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December 6, 2018 OrthoSpineNews

SCHLIEREN (ZURICH), Switzerland, Dec. 06, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX: KURN) today announced the publication of data from a clinically-relevant preclinical model comparing MagnetOs with autologous bone in instrumented posterolateral spinal fusion in sheep. Utilizing multiple assessments for fusion, the study concluded that MagnetOs is a suitable alternative to autograft when used as a standalone graft.

The publication, which is entitled “Biphasic calcium phosphate with submicron surface topography in an Ovine model of instrumented posterolateral spinal fusion” was included in the December issue JOR Spine, an open-access Orthopaedic Research Society (ORS)journal.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “This latest study demonstrates early bone healing and physiologically-appropriate graft resorption for MagnetOs in this clinically-relevant model of posterolateral spinal fusion and adds to the growing body of evidence proving that MagnetOs is a reliable alternative to autologous bone graft.”

Professor Bill Walsh, University of New South Wales, Australia, who was principal investigator of the study said: “I’ve investigated many of the leading synthetic bone grafts in this model and, in my experience, MagnetOs leads to the most compelling fusion outcomes of all the grafts I’ve tested.”

About the study
MagnetOs Granules and MagnetOs Putty were implanted standalone and compared to autograft bone. Twenty-five adult, female Merino sheep underwent posterolateral spinal fusion at L2-3 and L4-5 levels with instrumentation. After 6, 12, and 26 weeks, outcomes were evaluated by manual palpation, range of motion testing, micro-computed tomography, histology and histomorphometry. Fusion assessment by manual palpation 12 weeks after implantation revealed 100% fusion rates in all treatment groups. Similarly, the three treatment groups showed a statistically significant decrease in lateral bending at the fusion levels at 12 weeks and 26 weeks compared to the 6-week time-point, which further confirmed spinal fusion. No significant differences in range of motion were observed between the treatment groups at any of the time-points investigated. Histological assessment at 12 weeks showed fusion rates of 75%, 92%, and 83% for autograft, MagnetOs Granules and MagnetOs Putty, respectively. The fusion rates were further increased 26 weeks post-implantation. Similar trends of bone growth were observed by histomorphometry.


For further information, please contact: 
Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47

Media & Investors
Hans Herklots
LifeSci Advisors
+41 79 598 7149

About MagnetOs
MagnetOs promotes local bone formation equivalent to current gold standard, autograft. 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.

US indications statement
MagnetOs is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs must be used with autograft as a bone graft extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure.

EU indications statement
MagnetOs is intended for use as bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. MagnetOs is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. MagnetOs is intended to be packed into bony voids or gaps of the skeletal system (i.e. extremities, spine, cranial, mandible, maxilla and pelvis) and may be combined with autogenous bone. MagnetOs should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously. In load bearing situations, MagnetOs is to be used in conjunction with internal or external fixation devices.

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 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.


December 6, 2018 OrthoSpineNews

Dec 05, 2018 (Heraldkeeper via COMTEX) — New York, December 05, 2018: The Global Spine Biologics Market is expected to exceed more than US$ 2.5 Billion by 2022, at a CAGR of 4.4% in the given forecast period.

The report covers detailed competitive outlook including the market share and company profiles of the key participants operating in the global market. Key players profiled in the report include DePuy Spine, Precision Spine, Medtronic, Stryker Corporation, Smith & Nephew Plc, Orthovita Inc., Zimmer Spine Inc., K2M, Nuvasive, Arthrex, Inc., DMP Spine, Alphatec Spine, Orthofix Holdings, RTI Surgical, Wright Medical Technology, Cesca Therapeutics, and Lattice Biologics. Company profile includes assign such as company summary, financial summary, business strategy and planning, SWOT analysis and current developments.

You Can Browse Full Research Report:

The Global Spine Biologics Market has been segmented as below:

The Global Spine Biologics Market is Segmented on the lines of By Product Analysis, By Surgery Analysis and By Regional Analysis. By Product Analysis this market is segmented on the basis of Bone graft substitutes, Platelet rich plasma (PRP), Bone grafts and Bone marrow aspirates concentrate (BMAC) therapy.

By Surgery Analysis this market is segmented on the basis of Anterior cervical discectomy and fusion (ACDF), Anterior lumbar interbody fusion (ALIF), Transforaminal lumbar interbody fusion (TLIF), Lateral lumbar interbody fusion (LLIF) and Other surgeries. By Regional Analysis this market is segmented on the basis of North America, Europe, Asia-Pacific and Rest of the World.

A biologic is a material which energetically alters its surrounding atmosphere and effects a change during a biological process. Spine biologics are used through spine fusion surgical procedure for the treatment of spinal defect includes wound, degenerative disc disease, tumors, and spinal cord injuries and wounds by stimulating bone expansion formation through inflammatory repair stage, stage and remodeling stage. Therefore flow in the quantity of spinal fusion surgeries has fueled the acceptance of biologics.

The scope of the report includes a detailed study of global and regional markets for Global Spine Biologics Market with the reasons given for variations in the growth of the industry in certain regions.

Reasons to Buy this Report:

1) Obtain the most up to date information available on all Global Spine Biologics Market.
2) Identify growth segments and opportunities in the industry.
3) Facilitate decision making on the basis of strong historic and forecast of Global Spine Biologics Market data.
4) Assess your competitor’s refining portfolio and its evolution.

The major driving factors of Global Spine Biologics Market are as follows:

  • Innovative technological advancements
  • Advantages of biologics include faster recovery, minimal postoperative time and ability to activate cellular expansion.
  • Demand of minimally invasive spine surgeries is growing
  • Increasing ageing population
  • Incidences of spinal disorders are raising
  • Newly developed spine treatment techniques and devices

The restraining factors of Global Spine Biologics Market are as follows:

  • Unfavorable reimbursement policy
  • High cost of bone grafts
  • Ethical issues associated to bone grafting procedures
  • Lack of professional expertise
  • Lack of patient awareness and knowledge

Request Sample Report from here:

Table of Contents


2 Research Methodology

3 Executive Summary

4 Market Overview

5 Spine Biologics Market, By Surgery Type

5.1 Introduction
5.2 Anterior Cervical Discectomy and Fusion (ACDF)
5.3 Posterior Lumbar Interbody Fusion (PLIF)
5.4 Transforaminal Lumbar Interbody Fusion (TLIF)
5.5 Anterior Lumbar Interbody Fusion (ALIF)
5.6 Lateral Lumbar Interbody Fusion (LLIF)
5.7 Others

6 Spine Biologics Market By Product Type

7 Spine Biologics Market, By Geography

8 Competitive Landscape

9 Company Profiles

9.1 Zimmer Holding, Inc.

9.2 Depuy Synthes

9.3 Medtronic, Inc. (U.S.)

9.4 Nuvasive, Inc.

9.5 Stryker Corporation

9.6 Orthofix International N.V.

9.7 K2M, Inc.

9.8 Exactech, Inc.

9.9 Wright Medical Technology, Inc.

9.10 Nutech

9.11 Arthrex, Inc.

9.12 X-Spine Systems, Inc. (Bacterin International Holdings, Inc.)


Other Related Market Research Reports:

Spinal Implants and Surgical Devices Market is Projected to Reach US$ 17 Billion By 2022

Spinal Implants Market is Expected to Exceed US$ 19.5 Billion by 2024

Spine Surgery Devices Market is Projected to Reach US$ 3 Billion by 2022

Media Contact

Company Name: Market Research Engine

Contact Person: John Bay


Phone: +1-855-984-1862

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The post Spine Biologics Market Share will Increase US$ 2.5 Billion by 2022 appeared first on Herald Keeper.

The MarketWatch News Department was not involved in the creation of the content.


December 4, 2018 OrthoSpineNews

December 04, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that it has resumed global distribution of its solid HA-based treatments, including HYALOFAST, a biodegradable, HA-based cartilage repair scaffold, after a voluntary, non-safety related recall in the second quarter of 2018. Following recent regulatory approvals in Thailand, the United Arab Emirates and Colombia, HYALOFAST has a commercial footprint in approximately 15 countries.

Since May, our quality and operations teams have worked tirelessly to get us back on line to resume shipments before the end of this year, and we’ve delivered on that promise,” said Joseph Darling, President and CEO, Anika Therapeutics. “We are excited to bring the benefits of these products back to the patients who need them. HYALOFAST, in particular, is a truly remarkable advancement in the treatment of cartilage defects due to its flexible minimally-invasive means of application and adaptive fit to individual patient needs. These features have led to an overwhelmingly positive physician response to the therapy and illustrate its significant advantages over traditional microfracture surgeries and conventional scaffolds.”

HYALOFAST is a non-woven, single-step, off-the-shelf, biodegradable HA-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. To date, the Company has seen HYALOFAST used to treat more than 15,000 patients internationally and has compiled strong eight-year patient follow-up data. HYALOFAST is pending regulatory submission in the United States and its FastTRACK Phase III trial is currently enrolling patients across the U.S. and Europe.

About Anika Therapeutics, Inc.

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


For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer

For Media Inquiries:
W2O Group
Sonal Vasudev, 917-523-1418


November 27, 2018 OrthoSpineNews

November 27, 2018

MINNEAPOLIS–(BUSINESS WIRE)–Regentis Biomaterials today announced that Twin Cities-based TRIA Orthopedics is the first in Minnesota to perform a procedure using the GelrinC™ implant to treat damaged articular cartilage causing knee pain. GelrinC (pronounced “gel-rin-cee”) is an investigational device being evaluated as a treatment to help the body regrow cartilage in the knee. TRIA is the only site in Minnesota – and just one of 17 sites nationwide – enrolling patients with knee pain caused by damaged knee cartilage in the SAGE clinical trial.

Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. Damage to the cartilage layer can be extremely painful for patients and is generally associated with sudden trauma. Surgical intervention is often required because of the limited capacity for cartilage to repair itself. The current standard of care is a procedure called microfracture, which involves making tiny holes in the bone underneath the damaged cartilage to stimulate the growth of new cartilage. However, the cartilage is more like scar tissue than the original hyaline cartilage; as a result, microfracture often provides only short-term relief and may require repeat surgeries.

“There are limited options for patients who continue to experience knee pain caused by damage to their articular cartilage,” said Dr. Brad Nelson, orthopedic surgeon. “The hope is that GelrinC, which requires only a single minimally invasive procedure, will promote repair of the cartilage and alleviate pain.”

People 18-50 years old with pain in one knee caused by damaged articular cartilage can inquire about the study by visiting or by calling (833) 430-8686.

About GelrinC™

In the U.S., GelrinC™ from Regentis Biomaterials is an investigational device for patients with articular cartilage damage in their knee. GelrinC’s unique mode of action allows it to be implanted as a liquid so that it completely fills the cartilage defect in the knee, and then be cured into a gel that enables the body’s own stem cells to settle on its surface. Six to 12 months after surgery, the GelrinC is gradually resorbed by the body and replaced by new cartilage tissue. Preliminary clinical trials in Europe have indicated that this regenerated tissue provides excellent improvement in pain and function. To learn more about GelrinC, please visit

About the SAGE Clinical Trial

The SAGE study is a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study comparing GelrinC to microfracture, the current standard of care treatment for damaged knee cartilage. The multi-center Phase III pivotal study will enroll 120 patients. All patients who meet study requirements and agree to enter the trial are provided GelrinC as treatment.

About Regentis Biomaterials

With offices in Princeton, New Jersey, and Or Akiva, Israel, Regentis Biomaterials is a privately held company focused on developing and commercializing proprietary hydrogels for tissue regeneration. The technology was originally developed at the Technion-Israel Institute of Technology by Dr. Dror Seliktar. For more information, please visit

CAUTION Investigational device. Limited by United States law to investigational use.


For media inquiries, please contact:
Joni Ramirez
Merryman Communications

Annelise Heitkamp
TRIA Orthopedics


November 26, 2018 OrthoSpineNews

COLUMBIA, Md., Nov. 26, 2018 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, is pleased to announce that its Board of Directors appointed Samson Tom, PhD, MBA to serve as President and Chief Executive Officer, effective November 26, 2018. Dr. Tom was at Osiris from 2003 to 2011, where he held several leadership positions spanning multiple functional areas including Quality, Operations, Clinical Development, and Product Development. Subsequently, he served as Group Director, Biosurgery Research & Development at Ethicon, Inc. (a Johnson & Johnson company). Prior to rejoining Osiris, he served as Vice President, Research & Development for Surgical Orthobiologics at Bioventus, LLC. Dr. Tom brings a strong combination of scientific and commercial experience in the regenerative medicine space. He earned a BA in Biology and Chemistry from Cornell University, a MS and PhD in Biochemistry from the University of Rochester School of Medicine and Dentistry, and a MBA in General Management from the Johns Hopkins University Carey Business School.

“Returning to Osiris definitely feels like coming home,” said Dr. Tom. “Developing and launching novel solutions to address unmet needs for patients and the medical community have always been at the core of Osiris. I am truly energized to continue this legacy and look forward to working with the entire team during the next phase in the evolution of this innovative company.”

“I am pleased to welcome Dr. Tom back to Osiris as President and CEO,” said Peter Friedli, Chairman of the Board. “At this important juncture for the company, Dr. Tom is a great fit due to his familiarity with our technologies and our culture of innovation. I look forward to working with him to achieve greater operational efficiency and future growth.”

Jason Keefer, who previously served as Interim President and Chief Executive Officer, will transition to lead the commercial functions of the organization and serve on the management team as Chief Commercial Officer.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, researches, develops, manufactures and commercializes regenerative medicine products intended to improve the health and lives of patients and lower overall healthcare costs.  We have achieved commercial success with products in orthopedics, sports medicine and wound care, including the Grafix product line, Stravix®, BIO and Cartiform®.  We continue to advance our research and development by focusing on innovation in regenerative medicine, including the development of bioengineered stem cell and tissue‑based products.  Osiris®, Grafix®, GrafixPL®, GrafixPL PRIME Cartiform®, and Prestige Lyotechnologysm are our trademarks. BIO is a trademark of Howmedica Osteonics Corp., a subsidiary of Stryker Corporation. More information can be found on the Company’s website, (OSIR-G)

Forward-Looking Statements

Statements herein relating to the future of Osiris Therapeutics, Inc. and the ongoing research and development of our products are forward-looking statements.  Osiris Therapeutics, Inc. cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements.  These risks and uncertainties include those identified under the heading “Risk Factors” in the Osiris Therapeutics Inc. Annual Report on Form 10-K for the years ended December 31, 2017, 2016 and 2015 and Quarterly Report on Form 10-Q for the quarters ended March 31, 2018, June 30, 2018 and September 30, 2018 as filed with the Securities and Exchange Commission (SEC).  We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.  Examples of forward-looking statements may include, without limitation, statements regarding the anticipated efficiencies and advantages of products and the likelihood of customer clinical adoption of any new products.  Although well characterized in scientific literature and studies, preservation of tissue integrity, including cells, may not be indicative of clinical outcome.  Accordingly, you should not unduly rely on these forward-looking statements. You are encouraged to read our filings with the SEC, available at, for a discussion of these and other risks and uncertainties.  The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements.  Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

For additional information, please contact:
Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1834


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

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

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

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

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

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



Photo Credit: Ecole Polytechnique Federale de Lausanne


November 21, 2018 OrthoSpineNews

November 21, 2018

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

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

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

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

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

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

About GraftGun

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

About ViBone

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

About SurGenTec

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

About Aziyo Biologics

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


Ricki Goldman
Phone: 561-990-7882


November 21, 2018 OrthoSpineNews

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

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

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

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

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

About Innovasis, Inc.

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

About Stability Biologics®

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

Innovasis Media Contact

Hayley Hendrix, 801-261-2236

Stability Biologics® Media Contact

Brian Martin, 615-921-5551


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

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

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

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


Emil Billbäck, CEO

+46 (0) 46 286 53 70

Håkan Johansson, CFO

+46(0) 46 286 53 70

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7638 9571


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


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

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

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

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

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

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

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

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

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

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

BONESUPPORT® and CERAMENT® are registered trademarks

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

 About Us

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at*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.


November 16, 2018 OrthoSpineNews

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

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

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

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

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

Media Contact 
Megan Duggan
720. 382. 2766

SOURCE AlloSource

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