders, and spine procedures. The general outcomes achieved by physicians for these applications include:

Tendon and Ligament Repair:
- dHACM reduced pain and improved function following treatment of plantar fasciitis, anterior cruciate ligament (ACL) reconstruction, supraspinatus and infraspinatus tendon (rotator cuff) injury, common extensor tendon tear, lateral epicondylitis (tennis elbow), patellar tendon tear, and Achilles tendinopathy.
Cartilage and Joint Space Disorders:
- dHACM increased production of hyaluronic acid by human fibroblast-like synoviocytes in vitro, including in cells derived from osteoarthritis and rheumatoid arthritis donors.
- In a rat model of osteoarthritis, injection of micronized dHACM into the knee joint space attenuated cartilage degeneration with a significant reduction in lesions, erosions, and proteoglycan loss.
Spine Procedures:
- dHACM has been successfully used during transforaminal lumbar interbody fusion (TLIF) to minimize postlaminectomy epidural adhesions and scarring, resulting in significantly lower patient pain scores.

Parker H. Petit, Chairman and CEO, stated, “The outcomes that physicians have reported they are achieving when utilizing our dHACM allografts in orthopedic procedures are very impressive. We wanted to support those clinical outcomes with a comprehensive scientific and clinical review of orthopedic applications using dHACM.”

Study Background and Conclusions:

Amniotic membrane allografts are composed of extracellular matrix components such as collagen, fibronectin, and laminin, and contain a vast array of diverse growth factors and cytokines. dHACM allografts have been shown in randomized clinical trials to be effective therapies to enhance healing, and have demonstrated the ability to recruit the migration of stem cells to the site of injury in vitro and in vivo. The regenerative properties of dHACM include the ability to reduce scar tissue formation, modulate inflammation, and enhance healing, and these properties suggest that dHACM may be an effective therapy to promote healing within a variety of orthopedic tissues.

In this scientific review, the basic structure, function, and components of dHACM are discussed, and its current in vitro, in vivo, and clinical usages in orthopedic tissue repair applications are summarized as follows:

The delivery of growth factors, cytokines, and protease inhibitors by dHACM allografts modulates the three main phases of healing including inflammation, proliferation, and remodeling.
Current research and clinical cases for repairing orthopedic tissues have shown that dHACM allografts have promising results in repairing injured and diseased tissues due to their ability to reduce scar tissue formation, modulate inflammation, and enhance healing.
dHACM allografts have been evaluated for repair of tendon and ligament, attenuation of cartilage and joint space diseases, and prevention of scarring and adhesion formation in spinal fusion procedures.
Therefore, the use of dHACM allografts has great potential for regenerative applications in orthopedics.

Bill Taylor, President and COO, said, “Clinical usage in orthopedic repair is rapidly growing. We have numerous clinical trials ongoing in the area of orthopedics to evaluate the clinical efficacy of dHACM allografts in plantar fasciitis treatments, Achilles tendon repair, lumbar decompression and microdiscectomy, and total knee arthroplasty. We look forward to sharing the results of these studies when completed.”

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 900,000 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 results of clinical use of MiMedx products in various procedures and the significance of growth factor and protein content in various products. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that individual physician and patient clinical experiences may vary, other studies may show different or less favorable results, 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 10Q 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.

SANUWAVE Appoints Interventional Concepts as Territory Sales Manager and Partner to Access Clinical Trial Participation in Colombia; Revenue Expected Before Year End

Posted On June 15, 2017 By OrthoSpineNews In Biologics, Top Stories /

SUWANEE, GA–(Marketwired – Jun 14, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company has appointed Interventional Concepts, Inc. to act as Territory Sales Manager for sourcing and screening of potential distributors and access to clinical trials participation for SANUWAVE’s products in Colombia.

André Mouton, V.P. International Sales and Relations of SANUWAVE, stated, “This decision to engage Interventional Concepts was made to increase our focus and visibility within South America. It is of the utmost importance that we partner with distributors that have influence and a good track record within the Colombian market. We also need speedy access to potential clinical trials to ensure we add value with our product offering as well as clinically proven outcome. These factors will lead to faster market entry and closer ties with identified Key Opinion Leaders (KOL’s),” concluded André Mouton.

Julio G. Martinez-Clark, Interventional Concepts’ CEO, stated, “Interventional Concepts is an ideal partner for SANUWAVE by providing regulatory and commercial support when introducing and expanding the company’s medical device portfolio in Colombia.”

“By partnering with Interventional Concepts, SANUWAVE will have access to a multidisciplinary team of life science professionals in Colombia that will facilitate SANUWAVE’s local market access efforts,” continued Mr. Martinez-Clark. “Our expertise in medical device clinical trials and commercialization, knowledge of the local market, and wide network of local contacts enable us to offer a wide range of services to forward-thinking companies like SANUWAVE. This partnership will allow SANUWAVE to successfully enter the market and achieve long-term growth and success in Colombia.”

SANUWAVE is using this occasion to further educate on 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.

About Interventional Concepts, Inc.
Interventional Concepts is based in Miami, FL and was founded in 2010 by Dr. Pedro Martinez-Clark — an interventional cardiologist, an innovator, founder and advisor to MedTech companies — to help medical device companies conduct early-stage clinical trials and have access to the Colombian market. The company offers a wide range of market access services including market research and testing, product and trademark registration, regulatory legal representation, distributor search and selection, new entity set-up, and operations services for life science companies looking to enter and achieve long-term growth in Latin America — with a special focus on Colombia. Interventional Concepts has helped companies like Avinger, Mitralign, MitraSpan conduct clinical trials in Colombia; and companies like ClarVista Medical, CeloNova BioSciences, Abiomed, Volcano, and Mount Sinai’s Center For Personalized Cancer Therapeutics register their products and formulate a market access strategy in Colombia.

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

CONTACT INFORMATION

Contact:
Interventional Concepts, Inc.
2520 Coral Way, Suite 2120
Miami, FL 33145 USA
Julio G. Martinez-Clark, CEO
jmclark@interventionalconcepts.net
+1 (954) 903-7210
www.colombiamarketaccess.com

Contact:
Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com
investorrelations@sanuwave.com

SANUWAVE Health, Inc.
Andre Mouton
Vice President International Sales and Relations
+1-615-823-9907 (Cell)
+1-678-569-0881(Fax)
Skype: andre.w.mouton
Andre.Mouton@sanuwave.com

Bioventus Surgical Expands Portfolio Offering with Premier

Posted On June 8, 2017 By OrthoSpineNews In Biologics /

June 07, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologics, today announced that, effective June 1, 2017, its full surgical orthobiologics portfolio is available through Premier, Inc. Premier is a health care improvement company comprised of 3,750 US hospitals and more than 130,000 other provider organizations throughout the country. Bioventus Surgical has numerous offerings for bone healing and spine fusion including allograft bone, synthetic bone graft substitutes and cell and marrow extraction needles.

OSTEOAMP^®, an allograft fusion solution, has been available through Premier since 2012. Additional products in the new agreement include: SIGNAFUSE^™, a bioactive bone graft substitute, EXPONENT^™demineralized bone matrix, PUREBONE^® demineralized cancellous bone and cancellous chips, INTERFACE bioactive bone graft, OSTEOMATRIX^® biphasic mineral/collagen bone graft, OSTEOPLUS^® biphasic mineral bone graft, CELLXTRACT^®, an autologous cell and marrow extraction device, and EXTRACTOR^™ autologous cell and marrow extraction device.

“The Bioventus Surgical portfolio is designed to meet the needs of surgeons and their patients, across a broad range of clinical situations, procedures, and costs,” said Henry Tung, MD, Senior Vice President, Bioventus and President, Bioventus Surgical. “We expect the Premier alliance of hospitals and healthcare providers to benefit greatly from our clinically supported and cost-effective orthobiologic solutions.”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN^®Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSi, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, CELLXTRACT, OSTEOAMP, OSTEOMATRIX, OSTEOPLUS, PUREBONE and EXOGEN are registered trademarks, and EXPONENT, EXTRACTOR and SIGNAFUSE are trademarks of Bioventus LLC.

Summary of Indications for Use

Please see Instructions for Use for complete lists of indications, contraindications, warnings, and precautions on the product labels, at www.BioventusSurgical.com, or by calling 1-800-637-4391.

CELLXTRACT is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

EXPONENT Demineralized Bone Matrix is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

EXTRACTOR is intended for the purpose of harvesting bone marrow.

INTERFACE Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. INTERFACE Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis), and in the posterolateral spine when mixed with autograft. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

OSTEOAMP may be used in situations where an autograft is appropriate. It should be restricted to homologous use for the repair, replacement or reconstruction of musculoskeletal defects.

OSTEOMATRIX is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

OSTEOPLUS is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g., extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. OSTEOPLUS can be used with autograft as a bone graft extender. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

PUREBONE Demineralized Cancellous Tissue is restricted to use by a licensed physician. PUREBONE Demineralized Cancellous Tissue can be used in orthopedic, neurosurgical and reconstructive bone grafting procedures for homologous use for the repair, replacement, or reconstruction of musculoskeletal defects. It can be used by itself as a bone graft or in conjunction with autologous bone and other forms of allograft bone. PUREBONE Demineralized Cancellous Tissue has been tested for sterility and is ready for use. Do not subject the product to additional disinfection or sterilization procedures. PUREBONE Demineralized Cancellous Tissue is intended for single patient use only. In order to prevent contamination of the graft, any open and unused PUREBONE Demineralized Cancellous Tissue must be discarded and not used in other patients.

SIGNAFUSE is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SIGNAFUSE is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine fusion procedures). SIGNAFUSE can also be used with autograft as a bone graft extender in the posterolateral spine. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.

Contacts

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

Life Spine® Achieves Record Breaking Sales Growth of Biologics Product Line over Past Year

Posted On June 6, 2017 By OrthoSpineNews In Biologics, Top Stories /

June 06, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today exponential growth of their Biologics product line, OSTEO-LINK™ Demineralized Bone Matrix, over the past fiscal year.

“OSTEO-LINK has been engineered and processed to deliver the highest level of osteoinductivity. It is because of this technology that we have achieved record breaking revenue growth of 424% over the past year,” said Mariusz Knap, Vice President of Marketing for Life Spine. “From April to May alone, we experienced a 270% revenue jump. This has been possible through our many differentiated offerings of putty, strips, cubes and fillers all available to help influence better patient outcomes and reduce costs.”

Life Spine expects continued growth of their Biologics line with the announcement of two new Biologic offerings. First, OSTEO-LINK Hydratable ICM (Inductive Carrier Matrix), which is an osteoinductive bone matrix that may be hydrated with saline, blood, BMA, or PRP. OSTEO-LINK Hydratable ICM does not contain any extrinsic carriers and is made from 100% human bone. The graft also has exceptional handling characteristics that resists irrigation. All OSTEO-LINK products are verified for osteoinductivity post-sterilization prior to release for distribution. In-vivo test results demonstrate all 5 bone forming elements present (chondrocytes, osteocytes, bone marrow cells, cartilage, and new bone).

Second, the patent pending MARROW CELLUTION™ Bone Marrow Harvesting System, designed to overcome the limitations of a traditional bone marrow needle and results in a bone marrow harvest that is so rich in key stem and progenitor cells that the aspirate may no longer require manipulation through centrifugation prior to application. Traditional needles produce excess peripheral blood contamination, diminishing cellular yield; thereby requiring additional manipulation steps to achieve the cellular demand necessary for most clinical indications. MARROW CELLUTION uses its patent(s) pending technology to harvest high quality stem and progenitor cells from various levels within the marrow space, while limiting peripheral blood contamination.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

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