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BONESUPPORT Signs Strategic Agreement with Collagen Matrix, Inc. to Expand Product Offering in the US

Posted On May 24, 2018 By OrthoSpineNews In Biologics, Top Stories /  

Lund, Sweden, 13.00 CET, 24 May 2018 – BONESUPPORT, announces an agreement with Collagen Matrix, Inc. that will allow it to expand its US offering with products that are complementary to CERAMENT BVF. BONESUPPORT will start selling and marketing selected Collagen Matrix bone graft substitute products under its own brand name, and through its own US distribution network in Q4 2018.

Emil Billbäck, CEO of BONESUPPORT said, “Today’s deal with Collagen Matrix is important to our plans to build a larger, faster growing US business under our own control. The Collagen Matrix products can be osteoinductive and osteogenic when combined with bone marrow aspirate making them complementary to CERAMENT BVF, which is osteoconductive. We intend to launch these products under our own brand name later this year giving us a suite of products that will allow us to meet more of the bone graft substitute needs of the orthopedic surgeon. Establishing a broader portfolio of bone graft substitute technologies will also significantly improve our competitive position with payors including GPO/IDN’s (Group Purchasing Organization/Integrated Delivery Network), and help our new distribution channel to be more competitive.”

Collagen Matrix products, when combined with autogenous bone marrow, are both osteoinductive and osteogenic. They are used to fill bony voids or gaps of the skeletal system caused by surgery or traumatic injury.

On 17 May 2018, BONESUPPORT announced that it intended to create its own optimal US commercial platform by:

  • Building its own network of independent distributors that will be key in driving the sales of BONESUPPORT’s products, to a broad range of orthopedic indications.
  • Growing the size and capabilities of its own US commercial organization, which will increase from 14 to around 23 employees by the end of 2018
  • Extending its product offering based on new formulations of CERAMENT as well as synergistic bone graft substitute products via strategic collaborations such as the one announced with Collagen Matrix today.

For more information contact:

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

About Collagen Matrix Inc.

Collagen Matrix, Inc., founded in 1997, delivers a full line of the highest-quality collagen and mineral based medical devices that support the body’s natural ability to regenerate. The Company currently manufactures finished medical devices in the areas of Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair Surgery. The evolution of the Company’s leadership, proprietary technologies, manufacturing expertise and product portfolio has established a solid foundation for continued growth.

More information about Collagen Matrix can be found at www.CollagenMatrix.com

About BONESUPPORT™

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

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

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

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

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

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

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

BONESUPPORT™ and CERAMENT® are registered trademarks.

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 13.00 CET on 24 May 2018.

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Cerapedics Announces Presentation of Results from the IVANOS Study of i-FACTOR™ Peptide Enhanced Bone Graft in Uninstrumented Lumbar Posterolateral Spine Surgery

Posted On May 21, 2018 By OrthoSpineNews In Biologics, Top Stories /  

WESTMINSTER, Colo., May 21, 2018 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced results from the IVANOS study evaluating i-FACTOR™ Peptide Enhanced Bone Graft in lumbar posterolateral spine surgery. Results were presented by Mikkel O Andersen, MD, from the Sector for Spine Surgery and Research at Middelfart Hospital in Denmark, at the 7th Annual Global Spine Congress held May 2-5 in Singapore.

i-FACTOR Peptide Enhanced Bone Graft is based on proprietary synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment and activation. In spinal fusion procedures, surgeons use bone graft to join and stabilize vertebrae. i-FACTOR Peptide Enhanced Bone Graft was approved in the European Union in 2008 and in Australia in 2010 for use in the repair of bony voids or defects in orthopedic applications throughout the skeletal system (i.e., the spine and extremities). In the United States, i-FACTOR Peptide Enhanced Bone Graft was approved via a PMA in 2015 only for use in single level anterior cervical fusion procedures.

In the single center, double-blind, randomized IVANOS study, 98 patients (240 treated levels) age 60 and older with lumbar spinal stenosis (LSS) and concomitant degenerative olisthesis (DS) were treated with non-instrumented lumbar posterolateral spine surgery and received either i-FACTOR Peptide Enhanced Bone Graft or allograft. Results demonstrated a 50 percent fusion rate (63/126) using i-FACTOR Peptide Enhanced Bone Graft compared to a 20 percent fusion rate (23/114) using allograft at one-year postoperative follow-up. Patients with 1-level DS achieved estimated fusion rates of 40 percent (29/72) with i-FACTOR Peptide Enhanced Bone Graft versus 21 percent (17/80) with allograft. Patients with 2-level DS achieved estimated fusion rates of 63 percent (34/54) with i-FACTOR Peptide Enhanced Bone Graft versus 18 percent (6/34) with allograft.

“In Denmark the current surgical standard is the use of non-instrumented fusion in treating elderly patients with spinal stenosis and concomitant degenerative olisthesis. This patient population presents a challenging environment to obtain fusion due to their mechanical instability and biology,” said Dr. Andersen. “These data indicate that i-FACTOR Peptide Enhanced Bone Graft offers significant potential benefits in fusion rates compared to allograft.”

“This data from the IVANOS study is another significant milestone as we advance on our commitment to increase the level of clinical evidence evaluating our P-15 technology, and we are proud to be leading the effort to address the evidence gap around commercial bone grafts often used in spinal fusion procedures,” said Glen Kashuba, chief executive officer of Cerapedics.

Cerapedics received approval from the U.S. Food and Drug Administration (FDA) to initiate an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of its proprietary P-15 technology for use in transforaminal lumbar interbody fusion (TLIF) surgery in March 2018. The company is initiating enrollment in the study with the expectation that the results will support an additional Premarket Approval (PMA) application. P-15 currently remains investigational in the United States for use in the lumbar spine.

About Cerapedics

Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.

i-FACTOR Peptide Enhanced Bone Graft Indications for Use

Europe and Australia: i-FACTOR Peptide Enhanced Bone Graft is a bone graft substitute material for use in the repair of bony voids or defects in orthopedic applications throughout the skeletal system (i.e., the spine and extremities). The bony voids may be surgically created defects or may result from traumatic injury to the bone.

USA: i-FACTOR™ Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. i-FACTOR™ Peptide Enhanced Bone Graft must be used inside an allograft bone ring and with supplemental anterior plate fixation.

Media contact:
Jenna Iacurci
Berry & Company Public Relations
212-253-8881
jiacurci@berrypr.com

SOURCE Cerapedics

Related Links

https://cerapedics.com

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BONESUPPORT creates its own US Commercial Platform

Posted On May 17, 2018 By OrthoSpineNews In Biologics, Top Stories /  

Lund, Sweden, 08.45 CET, 17 May 2018 – BONESUPPORT HOLDING AB (publ) announces today that the current distribution agreement has been terminated and will be replaced by a network of independent distributors and its own commercial organization. This will allow BONESUPPORT to increase its market penetration while creating a stronger platform for current products and future launches in the US market.

“Taking control of our commercial platform in the US is crucial to the execution of our strategy to become a leading global orthobiologics company. We will be able to create a more direct relation with the US customers while better capitalizing the potential of our highly differentiated products, particularly CERAMENT G, which we hope will take to the market in 2021”, says Emil Billbäck, CEO of BONESUPPORT.

The company intends to create the optimal US commercial platform by:

  •  Building its own network of independent distributors driving the sales of the BONESUPPORT’s products, to a broad range of orthopedic indications.
  •  Extend the product offering based on new formulations of CERAMENT as well as synergistic bone graft substitute products.
  •  Increase the own commercial organization from 12 to 23 persons.

BONESUPPORT will start selling direct on October 20th 2018.

“CERAMENT G will be a highly innovative product – the first of its kind in the US market – the recruitment of the FORTIFY IDE study, which will provide data for the PMA application of CERAMENT G in 2020, is running according to plan. Expanding our commercial footprint, establishing direct access with our customers, and bolstering our product offering in the US will allow us to build a strong and increasing foundation in the world’s largest market for bone graft substitutes.”, comments Patrick O’Donnell, Executive Vice President of Commercial Operations, North America.

The Company expects that this decided change in market commercialization eventually will generate higher sales volumes in the US. In the short term, the turnover will be less in the US. This could also lead to that the 2020 targets will be achieved later than previously communicated. We will present updated objectives during Q3 2018 after the initiated strategic review is completed.


Conference Call/Webcast Details

The Company will host a conference call and an online presentation at 09:30 am CET on Thursday 17 May.

The dial-in numbers for the conference call are:

UK: +44 20 3008 9808
SE: +46 85 063 95 49
US: +1 85 5831 5946

Webcast

The presentation will also be webcast and can be accessed from the following web address:

https://tv.streamfabriken.com/2018-05-17-bonesupport-pressconference

Hosts: Emil Billbäck, CEO and Björn Westberg, CFO

For more information contact: BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

About BONESUPPORT™

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

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform. The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

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

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

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

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

BONESUPPORT™ and CERAMENT® are registered trademarks.

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 07.45 CET on 17 May 2018.

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DePuy Synthes Announces Agreement with Prosidyan to Exclusively Promote FIBERGRAFT® Family of Products for Spine Fusion Surgery

Posted On May 9, 2018 By OrthoSpineNews In Biologics, Spine /  

RAYNHAM, Mass. – May 9, 2018 – DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announced an exclusive agreement in the U.S. between DePuy Synthes Sales, Inc. and Prosidyan to promote the FIBERGRAFT® Family of Products, a line of synthetic bone graft materials which are ultra-porous, designed for ease of use, and have been engineered for optimal resorption in clinical use during spine fusion surgery. By adding FIBERGRAFT to its offerings, DePuy Synthes will further enhance the company’s biomaterials portfolio for spine, which currently includes cellular allograft, demineralized bone matrix and first generation synthetic solutions. Surgeons will now have a broad range of handling options based on the needs of each patient and surgical case.

Approximately 400,000 patients in the U.S. undergo spinal fusion surgery annually to help reduce pain and nerve root inflammation.1 Surgeons will often use a biomaterial to facilitate bone growth and fusion. Each case is unique, and providing a broad portfolio of offerings allows surgeons the opportunity to select the right consistency.

“Our exclusive agreement with Prosidyan allows us to complete our biomaterials offering through a next generation synthetic solution and provide our customers with a variety of options based on handling preference and needs of their patients,” said Juan-José Gonzalez, President, DePuy Synthes U.S. “This offering allows us to provide a more complete solution for our customers.”

Prosidyan was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on microsized fibers of bioactive glass. Prosidyan’s first product, FIBERGRAFT BG Morsels, a synthetic bone graft substitute, received FDA clearance in March 2014, and the first surgery utilizing this innovative bone substitute was performed in May 2014. The firm’s second product in the line, FIBERGRAFT BG Putty, received FDA clearance in March 2015, and comprises FIBERGRAFT BG Morsels delivered through Prosidyan’s proprietary bioactive carrier, OSSIGLIDE. Prosidyan’s third and flagship product FIBERGRAFT BG Matrix, received FDA clearance in October of 2017 and comprised FIBERGRAFT BG Morsels combined with Prosidyan’s proprietary type I collagen based bioactive carrier.

To date, FIBERGRAFT products have been provided for more than 10,000 patients across the U.S.

DePuy Synthes is expected to begin promoting FIBERGRAFT in Q2 2018.

About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, and interventional solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

About DePuy Synthes
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit: www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional businesses within Johnson & Johnson’s Medical Devices segment.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding an agreement with Prosidyan to exclusively promote the FIBERGRAFT Family of Products. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes, any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes, the Johnson & Johnson Medical Devices Companies, nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

The third party trademarks used herein are the trademarks of their respective owners.

©DePuy Synthes 2018. All rights reserved.

  1. Rajaee, Ss et al. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Spine. 2012 Jan 1;37(1):67-76.
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SANUWAVE Announces AMBIENSYS SRL as Distributor for dermaPACE® in Romania

Posted On May 9, 2018 By OrthoSpineNews In Biologics /  

SUWANEE, GA, May 09, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that it has appointed AMBIENSYS SRL as the distributor for the dermaPACE® System in Romania.  The expected revenue from this agreement will be north of $400,000 over the next three years.

Globally, AMBIENSYS SRL is known as a service provider in the areas of consulting, training in European funding, project management and implementation. AMBIENSYS SRL strives to provide clients with comprehensive information and services on funding opportunities, funding preparation, training and technical assistance during project implementation. AMBIENSYS SRL’s intent is to contribute to commercialization strength locally and regionally to sustainable innovations like the dermaPACE® System. After successful training, the cognitive and clinical knowledge will be transferred by Certified Trainers at AMBIENSYS SRL to hospitals throughout Romania to ensure the safe and effective use of dermaPACE® consistent with approved labeling, EU requirements and a focus on best practices of patient care and comfort during treatments.

Kevin A. Richardson II, Chairman of the Board of SANUWAVE, stated, “The decision to engage AMBIENSYS SRL was made to introduce the dermaPACE® system throughout the wound care market in Romania, which is the largest country in Southeastern Europe. It is paramount that we partner with global distributors that have complementary contacts and a positive impact within the local Romanian market.  It is well known that diabetes and related concerns need to be addressed within Romania and having access to outstanding technology such as SANUWAVE’s within the country is a remediable step towards a healthier tomorrow.”

Shipment of the first devices and training will occur in the second quarter of 2018 to AMBIENSYS SRL.

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

About AMBIENSYS SRL

AMBIENSYS SRL is registered as a consultancy and business development company with the Romanian Health Ministry and Romanian Agency for Medication and Medical Devices.  The company is authorized for the import and distribution of medical devices on the Romanian market.  AMBIENSYS SRL has the approval for the importation of dermaPACE® Systems from SANUWAVE.  AMBIENSYS SRL is located in Ramnicu Valcea, Strada General Magheru, Nr. 25, SOCOM Building, Suite 67, Judetul Valcea.

Contacts:

AMBIENSYS SRL

CEO/General Manager

Ing. Daniel Ioan Badescu

Executive Manager

Ing. Dan Crisu Turcitu

Phone: (40) 0350 419 770

Email: ambiensys.office@gmail.com

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.

Millennium Park Capital LLC

Christopher Wynne

312-724-7845

cwynne@mparkcm.com


SANUWAVE Health, Inc.

Kevin Richardson II

Chairman of the Board

978-922-2447

investorrelations@sanuwave.com
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Clinical Evidence Presented at SAWC on Application of AMNIOX Medical Products

Posted On May 8, 2018 By OrthoSpineNews In Biologics /  

May 08, 2018

MIAMI–(BUSINESS WIRE)–AMNIOX Medical, Inc., a TissueTech, Inc. company, highlighted four clinical posters demonstrating the effectiveness of NEOX® Wound Allograft at the Symposium on Advanced Wound Care (SAWC) in April.

The presentations illustrate applications of NEOX Wound Allograft in combination with other therapies, and among a range of severe wounds that are resistant to current standard of care or are under served.

“The clinical effectiveness and value of NEOX continues to be reinforced in these studies, as well as opportunities to combine different approaches to advanced wound care,” said Adrian Roji, Chief Commercial Officer of TissueTech. “The authors found that patients who received NEOX experienced closure of hard-to-heal wounds, further highlighting the unique properties of cryo-preserved umbilical cord tissue.”

The studies presented at SAWC included:

  • Treatment of Post-Operative Left Temporal Wound with Umbilical Cord Based Particulate and Negative Pressure Wound Therapy, Timothy Plackett, DO
  • Use of Hydrated Shelf Stable Umbilical Cord Allograft for the Treatment of Chronic Wounds, Allen Raphael, DPM
  • Treatment of Close-Range Gun Shot Wound with Umbilical Cord Based Particulate (pUC) and Negative Pressure Wound Therapy Timothy Plackett, DO
  • Treatment of Invasive Carcinoma Wound with Hyperbaric Oxygen and Cryopreserved Umbilical Cord, Luis Fernandez, MD

AMNIOX parent TissueTech pioneered the commercialization and clinical application of human umbilical cord and amniotic membrane to promote healing. AMNIOX utilizes its proprietary CryoTek® process, a cryopreservation technology, to preserve the biological and structural integrity of these tissues more effectively than other available technologies. Since the company’s inception, clinicians have performed more than 300,000 human transplants of its products and published more than 300 peer-reviewed studies supporting its technology platform.

About AMNIOX Medical, Inc.

Founded in 2011 to serve the orthopedic and wound care markets, AMNIOX Medical is dedicated to developing and marketing products processed from umbilical cord and amniotic membrane utilizing its proprietary CryoTek technology. AMNIOX Medical procures its tissue through elective donation following healthy live birth via Cesarean section. Thorough donor screening is performed to ensure safety of its products. For additional information, please visit http://www.AMNIOXmedical.com.

About TissueTech, Inc.

TissueTech, Inc., the parent company of AMNIOX Medical, Inc. and BioTissue, Inc., pioneered the development and clinical application of amniotic tissue-based products. AMNIOX Medical develops and markets products for use in the musculoskeletal and wound care markets; BioTissue develops and markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) has supported TissueTech’s research with more than 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.

Contacts

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

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Vivex Biomedical, Inc. Announces Peer-Reviewed Study of VIA Graft

Posted On May 4, 2018 By OrthoSpineNews In Biologics /  

ATLANTA, May 4, 2018 /PRNewswire/ — Vivex Biomedical, Inc. (Vivex) is pleased to announce the publication of a peer-reviewed study examining the use of its cellular bone matrix product, VIA Graft, for spinal fusion surgery. The peer-reviewed study was published in the January edition of the International Journal for Spine Surgery, and demonstrates exceptional clinical results.

The study represents a retrospective review of a single practice, single surgeon evaluation of VIA Graft. The study evaluated 75 consecutive patients for fusion by CT and radiographic evaluation at 12 months with a minimally invasive surgical approach. In total, 96% of the 75 patients with a total of 85 levels achieved fusion at 12 months – 96% of patients, 96.5% of levels treated.

“These clinical results with VIA Graft demonstrate Vivex’s commitment to developing a disruptive product that will revolutionize the standard of care in orthopaedic surgery,” states Tracy Anderson, President & CEO of Vivex.

The VIA product line was first launched in August of 2014 and has grown significantly with adoption across several orthopaedic surgical specialties. VIA Graft retains a biocompatible, mesenchymal stem cell-rich population that includes marrow-isolated adult multi-lineage inducible cells. The product also utilizes a proprietary non-DMSO cryoprotectant, affording optimal cell protection and streamlined preparation in the OR.

About Vivex Biomedical, Inc.

Vivex is a regenerative biologics company, dedicated to creating new standards in patient care. Vivex strives to create treatment options and solutions that will improve clinical, surgical, and therapeutic patient care through innovation. Under the guidance of experienced and successful business professionals, Vivex tasks the brightest minds from the medical and material science industries to explore new and different ways to help others. Vivex focuses on core products and new technologies to meet the ever-growing biologic needs of surgeons and patients while continuing our 45-year history of serving and honoring both tissue donors and recipients.  As a part of this mission, Vivex works with services that are committed to providing care and compassion to donor families while inspiring communities to share life through their donation. Partnering with families in the prospect of regenerative options, Vivex assures appropriate options are available to support regeneration and translation of their gifts. Vivex and its affiliates have distributed more than two million tissue allografts to 18 countries worldwide to better serve the needs of patients.

For more information, please visit http://vivex.com/.

SOURCE Vivex Biomedical, Inc.

Related Links

http://www.vivex.com

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Kuros Biosciences Receives European Clearance for MagnetOs Putty and Prepares for Commercial Roll-Out in the U.S. and Europe

Posted On May 2, 2018 By OrthoSpineNews In Biologics, Regulatory /  

SCHLIEREN (ZURICH), Switzerland, May 02, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX:KURN) announced today that it has received the CE Mark for MagnetOs Putty indicated for use as an osteoconductive and osteoinductive bone void filler in the skeletal system (i.e. spine, extremities, pelvis, cranium, mandible and maxilla). This market clearance allows commercialization of MagnetOs Putty in Europe, and complements the existing clearance for MagnetOs Granules, and the 510K clearance for both formulations from the U.S. Food and Drug Administration as an autograft extender in the posterolateral spine. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway. Numerous studies have shown that MagnetOs leads to progressive bone formation and implant resorption comparable to autograft (patient’s own bone), the current gold standard.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “MagnetOs Putty and MagnetOs Granules have now been cleared in our main target markets. We are gearing up for the commercial roll-out later this year in the U.S. and selected geographies in Europe, as we are executing on our strategy to build a leading orthobiologics company.”

MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

For further information, please contact:
Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47
michael.grau@kurosbio.com

Media & Investors
Hans Herklots
LifeSci Advisors
+41 79 598 7149
hherklots@lifesciadvisors.com

About Kuros Biosciences AG
Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, 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.

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DiscGenics Announces First Patient Treated in U.S. Clinical Trial of IDCT for Degenerative Disc Disease

Posted On April 30, 2018 By OrthoSpineNews In Biologics /  

SALT LAKE CITY, April 26, 2018 /PRNewswire/ — DiscGenics, Inc., a clinical stage regenerative medicine company focused on developing cell therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced the first patient has been treated in its phase I/II U.S. clinical trial of IDCT for mild-to-moderate degenerative disc disease (DDD). The treatment took place at Carolina Neurosurgery and Spine Associates in Charlotte, NC, led by the study’s principal investigator, Domagoj Coric, M.D.

IDCT is an allogeneic (donor-derived), non-invasive cell therapy comprised of proprietary Discogenic Cells and a viscous scaffold carrier. This prospective, randomized, double-blinded, vehicle- and placebo-controlled study is designed to evaluate the safety and preliminary efficacy of IDCT at varying dosage levels in subjects with single-level, symptomatic lumbar DDD, a major cause of chronic low back pain.

“We are thrilled to be participating in the clinical evaluation of this potentially game-changing therapy for patients with DDD,” said Dr. Coric. “If the outcomes observed in human subjects are consistent with preclinical study findings of IDCT, which indicated reduced inflammation and disc height restoration, the result could be reduced pain and disability, offering a truly regenerative therapy for one of the most common causes of chronic low back pain.”

“Commencing clinical evaluation of our first product candidate is a critical milestone for DiscGenics as we continue to advance IDCT as a potentially revolutionary treatment for DDD,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board of Directors for DiscGenics. “The millions of patients who suffer from low back pain every year currently have limited treatment options, one of which is opioid use for pain management. If proven effective, IDCT could be a vital tool for curtailing opioid addiction among those who suffer from this debilitating condition.”

The trial will take place in up to 10 centers across the U.S. and will enroll approximately 60 subjects. Those who meet all eligibility criteria will be randomized to one of four treatment cohorts: low dose IDCT (n=20), high dose IDCT (n=20), vehicle (n=10) and placebo (n=10).

Each subject will receive a single intradiscal injection of his or her assigned treatment into the target symptomatic lumbar intervertebral disc. Following treatment, subjects will be observed and evaluated for a period of one year, with a one-year extension period.

For more information, please visit clinicaltrials.gov/.

Initiation of this trial was supported by the U.S. Food and Drug Administration’s (FDA) acceptance of the Company’s investigational new drug (IND) application for IDCT, announced in the fourth quarter of 2017.

DiscGenics is one of just two companies in the world with an allogeneic cell-based product for disc degeneration that is pursuing a Biologics License Application (BLA) from the FDA through its rigorous clinical and regulatory IND pathway.

About DiscGenics
DiscGenics is a privately held, clinical stage regenerative medicine company focused on developing cell therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics is harnessing the restorative potential of cells native to the intervertebral disc to develop what we hope will be a profound therapeutic option for millions of patients suffering from the debilitating effects of back pain. DiscGenics’ first product candidate, IDCT, is a homologous, allogeneic injectable cell therapy that utilizes proprietary Discogenic Cells to offer a non-surgical, potentially regenerative solution for the treatment of patients with mild to moderate degenerative disc disease.

 

SOURCE DiscGenics, Inc.

Related Links

http://www.discgenics.com

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Fidia Announces Presentation of New Data Evaluating HYMOVIS® Effects on Cartilage Volume and Type II Collagen Turnover at Osteoarthritis Research Society Int’l (OARSI) World Congress Meeting

Posted On April 26, 2018 By OrthoSpineNews In Biologics /  

April 25, 2018

ABANO TERME, Italy–(BUSINESS WIRE)–Fidia Farmaceutici, a world leader in the research, development and manufacturing of hyaluronic acid (HA)-based products and its wholly owned subsidiary, Fidia Pharma USA Inc., announces that new data will be presented at the Osteoarthritis Research Society International (OARSI) World Congress Meeting in Liverpool, U.K., April 26-29.

The pilot study “MOKHA,” coordinated by Fidia Farmaceutici, which involved eight sites in France and Belgium, aimed to explore the potential structural modifying effect of HYMOVIS®, an HA viscosupplement, in patients suffering from symptomatic knee osteoarthritis (OA) using a combination of clinical outcomes and objective measurements including biological and MRI-based imaging markers. This open, multicenter, prospective study on 46 patients showed that HYMOVIS® significantly enhanced type II collagen turnover as suggested by the increase of Coll2-1 (p<0.001) and PIINAP (p<0.001) soluble biomarkers and by the decrease over time of the ratios Coll2-1/PIIANP and CTX-II/PIIANP (p<0.005). Cartilage volume and thickness enhancement was observed by MRI in some knee compartments (p<0.05). Furthermore, WORMS effusion (Whole-Organ Magnetic Resonance Imaging Score), an indicator of synovitis, significantly decreased (p<0.016).

In addition, global KOOS (Knee Injury and Osteoarthritis Outcome Score) and subscales significantly increased over time (p<0.001) while pain at rest, walking pain, and patients or investigators global assessment of disease activity decreased (p<0.001). Furthermore, HYMOVIS® showed a favorable safety profile with no serious adverse events related to the product and low incidence of injection-site pain. “Importantly, this study highlights the potential beneficial effect of HYMOVIS® on pain and function. Altogether, this data suggests that HYMOVIS® could have a structural modifying effect in knee OA and provides critical information for the design of a larger clinical trial,” said Dr. Pascal Richette, Service de Rhumatologie, Hôpital Lariboisière, Paris, France.

The new data will be presented at the Osteoarthritis Research Society International (OARSI) World Congress Meeting in Liverpool, U.K., April 26-29. Poster Title: “Hyaluronan Derivative Hymovis® Increases Cartilage Volume and Type II Collagen Turnover in Osteoarthritis Knee: Data from MOKHA (MRI, BiOmarkers, Knee, Hymovis®, OsteoArthritis) Study” – Henrotin Y. et al.

About HYMOVIS®

HYMOVIS® is a highly viscoelastic non-crosslinked hydrogel bioengineered using a proprietary process that increases lubrication and shock absorption properties. This results in a natural hyaluronan similar to the hyaluronan found in the synovial fluid present in human joints. The formulation allows this unique molecule to recover its original structure, even after repetitive mechanical stress. Due to reversible hydrophobic interactions, the non-crosslinked HYMOVIS® has increased elasticity, viscosity and residence time in the joint.* Its unique molecular structure results in enhanced biomechanical properties and long-lasting efficacy, all in a convenient two-dose regimen.

*Preclinical studies may not be indicative of human clinical outcomes.

In Europe, HYMOVIS® is indicated for the treatment of pain in osteoarthritic joints and in the conservative treatment of the meniscal lesion of the knee and for the improvement of joint mobility through the enhancement of synovial fluid viscoelasticity.

In the U.S., HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics.

HYMOVIS® is contraindicated in patients with known hypersensitivity to hyaluronate preparations or gram-positive bacterial proteins or patients with infections/skin diseases in the area of the injection site/joint. The safety and effectiveness of HYMOVIS® has not been tested in pregnant women, nursing mothers or children. See package insert for full prescribing information including adverse events, warnings, precautions, and side effects at www.hymovis.com.

Rx Only. HYMOVIS® and HYADD®4 are registered trademarks of Fidia Farmaceutici S.p.A., Abano Terme, Italy. ©2018 Fidia Pharma USA Inc., Florham Park, N.J., a wholly owned subsidiary of Fidia Farmaceutici S.p.A. FID622-04.2018

About Fidia Farmaceutici

Fidia Farmaceutici is part of Fidia Pharma Group, an Italian multinational company, with R&D, manufacturing and sales capabilities, and an extensive product portfolio mainly based on natural and functionalized hyaluronic acid (over 650 patents), in joint care, wound healing, ophthalmology, aesthetics and regenerative medicine. Manufacturing operations are FDA-inspected and approved, and the company extends its global reach through wholly-owned subsidiaries and partners in 100 countries worldwide. For more information, please visit www.fidiapharma.com.

Contacts

For more information:
FIDIA FARMACEUTICI S.p.A.
Tel: (+39) 0498232111
info@fidiapharma.it
or
FIDIA PHARMA USA INC.
Carolyn Kong, 1-973-507-5120
info@fidiapharma.us

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